Summary of Proposed Changes to Data Collection [for implementation in 2023]

National HIV Surveillance System (NHSS)

Attachment 10.
Summary of Proposed Changes in Data Collection Instruments for the
National HIV Surveillance System (NHSS) OMB # 0920-0573

Summary of Proposed Changes in Data Collection Instruments for the
National HIV Surveillance System (NHSS) OMB # 0920-0573
Summary of Changes
We are requesting continuation of the information collection request (ICR) for the National HIV
Surveillance System (NHSS) OMB #0920-0573 with some changes. We are requesting to extend data
collection on the currently approved data collection instruments through December 31, 2022 (expiration
November 30, 2022), and then implement collection that includes the changes described within this
document starting in January 2023. The changes requested for this ICR include modifications to
currently collected data elements on the Adult HIV Confidential Case Report Form (ACRF), combining
information collected for perinatal HIV exposures on two forms (the Perinatal HIV Exposure Reporting
[PHER] form and the Pediatric HIV Confidential Case Report Form [PCRF]) to collect on one form (PCRF),
and modifications to data system tables and variables as a result of the revisions. Requested changes for
forms and data elements have been developed with input of state and local HIV surveillance
coordinators and the Council of State and Territorial Epidemiologists (CSTE) HIV subcommittee and are
intended to improve usability and data collection and create efficiencies for conducting and evaluating
surveillance program activities. In addition, modifications to the Standards Evaluation Report (SER) are
requested in order to better align with needed information to assess program performance in January
2023. This information will be captured via REDCap, a secure web application for building and managing
online surveys and databases.
An overview of the form changes is provided below. The specific changes to the ACRF and PCRF are
described in detail in Table 1. The revised ACRF and PCRF that include the proposed changes are
included in Attachments 3(a) and 3(b).
Changes to the ACRF and PCRF (Table 1A)
A revised version of the ACRF is provided in Attachment 3(a) and the revised PCRF is provided in
Attachment 3(b). These forms will replace Attachments 3(a) and 3(b) of our previously approved ICR.
Existing collection of gender identity was updated in the Patient Demographics sections of the ACRF and
PCRF to revise the existing response option labels and to collect one additional gender identity response
option and the date associated with the gender identity to more accurately summarize a person’s
gender identity. We revised the designation of the collection of gender identity from recommended to
required to be able to more accurately release information about gender categories. With this revision
we have proposed to begin collecting information about a person’s sexual orientation, including the
date associated with the sexual orientation, so that data can be reported by sexual orientation rather
than by using information collected in the Patient History section as a proxy. In the Patient History
section, we updated the language to align with the Division of HIV Prevention terminology guide, which
recommends the use of ‘person who injects drugs’ instead of ‘injection drug user’.
The Laboratory section of the ACRF and PCRF was reformatted. Format changes included combining
sections, revising the order for collecting certain test types and the number of test results collected by
test type to better align data collection with the recommended HIV testing algorithm and to limit the
length of the section on the form. We updated some wording in the Laboratory Data section to reflect
current terminology. We added two new test types, HIV-1/HIV-2 RNA NAAT and HIV-1 RNA NAAT
(Qualitative and Quantitative), and revised response options on some existing test types to

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accommodate changes in HIV testing technology. For test types under the subsections HIV
Immunoassays and HIV Detection Tests, we added two new response options: "Self-test, result directly
observed by a provider" and "Lab test, self-collected sample" to the variable to collect testing options to
be able to summarize documented self-testing activity and self-collected specimens among persons with
diagnosed HIV. We have designated the collection of information about self-testing and specimen selfcollection in this section as required. We have updated information collection designations of facility
name and lab name from optional to required. We updated the information collection designation of
result so that all portions (including interpretation) are required. Previously, the interpretation portion
of the result had been designated as optional. The designations were changed to improve collection of
completed information and ensure consistency of collection across all test types and because this
laboratory information is crucial for data-to-care activities. We do not anticipate that changing these
designations will increase data collection burden because this information is typically provided through
electronic laboratory reporting.
Overall, we made some formatting changes to the ACRF and PCRF. We added roman numerals to each
section name to assist staff with referencing a particular section of the form. We removed the
State/Local Use section of the form to accommodate room for other form changes; information
collected in this section could duplicate information collected elsewhere on the form and state and local
HIV surveillance coordinators expressed no concerns with removing this section. We revised the
confidentiality statement in the footer of the ACRF and PCRF to remove the words “on file at the local
health department” to remove ambiguity about whether the assurance is specific to the local health
department or is managed by CDC. We removed the word “please” from the Patient Demographics,
Patient History, Clinical, and Treatment/Services Referrals sections to align wording with other
instructions throughout the ACRF and PCRF. We updated question labels and instructions so that the
language no longer reflects that a test is positive or negative but that the test result is positive or
negative.
Changes to the ACRF only (Table 1B)
In the Laboratory Data section of the ACRF we updated the labels for collecting information about HIV
diagnoses documented by a physician to clarify instructions for when these field should be completed.
In the HIV Testing History section we added three new fields to collect information about self-testing
associated with the first positive test result, the last negative test result, and previous negative test
results to be able to summarize self-testing activity among persons with diagnosed HIV.
Changes to the PCRF and PHER Form (Table 1C)
Information about perinatal HIV exposures was previously collected across two forms, the PCRF and
PHER form, and information about pediatric HIV infection was also collected on the PCRF. We received
feedback from state and local HIV surveillance coordinators and other partners in CDC involved with
perinatal HIV elimination efforts that the PCRF and PHER form should be combined to reduce
redundancy across the forms and better reflect the information necessary to assess progress with
perinatal HIV elimination efforts and to support HIV prevention activities; we concurred with the
feedback and consolidated the information to be collected into a single form still called the PCRF as part
of this revision. We retained the name of the PCRF because prior to this revision some information
about perinatal HIV exposures was collected on the form. However, we revised the instruction
associated with the form name from indicating the form was for “patients aged <13 years at time of
diagnosis” to “patients aged <13 years at time of perinatal exposure or patients aged <13 years at time
of diagnosis.” We worked closely with the perinatal HIV surveillance workgroup, which includes state

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and local HIV surveillance coordinators and other partners in CDC, while consolidating the collection of
information to a single form. Combining the form reduced the total number of pages for collecting the
information on the hard copy forms; we reduced from two forms with four pages each to one form with
six pages.
As part of combining the forms into a single PCRF, we identified some variables that collected the same
or similar information on both the existing PCRF and PHER form and consolidated the variables to collect
the information only one time. In total, we consolidated seven questions on the PHER form with existing
variables on the PCRF form; this sometimes included some minor changes in question meaning, question
wording, or the available response options. This included consolidating the collection of identifier
numbers, the timing of when prenatal care began, and antiretroviral information for the birthing person
and child.
We incorporated some key information collected on the PHER form by moving 13 numbered questions
from the PHER form to the PCRF. As part of moving the information to the PCRF, there were sometimes
minor changes made to the question meaning, question wording, or the available response options. We
moved information associated with the birth (e.g., onset of labor, reason for cesarean section, and
toxicology screening for the infant after birth) and information associated with the history of the
birthing person (e.g., reproductive history, reason birthing person did not receive antiretrovirals,
toxicology screening for the birthing person).
As part of the revision, we proposed to stop collecting 10 numbered questions previously collected on
the PHER form and two variables on the existing version of the PCRF. We proposed to stop collecting
most variables because similar information can be collected through other existing fields or the
information was no longer necessary to collect given changes in HIV testing requirements. For example,
we proposed to no longer collect whether the biological mother was counseled about HIV testing during
this pregnancy, labor, or delivery because routine opt-out HIV testing has been established in the
majority of jurisdictions and counseling is not required.
We added five new questions to the PCRF. Two new questions are related to
breastfeeding/chestfeeding and premastication by the birthing person to improve the ability to correctly
attribute infection to perinatal transmission and to identify when breastfeeding/chestfeeding or
premastication by the birthing person occurred. We added two new questions related to
breastfeeding/chestfeeding and premastication by a non-birthing person to improve the ability to
correctly attribute infection to non-perinatal transmission when child’s infection was determined to
occur during breastfeeding by a non-birthing person or through receipt of premasticated food from the
non-birthing person. We added one question to the Birthing Person History section to collect whether a
CD4 and quantitative NAAT test results were documented in the birthing person’s labor and delivery
record to identify whether medical providers were aware of recent HIV test results during labor and
delivery to make clinical decisions about medical care provided during labor and delivery.
We revised the response options for the existing variable to collect the delivery method in the Birth
History section on the PCRF to align with current medical practice for delivery methods. We also
updated the designation for collecting information for the delivery method from optional to required to
align with the designation on the current PHER form that indicators for a cesarean delivery is a required
field.

