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Attachment 4a.
Adult HIV Confidential Case Report Form
Technical Guidance
Technical Guidance for HIV
Surveillance Programs
Adult HIV Confidential Case Report Form
HIV Incidence and Case 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 ..................................................................................................... 3
Disposition of Form ............................................................................................................................ 3
Patient Identification ........................................................................................................................... 4
Health Department Use Only .......................................................................................... 5
Facility Providing Information ................................................................................................................ 7
Patient Demographics .............................................................................................................................. 8
Residence at Diagnosis........................................................................................................................... 10
State/Local Use Only ........................................................................................................................ 10
Facility of Diagnosis ......................................................................................................................... 11
Patient History ........................................................................................................................................ 12
Clinical: Acute HIV Infection and Opportunistic Illnesses............................................................... 15
Laboratory Data ................................................................................................................................ 18
Treatment/Services Referrals ............................................................................................................ 25
Antiretroviral Use History................................................................................................................. 27
HIV Testing History.......................................................................................................................... 28
Comments ......................................................................................................................................... 31
Local/Optional Fields ........................................................................................................................ 31
Appendix: Adult HIV Confidential Case Report ....................................................................................... 32
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Instructions for Completion
Purpose of Case Report Form
The Adult HIV Confidential Case Report (CDC 50.42A) form (ACRF) is designed to collect information
that promotes understanding of HIV infection morbidity and mortality among patients greater than or
equal to 13 years of age at time of diagnosis. This form reflects data that are required to be collected and
some that are recommended or optional. This guidance applies to all HIV infection data collection even if
state or local surveillance programs use a different form or medium for HIV case surveillance. See
Appendix for further guidance.
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 HIV case.
Patients for Whom Form is Indicated
•
•
•
Each person, greater than or equal to 13 years of age, who meets the HIV infection or stage 3
(AIDS) case definition (available at http://wwwn.cdc.gov/nndss/conditions/hiv-infection/).
Each person with HIV infection progressing from an earlier or unknown stage to stage 3
(AIDS) diagnosis.
Each person 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.
If the data are collected electronically and can be imported, recording the information on a hardcopy form is
not necessary.
Definition of Variable Designators
•
•
•
•
Required: Variables that must be collected by all programs.
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 the Centers for Disease
Control and Prevention (CDC)-supplied software.
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/AIDS 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 data network.
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1. Patient Identification
*Information NOT transmitted to CDC
•
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.
1.1
FIRST NAME (Required, applies to health department & health care providers)
• Enter patient’s first name.
1.2
MIDDLE NAME (Optional, applies to health department & health care providers)
• Enter patient’s middle name.
1.3
LAST NAME (Required, applies to health department & health care providers)
• Enter patient’s last name.
1.4
LAST NAME SOUNDEX (System generated)
• After patient name is entered into CDC-supplied software, 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
1.5
ALTERNATE NAME TYPE (Optional, applies to health department & health care providers)
• If available, write in the alternate name type (such as Alias, Married).
1.6
ALTERNATE FIRST NAME (Optional, applies to health department & health care providers)
• Enter patient’s alternate first name.
1.7
ALTERNATE MIDDLE NAME (Optional, applies to health department & health care
providers)
• Enter patient’s alternate middle name.
1.8
ALTERNATE LAST NAME (Optional, applies to health department & health care providers)
• Enter patient’s alternate last name.
1.9
ADDRESS TYPE (Required, applies to health department & health care providers)
• Select one of the address types for the patient’s current address.
1.10
CURRENT ADDRESS, STREET (Required, applies to health department & health care
providers)
• Enter the patient’s current street address.
1.11
ADDRESS DATE (Required, applies to health department & health care providers)
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•
•
•
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.
Enter date in mm/dd/yyyy format using ‘..’ for unknown values (e.g., 03/../2011).
1.12
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.
1.13
CITY (Required, applies to health department & health care providers)
• Enter patient’s current city.
1.14
COUNTY (Required, applies to health department & health care providers)
• Enter patient’s current county.
1.15
STATE/COUNTRY (Required, applies to health department & health care providers)
• Enter patient’s current state and country name.
1.16
ZIP CODE (Required, applies to health department & health care providers)
• Enter patient’s current zip code.
1.17
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.
• If the patient has more than one medical record number, enter the number of the primary
record that has 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.
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.
2. Health Department Use Only
2.1
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).
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2.2
eHARS DOCUMENT UID (System generated)
• Enter UID after CDC-supplied software generates this variable.
2.3
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 infection in each
state/jurisdiction where they are reported. 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 in the file Pediatric HIV Confidential Case Report Form and
Perinatal HIV Exposure Reporting Form 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 state number associated with diagnosed HIV infection on the case report
form.
• 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 the state datasets without duplication.
2.4
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.
2.5
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 infection
assigned by the separately funded city in which they are reported. If the city/county number
is the primary identifier and the patient was a 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 in the file Pediatric HIV Confidential Case Report Form and Perinatal HIV
Exposure Reporting Form 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 city/county number associated
with diagnosed HIV infection on the case report form.
• 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 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 allowable document source
codes.
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 refer to the 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.
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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 an 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
3.1
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.
3.2
PHONE (Recommended, applies to health department & health care providers)
• Enter facility’s current area code and telephone number.
3.3
STREET ADDRESS (Recommended, applies to health department & health care providers)
• Enter facility’s street address.
3.4
CITY (Recommended, applies to health department & health care providers)
• Enter city where facility providing information is located.
3.5
COUNTY (Recommended, applies to health department & health care providers)
• Enter county where facility providing information is located.
3.6
STATE/COUNTRY (Recommended, applies to health department & health care providers)
• Enter state and country name where facility providing information is located.
3.7
ZIP CODE (Recommended, applies to health department & health care providers)
• Enter ZIP code where facility providing information is located.
3.8
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
allowable facility types.
3.9
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).
3.10
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.
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3.11
PHONE (Recommended, applies to health department & health care providers)
• Enter the telephone number of the person completing the form.
4. Patient Demographics
4.1
SEX ASSIGNED AT BIRTH (Required, applies to health department & health care providers)
• Select patient’s sex assigned at birth.
• In addition to “Male” or “Female” sex at birth, CDC-supplied software includes a third
choice of “Unknown.”
4.2
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.
4.3
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).
4.4
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).
4.5
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 the file Death Ascertainment.
4.6
DATE OF DEATH (Required, if applicable, applies to health department & health care 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 the file Death Ascertainment.
