0920-0573 - VARHS -variant, atypical, and resistant HIV Surveillance Data Elements

Adult and Pediatric HIV/AIDS Confidential Case Reports for National HIV/AIDS Surveillance

Attachment G VARHS

0920-0573 - VARHS -variant, atypical, and resistant HIV Surveillance Data Elements

OMB: 0920-0573

Document [pdf]
Download: pdf | pdf
Attachment E.

Form Instructions in Technical Guidance for HIV/AIDS
Surveillance Programs Volume II: Data Collection Resources and
Reporting. Centers for Disease Control and Prevention; 2006

Technical Guidance for
HIV/AIDS Surveillance
Programs
Volume II: Data Collection Resources
and Reporting

HIV Incidence and Case Surveillance Branch
Atlanta, Georgia

Technical Guidance for HIV/AIDS Surveillance Programs — Volume II: Data Collection Resources and Reporting

All material contained in this document is in the public domain and may be used and reprinted
without permission; citation of the source is, however, appreciated.

Suggested Citation
Centers for Disease Control and Prevention and Council of State and Territorial
Epidemiologists. Technical Guidance for HIV/AIDS Surveillance Programs, Volume II: Data
Collection Resources and Reporting. Atlanta, Georgia: Centers for Disease Control and
Prevention; 2006.
The document is available at http://www2a.cdc.gov/hicsb/.

ii

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Technical Guidance for HIV/AIDS Surveillance Programs — Volume II: Data Collection Resources and Reporting

Contents

Adult HIV/AIDS Confidential Case Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Instructions for Completion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Purpose of case report form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
The case report form in the context of document-based surveillance . . . . . . . . . 1-3
Patients for whom form is indicated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Definition of variable designators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Disposition of form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Section I, State/local use only (patient identifier information). . . . . . . . . . . . . . . . 1-4
Section II, Health department use only. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Section III, Demographic information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Section IV, Facility of diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Section V, Patient history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Section VI, Laboratory data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Section VII, State/local use only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Section VIII, Clinical status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Section IX, Treatment/services referrals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Section X, Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Appendix: Adult HIV/AIDS Confidential Case Report . . . . . . . . . . . . . . . . . . . . . . . 1-26
Section I, State/local use only (patient identifier information). . . . . . . . . . . . . . . 1-26
Section II, Health department use only. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
Section III, Demographic information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Section IV, Facility of diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35
Section V, Patient history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35
Section VII, State/local use only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36
Section VIII, Clinical status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-36
Section IX, Treatment/services referrals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-40
Pediatric HIV/AIDS Confidential Case Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Instructions for Completion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Purpose of case report form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
The case report form in the context of document-based surveillance . . . . . . . . . 2-3
Patients for whom form is indicated . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Definition of variable designators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Disposition of form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Section I, State/local use only (patient identifier information). . . . . . . . . . . . . . . . 2-4
Section II, Health department use only. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Section III, Demographic information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Section IV, Facility of diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
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Contents

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Technical Guidance for HIV/AIDS Surveillance Programs — Volume II: Data Collection Resources and Reporting

iv

Section V, Patient/maternal history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section VI, State/local use only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section VII, Laboratory data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section VIII, Clinical status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section IX, Birth history (Required for perinatal cases only). . . . . . . . . . . . . . .
Section X, Treatment/services referrals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section XI, Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-11
2-16
2-18
2-23
2-24
2-29
2-31

Appendix: Pediatric HIV/AIDS Confidential Case Report . . . . . . . . . . . . . . . . . . .
Purpose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pediatric Cases of Public Health Importance (COPHI) . . . . . . . . . . . . . . . . . . .
Section I, State/local use only (patient identifier information) . . . . . . . . . . . . . .
Section II, Health department use only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section III, Demographic information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section IV, Facility of diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section V, Patient/maternal history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section VI, State/local use only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section VII, Laboratory data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section VIII, Clinical status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section IX, Birth history (for perinatal cases only) . . . . . . . . . . . . . . . . . . . . . .
Section X, Treatment/services referrals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2-32
2-32
2-33
2-33
2-33
2-37
2-44
2-45
2-47
2-48
2-48
2-49
2-54

Contents

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Technical Guidance for HIV/AIDS Surveillance Programs — Volume II: Data Collection Resources and Reporting

Contributors
This document, Technical Guidance for HIV/AIDS Surveillance Programs, was developed
by the HIV Incidence and Case Surveillance Branch of the Division of HIV/AIDS
Prevention, National Center for HIV, STD, and TB Prevention, Centers for Disease Control
and Prevention in collaboration with the Council of State and Territorial Epidemiologists.
The CDC/CSTE Advisory Committee provided oversight and leadership throughout the
entire process. Workgroup contributors consisted of state and local health department
representatives. Irene Hall, CDC, and Eve Mokotoff, CSTE, led the development.
Members of the CDC/CSTE Advisory Committee
CDC: Pamela Gruduah, Irene Hall, Martha Miller
CSTE: Gordon Bunch, California; Dena Ellison, Virginia; Jim Kent, Washington; Eve
Mokotoff, Michigan; Stanley See, Texas
Chairs of Workgroups, CDC
Michael Campsmith, Data Analysis and Dissemination
Sam Costa, Security and Confidentiality
Irene Hall, Data Quality
Laurie Kamimoto, Electronic Reporting
Lata Kumar, Data Dictionary
Martha Miller, Overview
Kathleen McDavid, HIV Risk Factor Ascertainment
Ruby Phelps, Case Residency Assignment
Richard Selik, Death Ascertainment
Richard Selik, Record Linkage
Suzanne Whitmore, Perinatal and Pediatric Case Surveillance
CDC Contributors
Lori Armstrong, Mi Chen, Betsey Dunaway, John Gerstle, Kate Glynn, Irene Hall, Felicia
Hardnett, David Hurst, Jennie Johnston, Danielle Kahn, Tebitha Kajese, Laurie Kamimoto,
Kevin Lyday, Martha Miller, Andy Mitsch, Michelle Pan, Richard Selik, Amanda Smith,
Damien Suggs, Patricia Sweeney, Kimberly Todd, Will Wheeler, Suzanne Whitmore, Irum
Zaidi.
State and Local Health Department Contributors and Reviewers
Alabama: Anthony Merriweather, Danna Strickland; California-Los Angeles: Gordon
Bunch, Mi Suk Harlan, Virginia Hu, Ann Nakamura; California-San Francisco: Ling Hsu,
Maree Kay Parisi, Sandra Schwarcz; District of Columbia: Gail Hansen, Kompan
Ngamsnga; Florida: Becky Grigg, Lorene Maddox; Illinois-Chicago: Margarita Reina;
Indiana: Jerry Burkman; Iowa: Randy Mayer; Louisiana: Joseph Foxhood, Greg Gaines,
William Robinson, Debbie Wendell, Amy Zapata; Massachusetts: Maria Regina Barros;
Michigan: Elizabeth Hamilton, Nilsa Mack, Eve Mokotoff, Yolande Moore;
March 2006

Contributors

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Technical Guidance for HIV/AIDS Surveillance Programs — Volume II: Data Collection Resources and Reporting

Minnesota: Luisa Pessoa-Brandao, Tracy Sides; New Hampshire: Chris Adamski;
New Jersey: Wogayehu Afework, Linda Dimasi, Abdel Ibrahim, John Ryan; New York City:
Melissa Pfeiffer, Judy Sackoff; New York State: Alexa Bontempo, Kathleen Brousseau,
Donna Glebatis; Ohio: Sandhya Ramachandran; Oklahoma: Mark Turner; Pennsylvania:
Bonnie Krampe, Ming Wei; South Carolina: Dana Giurgiutiu; Texas: Thomas Barnabas,
Dianna Highberg, Roy Reyna, Stanley See, Jan Veenstra; Virginia: Dena Ellison;
Washington: Maria Courogen; Washington-Seattle & King County: Amy Bauer, Jim Kent;
Wisconsin: Loujean Steenberg.

vi

Contributors

March 2006

Technical Guidance for
HIV/AIDS Surveillance
Programs
Adult HIV/AIDS Confidential Case
Report

HIV Incidence and Case Surveillance Branch
Atlanta, Georgia

Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

Contents — Adult HIV/AIDS Confidential Case Report
Instructions for Completion ................................................................................ 1-3
Purpose of case report form .......................................................................... 1-3
The case report form in the context of document-based surveillance ........... 1-3
Patients for whom form is indicated............................................................... 1-3
Definition of variable designators .................................................................. 1-3
Disposition of form......................................................................................... 1-3
Section I, State/local use only (patient identifier information) ........................ 1-4
Section II, Health department use only.......................................................... 1-4
Section III, Demographic information ............................................................ 1-6
Section IV, Facility of diagnosis ..................................................................... 1-9
Section V, Patient history............................................................................. 1-10
Section VI, Laboratory data ......................................................................... 1-14
Section VII, State/local use only .................................................................. 1-18
Section VIII, Clinical status .......................................................................... 1-20
Section IX, Treatment/services referrals...................................................... 1-22
Section X, Comments .................................................................................. 1-25
Appendix: Adult HIV/AIDS Confidential Case Report
(CDC 50.42A/CDC 50.42C)............................................................1-26
Instructions for Completion.......................................................................... 1-26
Section I, State/local use only (patient identifier information).................. 1-26
Section II, Health department use only ................................................... 1-26
Report Source Codes for HIV/AIDS Reporting ................................... 1-26
Section III, Demographic information ...................................................... 1-29
Section IV, Facility of diagnosis............................................................... 1-35
Section V, Patient history ........................................................................ 1-35
Section VII, State/local use only .............................................................. 1-36
Section VIII, Clinical status...................................................................... 1-36
Section IX, Treatment/services referrals ................................................. 1-40

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

Technical Guidance for HIV/AIDS Surveillance Programs —
Adult HIV/AIDS Confidential Case Report
Instructions for Completion
Purpose of case report form
The Adult HIV/AIDS Confidential Case Report (CDC 50.42A/CDC 50.42C) form is
designed to collect information that promotes understanding of HIV infection and AIDS
morbidity and mortality among United States residents greater than or equal to 13
years of age at time of diagnosis. This form reflects data that should be collected; this
guidance applies to this data collection even if surveillance sites use a different form or
medium for HIV/AIDS case surveillance.
The case report form in the context of document-based surveillance
Unlike case-based data management, document-based data management allows all
documents to be stored and retained electronically in their original formats. Instead of
completing one form for a given reported case, fill out the applicable part of the form for
each data source contributing to that HIV or AIDS case.
Patients for whom form is indicated
•

Each person with an HIV (not AIDS) diagnosis.

•

Each person with an AIDS diagnosis.

•

When a previously reported HIV (not AIDS) patient progresses to AIDS or an
HIV-infected/AIDS patient dies, use this form to report the new information.

Definition of variable designators
•

Required: Variables that are required to meet the case definitions of HIV or
AIDS, to identify and track cases, and to do meaningful statistical analysis.

•

Recommended: Information that is useful for analysis but not essential for core
surveillance.

•

Optional: Information that should be ascertained if readily available.

Disposition of form
•

The completed form is for state or local health agency use and is not to be sent to
the Centers for Disease Control and Prevention (CDC) with patient identifiers.
Some sites send forms to CDC for data entry.

•

Data obtained from these forms are entered into compatible or standardized
computer software provided by the Division of HIV/AIDS Prevention, National

March 2006

Instructions for Completion

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

Center for HIV, STD, and TB Prevention, CDC, and then transferred without
identifiers to CDC electronically by encrypted computer diskette or electronic
transfer via secure data network.
Section I, State/local use only (patient identifier information)

Patient identifier information is for state/local health department use only and is not
transmitted to CDC. Enter the data below for all AIDS cases and, where consistent with
statutory requirements, HIV (not AIDS) cases. Consult with your state/local health
department in jurisdictions with alternatives to name-based reporting.
1.1

1.2

PATIENT’S NAME (Required, applies to Health Dept & Health Care Providers)
•

Enter patient’s last name, first name, and middle initial.

•

If available, write in a.k.a.s, aliases, etc. for later data entry. Record these
names in Section X, Comments.

PHONE NO. (Required if patient has a telephone, applies to Health Dept &
Health Care Providers)
•

Enter patient’s current home area code and telephone number.

1.3–1.7 ADDRESS (each element Required, applies to Health Dept & Health Care
Providers)
•

Enter patient’s current street number and name, city, county, state, and ZIP
code.

Section II, Health department use only

•
2.1

Nonhealth department staff only need to complete DATE FORM COMPLETED
and REPORT STATUS fields.
DATE FORM COMPLETED (Required, applies to Health Dept & Health Care
Providers)
•

1-4

Enter date in mmddyy format.

Instructions for Completion

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

2.2

2.3

2.4

March 2006

REPORT SOURCE (Required, applies to Health Dept)
•

Enter the code for reporting source that provided the information for this
report.

•

To clearly identify multiple data sources for a given HIV/AIDS case, use a
separate case report form for each source.

•

Since legal values now exceed two digits, enter code immediately below this
box.

•

If coding proves difficult, write in report source for later coding.

•

Refer to Appendix 2.2 for code information.

SOUNDEX CODE (Required in accordance with state/local law, applies to
Health Dept)
•

After patient name is recorded, CDC-supplied software generates this
variable by using the patient’s last name entered in Section I. Because this
code is automatically generated, health department staff may leave this field
blank on the form.

•

This variable is a phonetic, alphanumeric code calculated by converting a
surname into an index letter and a three-digit code. The index letter is the
first letter of the surname.

REPORT STATUS (Required, applies to Health Dept and Health Care
Providers). This variable does not exist in eHARS.
•

Select applicable response.

•

Select “New Report” if the patient is not already in the state registry with the
condition reported—HIV or AIDS.

•

Select “Update” for patients previously reported to the registry with either
condition—HIV or AIDS.

•

Health department staff establishes report status by searching the HIV/AIDS
registry for previous reports on a particular patient. Public providers without
access to the registry may request a record search from their jurisdiction’s
surveillance program.

•

Providers from the public and private sectors unable to establish status may
assume “New Report.” As the report is processed by surveillance staff, status
entered can be confirmed or corrected.

•

When additional information on a previously reported case of HIV infection
(not AIDS) becomes available, select “Update.”

•

When a patient has been previously reported with HIV infection (not AIDS)
and later receives an AIDS diagnosis, select “New Report.” From a
surveillance perspective, the occurrence of AIDS is reportable in all US
jurisdictions as an event independent of the occurrence of HIV infection (not
Instructions for Completion

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

AIDS). Progression to AIDS among previously reported HIV case patients
represents new reports of AIDS rather than an update of previously reported
HIV cases.
2.5

REPORTING HEALTH DEPARTMENT
2.5.1–2.5.2 STATE, CITY/COUNTY (each element Required, applies to Health
Dept)
•

2.6

2.7

Enter name of state, city, and county of the health department that
receives the report from providers of surveillance data.

STATE PATIENT NO. (Required where state numbers are used, applies to Health
Dept)
•

Enter the assigned state patient number.

•

Each patient should have a unique state number throughout the course of
HIV disease. An exception to this is when a case is transferred to another
state, where another state number may be assigned.

•

Assigned numbers should not be reused, even if the case is later deleted.

•

The precise format of this 10-digit character variable is unique to each state.

•

This variable is used, along with the state of report, to uniquely identify cases
reported to CDC and to merge the state datasets without duplication.

CITY/COUNTY NUMBER (Required where city numbers are used, applies to
Health Dept)
•

Enter the assigned city/county patient number.

•

Each patient should have a unique city/county number throughout the course
of HIV disease. An exception to this is when a case is transferred to another
city/county and/or state, where another city number may be assigned.

•

Assigned numbers should not be reused, even if the case is later deleted.

Section III, Demographic information

1-6

Instructions for Completion

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

3.1

DIAGNOSTIC STATUS AT REPORT (Required, applies to Health Dept &
Health Care Providers)
•

Select “HIV Infection (not AIDS)” if the patient meets the case definition for
HIV infection and does not meet the 1993 CDC AIDS surveillance case
definition.

•

Select “AIDS” if patient does meet the 1993 CDC AIDS surveillance case
definition.

•

A patient may meet the case definition for HIV infection only, the case
definition for AIDS only, or both. These diagnostic criteria may be met
simultaneously or sequentially.

•

Irrespective of the interval between HIV and AIDS diagnosis dates, and even
where the same source of these data reported both events, use one form to
capture each event. Fill out two case report forms:
•
•

3.2

3.3

•

This second form, referred to in preceding bulleted item, must include at
least the following data: DIAGNOSTIC STATUS AT REPORT; RESIDENCE
AT DIAGNOSIS (see 3.11, below); and Facility of diagnosis (see Section IV,
below).

•

Refer to Appendix 3.1 for details.

AGE AT DIAGNOSIS (Optional, applies to Health Dept & Health Care
Providers)
•

Enter two-digit age at diagnosis in years.

•

Where this age is unknown and therefore cannot be entered, CDC-supplied
software calculates it automatically from other required entries (date of birth
at 3.3 below, and a variety of laboratory and clinical fields at Section VI and
Section VIII below).

•

The investigator must know if the patient was at least 13 years old when HIV
or AIDS was diagnosed to determine whether to use the Adult case report
form (CDC 50.42A or CDC 50.42C).

DATE OF BIRTH (Required, applies to Health Dept & Health Care Providers)
•

3.4

March 2006

Fill out the first form completely for the first diagnosis.
Fill out the second partially, capturing additional or updated data absent
from the first form.

Enter patient’s month, day, and year of birth.

CURRENT STATUS (Required, applies to Health Dept & Health Care
Providers)
•

Select applicable response.

•

For further guidance on death ascertainment, see CDC’s Technical Guidance
for HIV/AIDS Surveillance Programs, Volume I: Policies and Procedures,
Death Ascertainment.
Instructions for Completion

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

3.5

3.6

DATE OF DEATH (Required if applicable, applies to Health Dept & Health
Care Providers)
•

If patient is deceased, enter date of death.

•

For further guidance on death ascertainment, see CDC’s Technical Guidance
for HIV/AIDS Surveillance Programs, Volume I: Policies and Procedures,
Death Ascertainment.

STATE/TERRITORY OF DEATH (Recommended if applicable, applies to
Health Dept & Health Care Providers)
•

3.7

3.8

3.9

If patient is deceased, enter the state/territory where death occurred.

SEX (Required, applies to Health Dept & Health Care Providers)
•

Select patient’s sex at birth.

•

“CURRENT_GENDER” and “CURRENT_SEX” are optional fields
appearing in new CDC-supplied software but not on the case report form.

•

Refer to Appendix 3.7 for further details.

ETHNICITY (Required, applies to Health Dept & Health Care Providers)
•

Select applicable response.

•

If no ethnicity information is available, select “Unk.”

•

Do not choose “Unk.” unless search for this datum was unsuccessful.

•

Refer to Appendix 3.8 for further details.

RACE (Required, applies to Health Dept & Health Care Providers)
•

Select patient’s race even if information was submitted for ethnicity.

•

Select more than one race if applicable.

•

If no race information is available, select “Unk.”

•

Refer to Appendix 3.9 for further details.

3.10 COUNTRY OF BIRTH (Recommended, applies to Health Dept & Health Care
Providers)
•

Select applicable response from boxes provided.

•

Refer to Appendix 3.10 for legal values when dependency or country is to be
specified.

3.11 RESIDENCE AT DIAGNOSIS (each element Required, applies to Health Dept
& Health Care Providers)
•

1-8

Enter city, county, state/country, and ZIP code of patient’s residence at first
diagnosis with HIV or AIDS-defining clinical condition.

Instructions for Completion

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

•

The home address given by the patient at the time of HIV and/or AIDS
diagnosis usually populates these fields.

