ATT 4a - Technical Guidance ACRF 29AUG2025

National HIV Surveillance System (NHSS)

Attachment 4(a)
Technical Guidance for HIV Surveillance Programs:
Adult HIV Confidential Case Report Form

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

HIV Surveillance Branch
Division of HIV Prevention
National Center for HIV, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention
Atlanta, Georgia

Technical Guidance for HIV Surveillance Programs—Adult HIV Confidential Case Report Form

Acknowledgments
The Technical Guidance for HIV Surveillance Programs is a series of Technical Guidance files that are part
of a portfolio of resources to guide HIV surveillance programs at health departments in U.S. states, cities,
and territories on the implementation of HIV surveillance systems in accordance with state, local, and
territorial laws, regulations, and practices.
These files are living documents and the updates include adaptions and adjustments from previous iterations.
We acknowledge previous contributors from the Centers for Disease Control and Prevention (CDC), other
federal agencies, academic partners, and state, local, and territorial health departments.
The updates to these files were prepared by CDC in collaboration with the Council of State and Territorial
Epidemiologists (CSTE), with contributions from state, local, and territorial HIV surveillance programs.

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Contents
Acknowledgments .............................................................................................................................................. 2
Contents .............................................................................................................................................................. 3
Introduction ........................................................................................................................................................ 4
Instructions for Completion ................................................................................................................................ 4
Purpose of Case Report Form ........................................................................................................................ 4
The Case Report Form in the Context of Document-based Surveillance ...................................................... 5
Patients for Whom Form is Indicated ............................................................................................................ 5
Definition of Variable Designators ................................................................................................................ 5
Disposition of Form ....................................................................................................................................... 5
1. Patient Identification .............................................................................................................................. 6
2. Health Department Use Only ................................................................................................................. 8
3. Facility Providing Information ............................................................................................................. 10
4. Patient Demographics ........................................................................................................................... 11
5. Residence at Diagnosis ......................................................................................................................... 13
6. Facility of Diagnosis............................................................................................................................. 14
7. Patient History ...................................................................................................................................... 15
8. Clinical: Acute HIV Infection and Opportunistic Illnesses .................................................................. 19
9. Laboratory Data .................................................................................................................................... 22
10.
Treatment/Services Referrals ........................................................................................................... 29
11.
Antiretroviral Use History ................................................................................................................ 32
12.
HIV Testing History ........................................................................................................................ 34
13.
Comments (Optional, applies to health department & health care providers) ................................. 38
14.
Local/Optional Fields (Optional, applies to health department) ...................................................... 38
Appendix .......................................................................................................................................................... 39
Adult HIV Confidential Case Report (CDC 50.42A) .................................................................................. 39
Instructions for Completion .................................................................................................................... 39

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Introduction
The goals of HIV surveillance are to describe the burden and epidemiology of HIV, monitor HIV trends,
identify HIV clusters and outbreaks, and guide public health action at the federal, state, local, and territorial
levels.
The Technical Guidance for HIV Surveillance Programs is a series of Technical Guidance files that are part
of a portfolio of resources to guide HIV surveillance programs at health departments on the implementation
of HIV surveillance systems in accordance with state, local, and territorial laws, regulations, and practices.
These files are prepared by the Centers for Disease Control and Prevention (CDC) in collaboration with the
Council of State and Territorial Epidemiologists (CSTE), with contributions from state, local, and territorial
HIV surveillance programs. These files are living documents and the updates include adaptions and
adjustments from previous iterations.
State, local, and territorial HIV surveillance programs at health departments are responsible for their HIV
surveillance system, which encompasses surveillance activities, reporting sources, surveillance information
systems (including the enhanced HIV/AIDS Reporting System [eHARS]), and other supporting tools (like
ATra Blackbox, Secure HIV-TRACE). All HIV surveillance systems together contribute to the National HIV
Surveillance System (NHSS).
CDC provides technical assistance and support to HIV surveillance programs to ensure that HIV surveillance
systems have complete, accurate, and timely data for public health action. The HIV Surveillance Branch
(HSB) of the Division of HIV Prevention (DHP), National Center for HIV, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP) is responsible for NHSS.
The Technical Guidance files, periodically, will include examples of how eHARS can be used for collecting
and managing HIV surveillance data. Note that the same demonstrated concepts should also apply if another
surveillance information system is used by the HIV surveillance program.
Technical Guidance file Adult HIV Confidential Case Report Form (ACRF) describes the purpose and
indicators for use of the ACRF and instructions for completing the ACRF, which is designed to collect
information for persons with diagnosed HIV 13 years of age or older. The ACRF Technical Guidance file
supports standard data collection, which is important for ensuring accurate HIV surveillance data that can
guide public health action.
HIV surveillance programs should ensure that their policies and procedures include the activities described
in this Technical Guidance file and relevant public health actions; policies and procedures should be
reviewed at least annually and updated as needed. Ensure that staff are trained on the policies and procedures
with a focus on changes to procedures or areas needing improvement Contact the HIV surveillance
program’s CDC surveillance epidemiologist with any questions or feedback about this Technical Guidance
file. If needed, call the HSB main phone number at 404-639-2050 for assistance with identifying the HIV
surveillance program’s CDC surveillance epidemiologist.