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Overall, we made some formatting and wording changes to the PCRF to improve clarity. In the
Laboratory Data section of the PCRF, we updated the labels for collecting information about HIV
diagnoses documented by a physician to clarify instructions for when these field should be completed.
Throughout the Patient History section, we updated references from "biological mother" to "birthing
person” to better reflect that information should be collected for the birthing person regardless of
gender identity or parental status. We updated the instruction in the section titled "Birth History (for
Perinatal Cases only)" to "Birth History (for patients exposed perinatally with or without consequent
infection)" to clarify instructions for when this section of the form should be completed. In the Birth
History Section, we revised the label for a variable from “Birth Defects” to “Congenital Disorders” to
align with current preferred terminology. We added the Birthing Person History section to the PCRF to
limit the length of the existing Birth History information as information from the previous PHER form
was incorporated into the PCRF; this also included moving some information previously collected in the
Birth History section to the Birthing Person History section (e.g., birthing person last name soundex). The
addition of this section creates a more focused area for collecting the majority of data that are related
to the birthing person rather than the child. We added the gender identity variable to the Patient
History section of the hard copy PCRF for the first time; this information had been captured previously in
the electronic reporting system (i.e., enhanced HIV/ADS reporting system (eHARS)) on the PCRF
document, but not on the hard copy form. Refer to “Changes to the ACRF and PCRF” section of this
document above for other changes related to collecting gender identity that were shared across the
forms.
eHARS Only Changes (Table 2)
We proposed two changes that would be made only in eHARS but would not be reflected on the hard
copy forms. These include addition of 5 types of patient identifiers from other data collection systems
that can be entered or imported into eHARS to improve the ability to link with other data collection
systems. In addition, we also created new variables that summarize information submitted for each
person (i.e., person view summary variable) to summarize information associated with suspected acute
HIV infection.
SER Changes (Table 3)
We are requesting a non-substantial change to the Standards Evaluation Report (SER) as provided in
Attachment 3(d) and the specific changes are outlined in Table 3. The proposed form will be provided to
jurisdictions in January 2023 to report their outcomes. Most of the changes are minor edits for clarity
and consistency, and deletion of questions that are no longer needed. The word document format of the
SER will be provided to jurisdictions as a guide, but data collection will occur via REDCap.

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Table 1. Proposed Modifications to the Adult HIV Confidential Case Report Form (ACRF) and Pediatric HIV Confidential Case Report Form
(PCRF)
Table 1A. Changes to the ACRF and PCRF
Section, Variable

Change Proposed

Reason for Change Proposed

Section IV (ACRF & PCRF): Patient
Demographics, Variable: Gender Identity

Revised label from "Current Gender Identity" to
"Gender Identity"

Section IV (ACRF & PCRF): Patient
Demographics, Variable: Gender Identity

On ACRF, relabeled response options from “Male”
to “Man," "Female" to “Woman,” “Transgender
male-to-female (MTF)” to “Transgender woman,”
and “Transgender female-to-male" to
“Transgender man" on the ACRF.
On the PCRF, relabeled response options from
"Male" to "Boy," "Female" to "Girl," "Transgender
male-to-female" to "Transgender girl," and
"Transgender female-to-male" to "Transgender
boy."
Updated order of response options so that
"Transgender woman" (ACRF) and "Transgender
girl" (PCRF) is the last of these four response
options.

Section IV (ACRF & PCRF): Patient
Demographics, Variable: Gender Identity

Added one new gender identity response option:
Declined to answer.

Section IV (ACRF & PCRF): Patient
Demographics, Variable: Gender Identity

Added variable in eHARS to collect the response to
the "(specify)" option associated with "Additional
Gender Identity" on the hard copy form. No
changes to the hard copy form.

To reflect that the gender identity
collected might not reflect the gender
identity at the time the form was
completed.
To improve differentiation between
“sex assigned at birth” (e.g., male,
female) and gender identity (e.g., man,
woman, transgender man, transgender
woman). Similar terms for gender have
been used in HIV surveillance reports
by other city health departments (e.g.,
2018 Annual HIV Epidemiology Report
for San Francisco Department of Public
Health and the 2019 HIV Surveillance
Annual Report for New York City
Department of Health and Mental
Hygiene).
Updated to align gender identity terms
on the PCRF with terms used for this
age group on the CDC's Youth Risk
Behavior Survey.
To better differentiate between when a
person declined to provide their gender
identity and when gender identity was
not collected.
To allow place in eHARS to capture
information collected on the hard copy
form for consistency.

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Section IV (ACRF & PCRF): Patient
Demographics, Variable: Gender Identity

Added a field to collect "Date Identified"
associated with the gender identity collected.
Assigned designation of this field for collection as
required.

Section IV (ACRF & PCRF): Patient
Demographics, Variable: Gender Identity

Updated designation for collecting this
information from recommended to required.

Section IV (ACRF & PCRF): Patient
Demographics, Variable: Sexual
Orientation

Added question and response options to collect
sexual orientation.
□ Straight or heterosexual
□ Lesbian or gay
□ Bisexual
□ Additional sexual orientation
(specify)______________________
□ Declined to answer
□ Unknown

To be able to monitor changes in
gender identity over time and
accurately summarize a person’s
gender identity at specific points in
time presented in state/local and
national surveillance products.
To more accurately release information
about gender categories.
To allow for future release of aggregate
data by reported sexual orientation
rather than by using information
collected in the Patient History section
as a proxy.

Associated with the sexual orientation response
added the field "Date Identified" to collect sexual
orientation over time.

Section IV (ACRF & PCRF): Patient
Demographics, Variable: Country of Birth
Section VII (ACRF & PCRF): Patient History,
Variable: Other documented risk
Section VII (ACRF): Patient History,
Variable: Pediatric Risk
Section VIII (ACRF): Clinical, Variable: If
YES, describe

Assigned designation of these fields for collection
as required.
Removed "please" from question label and
response options.

To align wording with other instances
where a free text option is provided to
record other response options.

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Section XII (PCRF): Treatment/Services
Referrals, Variable: This child’s primary
caretaker is
Section VII (ACRF & PCRF): Patient History,
Variable: Heterosexual contact with
intravenous/injection drug user

Updated language to: “Heterosexual contact with
person who injected drugs”

To align with Division of HIV Prevention
terminology guide.