•

Refer to Appendix 3.11 for further details.

Section IV, Facility of diagnosis

The facility of diagnosis in this section should be for the diagnosis selected in the
DIAGNOSTIC STATUS AT REPORT box in Section III (3.1).
4.1

4.2

FACILITY NAME (Required, applies to Health Dept & Health Care Providers)
•

Enter name of the facility where patient first received a diagnosis of HIV or
AIDS.

•

If HIV and AIDS diagnoses occurred at different facilities, enter name of
each on separate forms, specifying which diagnosis occurred at which
facility.

•

Refer to Appendix 4.1 for further details.

CITY (Required, applies to Health Dept & Health Care Providers)
•

4.3

STATE/COUNTRY (Required, applies to Health Dept & Health Care Providers)
•

March 2006

Enter city name where facility of diagnosis is located.

Enter state and country name where facility of diagnosis is located.

Instructions for Completion

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

4.4

4.5

FACILITY SETTING (Recommended, applies to Health Dept & Health Care
Providers)
•

Select setting of patient’s HIV or AIDS diagnosis.

•

“Private” typically includes doctor’s offices or clinics not affiliated with a
health department.

•

“Public” includes public clinics, hospitals, or county/state correctional
institutions.

•

“Federal” includes Department of Veterans’ Affairs medical centers, military
clinics, and federal correctional institutions.

•

Refer to Appendix 4.4 for further details.

FACILITY TYPE (Recommended, applies to Health Dept & Health Care
Providers)
•

Select applicable response corresponding to the type of facility where patient
received HIV/AIDS diagnosis.

•

Refer to Appendix 4.5 for further details.

Section V, Patient history

•

1-10

The form’s direction to limit recording of risk factors to those occurring after 1977
is obsolete. Collect data about the risk factors that occurred before the first positive
HIV test or AIDS diagnosis. See Technical Guidance for HIV/AIDS Surveillance
Programs, Volume 1: Policies and Procedures, Risk Factor Ascertainment,
Epidemiologic follow-up.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

•

These data yield information about how patients may have acquired their
infections.

•

Respond to each risk factor, selecting “Yes” for all factors that apply; “No” for
those that do not apply, i.e., only select “No” if medical record specifically states
this is not a risk factor; and “Unk.” for those for which investigation failed to yield
an answer.

•

Record updates as additional risk factor information is obtained. For example, if
the patient received a blood transfusion after the documentation of HIV infection,
do not enter that information on the form.

•

If brief instructions in 5.1–5.8 are insufficient, see Appendix Section V for further
guidance about how to ascertain risk factor information. See Technical Guidance
for HIV/AIDS Surveillance Programs, Volume 1: Policies and Procedures, Risk
Factor Ascertainment for further guidance on HIV risk factor ascertainment,
relevant definitions, and clarification of risk factors.

5.1

5.2

SEX WITH MALE (Required, applies to Health Dept & Health Care Providers)
•

Select applicable response.

•

Abstractor may presume “Yes” for this risk factor among males as
anatomical site of sexually transmitted disease (STD) infection suggests. For
example, the presence of rectal gonorrhea in a male patient suggests a history
of receptive anal intercourse.

SEX WITH FEMALE (Required, applies to Health Dept & Health Care
Providers)
•

5.3

INJECTED NONPRESCRIPTION DRUGS (Required, applies to Health Dept &
Health Care Providers)
•

5.4

March 2006

Select applicable response.

Select applicable response.

RECEIVED CLOTTING FACTOR (Required, applies to Health Dept & Health
Care Providers)
•

“Coagulation disorder” or “hemophilia” refers only to a disorder of a clotting
factor; factors are any of the circulating proteins named Factor I through
Factor XII. These disorders include Hemophilia A and Von Willebrand’s
disease (Factor VIII disorders) and Hemophilia B (a Factor IX disorder).

•

Select applicable response.

•

This risk factor is generally documented in the history and physical section
of the patient’s medical chart.

•

If “Yes” to “Other” disorder, specify the disorder.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

5.5

HETEROSEXUAL RELATIONS WITH ANY OF THE FOLLOWING: This
section, addressed at 5.5.1–5.5.6, relates to ascertainment of risk among
heterosexual sex partners of the case patient.
5.5.1 INTRAVENOUS/INJECTION DRUG USER (Required, applies to
Health Dept & Health Care Providers)
•

Select applicable response.

5.5.2 BISEXUAL MALE (Required, applies to Health Dept & Health Care
Providers)
•

Applies only to female cases.

•

Select applicable response.

5.5.3 PERSON WITH HEMOPHILIA/COAGULATION DISORDER
(Required, applies to Health Dept & Health Care Providers)
•

“Coagulation disorder” or “hemophilia” refers only to a disorder of a
clotting factor, which is any of the circulating proteins named Factor
I, Factor II, Factor III, etc., through Factor XII. These disorders
include Hemophilia A and Von Willebrand’s disease (Factor VIII
disorders) and Hemophilia B (a Factor IX disorder).

•

They do not include other bleeding disorders, such as
thrombocytopenia, treatable by platelet transfusion.

•

If only a transfusion of platelets, other blood cells, or plasma was
received by the partner, then select “No.”

•

Select “Yes” for the field labeled 5.5.4 about transfusion recipient if
the partner was also known to be HIV infected.

•

Refer to Protocol for Evaluation of Identification and Follow-up of
Cases of Public Health Importance at
http://www2a.cdc.gov/hicsb/docs/COPHI_Protocol.pdf for more
information.

5.5.4–5.5.5 TRANSFUSION RECIPIENT WITH DOCUMENTED HIV
INFECTION—TRANSPLANT RECIPIENT WITH DOCUMENTED
HIV INFECTION (Required, applies to Health Dept & Health Care
Providers)

1-12

•

Select applicable response.

•

Consider documenting the reason for transfusion/transplant in the
Comments section.

•

Refer to Appendix 5.5.3 for further details.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

5.5.6 PERSON WITH AIDS OR DOCUMENTED HIV INFECTION, RISK
NOT SPECIFIED (Required, applies to Health Dept & Health Care
Providers)
•
5.6

Select “Yes” only if HETEROSEXUAL sex partner is known to be
HIV positive and that partner’s risk factor for HIV is unknown.

RECEIVED TRANSFUSION OF BLOOD/BLOOD COMPONENTS (OTHER
THAN CLOTTING FACTOR) (Required, applies to Health Dept & Health Care
Providers)
•

‘Blood,’ according to http://cancerweb.ncl.ac.uk/cgi-bin/omd?blood, is
defined as a circulating tissue composed of a fluid portion (plasma) with
suspended formed elements (red blood cells, white blood cells, platelets).

•

‘Blood components’ that can be transfused, according to
http://cancerweb.ncl.ac.uk/cgi-bin/omd?blood, include erythrocytes,
leukocytes, platelets, and plasma.

•

If “Yes,” specify month and year of first and last transfusions before
occurrence of patient’s HIV diagnosis.

•

It is often helpful to document the reason for the transfusion in the
Comments section.

5.7 RECEIVED TRANSPLANT OF TISSUE/ORGANS OR ARTIFICIAL
INSEMINATION (Required, applies to Health Dept & Health Care Providers)
•

Select applicable response.

•

Alert the state/local cases of public health importance (COPHI) coordinator.

5.8 WORKED IN HEALTH CARE OR CLINICAL LABORATORY SETTING
(Required, applies to Health Dept & Health Care Providers)

March 2006

•

Select applicable response.

•

If “Yes,” specify setting.

•

Investigate apparent occupational exposures to determine if this was the only
risk factor present.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

Section VI, Laboratory data

•

“TEST DATE” refers to the specimen collection date rather than the analysis or
report date.

•

If search for either or both of these data was unsuccessful, then enter “..” for
unknown month or year of “TEST DATE.”

•

In the presence of lab tests, record them all.

•

Include all diagnostic and CD4 tests where possible. Where number of tests
exceeds the number of fields available on the form, record such results in the
Comments section for later data entry.

•

In the absence of lab tests, record HIV or AIDS diagnostic evidence documented
in the chart by a physician.

•

If the following brief instructions for recording HIV-related tests are insufficient,
see Technical Guidance for HIV /AIDS Surveillance Programs, Volume I: Policies
and Procedures, Electronic Reporting, HIV and HIV-associated Laboratory Tests.

6.1

HIV ANTIBODY TESTS AT DIAGNOSIS
•

Enter results and test dates for first positive HIV antibody tests.

•

Assuming active case finding, review patient’s chart and lab reports for the
earliest date of documented HIV positivity.

•

“Ind.” refers to Indeterminate HIV antibody test results.

6.1.1 HIV-1 EIA (each element Required, applies to Health Dept & Health
Care Providers)

1-14

•

Enter result and date of first HIV-1 EIA, including rapid tests.

•

“Positive EIA” means repeatedly reactive tests on a single sample.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

6.1.2 HIV-1/HIV-2 COMBINATION EIA (each element Required, applies to
Health Dept & Health Care Providers)
•

Enter result and collection date of first HIV-1/HIV-2 combination EIA
test.

•

If tests indicate HIV-1 or HIV-2 results separately, please specify the
results as given in the laboratory report.

6.1.3 HIV-1 WESTERN BLOT/IFA (each element Required, applies to Health
Dept & Health Care Providers)
•

Enter result and collection date of first HIV-1 Western blot/IFA.

6.1.4 OTHER HIV-1 ANTIBODY TEST (each element Required, applies to
Health Dept & Health Care Providers)

6.2

•

If HIV-1 tests other than those at 6.1.1–6.1.3 were employed, specify
the type of test performed.

•

Enter result and collection date.

POSITIVE HIV DETECTION TEST (each element Required, applies to Health
Dept & Health Care Providers)
•

Select applicable response corresponding to earliest positive detection test.

•

These are all qualitative tests.

•

All varieties of such tests establish the presence of the pathogen, HIV. By
contrast, HIV tests such as the EIA or Western blot establish the presence of
our immune systems’ response to the pathogen—HIV antibodies.

6.2.1 CULTURE (Required, applies to Health Dept & Health Care Providers)
•

Enter result and collection date of earliest test by culture.

•

HIV culture tests cannot distinguish between HIV-1 and HIV-2.

6.2.2 ANTIGEN (Required, applies to Health Dept & Health Care Providers)
•

Enter result and collection date of earliest antigen test. Antigens are
the virus’s own proteins; such tests are specific for these proteins.

•

HIV antigen detection tests include Abbott HIVAG-1 Monoclonal and
Coulter HIV-1 p24 Antigen ELISA Test System.

6.2.3 PCR, DNA, OR RNA PROBE (Required, applies to Health Dept &
Health Care Providers)

March 2006

•

Enter result and date of earliest test by these methods.

•

The most commonly used DNA PCR test is Amplicor/COBAS HIV-1
DNA.
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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

•

The most commonly used RNA PCR test is Procliex RNA test.

•

Enter type of HIV detection test in the space provided, and result and
date by this other method.

6.2.4 OTHER (SPECIFY) (each element Required, applies to Health Dept &
Health Care Providers)

6.3

•

Enter type of HIV detection test in the space provided, and result and
date by this other method.

•

Other assays and their equivalents are any in-house HIV virus
detection tests that are not FDA approved.

DETECTABLE VIRAL LOAD
•

These are all quantitative tests.

•

Enter results in units of copies per milliliter (mL).

•

Enter the month and year test was performed.

•

Viral load tests with undetectable results should also be entered here. See
6.3.2, below.

6.3.1 TEST TYPE (each element Required, applies to Health Dept & Health
Care Providers)
•

Enter test type.

•

Two-digit codes are “11” = NASBA; “12” = RT-PCR; “13” = bDNA;
“18” = other.

•

Enter “19” for unspecified test type.

6.3.2 COPIES/ML (each element Required, applies to Health Dept & Health
Care Providers)
•

Enter result in units of viral copies per milliliter.

•

Where detectable results are reported with log data only, enter
“greater than detection limits for this assay” under the copies/mL
field.

•

Because undetectable results are typically reported as below the
detection limits of the assay rather than by a specific quantitative
value, enter “fewer than detectable by this assay” under the
copies/mL field.

6.3.3 TEST DATE (Required, applies to Health Dept & Health Care
Providers)

1-16

•

Enter the date the specimen was collected.

•

Do not confuse this date with the date the test was run or reported.
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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

6.4

6.5

DATE OF LAST DOCUMENTED HIV-NEGATIVE TEST (SPECIFY TYPE)
(Required if available, applies to Health Dept & Health Care Providers)
•

Enter type of test and specimen collection date.

•

A negative HIV test result does not necessarily represent absence of
infection. Because antibody tests such as the HIV-ELISA are the standard
means of screening for HIV infection, the test type specified in this field is
typically an antibody test. Additionally, HIV-2 infection would be missed by
assays specific to detection of HIV-1 antibodies; such case reports could
include a previous HIV-1 negative antibody test result here. By contrast,
other HIV tests, such as those measuring viral load, are typically ordered for
patients already known to be infected; so these are not included here.

•

Patient self report of last negative test is not considered “documented” and
thus should not be entered in this field.

IF HIV LABORATORY TESTS WERE NOT DOCUMENTED, IS HIV
DIAGNOSIS DOCUMENTED BY A PHYSICIAN? (Required if applicable,
applies to Health Dept & Health Care Providers)
•

Select applicable response.

•

If laboratory evidence of an HIV test is unavailable in the patient’s medical
or other record and written documentation of lab evidence of HIV infection
consistent with the HIV case definition is noted by the physician, enter
“Yes”; otherwise enter “No” or “Unk.”

6.5.1 IF “YES” (TO 6.5) PROVIDE DATE OF DOCUMENTATION BY
PHYSICIAN (Required in the absence of lab results, applies to Health
Dept & Health Care Providers)

6.6

March 2006

•

If antibody tests are not available in chart, enter date that physician
diagnosed or first knew about patient’s HIV infection.

•

Record the date on which physician accepts and notes patient’s
diagnosis of HIV infection. Do not record earlier date stated by the
patient.

IMMUNOLOGIC LAB TESTS
•

If both CD4 count and percent are available, record both.

•

Enter test date corresponding to the reported CD4 test result. Test date =
specimen collection date.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

6.6.1 CD4 COUNT AT OR CLOSEST TO CURRENT DIAGNOSTIC STATUS
6.6.1.1 CD4 COUNT (Required, applies to Health Dept & Health
Care Providers)
•

For HIV reports, record the CD4 count closest to the time
patient was determined to be HIV infected.

•

If this information is not available when the initial case
report is completed, it may be entered later.

•

For AIDS reports, record the CD4 count with date at or
closest to the date of AIDS diagnosis. This AIDS diagnosis
date is typically the date on which an AIDS-defining illness
is diagnosed or the specimen collection date of a CD4 count
< 200 cells/µL.

6.6.1.2 CD4 PERCENT (Required, applies to Health Dept & Health
Care Providers)
•

For HIV reports, record the CD4 percent with date at or
closest to the date of HIV diagnosis.

•

For AIDS reports, record the CD4 percent at or closest to the
time that an AIDS-defining clinical condition was first
diagnosed. This AIDS diagnosis date is typically the date on
which an AIDS-defining illness is diagnosed or the specimen
collection date of a CD4 count < 200 cells/µL.

6.6.2 CD4 COUNT (FIRST < 200 cells/µL or < 14%)
6.6.2.1 CD4 COUNT (Required if available, applies to Health Dept &
Health Care Providers)
•

Enter results and specimen collection date of first CD4 < 200
cells/µL.

6.6.2.2 CD4 PERCENT (Required if available, applies to Health Dept
& Health Care Providers)
•

Record results and specimen collection date of first CD4 <
14%.

Section VII, State/local use only

Physician identifier information is supplied in this section.
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7.1

7.2

7.3

7.4

7.5

PHYSICIAN’S NAME (Required, applies to Health Dept & Health Care
Providers)
•

For HIV infection reports, enter name of physician who ordered the test.

•

For AIDS case reports, enter name of physician medically managing patient.

•

Refer to Appendix 7.1 for further guidance.

PHONE NUMBER (Required, applies to Health Dept & Health Care Providers)
•

Enter phone number of physician named at 7.1, above.

•

If no physician is named, enter phone number of the facility of diagnosis.

MEDICAL RECORD NUMBER (Required, applies to Health Dept & Health
Care Providers)
•

Enter medical record number of the patient if available.

•

Refer to Appendix 7.3 for further guidance.

HOSPITAL/FACILITY (Required, applies to Health Dept & Health Care
Providers)
•

Enter the name of the facility where the report originated.

•

If this report is generated from a laboratory report of HIV infection, the
laboratory slip should contain the name of the facility where the specimen
was collected.

PERSON COMPLETING FORM (Required, applies to Health Dept & Health
Care Providers)
•

7.6

PHONE NUMBER (Required, applies to Health Dept & Health Care Providers)
•

March 2006

Enter the name of the person completing the form who can be contacted to
clarify entries and supply additional information.

Enter the telephone number of the person completing the form.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

Section VIII, Clinical status

8.1

CLINICAL RECORD REVIEWED (Recommended, applies to Health Dept &
Health Care Providers)
•

8.2

The person recording data in the form’s Clinical status section either
reviewed the patient’s medical chart or they did not do so. Select applicable
response.

ENTER DATE PATIENT WAS DIAGNOSED AS (Recommended, applies to
Health Dept & Health Care Providers)
•

If a year is present but search for month was unsuccessful, then enter “..” for
the unknown month, followed by the documented year.

8.2.1 ASYMPTOMATIC (including acute retroviral syndrome)
(Recommended, applies to Health Dept & Health Care Providers)

1-20

•

This category includes HIV-positive patients with no HIV-related
symptoms, with acute retroviral illnesses, or with persistent
generalized lymphadenopathy (PGL).

•

Enter date of patient’s evaluation.

•

Refer to Appendix 8.2.1 for further guidance.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

8.2.2 SYMPTOMATIC (not AIDS) (Recommended, applies to Health Dept &
Health Care Providers)

8.3

•

This category includes HIV-positive patients with symptoms
attributable to HIV infection other than acute illness or persistent
generalized lymphadenopathy (PGL).

•

Enter date of evaluation.

•

Refer to Appendix 8.2.2 for a list of conditions in this category.

AIDS INDICATOR DISEASES
8.3.1–8.3.26 (Recommended, applies to Health Dept & Health Care
Providers)
•

Select all that apply and enter diagnosis dates.

•

If search for month of “Initial Date” was unsuccessful, then enter “..”
for unknown month.

•

Definitive diagnoses are based on specific laboratory methods such as
histology or culture.

•

Presumptive diagnoses are made by the clinician based on
history/observations.

•

Refer to Appendix 8.3.1–8.3.26 for further details.

8.3.27 RVCT CASE NUMBER (Recommended if applicable, applies to Health
Dept)
•

8.4

March 2006

If this patient has a verified case of tuberculosis (TB), health
department staff enter the nine-digit alphanumeric code from the TB
case report or TB data management system. Providers in the private
and public sectors diagnosing tuberculosis in their AIDS patients may
get this number from TB surveillance staff.

IF TESTS WERE NOT POSITIVE OR WERE NOT DONE, DOES THIS
PATIENT HAVE AN IMMUNODEFICIENCY THAT WOULD DISQUALIFY
HIM/HER FROM THE AIDS CASE DEFINITION? (Required if applicable,
applies to Health Dept & Health Care Providers)
•

Select applicable response.