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4.7
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”.
4.8
CURRENT GENDER IDENTITY (Recommended, if applicable, applies to health department &
health care providers)
• Complete only if the patient is thought to be transgender.
• Enter the current gender identity of the patient.
• If the person’s stated gender identity differs from the selections provided, please check the
additional gender identity box and specify in the blank.
• Refer to the lookup codes in the eHARS Technical Reference Guide for allowable current
gender identity values.
4.9
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 CDC-supplied
software. These ethnicities and codes are documented in the eHARS Technical Reference
Guide.
4.10
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.
4.11
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.
4.12
EXPANDED RACE (Optional, if applicable, applies to health department & health care 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.
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5. Residence at Diagnosis
•
•
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.
5.1
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.
5.2
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.
5.3
STREET ADDRESS (Required, applies to health department & health care providers)
• Enter street address of residence at diagnosis.
5.4
CITY (Required, applies to health department & health care providers)
• Enter city of residence at diagnosis.
5.5
COUNTY (Required, applies to health department & health care providers)
• Enter county of residence at diagnosis.
5.6
STATE/COUNTRY (Required, applies to health department & health care providers)
• Enter the state and country name of residence at diagnosis.
5.7
ZIP CODE (Required, applies to health department & health care providers)
• Enter the ZIP code of residence at diagnosis.
6. State/Local Use Only
•
The information in this section is not transmitted to CDC and is meant only for state and
local health department use. State and local health departments should develop their own
policies for collecting the data elements within this section. Collection of information within
this section is Optional.
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7. Facility of Diagnosis
•
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.
7.1
DIAGNOSIS TYPE (Recommended, applies to health department & health care providers)
• Enter the diagnosis type that corresponds to the facility of diagnosis being
reported.
7.2
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 7.1.
• Refer to Appendix 7.2 for further details.
7.3
PHONE (Recommended, applies to health department & health care providers)
• Enter area code and telephone number of the facility of diagnosis.
7.4
STREET ADDRESS (Recommended, applies to health department & health care providers)
• Enter street address of the facility of diagnosis.
7.5
CITY (Recommended, applies to health department & health care providers)
• Enter city of the facility of diagnosis.
7.6
COUNTY (Recommended, applies to health department & health care providers)
• Enter county of the facility of diagnosis.
7.7
STATE/COUNTRY (Recommended, applies to health department & health care providers)
• Enter state and country name of the facility of diagnosis.
7.8
ZIP CODE (Recommended, applies to health department & health care providers)
• Enter ZIP code where the facility of diagnosis is located.
7.9
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.
7.10
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 7.1.
7.11
PROVIDER PHONE (Recommended, applies to health department & health care providers)
• Enter area code and telephone number for provider selected in 7.10.
7.12
SPECIALTY (Optional, applies to health department & health care providers)
• Enter provider’s specialty for provider selected in 7.10.
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8. Patient History
•
8.1
These data yield information about how patients may have acquired their infections.
o Check box at the top of this section if the risk factor was a pediatric risk factor and
enter additional information in the Comments section.
o 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 the file Risk Factor
Ascertainment.
o See Appendix 8.0 for further guidance on risk factor ascertainment.
SEX WITH MALE (Required, applies to health department & health care providers)
•
•
Select applicable response.
Some examples of information from the medical record which would strongly indicate sex
with a male are below.
o For male patient:
Married to or divorced from a male; and
Rectal gonorrhea.
o For female patient:
Married to or divorced from a male;
Boyfriend referenced in the medical record;
Living with a male “partner”;
History of pregnancy;
History of another sexually transmitted infection (in addition to HIV); and
Sex worker (either current or in the past).
8.2
SEX WITH FEMALE (Required, applies to health department & health care providers)
• Select applicable response.
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•
8.3
Some examples of information from the medical record which would strongly indicate sex
with a female are below.
o For male patient:
Married to or divorced from a female; and
Has a biological child
o For female patient:
Married to or divorced from a female.
INJECTED NON-PRESCRIPTION DRUGS (Required, applies to health department & health
care providers)
• Select applicable response.
• History of injected non-prescription drugs might have occurred at any time in the past
8.4-8.6 RECEIVED CLOTTING FACTOR FOR HEMOPHILIA/COAGULATION DISORDER,
SPECIFY CLOTTING FACTOR, and DATE RECEIVED (Required, applies to health
department & health care providers)
• Select applicable response.
• “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).
• This risk factor is generally documented in the history and physical section of the patient’s
medical chart.
• They do not include other bleeding disorders, such as thrombocytopenia, treatable by platelet
transfusion.
• If only a transfusion of platelets, other blood cells, or plasma was received by the partner,
then select “No.”
• See the file Risk Factor Ascertainment for further guidance on risk factor data collection and
cases of public health importance (COPHI).
• Alert state/local COPHI coordinator if select “Yes”.
• If “Yes”, specify the clotting factor and enter date received. Enter date in mm/dd/yyyy format
using ‘..’ for unknown values (e.g., 03/../2011).
8.7
HETEROSEXUAL RELATIONS WITH ANY OF THE FOLLOWING: This section, addressed
at 8.7.1–8.7.6, relates to ascertainment of risk among persons who had heterosexual contact (had
sex with) with the case patient. Verification of sex partner’s HIV infection status is not
necessary.
8.7.1
INTRAVENOUS/INJECTION DRUG USER (Required, applies to health department &
health care providers)
o Select applicable response.
8.7.2 BISEXUAL MALE (Required, applies to health department & health care providers)
o Select applicable response.
o Applies only to female cases.
8.7.3
PERSON WITH HEMOPHILIA/COAGULATION DISORDER WITH
DOCUMENTED HIV INFECTION (Required, applies to health department & health care
providers)
o Select applicable response.
o Refer to 8.4-8.6 for additional information.
8.7.4
TRANSFUSION RECIPIENT WITH DOCUMENTED HIV INFECTION (Required,
applies to health department & health care providers)
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o Select applicable response.
o Consider documenting the reason for transfusion in the Comments section.
8.7.5
TRANSPLANT RECIPIENT WITH DOCUMENTED HIV INFECTION (Required,
applies to health department & health care providers)
o Select applicable response.
o Consider documenting the reason for transplant in the Comments section.