Instructions for Completion
Purpose of Case Report Form
The ACRF (CDC 50.42A) 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
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guidance applies to all HIV infection data collection even if HIV surveillance programs use a different form
or medium for HIV case surveillance. The ACRF document in eHARS has been designed to generally align
with the information collected on the hardcopy ACRF described in this file.

The Case Report Form in the Context of Document-based Surveillance
Document-based data management allows all documents to be stored and retained electronically with their
original contents. 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 to enable traceability and provide a
longitudinal view of data reported for a case.

Patients for Whom Form is Indicated
•

Each person, aged 13 years or older, who meets the HIV infection case definition (available at
https://ndc.services.cdc.gov/conditions/hiv-infection-aids-has-been-reclassified-as-hiv-stage-iii/).

•

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 results from CD4 tests, viral load tests, or drug resistance tests (genotypic)
reported from a health care 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. 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 CDC via 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 the HSB SharePoint site:
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/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. Note. Some of these values
are unique identifiers.

Disposition of Form
•
•

The completed form is for health department use and is not to be sent to CDC. The Pacific Islands are
the only jurisdictions that submit forms to CDC for data entry in eHARS, and all patient identifiers
must be removed before submission.
Data obtained from these forms are entered in eHARS, which is provided by DHP, NCHHSTP, 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 health department use only and is not transmitted to CDC if
marked with an asterisk (*) 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 in eHARS, the software automatically generates this variable by
using the patient’s last name. After the code is generated, HIV surveillance program staff
should fill this field on the form.
• This variable is a phonetic, alphanumeric code calculated by converting a surname to an index
letter and a 3-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 the HSB SharePoint site:
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/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.

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1.11 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
ACRF document on the “Identification” tab.
• Enter date in mm/dd/yyyy format; use “..” 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. 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 (available at https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/default.aspx).

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2. Health Department Use Only

2.1

DATE RECEIVED AT HEALTH DEPARTMENT (Recommended, applies to health department)
• Enter date in mm/dd/yyyy format; use “..” for unknown values (e.g., 03/../2011).

2.2

eHARS DOCUMENT UID (System generated)
• Enter UID after eHARS 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 2 different state numbers: one associated
with the “Seroreverter” and another associated with the HIV infection diagnosis. Refer to
Appendix 4.1.4 in Technical Guidance file Pediatric HIV Confidential Case Report Form for
the definition of a pediatric “Seroreverter.” HIV surveillance programs must use the “Same as”
field on the “Duplicate Review” tab in eHARS to link the 2 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.
• Assigned numbers should not contain information that can be used to identify the person (e.g.,
name, residence), the reporting health department, or the testing site.
• This variable is used, along with the state of report, to uniquely identify cases reported to CDC
and to merge 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.
• When CDC provides technical assistance and support for conducting HIV surveillance to a city
or county, each patient must have a unique city/county number assigned by the city/county in
which they are reported, an identifier associated with the patient throughout the course of HIV
infection. 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 2 different
city/county numbers: one associated with the “Seroreverter” and another associated with the
HIV infection diagnosis. Refer to Appendix 4.1.4 in Technical Guidance file Pediatric HIV
Confidential Case Report Form for the definition of a pediatric “Seroreverter.” If the
city/county number is the primary identifier, the HIV surveillance program must use the “Same
as” field on the “Duplicate Review” tab in eHARS to link the 2 cases. Enter the appropriate
city/county number associated with the events being reported on the case report form.

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•
•

Assigned numbers must not be reused, even if the case is later deleted.
Assigned numbers should not contain information that can be used to identify the person (e.g.,
name, residence), the reporting health department, or the testing site.