Section IX (ACRF & PCRF): Laboratory
Data, Variable: Subheading

Combined subsection headings for "HIV
Immunoassays (Nondifferentiating)" and "HIV
Immunoassays (differentiating)" into a single
subsection heading titled "HIV Immunoassays."
Revised order of the test types collected in this
subsection.
Removed space to collect information about a
second test of the same test type (i.e., TEST 2).
Updated label from TEST 1 to TEST.
Updated to collect an overall result for the test
with response options of “Reactive” and
“Nonreactive”. Update to collect analyst results for
HIV-1 p24 antigen with response options of
“Reactive” and “Nonreactive” and HIV-1/2
antibody with response options of “Reactive” and
“Nonreactive.”
Added label "TEST" in front of test type option.

To better align collection of the
information with the recommended
HIV testing algorithm and to limit the
length of the section.

Removed from hard copy form. Updated label
from “HIV-1/2 type-differentiating immunoassay"
to "HIV-1/2 type-differentiating immunoassay
(supplemental)."

HIV-1/2 type-differentiating
immunoassay should only be used as
the supplemental test with current FDA
approved tests. Updated form to limit
routine collection of information on the

Section IX (ACRF & PCRF): Laboratory
Data, Variable: HIV-1/2 Ag/Ab
differentiating immunoassay, Result

Section IX (ACRF & PCRF): Laboratory
Data, Variable: HIV-1/2 Ag/Ab
differentiating immunoassay , HIV-1/2
Ag/Ab and type-differentiating
immunoassay , HIV-1/2 typedifferentiating immunoassay
Section IX (ACRF & PCRF): Laboratory
Data, Variable: Role of test in diagnostic
algorithm

To accommodate result options
available with new FDA-approved test
and align with changes made to eHARS
4.12.

To make consistent across the
Laboratory Data section.

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hard copy form about this test type to
approved use as a supplemental test.
Section IX (ACRF & PCRF): Laboratory
Data, Variable: HIV-1/2 typedifferentiating immunoassay, Result,
Overall Interpretation

Section IX (ACRF & PCRF): Laboratory
Data, Variable: HIV Detection Tests
(Qualitative) and HIV Detection Tests
(Quantitative viral load)

Section IX (ACRF & PCRF): Laboratory
Data, Variable: HIV-1 RNA/DNA NAAT and
HIV-2 RNA/DNA NAAT

Section IX (ACRF & PCRF): Laboratory
Data, Variable: HIV-1/HIV-2 RNA NAAT

Added response option of "HIV-1 positive with
HIV-2 cross-reactivity."
Update response option order:
□ HIV positive, untypable □ HIV-1 positive with
HIV-2 cross-reactivity □ HIV-2 positive with HIV-1
cross-reactivity □ HIV negative □ HIV
indeterminate □ HIV-1 indeterminate □ HIV-2
indeterminate □ HIV-1 positive □ HIV-2 positive
Combined subsection headings for "HIV Detection
Tests (Qualitative)" and "HIV Detection Tests
(Quantitative viral load)" into a single subsection
heading titled HIV Detection Tests."
Removed space to collect information about a
second test of the same test type (i.e., TEST 2).
Updated label from TEST 1 to TEST.
Removed instruction "(Note: Include earliest test
at or after diagnosis) associated with "HIV
Detection Tests (Quantitative viral load)"
subsection heading.
Updated label associated with each test type
option from "(Quantitative viral load)" to
"(Quantitative)." Update Result response options
from "Detectable" and "Undetectable" to
"Detectable above limits," "Detectable within
limit," and "Detectable below limit," and "Not
detected."
Created space to capture information associated
with HIV-1/HIV-2 RNA NAAT tests in a format to
similar test types.
TEST □ HIV-1/2 RNA NAAT (Qualitative)
Test brand name/Manufacturer

To account for a result option available
with new FDA-approved test and group
similar test results together in response
option order.

To limit the length of the Laboratory
Data section. To reflect the fact that
when reporting quantitative test results
on the form that it does not always
have to be the earliest test at or after
diagnosis.

To reflect current terminology and test
result reporting options for FDA
approved tests of this type.

To accommodate collection of
information associated with new FDAapproved tests and align with changes
made to eHARS 4.12. These updates do
not change the data collection burden

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Section IX (ACRF & PCRF): Laboratory
Data, Variable: HIV-1 RNA NAAT
(Qualitative and Quantitative)

Section IX (ACRF & PCRF): Laboratory
Data, Variable: Immunologic Tests (CD4
count and percentage)
Section IX (ACRF & PCRF): Laboratory
Data, Variable: N/A

Lab name
Facility name
Provider name
Result □ HIV-1 □ HIV-2 □ Both (HIV-1 and HIV-2) □
HIV, not differentiated (HIV-1 or HIV-2) □ Neither
(negative)
Collection Date __ __ / __ ___ / __ __ __ __
Created space to capture information associated
with HIV-1 RNA NAAT (Qualitative and
Quantitative) tests in a format to similar test types
TEST □ HIV-1 RNA NAAT (Qualitative and
Quantitative)
Test brand name/Manufacturer
Lab Name
Facility name
Provider name
Result Qualitative: □ Reactive □ Nonreactive
Analyte results: HIV-1 Quantitative: □
Detectable above limit □ Detectable within limits
□ Detectable below limit
Copies/mL Log
Collection Date __ __ / __ ___ / __ __ __ __
Reduced number of CD4 test results to be
collected from three at specific points in time (at
or closest to diagnosis, <200 cells/uL or 14%, and
other) to a single CD4 count without a specified
point in time.
Modified the instruction provided under the
Documentation of Tests heading. Changed from
"Complete the above only if none of the following
were positive for HIV-1: Western blot, IFA, culture,
viral load, qualitative NAAT (RNA or DNA), HIV-1/2
type-differentiating immunoassay (supplemental
test), stand-alone p24 antigen, or nucleotide

as this information was already being
reported by laboratories for tests of
these types. The current revision was
made to allow a dedicated space to
capture the information on the ACRF
and PCRF.
To accommodate collection of
information associated with new FDAapproved test and align with changes
made to eHARS 4.12. These updates do
not change the data collection burden
as this information was already being
reported by laboratories for tests of
these types. The current revision was
made to allow a dedicated space to
capture the information on the ACRF
and PCRF.

To limit the length of the Laboratory
Data section. To reflect the fact that a
CD4 test result at any point in time can
be reported.
To reflect current terminology for FDA
approved tests of this type.

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Section IX (ACRF & PCRF): Laboratory
Data, Variable: HIV-1/2 typedifferentiating immunoassay, Result and
HIV-1/2 Ag/Ab and type-differentiating
immunoassay, Result
Section IX (ACRF & PCRF): Laboratory
Data, Variable: If YES, provide specimen
collection date of earliest positive test for
this algorithm (existing label)/ If YES,
provide specimen collection date of
earliest positive test result for this
algorithm
Section VIII (ACRF): Clinical, Variable:
Suspect acute HIV infection
Section IX (ACRF): Laboratory Data,
Variable: Date of last documented
negative HIV test result
Section XII (ACRF): HIV Testing History,
Variable: Ever had previous positive HIV
test result?, Date of first positive HIV test
result, Ever had a negative HIV test result,
Date of last negative HIV test result,
Number of negative HIV test results within
the 24 months before the first positive
test result
Section VII (PCRF): Patient History,
Variable: Date of birthing person’s first
positive test result to confirm infection

sequence" to "Complete the above only 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, or nucleotide sequence."
Renumbered footnote. Moved footnote from area
specific to the test result to the end of the
Laboratory Data section.
Revised label from "test” to “test result(s).”

To accommodate additional footnote
added. To limit the length of the
Laboratory Data section.
To clarify that only the test results can
be positive or negative, not the test
itself.