8.7.6
PERSON WITH DOCUMENTED HIV INFECTION, RISK NOT SPECIFIED
(Required, applies to health department & health care providers)
o Select applicable response.
o Select “Yes” only if HETEROSEXUAL sex partner is known to be HIV positive and
that partner’s risk factor for HIV is unknown.
8.8-8.10 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)
• Select applicable response.
• Blood is defined as a circulating tissue composed of a fluid portion (plasma) with suspended
formed elements (red blood cells, white blood cells, platelets).
• Blood components that can be transfused include erythrocytes, leukocytes, platelets, and
plasma.
• It is often helpful to document the reason for the transfusion in the Comments section.
• See the file Risk Factor Ascertainment for further guidance on risk factor data collection and
COPHI.
• If the last transfusion was after March 1985, then alert state/local COPHI coordinator.
• If “Yes”, enter the dates first and last received in mm/dd/yyyy format using ‘..’ for unknown
values (e.g., 03/../2011).
8.11
RECEIVED TRANSPLANT OF TISSUE/ORGANS OR ARTIFICIAL INSEMINATION
(Required, applies to health department & health care providers)
• Select applicable response.
• See the file Risk Factor Ascertainment for further guidance on risk factor data collection and
COPHI.
• Alert the state/local COPHI coordinator if select “Yes”.
8.12-8.13 WORKED IN HEALTH CARE OR CLINICAL LABORATORY SETTING and IF
OCCUPATIONAL EXPOSURE IS BEING INVESTIGATED OR CONSIDERED AS
PRIMARY MODE OF EXPOSURE, SPECIFY OCCUPATION AND SETTING (Required
applies to health department & health care providers)
•
•
•
•
•
8.14
Select applicable response.
Investigate apparent occupational exposures to determine if this was the only risk factor
present.
See the file Risk Factor Ascertainment for further guidance on risk factor data collection and
COPHI.
Alert state/local COPHI coordinator if select “Yes”.
If “Yes”, specify occupation and setting.
OTHER DOCUMENTED RISK (Required applies to health department & health care providers)
•
•
•
See the file Risk Factor Ascertainment for further guidance on unusual transmission history
that could be considered as potential COPHI.
Select applicable response.
Document details of the risk information in the Comments section.
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9. Clinical: Acute HIV Infection and Opportunistic Illnesses
9.1
CLINICAL: ACUTE HIV INFECTION
• Collection of acute HIV infection information is recommended for all state and local health
departments.
• The purpose of this section is to facilitate the identification of persons with acute HIV
infection for more urgent follow-up, as applicable according to state and local health
department policies and practices. Acute HIV infections are more transmissible than other
HIV infections. Clinical criteria for acute HIV infection may overlap the surveillance case
definition of stage 0 (early HIV infection).
o Persons more likely to have acute HIV infection may be identified by a shorter
interval (relative to the stage-0-defining period of up to 180 days) between a negative
or indeterminate HIV test result and the first HIV-positive test result associated with
diagnosis. The maximum length of the interval between these two tests could range
from 30 to 90 days, and may be determined locally.
o This section includes clinical (non-laboratory) data to supplement the laboratorybased criteria for stage 0 to identify persons with probable or possible acute HIV
infection for follow-up as applicable.
• These variables indicative of probable or possible acute HIV infection may be used
separately or in combination with the eHARS stage 0 variable (stage_zero_dx) to inform
epidemiologic analyses.
• For further information about acute HIV infection, see the file, Early HIV Infection, HIV-2,
and Other Diagnostic Considerations.
9.1.1
SUSPECT ACUTE HIV INFECTION? (Recommended, applies to health department &
health care providers)
o This variable is meant to encompass all sources of available information that might
indicate acute HIV, and its use could vary with each state or local jurisdiction’s
policies and practices. The information about acute HIV status could include
laboratory-documented evidence from the laboratory-based HIV testing algorithm,
such as having a positive initial immunoassay result followed by a negative or
indeterminate type-differentiating supplemental test and a subsequent positive NAT;
or it could include a laboratory-documented or patient or provider reported history of
a previous negative HIV test before diagnosis. Additionally, it could include
information from a provider reporting that the person had acute HIV, or include
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National HIV Surveillance System Technical Guidance – ACRF, XXXX 2019
provider notes about symptoms of acute HIV, or there may have been clear
information about a specific exposure that occurred just before diagnosis and no
possibility of exposure prior to that specific occurrence.
o Select “Yes” if there is any evidence to suspect that the person had acute HIV
infection at diagnosis. If “Yes” is selected, then ensure the following:
Complete the items below for “Clinical signs/symptoms consistent with acute
retroviral syndrome” and “Other evidence suggestive of acute HIV infection.”
Documented negative or indeterminate HIV test results that include the type
of test and date should be entered in the Laboratory Data section.
Patient or provider reports of a previous negative HIV test should be entered
in the HIV Testing History section.
o “No” indicates sufficient evidence that the person did not have acute HIV infection at
diagnosis.
o “Unknown” indicates there is insufficient evidence to indicate whether the person had
acute HIV infection at diagnosis, after searching for the information, consulting with
the provider, or asking the patient.
9.1.2
CLINICAL SIGNS/SYMPTOMS CONSISTENT WITH ACUTE RETROVIRAL
SYNDROME (Recommended, applies to health department & health care providers)
o This field is intended for collecting evidence of the clinical signs/symptoms
consistent with acute retroviral syndrome (e.g., fever, malaise/fatigue, myalgia,
pharyngitis, rash, and/or lymphadenopathy; generally, two or more symptoms such as
these are present). For a more complete list of the clinical symptoms associated with
acute HIV, refer to Appendix 9.1.2.
o This information would typically be found in the clinical record and could be
explicitly stated as acute retroviral syndrome (ARS) or primary HIV infection (PHI),
or that the provider suspects acute infection, or there could just be a description of the
case’s presenting symptoms at the time of HIV testing together with plausible
information about a recent HIV exposure. Ideally, ARS or PHI would be determined
by a clinician who has ruled out other illness.
o If it is unclear whether any symptoms are related to acute HIV, consult with medical
professionals.
o Select “Yes” if there is clear evidence that the person had clinical signs/symptoms
consistent with acute retroviral syndrome.
o “No” indicates sufficient evidence that the person did not clinical signs/symptoms
consistent with acute retroviral syndrome.
o “Unknown” indicates there is insufficient evidence to indicate whether the person had
clinical signs/symptoms consistent with acute retroviral syndrome, after searching for
the information, consulting with the provider, or asking the patient.
