Guidance: Pediatric HIV Confidential Case Report Form

National HIV Surveillance System (NHSS)

Attachment 4(b)
Technical Guidance for HIV Surveillance Programs:
Pediatric HIV Confidential Case Report Form

Technical Guidance for HIV
Surveillance Programs
Pediatric HIV Confidential Case Report Form

HIV Surveillance Branch
Atlanta, Georgia

Contents
Instructions for Completion........................................................................................................................... 3
Purpose of Case Report Form ................................................................................................................... 3
The Case Report Form in the Context of Document-Based Surveillance ................................................. 3
Patients for Whom Form is Indicated ........................................................................................................ 3
Definition of Variable Designators............................................................................................................ 4
Disposition of Form................................................................................................................................... 4
1. Patient Identification ........................................................................................................................... 4
2. Health Department Use Only .............................................................................................................. 6
3. Facility Providing Information ........................................................................................................... 7
4. Patient Demographics ......................................................................................................................... 8
5. Residence at Diagnosis ..................................................................................................................... 12
6. Facility of Diagnosis ......................................................................................................................... 12
7. Patient History .................................................................................................................................. 14
8. Clinical: Opportunistic Illnesses ....................................................................................................... 18
9. Laboratory Data ................................................................................................................................ 20
10. Birth History (for patients exposed perinatally with or without consequent infection) ................... 27
11. Birthing Person History .................................................................................................................... 30
12. Treatment/Services Referrals............................................................................................................ 37
13. Comments ......................................................................................................................................... 38
14. Local/Optional Fields ....................................................................................................................... 39
Appendix. Pediatric HIV Confidential Case Report Form (CDC 50.42B) ................................................. 40

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Instructions for Completion
Purpose of Case Report Form
The Pediatric HIV Confidential Case Report (CDC 50.42B) form (PCRF) is designed to collect
information that promotes understanding of perinatal HIV exposure and HIV infection morbidity and
mortality among patients less than 13 years of age at time of diagnosis. This form reflects data that is
required to be collected and some that is recommended or optional. This guidance applies to all perinatal
HIV exposure and HIV infection data collection even if state or local surveillance programs use a
different form or medium for perinatal HIV exposure and HIV case surveillance. See Appendix for
further guidance.
Prior to 2023, CDC provided a separate Perinatal HIV Exposure Reporting (PHER) form to facilitate
collection of additional standardized data on HIV-exposed children. CDC revised the PCRF to include
some additional standardized data on HIV-exposed children and retired the separate PHER form in 2023.

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 reported case,
fill out the applicable part of the form for each data source contributing information to that perinatal HIV
exposure or HIV case.
Accurate data abstraction is critical. For example, the dates of receipt of prenatal care should be before
the infant’s date of birth. If inconsistent information is found in medical records indicate that in the
Comments section on the data abstraction form. This will serve as documentation that the inconsistency
was in the medical record and is not an error in abstraction, notation, or data entry. The HIV Surveillance
Coordinator in each jurisdiction, or their designee, should review all forms before the data are entered.

Patients for Whom Form is Indicated
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Each child less than 13 years of age, who meets the HIV infection or stage 3 (AIDS) case
definition (available at https://ndc.services.cdc.gov/conditions/hiv-infection-aids-has-beenreclassified-as-hiv-stage-iii/).
For perinatal exposure HIV reporting, all children born to HIV-infected persons. This includes
only live births. The definition of a live birth as defined by the World Health Organization is:
‘...the complete expulsion or extraction from its [birthing person] of a product of conception,
irrespective of the duration of the pregnancy, which, after such separation, breathes or shows
any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or
definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the
placenta is attached; each product of such a birth is considered live born.’
Thus, if a birth certificate has been completed for the infant and birthing person was HIVinfected, the form should be completed.
Includes each child whose infection status has not yet been determined, seroconverters, and
those exposed but determined not to be infected with HIV; inclusion of such patients is for
public health surveillance purposes only.
Each child with HIV infection progressing from an earlier or unknown stage to stage 3 (AIDS)
diagnosis before 13 years of age.
Each child with HIV infection who has been reported but for whom updated information is
available such as new CD4 tests, viral load tests, or drug resistance tests (genotypic) reported
from a medical provider, additional risk factor information, updated current address
information, or a change in vital status.
For each follow-up (typically every 6 months) of a child with perinatal HIV exposure whose

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infection status has not been determined until the diagnostic status is known or up to 18
months of age.
If the data is collected electronically and can be imported, recording the information on a hardcopy form
is not necessary. A federal assurance of confidentiality applies to information on children exposed
perinatally with or without consequent infection.

Definition of Variable Designators

Required: Variables that must be collected by all programs. Please note that for some of these
variables there must be a known value reported in order to meet the eligibility criteria for data
associated with the patient to be transmitted to the Centers for Disease Control and Prevention
(CDC) through the CDC-supplied enhanced HIV/AIDS Reporting System (eHARS). The
eHARS Technical Reference Guide details the specific variables required to meet the eligibility
criteria at the beginning of Chapter 3. The eHARS Technical Reference Guide can be accessed
through SharePoint: https://cdcpartners.sharepoint.com/sites/NCHHSTP/HICSB/default.aspx.
Recommended: Variables that programs are strongly encouraged to collect but are not
absolutely required.
Optional: Variables that programs may or may not choose to collect.
System generated: Variables where the value is generated by eHARS.

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Disposition of Form

The completed form is for state or local health agency use and is not to be sent to CDC. The
Pacific Islands are the only jurisdictions that send forms to CDC for data entry and all patient
identifiers must be removed before they are sent.
Data obtained from these forms are entered into standardized computer software provided by
the Division of HIV Prevention, National Center for HIV, Viral Hepatitis, STD, and TB
Prevention, CDC, and then transferred without identifiers to CDC by encrypted electronic
transfer via a secure access management service.

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•

1. Patient Identification

Patient identifier information is for state and local health department use only and is not
transmitted to CDC if marked with an * on the form.
• Enter the data below for all children reported as perinatally exposed to HIV or reported with
HIV infection.
FIRST NAME (Required, applies to health department & health care providers)
• Enter patient’s first name.
MIDDLE NAME (Optional, applies to health department & health care providers)
• Enter patient’s middle name.
LAST NAME (Required, applies to health department & health care providers)
• Enter patient’s last name.
LAST NAME SOUNDEX (System generated)
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1.1
1.2
1.3
1.4

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After patient name is entered into eHARS, the software automatically generates this variable
by using the patient’s last name. After the code is generated, health department staff should
fill this field 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. The
eHARS Technical Reference Guide describes exactly how the Last Name Soundex is
created.
• You can access the eHARS Technical Reference Guide through SharePoint:
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HICSB/default.aspx
ALTERNATE NAME TYPE (Optional, applies to health department & health care providers)
• If available, write in the alternate name type (e.g., Alias, Birth Name)
ALTERNATE FIRST NAME (Optional, applies to health department & health care providers)
• Enter patient’s alternate first name.
ALTERNATE MIDDLE NAME (Optional, applies to health department & health care
providers)
• Enter patient’s alternate middle name.
ALTERNATE LAST NAME (Optional, applies to health department & health care providers)
• Enter patient’s alternate last name.
ADDRESS TYPE (Required, applies to health department & health care providers)
• Select one of the address types for the patient’s current address.
CURRENT ADDRESS, STREET (Required, applies to health department & health care
providers)
• Enter the patient’s current street address.
ADDRESS DATE (Required, applies to health department & health care providers)
• Enter the earliest date that the patient was known to be residing at the current address
specified in 1.10. If the patient has resided at an address more than once (and has evidence
that they resided elsewhere in between), the address date captured should be the earliest date
that the patient moved to the address in the most recent instance.
• You may enter the most recent date the patient was known to be residing at the address in
the Comments section. In eHARS, enter the address with the most recent address date on a
separate PCRF document on the “Identification” tab.
• Enter date in mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
PHONE (Required if patient has a telephone, applies to health department & health care
providers)
• Enter patient’s primary area code and telephone number associated with the current address
specified in 1.10.
CITY (Required, applies to health department & health care providers)
• Enter patient’s current city.
COUNTY (Required, applies to health department & health care providers)
• Enter patient’s current county.
STATE/COUNTRY (Required, applies to health department & health care providers)
• Enter patient’s current state and country name.
ZIP CODE (Required, applies to health department & health care providers)
• Enter patient’s current zip code.
MEDICAL RECORD NUMBER (Optional, applies to health department & health care
providers)
• Enter medical record number of the patient if available.
• 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.
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1.5
1.6
1.7
1.8
1.9
1.10
1.11

1.12

1.13
1.14
1.15
1.16
1.17

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If the patient has more than one medical record number, enter the number of the primary
record that has perinatal HIV exposure, HIV infection, or stage 3 (AIDS) documentation.
Additional numbers can be noted in the Comments section annotating which facility is
associated with which record number. In eHARS, enter the additional medical record
numbers on the “Identification” tab.
1.18–1.19 OTHER ID TYPE and NUMBER (Optional, applies to health department & health care
providers)
• Enter any additional patient identifier type (such as social security number) and the number
of the other identifier. For a list of ID types, please reference the eHARS Technical
Reference Guide.
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2. Health Department Use Only

Enter the data below for all children reported as perinatally exposed to HIV or reported with
HIV infection.
DATE RECEIVED AT HEALTH DEPARTMENT (Recommended, applies to health
department)
• Enter date in mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
eHARS DOCUMENT UID (System generated)
• Enter UID after eHARS generates this variable.
STATE NUMBER (Required, applies to health department)
• Enter the assigned state number.
• Each patient must have a unique state number throughout the course of HIV disease
(including perinatal HIV exposure) in each state/jurisdiction where they are reported.
However, if the patient was a pediatric “Seroreverter” and was later infected with HIV, the
patient must be given two different state numbers; one associated with the “Seroreverter”
and another associated with the HIV infection diagnosis. Refer to Appendix 4.1.4 for the
definition of a pediatric “Seroreverter”. Jurisdictions must use the “Same as” field on the
“Duplicate Review” tab in eHARS to link the two cases. Enter the appropriate state number
associated with the events being reported on the case report form. For example, if providing
information about the “Seroreverter”, enter the state number associated with the
“Seroreverter”.
• Assigned numbers must not be reused, even if the case is later deleted.
• This variable is used, along with the state of report, to uniquely identify cases
reported to CDC and to merge state datasets without duplication.
REPORTING HEALTH DEPARTMENT -CITY/COUNTY (Required, applies to health
department)
• Enter name of city and county of the health department that receives the report from
providers of surveillance data.
CITY/COUNTY NUMBER (Optional, applies to health department)
• Enter the assigned city/county number.
• Each patient must have a unique city/county number throughout the course of HIV disease
(including perinatal HIV exposure) assigned by the separately funded city in which they are
reported. However, if the city/county number is the primary identifier and the patient was a
•

2.1
2.2
2.3

2.4

2.5

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pediatric “Seroreverter” and was later infected with HIV, the patient must be given two
different city/county numbers; one associated with the “Seroreverter” and another associated
with the HIV infection diagnosis. Refer to Appendix 4.1.4 for the definition of a pediatric
“Seroreverter”. If the city/county number is the primary identifier, the jurisdiction must use
the “Same as” field on the “Duplicate Review” tab in eHARS to link the two cases. Enter the
appropriate city/county number associated with the events being reported on the case report
form. For example, if providing information about the “Seroreverter”, enter the city/county
number associated with the “Seroreverter”.
• Assigned numbers must not be reused, even if the case is later deleted.
2.6 DOCUMENT SOURCE (Required, applies to health department)
• Enter the code for the document source that provided the information for this report
(formerly report source).
• To clearly identify multiple data sources for a given perinatal HIV exposure or HIV case (all
stages), use a separate case report form for each source.
• Refer to the eHARS Technical Reference Guide for a list of the document source codes
available in eHARS.
2.7 SURVEILLANCE METHOD (Required, applies to health department)
• Enter the method the case report was ascertained.
• For definitions of active, passive, follow up, re-abstraction see Technical Guidance File
Source Data and Completeness of Reporting.
2.8 DID THIS REPORT INITIATE A NEW INVESTIGATION? (Optional, applies to health
department)
• Enter whether this case report initiated a new investigation by the health department.
2.9 REPORT MEDIUM (Optional, applies to health department)
• Health department staff review medical records at provider facilities (i.e., field visits) or
receive information over the telephone, by fax, US mail, or other method, to establish a
perinatal HIV exposure or HIV case and to elicit information for HIV case report forms. The
health department can also receive HIV case reports from physicians, laboratories, or other
individuals or institutions through electronic transfer or CD/disks. Enter the medium in
which the case report was submitted.