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Section IX (ACRF & PCRF): Laboratory
Data, Variable: Test brand
name/manufacturer

Designated test brand name/manufacturer as an
optional field for the two new test types (HIV-1
RNA NAAT (Qualitative and Quantitative) and HIV1/HIV-2 RNA NAAT.

Section IX (ACRF & PCRF): Laboratory
Data, Variable: Facility name

Designated facility name as a required field for the
two new types. Updated the designation of facility
name from optional to required for all other
laboratory test types already collected.
Designated lab name as a required field for the
two new types. Updated the designation of lab
name from optional to required for all other
laboratory test types already collected.
Designated provider name as an optional field for
the two new test types (HIV-1 RNA NAAT
(Qualitative and Quantitative) and HIV-1/HIV-2
RNA NAAT.
Designated collection date as a required field for
the two new test types (HIV-1 RNA NAAT
(Qualitative and Quantitative) and HIV-1/HIV-2
RNA NAAT.
Designated result as a required field for the new
HIV-1/HIV-2 RNA NAAT. Designated the result
qualitative and analyte result as required fields for
the new HIV-1 RNA NAAT (Qualitative and
Quantitative) test type. Revised the designation
for HIV-1 RNA/DNA NAAT (Quantitative) and HIV-2
RNA/DNA NAAT (Quantitative) so that all portions
of the result are required; previously the
interpretation portion of the result was designated
as optional.
Updated so that the first letter in each word of the
following labels is capitalized: Test Brand

Section IX (ACRF & PCRF): Laboratory
Data, Variable: Lab name
Section IX (ACRF & PCRF): Laboratory
Data, Variable: Provider name
Section IX (ACRF & PCRF): Laboratory
Data, Variable: Collection date
Section IX (ACRF & PCRF): Laboratory
Data, Variable: Result (all portions)

Section IX (ACRF & PCRF): Laboratory
Data, Variable: Trend Branch

To align designation for collecting test
brand name/manufacturer for the new
test types with the designation for all
other laboratory test types already
collected.
Facility name is crucial for conducting
data to care activities.
Lab name is crucial for conducting data
to care activities.
To align designation for collecting
provider name for the new test types
with the designation for all other
laboratory test types already collected.
To align designation for collecting
collection date for the new test types
with the designation for all other
laboratory test types already collected.
To ensure that the designation of result
was consistent across all laboratory test
types collected.

To improve consistency in capitalization
of labels throughout the Laboratory
Data section.

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Name/Manufacturer, Lab Name, Facility
Name, Provider Name, Index Value

Name/Manufacturer, Lab Name, Facility Name,
Provider Name, Index Value.

Section IX (ACRF & PCRF): Laboratory
Data, Variable: Testing Option

For tests under the subsections HIV Immunoassays
and HIV Detection Tests, added label to designate
the testing option. Updated wording for response
option from "Point-of-care rapid test." Added two
new response options: " Self-test, result directly
observed by a provider" and "Lab test, selfcollected sample." Added associated footnote
below the Laboratory Data section.
Testing Option (if applicable) □ Point-of-care test
by provider □ Self-test, result directly observed by
a provider1 □ Lab test, self-collected sample
1
Results not directly observed by a provider should
be recorded in HIV Testing History.
Assigned designation of this field for collection as
required.
Associated with the last documented negative HIV
test under the Documentation of Tests subsection,
added label to designate the testing option and
three response options.
Testing Option (if applicable) □ Point-of-care test
by provider □ Self-test, result directly observed by
a provider1 □ Lab test, self-collected sample
1
Results not directly observed by a provider should
be recorded in HIV Testing History.
Assigned designation of this field for collection as
required.
Added roman numerals to designate each section.

To be able to summarize documented
self-testing activity and self-collected
specimens among persons with
diagnosed HIV.

Removed section from the hard copy form.

To accommodate room for other form
changes.

Section IX (ACRF & PCRF): Laboratory
Data, Variable: Testing Option

Section (ACRF & PCRF): All, Variable: N/A
Section (ACRF & PCRF): State/Local Use
(deleted), Variable: N/A

To be able to summarize documented
self-testing activity and self-collected
specimens among persons with
diagnosed HIV.

To assist staff with referencing a
particular section of the form.

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Section (ACRF & PCRF): Footer, Variable:
Confidentiality Statement

Removed the words “on file at the local health
department” from the confidentiality statement.

To remove ambiguity about whether
the assurance is specific to the local
health department or is managed by
CDC.

Change Proposed

Reason for Change Proposed

Section IX (ACRF): Laboratory Data,
Variable: Is earliest evidence of HIV
infection diagnosis documented by a
physician rather than by laboratory test
results?
Section IX (ACRF): Laboratory Data,
Variable: If YES, provide date of diagnosis
by physician

Updated label from "If HIV laboratory tests were
not documented, is HIV diagnosis documented by
a physician?" to "Is earliest evidence of HIV
infection diagnosis documented by a physician
rather than by laboratory test results?"
Updated label from "If YES, provide date of
diagnosis" to "If YES, provide date of diagnosis by
physician."

To clarify instructions for when this
field should be completed.

Section XII (ACRF): HIV Testing History,
Variable: Was the first positive test result
from a self-test performed by the patient?

Added the following question and responses after
"Date of first positive HIV test result" question:
Was the first positive test result from a self-test
performed by the patient? □ Yes □ No
□ Unknown
Assigned designation of this field for collection as
required.
Added the following question and responses after
"Date of last negative HIV test result" question:
Was the last negative test result from a self-test
performed by the patient? □ Yes □ No □
Unknown
Assigned designation of this field for collection as
required.
Added the following question and responses after
"Number of negative HIV test results within the 24
months before the first positive test result "
question:

To be able to summarize self-testing
activity among persons with diagnosed
HIV.

Table 1B. Changes to the ACRF Only
Section, Variable

Section XII (ACRF): HIV Testing History,
Variable: Was the last negative test result
from a self-test performed by the patient?

Section XII (ACRF): HIV Testing History,
Variable: How many of these negative test
results were from self-tests performed by
the patient?

To clarify which date should be used to
complete the field.

To be able to summarize self-testing
activity among persons with diagnosed
HIV.

To be able to summarize self-testing
activity among persons with diagnosed
HIV.

13

How many of these negative test results were
from self-tests performed by the patient? __ __ □
Unknown
Assigned designation of this field for collection as
required.
Table 1C. Changes to the PCRF and PHER Form
Variables Consolidated Across the PCRF and PHER Form
Section, Variable
Change Proposed
Section II (PCRF): Health Department Use
Only Header, Variable: State Number

Section II (PCRF): Health Department Use
Only Header, Variable: City/County
Number

Section XI (PCRF): Birthing Person History,
Variable: Birthing Person State ID Number

Section XI (PCRF): Birthing Person History,
Variable: Prenatal Care—Month of
Pregnancy Prenatal Care Began

Consolidated collection of PHER form "Infant's
State Number" into PCRF Health Department Use
Only section field "State Number" with change in
question wording on the PHER form, but with no
change to existing PCRF field label or response
options.
Consolidated collection of PHER form "Infant's City
Number" into PCRF Health Department Use Only
section field "City/County Number" with change in
question wording on the PHER form, but with no
change to existing PCRF field label or response
options.
Consolidated collection from PHER form "Mother's
State Number." Moved from Birth History section
to newly created Birthing Person History section
with change to question wording and no change to
the response options. Changed wording from
"Maternal" to "Birthing Person."
Consolidated collection from PHER form Q3 with
change in question meaning from collecting
weeks' gestation to months' gestation and no
change in response options. Moved from Birth
History section to newly created Birthing Person
History section with no changes to existing PCRF
field label or response options.