9.1.3
DATE OF SIGN/SYMPTOM ONSET (Recommended, applies to health department &
health care providers)
o Record the earliest date of sign/symptom onset.
o Enter date in mm/dd/yyyy format. If day is unknown, use ‘..’ for the unknown value
(e.g., 03/../2017).
9.1.4
OTHER EVIDENCE SUGGESTIVE OF ACUTE HIV INFECTION? (Recommended,
applies to health department & health care providers)
o Select “Yes” if there is any other evidence of acute HIV that is not based on
diagnostic HIV-related test information or signs/symptoms of acute HIV. An example
would be a person who had a high viral load (>500,000 copies/mL) at or within 6
weeks after diagnosis, or a clear exposure to HIV that occurred just before diagnosis
in the setting where an earlier source of infection is unlikely (e.g., a rape or an
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National HIV Surveillance System Technical Guidance – ACRF, XXXX 2019
occupational exposure).
Viral load data should be entered in the Laboratory Data section.
Note that an occupational exposure would also be followed up as a COPHI.
o “No” indicates sufficient information to indicate no other evidence of acute HIV
infection.
o “Unknown” indicates there is insufficient evidence to indicate whether there was any
other evidence of acute HIV infection, after searching for the information, consulting
with the provider, or asking the patient.
9.1.5
9.1.6
9.2
OTHER EVIDENCE SUGGESTIVE OF ACUTE HIV INFECTION (SPECIFY)
(Recommended, applies to health department & health care providers)
o Enter a brief description of the exposure leading to the determination of a
presumptive acute HIV diagnosis, (e.g. “High viral load—980,000 copies/mL,” or
“Patient raped in Feb, HIV diagnosis in March”).
DATE OF EVIDENCE (Recommended, applies to health department & health care
providers)
o Record the date associated with the other evidence.
o Enter date in mm/dd/yyyy format. If day is unknown, use ‘..’ for the unknown value
(e.g., 03/../2017).
CLINICAL: OPPORTUNISTIC ILLNESSES
9.2.1–9.2.26 (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 http://wwwn.cdc.gov/nndss/conditions/hiv-infection/).
9.2.27 RVCT CASE NUMBER (Optional, applies to health department & health care
providers)
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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10. Laboratory Data
•
Throughout this section, “Collection Date” refers to the date when the specimen was
collected or drawn. Enter collection dates in mm/dd/yyyy format using ‘..’ for unknown
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•
•
•
10.1
values (e.g., 03/../2011).
Record all laboratory tests. Include all diagnostic tests, viral load tests, CD4 tests, and drug
resistance tests (genotypic) where possible. Where the number of tests 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).
In the absence of lab tests, record HIV infection or stage 3 (AIDS) diagnostic evidence
documented in the chart by a physician.
HIV IMMUNOASSAYS (NON-DIFFERENTIATING)
• Assuming active case finding, review patient’s chart and lab reports for the earliest date of
documented HIV positivity. “Indeterminate” refers to Indeterminate HIV antibody test
results.
• Enter the brand name of the test and/or its manufacturer, lab 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).
• Check the Point-of-care rapid test box if the test is a CLIA waived point-of-care rapid test.
(Optional, applies to health department & health care providers)
10.1.1 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 repeatedly reactive tests on a single sample.
10.1.2 HIV-1/2 IA
o Enter result and collection date of first HIV-1/2 combination IA test. (Required,
applies to health department & health care providers)
10.1.3 HIV-1/2 AG/AB
o Enter result and collection date of combined p24 antigen and anti HIV1/2 antibody
screening assay. (Required, applies to health department & health care providers)
10.1.4 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,
1989:38:No.S-7).
10.1.5 HIV-1 IFA
o Enter the result and collection date of first HIV-1 IFA. (Required, applies to health
department & health care providers)
10.1.6 HIV-2 IA
o Enter result and date of first HIV-2 IA. (Required, applies to health department &
health care providers)
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o
“Positive IA” means repeatedly reactive tests on a single sample.
10.1.7 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)
10.2
HIV IMMUNOASSAYS (DIFFERENTIATING)
• Assuming active case finding, review patient’s chart and lab reports for the earliest date of
documented HIV positivity.
• Enter the brand name of the test and/or its manufacturer, lab 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).
10.2.1 HIV-1/2 TYPE-DIFFERENTIATING IMMUNOASSAY
o Enter collection date of first HIV-1/2 Type-Differentiating IA. (Required, applies to
health department & health care providers)
o Enter the role of the test in the diagnostic algorithm, “screening/initial” or
“confirmatory/supplemental”. That is, was the test used as a screening/initial test in
the recommend diagnostic algorithm or was the test used as a
confirmatory/supplemental test in the recommended diagnostic algorithm.
o Enter the overall interpretation of the test (Required, applies to health department &
health care providers)
o Record the result for each analyte (HIV-1Ab 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).
o Check the Point-of-care rapid test box if the test is a CLIA waived point-of-care rapid
test. (Optional, applies to health department & health care providers)
10.2.2 HIV-1/2 AG/AB-DIFFERENTIATING IMMUNOASSAY
o Enter result and collection date of first HIV-1/2 Ag/Ab-Differentiating IA.
(Required, applies to health department & health care providers)
o If the result is HIV Ab reactive or HIV Ag reactive and HIV Ab reactive, check the
box for “Ab positive” or “Both (Ag and Ab reactive)”, respectively, on the ACRF.
These indicate that antibodies to HIV-1 or HIV-2 were detected.
10.2.3 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)
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10.3
HIV DETECTION TESTS (QUALITATIVE)
• All varieties of such tests establish the presence of the pathogen, HIV. By contrast, HIV tests
such as the IA 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 lab reports for the earliest date of
documented HIV positivity.
• Enter the brand name of the test and/or its manufacturer, lab 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).