•

Refer to Appendix 8.4 for causes of disqualifying immunodeficiency.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

Section IX, Treatment/services referrals

This section should be completed by the person initially notifying the health department
of the HIV/AIDS case. Where health department staff populated fields in the
Treatment/Services Referrals section through chart abstraction, providers of surveillance
data may defer this task to public health workers.
9.1

9.2

HAS THIS PATIENT BEEN INFORMED OF HIS/HER HIV INFECTION?
(Optional, applies to Health Dept & Health Care Providers)
•

Select applicable response.

•

If notification is not documented, select “Unk.” unless the person completing
the form knows with certainty that the patient is aware of the infection.

THIS PATIENT’S PARTNERS WILL BE NOTIFIED ABOUT THEIR HIV
EXPOSURE AND COUNSELED BY (Optional, applies to Health Dept & Health
Care Providers)
•

9.3

Select applicable response.

THIS PATIENT IS RECEIVING OR HAS BEEN REFERRED FOR
•

Select “Yes” even if patient has yet to actually receive such services.

9.3.1 HIV-RELATED MEDICAL SERVICES (Recommended, applies to
Health Dept & Health Care Providers)
•

Select applicable response.

9.3.2 SUBSTANCE ABUSE TREATMENT SERVICES (Recommended,
applies to Health Dept & Health Care Providers)
•

1-22

Select applicable response.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

9.4

THE PATIENT RECEIVED OR IS RECEIVING
9.4.1 ANTIRETROVIRAL THERAPY (Recommended, applies to Health Dept
& Health Care Providers)
•

Select applicable response.

•

For list of antiretroviral therapies currently available and link to
treatment guidelines, refer to Appendix 9.4.1.

9.4.2 PCP PROPHYLAXIS (Recommended, applies to Health Dept & Health
Care Providers)

9.5

•

Select applicable response.

•

Examples of PCP prophylaxis include
Trimethoprim/sulfamethoxazole (TMP/SMX, Bactrim, Septra),
Pentamidine, and Dapsone.

THIS PATIENT HAS BEEN ENROLLED AT
9.5.1 CLINICAL TRIAL (Recommended, applies to Health Dept & Health
Care Providers)
•

Select applicable response, according to whether patient is enrolled in
a clinical trial that is sponsored by the National Institutes of Health
(NIH) or enrolled in a clinical trial sponsored by another organization.

9.5.2 CLINIC (Recommended, applies to Health Dept & Health Care
Providers)
•

9.6

9.7

Select applicable response according to whether patient is enrolled at
a clinic, particularly if that clinic is sponsored by the Health
Resources and Services Administration (HRSA).

THIS PATIENT’S MEDICAL TREATMENT IS PRIMARILY REIMBURSED
THROUGH (Recommended, applies to Health Dept & Health Care Providers)
•

Select applicable response.

•

Look for this information on the face sheet of patient’s chart.

FOR WOMEN
9.7.1 THIS PATIENT IS RECEIVING OR HAS BEEN REFERRED FOR
GYNECOLOGICAL OR OBSTETRICAL SERVICES (Recommended,
applies to Health Dept & Health Care Providers)
•

March 2006

Select applicable response.

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9.7.2 IS THIS PATIENT CURRENTLY PREGNANT? (Required, applies to
Health Dept & Health Care Providers)
•

Select applicable response. Response is dependent on which date was
selected for populating the field described at 2.1 above, Date form
completed. If patient was pregnant on that date, select “Yes.”

9.7.3 HAS THIS PATIENT DELIVERED LIVE-BORN INFANTS?
(Recommended, applies to Health Dept & Health Care Providers)

9.8

•

Select applicable response.

•

If “Yes” (disregard reference to delivery after 1977), provide birth
information for the most recent birth as described at 9.8, below.

•

Information on additional or multiple births can be recorded in
Section X, Comments.

CHILD’S DATE OF BIRTH (Recommended, applies to Health Dept & Health
Care Providers)
•

Enter child’s month, day, and year of birth.

•

Child to whom field refers is from the most recent birth (disregard reference
to delivery after 1977) as discussed at 9.7.3, above.

9.9–9.11 HOSPITAL OF BIRTH (Recommended, applies to Health Dept & Health
Care Providers)
•

Enter the name, city, and state of the hospital where the child described at
9.7–9.8 above was born.

•

If the child was born at home, enter “home birth.”

9.12 CHILD’S SOUNDEX (Recommended, applies to Health Dept)
•

To be completed by state/local health department personnel.

•

Refers to child described at 9.7–9.11, above.

•

Retrieve soundex from the HIV/AIDS registry (database) and enter here if
child’s name was previously entered in your database and a State No. exists.

•

If child’s name has not been entered yet, enter name and date of birth
information in the CDC-provided software. This software will convert
child’s surname to a soundex code.

9.13 CHILD’S STATE PATIENT NO. (Optional, applies to Health Dept)

1-24

•

To be completed by state/local health department personnel.

•

Refers to child described at 9.7–9.12, above.

•

This number is typically assigned by state/local health department personnel
if the child is known to have received a diagnosis of “confirmed HIV
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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

infection (not AIDS)” or “AIDS.” Some states also assign numbers for
children classified as “Perinatally HIV Exposed” or “Seroreverter.”
Section X, Comments

•

This section can be used for information not requested on the form. For example,
surveillance staff may document investigative progress toward ascertainment of
risk factor information.

•

If city or facility of treatment in another state is known, record these data on as
many case report forms (CRFs) as there are facilities. Each facility represents a
separate information source.

March 2006

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

Appendix: Adult HIV/AIDS Confidential Case Report
(CDC 50.42A/CDC 50.42C)
Instructions for Completion
Section I, State/local use only (patient identifier information)
Although Social Security number is not a field appearing on the 50.42A/50.42C, it is
useful as a patient identifier.
Section II, Health department use only
2.2

REPORT SOURCE
•

If “Other database,” “Other Clinic,” “Other,” or “Out of state” is selected,
specify source in Section X, Comments.

•

Two-level codes for report source are shown below. The first level of source
code is required, and the second level is recommended.

Report Source Codes for HIV/AIDS Reporting
First level source 

Second (more detailed) level source 

A01. = Inpatient

A01.01 = IP/Acute care facility
A01.01.02 = IP/ACF/OBGYN records
A01.01.03 = IP/ACF/Pediatric records
A01.01.04 = IP/ACF/Birth records
A01.02 = IP/VA
A01.03 = IP/Military hospital
A01.03.02 = IP/Military/OBGYN records
A01.03.03 = IP/Military/Pediatric records
A01.04 = IP/Long-term care facility
A01.04.03 = IP/LTCF/Drug TX program
A01.05 = IP/Hospice

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First level source 

Second (more detailed) level source 

A02. = Outpatient

A02.01 = OP/HMO
A02.02 = OP/VA
A02.03 = OP/Private physician
A02.04 = OP/Adult HIV Clinic
A02.05 = OP/Infect. Dis. Clinic
A02.06 = OP/County HD clinic
A02.07 = OP/Maternal HIV clinic
A02.08 = OP/Prenatal clinic or records
A02.09 = OP/Pediatric HIV clinic
A02.10 = OP/OBGYN clinic (not HIV related)
A02.11 = OP/Pediatric clinic
A02.12 = OP/TB clinic
A02.14 = OP/IHS clinic
A02.15 = OP/Early intervention nurse
A02.16 = OP/Visiting nurse service
A02.17 = OP/Hemophilia TX clinic
A02.18 = OP/Hospice
A02.19 = OP/Drug TX center
A02.20 = OP/Rehab center
A02.25 = OP/Other clinic

A03. = Emergency room

A03 = Emergency room

A04. = Screening, diagnosis, and A04.01 = Scr, Dx, Ref/Blood bank
referral agencies
A04.02 = Scr, Dx, Ref/Drug TX program
A04.03 = Scr, Dx, Ref/Family planning clinic
A04.04 = Scr, Dx, Ref/HIV case management agency
A04.05 = Scr, Dx, Ref/HIV counseling & testing site
A04.06 = Scr, Dx, Ref/Immigration report
A04.07 = Scr, Dx, Ref/Insurance report
A04.08 = Scr, Dx, Ref/Job Corps
A04.09 = Scr, Dx, Ref/Military
A04.10 = Scr, Dx, Ref/Partner referral & counseling
service
A04.11 = Scr, Dx, Ref/STD clinic

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First level source 

Second (more detailed) level source 

A05. = Laboratory

A05.01 = Lab/hosp.
A05.02 = Lab/state
A05.03 = Lab/private

A06. = Other databases

A06.01 = Other DB/ADAP
A06.02 = Other DB/ASD
A06.03 = Other DB/Birth certificate
A06.04 = Other DB/Birth defects registry
A06.05 = Other DB/Cancer registry
A06.06 = Other DB/Database from coroner
A06.07 = Other DB/Death certificate review
A06.08 = Other DB/EHRAP database
A06.09 = Other DB/EPS database
A06.10 = Other DB/HARS database
A06.11 = Other DB/Health department records
A06.12 = Other DB/Hepatitis registry
A06.13 = Other DB/Hosp billing summary or
discharge data
A06.14 = Other DB/HRSA HIV Care database
A06.15 = Other DB/Immunization registry
A06.16 = Other DB/Medicaid records
A06.17 = Other DB/NDI
A06.18 = Other DB/Out-of-state report
A06.19 = Other DB/Prison, jail, or other correctional
facility database
A06.20 = Other DB/PSD
A06.21 = Other DB/State disease registry
A06.22 = Other DB/SHAS
A06.23 = Other DB/SHDC database
A06.24 = Other DB/STD registry
A06.25 = Other DB/TB registry
A06.50 = Other DB/Other database or report

A07. = Other facility records

1-28

A07.01 = Oth facility records/Prison, jail, or other
correctional facility
A07.02 = Oth facility records/Coroner, not associated
with IP facility

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First level source 

Second (more detailed) level source 

A10 = Other source

A10 = Other source
(specify)_________________________________

Unknown
Section III, Demographic information
3.1

DIAGNOSTIC STATUS AT REPORT
The following three text boxes are provided to help determine if patients meet
HIV/AIDS diagnostic criteria; criteria were current as of January 2005.
BOX 1. Quick Reference Guide for HIV/AIDS Case Definitions
Necessary for HIV infection (not AIDS)

•
•
•
•
•

Documentation of +EIA plus +WB with date
Detectable viral load with date
Positive p24 antigen test with date
Positive viral culture with date
Physician documentation of HIV with date

or
or
or
or

Necessary for AIDS
•

Documentation of HIV (one or more of the above)
And

•
•

CD4 < 200 or < 14% with date
or
Any presumptively or definitively diagnosed opportunistic infection (See box 2,
below)

OR
•

Selected definitively diagnosed opportunistic infection with date (See box 3,
below)

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BOX 2. Adult AIDS indicator diseases—one or more sufficient
if definitively diagnosed in the absence of positive HIV test results
•
•
•
•
•
•
•
•
•
•
•
•

Candidiasis of bronchi, trachea, or lungs
Cryptococcosis, extrapulmonary
Cryptosporidiosis, chronic intestinal (greater than 1 month’s duration)
Cytomegalovirus disease (other than liver, spleen, or nodes)
Herpes simplex: chronic ulcer(s) (greater than 1 month’s duration); or
bronchitis, pneumonitis, or esophagitis
Kaposi’s sarcoma (among patients < 60 years of age)
Lymphoma, primary, of brain (among patients < 60 years of age)
Mycobacterium avium complex or M. kansasii, disseminated or
extrapulmonary
Mycobacterium, other species or unidentified species, disseminated or
extrapulmonary
Pneumocystis carinii pneumonia
Progressive multifocal leukoencephalopathy
Toxoplasmosis of brain

If HIV tests were not positive or were not done, does patient have an
immunodeficiency that would preclude an AIDS diagnosis?

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BOX 3. Adult AIDS indicator diseases—one or more sufficient
if diagnosed presumptively or definitively in the presence of positive HIV test
results
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•

Candidiasis of bronchi, trachea, or lungs
Candidiasis, esophageal
Cervical cancer, invasive
Coccidioidomycosis, disseminated or extrapulmonary
Cryptococcosis, extrapulmonary
Cryptosporidiosis, chronic intestinal (greater than 1 month’s duration)
Cytomegalovirus disease (other than liver, spleen, or nodes)
Cytomegalovirus retinitis (with loss of vision)
Encephalopathy, HIV-related
Herpes simplex: chronic ulcer(s) (greater than 1 month’s duration); or
bronchitis, pneumonitis, or esophagitis
Histoplasmosis, disseminated or extrapulmonary
Isosporiasis, chronic intestinal (greater than 1 month’s duration)
Kaposi’s sarcoma (among patients < 60 years of age)
Lymphoma, Burkitt’s (or equivalent term)
Lymphoma, immunoblastic (or equivalent term)
Lymphoma, primary, of brain (among patients < 60 years of age)
Mycobacterium avium complex or M. kansasii, disseminated or extrapulmonary
Mycobacterium tuberculosis, any site (pulmonary or extrapulmonary)
Mycobacterium, other species or unidentified species, disseminated or
extrapulmonary
Pneumocystis carinii pneumonia
Pneumonia, recurrent
Progressive multifocal leukoencephalopathy
Salmonella septicemia, recurrent
Toxoplasmosis of brain
Wasting syndrome due to HIV

•

For further guidance on current HIV case definition, see
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a2.htm.

•

For further guidance on current adult AIDS case definition, see
http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm.

•

For further guidance on the distinction between presumptive and definitive
diagnoses of opportunistic infections (OIs), see Appendix 8.3.1–8.3.26.

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3.7

SEX
•

In addition to “male” or “female” sex at birth, CDC-supplied software
includes a third choice of “Unk.” While “current sex” is not a variable
appearing on the case report form, the person completing the form may
record current sex in Section X (ten) or in the form’s margin next to Section
III—particularly if current sex differs from sex at birth.

•

Selections and legal values for “CURRENT_SEX” from eHARS Lookup
Codes are as follows:
CURRENT_SEX = F = Female Person’s current sex
CURRENT_SEX = I = Intersexed Person’s current sex
CURRENT_SEX = M = Male Person’s current sex

•

Additionally, the current form does not include fields for patient gender but
eHARS optionally does. A variety of genders may be recorded either in the
margin of the case report form at Section III or in Section X, Comments.
Note that “current gender” adds behavioral, biological, and iatrogenic
selections to those of “current sex.”

•

Selections and legal values for “CURRENT GENDER” from eHARS
Lookup Codes are as follows:

CURRENT_GENDER = CD = Cross Dresser Person’s current gender
CURRENT_GENDER = DQ = Drag Queen Person’s current gender
CURRENT_GENDER = F = Female Person’s current gender
CURRENT_GENDER = FM = Female to Male Person’s current gender
CURRENT_GENDER = I = Intersexed Person’s current gender
CURRENT_GENDER = M = Male Person’s current gender
CURRENT_GENDER = MF = Male to Female Person’s current gender
CURRENT_GENDER = SM = She Male Person’s current gender
3.8

1-32

ETHNICITY
•

Regardless of the presence of race or absence of any information, collect data
on ethnicity.

•

As of January 2003, the US Office of Management and Budget (OMB)
required that race and ethnicity (Hispanic, non-Hispanic) for a person be
collected as separate variables.

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•

3.9

A wide variety of ethnicities may be selected from legal values available in
CDC-supplied software. These ethnicities and codes are documented in the
eHARS Technical Reference Guide.

RACE
•

•

As of January 2003, the US Office of Management and Budget (OMB)
required that systems collect multiple races for a person (OMB Policy
Directive 15 updated standards); at a minimum, collect data on the following
categories:
•

American Indian or Alaska Native

•

Asian

•

Black or African American

•

Native Hawaiian or Other Pacific Islander

•

White

A wide variety of race categories may be selected from legal values available
in CDC-supplied software. These races and codes are documented in the
eHARS Technical Reference Guide.

3.10 COUNTRY OF BIRTH
•

Select first from boxes provided:
United States
US dependency, specify
Other, specify
Unknown

•

For patients born in US dependencies, specify from the following table:
US dependencies
American Samoa

Pacific Trust Terr.

Guam

Palau

Johnston Atoll

Puerto Rico

Mariana Islands

Ryukyu Islands

Marshall Islands

Swan Islands

Micronesia

US Virgin Islands

Midway Islands

Wake Island

Navassa Island

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3.11 RESIDENCE AT DIAGNOSIS
•

Residence may be identical to that listed above in Section I, unless otherwise
noted in the chart.

•

For HIV case reports, enter residence at the time of the first positive
confirmatory test for HIV infection.

•

If a diagnostic test result is not available, enter patient’s residence at the date
of physician diagnosis of HIV infection.

•

For AIDS case reports, enter patient’s residence at the date of the first AIDSdefining clinical condition or the date of the first immunologic marker that
reaches AIDS-defining thresholds.

Residence assignment can be problematic for patients who:
•

Have multiple residences

•

Are on vacation

•

Reside at a school

•

Are foster children

•

Are members of the armed forces

•

Are institutionalized in correctional or other types of facilities

•

Are foreign to the United States

•

Are US citizens diagnosed abroad

3.12.1 RESIDENCE, INCARCERATED
•

Enter home of record for sites of relatively brief incarceration such as
county jails.

•

For patients who are incarcerated in state or federal correctional
facilities at the time of diagnosis, record the correctional facility’s
address.

•

For patients incarcerated in city or county jails, record home address;
enter jail address only after unsuccessful search for address of
patient’s home of record.

3.12.2 RESIDENCE, HOMELESS
•

For homeless patients, enter the address that most accurately
describes where they stay—including a shelter address if applicable.

•

People without a usual residence should be reported by the
jurisdiction where they were staying at the time of diagnosis.

For further guidance about residency assignment, see Technical Guidance for
HIV/AIDS Surveillance Programs, Volume I: Policies and Procedures, Case
Residency Assignment.
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Section IV, Facility of diagnosis
4.1

FACILITY NAME

4.4

•

For HIV case reports, enter the name of the facility where the patient first
had blood drawn and was given a diagnosis of HIV infection.

•

If test results are not in the medical record, enter the name of the facility
where the patient’s HIV infection was diagnosed and documented by the
health care provider.

•

For AIDS case reports, enter the name of the facility where the patient’s
AIDS-defining clinical condition was first diagnosed, or a CD4 count below
200 cells/µL or a CD4 percentage below 14 was documented, whichever
came first.

•

Enter facility/physician name uniformly to prevent the occurrence of
multiple names for a given facility.

•

If a physician name is listed without a facility name, enter physician name.

FACILITY SETTING
•

4.5

State/local surveillance program staff may create tables of settings by
facilities in their jurisdictions to prevent misclassification.

FACILITY TYPE
•

Select “Physician, HMO” where diagnosis was made at a private, outpatient
care site not associated with a hospital. Examples of “other” include publicly
or privately operated facilities such as HIV counseling and testing sites, STD
clinics, drug treatment facilities, family planning clinics, prenatal/obstetrics
clinics, tuberculosis clinics, and correctional facilities.

Section V, Patient history
•

Surveillance staff has found such information within charts at discharge summary,
history and physical, social service notes, counseling and testing notes, and STD
diagnosis notes.

•

Where not explicitly annotated, contact patient’s provider about risk factor
information.

•

See Technical Guidance for HIV/AIDS Surveillance Programs, Volume I: Policies
and Procedures, Risk Factor Ascertainment, Risk Factor Ascertainment
Procedures, Epidemiologic Follow-Up for further guidance on risk factor data
collection.

•

This information can be difficult to find, particularly if the patient has not been
interviewed. States should have risk factor ascertainment procedures tailored to
their jurisdictions.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

5.5

HETEROSEXUAL CONTACT WITH ANY OF THE FOLLOWING:
5.5.3 PERSON WITH HEMOPHILIA/COAGULATION DISORDER
•

They do not include other bleeding disorders, such as
thrombocytopenia, treatable by platelet transfusion.