Reason for Change Proposed
To consolidate data collection into a
single form for persons <13 years at
time of HIV perinatal exposure or HIV
diagnosis.
To consolidate data collection into a
single form for persons <13 years at
time of HIV perinatal exposure or HIV
diagnosis.
To limit the length of the Birth History
section. To consolidate data collection
into a single form for persons <13 years
at time of HIV perinatal exposure or HIV
diagnosis.
To consolidate data collection into a
single form for persons <13 years at
time of HIV exposure or diagnosis. To
limit the length of the Birth History
section.
Updated designation to align with

14

Section XI (PCRF): Birthing Person History,
Variable: Did birthing person receive any
ARVs during this pregnancy?

Section XI (PCRF): Birthing Person History,
Variable: Did birthing person receive any
ARVs during labor/delivery?

Updated designation of this field for collection
from optional to required.
Consolidated collection of PHER form Q12 into
existing PCRF Birthing Person History section field
"Did mother receive any ARVs during pregnancy?"
with changes in question wording, and response
options. Moved to the PCRF Birthing Person
History section. Although the question wording
was updated from "prescribed" to "receive" the
information collected will reflect whether there is
any evidence of ARVs received, which includes
documentation that ARVs were prescribed.
Changed the question wording to state "birthing
person" instead of "mother”. Revised question
wording from "Drug name" to "If YES, specify all
ARVs", "Date drug started" to "Date began" and
"Date stopped" to "Date of last use." Removed
response options "Not documented" and "Record
not available." No longer collect "Gestational age
drug started," "Drug stopped," or "Stop codes." No
longer collect "Drug refused" separately from
other response options.
Updated designation of this field for collection
from recommended to required.
Consolidated collection of PHER form Q14 into
existing PCRF Birthing Person History section field
"Did mother receive any ARVs during labor and
delivery?" with changes in question wording, and
response options. Moved to the PCRF Birthing
Person History section. Although the question
wording was updated from "prescribed" to
"receive" the information collected will reflect
whether there is any evidence of ARVs received,
which includes documentation that ARVs were

current designation for this field when
collected on the PHER form.
To retain more frequently used practice
in existing National HIV Surveillance
System data collection to collect
information on antiretrovirals. To
better reflect that information should
be collected for the birthing person
regardless of gender identity or
parental status. To align with
document-based surveillance. To
consolidate data collection into a single
form for persons <13 years at time of
HIV perinatal exposure or HIV
diagnosis.
Updated designation to align with
current designation for this field when
collected on the PHER form.

To retain more frequently used practice
in existing National HIV Surveillance
System data collection to collect
information on antiretrovirals. To
better reflect that information should
be collected for the birthing person
regardless of gender identity or
parental status. To align with
document-based surveillance. To
consolidate data collection into a single

15

Section XII (PCRF): Treatment/Services
Referrals, Variable: This child ever taken
any ARVs?

prescribed. Changed the question wording to state
"birthing person" instead of "mother. Revised
question wording from "Drug name" to "If YES,
specify all ARVs", "Date received" to "Date began."
Removed response options "Not documented"
and "Record not available." No longer collect
"Time received" or "Type of administration." No
longer collect "Drug refused" separately from
other response options.
Updated designation of this field for collection
from recommended to required.
Consolidated collection of PHER form Q20 into
PCRF Treatment/Services Referrals section "This
child ever taken any ARVs?" with changes in
question meaning, question wording, and
response options. Changed question meaning
from collecting antiretrovirals prescribed to
antiretrovirals received. Revised question wording
from "Drug name" to "ARV medication", "Date
drug started" to "Date began" and "Stop Date" to
"Date of last use." Removed response options
"Not documented" and "Record not available." No
longer collect "Drug Refused," "Time started,"
"Drug stopped," or "Stop codes."
Modified layout of response options to change
from collecting all ARV medications received for a
specific reason in one row to allowing up to five
ARV medications to be documented on separate
rows along with the reason for use. Additional ARV
medications can be recorded in the Comments
section.

form for persons <13 years at time of
HIV perinatal exposure or HIV
diagnosis.
Updated designation to align with
current designation for this field when
collected on the PHER form.

To retain more frequently used practice
in existing National HIV Surveillance
System data collection to collect
information on antiretrovirals received
rather than prescribed. To reduce data
collection burden while consolidating
data collection into a single form for
persons <13 years at time of HIV
perinatal exposure or HIV diagnosis.

16

Variables Moved from the PHER Form to the PCRF
Section, Variable
Change Proposed
Section X (PCRF): Birth History, Variable: If
Cesarean delivery, mark all the following
indications that apply

Moved from PHER form Q18 to PCRF Birth History
section with no change in question meaning or
question wording, but changes to response
options. Removed "Not applicable" response
option. Changed the response option wording to
state "birthing person" instead of "mother."

Section X (PCRF): Birth History, Variable:
Birth information

Moved from PHER form Q17 to PCRF Birth History
section with no changes to question wording, but
changes in question meaning and response
options. Question meaning changed by no longer
collecting the date and time associated with the
"Onset of labor" or "Admission to labor and
delivery." Removed response options "Birth not in
hospital" and "Record not available."
Moved from PHER form Q10 to PCRF Birth History
section with no change in question meaning, but
changes in question wording and response
options. Updated label from "at birth" to "after
birth." Updated response options to include
results for three additional substances (fentanyl,
K2, and PCP). Removed "Toxicology screening not
documented" response option. Added "Unknown"
response option. Revised question wording and
collection of response options to collect
information about each specific substance
screened and whether the result of the screening
was "Positive," "Negative," "Unknown," or "Not
screened" for each substance. Added field to
collect date screened for each substance. Added
instruction to clarify how to complete the form is

Section X (PCRF): Birth History, Variable:
Was a toxicology screen done on the
infant at birth?

Reason for Change Proposed
To better reflect that information
should be collected for the birthing
person regardless of gender identity or
parental status. To consolidate data
collection into a single form for persons
<13 years at time of HIV perinatal
exposure or HIV diagnosis.
To consolidate data collection into a
single form for persons <13 years at
time of HIV exposure or diagnosis.

To reflect that information should be
collected on any infant toxicology
screening done within a time period
after birth rather than just a toxicology
screening done only at time of birth. To
update current list of substances to
include substances with a growing
frequency of use so that they are
systematically collected rather than
captured through the "Other" response
option. To differentiate which
substances were included in the
toxicology screening and the toxicology
screening result for each specific
substance. To consolidate data
collection into a single form for persons

17

Section XI (PCRF): Birthing Person History,
Variable: Birthing Person City/County ID
Number

Section XI (PCRF): Birthing Person History,
Variable: Has the birthing person ever
been pregnant before this pregnancy?
Include previous pregnancies that ended
in a live birth, miscarriage, stillbirth, or
induced abortion

Section XI (PCRF): Birthing Person History,
Variable: If NO, select reason (Associated
with “Did birthing person receive any
ARVs during this pregnancy?)

the same substance is screened for more than one
time.
Moved collection of PHER form "Mother's City
Number" to PCRF Birthing Person History section
with change in question wording, but no change in
question meaning or response options. Changed
question wording from "Mother's City Number" to
"Birthing Person City/County ID Number."