3. Facility Providing Information

Facility information is for state and local health department use only and is not transmitted
to CDC if marked with an * on the form.
• Enter the data below for all children reported as perinatally exposed to HIV or reported with
HIV infection.
FACILITY NAME (Recommended, applies to health department & health care providers)
• Enter name of the facility providing the information.
• If data was reported from different facilities, enter name of each on separate forms.
PHONE (Recommended, applies to health department & health care providers)
• Enter facility’s current area code and telephone number.
•

3.1
3.2

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3.3
3.4
3.5
3.6
3.7
3.8

3.9
3.10

3.11

STREET ADDRESS (Recommended, applies to health department & health care providers)
• Enter facility’s street address.
CITY (Recommended, applies to health department & health care providers)
• Enter city where facility providing information is located.
COUNTY (Recommended, applies to health department & health care providers)
• Enter county where facility providing information is located.
STATE/COUNTRY (Recommended, applies to health department & health care providers)
• Enter state and country name where facility providing information is located.
ZIP CODE (Recommended, applies to health department & health care providers)
• Enter ZIP code where facility providing information is located.
FACILITY TYPE (Required, applies to health department & health care providers)
• Select the type of facility providing information.
• Refer to the eHARS Technical Reference Guide for additional information regarding facility
types available in eHARS.
DATE FORM COMPLETED (Required, applies to health department & health care providers)
• Enter date in mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
PERSON COMPLETING FORM (Optional, applies to health department & health care
providers)
• Enter the name of the person completing the form who can be contacted to clarify entries
and supply additional information.
PHONE (Recommended, applies to health department & health care providers)
• Enter the telephone number of the person completing the form.

4. Patient Demographics

Enter the data below for all children reported as perinatally exposed to HIV or reported with
HIV infection.
DIAGNOSTIC STATUS AT REPORT (Optional, applies to health department & health care
providers)
• Use one form to capture each event regardless of the interval between diagnostic status
dates, and where the same source of these data reported more than one event. Fill out
suitable number of case report forms:
o Fill out the first form completely for the first event.
o Fill out subsequent forms partially, capturing additional or updated data absent
from the first form.
• Status depends on child’s age, clinical profile, and laboratory findings. Refer to Appendix
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4.1

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4.1.1–4.1.4 for further guidance.
4.1.1
PERINATAL HIV EXPOSURE
o Select “Perinatal HIV Exposure” if the patient is less than 18 months of age, was
born to an HIV-infected person, and has an undetermined HIV infection status.
o Refer to Appendix 4.1.1 for further guidance.
4.1.2
PEDIATRIC HIV
o Select “Pediatric HIV” if the patient meets the criteria specified in the Revised
Surveillance Case Definition for HIV Infection in children < 13 years of age and
does not meet the current CDC pediatric HIV infection stage 3 (AIDS) case
definition.
o Refer to Appendix 4.1.2 for further guidance.
4.1.3
PEDIATRIC AIDS
o Select “Pediatric AIDS” if patient meets the current HIV infection stage 3 case
definition for children < 13 years of age.
o Refer to Appendix 4.1.3 for further guidance.
4.1.4
PEDIATRIC SEROREVERTER
o 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 4.1.4.
o Of the four diagnostic status categories available on the case report form,
“Pediatric Seroreverter” is synonymous with “Not Infected with HIV”.
4.2 SEX ASSIGNED AT BIRTH (Required, applies to health department & health care providers)
• Select patient’s sex assigned at birth.
• If search for this datum was completed and sex assigned at birth could not be assigned as
“Male” or “Female”, select “Unknown”.
4.3 COUNTRY OF BIRTH (Recommended, applies to health department & health care providers)
• Select applicable response.
• For patients born in US minor outlying areas, specify the name of the US dependency from
the following table:
US Dependencies
Baker Island
Howland Island
Jarvis Island
Johnston Atoll
Kingman Reef

Midway Islands
Navassa Island
Palmyra Atoll
Wake Island

For patients born in any other area outside of the US and US minor outlying areas, specify
the country/US dependency name.
4.4 DATE OF BIRTH (Required, applies to health department & health care providers)
• Enter patient’s date of birth in mm/dd/yyyy format using “..” for unknown values (e.g.,
03/../2011).
4.5 ALIAS DATE OF BIRTH (Optional, applies to health department & health care providers)
• If available, enter the alias date of birth in mm/dd/yyyy format using “..” for unknown values
(e.g., 03/../2011).
4.6 VITAL STATUS (Required, applies to health department & health care providers)
• Enter vital status at time of this report.
• For further guidance on death ascertainment, see Technical Guidance File Death
Ascertainment.
4.7 DATE OF DEATH (Required if applicable, applies to health department & health care
•

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providers)
• If patient is deceased, enter date of death in mm/dd/yyyy format using “..” for unknown
values (e.g., 03/../2011).
• For further guidance on death ascertainment, see Technical Guidance File Death
Ascertainment.
4.8 STATE OF DEATH (Required, if applicable, applies to health department & health care
providers)
• If patient is deceased, enter the state name where the death occurred. If the death occurred
outside of the US, enter “Foreign Country”.
4.9 DATE OF LAST MEDICAL EVALUATION (Optional, applies to health department & health
care providers)
• Enter the date of the child’s last medical evaluation in mm/dd/yyyy format using “..” for
unknown values (e.g., 03/../2011) regardless of reason for exam. This includes emergency
room visits.
4.10 DATE OF INITIAL EVALUATION FOR HIV INFECTION (Optional, applies to health
department & health care providers)
• Enter the date of initial evaluation for HIV infection in mm/dd/yyyy format using “..” for
unknown values (e.g., 03/../2011). This is the date when HIV infection was first considered,
either clinically or through laboratory evaluation.
• For a child whose birthing person 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.
• Evidence of HIV infection in a child must be obtained on or after the birth date.
4.11

GENDER IDENTITY and DATE IDENTIFIED (Required if not perinatal exposure or
perinatal transmission, applies to health department & health care providers)
• Enter the gender identity of the patient.
• If the patient’s stated gender identity differs from the selections provided or the patient’s
stated gender identity at a point in time includes more than one of the selections provided,
select “Additional gender identity” and specify the gender identity or gender identities.
• If documented that the patient declined to provide their gender identity, select “Declined to
answer”.
• If search for this datum was completed and gender identity could not be determined or if
gender identity was documented to be unknown, select “Unknown”.
• Refer to the lookup codes in the eHARS Technical Reference Guide for gender identity
values available in eHARS.
• For date identified, please enter the date the patient indicated identifying as the selected
gender identity, if documented. If this date is unknown, enter the date of service (e.g.,
medical appointment, partner services interview) for when the information on gender
identity was obtained. If that date is unknown, enter the most recent date of service. You
may also enter the most recent date associated with the patient’s gender identity in the
Comments section. In eHARS, enter the gender identity value associated with the most
recent date on a separate PCRF document on the “Demographics” tab. Record the date in
mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
• If the patient’s gender identity has changed over time, record the other gender identities and
associated dates identified in the Comments section. In eHARS, enter each additional value
on separate PCRF documents on the “Demographics” tab.

4.12

SEXUAL ORIENTATION and DATE IDENTIFIED (Required if not perinatal exposure or

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4.13

4.14

4.15

4.16

perinatal transmission, applies to health department & health care providers)
• Enter sexual orientation of the patient.
• If the patient’s stated sexual orientation differs from the selections provided or the
patient’s stated sexual orientation at a point in time includes more than one of the
selections provided, select “Additional sexual orientation” and specify the sexual
orientation or sexual orientations.
• If documented that the patient declined to provide their sexual orientation, select
“Declined to answer”.
• If search for this datum was completed and sexual orientation could not be determined or
if the sexual orientation was documented to be unknown, select “Unknown”.
• Refer to the lookup codes in the eHARS Technical Reference Guide for sexual orientation
values available in eHARS.
• For date identified, please enter the date the patient indicated identifying as the selected
sexual orientation, if documented. If this date is unknown, enter the date of service for
when the information on sexual orientation was obtained. If that date is unknown, enter the
most recent date of service. You may also enter the most recent date associated with the
patient’s sexual orientation in the Comments section. In eHARS, enter the sexual
orientation value associated with the most recent date on a separate PCRF document on the
“Demographics” tab. Record it in mm/dd/yyyy format using “..” for unknown values (e.g.,
03/../2011).
• If the patient’s sexual orientation has changed over time, record other sexual
orientations and associated dates identified in the Comments section. In eHARS, enter
each additional value on separate PCRF documents on the “Demographics” tab.
ETHNICITY (Required, applies to health department & health care providers)
• If search for this datum was completed and ethnicity could not be determined or if ethnicity
was documented to be unknown, select “Unknown”.
• If no search for this datum was completed, leave this field blank.
• Regardless of the availability of data on race, collect data on ethnicity.
• As of January 2003, the US Office of Management and Budget (OMB) required that race
and ethnicity (Hispanic/Latino, Not Hispanic/Latino) for a person be collected as separate
variables.
• A wide variety of ethnicities may be selected from values available in eHARS. These
ethnicities and codes are documented in the eHARS Technical Reference Guide.
EXPANDED ETHNICITY (Optional if applicable, applies to health department & health care
providers)
• Enter more specific ethnicity information for greater detail such as “Hispanic or Latino Cuban” or “Hispanic or Latino - Puerto Rican”.
• Refer to the eHARS Technical Reference Guide for listing of expanded ethnicity.
RACE (Required, applies to health department & 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 “Unknown”.
• 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 five categories: American Indian or Alaska Native,
Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White.
• Refer to the eHARS Technical Reference Guide for further details.
EXPANDED RACE (Optional, if applicable, applies to health department & health care

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providers)
• Enter more specific race information for greater detail such as “American Indian or Alaska
Native.Navajo” or “White.Middle Eastern or North African”.
• Refer to the eHARS Technical Reference Guide for listing of expanded race.

5. Residence at Diagnosis

Residence information is for state and local health department use only and is
not transmitted to CDC if marked with an * on the form.
• Enter the data below for all children reported as perinatally exposed to HIV or reported with
HIV infection.
• Refer to Appendix 5.0 for further guidance.
• If patient’s residence at HIV diagnosis and stage 3 (AIDS) diagnosis are different, enter the
address information associated with the stage 3 (AIDS) diagnosis in the Comments section.
In eHARS, enter the address information associated with stage 3 (AIDS) diagnosis on the
“Demographics” tab with the applicable address event type.
ADDRESS EVENT TYPE (Required, applies to health department & health care providers)
• Select the address event type for the patient’s residence at diagnosis.
• If the patient’s residence at HIV diagnosis and stage 3 (AIDS) diagnosis was the same, you
may check both.
ADDRESS TYPE (Required, applies to health department & health care providers)
• Select one of the address types for the patient’s address of residence at diagnosis.
STREET ADDRESS (Required, applies to health department & health care providers)
• Enter street address of residence at diagnosis.
CITY (Required, applies to health department & health care providers)
• Enter city of residence at diagnosis.
COUNTY (Required, applies to health department & health care providers)
• Enter county of residence at diagnosis.
STATE/COUNTRY (Required, applies to health department & health care providers)
• Enter the state and country name of residence at diagnosis.
ZIP CODE (Required, applies to health department & health care providers)
• Enter the ZIP code of residence at diagnosis.
•

5.1

5.2
5.3
5.4
5.5
5.6
5.7

6. Facility of Diagnosis

•
•

Facility information is for state and local health department use only and is
not transmitted to CDC if marked with an * on the form.
Enter the data below for all children reported as perinatally exposed to HIV or reported with

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HIV infection.
• If the patient’s HIV diagnosis and stage 3 (AIDS) diagnosis occurred at different facilities,
enter the stage 3 (AIDS) facility information in the Comments section. In eHARS, enter the
facility information associated with stage 3 (AIDS) diagnosis on the “Facility” tab with the
applicable diagnosis type.
6.1 DIAGNOSIS TYPE (Recommended, applies to health department & health care providers)
• Enter the diagnosis type that corresponds to the facility of diagnosis being
reported.
6.2 FACILITY NAME (Recommended, applies to health department & health care providers)
• Enter name of the facility where patient was first diagnosed which
corresponds with the “Diagnosis Type” reported in 6.1.
• Refer to Appendix 6.2 for further details.
6.3 PHONE (Recommended, applies to health department & health care providers)
• Enter area code and telephone number of the facility of diagnosis.
6.4 STREET ADDRESS (Recommended, applies to health department & health care providers)
• Enter street address of the facility of diagnosis.
6.5 CITY (Recommended, applies to health department & health care providers)
• Enter city of the facility of diagnosis.
6.6 COUNTY (Recommended, applies to health department & health care providers)
• Enter county of the facility of diagnosis.
6.7 STATE/COUNTRY (Recommended, applies to health department & health care providers)
• Enter state and country name of the facility of diagnosis.
6.8 ZIP CODE (Recommended, applies to health department & health care providers)
• Enter ZIP code where the facility of diagnosis is located.
6.9 FACILITY TYPE (Required applies to health department & health care
providers)
• Select the type of facility of diagnosis.
• Refer to the eHARS Technical Reference Guide for listing of facility types.
6.10 PROVIDER NAME (Recommended, applies to health department & health care providers)
• Enter provider’s name where the patient was first diagnosed which
corresponds with the “Diagnosis Type” reported in 6.1.
6.11 PROVIDER PHONE (Recommended, applies to health department & health care
providers)
• Enter area code and telephone number for provider selected in 6.10.
6.12 SPECIALTY (Optional, applies to health department & health care providers)
• Enter provider’s specialty for provider selected in 6.10.