•

If only a transfusion of platelets, other blood cells, or plasma was
received by the partner, then select “No.”

•

Select “Yes” for the field labeled 5.5.4 about transfusion recipient if
the partner was also known to be HIV infected.

•

Refer to Protocol for Evaluation of Identification and Follow-up of
Cases of Public Health Importance at
http://www2a.cdc.gov/hicsb/docs/COPHI_Protocol.pdf for more
information. COPHI is also covered in Technical Guidance for
HIV/AIDS Surveillance Programs, Volume I: Policies and
Procedures, Risk Factor Ascertainment, Cases of Public Health
Importance (COPHI).

Section VII, State/local use only
7.1

PHYSICIAN’S NAME
•

7.3

If the test was provided as part of a visit to a health department, an STD
clinic, an HIV counseling and testing site, or other facility where no single
individual is responsible for medical management of the patient, leave this
space blank and complete the “FACILITY OF DIAGNOSIS” section
(Section IV of the CRF), appropriately.

MEDICAL RECORD NUMBER
•

This field may be left blank unless patient was hospitalized as an inpatient or
treated as an outpatient in a hospital, community health center, or health
department clinic.

•

If the patient has more than one medical record number, enter the number of
the primary record that has HIV/AIDS documentation. Additional numbers
can be noted in the Comments section, clearly annotating which facility is
associated with which record number.

Section VIII, Clinical status
8.2.1 ASYMPTOMATIC (including acute retroviral syndrome and persistent
generalized lymphadenopathy)
•

1-36

Populate this field if there is documentation of asymptomatic
infection (Group A1 and A2). For further guidance, see the 1993 CDC
Revised Classification System for HIV Infection and Expanded

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Surveillance Case Definition for AIDS among Adolescents and
Adults at
http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm.
8.2.2 SYMPTOMATIC (not AIDS)
•

•
•
•
•
•
•
•
•
•
•
•

Populate this field if there is documentation of symptomatic (Group
B1 and B2) infection as outlined in the 1993 CDC Revised
Classification System for HIV Infection and Expanded Surveillance
Case Definition for AIDS among Adolescents and Adults, or if the
conditions are documented to be related to HIV infection. Examples
of conditions in clinical Category B include, but are not limited to:

Bacillary angiomatosis
Candidiasis, oropharyngeal (thrush)
Candidiasis, vulvovaginal; persistent, frequent, or poorly responsive to therapy
Cervical dysplasia (moderate or severe)/cervical carcinoma in situ
Constitutional symptoms, such as fever (38.5 C) or diarrhea lasting greater than
1 month
Hairy leukoplakia, oral
Herpes zoster (shingles), involving at least two distinct episodes or more than
one dermatome
Idiopathic thrombocytopenic purpura
Listeriosis
Pelvic inflammatory disease, particularly if complicated by tubo-ovarian
abscess
Peripheral neuropathy
•

For further guidance, see the 1993 CDC Revised Classification
System for HIV Infection and Expanded Surveillance Case Definition
for AIDS among Adolescents and Adults at
http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm.

8.3.1–8.3.26 AIDS INDICATOR DISEASES

March 2006

•

Definitive diagnostic methods are detailed in the 1987 and 1993
MMWR case definition supplement and recommendations (1987;36:1
15S and 1992;41:1 17RR). Guidance on diagnosis of these diseases in
the context of all nationally notifiable diseases is available at
http://www.cdc.gov/epo/dphsi/casedef/case_definitions.htm.

•

For another view of this distinction in the context of treatment of
opportunistic infections, see Treating Opportunistic Infections
Among HIV-Infected Adults and Adolescents, available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5315a1.htm.
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The following box is an excerpt from the 1993 case definition, available
at http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm:
Definitive diagnostic methods for diseases indicative of AIDS
Cryptosporidiosis, Isosporiasis, Kaposi’s sarcoma, Lymphoma, Pneumocystis carinii
pneumonia, Progressive multifocal leukoencephalopathy, Toxoplasmosis, Cervical
cancer: Microscopy (histology or cytology).
Candidiasis: Gross inspection by endoscopy or autopsy or by microscopy (histology
or cytology) on a specimen obtained directly from the tissues affected (including
scrapings from the mucosal surface), not from a culture.
Coccidioidomycosis, Cryptococcosis, Cytomegalovirus, Herpes simplex virus,
Histoplasmosis: Microscopy (histology or cytology), culture, or detection of antigen
in a specimen obtained directly from the tissues affected or a fluid from those tissues.
Tuberculosis, Other mycobacteriosis, Salmonellosis: Culture.
HIV encephalopathy (dementia): Clinical findings of disabling cognitive or motor
dysfunction interfering with occupation or activities of daily living, progressing over
weeks to months, in the absence of a concurrent illness or condition other than HIV
infection that could explain the findings. Methods to rule out such concurrent illness
and conditions must include cerebrospinal fluid examination and either brain
imaging (computed tomography or magnetic resonance) or autopsy.
HIV wasting syndrome: Findings of profound involuntary weight loss of greater than
10% of baseline body weight plus either chronic diarrhea (at least two loose stools
per day for greater than or equal to 30 days), or chronic weakness and documented
fever (for greater than or equal to 30 days, intermittent or constant) in the absence of
a concurrent illness or condition other than HIV infection that could explain the
findings (e.g., cancer, tuberculosis, cryptosporidiosis, or other specific enteritis).
Pneumonia, recurrent (more than one episode in a 1-year period), acute (new x-ray
evidence not present earlier) pneumonia diagnosed by both: a) culture (or other
organism—specific diagnostic method) obtained from a clinically reliable specimen
of a pathogen that typically causes pneumonia (other than Pneumocystis carinii or
Mycobacterium tuberculosis), and b) radiologic evidence of pneumonia; cases that
do not have laboratory confirmation of a causative organism for one of the episodes
of pneumonia will be considered to be presumptively diagnosed.
•

1-38

Methods for the presumptive diagnosis of diseases indicative of AIDS listed in
the case definition supplement are simply suggested guidelines, not
requirements. Among illnesses that can be presumptively diagnosed and if a
method does not meet the requirements for definitive diagnosis, then it meets the
requirements for presumptive diagnosis. Accept any method that the clinician
considers diagnostic.

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Technical Guidance for HIV/AIDS Surveillance Programs — Adult HIV/AIDS Confidential Case Report

8.4

IF HIV TESTS WERE NOT POSITIVE OR WERE NOT DONE, DOES THIS
PATIENT HAVE AN IMMUNODEFICIENCY THAT WOULD DISQUALIFY
HIM/HER FROM THE AIDS CASE DEFINITION?
•

Causes of immunodeficiency that disqualify clinical conditions as indicators
of AIDS in the absence of laboratory evidence for HIV infection are:

•

High-dose or long-term systemic corticosteroid therapy or other
immunosuppressive/cytotoxic therapy within 3 months before the onset of
the AIDS-defining clinical condition.

•

Any of the following diseases diagnosed before or within 3 months after the
AIDS-defining clinical condition was diagnosed:

•

March 2006

•

Hodgkin’s disease

•

non-Hodgkin’s lymphoma (other than primary brain lymphoma)

•

lymphocytic leukemia

•

multiple myeloma

•

any other cancer of lymphoreticular or histiocytic tissue

•

angioimmunoblastic lymphadenopathy

A genetic (congenital) immunodeficiency syndrome or an acquired
immunodeficiency syndrome atypical of HIV infection, such as one
involving hypogammaglobulinemia.

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Section IX, Treatment/services referrals
9.4.1 ANTIRETROVIRAL THERAPY
A single drug formulation often has multiple names; trade names are in
bold. Drug names include the following, which serves only as a guide as
of January 2005; and the reference indicated below gives an updated
guideline for treatment:
Drug type among antiretroviral class
Nucleoside/
Non-Nucleoside
Protease
Nucleotide Reverse Reverse Transcriptase Inhibitors
Transcriptase
Inhibitors (NNRTIs)
Inhibitors (NRTIs)

Fusion
Inhibitors

NRTI
Combination
Drugs

Drug name
Abacavir—ABC,
Ziagen

Delavirdine—
Rescriptor

Amprenavir— Enfuvirtide
Agenerase
—Fuzeon

Combivir

Didanosine—ddI,
Videx, Videx EC

Efavirenz—Sustiva

Atazanavir—
Reyataz

Trizivir

Emtricitabine—
FTC, Emtriva

Nevirapine—
Viramune

Indinavir—
Crixivan

Truvada

Lamivudine—3TC,
Epivir

Lopinavir +
Ritonavir—
Kaletra

Abacavir
combo

Stavudine—D4T,
Zerit

Nelfinavir—
Viracept

Tenofovir—
Disoproxil,
Fumarate, Viread

Ritonavir—
Norvir

Zalcitabine—ddC,
HIVID

Saquinavir
(hard gel
capsule)—
Invirase

Zidovudine—AZT,
ZDV, Retrovir

Saquinavir
(soft gel
capsule)—
Fortovase

•

1-40

For Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and
Adolescents, see http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.

Appendix: Adult HIV/AIDS Confidential Case Report (CDC 50.42A/CDC 50.42C)

March 2006

Technical Guidance for
HIV/AIDS Surveillance
Programs
Pediatric HIV/AIDS Confidential Case
Report

HIV Incidence and Case Surveillance Branch
Atlanta, Georgia

Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

Contents — Pediatric HIV/AIDS Confidential Case Report
Instructions for Completion ................................................................................ 2-3
Purpose of case report form .......................................................................... 2-3
The case report form in the context of document-based surveillance ........... 2-3
Patients for whom form is indicated............................................................... 2-3
Definition of variable designators .................................................................. 2-3
Disposition of form......................................................................................... 2-4
Section I, State/local use only (patient identifier information) ........................ 2-4
Section II, Health department use only.......................................................... 2-4
Section III, Demographic information ............................................................ 2-7
Section IV, Facility of diagnosis ................................................................... 2-10
Section V, Patient/maternal history...............................................................2-11
Section VI, State/local use only ................................................................... 2-16
Section VII, Laboratory data ........................................................................ 2-18
Section VIII, Clinical status .......................................................................... 2-23
Section IX, Birth history (Required for perinatal cases only) ....................... 2-24
Section X, Treatment/services referrals....................................................... 2-29
Section XI, Comments................................................................................. 2-31
Appendix: Pediatric HIV/AIDS Confidential Case Report (CDC 50.42B)......... 2-32
Instructions for Completion.......................................................................... 2-32
Purpose ................................................................................................... 2-32
Pediatric Cases of Public Health Importance (COPHI) ........................... 2-33
Section I, State/local use only (patient identifier information).................. 2-33
Section II, Health department use only ................................................... 2-33
Report Source Codes for HIV/AIDS Reporting ................................... 2-34
Section III, Demographic information ...................................................... 2-37
Section IV, Facility of diagnosis............................................................... 2-44
Section V, Patient/maternal history ......................................................... 2-45
Section VI, State/local use only ............................................................... 2-47
Section VII, Laboratory data.................................................................... 2-48
Section VIII, Clinical status...................................................................... 2-48
Section IX, Birth history (for perinatal cases only)................................... 2-49
Section X, Treatment/services referrals .................................................. 2-54

2-2

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

Technical Guidance for HIV/AIDS Surveillance Programs —
Pediatric HIV/AIDS Confidential Case Report
Instructions for Completion
Purpose of case report form
•

The Pediatric HIV/AIDS Confidential Case Report (CDC 50.42B) form is
designed to collect information that promotes understanding of HIV/AIDS
morbidity and mortality among patients less than 13 years of age at time of
diagnosis. This form reflects data that should be collected; these guidelines apply
to this data collection even if surveillance sites use a different form or medium for
HIV/AIDS case surveillance.

•

See Appendix for further details.

The case report form in the context of document-based surveillance
Unlike case-based data management, document-based data management allows all
documents to be stored and retained electronically in their original formats. Instead of
completing one form for a given reported case, fill out the applicable part of the form for
each data source contributing to that case.
Patients for whom form is indicated
•

Each child who meets the pediatric AIDS case definition, and for those with
confirmed HIV infection in areas where HIV reporting is required by law.

•

In areas with confidential perinatal exposure HIV reporting, all children born to
HIV-infected mothers.
•

Includes children whose infection status has not yet been determined,
seroreverters, and those exposed but determined not to be infected with HIV;
inclusion of such patients is for public health surveillance purposes only.

•

A federal assurance of confidentiality applies to information on children
exposed perinatally with or without consequent infection.

Definition of variable designators
•

Required: Variables that are required to meet the case definitions of HIV or
AIDS, to identify and track cases, and to do meaningful statistical analysis.

•

Recommended: Information that is useful for analysis but not essential for core
surveillance.

•

Optional: Information that should be ascertained if readily available.

March 2006

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

Disposition of form
•

The completed form is for state or local health agency use and is not to be sent to
the Centers for Disease Control and Prevention (CDC) with patient identifiers.
Some sites send forms to CDC for data entry.

•

Data obtained from these forms are entered into compatible or standardized
computer software provided by the Division of HIV/AIDS Prevention, National
Center for HIV, STD, and TB Prevention, CDC, and then transferred without
identifiers to CDC electronically by encrypted computer diskette or electronic
transfer via secure data network.

Section I, State/local use only (patient identifier information)

Patient identifier information is for state/local health department use only and is not
transmitted to CDC. Enter the data below for all AIDS cases and, where consistent with
statutory requirements, HIV (not AIDS) cases. Consult with your state/local health
department in jurisdictions with alternatives to name-based reporting.
1.1

1.2

PATIENT’S NAME (Required, applies to Health Dept & Health Care Providers)
•

Enter patient’s last name, first name, and middle initial.

•

If available, write in a.k.a.s, aliases, etc. for later data entry. Record these
names in Section XI, Comments.

PHONE NO. (Required if patient has a telephone, applies to Health Dept &
Health Care Providers)
•

Enter patient’s current home area code and telephone number.

1.3–1.7 ADDRESS (each element Required, applies to Health Dept & Health Care
Providers)
•

Enter patient’s current street number and name, city, county, state, and ZIP
code.

Section II, Health department use only

2-4

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

•

Nonhealth department staff only need to complete DATE FORM COMPLETED
and REPORT STATUS fields.

2.1

DATE FORM COMPLETED (Required, applies to Health Dept & Health Care
Providers)
•

2.2

2.3

2.4

March 2006

Enter date in mmddyy format.

REPORT SOURCE (Required, applies to Health Dept)
•

Enter the code for reporting source that provided the information for this
report.

•

To clearly identify multiple data sources for a given HIV/AIDS case, use a
separate case report form for each source.

•

Since legal values now exceed two digits, enter code immediately below this
box.

•

If coding proves difficult, write in report source for later coding.

•

Refer to Appendix 2.2 for code information.

SOUNDEX CODE (Required in accordance with state/local law, applies to
Health Dept)
•

After patient name is recorded, CDC-supplied software generates this
variable by using the patient’s last name entered in Section I. Because this
code is automatically generated, health department staff may leave this field
blank on the form.

•

This variable is a phonetic, alphanumeric code calculated by converting a
surname into an index letter and a three-digit code. The index letter is the
first letter of the surname.

REPORT STATUS (Required, applies to Health Dept and Health Care
Providers). This variable does not exist in eHARS.
•

Select applicable response.

•

Select “New Report” if the patient is not already in the state registry with the
condition reported—HIV or AIDS.

•

Select “Update” for patients previously reported to the registry with either
condition—HIV or AIDS.

•

Health department staff establishes report status by searching the HIV/AIDS
registry for previous reports on a particular patient. Public providers without
access to the registry may request a record search from their jurisdiction’s
surveillance program.

•

Providers from the public and private sectors unable to establish status may
assume “New Report.” As the report is processed by surveillance staff, status
entered can be confirmed or corrected.
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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

2.5

•

When additional information on a previously reported case of HIV infection
(not AIDS) becomes available, select “Update.”

•

When a patient has been previously reported with HIV infection (not AIDS)
and later receives an AIDS diagnosis, select “New Report.” From a
surveillance perspective, the occurrence of AIDS is reportable in all US
jurisdictions as an event independent of the occurrence of HIV infection (not
AIDS). Progression to AIDS among previously reported HIV case patients
represents new reports of AIDS rather than an update of previously reported
HIV cases.

REPORTING HEALTH DEPARTMENT
2.5.1–2.5.2 STATE, CITY/COUNTY (each element Required, applies to Health
Dept)
•

2.6

2.7

2-6

Enter name of state, city, and county of the health department that
receives the report from providers of surveillance data.

STATE PATIENT NO. (Required where state numbers are used, applies to Health
Dept)
•

Enter the assigned state patient number.

•

Each patient should have a unique state number throughout the course of
HIV disease. An exception to this is when a case is transferred to another
state, where another state number may be assigned.

•

Assigned numbers should not be reused, even if the case is later deleted.

•

The precise format of this 10-digit character variable is unique to each state.

•

This variable is used, along with the state of report, to uniquely identify cases
reported to CDC and to merge the state datasets without duplication.

CITY/COUNTY NUMBER (Required where city numbers are used, applies to
Health Dept)
•

Enter the assigned city/county patient number.

•

Each patient should have a unique city/county number throughout the course
of HIV disease. An exception to this is when a case is transferred to another
city/county and/or state, where another city number may be assigned.

•

Assigned numbers should not be reused, even if the case is later deleted.

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

Section III, Demographic information

3.1

DIAGNOSTIC STATUS AT REPORT (Required, applies to Health Dept &
Health Care Providers)
•

Select applicable response.

•

Irrespective of the interval between diagnostic status dates, and even where
the same source of these data reported more than one event, use one form to
capture each event. Fill out suitable number of case report forms:
•

Fill out the first form completely for the first diagnosis.

•

Fill out subsequent forms partially, capturing additional or updated data
absent from the first form.

•

Forms referred to at preceding bulleted item must include at least the
following data: DIAGNOSTIC STATUS AT REPORT; RESIDENCE AT
DIAGNOSIS (see 3.14, below); and Facility of Diagnosis (see Section IV,
below).

•

Status depends on child’s age, clinical profile, and laboratory findings. Refer
to Appendix 3.1.1–3.1.4 for further details.

3.1.1 PERINATALLY HIV EXPOSED
•

Select “Perinatally HIV Exposed” if the patient is aged less than 18
months, was born to an HIV-infected mother, and does not meet the
criteria for HIV infection or the criteria for “Not Infected with HIV.”

•

Refer to Appendix 3.1.1 for elaboration.

3.1.2 CONFIRMED HIV INFECTION (NOT AIDS)

March 2006

•

Select “Confirmed HIV Infection (not AIDS)” if the patient meets
criteria specified in the Revised Surveillance Case Definition for HIV
Infection and does not meet the current CDC pediatric AIDS case
definition.

•

Refer to Appendix 3.1.2 for elaboration.

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3.1.3 AIDS
•

Select “AIDS” if patient meets the current AIDS case definition for
children < 13 years of age.

•

Refer to Appendix 3.1.3 for elaboration.

3.1.4 SEROREVERTER

3.2

3.5

3.6

2-8

•

With respect to the four diagnostic status categories available on the
case report form (CRF), “Seroreverter” is synonymous with “Not
Infected with HIV.”

Enter the year and month of the child’s last medical evaluation, regardless of
reason for exam. This includes emergency room visits.

DATE OF BIRTH (Required, applies to Health Dept & Health Care Providers)
•

3.4

Select “Seroreverter” if the perinatally exposed child initially has a
positive HIV test but is found NOT to be HIV-infected through
criteria listed in Appendix 3.1.4.