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 document source codes
available in eHARS (available at
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/default.aspx).

2.7

SURVEILLANCE METHOD (Required, applies to health department)
• Enter the method the case report was ascertained.
• For definitions of active, passive, follow up, and reabstraction, see Technical Guidance file
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)
• Enter the medium in which the case report was submitted.
• Select “1-Field visit” if HIV surveillance program staff review medical records at provider
facilities or access the medical records remotely to elicit information for the HIV case report
forms.
• Select “2-Mailed” if the HIV case report form is received by US mail.
• Select “3-Faxed” if the HIV case report form is received by fax.
• Select “4-Phone” if the telephone is used to elicit information to complete the HIV case report
form.
• Select “5-Electronic transfer” if electronic transfer of information is used to complete the HIV
case report form.
• Select “6-CD/disk” if information for the HIV case report form is received on CD/disk.

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3. Facility Providing Information

•

Facility information is not transmitted to CDC if marked with an * on the form.

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 facility
types available in eHARS (available at
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/default.aspx).

3.9

DATE FORM COMPLETED (Required, applies to health department & health care providers)
• Enter date in mm/dd/yyyy format; use “..” 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.
3.11 PHONE (Recommended, applies to health department & health care providers)
• Enter the telephone number of the person completing the form.

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4. Patient Demographics

4.1

SEX (Required, applies to health department & health care providers)
• Select patient’s sex.
• If search for this datum was completed and sex could not be determined as “Male” or
“Female,” select “Unknown/Undetermined.” Patients with an “Unknown/Undetermined” value
for sex on the eHARS Person View will not be transmitted to CDC and select variables in
eHARS will not be calculated.

4.2

COUNTRY OF BIRTH (Recommended, applies to health department & health care providers)
• Select applicable response.
• For patients born in U.S. minor outlying areas, specify the name of the U.S. dependency from
the following table:
U.S. Dependencies

•

Baker Island

Johnston Atoll

Navassa Island

Howland Island

Kingman Reef

Palmyra Atoll

Jarvis Island

Midway Islands

Wake Island

For patients born in any other area outside of the United States and U.S. minor outlying areas,
specify the country 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; use “..” 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; use “..” 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 Technical Guidance 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; use “..” for unknown values
(e.g., 03/../2011).

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•

For further guidance on death ascertainment, see Technical Guidance file Death Ascertainment.

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

SEXUAL ORIENTATION and DATE IDENTIFIED (Required, applies to health department &
health care providers)
• Enter sexual orientation of the patient. Sexual orientation should not be assigned based on
review of other recorded information (e.g., responses to questions about sex of sexual partners);
use only information where sexual orientation is explicitly indicated.
• 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 (available at
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/default.aspx).
• For date identified, please enter the date the patient indicated identifying as the selected sexual
orientation, if documented. If this date is unknown or the selected response option for sexual
orientation was “Declined to answer” or “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 ACRF document on the “Demographics” tab. Record it
in mm/dd/yyyy format; use “..” 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 ACRF documents on the “Demographics” tab.

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.
• Consistent with the US Office of Management and Budget (OMB) guidance (2003) the race
and ethnicity (Hispanic/Latino, Not Hispanic/Latino) for a person is 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 (available at
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/default.aspx).

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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 (available at
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/default.aspx).

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 U.S. 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 5 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 (available at
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/default.aspx).
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 (available at
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/default.aspx).

5. Residence at Diagnosis

•

Residence information is not transmitted to CDC if marked with an * on the form.

•

Refer to Appendix (5) 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.

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.

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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. Facility of Diagnosis

•

Facility information is not transmitted to CDC if marked with an * on the form.

•

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.

•

For details about documenting the information for a telemedicine facility, refer to Appendix (6).

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.
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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 (available at
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/default.aspx).

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.