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7. Patient History

Enter all data below for children reported with HIV infection. For children reported as
perinatally exposed to HIV, enter data below through 7.7.4; do not enter data under the
heading “Before the diagnosis of HIV infection, this child had:”.
• These data yield information about how patients may have acquired their infection.
• Respond to each risk factor, selecting “Yes” for all factors that apply; “No” for those that do
not apply (only select “No” if medical record specifically states this is not a risk factor); and
“Unknown” for those for which investigation failed to yield an answer. If an investigation
for a particular item was not performed, then you should leave it blank. Collect data about
risk factors that occurred before the earliest known diagnosis of HIV infection. For further
guidance, see Technical Guidance File Risk Factor Ascertainment.
• 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 infected. For
example, if the child received a blood transfusion after the documentation of HIV infection,
do not enter that information on the form.
• 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 guidance, see Technical Guidance File Risk Factor Ascertainment.
BIRTHING PERSON’S HIV INFECTION STATUS (Required, applies to health department
& health care providers)

•

7.1

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For the birthing person, if HIV infection was diagnosed then select from boxes 3–8 (i.e., box
“Known HIV+ before pregnancy” to box “HIV+, time of diagnosis unknown”), depending
on information available to determine the timing of diagnosis. Where date of the birthing
person’s first positive test result to confirm HIV infection is available, select the appropriate
box by comparing the date of birth of the child to the date of HIV infection diagnosis of the
birthing person.
• Refer to Appendix 7.1 for further guidance.
DATE OF BIRTHING PERSON’S FIRST POSITIVE TEST RESULT TO CONFIRM
INFECTION (Optional, applies to health department & health care providers)
• Where the birthing person is known to be HIV infected, enter month, day, and year of the
specimen collection date of the first positive test result to confirm HIV infection in
mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
CHILD BREASTFED/CHESTFED BY BIRTHING PERSON (Required, applies to health
department and health care providers)
• Select applicable response.
• Select “Yes” is there is evidence that the patient was fed milk from the birthing person’s
chest or documentation indicates that the patient was bodyfed by the birthing person.
• When the birthing person was known to be not HIV infected at the time of child’s birth an
investigation should be initiated and the state/local Cases of Public Health Importance
(COPHI) coordinator should be alerted. In all other situations, investigation is not required
but the CDC COPHI coordinator can be consulted if interested in further investigating
breastfeeding/chestfeeding as the mode of transmission.
CHILD RECEIVED PREMASTICATED/PRE-CHEWED FOOD FROM BIRTHING PERSON
(Required, applies to health department and health care providers)
• Select applicable response.
• When the birthing person was known to be not HIV infected at the time of child’s birth an
investigation should be initiated and the state/local COPHI coordinator should be alerted. In
all other situations, investigation is not required, but the CDC COPHI coordinator can be
consulted if interested in further investigating premastication/pre-chewing as the mode of
transmission.
AFTER 1977 AND BEFORE THE EARLIEST KNOWN DIAGNOSIS OF HIV INFECTION,
THE BIRTHING PERSON HAD:
7.5.1
PERINATALLY ACQUIRED HIV INFECTION (Required, applies to health
department & health care providers)
o Select applicable response.
7.5.2
INJECTED NON-PRESCRIPTION DRUGS (Required, applies to health department
& health care providers)
o Select applicable response.
o Select “Yes” if the birthing person injected illicit or nonprescription drugs at any
time in the past or if a drug prescribed to the birthing person was injected when
there is evidence that injection equipment was shared (e.g., syringes, needles,
cookers).
•

7.2

7.3

7.4

7.5

7.6

BIRTHING PERSON HAD HETEROSEXUAL RELATIONS WITH ANY OF THE
FOLLOWING:
• This section relates to ascertainment of risk among heterosexual sex partners of the birthing
person of the case patient.
• Heterosexual contact is defined as the birthing person having sexual contact with a partner
whose sex assigned at birth is different from the patient’s sex assigned at birth.
• Verification of sex partner’s HIV infection status is not necessary.

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7.6.1

7.7

PERSON WHO INJECTED DRUGS (Required, applies to health department &
health care providers)
o Select applicable response. Select “Yes” if the partner injected illicit or
nonprescription drugs at any time in the past or if a drug prescribed to the partner
was injected when there is evidence that injection equipment was shared (e.g.,
syringes, needles, cookers).
7.6.2
BISEXUAL MALE (Required, applies to health department & health care providers)
o Select applicable response. “Yes” should be selected only if the partner’s sex
assigned at birth is male and there is evidence that the partner also had sex with
another person whose sex assigned at birth was male.
7.6.3
PERSON WITH HEMOPHILIA/COAGULATION DISORDER WITH
DOCUMENTED HIV INFECTION (Required, applies to health department & health
care providers)
o “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).
o Do not include other bleeding disorders, such as thrombocytopenia, treatable by
platelet transfusion.
o If a transfusion of only platelets, other blood cells, or plasma was received by the
partner, then code “No” and see question 7.6.4 below.
o If yes, alert the state/local COPHI coordinator.
7.6.4
TRANSFUSION RECIPIENT WITH DOCUMENTED HIV INFECTION (Required,
applies to health department & health care providers)
o Consider documenting the reason for transfusion in the Comments section. In
eHARS, enter on the “Comments” tab.
o Refers to someone with documented HIV infection who received a transfusion of
blood cells (red cells, white cells, platelets) or plasma.
o If yes, alert the state/local COPHI coordinator.
7.6.5
TRANSPLANT RECIPIENT WITH DOCUMENTED HIV INFECTION (Required,
applies to health department & health care providers)
o Consider documenting the reason for transfusion/transplant in the Comments
section. In eHARS, enter on the “Comments” tab.
o If yes, alert the state/local COPHI coordinator.
7.6.6
PERSON WITH DOCUMENTED HIV INFECTION, RISK NOT SPECIFIED
(Required, applies to health department & health care providers)
o Select “Yes” only if partner is known to be HIV-positive and that partner’s risk for
HIV is unknown.
BIRTHING PERSON HAD:
7.7.1-7.7.3 RECEIVED TRANSFUSION OF BLOOD/BLOOD COMPONENTS (OTHER
THAN CLOTTING FACTOR), FIRST DATE RECEIVED, and LAST DATE
RECEIVED (Required, applies to health department & health care providers)
o ‘Blood,’ is defined as a circulating tissue composed of a fluid portion (plasma) with
suspended formed elements (red blood cells, white blood cells, platelets).
o ‘Blood components’ that can be transfused, include erythrocytes, leukocytes,
platelets, and plasma.
o If “Yes”, specify the month, day, and year of the first and last transfusion before
the birthing person received a diagnosis of HIV infection (stage 1,2, unknown) or
stage 3 (AIDS). Enter date in mm/dd/yyyy format using “..” for unknown values

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(e.g., 03/../2011).
o Consider documenting the reason for transfusion/transplant in the Comments
section. In eHARS, enter on the “Comments” tab.
o If the last transfusion was after March 1985, alert the state/local COPHI
coordinator.
7.7.4
RECEIVED TRANSPLANT OF TISSUES/ORGANS OR ARTIFICIAL
INSEMINATION (Required, applies to health department & health care providers)
o If this is the only risk factor present and the birthing person did not have HIV
infection diagnosed 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.
o If yes, alert the state/local COPHI coordinator.
7.8 BEFORE THE DIAGNOSIS OF HIV INFECTION, THIS CHILD HAD
• Alert state/local COPHI coordinator if the child had one or more of the risk factors
documented in this section.
7.8.1
INJECTED NON-PRESCRIPTION DRUGS (Required, applies to health department
& health care providers)
o Select applicable response.
o Select “Yes” if the patient injected illicit or nonprescription drugs at any time in the
past or if a drug prescribed to the patient was injected when there is evidence that
injection equipment was shared (e.g., syringes, needles, cookers).
7.8.2-7.8.4 RECEIVED CLOTTING FACTOR FOR HEMOPHILIA/COAGULATION
DISORDER, SPECIFY CLOTTING FACTOR, and DATE RECEIVED (Required,
applies to health department & health care providers)
o “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).
o This risk factor is generally documented in the history and physical section of the
patient’s medical chart.
o They do not include other bleeding disorders, such as thrombocytopenia, treatable
by platelet transfusion.
o If only a transfusion of platelets, other blood cells, or plasma was received by the
partner, then select “No”.
o Alert state/local COPHI coordinator if child was born after March 1998 and receipt
of clotting factor is the suspected mode of HIV transmission.
o If “Yes”, then enter the specific clotting factor and the date the clotting factor was
received in mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
7.8.5
RECEIVED TRANSFUSION OF BLOOD/BLOOD COMPONENTS (OTHER
THAN CLOTTING FACTOR) (Required, applies to health department & health care
providers)
o If child received a transfusion of blood cells (red cells, white cells, and platelets) or
plasma, specify month, day, and year of first and last transfusion before the patient
was infected with HIV or received a diagnosis of stage 3 (AIDS). Enter date in
mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
o It is often helpful to document the reason for the transfusion in the Comments
section. In eHARS, enter on the “Comments” tab.
7.8.6
RECEIVED TRANSPLANT OF TISSUE/ORGANS (Required, applies to health
department & health care providers)
o The case will be initially classified as “risk not reported/identified” pending
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7.8.7

7.8.8

7.8.9

7.8.10
7.8.11

outcome of the no identified risk (NIR) investigation.
SEXUAL CONTACT WITH A MALE (Required, applies to health department &
health care providers)
o If child is known to have had sexual contact/abuse, mark the appropriate box based
on the partner’s sex assigned at birth. If search for this datum was completed and
the partner’s sex assigned at birth cannot be determined, select “Unknown”.
o If this is the only risk history, the case will be initially classified as “risk not
reported/identified” pending outcome of NIR investigation.
SEXUAL CONTACT WITH A FEMALE (Required, applies to health department &
health care providers)
o If the child is known to have had sexual contact/abuse, mark the appropriate box
based on the partner’s sex assigned at birth. If search for this datum was completed
and the partner’s sex assigned at birth cannot be determined, select “Unknown”.
o If this is the only risk history, the case will be initially classified as
“risk not reported/identified” pending outcome of NIR investigation.
BEEN BREASTFED/CHESTFED BY NON-BIRTHING PERSON (Required,
applies to health department & health care providers)
o Select applicable response.
o Select “Yes” is there is evidence that the patient was fed milk from the chest of a
non-birthing person or documentation indicates that the patient was bodyfed by a
non-birthing person.
RECEIVED PREMASTICATED/PRE-CHEWED FOOD FROM NON-BIRTHING
PERSON (Required, applies to health department & health care providers)
o Select applicable response.
OTHER DOCUMENTED RISK (Required, applies to health department & health
care providers)
o Include detail in Comments section. In eHARS, enter on the “Comments” tab.

8. Clinical: Opportunistic Illnesses

8.1

CLINICAL: OPPORTUNISTIC ILLNESSES
8.1.1–8.1.27 (Optional, applies to health department & health care providers)
o Select all that apply and enter diagnosis dates. Enter date in mm/dd/yyyy format
using “..” for unknown values (e.g., 03/../2011).
o For additional information, refer to the most recent case definition for HIV
infection (available at https://ndc.services.cdc.gov/conditions/hiv-infection-aidshas-been-reclassified-as-hiv-stage-iii/).
8.1.28 RVCT CASE NUMBER (Optional, applies to health department & health care
providers)

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o 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
stage 3 (AIDS) patients may get this number from TB surveillance staff.

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9. Laboratory Data

•

Throughout this section, “Collection Date” refers to the date when the specimen was

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•

•

•
•
9.1

collected or drawn. Enter collection dates in mm/dd/yyyy format using “..” for unknown
values (e.g., 03/../2011).
Record all laboratory test results. Include results all diagnostic tests, viral load tests, CD4
tests, and drug resistance tests (genotypic) where possible. Where the number of test results
exceeds the number of fields available on the form, record such results in the Comments
section. In eHARS, enter the additional test results on the “Lab Data” tab with the applicable
test type.
Include tests with negative or indeterminate results that are part of a diagnostic testing
algorithm whose overall interpretation is positive (that the patient is HIV-infected). For
information on the current HIV diagnostic testing algorithm, please refer to
https://stacks.cdc.gov/view/cdc/50872.
In the absence of laboratory tests, record HIV infection or stage 3 (AIDS) diagnostic
evidence documented in the chart by a physician.
For children reported as perinatally exposed to HIV, record all test results of tests performed
to determine the diagnostic status of the child.