DATE OF LAST MEDICAL EVALUATION (Required, applies to Health Dept &
Health Care Providers)
•

3.3

•

Enter patient’s month, day, and year of birth.

AGE AT DIAGNOSIS (Optional, applies to Health Dept & Health Care
Providers)
•

Enter age in months if child is less than 18 months of age, or enter age in
years if child is greater than 18 months and less than 13 years of age.

•

If precise age is not known, investigator must know if the patient is less than
13 years old at time of diagnosis to determine whether to use the Pediatric
case report form (CDC 50.42B).

CURRENT STATUS (Required, applies to Health Dept & Health Care
Providers)
•

Select applicable response.

•

Refer to Appendix 3.5 for further guidance.

DATE OF DEATH (Required if applicable, applies to Health Dept & Health
Care Providers)
•

If child is deceased, enter date of death.

•

For further guidance on death ascertainment, see Technical Guidance for
HIV/AIDS Surveillance Programs, Volume 1: Policies and Procedures,
Death Ascertainment.

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3.7

STATE/TERRITORY OF DEATH (Recommended if applicable, applies to
Health Dept & Health Care Providers)
•

3.8

3.9

If child is deceased, enter the state/territory of death.

DATE OF INITIAL EVALUATION FOR HIV INFECTION (Required, applies to
Health Dept & Health Care Providers)
•

Enter the date of initial evaluation for HIV infection. This is the date when
HIV infection was first considered, either clinically or through laboratory
evaluation.

•

For a child whose mother is known to be HIV infected at the time of birth
and for whom assessment of HIV is done at birth, use the date of birth. This
assessment does not necessarily include an order for an HIV test, although
documentation of an HIV test is often the earliest evidence that the diagnosis
was considered.

•

Refer to Appendix 3.8 for further details.

REASON FOR INITIAL HIV EVALUATION (Required, applies to Health Dept
& Health Care Providers)
•

Select applicable response.

3.10 SEX (Required, applies to Health Dept & Health Care Providers)
•

Select patient’s sex at birth.

•

“CURRENT_GENDER” and “CURRENT_SEX” are optional fields
appearing in new CDC-supplied software but not on the case report form.

•

Refer to Appendix 3.10 for further details.

3.11 ETHNICITY (Required, applies to Health Dept & Health Care Providers)
•

Select applicable response.

•

If no ethnicity information is available but was searched for, select “Unk.”

•

Refer to Appendix 3.11 for further details.

3.12 RACE (Required, applies to Health Dept & Health Care Providers)
•

Select patient’s race even if information was submitted for ethnicity.

•

Select more than one race if applicable.

•

If no race information is available, select “Unk.”

•

Refer to Appendix 3.12 for further details.

3.13 COUNTRY OF BIRTH (Recommended, applies to Health Dept & Health Care
Providers)
•
March 2006

Select applicable response from boxes provided.
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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

•

Refer to Appendix 3.13 for legal values when dependency or country is to be
specified.

3.14 RESIDENCE AT DIAGNOSIS (each element Required, applies to Health Dept
& Health Care Providers)
•

Enter city, county, state/country, and ZIP code of patient’s residence at first
diagnosis with HIV or AIDS-defining clinical condition (or remaining
pediatric diagnostic status categories at 3.1, above).

•

The home address as given by the parent/guardian of the patient at the time
of HIV and/or AIDS diagnosis usually populates these fields.

•

Refer to Appendix 3.14 for further details.

Section IV, Facility of diagnosis

4.1

4.2

FACILITY NAME (Required, applies to Health Dept & Health Care Providers)
•

Enter name of the facility where patient first received a diagnosis of HIV or
AIDS. This may or may not be the facility where infant was born.

•

For occurrences of seroreversion or perinatal exposure pending investigative
closure, enter name of the facility where child received initial evaluation for
HIV infection.

•

When these diagnoses or events occurred at different facilities, enter name of
each and specify which diagnosis occurred at which facility.

•

Refer to Appendix 4.1 for further details.

CITY (Required, applies to Health Dept & Health Care Providers)
•

4.3

STATE/COUNTRY (Required, applies to Health Dept & Health Care Providers)
•

4.4

2-10

Enter city name where facility of diagnosis is located.

Enter state and country name where the facility of diagnosis is located.

FACILITY SETTING (Recommended, applies to Health Dept & Health Care
Providers)
•

Select applicable response.

•

“Private” typically includes doctor’s offices or clinics not affiliated with a
health department.

•

“Public” includes public clinics, hospitals, or county/state correctional
institutions.
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4.5

•

“Federal” includes Department of Veterans’ Affairs medical centers, military
clinics, and federal correctional institutions.

•

Refer to Appendix 4.4 for further details.

FACILITY TYPE (Recommended, applies to Health Dept & Health Care
Providers)
•

Select applicable response corresponding to the type of facility where patient
received HIV/AIDS diagnosis.

•

Refer to Appendix 4.5 for further details.

Section V, Patient/maternal history

•

Maternal perinatal exposure is the predominant risk factor for pediatric HIV cases.

•

Respond to each risk factor, selecting “Yes” for all factors that apply, “No” for
those that do not apply, and “Unk.” for those for which investigation failed to yield
an answer. See Appendix Section V for more general guidance or further
information about how to ascertain risk factor information.

•

The form’s direction to limit recording maternal risk factors to those occurring
after 1977 is obsolete (see 5.5, below). Collect data about the risk factors that
occurred before the first positive HIV test or AIDS diagnosis. See Technical
Guidance for HIV/AIDS Surveillance Programs, Volume 1: Policies and
Procedures, Risk Factor Ascertainment, Epidemiologic follow-up. Risk factor
information on the mother refers to behaviors that started before the child’s birth.

•

Information on the child refers to circumstances or behaviors that were thought to
have exposed the child to HIV, not to treatments since the child became HIV

March 2006

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

infected. For example, if the child received a blood transfusion after the
documentation of HIV infection, do not enter that information on the form.
•

5.1

5.2

5.3

5.4

2-12

The state or local Cases of Public Health Importance (COPHI) coordinator should
contact the CDC COPHI coordinator as soon as possible if any unusual
transmission circumstances are suspected. For further information on Cases of
Public Health Importance, refer to this password-protected site:
http://www2a.cdc.gov/hicsb/docs/COPHI_Protocol.pdf. Consult your local
HIV/AIDS Surveillance Coordinator for access. COPHI is also covered in
Technical Guidance for HIV/AIDS Surveillance Programs, Volume I: Policies and
Procedures, Risk Factor Ascertainment, Cases of Public Health Importance.
CHILD’S BIOLOGIC MOTHER’S HIV INFECTION STATUS (Required,
applies to Health Dept & Health Care Providers)
•

Select applicable response.

•

Refer to Appendix 5.1 for further details.

(MOTHER) DIAGNOSED WITH HIV INFECTION/AIDS (Required, applies
to Health Dept & Health Care Providers)
•

If mother was diagnosed with HIV infection/AIDS, select from boxes 3–8,
depending on information available to determine the timing of her diagnosis.
Where date of mother’s first positive HIV confirmatory test is available,
establish which box to select by comparing to the date of birth and then
selecting the appropriate box.

•

Refer to Appendix 5.2 for further details.

DATE OF MOTHER’S FIRST POSITIVE HIV CONFIRMATORY TEST
(Required, applies to Health Dept & Health Care Providers)
•

Where mother is known to be HIV infected, enter month and year of the first
positive HIV confirmatory test.

•

If year is present and search for month was unsuccessful, then enter “..” for
the unknown month followed by the documented year.

•

Refer to Appendix 5.3 for further details.

MOTHER WAS COUNSELED ABOUT HIV TESTING DURING THIS
PREGNANCY, LABOR, OR DELIVERY? (Required, applies to Health Dept &
Health Care Providers)
•

Select applicable response.

•

Select “Yes” if mother was counseled at anytime during this pregnancy,
labor, or delivery by a health care provider (private or public) about the risks
of HIV in pregnancy and the risks, benefits, and meaning of HIV testing.

•

Refer to Appendix 5.4 for further details.

Instructions for Completion

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

5.5

AFTER 1977, THIS CHILD’S BIOLOGIC MOTHER HAD
5.5.1 INJECTED NONPRESCRIPTION DRUGS (Required, applies to
Health Dept & Health Care Providers)
•

Select applicable response.

5.5.2 HETEROSEXUAL RELATIONS WITH ANY OF THE FOLLOWING:
•

This section, addressed at 5.5.2–5.5.2.6, relates to ascertainment of
risk among heterosexual sex partners of the biologic mother of the
case patient.

•

Verification of sex partner’s HIV infection status is not necessary.

5.5.2.1 INTRAVENOUS/INJECTION DRUG USER (Required,
applies to Health Dept & Health Care Providers)
•

Select applicable response.

5.5.2.2 BISEXUAL MALE (Required, applies to Health Dept & Health
Care Providers)
•

Applies only to female case patients.

•

Select applicable response.

5.5.2.3 PERSON WITH HEMOPHILIA/COAGULATION DISORDER
(Required, applies to Health Dept & Health Care Providers)
•

“Coagulation disorder” or “hemophilia” refers only to a
disorder of a clotting factor, which is any of the circulating
proteins named Factor I, Factor II, Factor III, etc., through
Factor XII. These disorders include Hemophilia A and Von
Willebrand’s disease (Factor VIII disorders) and Hemophilia
B (a Factor IX disorder).

•

Refer to Appendix 5.5.2.3 for further details.

5.5.2.4 TRANSFUSION RECIPIENT WITH DOCUMENTED HIV
INFECTION (Required, applies to Health Dept & Health Care
Providers)

March 2006

•

Select applicable response.

•

Consider documenting the reason for transfusion in the
Comments section.

•

Refer to Appendix 5.5.2.4 for further details.

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5.5.2.5 TRANSPLANT RECIPIENT WITH DOCUMENTED HIV
INFECTION (Required, applies to Health Dept & Health Care
Providers)
•

Select applicable response.

•

Consider recording documentation available about the
transplant in the Comments section.

•

Alert state/local COPHI coordinator.

5.5.2.6 MALE WITH AIDS OR DOCUMENTED HIV INFECTION,
RISK NOT SPECIFIED (Required, applies to Health Dept &
Health Care Providers)
•

Select “Yes” only if male partner is known to be HIV
positive and that partner’s risk for HIV is unknown.

5.5.3 RECEIVED TRANSFUSION OF BLOOD/BLOOD COMPONENTS
(each element Required, applies to Health Dept & Health Care
Providers)
•

Select applicable response.

•

If “Yes,” specify the month and year of the first and last transfusion
before the child’s biologic mother received a diagnosis of HIV or
AIDS.

•

If the last transfusion was after March 1985, then alert state/local
COPHI coordinator.

5.5.4 RECEIVED TRANSPLANT OF TISSUES/ORGANS OR ARTIFICIAL
INSEMINATION (each element Required, applies to Health Dept &
Health Care Providers)

5.6

Select applicable response.

•

If this is the only risk factor present and the biologic mother did not
have a diagnosis of HIV infection at the time of child’s birth, the
transmission mode will be initially classified as “risk not
reported/identified” pending outcome of the COPHI investigation;
then alert state/local COPHI coordinator.

•

If the biologic mother is known to be HIV infected and this is the only
maternal risk, then the case patient will initially be classified as
“mother has HIV infection, risk not specified.”

BEFORE THE DIAGNOSIS OF HIV INFECTION, THIS CHILD HAD
•

2-14

•

Alert state/local COPHI coordinator if the child had one or more of the risk
factors documented in this section.

Instructions for Completion

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

5.6.1 RECEIVED CLOTTING FACTOR FOR COAGULATION DISORDER
(Required, applies to Health Dept & Health Care Providers)
•

“Coagulation disorder” or “hemophilia” refers only to a disorder of a
clotting factor, which is any of the circulating proteins named Factor
I, Factor II, Factor III, etc., through Factor XII. These disorders
include Hemophilia A and Von Willebrand’s disease (Factor VIII
disorders) and Hemophilia B (a Factor IX disorder).

•

Select applicable response.

•

If “Yes” to “Other” disorder, specify.

•

Alert state/local COPHI coordinator if child was born after March
1998 and receipt of clotting factor is the suspected mode of HIV
transmission.

•

Refer to Appendix 5.6.1 for further details.

5.6.1.1 SPECIFY DISORDER (Required, applies to Health Dept &
Health Care Providers)
•

If “Yes” to 5.6.1, above, then enter the specific disorder.

5.6.2 TRANSFUSION OF BLOOD/BLOOD COMPONENTS (OTHER THAN
CLOTTING FACTOR) (Required, applies to Health Dept & Health
Care Providers)
•

If child received a transfusion of blood cells (red cells, white cells,
and platelets) or plasma, specify month and year of first and last
transfusion before the patient was infected with HIV or received a
diagnosis of AIDS.

•

It is often helpful to document the reason for the transfusion in the
Comments section.

5.6.3 TRANSPLANT OF TISSUE/ORGANS (Required, applies to Health
Dept & Health Care Providers)
•

The case will be initially classified as “risk not reported/identified”
pending outcome of the no identified risk (NIR) investigation.

•

Alert the state/local COPHI coordinator.

5.6.4 SEXUAL CONTACT WITH A MALE (Required, applies to Health Dept
& Health Care Providers)

March 2006

•

If child is known to have had sexual contact/abuse, mark the
appropriate box.

•

If this is the only risk history, the case will be initially classified as
“risk not reported/identified” pending outcome of NIR investigation.

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

•

Alert state/local COPHI coordinator.

5.6.5 SEXUAL CONTACT WITH A FEMALE (Required, applies to Health
Dept & Health Care Providers)
•

If the child is known to have had sexual contact/abuse, mark the
appropriate box.

•

If this is the only risk history, the case will be initially classified as
“risk not reported/identified” pending outcome of NIR investigation.

•

Alert state/local COPHI coordinator.

5.6.6 INJECTED NONPRESCRIPTION DRUGS (Required, applies to
Health Dept & Health Care Providers)
•

Mark the appropriate box.

•

If this is the only risk history, the case will be initially classified as
“risk not reported/identified” pending outcome of the NIR
investigation.

•

Alert state/local COPHI coordinator.

5.6.7 OTHER (Alert State/Local NIR Coordinator) (Required, applies to
Health Dept & Health Care Providers)
•

Select this response only if directed to do so by the state/local NIR
coordinator.

Section VI, State/local use only

Physician identifier information is for state/local health department use only and is not
transferred to CDC.
6.1

6.2

2-16

PHYSICIAN’S NAME (Required, applies to Health Dept & Health Care
Providers)
•

For HIV infection reports, enter name of physician who ordered the test.

•

For AIDS case reports, enter name of physician medically managing patient.

•

Refer to Appendix 6.1 for further guidance.

PHONE NUMBER (Required, applies to Health Dept & Health Care Providers)
•

Enter phone number of physician named at 6.1, above.

•

If no physician is named, enter phone number of the facility of diagnosis.
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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

6.3

6.4

6.5

MEDICAL RECORD NUMBER (Required, applies to Health Dept & Health
Care Providers)
•

Enter medical record number of the patient if inpatient or outpatient services
were received.

•

Refer to Appendix 6.3 for further guidance.

HOSPITAL/FACILITY (Required, applies to Health Dept & Health Care
Providers)
•

Enter the name of the hospital or clinic where the report originated.

•

If this report is generated from a laboratory report of HIV infection, the
laboratory slip should contain the name of the facility where the specimen
was collected.

•

If this report is generated from a laboratory report of an HIV counseling and
testing site or other facility where no single individual is responsible for
medical management of the patient, leave the space blank and complete the
CRF’s Section IV, Facility of diagnosis, appropriately.

PERSON COMPLETING FORM (Required, applies to Health Dept & Health
Care Providers)
•

6.6

PHONE NUMBER (Required, applies to Health Dept & Health Care Providers)
•

March 2006

Enter the name of the person completing the form who can be contacted to
clarify entries and supply additional information.

Enter the telephone number of the person completing the form.

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Section VII, Laboratory data

2-18

•

“Test date” refers to the specimen collection date rather than the analysis or report
date.

•

If search for either or both of these data was unsuccessful, then enter “..” for
unknown month or year of “TEST DATE.”

•

In the presence of lab tests, record them all.

•

Include all diagnostic and CD4 tests where possible. Where number of tests
exceeds the number of fields available on the form, record such results in the
Comments section for later data entry.

•

For children not infected with HIV (seroreverter), include all negative viral
detection and negative antibody tests.

•

All “Confirmed HIV infection (not AIDS)” or AIDS case reports must include
documentation of all children having tested positive for HIV.

•

If “Perinatally HIV Exposed,” include all test results regardless of result.

•

In the absence of lab tests, record HIV or AIDS diagnostic evidence documented
in the medical chart by a physician.

•

See also Technical Guidance for HIV/AIDS Surveillance Programs, Volume I:
Policies and Procedures, Electronic Laboratory Reporting.

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

7.1

HIV ANTIBODY TESTS AT DIAGNOSIS
•

Enter results and test dates for positive HIV antibody tests.

•

“Ind.” means Indeterminate HIV antibody test results.

7.1.1 HIV-1 EIA (each element Required, applies to Health Dept & Health
Care Providers)
•

Enter results and dates of HIV-1 EIA tests, including rapid tests.

•

“Positive EIA” designates repeatedly reactive tests on a single
sample.

7.1.2 HIV-1/HIV-2 COMBINATION EIA (each element Required, applies to
Health Dept & Health Care Providers)
•

Enter results and collection dates of HIV-1/HIV-2 combination EIA
tests.

•

If tests indicate HIV-1 or HIV-2 results separately, please specify the
results as given in the laboratory report.

7.1.3 HIV-1 WESTERN BLOT/IFA (each element Required, applies to Health
Dept & Health Care Providers)
•

Enter results and collection dates of HIV-1 Western blot/IFA tests.

•

Refer to Appendix 7.1.3 for further guidance.

7.1.4 OTHER HIV ANTIBODY TEST, SPECIFY (each element Required,
applies to Health Dept & Health Care Providers)

7.2

•

If HIV-1 antibody tests other than those at 7.1.1–7.1.3 were
employed, specify types of tests performed.

•

Enter results and dates of collection.

POSITIVE HIV DETECTION TESTS
•

Record all tests, including earliest positive.

•

Select applicable response.

•

These are all qualitative tests.

•

All varieties of such tests establish the presence of the pathogen, HIV. By
contrast, HIV tests such as the EIA or Western blot establish the presence of
our immune systems’ response to the pathogen—HIV antibodies.

7.2.1 HIV CULTURE (each element Required, applies to Health Dept &
Health Care Providers)
•

March 2006

Enter results and collection dates of tests by culture.

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

7.2.2 HIV ANTIGEN TEST (each element Required, applies to Health Dept
& Health Care Providers)
•

Enter results and collection dates of antigen tests. Antigens are the
virus’s own proteins; such tests are specific for these proteins.

•

HIV antigen detection tests include Abbott HIVAG-1 Monoclonal and
Coulter HIV-1 p24 Antigen ELISA Test System.

7.2.3 HIV DNA PCR (each element Required, applies to Health Dept &
Health Care Providers)
•

Enter results and dates of DNA PCR tests, including most recent
negative tests.

•

The most commonly used DNA PCR test is Amplicor/COBAS HIV-1
DNA test.

7.2.4 HIV RNA PCR (each element Required, applies to Health Dept &
Health Care Providers)
•

Enter results and dates of RNA PCR tests, including most recent
negative tests.

•

The most commonly used RNA PCR test is Procliex RNA test.

7.2.5 OTHER (SPECIFY) (each element Required, applies to Health Dept &
Health Care Providers)

7.3

•

Enter type of HIV detection test in the space provided, result and date
by this other method.