7. Patient History

•

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. In eHARS, on the ACRF select the “Show
Pediatric Risk Factors” check box on the “History tab to display and record the pediatric risk
factor.
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
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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.
o See Appendix (7) for further guidance on risk factor ascertainment.
o HIV surveillance programs are expected to report COPHI to CDC’s COPHI coordinator by
contacting the CDC HIV Surveillance Branch surveillance epidemiologist assigned to the state,
local, or territorial HIV surveillance program once a potential COPHI is identified. For further
guidance, see Technical Guidance file Cases of Public Health Importance (COPHI).
7.1

SEX WITH MALE (Required, applies to health department & health care providers)
• Select applicable response based on the partner’s sex. If search for this datum was completed
and the partner’s sex cannot be determined, select “Unknown.”
• Some examples of information from the medical record which would strongly indicate sex with
a male are the following:
o For male patient:
▪ Married to or divorced from a male
▪ 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)
▪ Sex worker (either current or in the past)
7.2 SEX WITH FEMALE (Required, applies to health department & health care providers)
• Select applicable response based on the partner’s sex. If search for this datum was completed
and the partner’s sex cannot be determined, select “Unknown.”
• Some examples of information from the medical record which would strongly indicate sex with
a female are the following:
o For male patient:
▪ Married to or divorced from a female
▪ Has a biological child
o For female patient:
▪ Married to or divorced from a female
7.3 INJECTED NON-PRESCRIPTION DRUGS (Required, applies to health department & health
care providers)
• Select applicable response.
• Select “Yes” if the patient injected 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).
7.4–7.6 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).
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•

7.7

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 patient, then
select “No.”
• See Technical Guidance files Risk Factor Ascertainment and Cases of Public Health
Importance (COPHI) for further guidance on risk factor data collection and COPHI.
• If “Yes,” alert state, local, or territorial COPHI coordinator.
• If “Yes,” specify the clotting factor and enter date received. Enter date in mm/dd/yyyy format;
use “..” for unknown values (e.g., 03/../2011).
HETEROSEXUAL RELATIONS WITH ANY OF THE FOLLOWING:
• This section, addressed at 7.7.1–7.7.6, relates to ascertainment of risk factor among persons
who had heterosexual contact (had sex with) with the case patient.
• Heterosexual contact is defined as the patient having sexual contact with a partner whose sex is
different from the patient’s sex.
• Verification of sex partner’s HIV infection status is not necessary.
7.7.1 PERSON WHO INJECTED DRUGS (Required, applies to health department & health
care providers)
o Select applicable response.
o Select “Yes” if the partner injected 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).
7.7.2 BISEXUAL MALE (Required, applies to health department & health care providers)
o Select applicable response only if patient’s sex is female. “Yes” should be selected only
if the partner’s sex is male and there is evidence that the partner also had sex with
another person whose sex was male.
7.7.3 PERSON WITH HEMOPHILIA/COAGULATION DISORDER WITH DOCUMENTED
HIV INFECTION (Required, applies to health department & health care providers)
o Select applicable response.
o Refer to 7.4–7.6 for additional information.
7.7.4 TRANSFUSION RECIPIENT WITH DOCUMENTED HIV INFECTION (Required,
applies to health department & health care providers)
o Select applicable response.
o Consider documenting the reason for transfusion in the Comments section. In eHARS,
enter on the “Comments” tab.
7.7.5 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. In eHARS,
enter on the “Comments” tab.
7.7.6 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.

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7.8–7.10 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. In
eHARS, enter on the “Comments” tab.
• See Technical Guidance files Risk Factor Ascertainment and Cases of Public Health
Importance (COPHI) for further guidance on risk factor data collection and COPHI.
• If the last transfusion was after March 1985, then alert state, local, or territorial COPHI
coordinator.
• If “Yes,” enter the dates first and last received in mm/dd/yyyy format; use “..” for unknown
values (e.g., 03/../2011).
7.11 RECEIVED TRANSPLANT OF TISSUE/ORGANS OR ARTIFICIAL INSEMINATION
(Required, applies to health department & health care providers)
• Select applicable response.
• See Technical Guidance files Risk Factor Ascertainment and Cases of Public Health
Importance (COPHI) for further guidance on risk factor data collection and COPHI.
• If “Yes,” alert the state, local, or territorial COPHI coordinator.
7.12–7.13 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)
• Select applicable response.
• Investigate apparent occupational exposures to determine if this was the only risk factor
present.
• See Technical Guidance files Risk Factor Ascertainment and Cases of Public Health
Importance (COPHI) for further guidance on risk factor data collection and COPHI.
• If “Yes,” alert state, local, or territorial COPHI coordinator.
• If “Yes,” specify occupation and setting.
7.14 OTHER DOCUMENTED RISK (Required applies to health department & health care providers)
• See Technical Guidance files Risk Factor Ascertainment and Cases of Public Health
Importance (COPHI) for further guidance on unusual transmission history that could be
considered as potential COPHI.
• Select applicable response.
• Document details of the risk factor information in the Comments section. In eHARS, enter on
the “Comments” tab.