HIV IMMUNOASSAYS (IA)
• Assuming active case finding, review patient’s chart and laboratory reports for the earliest
date of documented HIV positivity.
• Enter the brand name of the test and/or its manufacturer, laboratory name, facility name and
provider name. (Optional, applies to health department & health care providers)
• Enter results and collection dates for all tests (including negative or indeterminate test
results) that are part of a diagnostic testing algorithm whose overall interpretation is positive
(that the patient is HIV-infected). (Required, applies to health department & health care
providers)
o Enter specimen collection date in mm/dd/yyyy format using “..” for unknown
values (e.g., 03/../2011).
• Enter testing option for all tests. (Optional, applies to health department & health care
providers)
o Enter “Point-of-care test by provider” if the test was performed by the provider
either in a healthcare setting or other testing venue.
o Enter “Self-test, result directly observed by provider” if the test was performed by
the patient but directly observed by a provider (including via a telemedicine
appointment).
o Enter “Lab-test, self-collected sample” if the patient collected the sample (blood or
oral fluid) and sent it to the laboratory for testing.
9.1.1
HIV-1 IA
o Enter result and collection date of first HIV-1 IA. (Required, applies to health
department & health care providers)
o “Positive IA” means a result of repeatedly reactive on a single sample.
9.1.2

9.1.3

9.1.4

HIV-1/2 IA
o Enter result and date of first HIV-1/2 IA. (Required, applies to health department
& health care providers)
o “Positive IA” means a result of repeatedly reactive on a single sample.
HIV-1/2 AG/AB
o Enter result and collection date of first HIV-1/2 combination IA test. (Required,
applies to health department & health care providers)
o “Positive IA” means a result of repeatedly reactive on a single sample.
HIV-2 IA

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9.2

o Enter result and collection date of first HIV-2 IA. (Required, applies to health
department & health care providers)
o “Positive IA” means a result of repeatedly reactive on a single sample.

9.1.5

HIV-1/2 AG/AB-DIFFERENTIATING IMMUNOASSAY
o Enter collection date of first HIV-1/2 Ag/Ab-Differentiating IA. (Required,
applies to health department & health care providers)
o Enter the Overall interpretation of the test. (Required, applies to health department
& health care providers)
o Record the result for each analyte (HIV-1 Ag and HIV-1/2 Ab). That is, one result
should be recorded for HIV-1 Ag, one result for HIV-1/2 Ab result. (Required,
applies to health department & health care providers)

9.1.6

HIV-1/2 AG/AB AND TYPE-DIFFERENTIATING IMMUNOASSAY
o Enter collection date of first HIV-1/2 Ag/Ab and Type-Differentiating IA.
(Required, applies to health department & health care providers)
o Enter the Overall interpretation of the test. (Required, applies to health department
& health care providers)
o If provided, enter index value for the overall interpretation. (Optional, applies to
health department & health care providers)
o Record the result for each analyte (HIV-1 Ag and HIV-1 Ab and HIV-2 Ab). That
is, one result should be recorded for HIV-1 Ag, one result for HIV-1 Ab and one
result should be recorded for HIV-2 Ab. (Required, applies to health department &
health care providers)
o Enter the index value for each analyte. (Optional, applies to health department &
health care providers)

9.1.7

HIV-1/2 TYPE-DIFFERENTIATING IMMUNOASSAY (supplemental)
o Enter collection date of first HIV-1/2 Type-Differentiating IA. (Required, applies
to health department & health care providers)
o Enter the overall interpretation of the test. (Required, applies to health department
& health care providers)
o Record the result for each analyte (HIV-1 Ab and HIV-2 Ab). That is, one result
should be recorded for HIV-1 Ab and one result should be recorded for HIV-2 Ab.
(Required, applies to health department & health care providers)

9.1.8

HIV-1 WESTERN BLOT
o Enter the result and collection date of first HIV-1 western blot. (Required, applies
to health department & health care providers)
o Western blot banding patterns should be interpreted according to the
CDC/Association of State and Territorial Public Health Laboratory Directors
(ASTPHLD) recommendations Interpretation and use of the western blot assay for
serodiagnosis of human immunodeficiency virus type 1 infections. MMWR Suppl.
1989 Jul 21;38(7):1-7. PMID: 2501638.

9.1.9

HIV-1 IFA
o Enter the result and collection date of first HIV-1 IFA. (Required, applies to health
department & health care providers)

9.1.10

HIV-2 WESTERN BLOT
o Enter the result and collection date of first HIV-2 western blot. (Required, applies
to health department & health care providers)

HIV DETECTION TESTS

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•

All varieties of such tests establish the presence of the pathogen, HIV. By contrast, HIV tests
such as an immunoassay or western blot establish the presence of the immune system’s
response to the pathogen (i.e., HIV antibodies).
• Assuming active case finding, review patient’s chart and laboratory reports for the earliest
date of documented HIV positivity.
• Enter the brand name of the test and/or its manufacturer, laboratory name, facility name
and provider name. (Optional, applies to health department & health care providers)
• Enter results and collection dates for all tests (including negative or indeterminate test
results) that are part of a diagnostic testing algorithm whose overall interpretation is
positive (that the patient is HIV-infected). (Required, applies to health department &
health care providers)
o Enter specimen collection date in mm/dd/yyyy format using “..” for unknown
values (e.g., 03/../2011).
• Enter testing option for all tests. (Optional, applies to health department & health care
providers)
o Enter “Point-of-care test by provider” if the test was performed by the provider
either in a healthcare setting or other testing venue.
o Enter “Self-test, result directly observed by provider” if the test was performed by
the patient but directly observed by a provider (including via a telemedicine
appointment).
o Enter “Lab-test, self-collected sample” if the patient collected the sample (blood or
oral fluid) and sent it to the laboratory for testing.

9.2.1
9.2.2

HIV-1/2 RNA NAAT (QUALITATIVE)
o Enter result and collection date of earliest nucleic acid amplification test (NAAT).
(Required, applies to health department & health care providers)
HIV-1 RNA NAAT (QUALITATIVE and QUANTITATIVE)
o Enter the collection date of earliest NAAT. (Required, applies to health
department & health care providers)
o Enter the qualitative result of the test. (Required, applies to health department &
health care providers)
o For all reactive qualitative results, record the result for the analyte (quantitative
result). (Required, applies to health department & health care providers)
 Where results are reported as “Detected” above the limit of quantification
(LOQ), select “Detectable above limit” and the result value in the
copies/mL field. For example, a result of “>10,000,000 cp/mL detected”
should be entered into the copies/ml field as “greater than detectable by
this assay - 10,000,000 cp/mL”.
 Where results are reported as “Detected”, select “Detectable within
limits” and the result value in the copies/mL field.
 Where the results reported as “Detected” below the LOQ, select
“Detectable below limit” and the result value in the copies/mL field. For
example, a result of “<20 cp/mL detected” should be entered into the
copies/ml field as “fewer than detectable by this assay - 20 cp/mL”.

9.2.3

HIV-1 RNA/DNA NAAT (QUALITATIVE)
o Enter result and collection date of earliest NAAT. (Required, applies to health
department & health care providers)

9.2.4

HIV-1 Culture
o Enter result and collection date of earliest culture result. (Required, applies to

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health department & health care providers)

9.3

9.2.5

HIV-2 RNA/DNA NAAT (QUALITATIVE)
o Enter result and collection date of earliest NAAT. (Required, applies to health
department & health care providers)

9.2.6

HIV-2 Culture
o Enter result and collection date of earliest culture result. (Required, applies to
health department & health care providers)

9.2.7

HIV-1 RNA/DNA NAAT (QUANTITATIVE)
o Enter date of earliest NAAT. (Required, applies to health department & health
care providers)
o Enter the result of the test. (Required, applies to health department & health care
providers)
 Where results are reported as “Detected” above the limit of quantification
(LOQ), select “Detectable above limit” and the result value in the
copies/mL field. For example, a result of “>10,000,000 cp/mL detected”
should be entered into the copies/ml field as “greater than detectable by
this assay - 10,000,000 cp/mL”.
 Where results are reported as “Detected”, select “Detectable within
limits” and the result value in the copies/mL field.
 Where the results reported as “Detected” below the LOQ, select
“Detectable below limit” and the result value in the copies/mL field. For
example, a result of “<20 cp/mL detected” should be entered into the
copies/ml field as “fewer than detectable by this assay - 20 cp/mL”.
 Where the results reported as “Not detected”, select “Not detected”.

9.2.8

HIV-2 RNA/DNA NAAT (QUANTITATIVE)
o Enter date of earliest NAAT. (Required, applies to health department & health
care providers)
o Enter the result of the test. (Required, applies to health department & health care
providers)
 Where results are reported as “Detected” above the limit of quantification
(LOQ), select “Detectable above limit” and the result value in the
copies/mL field. For example, a result of “>10,000,000 cp/mL detected”
should be entered into the copies/ml field as “greater than detectable by
this assay - 10,000,000 cp/mL”.
 Where results are reported as “Detected”, select “Detectable within
limits” and the result value in the copies/mL field.
 Where the results reported as “Detected” below the LOQ, select
“Detectable below limit” and the result value in the copies/mL field. For
example, a result of “<20 cp/mL detected” should be entered into the
copies/ml field as “fewer than detectable by this assay - 20 cp/mL”.
 Where the results reported as “Not detected”, select “Not detected”.

DRUG RESISTANCE TESTS (GENOTYPIC)
• This section should be completed if there is evidence of a drug resistance test (genotypic),
regardless of the type of drug resistance test, in the patient’s medical or other record.
• Enter the brand name of the test and/or its manufacturer, laboratory name, facility name and
provider name. (Optional, applies to health department & health care providers)
• Enter the collection date of the earliest test. (Required, applies to health department &
health care providers)

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•

9.4

9.5

When entering this information in eHARS, you should use the “Lab Data” tab and choose
“HIV-1 Genotype (Unspecified)” as the test type. You will not be able to enter a genotype
sequence since this test type only captures evidence of a drug resistance test (genotypic). If a
corresponding genotype sequence is subsequently received, you should import this
information as a separate laboratory document using the test type that reflects the type of
drug resistance test that was conducted (e.g., HIV-1 Genotype (PR/RT RNA Nucleotide
Sequence-Sanger method)).

IMMUNOLOGIC TESTS (CD4 COUNT AND PERCENTAGE)
• Enter the results of all HIV-related CD4 tests that are available from the source where
information is being collected to complete the form. At minimum, the first CD4 results
closest to the date of initial HIV infection diagnosis should be reported and the first CD4
results indicative of stage 3 (AIDS) should be reported if available.
• Enter the brand name of the test and/or its manufacturer, laboratory name, facility name and
provider name. (Optional, applies to health department & health care providers)
• Whenever CD4 count and percentage are both available for the same specimen collection
date, record both.
• Enter specimen collection date in mm/dd/yyyy format using “..” for unknown values (e.g.,
03/../2011). (Required, applies to health department & health care providers)
9.4.1

CD4 COUNT
o Enter result and specimen collection date of all CD4 counts. (Required, applies to
health department & health care providers)

9.4.2

CD4 PERCENTAGE
o Record result and specimen collection date of all CD4 percentages. (Required,
applies to health department & health care providers)

DOCUMENTATION OF TESTS
9.5.1

DID DOCUMENTED LABORATORY TEST RESULTS MEET APPROVED HIV
DIAGNOSTIC ALGORITHM CRITERIA? (Required if applicable, applies to health
department & health care providers)
o This section captures diagnoses through novel algorithms and should only be
completed if none of the following were positive for HIV-1: western blot, IFA,
culture, quantitative NAAT (RNA or DNA), qualitative NAAT (RNA or DNA),
HIV-1/2 type-differentiating immunoassay (supplemental test), stand-alone p24
antigen test, or nucleotide sequence.
o HIV-1 antigen analyte results from combination antigen/antibody tests in which the
antigen result can be differentiated from the antibody result, such as an “HIV-1/2
Ag/Ab differentiating immunoassay” or an “HIV-1/2 Ag/Ab and typedifferentiating immunoassay”, are not considered stand-alone p24 antigen tests.
Refer to sections 9.1.5 and 9.1.6 for more information regarding combination
Ag/Ab IA.
o “Yes” indicates that the test results were determined to be part of a diagnostic
testing algorithm that satisfies the HIV surveillance case definition for HIV-1 or
HIV-2 (refer to the most recent case definition for HIV infection available at
https://ndc.services.cdc.gov/conditions/hiv-infection-aids-has-been-reclassified-ashiv-stage-iii/), regardless of whether the tests were approved for other purposes
such as laboratory-based HIV testing or point-of-care HIV screening.
 If “Yes”, enter date of earliest positive test result for this algorithm in
mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
(Required if applicable, applies to health department & health care

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providers).
o “No” indicates that the test results were determined to not be a part of a diagnostic
testing algorithm that satisfies the HIV surveillance case definition for HIV-1 or
HIV-2.
o “Unknown” indicates that you are unable to determine whether the test results were
part of a diagnostic testing algorithm that satisfies the HIV surveillance case
definition for HIV-1 or HIV-2.
o Values of “No” and “Unknown” should generally not be selected. This form is
intended to be used to ascertain that two tests are part of an algorithm that meet the
HIV surveillance case definition. Carefully review all “No” and “Unknown”
responses before entering into the surveillance system.
9.5.2

IS EARLIEST EVIDENCE OF DIAGNOSIS DOCUMENTED BY A PHYSICIAN
RATHER THAN BY LABORATORY TEST RESULTS? (Required if applicable,
applies to health department & health care providers)
o If laboratory evidence of an HIV test is unavailable or was insufficient to meet
surveillance case definition in the patient’s medical or other record and written
documentation of laboratory evidence of HIV infection consistent with the HIV
case definition is noted by the physician, enter “Yes”; otherwise enter “No” or
“Unknown”.
9.5.2.1 HIV-INFECTED (Required if applicable, applies to health department &
health care providers)
 IF “YES” TO 9.5.2.1, PROVIDE DATE OF DIAGNOSIS BY
PHYSICIAN (Required in the absence of laboratory results, applies to
health department & health care providers)
 Date of diagnosis is defined as the date (at least the year) of diagnosis
reported in the content of the medical record. If the diagnosis date was not
reported in the note, the date when the note was written can be used as a
proxy. For example, if a health care provider writes a note in a medical
chart on 4/10/2010 stating the patient had received a diagnosis of HIV
infection on 2/11/2010, then 2/11/2010 should be recorded as the date of
diagnosis by the physician.
9.5.2.2 NOT HIV-INFECTED (Required if applicable, applies to health department
& health care providers)
 IF “YES” TO 9.5.2.2, PROVIDE DATE OF DIAGNOSIS BY
PHYSICIAN (Required in the absence of laboratory results, applies to
health department & health care providers)
 Date of diagnosis is defined as the date (at least the year) when the patient
was determined to be “not HIV-infected”.