•

Other assays and their equivalents are any in-house HIV virus
detection tests that are not FDA approved.

HIV VIRAL LOAD TEST
7.3.1 TEST TYPE (Required, applies to Health Dept & Health Care
Providers)
•

Enter test type.

•

Two-digit codes are “11” = NASBA; “12” = RT-PCR; “13” = bDNA;
“18” = other.

•

Enter “19” for unspecified test type.

7.3.2 DETECTABLE (Required, applies to Health Dept & Health Care
Providers)
•

2-20

Enter whether HIV viral load was detectable.

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

7.3.3 COPIES/ML (Required, applies to Health Dept & Health Care
Providers)
•

If viral load was detectable, enter test result in copies per milliliter.

7.3.4 TEST DATE (Required, applies to Health Dept & Health Care
Providers)
•
7.4

Enter date of specimen collection.

IMMUNOLOGIC LAB TESTS (AT OR CLOSEST TO CURRENT DIAGNOSTIC
STATUS)
•

If both CD4 count and percent are available, record both.

•

For all tests, indicate the results and enter the month and year of the test.

•

In the presence of more than two test results for CD4 count or percent, record
additional test information in Section XI, Comments, for later data entry.

7.4.1 CD4 COUNT (each element Required, applies to Health Dept & Health
Care Providers)
•

Record the first CD4 count, the CD4 count at or closest to current
diagnostic status (Section 3.1), and the most recent CD4 counts.

•

For AIDS cases, record the CD4 count closest to an AIDS-defining
clinical condition.

•

Enter month and year of the test.

7.4.2 CD4 PERCENT (each element Required, applies to Health Dept &
Health Care Providers)

7.5

Record the CD4 percent that corresponds with the CD4 count, as
described at 7.4.1, above.

•

If no CD4 count is available, record first CD4 percent, CD4 percent at
or closest to current diagnostic status (Section 3.1), and most recent
CD4 percent values.

•

For AIDS cases, record the CD4 percent closest to an AIDS-defining
clinical condition.

•

Enter month and year of the test.

IF HIV TESTS WERE NOT POSITIVE OR WERE NOT DONE, OR THE
PATIENT IS LESS THAN 18 MONTHS OF AGE, DOES THIS PATIENT HAVE
AN IMMUNODEFICIENCY THAT WOULD DISQUALIFY HIM/HER FROM
THE AIDS CASE DEFINITION? (Required, applies to Health Dept & Health
Care Providers)
•

March 2006

•

Select applicable response.

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•
7.6

Refer to Appendix 7.5 for causes of disqualifying immunodeficiency.

IF HIV LABORATORY TESTS WERE NOT DOCUMENTED, IS HIV
INFECTION CONFIRMED BY A PHYSICIAN AS
•

Documentation by a physician of a patient/parent history or patient self
report is not considered a “physician diagnosis.”

7.6.1 HIV-INFECTED (Required, applies to Health Dept & Health Care
Providers)
•

Select applicable response.

•

If laboratory evidence of an HIV test is unavailable in the patient’s
medical or other record and written documentation of positive HIV
test is noted by the physician, enter “Yes”; otherwise enter “No” or
“Unk.”

7.6.1.1 DATE OF DOCUMENTATION (Required, applies to Health
Dept & Health Care Providers)
7.6.2 NOT HIV-INFECTED (Required, applies to Health Dept & Health Care
Providers)

2-22

•

Select applicable response.

•

If laboratory evidence of negative HIV tests is not available in the
patient’s medical or other record and there is written documentation
by a physician of a diagnosis of seroreverter, based on evidence of
negative HIV laboratory tests noted in the patient medical record,
enter a physician diagnosis of “not infected with HIV” or
“Seroreverter.”

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7.6.2.1 DATE OF DOCUMENTATION (Required, applies to Health
Dept & Health Care Providers)
Section VIII, Clinical status

8.1.1–8.1.24 AIDS INDICATOR DISEASES (Recommended, applies to Health Dept
& Health Care Providers)

8.2

March 2006

•

Select all that apply and enter diagnosis dates.

•

Where search for this datum was unsuccessful, enter “..” where month is
unknown for “Initial Date.”

•

Definitive diagnoses are based on specific laboratory methods such as
histology or culture.

•

Presumptive diagnoses are made by the clinician based on
history/observations.

•

Refer to Appendix 8.1.1–8.1.24 for further guidance.

HAS THIS CHILD BEEN DIAGNOSED WITH PULMONARY
TUBERCULOSIS? (Recommended, applies to Health Dept & Health Care
Providers)
•

Select applicable response.

•

If “Yes,” provide the month and year of diagnosis.

•

The definitive diagnostic method for tuberculosis is culture.

•

For presumptive diagnosis when bacteriologic confirmation is not available,
other reports may be considered to be verified cases of pulmonary
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tuberculosis if the criteria of the Division of Tuberculosis Elimination,
National Center for HIV, STD, and TB Prevention, CDC, are used.
8.2.1 IF “YES,” INITIAL DIAGNOSIS AND DATE (Recommended if
applicable, applies to Health Dept & Health Care Providers)
•

Select applicable response and enter month and year of diagnosis.

•

If search for this datum was unsuccessful, enter “..” for month of
initial diagnosis followed by the documented year.

8.2.2 RVCT CASE NO. (Recommended if applicable, applies to Health Dept)
•

If this patient has a verified case of tuberculosis (TB), health
department staff enter the nine-digit alphanumeric code from the TB
case report or TB data management system. Providers in the private
and public sectors diagnosing tuberculosis in their AIDS patients may
get this number from TB surveillance staff.

Section IX, Birth history (Required for perinatal cases only)

9.1

2-24

BIRTH HISTORY WAS AVAILABLE FOR THIS CHILD (Recommended, applies
to Health Dept & Health Care Providers)
•

Select applicable response.

•

If birth history is not available, proceed to Section X.

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9.2

9.3

9.4

9.5

HOSPITAL OF BIRTH (Recommended, applies to Health Dept & Health Care
Providers)
•

Enter name, city, state, and country of the hospital/clinic of birth.

•

Sites should uniformly record hospital names, including abbreviations.

•

If this child was born at home, enter “home birth.”

RESIDENCE AT BIRTH (Recommended, applies to Health Dept & Health Care
Providers)
•

Enter name of city, county, state, country, and ZIP code of residence of the
patient at birth.

•

Use mother’s residence at time of infant’s birth.

•

After an unsuccessful search for these data, enter “Unk.”

BIRTH WEIGHT (Recommended, applies to Health Dept & Health Care
Providers)
•

Enter the birth weight in pounds or grams as requested on the form.

•

If recorded in pounds and ounces, convert to grams.

BIRTH
9.5.1 TYPE (Recommended, applies to Health Dept & Health Care
Providers)
•

Select applicable response. If unknown, select “9.”

9.5.2 DELIVERY (Recommended, applies to Health Dept & Health Care
Providers)
•

Select applicable response. If unknown, select “9.”

•

Notes in the child’s records are acceptable even if no birth records are
available.

•

Refer to Appendix 9.5.2 for further details.

9.5.3 BIRTH DEFECTS (Recommended, applies to Health Dept & Health
Care Providers)

March 2006

•

Select applicable response.

•

If “Yes,” specify type.

•

Refer to Appendix 9.5.3 for further details and an abbreviated list of
birth defects.

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9.5.3.1 CODE (Recommended, applies to Health Dept & Health Care
Providers)

9.6

9.7

•

Record all codes.

•

Refer to Appendix 9.5.3.1 for further details and list of birth
defect codes.

NEONATAL STATUS (Recommended, applies to Health Dept & Health Care
Providers)
•

Select applicable response and record the child’s gestational age, if known, in
the boxes provided.

•

“Full term” is defined as gestational age greater than or equal to 37 weeks.

•

“Premature” is defined as gestational age less than 37 weeks.

•

If search for gestational age was unsuccessful, then enter “..” for unknown
number of weeks.

•

Post mature neonatal status (after 40 weeks) should be recorded as full term.

PRENATAL CARE (Recommended, applies to Health Dept & Health Care
Providers)
•

Prenatal care is defined as any care for the pregnancy beyond pregnancy
testing and before delivery, even if no regular follow-up ensued.

9.7.1 MONTH OF PREGNANCY PRENATAL CARE BEGAN
(Recommended, applies to Health Dept & Health Care Providers)
•

Record the month of pregnancy (01 to 09) that the mother began her
prenatal care.

•

If any fraction of a month is reported, round to the next whole month.

•

In the absence of prenatal care, enter “00.”

•

Refer to Appendix 9.7.1 for further details.

•

If search for this datum was unsuccessful, then enter “..” for month of
first visit.

9.7.2 TOTAL NUMBER OF PRENATAL CARE VISITS (Recommended,
applies to Health Dept & Health Care Providers)

2-26

•

Record the total number of times the mother went to the clinic or
doctor for her prenatal care; exclude visits unrelated to prenatal care.

•

In the absence of prenatal care visits, enter “00.”

•

In the presence of prenatal care and search for this datum was
unsuccessful, then enter “..” for number of prenatal visits.

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•

Where data source reports a range of visits (e.g., “10–13”), enter the
lowest number (e.g., “10”).

9.8.1 DID MOTHER RECEIVE ZIDOVUDINE (ZDV, AZT) DURING
PREGNANCY? (Recommended, applies to Health Dept & Health Care
Providers)
•

‘Pregnancy’ is defined as: The condition of having a developing
embryo or fetus in the body after union of an ovum and
spermatozoon. Labor and delivery occur after this interval, so they are
not considered part of the ‘pregnancy.’

•

If a woman did not receive zidovudine, do not assume it was because
she refused it.

•

Select “Refused” only if explicit documentation in the medical record
indicates that the patient was offered the drug, but the patient
declined.

•

In the absence of evidence of the patient having taken the drug, select
“No.”

•

Select “Unk.” after an unsuccessful search for this datum.

9.8.2 IF “YES,” WHAT WEEK OF PREGNANCY WAS ZIDOVUDINE (ZDV,
AZT) STARTED? (Recommended, applies to Health Dept & Health
Care Providers)
•

Enter the time of the start of ZDV, AZT.

9.8.3 DID MOTHER RECEIVE ZIDOVUDINE (ZDV, AZT) DURING
LABOR/DELIVERY? (Recommended, applies to Health Dept & Health
Care Providers)
•

If a woman did not receive zidovudine, do not assume it was because
she refused it.

•

Select “Refused” only if specific documentation in the record clearly
states that she was offered the drug but she declined.

•

In the absence of evidence of the patient having taken the drug, select
“No.”

•

“Unk.” should be used only if the labor/delivery records are not
available.

9.8.4 DID MOTHER RECEIVE ZIDOVUDINE (ZDV, AZT) PRIOR TO THIS
PREGNANCY? (Recommended, applies to Health Dept & Health Care
Providers)
•

March 2006

Select “Yes” if information is available that states that the mother
used ZDV anytime before this pregnancy.
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•

Select “No” if mother never used this antiretroviral.

•

Select “Unk.” if it is unknown whether the mother ever used ZDV
before this pregnancy.

9.9.1 DID MOTHER RECEIVE ANY OTHER ANTIRETROVIRAL
MEDICATION DURING PREGNANCY? (Recommended, applies to
Health Dept & Health Care Providers)
•

Select applicable response.

•

If “Yes,” enter type of medication received.

•

For a list of antiretroviral therapies currently available and link to
treatment guidelines, refer to Appendix 9.9.1.

9.9.2 DID MOTHER RECEIVE ANY OTHER ANTIRETROVIRAL
MEDICATION DURING LABOR/DELIVERY? (Recommended,
applies to Health Dept & Health Care Providers)
•

If “Yes,” write in the type of medication received.

•

Examples of other antiretrovirals are listed in Appendix 9.9.1.

9.10 State/local health department to complete shaded area appearing above section X
9.10.1 MATERNAL DATE OF BIRTH (Recommended, applies to Health
Dept)
•

Enter the biologic mother’s month, day, and year of birth.

9.10.2 MATERNAL SOUNDEX (Recommended, applies to Health Dept)
•

Enter maternal soundex here.

•

Refer to Appendix 9.10.2 for further details.

9.10.3 MATERNAL STATE PATIENT NO. (Recommended, applies to Health
Dept)
•

Enter assigned state patient number if the biologic mother is known to
be HIV infected.

•

State patient numbers should not be reused.

9.10.4 BIRTHPLACE OF BIOLOGIC MOTHER (Recommended, applies to
Health Dept)

2-28

•

Mark the box corresponding to the biologic mother’s country of birth.

•

If this information is not available in the child’s records, it can be left
blank and updated on follow-up.

•

Refer to Appendix 9.10.4 for further details.
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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

Section X, Treatment/services referrals

•

This section should be completed by the person initially notifying the health
department of the HIV/AIDS case. Where health department staff populated fields
in the Treatment/Services Referrals section through chart abstraction, providers of
surveillance data may defer this task to public health workers.

•

This information should be updated for each child when there is a change in
diagnostic status, whenever possible.

10.1 THIS CHILD RECEIVED OR IS RECEIVING
10.1.1 NEONATAL ZIDOVUDINE (ZDV, AZT) FOR HIV PREVENTION
(Recommended, applies to Health Dept & Health Care Providers)
•

Record whether child received any neonatal (first 6 weeks of life)
zidovudine to prevent perinatal HIV infection.

•

Refer to Appendix 10.1.1 for further details.

10.1.2 DID NEONATE RECEIVE ANY OTHER ANTIRETROVIRAL
MEDICATION DURING THE NEONATAL PERIOD FOR HIV
PREVENTION? (Recommended, applies to Health Dept & Health Care
Providers)
•

Select applicable response.

•

If “Yes,” record the day, month, and year the child was started on
other antiretrovirals as prophylaxis during the first 6 weeks of life.

•

If the year and month are present but search for day was unsuccessful,
then enter “..” for the day followed by the documented year and
month.

10.1.2.1 IF “YES,” SPECIFY (Recommended, applies to Health Dept
& Health Care Providers)

March 2006

•

If “Yes,” write in the type of medication received.

•

Refer to Appendix 10.1.2.1 for examples.
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10.1.3 ANTIRETROVIRAL THERAPY FOR HIV TREATMENT
(Recommended, applies to Health Dept & Health Care Providers)
•

Select applicable response.

•

If “Yes,” record day, month, and year the child started on any
antiretroviral therapy for treatment of confirmed HIV infection.

•

Refer to Appendix 10.1.3 for further details.

10.1.4 PCP PROPHYLAXIS (Recommended, applies to Health Dept & Health
Care Providers)
•

Select applicable response.

•

If “Yes,” enter the month, day, and year the child was started on
therapy to prevent the occurrence of PCP.

•

If the year and month are present without a designated day, “..” should
be entered for the day followed by the documented year and month.

•

Refer to Appendix 10.1.4 for further details.

•

If nothing in the medical chart indicates the use of any of these drugs
or refers to the prophylactic treatment of PCP, then select “No.”

•

“Unk.” is used if treatment information in the medical chart is unclear
or was unavailable.

10.2 WAS CHILD BREASTFED? (Recommended, applies to Health Dept & Health
Care Providers)
•

Select applicable response.

•

Refer to Appendix 10.2 for further details.

•

If there is suspicion that the child’s only exposure to HIV was through breast
milk, the local/state NIR coordinator should be alerted.

10.3 THIS CHILD HAS BEEN ENROLLED AT
10.3.1 CLINICAL TRIAL (Recommended, applies to Health Dept & Health
Care Providers)
•

Select applicable response according to whether patient is enrolled in
a clinical trial, particularly if that trial is sponsored by the National
Institutes of Health (NIH).

•

Children treated under the AIDS Clinical Trials Group (ACTG)
protocols or enrolled in the Women and Infants Transmission Study
(WITS) are participating in NIH-sponsored clinical trials.

10.3.2 CLINIC (Recommended, applies to Health Dept & Health Care
Providers)
2-30

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•

Select applicable response according to whether patient is enrolled at
a clinic, particularly if that clinic is sponsored by the Health
Resources and Services Administration (HRSA).

10.4 THIS CHILD’S MEDICAL TREATMENT IS PRIMARILY REIMBURSED BY
(Recommended, applies to Health Dept & Health Care Providers)
•

Select the most appropriate response for primary source of reimbursement
for this child’s clinical care.

•

Refer to Appendix 10.4 for further details.

10.5 THIS CHILD’S PRIMARY CARETAKER IS (Recommended, applies to Health
Dept & Health Care Providers)
•

Select the response corresponding to the persons who give the majority of
care for the child.

•

For children living with two biologic parents or just one, “Biologic
parent(s)” should be selected.

•

Refer to Appendix 10.5 for further details.

Section XI, Comments

•

This section can be used for information not requested on the form. For example,
surveillance staff may document investigative progress toward ascertainment of
risk factor information.

•

If city or facility of treatment in another state is known, record these data on as
many CRFs as there are facilities. Each facility represents a separate information
source.

March 2006

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Appendix: Pediatric HIV/AIDS Confidential Case Report
(CDC 50.42B)
Instructions for Completion
Purpose

2-32

•

Information captured on the form provides population-based data on diagnostic
testing and initiation of prophylaxis and treatment, as well as HIV-related
morbidity and mortality among children (CARE Amendments [Section 2626]) to
support states with their prevention activities.

•

CDC’s Division of HIV/AIDS Prevention (DHAP) needs reports and updates to
reflect the earliest dates that children meet each reporting criteria (i.e., perinatal
exposure, HIV infection, AIDS, seroreverter), as well as changes in diagnostic or
vital status.

•

When a child who was previously reported as HIV infected has progressed to
AIDS or has died, state/reporting area personnel update the database accordingly.

•

After programs receive initial reports of evidence of HIV exposure or infection
among children, surveillance staff follow up to determine whether diagnostic
status of the child changes. For example, staff update reports of children with
perinatal exposure after 6 months of age to confirm or refute HIV infection and
again at 18 months of age.

•

The form can accommodate updated information including immunologic markers
and diagnoses of opportunistic infections.

•

CDC updated the HIV/AIDS reporting form and related software in 2000 to:
•

evaluate the implementation and impact of the Public Health Service (PHS)
recommendations on the prevention of transmission of HIV from mother to
child,

•

accommodate surveillance requirements of the Ryan White CARE Act
Amendments of 1996, and

•

accommodate the revised 2000 HIV case definition for perinatal HIV
exposure, pediatric infection, and those perinatally exposed but not infected
with HIV.

•

In 1995, CDC added variables on receipt of maternal ZDV during pregnancy and
labor/delivery and neonatal ZDV.

•

Maternal HIV counseling and testing, prenatal care, and refusal of ZDV treatment
were added in 1996.

•

Viral load tests, receipt of additional antiretroviral (ARV) therapy during
labor/delivery or to the newborn, and elective cesarean were added to the pediatric
reporting form in 1999.

Appendix: Pediatric HIV/AIDS Confidential Case Report (CDC 50.42B)

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•

These additions enable reporting areas to identify possible reasons for failures in
preventing HIV transmission related to childbirth (i.e., receipt of maternal HIV
testing, prenatal care, and antiretroviral treatment).

•

As states move toward pediatric HIV exposure reporting, information on receipt of
prenatal, intrapartum, and neonatal ZDV and receipt of other antiretroviral therapy
can be collected for all children born to HIV-infected women. Timely follow-up of
these children to determine infection status will aid in evaluating the impact of
these recommendations most effectively.