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8. Clinical: Acute HIV Infection and Opportunistic Illnesses

8.1

CLINICAL: ACUTE HIV INFECTION
• Collection of acute HIV infection information is recommended for all state, local, and
territorial 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, local, and territorial 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 2 tests could range from 30 to
90 days and may be determined locally.
o This section includes clinical (non-laboratory) data to supplement the laboratory-based
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 Technical Guidance file Early HIV
Infection, HIV-2, and Other Diagnostic Considerations.
8.1.1 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 HIV surveillance program’s
policies and practices. For further information about the sources of information, see
Technical Guidance file Reporting. 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
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NAAT; or it could include a laboratory-documented or patient or health care provider
reported history of a previous negative HIV test before diagnosis. Additionally, it could
include information from a health care provider reporting that the patient had acute
HIV, or include 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 patient 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 health care provider reports of a previous negative HIV test should be
entered in the HIV Testing History section.
o “No” indicates sufficient evidence that the patient did not have acute HIV infection at
diagnosis.
o “Unknown” indicates there is insufficient evidence to indicate whether the patient had
acute HIV infection at diagnosis, after searching for the information, consulting with
the health care provider, or asking the patient.
8.1.2 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, 2 or more symptoms such as these are present). For
a more complete list of the clinical symptoms associated with acute HIV, refer to
Appendix (8.1.2).
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
health care 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 health care provider 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 patient had clinical signs/symptoms
consistent with acute retroviral syndrome.
o “No” indicates sufficient evidence that the patient did not clinical signs/symptoms
consistent with acute retroviral syndrome.
o “Unknown” indicates there is insufficient evidence to indicate whether the patient had
clinical signs/symptoms consistent with acute retroviral syndrome, after searching for
the information, consulting with the health care provider, or asking the patient.
8.1.3 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).
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8.1.4 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
patient 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 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. See
Technical Guidance files Risk Factor Ascertainment and Cases of Public Health
Importance (COPHI) for further guidance on unusual transmission history that
could be considered as potential 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 health care provider, or asking the patient.
8.1.5 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”).
8.1.6 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).
8.2

CLINICAL: OPPORTUNISTIC ILLNESSES
8.2.1–8.2.26 (Optional, applies to health department & health care providers)
o Select all that apply and enter diagnosis dates. Enter date in mm/dd/yyyy format; use “..”
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-aids-has-beenreclassified-as-hiv-stage-iii/).
8.2.27 RVCT CASE NUMBER (Optional, applies to health department & health care providers)
o If this patient has a verified case of tuberculosis (TB), HIV surveillance program staff
enter the 9-digit alphanumeric code from the TB case report or TB data management
system. Health care 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

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•
•

Throughout this section, “Collection Date” refers to the date when the specimen was collected or
drawn. Enter collection dates in mm/dd/yyyy format; use “..” for unknown values (e.g., 03/../2011).
Record all laboratory test results. Include results of 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 the 2018 Quick reference guide available at
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.

9.1

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
health care 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; use “..” 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 health care provider
either in a health care 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 health care 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 repeatedly reactive result on a single sample.
9.1.2 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 repeatedly reactive result on a single sample.
9.1.3 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 repeatedly reactive result on a single sample.

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9.1.4 HIV-2 IA
o Enter result and collection date of first HIV-2 IA. (Required, applies to health
department & health care providers)
o “Positive IA” means a repeatedly reactive result 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 in Interpretation and use of the western blot assay for serodiagnosis
of human immunodeficiency virus type 1 infections. In MMWR;38(7):1–7, available at
https://www.cdc.gov/mmwr/preview/mmwrhtml/00001431.htm.
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)
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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)
9.2

HIV DETECTION TESTS
• 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
health care 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; use “..” 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 health care provider
either in a health care 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 health care 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 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)
9.2.2 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 in 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 results are 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 in the copies/mL field as “fewer than detectable
by this assay - 20 cp/mL.”
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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 health
department & health care providers)
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 in 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 results are 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 in the copies/mL field as “fewer than detectable
by this assay - 20 cp/mL.”
▪ Where results are 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 in 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 results are 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 in the copies/mL field as “fewer than detectable
by this assay - 20 cp/mL.”
▪ Where results are reported as “Not detected,” select “Not detected.”