<13 years at time of HIV perinatal
exposure or HIV diagnosis.
To consolidate data collection into a
single form for persons <13 years at
time of HIV perinatal exposure or HIV
diagnosis. To better reflect that
information should be collected for the
birthing person regardless of gender
identity or parental status.
Moved from PHER form Q6 to PCRF Birthing
To better reflect that information
Person History section with no change in question should be collected for the birthing
meaning, but changes in question wording and
person regardless of gender identity or
response options. Changed the question wording
parental status. To improve quality
to state "birthing person" instead of "mother."
assurance activities associated with
Changed sub-question wording from "No. of
reporting of HIV status of previous
previous pregnancies" to "If YES, specify how many pregnancies. To consolidate data
previous pregnancies." Revised response options
collection into a single form for persons
from collecting the number of previous live births, <13 years at time of HIV perinatal
previous miscarriages or stillbirths, and previous
exposure or HIV diagnosis.
induced abortion to collect pregnancy outcome
and year of outcome for each individual previous
pregnancy. No longer collect total previous
abortions.
Moved from PHER form Q12a to PCRF Birthing
To retain more frequently used practice
Person Information section with changes in
in existing National HIV Surveillance
question meaning, question wording, and
System data collection to collect
response options. Updated question meaning by
information on antiretrovirals received
changing to respond if antiretrovirals were not
rather than prescribed. To better reflect
received instead of not prescribed. Updated
that information should be collected for
question wording from "If no antiretroviral drug
the birthing person regardless of
was prescribed during pregnancy, check reason."
gender identity or parental status. To
to "If NO, select reason." Removed response
align with document-based
option "Not documented." Updated wording in
surveillance. To consolidate data
collection into a single form for persons

18

Section XI (PCRF): Birthing Person History,
Variable: If NO, select reason (Associated
with Did birthing person receive any ARVs
during labor/delivery?)

Section XI (PCRF): Birthing Person History,
Variable: Was the birthing person
screened for any of the following
conditions during this pregnancy?

Section XI (PCRF): Birthing Person History,
Variable: Were any of the following
conditions diagnosed for the birthing
person during this pregnancy or at the
time of labor and delivery?

response options to state "birthing person"
instead of "mother."
Moved from PHER form Q14a to PCRF Birthing
Person Information section with changes in
question meaning, question wording, and
response options. Updated question meaning by
changing to respond if antiretrovirals were not
received instead of not prescribed. Updated
question wording from "If no antiretroviral drug
was prescribed during pregnancy, check reason."
to "If NO, select reason." Removed response
option "Not documented." Updated wording in
response options to state "birthing person"
instead of "mother."
Moved from PHER form Q4 to PCRF Birthing
Person Information section with changes in
question wording, question meaning, and
response options. Changed the question wording
to state "birthing person" instead of "mother."
Changed question meaning by updating
instructions from "Check test(s) performed before
birth, but closest to date of delivery or admission
to labor and delivery" to "Check test(s) performed
before birth." Removed "Not documented" and
"Record not available" from response options for
specific diagnoses.
Moved from PHER form Q5 to PCRF Birthing
Person Information section with no change in
question meaning, but changes in question
wording and response options. Changed the
question wording to state "birthing person"
instead of "mother" and to state as a question
rather than a statement. Updated abbreviation in

<13 years at time of HIV perinatal
exposure or HIV diagnosis.
To retain more frequently used practice
in existing National HIV Surveillance
System data collection to collect
information on antiretrovirals received
rather than prescribed. To better reflect
that information should be collected for
the birthing person regardless of
gender identity or parental status. To
align with document-based
surveillance. To consolidate data
collection into a single form for persons
<13 years at time of HIV perinatal
exposure or HIV diagnosis.
To better reflect that information
should be collected for the birthing
person regardless of gender identity or
parental status. To align with
document-based surveillance. To
consolidate data collection into a single
form for persons <13 years at time of
HIV perinatal exposure or HIV
diagnosis.

To better reflect that information
should be collected for the birthing
person regardless of gender identity or
parental status. To make HBsAg
terminology consistent throughout the
form. To align with document-based
surveillance. To consolidate data

19

Section XI (PCRF): Birthing Person History,
Variable: Were substances used by the
birthing person during this pregnancy?

Section XI (PCRF): Birthing Person History,
Variable: Collection of whether specific
substances were used or injected
(Associated with Were substances used by
the birthing person during this
pregnancy?)

Section XI (PCRF): Birthing Person History,
Variable: Was a toxicology screen done on
the birthing person (either during this
pregnancy or at the time of delivery)?

one of the diagnoses collected from "HbSAg+" to
"HBsAg." Removed instruction "See instructions
for data abstraction for definitions." Removed
"Not document" and "Record not available" from
response options.
Moved from PHER form Q8 to PCRF Birthing
Person History section with no change in question
meaning, but changes in the question wording and
response options. Changed the question wording
from "Was substance use during pregnancy noted
in the medical or social work records?" to "Were
substances used by the birthing person during this
pregnancy?" Removed the overall "Record Not
Available" response option; updated wording of
response option from "No (Go to 9)" to "No."
Moved questions from PHER form Q8a and 8b to
PCRF Birthing Person History section with no
change in question meaning, but changes in
question wording and response options. Update
question wording from "If yes, indicate which
substances were used during pregnancy" and “If
substances used, were any injected?" to collect
whether each substance was used and injected.
Updated response options to include results for
three additional substances (fentanyl, K2, and
PCP). Updated to record response options of
"Used and injected," "Used and did not inject,"
"Used and unknown if injected," "Did not use,"
and "Unknown if used" for each specific substance
rather than just selecting substance if "Yes."
Moved from PHER form Q9 to PCRF Birthing
Person History section with no change in question
meaning, but changes in question wording and
response options. Changed the question wording

collection into a single form for persons
<13 years at time of HIV perinatal
exposure or HIV diagnosis.
To align with document-based
surveillance. To consolidate data
collection into a single form for persons
<13 years at time of HIV perinatal
exposure or HIV diagnosis.

To update current list of substances to
include substances with a growing
frequency of use so that they are
systematically collected rather than
captured through the "Other" response
option. To differentiate between when
a specific substance was not used or
injected versus when there's not
sufficient documentation to indicate
whether a specific substance was used
or injected. To consolidate data
collection into a single form for persons
<13 years at time of HIV perinatal
exposure or HIV diagnosis.
To consolidate data collection into a
single form for persons <13 years at
time of HIV perinatal exposure or HIV
diagnosis.

20

to state "birthing person" instead of "mother."
Updated response options to include results for
three additional substances (fentanyl, K2, and
PCP). Removed "Toxicology screening not
documented" response option. Added "Unknown"
response option. Revised question wording and
collection of response options to collect
information about each specific substance
included in the toxicology screening and whether
the result of the screening was "Positive,"
"Negative," "Unknown," or "Not screened" for
each substance. Added field to collect date
screened for each substance. Added instruction to
clarify how to complete the form is the same
substance is screened for more than one time.
Variables on PHER Form No Longer Collected
Section, Variable
Change Proposed
Section VII (PCRF): Patient History,
Variable: Was the biological mother
counseled about HIV testing during this
pregnancy, labor, or delivery?

No longer collect.

Section XII (PCRF): Treatment/Services
Referrals, Variable: Was this child
breastfed?

No longer collect.

Section (PHER): Comments, Variable:
Comments
Section (PHER): Q1, Variable: If
information on the mother is not

No longer collect.
No longer collect.

Reason for Change Proposed
To reduce burden given
implementation of routine opt-out
testing without requirements for
counseling in the majority of
jurisdictions.
Important to differentiate whether
breastfeeding was by the birthing
person or a non-birthing person. New
fields proposed to add to the Patient
History section to collect information
about breastfeeding by birthing person
and non-birthing person.
Existing Comments section on the PCF
can be used to collect the information.
Existing field "This child’s primary
caretaker is" in the PCRF

21

available, was the child adopted, or in
foster care?
Section (PHER): Q2, Variable: Records
abstracted

No longer collect.