•

For evolution of the pediatric case definition, please refer to the 1987 pediatric
AIDS case definition (MMWR 1987;36(suppl):1–15S), the 1994 revised
classification system for HIV infection in children less than 13 years of age
(MMWR 1994;43:(No. RR-12):1–10), and the 2000 HIV case definition in the
CDC Guidelines for National Human Immunodeficiency Virus Case Surveillance,
Including Monitoring for Human Immunodeficiency Virus Infection and Acquired
Immunodeficiency Syndrome (MMWR 1999;48(RR-13):1–31), available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a1.htm

Pediatric Cases of Public Health Importance (COPHI)
•

COPHI—Reporting area staff should continue to discuss certain priority cases
directly with CDC surveillance staff. These include HIV infection in a health care
setting, HIV-2 infection, HIV infection attributed to tissue or organ transplantation,
suspected transmission due to sexual contact, mother-to-infant transmission due to
breast feeding, transfusions after March 1985, or any unusual transmission
circumstances. This direct communication will ensure the timeliest technical
support. COPHI is covered in Technical Guidance for HIV/AIDS Surveillance
Programs, Volume I: Policies and Procedures for HIV/AIDS Surveillance under
risk factor ascertainment.

Section I, State/local use only (patient identifier information)
•

Although Social Security number is not a field appearing on the 50.42B, it is
useful as a patient identifier.

Section II, Health department use only
2.2

March 2006

REPORT SOURCE
•

If “Other database,” “Other Clinic,” “Other,” or “Out of state” is selected,
specify source in Section X, Comments.

•

Two-level codes for report source are shown below. The first level of source
code is required, and the second level is recommended.

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Report Source Codes for HIV/AIDS Reporting
First level source 

Second (more detailed) level source 

A01. = Inpatient

A01.01 = IP/Acute care facility
A01.01.02 = IP/ACF/OBGYN records
A01.01.03 = IP/ACF/Pediatric records
A01.01.04 = IP/ACF/Birth records
A01.02 = IP/VA
A01.03 = IP/Military hospital
A01.03.02 = IP/Military/OBGYN records
A01.03.03 = IP/Military/Pediatric records
A01.04 = IP/Long-term care facility
A01.04.03 = IP/LTCF/Drug TX program
A01.05 = IP/Hospice

A02. = Outpatient

A02.01 = OP/HMO
A02.02 = OP/VA
A02.03 = OP/Private physician
A02.04 = OP/Adult HIV Clinic
A02.05 = OP/Infect. Dis. Clinic
A02.06 = OP/County HD clinic
A02.07 = OP/Maternal HIV clinic
A02.08 = OP/Prenatal clinic or records
A02.09 = OP/Pediatric HIV clinic
A02.10 = OP/OBGYN clinic (not HIV related)
A02.11 = OP/Pediatric clinic
A02.12 = OP/TB clinic
A02.14 = OP/IHS clinic
A02.15 = OP/Early intervention nurse
A02.16 = OP/Visiting nurse service
A02.17 = OP/Hemophilia TX clinic
A02.18 = OP/Hospice
A02.19 = OP/Drug TX center
A02.20 = OP/Rehab center
A02.25 = OP/Other clinic

A03. = Emergency room

A03 = Emergency room

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

First level source 

Second (more detailed) level source 

A04. = Screening, diagnosis, and A04.01 = Scr, Dx, Ref/Blood bank
referral agencies
A04.02 = Scr, Dx, Ref/Drug TX program
A04.03 = Scr, Dx, Ref/Family planning clinic
A04.04 = Scr, Dx, Ref/HIV case management agency
A04.05 = Scr, Dx, Ref/HIV counseling & testing site
A04.06 = Scr, Dx, Ref/Immigration report
A04.07 = Scr, Dx, Ref/Insurance report
A04.08 = Scr, Dx, Ref/Job Corps
A04.09 = Scr, Dx, Ref/Military
A04.10 = Scr, Dx, Ref/Partner referral & counseling
service
A04.11 = Scr, Dx, Ref/STD clinic
A05. = Laboratory

March 2006

A05.01 = Lab/hosp.
A05.02 = Lab/state
A05.03 = Lab/private

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First level source 

Second (more detailed) level source 

A06. = Other databases

A06.01 = Other DB/ADAP
A06.02 = Other DB/ASD
A06.03 = Other DB/Birth certificate
A06.04 = Other DB/Birth defects registry
A06.05 = Other DB/Cancer registry
A06.06 = Other DB/Database from coroner
A06.07 = Other DB/Death certificate review
A06.08 = Other DB/EHRAP database
A06.09 = Other DB/EPS database
A06.10 = Other DB/HARS database
A06.11 = Other DB/Health department records
A06.12 = Other DB/Hepatitis registry
A06.13 = Other DB/Hosp billing summary or
discharge data
A06.14 = Other DB/HRSA HIV Care database
A06.15 = Other DB/Immunization registry
A06.16 = Other DB/Medicaid records
A06.17 = Other DB/NDI
A06.18 = Other DB/Out-of-state report
A06.19 = Other DB/Prison, jail, or other correctional
facility database
A06.20 = Other DB/PSD
A06.21 = Other DB/State disease registry
A06.22 = Other DB/SHAS
A06.23 = Other DB/SHDC database
A06.24 = Other DB/STD registry
A06.25 = Other DB/TB registry
A06.50 = Other DB/Other database or report

A07. = Other facility records

A07.01 = Oth facility records/Prison, jail, or other
correctional facility
A07.02 = Oth facility records/Coroner, not associated
with IP facility

A10 = Other source

A10 = Other source
(specify)_________________________________

Unknown

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Section III, Demographic information
3.1

DIAGNOSTIC STATUS AT REPORT
•

See 3.1.1–3.1.4, below.

3.1.1 PERINATALLY HIV EXPOSED
•

The “Perinatally HIV Exposed” category is composed of
“Presumptively Not Infected,” “Definitively Not Infected,” and
“Indeterminate.”

•

A child aged less than 18 months born to an HIV-infected mother will
be categorized as having perinatal exposure to HIV infection if the
child does not meet the criteria for HIV infection or the criteria for
“not infected with HIV.”

3.1.2 CONFIRMED HIV INFECTION (NOT AIDS)
•

Among children aged greater than or equal to 18 months and less than
13 years, a reportable case of HIV infection must meet at least one of
the following criteria:

Laboratory Criteria
•

•

Positive result on a screening test for HIV antibody (e.g., repeatedly reactive
enzyme immunoassay), followed by a positive result on a confirmatory
(sensitive and more specific) test for HIV antibody (e.g., Western blot or
immunofluorescence antibody test) or
Positive result or report of a detectable quantity on any of the following HIV
virologic (nonantibody) tests:
• HIV nucleic acid (DNA or RNA) detection (e.g., DNA polymerase chain
reaction [PCR] or plasma HIV-1 RNA)
• HIV p24 antigen test, including neutralization assay
• HIV isolation (viral culture)

OR
Clinical or Other Criteria (if the above laboratory criteria are not met)
•
•

Diagnosis of HIV infection, based on the laboratory criteria above, that is
documented in a medical record by a physician or
Conditions that meet criteria included in the case definition for AIDS

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•

Among children aged less than 18 months, a reportable case of HIV
infection must meet at least one of the following criteria:

Laboratory Criteria
Definitive
•

Positive results on two separate specimens (excluding cord blood) using one or
more of the following HIV virologic (nonantibody) tests:
• HIV nucleic acid (DNA or RNA) detection
• HIV p24 antigen test, including neutralization assay, in a child greater than
or equal to 1 month of age
• HIV isolation (viral culture)
OR

Presumptive
A child who does not meet the criteria for definitive HIV infection but who has:
•

Positive results on only one specimen (excluding cord blood) using the above
HIV virologic tests and no subsequent negative HIV virologic or negative HIV
antibody test
OR

Clinical or Other Criteria (if the above definitive or presumptive laboratory
criteria are not met)
•
•

2-38

Diagnosis of HIV infection, based on the laboratory criteria above, that is
documented in a medical record by a physicianOR
Conditions that meet criteria included in the 1987 pediatric surveillance case
definition for AIDS (http://www.cdc.gov/mmwr/pdf/other/mmsu3601.pdf)—
see next page for detailed listing
•

In the absence of laboratory evidence of HIV infection in the child,
that child meets the HIV case definition if diagnosed with conditions
that meet the criteria in the 1987 pediatric case definition for AIDS if
born to a mother known to be infected at the time of birth.

•

The current HIV case definition for children less than 13 years of age,
and persons of all ages, is available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a2.htm.

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3.1.3 AIDS

•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•

•

The current pediatric AIDS case definition is available at
http://www.cdc.gov/mmwr/pdf/other/mmsu3601.pdf. The 1994
revised classification system for HIV infection in children less than
13 years of age is available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/00032890.htm.

•

Children who are HIV infected and exhibit any of the following
AIDS-defining clinical conditions should be reported as presumptive
AIDS cases; although most of these conditions appear among adult
AIDS diagnostic criteria, asterisked conditions apply only to pediatric
cases.

•

For children with an AIDS-defining condition that requires laboratory
evidence of HIV infection, a single positive HIV-detection test (i.e.,
HIV culture, HIV PCR, or HIV p24 antigen) is sufficient for a
reportable AIDS diagnosis if the diagnosis is confirmed by a
clinician.

Candidiasis, esophageal
Cervical cancer, invasive
Coccidioidomycosis, disseminated or extrapulmonary
Cryptococcosis, extrapulmonary
Cryptosporidiosis, chronic intestinal (>1 month’s duration)
Cytomegalovirus disease (other than liver, spleen, or nodes)
Cytomegalovirus retinitis (with loss of vision)
Encephalopathy, HIV related
Herpes simplex: chronic ulcer(s) (>1 month’s duration); or bronchitis,
pneumonitis, or esophagitis
Histoplasmosis, disseminated or extrapulmonary
Isosporiasis, chronic intestinal (>1 month’s duration)
Kaposi’s sarcoma
Lymphoid interstitial pneumonia*
Lymphoma, Burkitt’s (or equivalent term)
Lymphoma, immunoblastic (or equivalent term)
Lymphoma, primary, of brain
Multiple recurrent bacterial infections*
Mycobacterium avium complex or M. kansasii, disseminated or extrapulmonary
Mycobacterium, other species or unidentified species, disseminated or
extrapulmonary
Pneumocystis carinii pneumonia
Progressive multifocal leukoencephalopathy
Salmonella septicemia, recurrent
Toxoplasmosis of brain
Wasting syndrome due to HIV

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3.1.4 SEROREVERTER
•

Virtually all children less than 18 months of age born to HIV-infected
mothers are antibody positive at birth.

•

A child aged < 18 months born to an HIV-infected mother will be
categorized for surveillance purposes as “not infected with HIV” if
the child does not meet the criteria for HIV infection but meets the
following criteria:

Laboratory Criteria
Definitive
• At least two negative HIV antibody tests from separate specimens obtained at > 6
months of age
• At least two negative HIV virologic tests* from separate specimens, both of which
were performed at > 1 month of age and one of which was performed at > 4
months of age
AND
No other laboratory or clinical evidence of HIV infection (i.e., has not had any
positive virologic tests, if performed, and has not had an AIDS-defining condition)
OR
Presumptive
A child who does not meet the above criteria for definitive “not infected” status but
who has:
• One negative EIA HIV antibody test performed at > 6 months of age and NO
positive HIV virologic tests, if performed
OR
• One negative HIV virologic test* performed at > 4 months of age and NO positive
HIV virologic tests, if performed
OR
• One positive HIV virologic test with at least two subsequent negative virologic
tests*, at least one of which is at > 4 months of age; or negative HIV antibody test
results, at least one of which is at > 6 months of age
AND
No other laboratory or clinical evidence of HIV infection (i.e., has not had any
positive virologic tests, if performed, and has not had an AIDS-defining condition).
OR
Clinical or Other Criteria (if the above definitive or presumptive laboratory criteria
are not met)
Determined by a physician to be “not infected,” and a physician has noted the results
of the preceding HIV diagnostic tests in the medical record
AND
NO other laboratory or clinical evidence of HIV infection (i.e., has not had any
positive virologic tests, if performed, and has not had an AIDS-defining condition)
* HIV nucleic acid (DNA or RNA) detection tests are the virologic methods of choice to exclude infection in children aged < 18
months. Although HIV culture can be used for this purpose, it is more complex and expensive to perform and is less well
standardized than nucleic acid detection tests. The use of p24 antigen testing to exclude infection in children aged < 18 months
is not recommended because of its lack of sensitivity.

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3.5

CURRENT STATUS
•

3.8

For further guidance on death ascertainment, see Technical Guidance for
HIV/AIDS Surveillance Programs, Volume I: Policies and Procedures,
Death Ascertainment.

DATE OF INITIAL EVALUATION FOR HIV INFECTION
•

Enter the date of initial evaluation for HIV infection.

•

Evidence of HIV infection in a child must be obtained on or after the birth
date.

3.10 SEX
•

In addition to “Male” or “Female” sex at birth, CDC-supplied software
includes a third choice of “Unk.” Although “CURRENT_SEX” is not a
variable appearing on the case report form, the person completing the form
may record current sex in Section XI or in the form’s margin next to Section
III—particularly if current sex differs from sex at birth.

•

Selections and legal values for “CURRENT_SEX” from eHARS Lookup
Codes are as follows:
CURRENT_SEX = F = Female Person’s current sex
CURRENT_SEX = I = Intersexed Person’s current sex
CURRENT_SEX = M = Male Person’s current sex

•

March 2006

Additionally, the current form does not include fields for patient gender, but
eHARS optionally does. A variety of genders may be recorded either in the
margin of the case report form at Section III or in the Comments section.
Note that “CURRENT_GENDER” adds behavioral, biological, and
iatrogenic selections to those of “current sex.”

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•

Selections and legal values for “CURRENT GENDER” from eHARS
Lookup Codes are as follows:

CURRENT_GENDER = CD = Cross Dresser Person’s current gender
CURRENT_GENDER = DQ = Drag Queen Person’s current gender
CURRENT_GENDER = F = Female Person’s current gender
CURRENT_GENDER = FM = Female to Male Person’s current gender
CURRENT_GENDER = I = Intersexed Person’s current gender
CURRENT_GENDER = M = Male Person’s current gender
CURRENT_GENDER = MF = Male to Female Person’s current gender
CURRENT_GENDER = SM = She Male Person’s current gender
3.11 ETHNICITY
•

Regardless of the presence of race or absence of any information, collect data
on ethnicity.

•

As of January 2003, the US Office of Management and Budget (OMB)
required that race and ethnicity (Hispanic, non-Hispanic) for a person be
collected as separate variables.

•

A wide variety of ethnicities may be selected from legal values available in
CDC-supplied software. These ethnicities and codes are documented in the
eHARS Technical Reference Guide.

3.12 RACE
•

•

2-42

As of January 2003, the US Office of Management and Budget (OMB)
required that systems collect multiple races for a person (OMB Policy
Directive 15 updated standards); at a minimum, collect data on the following
categories:
•

American Indian or Alaska Native

•

Asian

•

Black or African American

•

Native Hawaiian or Other Pacific Islander

•

White

A wide variety of race categories may be selected from legal values available
in CDC-supplied software. These races and codes are documented in the
eHARS Technical Reference Guide.

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3.13 COUNTRY OF BIRTH
•

Select first from boxes provided:
United States
US dependency, specify
Other, specify
Unknown

•

For patients born in US dependencies, specify from the following table:
US dependencies
American Samoa

Pacific Trust Terr.

Guam

Palau

Johnston Atoll

Puerto Rico

Mariana Islands

Ryukyu Islands

Marshall Islands

Swan Islands

Micronesia

US Virgin Islands

Midway Islands

Wake Island

Navassa Island
3.14 RESIDENCE AT DIAGNOSIS

March 2006

•

For reports of HIV infection or perinatal HIV exposure, enter the patient’s
city, county, state/country, and ZIP code of residence at the time of the first
confirmatory test for HIV infection or when HIV infection was first
considered, either clinically or through laboratory evaluation.

•

Documentation of an HIV test is often the earliest evidence that HIV
diagnosis was considered; however, an HIV test may not have been ordered
at that time.

•

If the patient’s residence changes between diagnosis of perinatal HIV
exposure and confirmed HIV infection, record new address.

•

If laboratory slips are not available, enter the patient’s residence at the date of
physician diagnosis of HIV infection.

•

For AIDS case reports, enter the patient’s residence at the date of the first
AIDS-defining clinical condition or the date of the first immunologic marker
that reaches AIDS-defining thresholds.

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3.14.1 RESIDENCE, HOMELESS
•

For homeless patients, enter the address that most accurately
describes where they stay—including a shelter address if applicable.

•

People without a usual residence should be reported by the
jurisdiction where they were staying at the time of diagnosis.

For further guidance about residency assignment, see Technical Guidance for
HIV/AIDS Surveillance Programs, Volume I: Policies and Procedures, Case
Residency Assignment.
Section IV, Facility of diagnosis
4.1

4.4

FACILITY NAME
•

For reports of perinatal HIV exposure, enter the name of the facility where
child was first evaluated for HIV infection, either clinically or through
laboratory evaluation.

•

The hospital where the mother obtained prenatal care should not be used to
answer this question unless it was also the facility where the child was born
and HIV infection was considered as a diagnosis at the time of the child’s
birth or at the time of subsequent physician/clinic visits.

•

For reports of confirmed HIV infection, enter the name of the facility where
the child was confirmed to be HIV-infected.

•

If test results were not in the medical record, enter the name of the facility
where the child’s HIV infection was diagnosed and documented by the health
care provider.

•

If a facility name is not documented but a physician’s name is listed, enter
“Private Physician” or a numeric code for each physician; enter the name of
the physician under Physician Identifier Information (Section VI).

•

For reports of AIDS, enter the name of the facility where the patient’s AIDSdefining clinical condition was first diagnosed.

•

If a physician name is listed without facility name, enter physician name.

•

These fields strictly apply to facility where HIV or AIDS was diagnosed.
Where chart abstraction is accomplished at a facility other than the Facility
of Diagnosis (Section IV), document report source at “report source” field;
refer to 2.2 for further details.

FACILITY SETTING
•

2-44

State/local surveillance program staff may create tables of settings by
facilities in their jurisdictions to prevent misclassification.

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4.5

FACILITY TYPE
•

Select “Physician, HMO” where diagnosis was made at a private, outpatient
care site not associated with a hospital.

•

Examples of “Other” include HIV counseling and testing sites, STD clinics,
drug treatment facilities, family planning clinics, prenatal/obstetrics clinics,
tuberculosis clinics, and correctional facilities. Select “Other” for any public
outpatient setting.

Section V, Patient/maternal history
•

Surveillance staff have found such information within mother’s chart at discharge
summary, history and physical, social service notes, counseling and testing notes,
and STD diagnosis notes.

•

Where not explicitly annotated, contact child’s provider about maternal/child risk
factor information.

•

Definition of ‘Risk factors’: The collective term for the individual routes of
exposure/transmission on which data are routinely collected for surveillance of
HIV/AIDS cases. “Yes,” “No,” or “Unk.” must be selected.

•

See Technical Guidance for HIV/AIDS Surveillance Programs, Volume I: Policies
and Procedures, Risk Factor Ascertainment for further guidance on risk factor data
collection. States should have risk factor ascertainment procedures tailored to their
jurisdictions as well.

5.1

CHILD’S BIOLOGIC MOTHER’S HIV INFECTION STATUS
•

“Refused HIV testing” should be selected if mother’s refusal is documented
in the medical chart.

•

If the biologic mother has been tested for HIV and found to be uninfected at
or after the child’s birth, then perinatal transmission is not the presumed
mode of exposure to HIV infection.

•

If, however, mother-to-infant transmission through breast-feeding is
considered as the only mode of transmission, please alert the state or local
NIR coordinator and enter in the field labeled “other” in the patient/maternal
history section.