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9.3

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
health care 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
“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 by 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]).

9.4

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
health care 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; use “..” 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)

9.5

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 typedifferentiating 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

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o

o
o

o

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.
“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-as-hivstage-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; use “..” for unknown values (e.g., 03/../2011). (Required if applicable,
applies to health department & health care providers).
“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.
“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.
Values of “No” and “Unknown” should generally not be selected. This form is intended
to be used to ascertain that 2 tests are part of an algorithm that meet the HIV
surveillance case definition. Carefully review all “No” and “Unknown” responses
before entering in eHARS.

9.5.2 IS EARLIEST EVIDENCE OF HIV INFECTION 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.”
o IF “YES” TO 9.5.2, PROVIDE DATE OF DIAGNOSIS BY PHYSICIAN (Required
in the absence of laboratory results, applies to health department & health care
providers)
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 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.
9.5.3 DATE OF LAST DOCUMENTED NEGATIVE HIV TEST RESULT (SPECIFY TYPE)
(Required, applies to health department & health care providers)
o This represents the last documented date when the patient 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 result is not considered “documented” and thus
should not be entered in this field but rather in the HIV Testing History section (see
sections 12.6 and 12.7 below).

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o Enter the specimen collection date for the date of the last negative HIV test result in
mm/dd/yyyy format; use “..” 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 patient 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 patient 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 health care provider ordering the tests.
o Do not include an undetectable viral load result, unless there is evidence that the patient
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 patient 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.

10. Treatment/Services Referrals

•

Treatment/services referrals information is not transmitted to CDC if marked with an * on the form.

10.1 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.

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10.2 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.
10.3 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. In eHARS, enter on the
“Comments” tab.
10.4 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).
10.5 FOR FEMALE PATIENT
• Complete if the patient’s sex is female.
10.5.1 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.
10.5.2 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.”
10.5.3 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 10.6 below.
10.6 FOR CHILDREN OF PATIENT
• Record information related to the most recent birth in this section. Record additional or
multiple births in the Comments section. In eHARS, enter the additional births on the
“Treatment” tab.
10.6.1 CHILD’S NAME (Recommended, applies to health department & health care providers)
o Enter child’s first name, middle name, and last name.
10.6.2 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; use “..” for unknown values (e.g.,
03/../2011).
10.6.3 CHILD’S LAST NAME SOUNDEX (System generated)
o After the child’s name is entered in eHARS, the software automatically generates this
variable by using the child’s last name. After the code is generated, HIV surveillance
program staff should fill this field on the form.
o This variable is a phonetic, alphanumeric code calculated by converting a surname to an
index letter and a 3-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
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created (available at
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/default.aspx).
10.6.4 CHILD’S STATE NUMBER (Recommended, applies to health department)
o Enter the assigned state number, if applicable. This number is typically assigned by the
HIV surveillance program if the child is known to have received a diagnosis of HIV
infection. Some HIV surveillance programs 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 2 different state numbers: one associated with the “Seroreverter” and another
associated with the HIV infection diagnosis. Refer to Appendix 4.1.4 in Technical
Guidance file Pediatric HIV Confidential Case Report 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.
10.6.5 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.”
10.6.6 PHONE (Optional, applies to health department & health care providers)
o Enter area code and telephone number of the facility of birth.
10.6.7 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 (available at
https://cdcpartners.sharepoint.com/sites/NCHHSTP/HSB/default.aspx).
10.6.8 STREET ADDRESS (Optional, applies to health department & health care providers)
o Enter street address of the facility of birth.
10.6.9 ZIP CODE (Optional, applies to health department & health care providers)
o Enter ZIP code where the facility of birth is located.
10.6.10 CITY (Optional, applies to health department & health care providers)
o Enter city of the facility of birth.
10.6.11 COUNTY (Optional, applies to health department & health care providers)
o Enter county of the facility of birth.
10.6.12 STATE/COUNTRY (Optional, applies to health department & health care providers)
o Enter state and country name of the facility of birth.

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11. 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.

11.1 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.
11.2 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; use “..” 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 use 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 use information was obtained
from the patient. If the health care 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 completed.