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10. Birth History (for patients exposed perinatally with or without consequent infection)

Birth history information is for state and local health department use only and is not
transmitted to CDC if marked with an * on the form.
• Enter the data below for all children reported as perinatally exposed with or without
consequent HIV infection.
10.1 BIRTH HISTORY AVAILABLE (Optional, applies to health department & health care
providers)
• If none of the birth history elements in the section are available, proceed to next section,
Birthing Person History.
10.2 RESIDENCE AT BIRTH (Required, applies to health department & health care providers)
• Select one of the address types for the patient’s residence at time of birth.
• Enter the street address, city, county, state, country name, and zip code of the patient’s
residence at time of birth
10.3 FACILITY OF BIRTH (Optional, applies to health department & health care providers)
• Check if same as facility providing information.
•

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Enter name, address, phone, city, county, state/country and zip code of the hospital/clinic of
birth.
• Sites should uniformly record hospital names, including abbreviations.
• If this child was born at home, enter “home birth”.
10.4 BIRTH HISTORY
10.4.1 BIRTH WEIGHT (Optional, applies to health department & health care providers)
o Enter the birth weight in pounds and ounces, or grams.
10.4.2 TYPE (Optional, applies to health department & health care providers)
o Select applicable response. If unknown, select “9”.
10.4.3 DELIVERY (Required, applies to health department & health care providers)
o Select the applicable response.
o Notes in the child’s records are acceptable even if no birth records are available.
o If search for this datum was completed and the delivery method could not be
determined or if the delivery method was documented to be unknown, select
“Unknown”.
10.4.4 IF CESAREAN DELIVERY, MARK ALL THE FOLLOWING INDICATIONS
THAT APPLY (Required, if applicable, applies to health department & health care
providers)
o Select the appliable indications.
o The reason(s) for a cesarean delivery should be documented in the labor and
delivery medical record. Notes in the child’s records are acceptable even if no birth
records are available.
o If search for this datum was completed and the indications could not be
determined, select “Not specified”.
10.4.5 BIRTH INFORMATION (Required, if applicable, applies to health department &
health care providers)
o This information may be listed in the labor and delivery record or in a
dictated/transcribed labor and delivery summary by the physician. Write time in
military hours (e.g., 9:15 a.m. is 09:15, 1:00 p.m. is 13:00). Midnight is 00:00 and
noon is 12:00. To calculate military time, count the number of hours and minutes
after midnight or 00:00 hours. Enter the date in mm/dd/yyyy format using “..” for
unknown values (e.g., 03/../2011).
 Rupture of membranes information should be found on the labor and
delivery summary sheet. The date and time are necessary to calculate the
duration of ruptured membranes and duration of labor. Rupture of
membranes refers to the time when the amniotic sac is either purposely
broken or ruptures on its own. When a physician/health care provider
ruptures the membranes this is referred to as artificial rupture of
membranes--often abbreviated as AROM. When membranes rupture on
their own, spontaneously, this is referred to as spontaneous rupture of
membranes (SROM). Premature rupture of membranes is referred to as
PROM. In the case of cesarean section, the rupture of membranes may be
almost concurrent with time of delivery.
 Delivery information should be found on the labor and delivery summary
sheet. The date and time are necessary to calculate the duration of
ruptured membranes and duration of labor. If the time of delivery is
unknown because of a home or out-of-hospital delivery, enter ‘‘..:..”.
Verify that the delivery date is the same as the date of birth noted on the
•

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first page of the abstraction form. If there is an inconsistency, verify the
correct date of birth and update eHARS if necessary.
10.4.6-10.4.7
CONGENTIAL DISORDERS and IF YES, SPECIFY TYPES (Optional,
applies to health department & health care providers)
o If “Yes”, specify type.
o Refer to Appendix 10.4.6 for further guidance.
10.4.8 NEONATAL STATUS (Optional, applies to health department & health care
providers)
o Select applicable response and record the child’s gestational age, if known, in the
boxes provided.
o “Full term” is defined as gestational age greater than or equal to 37 weeks.
o “Premature” is defined as gestational age less than 37 weeks.
o If search for gestational age was unsuccessful, then enter “99” for unknown
number of weeks.
o Post mature neonatal status (after 40 weeks) should be recorded as full term.
o If search for this datum was completed and the gestational age cannot be
determined, select “Unknown”.
10.4.8.1 NEONATAL GESTATIONAL AGE IN WEEKS
 Enter weeks of gestation.
 If search for gestational age was unsuccessful, then enter “99” for
unknown number of weeks.
10.4.9 WAS A TOXICOLOGY SCREEN DONE ON THE INFANT AFTER BIRTH
(Recommended, if applicable, applies to health department & health care providers)
o Select applicable response. Include any toxicology screen with a specimen
collection date on the child’s date of birth or within the 6 days following the child’s
date of birth.
o If search for this datum was completed but a response of “Yes” or “No” cannot be
determined, select “Unknown”.
o Most toxicology screens on infants are done using urine. A positive screen at birth
indicates drug use by the birthing person before delivery. This information should
be noted in the infant’s birth chart.
o If the specimen for any toxicology screen was collected for the infant on the date of
birth or the following 6 days after birth, complete the following information for
each substance.
 If the substance was not included in any toxicology screen in the 7 days
on or after the child’s date of birth, select “Not screened” for the
particular substance.
 If the substance was included in any toxicology screen in the 7 days on or
after the child’s date of birth, enter the date of screen for the substance in
mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011) and
select the applicable result; select “Unknown” if a search for the result
was completed but the result was not documented.
 If the same substance was screened more than one time during the 7 days
on or after the child’s date of birth, enter the subsequent date of screen
and result values in the Comments section. In eHARS, enter the
additional information on the PCRF on the “Birth History” tab.
 If screening for ‘Other’ substance was done, specify the substance in the
space provided.

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11. Birthing Person History

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Birthing person history is for state and local health department use only and is
not transmitted to CDC if marked with an * on the form.
• Enter the data below regarding the birthing person for all children reported as perinatally
exposed with or without consequent HIV infection. If information for the birthing person is
not available (e.g., because child is adopted), proceed to the next section, Treatment/Services
Referrals.
BIRTHING PERSON DATE OF BIRTH (Optional, applies to health department & health care
providers)
• Enter the birthing person’s date of birth in mm/dd/yyyy format using “..” for unknown values
(e.g., 03/../2011).
BIRTHING PERSON LAST NAME SOUNDEX (Optional, applies to health department)
• After the birthing person’s last name is entered into eHARS, the software automatically
generates this variable by using the birthing person’s last name. After the code is
generated, health department staff should fill in this field 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. The
eHARS Technical Reference Guide describes exactly how the Last Name Soundex is
created. You can access the eHARS Technical Reference Guide through SharePoint:
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HICSB/default.aspx
BIRTHING PERSON COUNTRY OF BIRTH (Optional, applies to health department & health
care providers)
• Select applicable response.
• For birthing persons born in US minor outlying areas, specify the name of the US
dependency from the following table:
US Dependencies
Baker Island
Midway Islands
Howland Island
Navassa Island
Jarvis Island
Palmyra Atoll
Johnston Atoll
Wake Island
Kingman Reef
• For birthing persons born in any other area outside of the US and US minor outlying areas,
specify the country name.
• If this information is not available in the child’s records, it can be left blank and updated
on follow-up.
BIRTHING PERSON STATE ID NUMBER (Optional, applies to health department)
• Enter assigned state number if the birthing person is known to be HIV infected.
• State numbers should not be reused.
BIRTHING PERSON CITY/COUNTY ID NUMBER (Optional, applies to health department)
• Enter the assigned city/county number if the birthing person is known to be HIV infected.
• City/County numbers should not be reused.
OTHER BIRTHING PERSON ID (Optional, applies to health department & health care
providers).
• Enter any other ID type (such as social security number) for the birthing person and the
number of the other ID.
PRENATAL CARE
• Prenatal care is defined as any care for the pregnancy beyond pregnancy testing and before
delivery, even if no regular follow-up ensued.
•

11.1

11.2

11.3

11.4
11.5
11.6

11.7

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11.7.1

MONTH OF PREGNANCY PRENATAL CARE BEGAN (Optional, applies to
health department & health care providers)
o Record the gestational month of pregnancy (01 to 09) that the birthing person
began prenatal care. A prenatal care visit is the first visit where intake information
is obtained. Normally a birthing person knows they is pregnant at the time of this
first prenatal care visit. A visit to a doctor to confirm pregnancy status would not
be considered the first prenatal care visit unless intake data and other services
typical of the first prenatal care visit are obtained at the time of that confirmation.
Such services would include intake prenatal blood tests, for example. If the birthing
person had been seen by more than one prenatal care provider, then the date of the
visit to the first prenatal care provider seen should be documented.
o If any fraction of a month is reported, round to the next whole month.
o In the absence of prenatal care, enter “00”.
o If search for this datum was unsuccessful, then enter “99” for month of first visit.
o If entry is reported in weeks, convert to appropriate months as follows:
Weeks
Months
Weeks
Months
1–4

1

22–26

6

5–8

2

27–30

7

9–13

3

31–35

8

14–17

4

36–40

9

18–21

5

41+

10

o Abstractors should use the gestational age value available in the record. The
method (LMP, ultrasound, infant exam) for assigning gestational age in the
medical record might vary.
11.7.2 TOTAL NUMBER OF PRENATAL CARE VISITS (Optional, applies to health
department & health care providers)
o Record the total number of times the birthing person went to the clinic or doctor for
prenatal care; exclude visits unrelated to prenatal care.
o In the absence of prenatal care visits, enter “00”.
o In the presence of prenatal care and search for this datum was unsuccessful, then
enter “99” for number of prenatal visits.
o Where data source reports a range of visits (e.g., “10–13”), enter the lowest number
(e.g., “10”).
11.8 HAS THE BIRTHING PERSON EVER BEEN PREGNANT BEFORE THIS PREGNANCY
(Optional, if applicable, applies to health department & health care providers)
• Select applicable response. If search for this datum was completed but a response of “Yes”
or “No” cannot be determined, select “Unknown”.
11.8.1 IF YES, NUMBER OF PREVIOUS PREGNANCIES (Optional, if applicable, applies
to health department & health care providers)
o This number should include all pregnancies, regardless of outcome (e.g., including
abortions and miscarriages) up to but EXCLUDING the pregnancy that is being
abstracted.
11.8.2. PREGNANCY OUTCOME (Optional, if applicable, applies to health department &
health care providers)
o For each previous pregnancy where the pregnancy outcome is known, select the
applicable response.
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o Live birth includes preterm and term births
o Miscarriage or stillbirth includes spontaneous abortions/fetal deaths that occur
before 20 weeks (miscarriage) or after 20 weeks (stillbirth).
o Induced abortion includes abortions brought on purposely and may also be known
as an ‘artificial’ or ‘therapeutic’ abortion (TAB) or referred to as a ‘termination of
pregnancy’ (TOP). the chart may abbreviate this as ‘A’ or ‘Ab’ or ‘TAB’ or ‘TOP’
followed by a number designating the number of abortions prior to this pregnancy.
o If there are more than 5 previous pregnancies, record the additional information in
the Comments section. In eHARS, record additional pregnancies on the PCRF on
the “Birthing Person History” tab.
11.8.3 YEAR OUTCOME OCCURRED (Optional, if applicable, applies to health
department & health care providers)
o For each previous pregnancy where the pregnancy outcome is known, record the
four-digit year associated with the pregnancy outcome.
o If the year of the pregnancy outcome is unknown, enter “9999”.
o If there are more than 5 previous pregnancies, record the additional information in
the Comments section. In eHARS, record additional pregnancies on the PCRF on
the “Birthing Person History” tab.
11.9 WAS A TEST RESULT (WITH A SPECIMEN COLLECTION DATE WITHIN THE 6
WEEKS ON OR BEFORE DELIVERY) DOCUMENTED IN THE BIRTHING PERSON’S
LABOR/DELIVERY RECORD (Optional, applies to health department and health care
providers)
• Select applicable response for both the CD4 and quantitative NAAT (RNA or DNA) test
types.
• Limited to test results with specimens collected within the 6 weeks on or before delivery.
• If a search for this datum was completed but a response of “Yes” or “No” cannot be
determined, select “Unknown”
11.10
DID BIRTHING PERSON RECEIVE ANTIRETROVIRALS (ARVs) PRIOR TO THIS
PREGNANCY? (Recommended, applies to health department & 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’.
• Select “Yes” if information is available that states that the birthing person used ARVs prior
to this pregnancy. If “Yes”, record the date ARV treatment began and the date of last use.
Enter date in mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
• Select “No” if the birthing person did not use ARVs prior to this pregnancy.
• If a birthing person did not receive ARVs, do not assume it was because they refused. Select
“Refused” only if explicit documentation in the medical record indicates that the birthing
person was offered the drug, but the birthing person declined.
• Select “Unknown” after an unsuccessful search for this datum.
11.10.1 IF “YES”, PLEASE SPECIFY ALL
o Record all ARVs received prior to this pregnancy.
11.11
DID BIRTHING PERSON RECEIVE ARVs DURING PREGNANCY? (Required,
applies to health department & health care providers)
• Select “Yes” if information is available that states that the birthing person used ARVs any
time during pregnancy. If “Yes”, record the date ARV treatment began and the date of last
use. Enter date in mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
• Select “No” if the birthing person did not use ARVs during pregnancy.