10.3.1 HIV-1 RNA/DNA NAAT (QUALITATIVE)
o Enter result and collection date of earliest NAAT. (Required, applies to health
department & health care providers)
10.3.2 HIV-1 CULTURE
o Enter result and collection date of earliest test by culture. (Required, applies to health
department & health care providers)
10.3.3 HIV-2 RNA/DNA NAAT (QUALITATIVE)
o Enter result and collection date of earliest NAAT. (Required, applies to health
department & health care providers)
10.3.4 HIV-2 CULTURE
o Enter result and collection date of earliest test by culture. (Required, applies to health
department & health care providers)
10.4
HIV DETECTION TESTS (QUANTITATIVE VIRAL LOAD)
• Enter the brand name of the test and/or its manufacturer, lab name, facility name and
provider name. (Optional, applies to health department & health care providers)
• Indicate if results are “Detectable” or “Undetectable”. Viral load tests with undetectable
results should also be entered. (Optional, applies to health department & health care
providers)
• Enter results in units of viral copies per milliliter (mL) and Log. (Required, applies to health
department & health care providers)
o Where results are reported above the limit of quantification (LOQ), select
“Detectable” then enter “greater than detection limits for this assay” and the result
value in the copies/mL field.
o Where the results reported are below the LOQ, select “Undetectable” then enter
“fewer than detectable by this assay” and the result value in the copies/mL field.
For example, a result of “<48 cp/mL detected” should be entered into the copies/ml
field as “fewer than detectable by this assay - 48 cp/mL”.
• Enter specimen collection date in mm/dd/yyyy format using ‘..’ for unknown values (e.g.,
03/../2011).
10.4.1 HIV-1 RNA/DNA NAAT (QUANTITATIVE VIRAL LOAD)
o Enter result and collection date of earliest test. (Required, applies to health
department & health care providers)
10.4.2 HIV-2 RNA/DNA NAAT (QUANTITATIVE VIRAL LOAD)
o Enter result and collection date of earliest test. (Required, applies to health
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department & health care providers)
10.5
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, lab 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)
• When entering this information in eHARS, you should use the lab data tab and choose “HIV1 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 Nucleotide
Sequence)).
10.6
IMMUNOLOGIC TESTS (CD4 COUNT AND PERCENTAGE)
• Enter the brand name of the test and/or its manufacturer, lab 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)
10.6.1 CD4 AT OR CLOSEST TO DIAGNOSIS
o This is the first CD4 result closest to the date of initial HIV infection diagnosis,
regardless of stage of disease at diagnosis.
10.6.1.1 CD4 COUNT
Record the CD4 count closest to the time when the patient was determined to
be HIV infected. If this information is not available when the initial case
report is completed, it may be entered later.
Enter result and specimen collection date of first CD4 count. (Required,
applies to health department & health care providers)
10.6.1.2 CD4 PERCENTAGE
Record the CD4 percentage closest to the time when the patient was
determined to be HIV infected. If this information is not available when the
initial case report is completed, it may be entered later.
Record result and specimen collection date of first CD4 percentage.
(Required, applies to health department & health care providers)
10.6.2 FIRST CD4 RESULT < 200 cells/μL or < 14%
o This is the first CD4 result indicative of stage 3 (AIDS). The stage is based primarily
on the CD4 count; the CD4 count takes precedence over the CD4 percentage, and the
percentage is considered only if the count is missing.
10.6.2.1 CD4 COUNT
Record results and specimen collection date of first CD4 indicative of stage 3
(i.e., < 200 cells/μL). (Required, applies to health department & health care
providers)
10.6.2.2 CD4 PERCENTAGE
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Record results and specimen collection date if: (Required, applies to health
department & health care providers)
• The CD4 percentage was from a specimen collected on the same date
as the first CD4 count indicative of stage 3 (see section 9.5.2.1 above)
or
• The first CD4 percentage indicative of stage 3 (i.e., <14%) was from a
specimen collected on an earlier date than the first CD4 count
indicative of stage 3 and was not accompanied by a CD4 count for the
same date.
10.6.3 Other CD4 RESULT
10.6.3.1 CD4 COUNT
Enter results and specimen collection date of other CD4 count. (Required,
applies to health department & health care providers)
10.6.3.2 CD4 PERCENTAGE
Record results and specimen collection date of other CD4 percentage.
(Required, applies to health department & health care providers)
10.7
DOCUMENTATION OF TESTS
10.7.1 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, viral load, 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 type-differentiating
immunoassay”, are not considered stand-alone p24 antigen tests. Refer to sections
10.2.2 and 10.2.3 for more information regarding these combination Ag/Ab
immunoassays.
o “Approved HIV diagnostic algorithm criteria” means any criteria that satisfy the HIV
surveillance case definition, regardless of whether approved for other purposes such
as laboratory-based HIV testing or point-of-care HIV screening.
o If “Yes”, enter date of earliest positive test 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 providers)
10.7.2 IF HIV LABORATORY TESTS WERE NOT DOCUMENTED, IS HIV DIAGNOSIS
DOCUMENTED BY A PHYSICIAN? (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 lab evidence of HIV infection consistent with the HIV case
definition is noted by the physician, enter “Yes”; otherwise enter “No” or
“Unknown.”
o IF “YES” TO 10.7.2, PROVIDE DATE OF DIAGNOSIS BY PHYSICIAN
(Required in the absence of lab results, applies to health department & health care
providers)
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o 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 positive
HIV EIA and WB on 2/11/2010, this should be recorded as 2/11/2010 as the date of
diagnosis by the physician.
10.7.3 DATE OF LAST DOCUMENTED NEGATIVE HIV TEST (SPECIFY TYPE)
(Required, applies to health department & health care providers)
o This represents the last documented date when the person was considered not to be
HIV infected, as documented by laboratory or medical record evidence accompanied
by test type information.
o Patient self-report of last negative test is not considered “documented” and thus
should not be entered in this field but rather in the HIV Testing History section (see
sections 13.5 and 13.6 below).
o Enter the specimen collection date for the date of the last negative HIV test in
mm/dd/yyyy format using ‘..’ for unknown values (e.g., 03/../2011). (Required,
applies to health department & health care providers)
o Enter the type of test that yielded the last negative HIV test result. (Required, applies
to health department & health care providers)
o Include the last negative HIV laboratory test result before the person was known to be
infected. Do not include in this field a negative test result as part of a sequence of
tests in an algorithm that has a final interpretation indicating that the person was
infected with HIV. Negative test results that are part of a sequence of HIV tests in an
algorithm should be recorded in the appropriate laboratory test fields above.
o If it is unclear how to interpret a negative test result that is part of a testing algorithm,
it may be necessary to contact the provider ordering the tests.
o Do not include an undetectable viral load result, unless there is evidence that the
person was not receiving antiretroviral therapy at the time the viral load specimen
was obtained. A viral load result alone is not considered sufficient evidence of the
absence of HIV infection (e.g., the person may have been receiving antiretroviral
therapy when the specimen was obtained, or may naturally have a suppressed viral
load without antiretroviral therapy).
o Do not include tests with indeterminate, inconclusive, or unknown results in this
field. Any indeterminate HIV test results that are part of a diagnostic testing
algorithm should be recorded in the appropriate laboratory test fields above.