Section (PHER): Q7, Variable: Complete
the chart for all siblings. (DOB, age, HIV
serostatus)

No longer collect.

Section (PHER): Q11, Variable: Was the
mother’s HIV serostatus noted in her
prenatal care medical records?

No longer collect.

Section (PHER): Q13, Variable: Was
mother’s HIV serostatus noted in her labor
and delivery records?

No longer collect.

Section (PHER): Q15, Variable: Was
mother referred to HIV care after
delivery?

No longer collect.

Section (PHER): Q16, Variable: First CD4 or
first viral load after discharge

No longer collect.

Section (PHER): Q19, Variable: Was
mother’s HIV serostatus noted on the
child’s birth record?

No longer collect.

Treatment/Services Referrals section
with no changes to the existing
question or response option can be
used to collect similar information.
Existing field "Document Source" in the
PCRF Health Department Use only
section with no changes can be used to
collect similar information.
Information can be collected by
completing separate PCRFs for each
sibling and linking with the birthing
person's record.
Field "Birthing person's ’s HIV infection
status" in the PCRF Patient History
section can be used to collect similar
information.
Field "Birthing person's ’s HIV infection
status" in the PCRF Patient History
section can be used to collect similar
information.
Information about referrals to medical
care are not well documented. Existing
fields in the Laboratory Data section of
the birthing person's ACRF can be used
to assess receipt of HIV care after
delivery.
Existing fields in the Laboratory Data
section of the birthing person's ACRF
can be used to collect this information.
Field "Birthing person's ’s HIV infection
status" in the PCRF Patient History
section can be used to collect similar
information.

22

Section (PHER): Q20a, Variable: If no
antiretroviral drug as prescribed, indicate
reason.

New Variables to Collect
Section, Variable
Section VII (PCRF): Patient History,
Variable: Child breastfed/chestfed by
birthing person
Section VII (PCRF): Patient History,
Variable: Child received
premasticated/pre-chewed food from
birthing person
Section VII (PCRF): Patient History,
Variable: Child breastfed/chestfed by nonbirthing person
Section VII (PCRF): Patient History,
Variable: Child received
premasticated/pre-chewed food from
non-birthing person
Section XI (PCRF): Birthing Person History,
Variable:

No longer collect.

To reduce data collection burden while
consolidating data collection into a
single form for persons <13 years at
time of HIV perinatal exposure or HIV
diagnosis.

Change Proposed

Reason for Change Proposed

Added new field labeled "Child breastfed/chestfed
by birthing person" with response options of
"Yes," "No," and "Unknown."
Assigned designation of this field for collection as
required.
Added new field labeled "Child received
premasticated/pre-chewed food from birthing
person" with response options of "Yes," "No," and
"Unknown."
Assigned designation of this field for collection as
required.
Added new field labeled "Child breastfed/chestfed
by non-birthing person" with response options of
"Yes," "No," and "Unknown."
Assigned designation of this field for collection as
required.
Added new field labeled "Child received
premasticated/pre-chewed food from non-birthing
person" with response options of "Yes," "No," and
"Unknown."
Assigned designation of this field for collection as
required.
Added new field labeled "Was a test result (with a
specimen collection date within the 6 weeks on or
before delivery) documented in the birthing
person’s labor/delivery record" with response

To improve the ability to correctly
attribute infection to perinatal
transmission when child’s infection was
determined to occur during
breastfeeding by the birthing person.
To improve the ability to correctly
attribute infection to perinatal
transmission when child’s infection was
determined to occur due to receipt of
premasticated/pre-chewed food from
the birthing person.
To improve the ability to correctly
attribute infection to non-perinatal
transmission when child’s infection was
determined to occur during
breastfeeding by a non-birthing person.
To improve the ability to correctly
attribute infection to perinatal
transmission when child’s infection was
determined to occur due to receipt of
premasticated/pre-chewed food from
the non-birthing person.
To identify whether medical providers
were aware of recent HIV test results
during labor and delivery to make

23

Other Changes
Section, Variable
Section (PCRF): Form Title, Variable: N/A

Section N/A (PCRF): N/A, Variable: N/A

options of "Yes," "No," and "Unknown" for both
CD4 and Quantitative NAAT (RNA or DNA) test
types.

clinical decisions about medical care
provided during labor and delivery.

Change Proposed

Reason for Change Proposed

Changed title of PCRF form from "Pediatric HIV
Confidential Case Report Form (Patients aged <13
years at time of diagnosis)" to "Pediatric HIV
Confidential Case Report Form (Patients aged <13
years at time of perinatal exposure or patients
aged <13 years at time of diagnosis)."
Increased number of pages of the hard copy PCRF
from 4 pages to 6 pages.

To reflect that the form should be
completed for patients exposed
perinatally with or without consequent
infection along with patients <13 years
at time of HIV diagnosis.

Section IV (PCRF): Patient Demographics,
Variable: Gender Identity

Added variable to the hard copy PCRF.

Section VII (PCRF): Patient History,
Variable: All

Changed references from "biological mother" to
"birthing person" for all questions in this section.

Section IX (PCRF): Laboratory Data,
Variable: Is earliest evidence of diagnosis
documented by a physician rather than by
laboratory test results?

Updated label from "If laboratory tests were not
documented, is patient confirmed by a physician
as" to "Is earliest evidence of diagnosis
documented by a physician rather than by
laboratory test results?"
Update label from "Date of diagnosis" to "Date of
diagnosis by physician" for both fields collected
associated with "If laboratory tests were not
documented, is patient confirmed by a physician
as."

Section IX (PCRF): Laboratory Data,
Variable: Date of diagnosis by physician

To accommodate new variables being
collected and the consolidation of the
PHER form (4 pages) and existing PCRF
(4 pages).
Current gender identity is already
collected in eHARS on the PCRF
document. Updated for consistency
between hard copy form and eHARS.
To better reflect that information
should be collected for the birthing
person regardless of gender identity or
parental status.
To clarify instructions for when this
field should be completed.

To clarify which date should be used to
complete the fields.

24

Section X (PCRF): Birth History, Variable:
N/A
Section X (PCRF): Birth History, Variable:
Delivery

Section X (PCRF): Birth History, Variable:
Congenital Disorders
Section XI: Birthing Person History,
Variable: N/A
Section XI (PCRF): Birthing Person History,
Variable: Birthing Person Date of Birth,
Birthing Person Last Name Soundex,
Birthing Person Country of Birth, Other
Birthing Person ID (specify type of ID and
ID number), Prenatal Care—Total Number
of Prenatal Care Visits, Did birthing person
receive any antiretrovirals (ARVs) prior to
this pregnancy?

Changed instruction associated with section title
from "Birth History (for Perinatal Cases only)" to
"Birth History (for patients exposed perinatally
with or without consequent infection)."
Revised response options. Added new response
option " Cesarean," removed the numbers from
the start of the other remaining response options,
and removed response options "2-2-Elective
Cesarean," "3-Nonelective Cesarean" and "4Cesarean, unknown type."
Updated designation of this field for collection
from optional to required.
Revised label from "Birth Defects" to "Congenital
Disorders." Updated from “If yes, specify types” to
“If YES, specify types.”
Added a new section to PCRF with title "Birthing
Person History (for patients exposed perinatally
with or without consequent infection)."

To clarify instructions for when this
section of the form should be
completed.

Moved from Birth History section to newly created
Birthing Person History section with change to
question wording and no change to the response
options. As applicable, changed wording from
"Maternal" to "Birthing Person." Updated label for
variable to collect the birthing person’s date of
birth from "DOB" to "Date of Birth."

To limit the length of the Birth History
section. To better reflect that
information should be collected for the
birthing person regardless of gender
identity or parental status.