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Select “Refused” only if explicit documentation in the medical record indicates that the
birthing person was offered the drug, but the birthing person declined.
• Select “Unknown” if it is unknown whether the birthing person ever used ARVs during
pregnancy.
11.11.1 IF “YES”, PLEASE SPECIFY ALL
o Record all ARVs received during pregnancy.
o For additional information about antiretroviral regimens for pregnant patients with
HIV infection refer to Recommendations for Use of Antiretroviral Drugs During
Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United
States at
https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/Perinatal_GL.p
df.
11.11.2 IF NO, SELECT REASON
o Select “No prenatal care” if the birthing person did not receive any prenatal care
during pregnancy.
o Select “Birthing person known to be HIV-negative during pregnancy” if the
birthing person tested HIV negative during pregnancy and no further testing was
documented. There must be evidence of a negative test during pregnancy in the
chart; do not use patient report.
o Select “HIV serostatus of birthing person unknown” if the physician did not know
the HIV status of the birthing person because the birthing person refused testing or
the physician did not offer testing during pregnancy.
o Select “Other” if another reason for not receiving ARVs was documented. If
“Other” is selected specify the specific reason.
o Select “Unknown” after an unsuccessful search for this datum.
o If more than one reason applies, enter the additional reason(s) in the Comments
section. In eHARS, enter each reason on a separate PCRF document.
11.12
DID BIRTHING PERSON RECEIVE ARVs DURING LABOR/DELIVERY? (Required,
applies to health department & health care providers)
• Select “Yes” if information is available that states that the birthing person used ARVs any
time during labor/delivery. Labor and delivery period is also termed the intrapartum period
and refers to the time from which the person was admitted to the hospital for labor to the
time of delivery. If “Yes”, record the date ARV treatment began and the date of last use.
Enter date in mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
• Select “No” if the birthing person did not use ARVs during labor/delivery.
• Select “Refused” only if explicit documentation in the medical record indicates that the
birthing person was offered the drug, but the birthing person declined.
• Select “Unknown” if it is unknown whether the birthing person ever used ARVs during
labor/delivery.
11.12.1 IF “YES”, PLEASE SPECIFY ALL
o Record all ARVs received during labor/delivery.
o For additional information about antiretroviral regimens during the intrapartum
period refer to Recommendations for Use of Antiretroviral Drugs During
Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United
States at
https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/Perinatal_GL.p
df.
11.12.2 IF NO, SELECT REASON
o Select “Precipitous delivery/STAT Cesarean delivery” if an eminent delivery of an
infant may preclude prescription and/or administration of ARV to the birthing
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person.
o Select “HIV serostatus of birthing person unknown” if the physician did not know
the HIV status of the birthing person because the birthing person refused testing or
the physician did not offer testing during pregnancy.
o Select “Birth not in hospital” if the birth occurred outside a hospital; in all
likelihood ARV would not have been administered.
o Select “Birthing person tested HIV negative during pregnancy” if the birthing
person tested HIV negative during pregnancy and no further testing was
documented. There must be evidence of a negative test during pregnancy in the
chart; do not use patient report.
o Select “Other” if another reason for not receiving ARVs was documented. If
“Other” is selected specify the specific reason.
o Select “Unknown” after an unsuccessful search for this datum.
o If more than one reason applies, enter the additional reason(s) in the Comments
section. In eHARS, enter each reason on a separate PCRF document.
11.13
WAS THE BIRTHING PERSON SCREENED FOR ANY OF THE FOLLOWING
CONDITIONS DURING THIS PREGNANCY (Recommended, applies to health department
& health care providers)
• Select “Yes” if the birthing person was screened for the condition during this pregnancy. If
screened, enter the date of the screening; if a sample was drawn for the screening use the
date of specimen collection. Enter date in mm/dd/yyyy format using “..” for unknown values
(e.g., 03/../2011). If the birthing person was screened for the same condition more than once
during this pregnancy, enter the additional screening dates in the Comments section. In
eHARS, enter the additional screening information on the PCRF on the “Birthing Person
History” tab.
• Select “No” if the birthing person was not screened for the condition during this pregnancy.
• Select “Unknown” after an unsuccessful search for this datum.
• Refer to Appendix 11.13 for additional information about each condition.
11.14
WERE ANY OF THE FOLLOWING CONDITIONS DIAGNOSED FOR THE
BIRTHING PERSON DURING THIS PREGNANCY OR AT THE TIME OF LABOR AND
DELIVERY (Recommended, applies to health department & health care providers)
• For this question, “diagnosed” refers to newly diagnosed, a recurrence of, or a chronic
infection with any of the following conditions. Screening for syphilis, gonorrhea, and
chlamydia is typically done during prenatal care. Generally, diagnosis of an STD/STI will be
documented in multiple places in the chart including progress notes, a prenatal clinic visit
summary sheet (which should include summary of laboratory tests for various sexually
transmitted diseases), laboratory results section, or in sexually transmitted disease summary
sheets (typical in public health clinics).
• Diagnoses may be presumptive or definitive depending on symptoms and laboratory tests. If
a diagnosis is made either presumptively or definitively, note the answer as “Yes”. For
specific criteria for answering “Yes” to this question refer to Appendix 11.14. If diagnosed,
enter the date of diagnosis; if the diagnosis was based on test results, use the date of
specimen collection for the date of diagnosis. Enter date in mm/dd/yyyy format using “..” for
unknown values (e.g., 03/../2011). If the same condition was diagnosed for the birthing
person more than once during this pregnancy, enter the additional diagnosis dates in the
Comments section. In eHARS, enter the additional diagnosis information on the PCRF on
the “Birthing Persons History” tab.
• Select “No” if evidence that the birthing person was screened for the condition during
pregnancy but the condition was not diagnosed.
• Select “Unknown” after unsuccessful search for this datum.
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11.15

WERE SUBSTANCES USED BY THE BIRTHING PERSON DURING THIS
PREGNANCY (Recommended, applies to health department & health care providers)
• Indicate whether substances were used during this pregnancy by selecting “Yes”, “No”, or
“Unknown”.
• If “Yes”, indicate for each substance select whether the substance was
o “Used and injected” if there is evidence that the birthing person used the substance
during this pregnancy and the substance was injected,
o “Used and did no inject” if there is evidence that the birthing person used the
substance during this pregnancy but the substance was not injected,
o “Used and unknown if injected” if there is evidence that the birthing used the
substance during this pregnancy but there was no evidence to determine whether the
substance was injected,
o “Did not use” if there is evidence that the birthing person did not use that particular
substance during this pregnancy,
o “Unknown if used” if there is not sufficient evidence to determine whether the
birthing person used the particular substance during this pregnancy.
o Leave blank if you did not search for whether specific substances were used during
this pregnancy.
o The drugs listed here are in alphabetical order and may be checked if there is
evidence of a toxicology screen or a notation in records not based on a toxicology
screen (e.g., patient self-report).
• Heroin is a semisynthetic narcotic and opiate and should be listed as heroin, opiate, or opioid
on the urine toxicology laboratory results sheet.
• Marijuana may be listed on the urine toxicology results as cannabis, a cannabinoid, THC or
simply marijuana.
• Methadone is a synthetic narcotic and should be listed as methadone. Any methadone use,
whether legal or illegal, should be included as “Yes” to this question.
• If “Other”, specify the name of the substance(s) used.
11.16
WAS A TOXICOLOGY SCREEN DONE ON THE BIRTHING PERSON (EITHER
DURING PREGNANCY OR AT THE TIME OF DELIVERY) (Recommended, applies to
health department & health care providers).
• Select ”Yes” if a screen was conducted on the birthing pregnancy during this pregnancy or at
the time of delivery. The toxicology testing must have been completed during pregnancy,
not before pregnancy. Toxicology screens are usually done using urine or serum.
o For each substance, select “Not screened” if there’s evidence that the substance
was not included in the toxicology screen. If the substance was screened, enter the
date of the toxicology screen in mm/dd/yyyy format using “..” for unknown values
(e.g., 03/../2011). Select “Positive” if there was a positive test result for the
substance. Select “Negative” if there was a negative test result for the substance.
Select “Unknown” if a search for the test result for the substance was documented
but the result could not be determined.
o If screening was for a substance other than those listed, select “Other” and specify
the drug metabolites in the space provided.
o If a screening for the same substance was done on more than one occasion, record
additional dates and results in the Comments section. In eHARS, enter the
additional screening information on the PCRF on the “Birthing Person History”
tab.
o Heroin is a semisynthetic narcotic and opiate and should be listed as heroin, opiate,
or opioid on the urine toxicology laboratory results sheet.
o Marijuana may be listed on the urine toxicology results as cannabis, a cannabinoid,

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•
•

THC or simply marijuana.
o Methadone is a totally synthetic narcotic and should be listed as methadone. Any
methadone use, whether legal or illegal, should be included as “Yes” to this
question.
Check “No” if it is known that a screen was not conducted.
Select “Unknown” after unsuccessful search for this datum.

12. Treatment/Services Referrals

Enter the data below for all children reported as perinatally exposed with or without
consequent HIV infection; the field “Has this child ever taken PCP prophylaxis” and the
associated date field need to be completed only if the child is HIV infected.
12.1 HAS THIS CHILD EVER TAKEN ANY ARVS (Required, applies to health department &
health care providers)
• This variable indicates whether the patient has ever taken any antiretroviral medication.
“Yes” indicates there is evidence that the patient has taken ARVs, including self-report.
• If “Yes”, it is important to enter the dates when use began and, if appropriate, ended. Enter
date in mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
• “No” indicates there is evidence that the patient has never taken ARVs.
• “Unknown” should be used when the person completing the form does not know whether or
not the patient has ever taken ARVs, after searching for the information or asking the
patient.
• Leave the field blank if there was no attempt to find the information.
12.2 ARV MEDICATION (Recommended, applies to health department & health care providers)
• List the medications taken.
• This variable is used to verify that the medication taken was actually an antiretroviral.
• Enter “unspecified” if an ARV was taken but the name is not known.
• Refer to Appendix 12.2 for further guidance.
12.3 REASON FOR ARV USE (Required, applies to health department & health care providers)
• Select reason that applies for each specific ARV medication.
• “HIV Tx” indicates that the patient used the ARV medication to treat HIV infection.
• “PrEP” indicates that the patient used the ARV medication prior to HIV diagnosis for HIV
preexposure prophylaxis (PrEP). If “PrEP” is selected, please refer to the updated clinical
practice guideline for PrEP at https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prepguidelines-2021.pdf. For surveillance activities, additional follow up with health care
providers may be required for certain test results for final determination of HIV status.
Federal Drug Administration (FDA) intended usage of ARV medications for PrEP is for
persons who weigh at least 35 kg and are sexually active or inject drugs.
•

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“PEP” indicates that the patient used the ARV medication as postexposure prophylaxis
(PEP).
• “PMTCT” indicates that the patient used the ARV medication to prevent HIV birthing
person-to-child-transmission.
• “HBV Tx” indicates that the patient used the ARV medication to treat hepatitis B virus
infection.
• “Other” indicates that the patients used the ARV medication for a reason other than those
indicated above.
DATE BEGAN (Required, applies to health department & health care providers)
• For each ARV medication indicated in 12.2, enter the earliest date that the patient took the
ARVs, even if ARV use was sporadic.
• If the first time ARVs were taken occurred after HIV diagnosis, it is very important to enter
a date, even an estimated date, later than the date of HIV diagnosis.
• Enter date in mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
DATE OF LAST USE (Required, applies to health department & health care providers)
• For each ARV medication indicated in 12.2, enter the most recent date of ARV use.
• For patients currently on ARVs, record the date of the most recent prescription or known
usage. If the information was collected during a patient interview, the date would be the
interview date. If the information was collected as part of a medical record review, record
the date of the most recent prescription or date of the most recent physician’s note.
• Enter date in mm/dd/yyyy format using “..” for unknown values (e.g., 03/../2011).
HAS THIS CHILD EVER TAKE PCP PROPHYLAXIS? (Optional, applies to health
department & health care providers)
• 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”.
• If “Yes”, enter the date the child was started on therapy to prevent the occurrence of PCP
and the date of last use in mm/dd/yyyy format using “..” for unknown values (e.g.,
03/../2011).
• “Unknown” is used if treatment information in the medical chart is unclear or was
unavailable.
• Refer to Appendix 12.6 for further guidance.
THIS CHILD’S PRIMARY CARETAKER IS (Optional, applies to health department & health
care providers)
• Select the person who provides the majority of care for the child.
• Refer to Appendix 12.7 for further guidance.
•

12.4

12.5

12.6

12.7

13. Comments (Optional, applies to health department & health care providers)

•
•
•

This section can be used for information not requested on the form or for information
requested but where there might not be room in the space provided.
As appropriate, information collected in this section can be entered in existing fields on the
PCRF of eHARS.
Information entered into the “Comments” tab on the PCRF of eHARS will not be
transmitted to CDC.