5.2. (MOTHER) DIAGNOSED WITH HIV INFECTION/AIDS
•

If dates are not available, please review medical charts to determine when
maternal HIV diagnosis occurred in relationship to the child’s birth and
select:
3) before this child’s pregnancy;
4) during this child’s pregnancy;

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5) at time of delivery (i.e., when admitted for labor/delivery and before
discharge from the birth hospital or within 7 days of birth;
6) before child’s birth, exact period unknown;
7) after the child’s birth (i.e., anytime after discharge from birth hospital
or after 7 days of birth); or
8) HIV-infected, unknown when diagnosed.
•

If no information is available regarding maternal HIV status, please select:
9) HIV status unknown.

5.3

DATE OF MOTHER’S FIRST POSITIVE HIV CONFIRMATORY TEST
The following is adapted from an excerpt of the adult/adolescent HIV
surveillance case definition, accessible at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a2.htm:
Necessary for HIV infection (not AIDS)

5.4

5.5

•

Documentation of +EIA plus +WB/IFA with date

or

•

Detectable viral load with date

or

•

Positive p24 antigen test with date

or

•

Positive viral culture with date

or

•

Physician documentation of HIV with date

MOTHER WAS COUNSELED ABOUT HIV TESTING DURING THIS
PREGNANCY, LABOR, OR DELIVERY?
•

Complete this question for all mothers regardless of whether they were
diagnosed with HIV infection before this pregnancy.

•

If not, then select “No.”

•

If no information in the medical chart is available regarding counseling, then
select “Unk.”

AFTER 1977, THIS CHILD’S BIOLOGIC MOTHER HAD
5.5.2.3 HETEROSEXUAL RELATIONS WITH PERSON WITH
HEMOPHILIA/COAGULATION DISORDER

2-46

•

They do not include other bleeding disorders, such as
thrombocytopenia, treatable by platelet transfusion.

•

If only a transfusion of platelets, other blood cells, or plasma
was received by the partner, then the correct answer to this
question is “No”; and the question below about transfusion
recipient should be answered “Yes” if the partner was also
known to be HIV infected.

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•

Refer to Protocol for Evaluation of Identification and
Follow-up of Cases of Public Health Importance at
http://www2a.cdc.gov/hicsb/docs/COPHI_Protocol.pdf for
more information.

5.5.2.4 HETEROSEXUAL RELATIONS WITH TRANSFUSION
RECIPIENT WITH DOCUMENTED HIV INFECTION
•

This refers to someone with documented HIV infection who
received a transfusion of blood cells (red cells, white cells,
platelets) or plasma.

5.6.1 RECEIVED CLOTTING FACTOR FOR COAGULATION DISORDER
•

They do not include other bleeding disorders, such as
thrombocytopenia, treatable by platelet transfusion.

•

If only a transfusion of platelets, other blood cells, or plasma was
received, then the correct answer to this question is “No”; and the
question below about blood transfusion should be answered “Yes.” If
“Yes,” please specify disorder.

•

If child was born after March 1985 and receipt of clotting factor is the
suspected mode of HIV transmission, alert the state/local NIR
coordinator.

Section VI, State/local use only
6.1

PHYSICIAN’S NAME
•

6.3

March 2006

If the test was provided as part of a visit to a health department, an STD
clinic, an HIV counseling and testing site, or other facility where no single
individual is responsible for medical management of the patient, leave this
space blank and complete the “Facility of Diagnosis” section appropriately.

MEDICAL RECORD NUMBER
•

This field may be left blank unless patient was hospitalized as an inpatient or
treated as an outpatient in a hospital, community health center, or health
department clinic.

•

If the patient has more than one medical record number, enter the number of
the primary record that has HIV/AIDS documentation. Additional numbers
can be noted in the Comments section, clearly annotating which facility is
associated with which record number.

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Section VII, Laboratory data
7.1.3 HIV-1 Western blot/IFA
•

7.5

Western blot banding patterns should be interpreted according to the
CDC/Association of State and Territorial Public Health Laboratory
Directors (ASTPHLD) recommendations “Human Immunodeficiency
Virus Type 1 Infections” (MMWR, 1989:38:No.S-7).

IF HIV TESTS WERE NOT POSITIVE OR WERE NOT DONE, OR THE
PATIENT IS LESS THAN 18 MONTHS OF AGE, DOES THIS PATIENT HAVE
AN IMMUNODEFICIENCY THAT WOULD DISQUALIFY HIM/HER FROM
THE AIDS CASE DEFINITION?
Causes of immunodeficiency that disqualify clinical conditions as indicators of
AIDS in the absence of laboratory evidence for HIV infection are:

•

•

•

High-dose or long-term systemic corticosteroid therapy or other
immunosuppressive/cytotoxic therapy within 3 months before the onset of the
AIDS-defining clinical condition.
Any of the following diseases diagnosed before or within 3 months after the
AIDS-defining clinical condition was diagnosed:
• Hodgkin’s disease
• non Hodgkin’s lymphoma (other than primary brain lymphoma)
• lymphocytic leukemia
• multiple myeloma
• any other cancer of lymphoreticular or histiocytic tissue
• angioimmunoblastic lymphadenopathy
A genetic (congenital) immunodeficiency syndrome or an acquired
immunodeficiency syndrome atypical of HIV infection, such as one involving
hypogammaglobulinemia.

Section VIII, Clinical status
8.1.1–8.1.24 AIDS INDICATOR DISEASES

2-48

•

Enter the dates of initial diagnosis of each indicator disease.

•

If at all possible, it is important to include both month and year for future
trend analysis.

•

In rare circumstances, both month and year may not be available. However,
if after further searches the investigator finds that the only documentation of
the diagnosis date is the year, without a designated month, “..” should be
entered for the unknown month followed by the documented year.

•

Choosing an arbitrary month is not recommended.
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•

Definitive diagnoses are based on specific laboratory evidence such as
histology or culture.

•

Methods for the presumptive diagnosis of diseases indicative of AIDS listed
in the case definition supplement are simply suggested guidelines, not
requirements. If a method does not meet the requirements for definitive
diagnosis, it meets the requirements for presumptive diagnosis for those
conditions that may be diagnosed presumptively. Accept any method that the
clinician considers diagnostic.

Section IX, Birth history (for perinatal cases only)
9.5.2 DELIVERY
•

Elective cesarean section refers to a cesarean section that occurs
before rupture of membranes and before the onset of labor.

•

Elective cesarean section has been demonstrated to reduce perinatal
transmission of HIV, if performed before the onset of labor.

•

It will be important to monitor the trends in the use of elective
cesarean section for the prevention of perinatal HIV.

9.5.3 DEFECTS

March 2006

•

Data collected will be used to evaluate changes in incidence or other
unusual patterns of serious birth defects among children exposed to
zidovudine in utero compared with those who were not exposed and
with the general population.

•

Approximately 3%–4% of all babies will have serious birth defects
(i.e., neural tube defects, congenital heart defects, esophageal atresia,
cleft lip/palate, etc.).

•

The methods and definitions used were developed by the CDC
National Center on Birth Defects and Developmental Disabilities and
are currently used in the Metropolitan Atlanta Congenital Defects
Program, an active surveillance system for birth defects in the Atlanta
metropolitan area.

•

Select “Yes” if the child meets the case definition for birth defects as
defined by the CDC National Center on Birth Defects and
Developmental Disabilities and used in the Metropolitan Atlanta
Congenital Defects Program and listed below:

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Criteria for Inclusion as Reportable Birth Defect:
•

The child must have a structural or genetic birth defect or
other specified birth outcome that can adversely affect his or
her health and development.

•

The structural or genetic birth defect must be diagnosed or
its signs or symptoms recognized within the first year of life.

•

The infant must have a gestational age of at least 20 weeks or
a birth weight of at least 500 grams.

•

A case must be abstracted by the child’s sixth birthday.

Criteria for Exclusion:
•

2-50

Defects such as normal variants or minor anomalies are
considered excludable. Diagnoses that may be normal
variants or minor anomalies may be included only if
associated with another reportable defect.

•

Imprecise diagnoses (probable, possible, compatible with, consistent
with, suspected, questionable, suggestive of, etc.) should be
abstracted and coded as such and follow-up conducted to ascertain
true status.

•

For children with possible birth defects, please review newborn and
hospital records including the face sheet; history and physical;
discharge summary; operative, laboratory, x-ray, cardiac
catheterization, and autopsy reports; and notes and consultations by
physicians, nurses, and social and psychologic services.

•

In addition, birth defect (i.e., congenital anomalies) information is
also collected on the standard US birth certificate.

•

Hospital records should be reviewed to determine if a reportable
defect is present. Each reportable condition is coded separately
according to the birth defect code (see below). These codes are based
on ICD-9 codes but provide more specific diagnostic information.

•

If reportable birth defects are diagnosed, select “Yes” and abstract all
diagnoses onto the case report form.

•

Include discrepant diagnoses. Also include diagnoses appearing in the
chart that have not been ruled out by an expert or lab test.

•

If the infant is diagnosed with a syndrome, record the name and code
of the syndrome as well as the individual defects.

•

If there is a question about whether a diagnosis is reportable or how to
code any diagnosis, please call the CDC HIV Incidence and Case
Surveillance Branch (HICSB) at (404) 639-2050. For reference, you
may request the full copy of the Metropolitan Atlanta Congenital
Defects Program Procedure Manual from HICSB at (404) 639-2050.

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9.5.3.1 CODE
•

The 6-digit defect code is based on 3- or 5-digit ICD-9
codes. The ICD-9 code, which may be available in the
child’s medical record, can be used in place of the 6-digit
code. If defects exist, list all on the case report form and
enter in the Comments section. Call CDC’s DHAP Help
Desk by phone at (877) 659-7725 for assistance with coding.

•

The following is an abbreviated reference list for birth defect
coding:

System

Condition

6-digit Codes

Central Nervous System

Spina Bifida (meningocele)

741.000–741.990 A04

Anencephaly

740.000–740.100 A01

Encephalocele

742.000–742.090 A13

Atrial septal defects

745.510–745.590 D06

Ventricular septal defects

745.400–745.490 D05

Pulmonary valve anomalies

746.000–746.090 D12

Coarctation of the aorta

747.100–747.190 D26

Aortic valve anomalies

746.300–746.490 D14

Transposition of the Great Arteries

745.100–745.190 D02

Tetralogy of Fallot

745.200–742.210 D03

Hypoplastic left heart syndrome

746.700

Cleft palate without cleft lip

749.000–749.090 F01

Cleft lip with and without cleft palate

749.100–749.290 F02

Clubfoot

754.730

Reduction defect of upper limb

755.200–755.290 K01

Reduction defect of lower limb

755.300–755.390 K02

Down syndrome

758.000–758.098 R01

Trisomy 13 (Patau Syndrome)

758.100–758.198 R02

Trisomy 18 (Edwards Syndrome)

758.200–758.298 R03

22q11.2 deletion

758.370

Cataract

743.320–743.326 B04

Anophthalmos and microphthalmus

743.000–743.100 B01

Hypospadius

752.600–752.607 G02

Anomalies of renal pelvis and ureter

753.200–753.290 H06

Ambiguous genitalia

752.700–752.790 G04

Cardiovascular

Orofacial
Musculoskeletal

Chromosomal

Eye
Genitourinary

Abdominal Wall Anomalies Gastrochisis
Diaphragmatic Anomalies

Note:

3-digit Codes

D18

J05

R04

756.710

N04

Omphalocele

756.700

N02

Diaphragmatic hernia

756.600–756.616 N01

To add a birth defect that is not in this abbreviated list, please refer to the codes
from the Metropolitan Atlanta Congenital Defects Program Procedure Manual.

March 2006

Appendix: Pediatric HIV/AIDS Confidential Case Report (CDC 50.42B)

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

9.7.1 MONTH OF PREGNANCY PRENATAL CARE BEGAN

2-52

•

Enter “09” if care began in the ninth month or later.

•

If entry is reported in weeks, convert to appropriate months as
follows:
Weeks

Months

Weeks

Months

1–4

1

23–26

6

5–9

2

27–30

7

0–13

3

31–35

8

14–17

4

36+

9

18–22

5

Appendix: Pediatric HIV/AIDS Confidential Case Report (CDC 50.42B)

March 2006

Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

9.9.1 DID MOTHER RECEIVE ANY OTHER ANTIRETROVIRAL
MEDICATION DURING PREGNANCY?
•

A single drug formulation often has multiple names; trade names are
in bold. Drug names include the following, which serves only as a
guide. This guide is current as of January 2005:
Drug type among antiretroviral class

Nucleoside/
Non-Nucleoside
Protease
Nucleotide Reverse Reverse Transcriptase Inhibitors
Transcriptase
Inhibitors (NNRTIs)
Inhibitors (NRTIs)

Fusion
Inhibitors

NRTI
Combination
Drugs

Drug name
Abacavir—ABC,
Ziagen

Delavirdine—
Rescriptor

Amprenavir— Enfuvirtide
Agenerase
—Fuzeon

Combivir

Didanosine—ddI,
Videx, Videx EC

Efavirenz—Sustiva

Atazanavir—
Reyataz

Trizivir

Emtricitabine—
FTC, Emtriva

Nevirapine—
Viramune

Indinavir—
Crixivan

Truvada

Lamivudine—3TC,
Epivir

Lopinavir +
Ritonavir—
Kaletra

Abacavir
combo

Stavudine—D4T,
Zerit

Nelfinavir—
Viracept

Tenofovir—
Disoproxil,
Fumarate, Viread

Ritonavir—
Norvir

Zalcitabine—ddC,
HIVID

Saquinavir
(hard gel
capsule)—
Invirase

Zidovudine—AZT,
ZDV, Retrovir

Saquinavir
(soft gel
capsule)—
Fortovase

•

Clinicians initiating antiretroviral regimens in the HIV-1-infected pregnant patient
should refer to Recommendations for Use of Antiretroviral Drugs in Pregnant
HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal
HIV-1 Transmission in the United States at
http://www.aidsinfo.nih.gov/guidelines/.

March 2006

Appendix: Pediatric HIV/AIDS Confidential Case Report (CDC 50.42B)

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

9.10.2 MATERNAL SOUNDEX
•

If name of the patient’s biologic mother has not been entered in the
database, enter name and date of birth in the CDC-supplied software.

•

The biologic mother’s surname will be converted to a SOUNDEX
CODE when entered into the CDC-supplied software.

•

If name of the biologic mother has been entered in your database and
a “stateno” exists, retrieve the soundex code from the database and
enter here.

•

Consult with your state/local health department in jurisdictions with
alternatives to name-based reporting.

9.10.4 BIRTHPLACE OF BIOLOGIC MOTHER
•

Select first from boxes provided:
United States
US dependency, specify
Other, specify
Unknown

•

For patients born in US dependencies, specify from the following
table:
US dependencies
American Samoa

Pacific Trust Terr.

Guam

Palau

Johnston Atoll

Puerto Rico

Mariana Islands

Ryukyu Islands

Marshall Islands

Swan Islands

Micronesia

US Virgin Islands

Midway Islands

Wake Island

Navassa Island
Section X, Treatment/services referrals
10.1.1 NEONATAL ZIDOVUDINE (ZDV, AZT) FOR HIV PREVENTION
•

2-54

The neonatal component of the ACTG protocol 076 consisting of 6
weeks of neonatal prophylactic ZDV therapy should begin within 24
hours of birth. Therefore, to monitor implementation and impact, we

Appendix: Pediatric HIV/AIDS Confidential Case Report (CDC 50.42B)

March 2006

Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

collect the day, month, and year the child was first started on ZDV for
prophylaxis.
•

If “Yes,” record the day, month, and year the child was started on
AZT or ZDV as prophylaxis during the first 6 weeks of life.

•

If search for day was unsuccessful and year and month are present,
then enter “..” for the unknown day followed by the documented year
and month.

10.1.2 DID NEONATE RECEIVE ANY OTHER ANTIRETROVIRAL
MEDICATION DURING THE NEONATAL PERIOD FOR HIV
PREVENTION?
10.1.2.1 IF “YES,” SPECIFY
•

Examples of other antiretrovirals are as follows: Didanosine
(ddI, dideoxyinosine, Videx), Dideoxycytidine (ddC,
HIVID, Zalcitabine), Lamivudine (3TC, Epivir), Stavudine
(d4t, Zerit), Nevirapine, Indinavir (Crixivan), Ritonavir, and
Saquinavir (Invirase).

10.1.3 ANTIRETROVIRAL THERAPY FOR HIV TREATMENT
•

Please refer to the Guidelines for the Use of Antiretroviral Agents in
Pediatric HIV Infection (MMWR 1998;47(RR-4):1–43). Examples of
antiretroviral therapies include Zidovudine (ZDV, AZT, Retrovir),
Didanosine (ddI, dideoxyinosine, Videx), Dideoxycytidine (ddC,
HIVID, Zalcitabine), Lamivudine (3TC, Epivir), Stavudine (d4T,
Zerit), Nevirapine, Indinavir (Crixivan), Ritonavir, and Saquinavir
(Invirase).

10.1.4 PCP PROPHYLAXIS

March 2006

•

Please refer to MMWR 1995;44(RR-4):1–11 for the 1995 Revised
Guidelines for Prophylaxis Against Pneumocystis carinii Pneumonia
(PCP) for Children Infected with or Perinatally Exposed to HIV.
Examples of PCP prophylaxis include
Trimethoprim/sulfamethoxazole (TMP/SMX, Bactrim, Septra),
Pentamidine, and Dapsone.

•

TMP/SMX (Bactrim, Septra) can be used to treat infections other than
HIV but is usually used for a shorter period. For example, TMP/SMX
is used for 2–3 weeks to treat otitis media and would NOT be
recorded as “Yes” in this field.

•

Include as PCP prophylaxis if it is clearly noted as such in the medical
chart or given for a period of 2 weeks or longer.

Appendix: Pediatric HIV/AIDS Confidential Case Report (CDC 50.42B)

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Technical Guidance for HIV/AIDS Surveillance Programs — Pediatric HIV/AIDS Confidential Case Report

10.2 WAS CHILD BREASTFED?
•

Avoidance of breast-feeding to prevent postpartum transmission of HIV has
been recommended for HIV-infected mothers in the United States.

10.4 THIS CHILD’S MEDICAL TREATMENT IS PRIMARILY REIMBURSED BY
•

Medicaid reimbursement means specifically Medicaid and includes
Medicaid HMOs.

•

For clinical trial or government program, please select the applicable trial or
program. For example, State Crippled Children’s services would be “other
public funding.” HRSA clinic would be “Clinical trial/government
program.”

10.5 THIS CHILD’S PRIMARY CARETAKER IS

2-56

•

“Other relative” refers to children living with an aunt, grandmother, etc. in an
informal arrangement, and the relative does not receive a stipend for
providing care.

•

If a child lives with a relative and that relative is paid a stipend for caring for
the child, “Foster/Adoptive parent, relative” should be selected.

•

A child is in “foster/adoptive parent, unrelated” if living with someone other
than a relative.

•

“Adoptive parent, relative” refers to child who has been legally adopted by a
relative. This includes children with dead parents whose legal custody has
been transferred to a relative.

•

If the adoptive parent is unrelated please select “foster/adoptive parent,
unrelated.” This includes children with dead parents whose legal custody has
been transferred to a person who is unrelated to the child.

•

“Social service agency” refers to children whose primary caretaker is a social
service agency, which usually refers to children living in group home
situations.

•

For children being cared for in situations not described above, select “other”
and specify in section XI.

Appendix: Pediatric HIV/AIDS Confidential Case Report (CDC 50.42B)

March 2006


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