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11. Treatment/Services Referrals
11.1
HAS THIS PATIENT BEEN INFORMED OF HIS/HER HIV INFECTION (Optional, applies
to health department & health care providers)
• Select applicable response
• If notification is not documented, select “Unknown” unless the person completing the form
knows with certainty that the patient is aware of the infection.
11.2
THIS PATIENT’S PARTNERS WILL BE NOTIFIED ABOUT THEIR HIV EXPOSURE AND
COUNSELED BY (Optional, applies to health department & health care providers)
• Select applicable response.
11.3
EVIDENCE OF RECEIPT OF HIV MEDICAL CARE OTHER THAN LABORATORY TEST
RESULT (Optional, applies to health department & health care providers)
• Select applicable response.
• Additional evidence may be recorded in the comments section.
11.4
DATE OF MEDICAL VISIT OR PRESCRIPTION
• Enter date in mm/dd/yyyy format. If day is unknown, use ‘..’ for the unknown value (e.g.,
03/../2017).
11.5
FOR FEMALE PATIENT
11.5.1 THIS PATIENT IS RECEIVING OR HAS BEEN REFERRED FOR
GYNECOLOGICAL OR OBSTETRICAL SERVICES (Optional, applies to health
department & health care providers)
o Select applicable response.
11.5.2 IS THIS PATIENT CURRENTLY PREGNANT (Required, applies to health department
& health care providers)
o Response is dependent on which date was selected for populating the field 3.9 (DATE
FORM COMPLETED). If patient was pregnant on that date, select “Yes”.
11.5.3 HAS THIS PATIENT DELIVERED LIVE-BORN INFANTS (Optional, applies to
health department & health care providers)
o Select applicable response.
o If “Yes”, provide birth information for the most recent birth as described at 11.4
below.
11.6
FOR CHILDREN OF PATIENT
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•
Record information related to the most recent birth in this section. Record additional or
multiple births in the Comments section.
11.6.1 CHILD’S NAME (Recommended, applies to health department & health care providers)
o Enter child’s first name, middle name, and last name.
11.6.2 CHILD’S DATE OF BIRTH (Recommended, applies to health department & health care
providers)
o Enter child’s date of birth in mm/dd/yyyy format using ‘..’ for unknown values (e.g.,
03/../2011).
11.6.3 CHILD’S LAST NAME SOUNDEX (System generated)
o After the child’s name is entered into CDC-supplied software, the software
automatically generates this variable by using the child’s last name. After the code is
generated, health department staff should fill this field on the form.
o 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.
11.6.4 CHILD’S STATE NUMBER (Recommended, applies to health department)
o Enter the assigned state number, if applicable. This number is typically assigned by
state/local health department personnel if the child is known to have received a
diagnosis of HIV infection. Some jurisdictions also assign numbers for children
classified as “Perinatally HIV Exposed” or “Seroreverter.”
o If a child was a pediatric “Seroreverter” and was later infected with HIV, the child
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 in the
file Pediatric HIV Confidential Case Report Form and Perinatal HIV Exposure
Reporting Form for the definition of a pediatric “Seroreverter”. Enter the child’s state
number associated with the “Seroreverter” on the case report form.
o Assigned numbers must not be reused, even if the case is later deleted.
o This variable is used, along with the state of report, to uniquely
identify cases reported to CDC and to merge the state datasets without
duplication.
11.6.5 FACILITY NAME OF BIRTH (Optional, applies to health department & health care
providers)
o Enter the name of the facility where the child was born.
o If the child was born at home, enter “home birth”.
11.6.6 PHONE (Optional, applies to health department & health care providers)
o Enter area code and telephone number of the facility of birth.
11.6.7 FACILITY TYPE (Optional, applies to health department & health care providers)
o Select the type of facility of birth.
o Refer to the eHARS Technical Reference Guide for listing of facility types.
11.6.8 STREET ADDRESS (Optional, applies to health department & health care providers)
o Enter street address of the facility of birth.
11.6.9 ZIP CODE (Optional, applies to health department & health care providers)
o Enter ZIP code where the facility of birth is located.
11.6.10 CITY (Optional, applies to health department & health care providers)
o Enter city of the facility of birth.
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National HIV Surveillance System Technical Guidance – ACRF, XXXX 2019
11.6.11 COUNTY (Optional, applies to health department & health care providers)
o Enter county of the facility of birth.
11.6.12 STATE/COUNTRY (Optional, applies to health department & health care providers)
o Enter state and country name of the facility of birth.
12. Antiretroviral Use History
•
•
ARV use history data are used to assess the prevalence of acquired and transmitted HIV
drug resistance.
Unlike other sections on the ACRF, patient self-reported information is accepted for all
answers.
12.1
MAIN SOURCE OF ANTIRETROVIRAL (ARV) USE INFORMATION (Required, applies to
health department & health care providers)
• Check only one source (the main source from which the information in this section was
obtained).
o “Patient Interview” should be selected only if the patient was directly asked a series
of questions from this or another structured form. Interviewer should have been
trained on the proper collection of ARV use history data.
o “Medical Record Review” indicates that this information was obtained through
abstraction of medical charts, electronic medical records or databases.
o “Provider Report” indicates this form was filled out by a health care provider.
o “NHM&E” indicates that data were abstracted from the National HIV Monitoring and
Evaluation (NHM&E) project forms or databases.
o “Other” indicates that information came from a source other than those listed above.
12.2
DATE PATIENT REPORTED INFORMATION (Required, applies to health department &
health care providers)
• The appropriate date to enter depends on the MAIN SOURCE OF ARV USE
INFORMATION. Enter date in mm/dd/yyyy format using ‘..’ for unknown values (e.g.,
03/../2011).
• If there was a structured patient interview, enter the date of interview.
• For a medical record review, enter the date of the most recent patient encounter that
contributed to the ARV information collected. If there was no patient encounter, then enter
the date the medical record was reviewed. If the ACRF was completed by a health care
provider, enter the date of the most recent patient encounter during which the ARV
information was obtained from the patient. If the provider information was obtained from
another data source, enter the date of receipt of the information. If these dates are not
available, enter the date the ACRF was completed.