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11.3 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 patient has taken ARV drugs, 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; use “..” for unknown values (e.g., 03/../2011).
• “No” indicates there is evidence that the patient has never taken ARV drugs.
• “Unknown” should be used when the person completing the form does not know whether the
patient has ever taken ARV drugs, after searching for the information or asking the patient.
• Leave the field blank if there was no attempt to find the information.
11.4 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 ARV drugs to treat HIV infection.
• “PrEP” indicates that the patient used ARV drugs 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-prep-guidelines-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.
• “PEP” indicates that the patient used ARV drugs as postexposure prophylaxis (PEP).
• “PMTCT” indicates that the patient used ARV drugs to prevent HIV mother-to-childtransmission during pregnancy.
• “HBV Tx” indicates that the patient used ARV drugs to treat hepatitis B virus infection.
• “Other” indicates that the patients used ARV drugs for a reason other than those indicated
above.
11.5 ARV MEDICATIONS (Recommended, applies to health department & health care providers)
• For each ARV use reason indicated in 11.4, list the medications taken.
• This variable is used to verify that the medication taken was actually an antiretroviral drug.
• It is not necessary to list every drug combination that may have been used; record at least one
ARV drug. Enter “unspecified” if an ARV drug was taken but the name is not known.
11.6 DATE BEGAN (Required, applies to health department & health care providers)
• For each ARV use reason indicated in 11.4, enter the earliest date that the patient took the ARV
drugs, even if ARV use was sporadic.
• If the first time ARV drugs 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; use “..” for unknown values (e.g., 03/../2011).
11.7 DATE OF LAST USE (Required, applies to health department & health care providers)
• For each ARV use reason indicated in 11.4, enter the most recent date of ARV use.
• For patients currently on ARV drugs, 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; use “..” for unknown values (e.g., 03/../2011).

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12. HIV Testing History

•

Unlike other sections on the ACRF, patient self-reported information is accepted for all answers.

12.1

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.

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 TESTING HISTORY
INFORMATION. Enter date in mm/dd/yyyy format; use “..” 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 laboratory report was accessed, enter the date
of receipt of the laboratory results. If there was no patient encounter or laboratory 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
health care provider’s information only came from another data source, such as a laboratory
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.

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12.3

EVER HAD PREVIOUS POSITIVE HIV TEST RESULT (Required, applies to health
department & health care providers)
• The purpose of this variable is to ascertain whether a positive HIV test result occurred earlier
than the current HIV diagnosis date but was not reported to the HIV surveillance program.
For example, a patient could have received a diagnosis of HIV infection in another
state/country or tested anonymously.
• Self-reported information is acceptable.
• “Yes” indicates sufficient evidence that there was a previous positive HIV test result.
• “No” indicates sufficient evidence that there was no previous positive HIV test result.
• “Unknown” indicates that there is lack of evidence about previous HIV test results. 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 health care provider had no
knowledge of whether there was a previous positive HIV test result 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
asked.
• Do not include indeterminate HIV test results, false positive test results, and tests with
inconclusive or unknown results.

12.4

DATE OF FIRST POSITIVE HIV TEST RESULT (Required, applies to health department &
health care providers)
• “Yes” indicates that there was a known previous positive HIV test result. Record the date of
the earliest known positive HIV test result, 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; use “..” for unknown values (e.g.,
03/../2011).
• “No” indicates there were no known previous positive HIV test results. Enter the date of the
current positive HIV test result (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
result.
• Do not include indeterminate HIV test results, false positive test results, and tests with
inconclusive or unknown results.

12.5

WAS THE FIRST POSITIVE TEST RESULT FROM A SELF-TEST PERFORMED BY THE
PATIENT (Required, applies to health department & health care providers)
• “Yes” indicates the first positive test result was from a self-test performed by the patient.
• “No” indicates the first positive test result was not from a self-test performed by the patient.
• “Unknown” indicates that there is a lack of evidence about the test result. 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 health care provider had no knowledge of whether
the first positive HIV test result was from a self-test after searching for the information or
asking the patient. Leave the field blank if there was no attempt to find the information.

12.6

EVER HAD A NEGATIVE HIV TEST RESULT (Required, applies to health department &
health care providers)
• This variable ascertains whether the patient ever had a negative HIV test result at any time in
the past that indicated the patient was not HIV infected. The mere absence of information

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•
•
•

•

•

•

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 patient was infected with HIV.
Self-reported information is acceptable for this data field.
“Yes” indicates there is knowledge of a previous negative HIV test result, either self-reported
or confirmed by a laboratory report.
“No” indicates there is evidence that the patient never had a negative HIV test result (e.g.,
patient states they have never been tested before). Do not enter “No” if there is simply no
evidence either way about a previous HIV test result.
“Unknown” indicates there is insufficient evidence supporting or denying the occurrence of a
negative HIV test result, 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 patient 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.