To align with current medical practice;
cesareans are not an elective
procedure.
Updated designation to align with the
current designation that the indicators
for Cesarean delivery is required.
To align with current preferred
terminology and improve consistency
of capitalization for “if yes” questions.
To limit the length of the Birth History
section.

25

Table 2. eHARS Only Changes
Description
ID Type

Person View Hierarchy

Table 3. SER Changes

Change Proposed

Reason for Change Proposed

Added additional types of patient identifiers from
other data collection systems that can be entered
or imported into eHARS:
EvalWeb Client ID
EvalWeb Form ID
EvalWeb Partner Services Case Number
Integrated Disease Surveillance System Person ID
Integrated Disease Surveillance System Event ID
No changes to the hard copy form.
Created a person view hierarchy associated with
the variables under the heading “Acute HIV
Infection” on the Clinical tab.

To improve linkages with other data
collection systems.

Form, Page, Section, Question/Field
SER Form Pages 1-9

Change Proposed
All evaluation periods are updated to reflect the 2023 report.

SER Form Pages 2-9

Minor edits in wording were made throughout for consistency and clarity.

SER Form Page 1

Examples:
Introduction
Moved key personnel names to table format for improved formatting
Part F. Submission of Required Outcome Standards with SAS Tables
Corrected the jurisdictions listed in the EHE footnote to include only
the jurisdictions expected to report on the EHE indicators.
Added a field to capture email addresses of contacts.

SER Form
Page 2. Section B. Laboratory,
Question 2

Updated the timeframe:

To summarize information associated
with suspected acute HIV infection.

Reason for Change Proposed
To ensure that jurisdictions are reporting on
the correct evaluation periods.
These minor edits were made to make the
document more consistent and accurate in its
language. These changes do not impact the
meaning of any questions.

Previously we captured the names of the
primary surveillance contact, the secondary
surveillance contact, and the Overall
Responsible Party. We are now going to
capture the email addresses for these
contacts as well, so we have up to date
information on these key staff members.
In the 2022 SER, jurisdictions were asked if
they had completed an assessment up until
that point in the NOFO. Now that we have

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SER Form Page 2. Section B.
Laboratory, Question 3

2. Since 2018, In 2022 did your surveillance program conduct an assessment on
laboratories that conduct HIV-related testing for persons who reside in your
jurisdiction? This assessment is to maintain documentation, such as types of
tests performed and LOINC usage, by all laboratories that report to your
jurisdiction.
☐ Yes
•
What year(s)? Click here to enter text.
☐ No
Edited the follow up questions to Question 3 to capture time frame:
3. Are you aware of any laboratory reporting lapses of HIV-related test
results for persons who reside within your jurisdiction that resulted in
missing laboratory data in your December 2022 data transfer? Please
include lapses in laboratory reporting to CDC, including those attributed to
the laboratory not reporting test results or because the HL7
reader/transmitter in the health department did not send the results to HIV
surveillance.

☐ Yes
Year of
Approximately what
specimen
percentage of your total
collection jurisdiction’s laboratory
volume is missing for
the calendar year
indicated?
2022*
2021

that information, we only need to ask if an
assessment was done in the most recent year,
i.e., 2022, in the 2023 SER.

Question 3 was edited in order to capture
what year a reporting lapse occurred in. This
is important for determining which years a
jurisdiction did not have complete laboratory
reporting.

Approximately what percentage
of your total jurisdiction’s CD4
results (< 200 and ≥ 200) and
viral load results (detectable and
undetectable) are missing for the
calendar year indicated?

*At a minimum, lab results through September 2022

•
Approximately what percentage of your total jurisdiction’s laboratory
volume is missing because of this?
•
Approximately what percentage of all CD4 results (< 200 and ≥ 200)
and all viral load results (detectable and undetectable) are missing because
of this? Click here to enter text.
☐ No
•
In 2022, did your program monitor the quality of incoming
reports of laboratory test results (including test result volumes)
on a quarterly basis or more frequently? ☐ Yes ☐ No
SER Form Page 2. Section B.
Laboratory, Question 4

Deleted question 4:
4.

By December 2021, did your surveillance program transfer to CDC
via eHARS all CD4 (<200 and ≥200) and viral load (detectable and

Question 4 is no longer needed to determine
laboratory reporting completeness. Question
3 is sufficient.

27

undetectable) test results from laboratory reports received from 20192021?
Year
reports
were
received
2019
2020
2021*

CD4 (<200 and ≥200)

Yes

No

☐
☐

☐

Describe
type of CD4
results
received

Viral load tests

Yes

No

☐

☐

☐

☐

☐

☐

☐

☐

Describe
type of
viral load
results
received

☐

*At a minimum, reports received from January 2021 through
September 2021
SER Form
Page 4. Section E. Cluster Detection
and Response, Question 1

SER Form
Page 4. Section E. Cluster Detection
and Response, Follow-up questions

SER Form
Pages 4-5. Section F. Submission of
Required Outcome Standards with
SAS Tables

The following question was deleted:
Did your program submit a final written plan for establishing and maintaining
capacity for cluster and outbreak detection and response according to the
guidance in Detecting and Responding to HIV Transmission Clusters: A Guide
for Health Departments by July 15, 2021?
The follow up questions on Cluster and Detection Response was deleted.
If you did not meet the standards in 1 - 3 above, please discuss each unmet
standard:
a. Why you did not meet the minimum standard for cluster detection and
response in 2021.
b. Your plan to ensure your program meets this standard in 2022.
Deleted yes/no question for whether each output report was attached.
Deleted the portion of the outcome measure table that required data entry
and instead just listed outcome measures for reference.
One table was added, “Outcome indicator summary”.
Moved to Section C. Perinatal:
Provide percentage of perinatally HIV exposed infants born in 2020 who have
HIV infection status determined by 18 months of age (Standard: 85%):
Wording of timeliness of laboratory reporting indicator was updated:

This question on summiting a final cluster and
outbreak detection and response plan is not
relevant in the 2023 SER.

This information is no longer needed to be
captured in the SER. It will be captured in the
End of Year report (EOYR), which is where
information on all other standards that were
not met is currently collected.

All the outcome measures are included in the
output reports that are submitted with the
SER, so they do not need be entered into the
form. The one indicator that was in the
outcome table that is not included in any of
the output reports (perinatal HIV exposure
reporting) was moved to Section C. Perinatal.
The language in the timeliness of laboratory
reporting indicator was updated to more
accurately reflect how the indicator is being
measured.

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SER Form
Page 6. Section F. Submission of
Required Outcome Standards with
SAS Tables

SER Form
Page 10. Section I. Security and
Confidentiality, Question 6

Of all laboratory test results entered into eHARS with a specimen collection
date during 2021 for persons with HIV infection diagnosed during 2021, at least
85% were entered into eHARS within 60 days of the specimen collection date,
assessed December 2022
Deleted the following question:
If you did not meet the Previous Negative HIV Test or Viral Suppression for
Cluster Members standard above, please discuss:
a. Why you did not meet the minimum standard in 2022.
b. Your plan to ensure your program meets the standard in 2023.
Added a ‘Not Applicable’ response option and clarified that that the question
refers to data sharing with the Medical Monitoring Project.
Did your program implement practices that support secure sharing and use of
HIV data across necessary programs within the health department, including for
collaboration with the Medical Monitoring Project (MMP) (if applicable)?

This information is no longer needed to be
captured in the SER. It will be captured in the
EOYR, which is where information on all other
standards that were not met is currently
collected.
Clarified that the question refers to data
sharing with MMP, which is only application
to sites funded for MMP, so a ‘Not applicable’
response option was added.

☐Not applicable

29