• For information obtained through NHM&E, use the date entered on the HIV testing form.
• If there are no data available from the above sources, enter the date the ACRF was
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National HIV Surveillance System Technical Guidance – ACRF, XXXX 2019
completed.
12.3
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 person 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.
12.4
IF YES, REASON FOR ARV USE (Required, applies to health department & health care
providers)
• Select all that apply.
• “HIV Tx” indicates that the patient used ARVs to treat HIV infection.
• “PrEP” indicates that the patient used ARVs prior to HIV diagnosis for HIV preexposure
prophylaxis (PrEP).
• “PEP” indicates that the patient used ARVs as postexposure prophylaxis (PEP).
• “PMTCT” indicates that the patient used ARVs to prevent HIV mother-to-child-transmission
during pregnancy.
• “HBV Tx” indicates that the patient used ARVs to treat hepatitis B virus infection.
• “Other” indicates that the patients used ARVs for a reason other than those indicated above.
12.5
ARV MEDICATIONS (Recommended, applies to health department & health care providers)
• For each ARV use reason indicated in 12.4, list the medications taken.
• This variable is used to verify that the medication taken was actually an antiretroviral.
• It is not necessary to list every drug combination that may have been used; record at least one
ARV. Enter “unspecified” if an ARV was taken but the name is not known.
12.6
DATE BEGAN (Required, applies to health department & health care providers)
• For each ARV use reason indicated in 12.4, 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).
12.7
DATE OF LAST USE (Required, applies to health department & health care providers)
• For each ARV use reason indicated in 12.4, 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).
13. HIV Testing History
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National HIV Surveillance System Technical Guidance – ACRF, XXXX 2019
•
Unlike other sections on the ACRF, patient self-reported information is accepted for all answers.
13.1
MAIN SOURCE OF TESTING HISTORY INFORMATION (Required, applies to health
department & health care providers)
• Check only one source (the main source from which the information in this section was
obtained).
o “Patient Interview” should be selected only if the patient was directly asked a series
of questions from this or another structured form. Interviewer should have been
trained on the proper collection of testing history data.
o “Medical Record Review”’ indicates that this information was obtained through
abstraction of medical charts, electronic medical records, or databases. Information
may also have come from a database of HIV test results or pharmacy records.
o “Provider Report” indicates this form was filled out by a health care provider.
o “NHM&E” indicates that data were abstracted from the National HIV Monitoring and
Evaluation (NHM&E) project forms or databases.
o “Other” indicates that information came from a source other than those listed above.
13.2
DATE PATIENT REPORTED INFORMATION (Required, applies to health department &
health care providers)
• The appropriate date to enter depends on the MAIN SOURCE OF TESTING HISTORY
INFORMATION. Enter date in mm/dd/yyyy format using ‘..’ for unknown values (e.g.,
03/../2011).
• For a medical record review, enter the date of the last patient encounter that contributed to
the testing history information collected. If only a lab report was accessed, enter the date of
receipt of the lab results. If there was no patient encounter or lab test receipt date, then enter
the date the medical record review was performed.
• If there was a structured patient interview, enter the date of the interview.
• If the ACRF was completed by a health care provider, enter the date of the last patient
encounter when the most recent testing history information was obtained from the patient. If
provider’s information only came from another data source, such as a lab report, enter the
date of receipt of the information. If there are no such dates, enter the date the ACRF was
completed.
• For information obtained through NHM&E, use the date entered on the HIV Test Form.
• If there are no data available from the above sources, enter the date the ACRF was
completed.
13.3
EVER HAD PREVIOUS POSITIVE HIV TEST (Required, applies to health department &
health care providers)
• The purpose of this variable is to ascertain whether a positive HIV test occurred earlier than
the current HIV diagnosis date, but was not reported to the HIV surveillance system. For
example, a patient could have been diagnosed in another state/country or tested
anonymously.
• Self-reported information is acceptable.
• “Yes” indicates sufficient evidence that there was a previous positive HIV test.
• “No” indicates sufficient evidence that there was no previous positive HIV test.
• “Unknown” indicates that there is lack of evidence about previous HIV tests. Select
“Unknown” if the patient refused to answer the question, if the facility refused to permit
medical record review, or if the patient, chart reviewer, or provider had no knowledge of
whether or not there was a previous positive HIV test after searching for the information or
asking the patient.
• The field should be left blank if the medical record was not searched or the question was not
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National HIV Surveillance System Technical Guidance – ACRF, XXXX 2019
•
asked.
Do not include indeterminate HIV tests, false positive tests, and tests with inconclusive or
unknown results.
13.4
DATE OF FIRST POSITIVE HIV TEST (Required, applies to health department & health care
providers)
• “Yes” indicates that there was a known previous positive HIV test. Record the date of the
earliest known positive HIV test, including patient self-reported dates and anonymous tests.
It is acceptable to enter an estimated or incomplete date, as long as it contains a year. Enter
date in mm/dd/yyyy format using ‘..’ for unknown values (e.g., 03/../2011).
• “No” indicates there were no known previous positive HIV tests. Enter the date of the
current positive HIV test (i.e., the collection date of the current diagnostic HIV test).
• If you do not know the date of HIV diagnosis, enter the earliest known positive HIV test.
• Do not include indeterminate HIV tests, false positive tests, and tests with inconclusive or
unknown results.
13.5
EVER HAD A NEGATIVE HIV TEST (Required, applies to health department & health care
providers)
• This variable ascertains whether or not the person ever had a negative HIV test result at any
time in the past that indicated the person was not HIV infected. The mere absence of
information about previous tests in a medical record should not be recorded as “No”, since
tests can occur in other venues. Do not include a negative test result as part of a sequence of
tests in an algorithm that has a final interpretation indicating that the person was infected
with HIV.
• Self-reported information is acceptable for this data field.
• “Yes” indicates there is knowledge of a previous negative HIV test, either self-reported or
confirmed by a laboratory report.
• “No” indicates there is evidence that the person never had a negative HIV test (e.g., person
states they have never been tested before). Do not enter “No” if there is simply no evidence
either way about a previous HIV test.
• “Unknown” indicates there is insufficient evidence supporting or denying the occurrence of a
negative HIV test, after searching for the information or asking the patient. Leave the field
blank if there was no attempt to find the information.
• Do not include an undetectable viral load result, as this result alone is not considered
sufficient evidence of the absence of HIV infection (e.g., the person may have been receiving
antiretroviral therapy when the specimen was obtained, or may naturally have a suppressed
viral load without antiretroviral therapy).