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14. Local/Optional Fields (Optional, applies to health department)

•
•

This section is for collection of data that are not on the form at the state and local level.
This information is not sent to CDC.

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Appendix. Pediatric HIV Confidential Case Report Form (CDC 50.42B)
Instructions for Completion
Purpose

•

•
•
•

•
•

•

•
•
•
•
•

•

Information captured on the Pediatric HIV Confidential Case Report Form (PCRF) 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 prevention activities.
CDC’s Division of HIV Prevention (DHP) needs initial reports and updates to reflect the
earliest dates that children meet each reporting criteria (i.e., perinatal exposure, HIV
infection, stage 3 or AIDS, seroreverter), as well as changes in diagnostic or vital status.
When a child who was previously reported as HIV infected has progressed to stage 3 (AIDS)
or has died, state/reporting area personnel update the National HIV Surveillance System
(NHSS) 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 PCRF can accommodate updated information including immunologic markers and
diagnoses of opportunistic infections.
Prior to 2023, CDC provided a separate Perinatal HIV Exposure Reporting (PHER) form to
facilitate collection of additional standardized data on HIV-exposed children. CDC revised
the PCRF to include some additional standardized data on HIV-exposed children and retired
the separate PHER form in 2023.
CDC updated the PCRF 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 birthing person 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 ARVs during pregnancy and
labor/delivery and neonatal ARV.
Maternal HIV counseling and testing, prenatal care, and refusal of ARV treatment were
added in 1996.
Viral load tests, receipt of additional antiretroviral (ARV) therapy during labor/delivery for
the newborn and elective cesarean were added to the pediatric reporting form in 1999.
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 ARV and receipt of other antiretroviral therapy can be collected
for all children born to HIV-infected persons. 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

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Infection and Acquired Immunodeficiency Syndrome (MMWR 1999;48(RR-13):1–31),
available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a1.htm, the 2008 case
definition (MMWR 2008; 57 (RR-10) 1-12 at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a1.htm, and the Revised Surveillance
Case Definition for HIV Infection — United States, 2014 (MMWR 2014;63 (RR03);1-10 at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm?s_cid=rr6303a1_e.

Pediatric Cases of Public Health Importance (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, transmission from the birthing person to the infant due to breast feeding or premastication of food , transfusions after March 1985, or any other unusual transmission
circumstances. This direct communication will ensure the timeliest technical support. For
further guidance, see Technical Guidance File Risk Factor Ascertainment.

4. Patient Demographics
4.1

DIAGNOSTIC STATUS AT REPORT
4.1.1
PERINATAL HIV EXPOSURE
o Although all children aged less than 18 months born to an HIV-infected person
were perinatally exposed to HIV, the “Perinatal HIV Exposure” category on the
case report form is composed of those with an undetermined HIV infection status.
o A child aged less than 18 months born to an HIV-infected person will be
categorized as “Perinatal HIV Exposure” if the child does not meet the criteria for
HIV infection or the criteria for presumptively or definitely uninfected.
4.1.2
PEDIATRIC HIV
o Among children <18 months old whose birthing persons were not infected and all
children aged ≥18 months, a reportable case of HIV infection must meet at least
one of the following criteria:
1.1: Persons Aged ≥18 Months and Children Aged <18 Months whose Birthing
Persons were Not Infected
1.1.1: Laboratory Evidence
Laboratory criteria require reporting of the date of the specimen collection for
positive test results in multitest algorithms or stand-alone virologic tests and enough
information about the tests to determine that they meet any of the following criteria:
•

A multitest algorithm consisting of
o A positive (reactive) result from an initial HIV antibody or
combination antigen/antibody test, and
o An accompanying or subsequent positive result from a supplemental
HIV test different from the initial test.
The initial HIV antibody or antigen/antibody test and the supplemental HIV
test that is used to verify the result from the initial test can be of any type used
as an aid to diagnose HIV infection. For surveillance purposes, supplemental
tests can include some not approved by the Food and Drug Administration
(FDA) for diagnosis (e.g., HIV-1 viral load test, HIV-2 western
blot/immunoblot antibody test, and HIV-2 NAT). However, the initial and
supplemental tests must be "orthogonal" (i.e., have different antigenic

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constituents or use different principles) to minimize the possibility of
concurrent nonspecific reactivity. Because the antigenic constituents and test
principles are proprietary information that might not be publicly available for
some tests, tests will be assumed to be orthogonal if they are of different
types. For example:
o One test is a combination antigen/antibody test and the other an antibodyonly test.
o One test is an antibody test and the other a NAT.
o One test is a rapid immunoassay (a single-use analytical device that
produces results in <30 minutes) and the other a conventional
immunoassay.
o One test is able to differentiate between HIV-1 and HIV-2 antibodies and
the other is not.
Tests also will be assumed to be orthogonal if they are of the same type (e.g., two
conventional immunoassays) but made by different manufacturers. The type of
HIV antibody test that verifies the initial test might be one formerly used only as
an initial test (e.g., conventional or rapid immunoassay, HIV-1/2 typedifferentiating immunoassay), or it might be one traditionally used as a
supplemental test for confirmation (e.g., western blot, immunofluorescence
assay).
•

A positive result of a multitest HIV antibody algorithm from which only the
final result was reported, including a single positive result on a test used only
as a supplemental test (e.g., HIV western blot, immunofluorescence assay) or
on a test that might be used as either an initial test or a supplemental test (e.g.,
HIV-1/2 type-differentiating rapid antibody immunoassay) when it might
reasonably be assumed to have been used as a supplemental test (e.g., because
the algorithm customarily used by the reporting laboratory is known).

•

A positive result or report of a detectable quantity (i.e., within the established
limits of the laboratory test) from any of the following HIV virologic (i.e.,
non-antibody) tests:
o Qualitative HIV NAT (DNA or RNA)
o Quantitative HIV NAT (viral load assay)
o HIV-1 p24 antigen test
o HIV isolation (viral culture) or
o HIV nucleotide sequence (genotype).

1.1.2: Clinical (Non-Laboratory) Evidence
Clinical criteria for a confirmed case (i.e., a "physician-documented" diagnosis for
which the surveillance staff have not found sufficient laboratory evidence described
above) are met by the combination of:
• A note in a medical record by a physician or other qualified medical-care
provider that states that the patient has HIV infection, and
• One or both of the following:
o The laboratory criteria for a case were met based on tests done after the
physician's note was written (validating the note retrospectively).
o Presumptive evidence of HIV infection (e.g., receipt of HIV antiretroviral
therapy or prophylaxis for an opportunistic infection), an otherwise
unexplained low CD4+ T-lymphocyte count, or an otherwise unexplained
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diagnosis of an opportunistic illness.
o Among children aged less than 18 months whose birthing persons have an
unknown infection status or were known to be infected a reportable case of HIV
infection must meet at least one of the following criteria:
1.2: Children Aged <18 Months Born to Birthing Persons Who Have an
Unknown Infection Status or were Known to be Infected
1.2.1: Laboratory Evidence
A child aged <18 months is categorized for surveillance purposes as HIV infected if
all of the following criteria are met:
• Positive results on at least one specimen (not including cord blood) from any
of following HIV virologic tests:
o HIV-1 NAT (DNA or RNA)
o HIV-1 p24 antigen test, including neutralization assay for a child aged >1
month
o HIV isolation (viral culture) or
o HIV nucleotide sequence (genotype).
• The test date (at least the month and year) is known.
• One or both of the following:
o Confirmation of the first positive result by another positive result on one
of the above virologic tests from a specimen obtained on a different date
or
o Both of the following:
 No subsequent negative result on an HIV antibody test, and no
subsequent negative result on an HIV NAT before age 18 months.

4.1.3

1.2.2: Clinical Evidence
• The same criteria as for section 1.1.2 above (1.1.2 Clinical [Non-Laboratory]
Evidence for Persons Aged ≥18 Months and Children Aged <18 Months
whose Birthing Persons were Not Infected) or
• All three of the following alternative criteria:
o Evidence of perinatal exposure to HIV infection before 18 months of age:
 A birthing person with documented HIV infection or
 A confirmed positive test for HIV antibody (e.g., a positive initial
antibody test confirmed by a supplemental antibody test) and a
birthing person whose infection status is unknown or undocumented.
o Diagnosis of a stage-3-indicative opportunistic illness.
o No subsequent negative result on an HIV antibody test.
PEDIATRIC AIDS
o Children who are HIV infected and exhibit any of the following stage 3 (AIDS)defining clinical conditions should be reported as stage 3 (AIDS) cases; although
most of these conditions appear among adult stage 3 (AIDS) diagnostic criteria,
asterisked conditions apply only to aged <6 years, and conditions with a dagger

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footnote symbol apply only to children aged ≥6 years and adults.
Bacterial infections, multiple or recurrent*
Candidiasis of bronchi, trachea, or lungs
Candidiasis of esophagus
Cervical cancer, invasive†
Coccidioidomycosis, disseminated or extrapulmonary
Cryptococcosis, extrapulmonary
Cryptosporidiosis, chronic intestinal (>1 month’s duration)
Cytomegalovirus disease (other than liver, spleen, or nodes), onset at age >1 month
Cytomegalovirus retinitis (with loss of vision)
Encephalopathy, HIV related
Herpes simplex: chronic ulcer(s) (>1 month’s duration); or bronchitis, pneumonitis, or
esophagitis (onset at age >1 month)
• Histoplasmosis, disseminated or extrapulmonary
• Isosporiasis, chronic intestinal (>1 month’s duration)
• Kaposi’s sarcoma
• Lymphoma, Burkitt (or equivalent term)
• Lymphoma, immunoblastic (or equivalent term)
• Lymphoma, primary, of brain
• Mycobacterium avium complex or M. kansasii, disseminated or extrapulmonary
• Mycobacterium tuberculosis of any site, pulmonary†, disseminated, or extrapulmonary
• Mycobacterium, other species or unidentified species, disseminated or extrapulmonary
• Pneumocystis jirovecii (previously known as “Pneumocystis carinii”) pneumonia
• Pneumonia, recurrent†
• Progressive multifocal leukoencephalopathy
• Salmonella septicemia, recurrent
• Toxoplasmosis of brain, onset at age >1 month
• Wasting syndrome due to HIV
†
Only among adults and children aged ≥6 years.
* Only among children aged <6 years.
•
•
•
•
•
•
•
•
•
•
•

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4.1.4

PEDIATRIC SEROREVERTER
o Virtually all children less than 18 months of age born to HIV-infected persons are
antibody positive at birth.
o A child aged < 18 months born to an HIV-infected person 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:
3.1: Uninfected
A child aged <18 months who was born to an HIV-infected person or had a
positive HIV antibody test result is classified for surveillance purposes as not
infected with HIV if all three of the following criteria are met:
• Laboratory criteria for HIV infection are not met (see section 1.2.1)
• No diagnosis of a stage-3-defining opportunistic illness attributed to
HIV infection and
• Either laboratory or clinical evidence as described below.
3.1.1: Laboratory Evidence
Definitively Uninfected
• No positive HIV NAT (RNA or DNA) and
• At least one of the following two criteria:
o At least two negative HIV NATs from specimens obtained on
different dates, both of which were at age ≥ 1 month and one of
which was at age ≥ 4 months.
o At least two negative HIV antibody tests from specimens obtained
on different dates at age ≥ 6 months.
Presumptively Uninfected
• Criteria for definitively uninfected with HIV are not met
• At least one of the following four laboratory criteria are met:
o At least two negative NATs from specimens obtained on different
dates, both of which were at age ≥2 weeks and one of which was at
age ≥4 weeks.
o One negative NAT (RNA or DNA) from a specimen obtained at age
≥8 weeks.
o One negative HIV antibody test from a specimen obtained at age ≥6
months.
o If criteria for HIV infection had initially been met by one positive
HIV NAT test then it must have been followed by at least two
negative test results from specimens obtained on different dates, one
of which is:
 A NAT test from a specimen obtained at age ≥ 8 weeks, or
 An HIV antibody test from a specimen obtained at age ≥ 6
months.
• No subsequent positive NAT
3.1.2: Clinical Evidence
A note in a medical record by a physician or other qualified medical-care
provider states that the patient is not infected with HIV.