12.7

DATE OF LAST NEGATIVE HIV TEST RESULT (Required, applies to health department &
health care providers)
• This variable represents the last date when the patient 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 result 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; use “..” 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 patient 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 patient 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.

12.8

WAS THE LAST NEGATIVE TEST RESULT FROM A SELF-TEST PERFORMED BY THE
PATIENT (Required, applies to health department & health care providers)
• “Yes” indicates the last negative test result was from a self-test performed by the patient.
• “No” indicates the last negative test result was not from a self-test performed by the patient.
• “Unknown” indicates that there is a lack of evidence about the test result. 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 health care provider had no knowledge of whether
the last negative test result was from a self-test after searching for the information or asking
the patient. Leave the field blank if there was no attempt to find the information.

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12.9

NUMBER OF NEGATIVE HIV TEST RESULTS WITHIN 24 MONTHS BEFORE FIRST
POSITIVE TEST RESULT (Required, applies to health department & health care providers)
• Count the number of negative HIV test results 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 result. Do not enter “0” if there is simply no evidence about a previous HIV test
result.
• “Unknown” indicates there is evidence that 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 result, or the health care provider or abstractor has no evidence about
whether there was a previous test result. 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 patient 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 patient 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.

12.10 HOW MANY OF THESE NEGATIVE TEST RESULTS WERE FROM SELF-TESTS
PERFORMED BY THE PATIENT? (Required, applies to health department & health care
providers)
• Of the total number of negative HIV test results within 24 months before first positive test
result from 12.9, enter the number of tests that were self-tests performed by the patient.
• Enter “0” if it is known that the patient has never had a self-test with a negative test result. Do
not enter “0” if there is simply no evidence about a previous self-test with a negative test
result.
• “Unknown” indicates there is evidence that 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 result, or the health care provider or abstractor has no evidence about
whether there was a previous test result. Leave the field blank if there was no attempt to find
the information.

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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 ACRF of
eHARS.

•

Information entered in the “Comments” tab on the ACRF of eHARS will not be transmitted to CDC.

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, local, and territorial level.

•

This information is not sent to CDC.

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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 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, available 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.

•

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 Technical Guidance file Date and Place of
Residence.

6. Facility of Diagnosis
•

For a facility offering only telemedicine services, the address for the facility should reflect the
address where the facility providing telemedicine services is located. The facility type should be
Outpatient/Other, specify with “telemedicine” being the value specified. For information about
assigning facility types in eHARS, including for facilities offering only telemedicine services, see
Technical Guidance file Data Management Appendix B.

6.2 FACILITY NAME
•

For HIV, stage 0, 1, 2, and unknown case reports, 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

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accordance with laboratory and clinical criteria (see the revised surveillance case definition
for HIV infection, available at http://www.cdc.gov/mmwr/pdf/rr/rr6303.pdf).
•

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 associated with the date
of the first stage 3 (AIDS) diagnosis based on the applicable case definition.

•

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

7. Patient History
•

This information is often found in a discharge summary, history and physical, social service notes,
HIV testing notes, and STD diagnosis notes.

•

Where not explicitly annotated, contact patient’s health care provider about 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.

8. Clinical: Acute HIV Infection and Opportunistic Illnesses
8.1 CLINICAL: ACUTE HIV INFECTION
8.1.2 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 1 or more of the following from the list below; typically, ARS may be
suspected if fever and 1 or more signs/symptoms are present, or in the absence of fever,
2 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 (refer to Guidelines for the Use of
Antiretroviral Agents in Adults and Adolescents with HIV, available at
https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescentarv/early-acute-and-recent-hiv-infection). 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 (see “Frequency and spectrum of unexpected clinical manifestations of
primary HIV-1 infection,” available at https://www.zora.uzh.ch/id/eprint/116183/).
o Signs/symptoms:
▪ Clinical manifestation
• Fever
• Malaise/fatigue
• Pharyngitis
• Rash
• Lymphadenopathy
• Weight loss
• Headache
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▪
▪

• Diarrhea
• Night sweats
• Myalgia
• Nausea
• Arthralgia
• Cough
• Vomiting
• Oral ulcers
• Neurological symptoms
• Genital ulcers
Elevated liver enzymes
Thrombocytopenia

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