• Do not include tests with indeterminate, inconclusive, or unknown results.
13.6
DATE OF LAST NEGATIVE HIV TEST (Required, applies to health department & health care
providers)
• This variable represents the last date when the person was considered not to be HIV infected,
based on self-reported information, or by physician or testing site reports that do not have
documented laboratory test result and type information.
• Negative HIV test dates documented by a laboratory report or medical record accompanied
by test type information should be entered in the Laboratory Data section (9.6.3) and not
here. Incomplete dates are acceptable if the year is included. Enter date in mm/dd/yyyy format
using ‘..’ for unknown values (e.g., 03/../2011).
• Do not include a negative test result as part of a sequence of tests in an algorithm that has a
final interpretation indicating that the person was infected with HIV.
• Do not include an undetectable viral load result, as this result alone is not considered
sufficient evidence of the absence of HIV infection (e.g., the person may have been receiving
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National HIV Surveillance System Technical Guidance – ACRF, XXXX 2019
•
13.7
antiretroviral therapy when the specimen was obtained, or may naturally have a suppressed
viral load without antiretroviral therapy).
Do not include tests with indeterminate, inconclusive, or unknown results.
NUMBER OF NEGATIVE HIV TESTS WITHIN 24 MONTHS BEFORE FIRST POSITIVE
TEST (Required, applies to health department & health care providers)
• Count the number of negative HIV tests in the 24 months before the first positive HIV test.
• Enter “0” if it is known that the patient has never been tested for HIV before or never had a
negative test. Do not enter “0” if there is simply no evidence about a previous HIV test.
• “Unknown” indicates the patient refused to answer the question, the facility refused to permit
medical record review, the patient does not remember whether they had a negative test, or the
provider or abstractor has no evidence about whether or not there was a previous test. Leave
the field blank if there was no attempt to find the information.
• Do not include a negative test result as part of a sequence of tests in an algorithm that has a
final interpretation indicating that the person was infected with HIV.
• Do not include an undetectable viral load result, as this result alone is not considered
sufficient evidence of the absence of HIV infection (e.g., the person may have been receiving
antiretroviral therapy when the specimen was obtained, or may naturally have a suppressed
viral load without antiretroviral therapy).
• Do not include tests with indeterminate, inconclusive, or unknown results.
14. 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
ACRF of the CDC-supplied software.
• Information entered into the “Comments” tab on the ACRF of the CDC-supplied software
will not be transmitted to CDC.
15. 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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National HIV Surveillance System Technical Guidance – ACRF, XXXX 2019
Appendix: Adult HIV Confidential Case Report (CDC 50.42A)
Instructions for Completion
5.
Residence at Diagnosis
• Residence may be identical to that listed above in Patient Identification, unless otherwise
noted in the chart.
• For HIV, stage 0, 1, 2, and unknown case reports, enter residence at the time of the first
positive confirmatory test for HIV infection.
• If a diagnostic test result is not available, enter patient’s residence at the date of physician
diagnosis of HIV infection.
• For 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.
Residence assignment can be problematic for patients who:
o Have multiple residences
o Are on vacation
o Reside at a school
o Are foster children
o Are members of the armed forces
o Are institutionalized in correctional or other types of facilities
o Are foreign to the United States
o Are US citizens diagnosed abroad
For further guidance about residency assignment, see the file Date and Place of Residence.
7.
Facility of Diagnosis
7.2
8.
FACILITY NAME
• For HIV, stage 0, 1, 2, and unknown case reports, enter the name of the facility where the
patient first had blood drawn and was given a diagnosis of HIV infection.
• If test results are not in the medical record, enter the name of the facility where the patient’s
HIV infection was diagnosed and documented by the health care provider.
• For HIV, stage 3 (AIDS) case reports, enter the name of the facility where the patient was
first diagnosed with stage 3 (AIDS) based on the applicable case definition.
• Enter facility uniformly to prevent the occurrence of multiple names for a given facility.
Patient History
• This information is often found in a discharge summary, history and physical, social
service notes, counseling and testing notes, and STD diagnosis notes.
• Where not explicitly annotated, contact patient’s provider about risk factor information.
• See the 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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National HIV Surveillance System Technical Guidance – ACRF, XXXX 2019
9.
Clinical: Acute HIV Infection and Opportunistic Illnesses
9.1.
CLINICAL: ACUTE HIV INFECTION
9.1.2
CLINICAL SIGNS/SYMPTOMS CONSISTENT WITH ACUTE RETROVIRAL
SYNDROME
o Acute HIV infection may be suspected in persons with signs and symptoms of
acute retroviral syndrome (ARS) at or just before diagnosis and within 6 weeks
after a possible exposure to HIV. Signs and symptoms of acute HIV infection may
include but are not limited to one or more of the following from the list below;
typically, ARS may be suspected if fever and one or more signs/symptoms are
present, or in the absence of fever, two or more signs/symptoms, and differential
diagnosis rules out other illness such as Epstein-Barr virus (EBV) and non-EBV
infectious mononucleosis syndromes, influenza, viral hepatitis, streptococcal
infection, or syphilis (Reference: Panel on Antiretroviral Guidelines for Adults and
Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected
adults and adolescents. Department of Health and Human Services. Available at
http://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf).
However, ARS may also be clinically determined in atypical circumstances by a
single sign or symptom, and include other signs or symptoms not listed below,
such as opportunistic illness or unusual clinical manifestations. (Reference: Braun
DL, Kouyous RD, Blamer B, Grube C, Weber R, Gunthard HF. Frequency and
spectrum of unexpected clinical manifestations of primary HIV-1 infection. CID
2015; 61:1013-1021).
o Signs/symptoms:
Clinical manifestation
• Fever
• Malaise/fatigue
• Pharyngitis
• Rash
• Lymphadenopathy
• Weight loss
• Headache
• Diarrhea
• Night sweats
• Myalgia
• Nausea
• Arthralgia
• Cough
• Vomiting
• Oral ulcers
• Neurological symptoms
• Genital ulcers
Elevated liver enzymes
Thrombocytopenia
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National HIV Surveillance System Technical Guidance – ACRF, XXXX 2019
| File Type | application/pdf |
| File Title | Technical_Guidance_vol2.book |
| Author | bnk5 |
| File Modified | 2019-05-31 |
| File Created | 2019-05-31 |