5. Residence at Diagnosis
•

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

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•

•
•
•
•

For HIV, stage 0, 1, 2, and unknown case reports, enter residence at the date of HIV infection
diagnosis. The date of diagnosis of HIV infection is the earliest date on which the
surveillance case definition for HIV infection, any stage, was satisfied in accordance with
laboratory and clinical criteria (see the Revised Surveillance Case Definition for HIV
Infection at http://www.cdc.gov/mmwr/pdf/rr/rr6303.pdf).
If a test result is not available, enter patient’s residence at the date of physician diagnosis of
HIV infection.
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 HIV, stage 3 (AIDS) case reports, enter patient’s residence
at the date of the first stage 3 (AIDS) diagnosis based on the applicable case definition.
For further guidance about residency assignment, see Technical Guidance File Date and
Place of Residence.

6. Facility of Diagnosis
6.2

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 birthing person 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 associated with the
date of HIV infection diagnosis. The date of diagnosis of HIV infection is the earliest date on
which the surveillance case definition for HIV infection, any stage, was satisfied in
accordance with laboratory and clinical criteria (see the Revised Surveillance Case
Definition for HIV Infection at http://www.cdc.gov/mmwr/pdf/rr/rr6303.pdf)..
• 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. Enter facility
uniformly to prevent the occurrence of multiple names for a given facility.
• For HIV, stage 3 (AIDS) case reports, enter the name of the facility associated with the date
of the first stage 3 (AIDS) diagnosis based on the applicable case definition.
• These fields strictly apply to facility where HIV or HIV infection stage 3 (AIDS) was
diagnosed. Where chart abstraction is conducted at a facility other than the Facility of
Diagnosis document report source in the document source field in the II. Health Department
Use Only section of the case report form and in III. Facility Providing Information section of
the case report form, as applicable.

7. Patient History
•

•
•

This information is often found in the birthing person’s chart in the discharge summary,
history and physical, social service notes, counseling and testing notes, and STD diagnosis
notes.
Where not explicitly annotated, contact the child’s provider about birthing person and child
risk factor information.
See Technical Guidance File Risk Factor Ascertainment 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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7.1

BIRTHING PERSON’S HIV INFECTION STATUS
• “Refused HIV testing” should be selected if birthing person’s refusal is documented in the
medical chart.
• If the birthing person 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 birthing person-to-infant transmission through breast-feeding is considered to be the only
mode of transmission, please alert the state or local NIR coordinator.
• If dates are not available, please review medical charts to determine when HIV diagnosis for
the birthing person occurred in relationship to the child’s birth and select:
Known HIV+ before pregnancy;
Known HIV+ during pregnancy;
Known HIV+ sometime before birth;
Known HIV+ at delivery;
Known HIV+ after child’s birth; or
HIV+, time of diagnosis unknown.
• If no information is available regarding HIV status for the birthing person, please select:
HIV status unknown.

10. Birth History (for patients exposed perinatally with or without consequent infection)

10.4 BIRTH HISTORY
10.4.6 CONGENITAL DISORDERS
o 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.
o Approximately 3%–4% of all babies will have serious birth defects (e.g., neural
tube defects, congenital heart defects, esophageal atresia, and cleft lip/palate).
o 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.
o 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 as listed
below.
o 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; and
 A case must be abstracted by the child’s sixth birthday.
o Criteria for Exclusion:
 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

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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 psychological 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 or ICD-10
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 laboratory 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 contact the CDC HIV Surveillance Branch
surveillance project officer assigned to the state/local HIV surveillance
program.
o BIRTH DEFECTS CODE
 The 6-digit defect codes
(https://www.cdc.gov/ncbddd/birthdefects/macdp.html) are based on 3- to
5-digit ICD-9-CM or ICD-10-CM codes from a birth certificates or
medical records (or ICD-9 or ICD-10 codes from death certificates). The
shorter codes may be used in place of the 6-digit codes. Enter the code for
the birth defect given in the birth certificate, medical record, or death
certificate. If the code is not available in those places, but the birth defect
is described using medical terminology, then look up the corresponding
code in the ICD-9-CM-based list (downloadable from
http://www.cdc.gov/ncbddd/birthdefects/macdp.html) if the record was
from before October 1, 2014, or in the ICD-10-CM-based list
(downloadable from http://www.cdc.gov/nchs/icd/icd10cm.htm) if the
record was from October 1, 2014 or later.
 If defects exist, list all on the case report form and enter in the Comments
section. In eHARS, if there are more than five congenital defects then
enter the information on the additional congenital defects on a separate
PCRF document.

11. Birthing Person History

11.13 WAS THE BIRTHING PERSON SCREENED FOR ANY OF THE FOLLOWING
CONDITIONS DURING THIS PREGNANCY
• GROUP B STREP (GBS) - Group B streptococci. A major cause of perinatal bacterial
infections and systemic and focal infections in infants. Invasive disease categorized into
early onset (1st week of life) and late onset (usually at 3-4 weeks of life). Colonization late in
pregnant persons and newborns ranges from 5% to 35%. Intrapartum chemoprophylaxis is
IV Penicillin G. Two types of prevention strategies may be used:
o Screening all pregnant persons at 35 to 37 weeks for vaginal and rectal GBS
colonization and offering intrapartum chemoprophylaxis to those identified as GBS
carriers; or

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o Risk factor-based strategy - prophylaxis given to persons with intrapartum risk
factors including gestation < 37 weeks, ≥ 18 hours since rupture of membrane, or
temperature of 38° C or greater.
• HEPATITIS B (Hepatitis B surface antigen, HBsAg) - Detects acutely or chronically
infected persons. Prenatal HbsAg screening of all pregnant persons is recommended. Babies
of birthing persons who are HbsAg (+) must have HBIG and HBV vaccine within 12 hours
of birth to prevent perinatal HBV infection. Be sure the test result is for the surface antigen
rather than the antibody (anti-HBs), core antigen (HbcAg), or antibody (anti-HBc); or
Hepatitis B e antigen (HbeAg) or antibody (anti-HBe). This test is usually done at the initial
prenatal visit or at the time of labor and delivery for persons with risk factors for hepatitis B
infection and persons whose status is unknown.
• RUBELLA - Screening is usually done at the initial prenatal visit. If ‘negative’ the birthing
person should be immunized.
• SYPHILIS - All pregnant persons should receive serologic screening for syphilis early in
pregnancy with a nontreponemal test (e.g., VDRL and RPR). In addition, screening is
recommended in the third trimester for those in high prevalence areas or for persons with
risk factors for syphilis infection. Nontreponemal antibody tests are used for screening
purposes and presumptive diagnosis: VDRL (venereal disease research laboratory); RPR
(rapid plasma reagin test; STS serologic test for syphilis, syphilis screening test); ART
(automated reagin test). The nontreponemal antibody test should be confirmed with a
treponemal antibody test (e.g., FTA-ABS, MHA-TP). If a pregnant person has a reactive
nontreponemal test and a persistently negative treponemal test, a false positive test is
inferred.(Reference: Red Book 2021- American Academy of Pediatrics).
11.14
WERE ANY OF THE FOLLOWING CONDITIONS DIAGNOSED FOR THE
BIRTHING PERSON DURING THIS PREGNANCY OR AT THE TIME OF LABOR AND
DELIVERY
• BACTERIAL VAGINOSIS - Clinician diagnosis of bacterial vaginosis. Sometimes
abbreviated BV.
• CHLAMYDIA (Chlamydia trachomatis) - Record positive test for chlamydia (a positive
culture, positive EIA, or detection of chlamydial antigen or nucleic acid).
o Name of laboratory tests - Chlamydia cell culture (TRIC Agent Culture); direct
fluorescent antibody (DFA) tests; enzyme immunoassay (EIA) tests; nucleic
hybridization (DNA probe) tests; and PCR and LCR.
• GENITAL HERPES - Active (herpes genitalis) - Primary herpes (first episode of herpes) or
recurrence of herpes during pregnancy or at labor and delivery.
o Name of laboratory tests - herpes virus culture; herpes cytology (herpetic inclusion
bodies, cytology, inclusion body stain, Tzanck smear, Giemsa stain viral study);
rapid diagnostic tests- direct immunofluorescent AB or EIA; HSV Ag; or
polymerase chain reaction (PCR).
• GONORRHEA (Neisseria gonorrhea) - Record if culture positive.
o Name of laboratory tests - Neisseria gonorrhea culture (GC Culture, Gonorrhea
Culture); Thayer-Martin medium; chocolate agar; detection of nucleic acid.

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GROUP B STREP - Group B streptococci. A major cause of perinatal bacterial infections
and systemic and focal infections in infants. Invasive disease categorized as early onset (1st
week of life) and late onset (usually at 3-4 weeks of life). Colonization late in pregnant
persons and newborns ranges from 5% to 35%. Intrapartum chemoprophylaxis is IV
Penicillin G. Two types of prevention strategies may be used:
o Screening all pregnant persons at 35 to 37 weeks for vaginal & rectal GBS
colonization, offering intrapartum chemoprophylaxis to those identified as GBS
carriers; or
o Risk factor-based strategy in which prophylaxis is given to persons with
intrapartum risk factors: gestation < 37 weeks, ≥ 18 hours since rupture of
membrane, or temperature 38° C or greater.
HEPATITIS B (Hepatitis B surface antigen, HbsAg) - Detects acutely or chronically
infected persons. Prenatal HbsAg screening of all pregnant persons is recommended. Babies
of birthing persons who are HbsAg (+) must have HBIG & HBV vaccine within 12 hours of
birth to prevent perinatal HBV infection.
o Be sure the test result is for the surface antigen rather than the antibody (anti-HBs),
core antigen (HbcAg) or antibody (anti-HBc); or Hepatitis B e antigen (HbeAg) or
antibody (anti-HBe). Tests are usually done at the initial prenatal visit or at the
time of labor and delivery for persons with risk factors of hepatitis B infection and
persons whose status is unknown.
HEPATITIS C - Tests do not distinguish between acute, chronic, or resolved infection.
Diagnosis by antibody assays involves initial screening EIA. Repeatedly positive results are
confirmed by a recombinant immunoblot assay (RIBA). Highly sensitive PCR assays for
detection of HCV RNA are also available.
o Name of laboratory test - EIA (Enzyme immunoassay) screen, confirmed by
recombinant immunoblot assay (RIBA).
PELVIC INFLAMMATORY DISEASE (PID) - Look for documentation of a clinical
diagnosis of PID. A note stating ‘rule out PID’ does not indicate the person had PID.
SYPHILIS (Treponema pallidum) - All pregnant persons should receive a serologic screen
for syphilis early in pregnancy with a nontreponemal test (e.g., VDRL, RPR, STS, and ART)
and preferably again at delivery. In addition, screening is recommended in the third trimester
for those in high prevalence areas or those at high risk.
o Nontreponemal antibody tests are used for screening. Any reactive nontreponemal
test must be confirmed by a specific treponemal test (FTA-ABS and MHA-TP) to
exclude false positive results which can be caused by a viral infection (e.g.,
infectious mononucleosis, hepatitis, varicella and measles), lymphoma, TB,
malaria, endocarditis, connective tissue disease, pregnancy, or abuse of injection
drugs. If a pregnant person has a reactive nontreponemal test and a persistently
negative treponemal test, a false positive test is inferred. A positive FTA-ABS or
MHA-TP usually remains reactive for life, even after successful therapy. Also,
look for evidence of treatment for syphilis - receipt of penicillin (bicillin) 2.4
million units is the standard treatment for syphilis in the birthing person. Check
whether the child was diagnosed with or treated for congenital syphilis with
penicillin for 10 days. A physician diagnosis will be clearly documented in the
infant's birth chart. Also check the congenital syphilis registry to confirm
congenital syphilis, with consideration for confidentiality and security of an
individual’s HIV or stage 3 or AIDS status.

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o Name of laboratory tests - Presumptive diagnosis: nontreponemal tests (for
screening purposes) VDRL (venereal disease research laboratory); RPR (rapid
plasma reagin test, serologic test for syphilis, STS, syphilis screening test, ARTautomated reagin test). Definitive diagnosis: treponemal tests (for diagnostic
purposes) Darkfield examination (Darkfield microscopy, syphilis; Treponema
Pallidum Darkfield examination); FTA-ABS (Fluorescent Treponemal Antibody
Absorbed Test, Fluorescent Treponemal Antibody Adsorption); MHA-TP
(Microhemagglutination assay for Antibody to Treponema Pallidum;
Microhemagglutination, Treponema Pallidum.
TRICHOMONAS (Trichomonas vaginalis) - Record clinician diagnosis of trichomonas.
Trichomonas is diagnosed by finding trichomonas on a wet mount.
o Name of laboratory tests - Trichomonas preparation (Hanging Drop Mount for
Trichomonas, Trichomonas vaginalis wet preparation; Trich Prep; wet preparation
for Trichomonas vaginalis.

12. Treatment/Services Referrals

12.2 ARV MEDICATION
• Please refer to the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection
https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/PedARV_GL.pdf.
12.6 HAS THIS CHILD EVER TAKE PCP PROPHYLAXIS?
• 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.
12.7 THIS CHILD’S PRIMARY CARETAKER IS
• “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 deceased 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 deceased 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
this section.

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