Summary of Changes in this Revision

National HIV Surveillance System (NHSS)

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

Summary of Proposed Changes in the ICR 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 to accommodate activities under our new funding
announcement PS18-1802: Integrated HIV Surveillance and Prevention Programs for Health Departments. The
changes requested for this ICR include minor modifications to currently collected data elements and forms
(including the Adult Case Report Form (ACRF) and the Pediatric Case Report Form (PCRF)), modifications to
data system variables used to summarize geocoded address data collected as part of the geocoding activities,
addition of a new cluster report form for health departments to report on progress for HIV cluster
investigations and addition of investigation reporting and evaluation activities required under PS18-1802 (e.g.,
data-to-care not in care investigations of persons identified to be not-in-care and cluster investigations). No
changes are being requested to data elements collected on the Perinatal HIV Exposure Reporting (PHER) form,
but the number of jurisdictions (respondents) completing the form has changed. Requested changes for forms
and data elements have been developed with input of state and local HIV surveillance coordinators and the
CSTE HIV subcommittee, are non-substantive and are intended to improve usability and data collection and
create efficiencies for conducting and evaluating surveillance program activities. Finally, we have updated our
burden calculations to more accurately reflect current data collection practices (e.g., adjusting the average
burden per response for electronic laboratory updates and including a separate line item for deduplication
activities previously included with case report evaluations and including new cumulative deduplication
activities) and incorporated those changes into our burden estimates.
A detailed description of changes are outlined below. The specific changes to the ACRF and PCRF are
summarized below and 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). The PHER form, with no proposed changes, is included in
Attachment 3(d). In addition, minor modifications to existing data systems variables and two new data systems
variables that may be used by health departments for geocoding activities are described in Table 2. The
changes in estimated burden hours are described below and revised burden provided in table 12.A
Changes to the ACRF and PCRF
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. The Patient
Identification sections of the ACRF and PCRF have been revised to include two additional response options for
the “Address Type” field (“Military” and “Other”). This was done to meet the needs of the geocoding activities
required under cooperative agreement PS18-1802: Integrated HIV Surveillance and Prevention Programs for
Health Departments. In the Residence at Diagnosis sections of the ACRF and PCRF, the field labeled “Address
Type” was updated to “Address Event Type” to better reflect that the response options for this field indicate
the event associated with the address (e.g., residence at HIV diagnosis); the response options were not
changed. In the Residence at Diagnosis sections of the ACRF and PCRF, a new field labeled “Address Type” was
added. The response options for “Address Type” in the Residence at Diagnosis sections align with the “Address
Type” options collected in the Patient Identification sections of the ACRF and PCRF. These changes were also
made to meet geocoding activity requirements.
Finally, a modification was made to the instruction provided under the Documentation of Tests heading in the
Laboratory Data sections of the ACRF and PCRF. The wording of the instruction was updated to clarify when
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the field “Did documented laboratory test results meet approved HIV diagnostic algorithm criteria?” needs to
be completed.
Technical guidance documents including instructions for completing the forms have been revised to align with
the changes in the case report forms. Both Attachment 4(a) Technical Guidance for HIV Surveillance Programs Adult HIV confidential Case Report form and Attachment 4(b) Technical Guidance for HIV Surveillance
Programs- Pediatric HIV Confidential Case Report Form and Perinatal HIV Exposure Reporting Form will replace
Attachments 4(a) and 4(b) in our ICR.
Changes to the PCRF Only
A revised PCRF is provided in Attachment 3(b) Y and changes to the form are outlined in Table 1. Within the
Birth History section of the PCRF, a new field labeled “Address Type” was added. The response options for
“Address Type” in the Birth History section aligns with the “Address Type” options collected in the Patient
Identification sections of the ACRF and PCRF. This update was made to be consistent with how other address
information on the form is collected. The designation of the address variables collected in the Birth History
section (Street Address, City, County, State/Country, and Zip Code) was changed from optional (i.e., variables
that programs may or may not choose to collect) to required (i.e., variables that must be collected by all
programs) to align with the designations already in place for collecting address variables in other sections of
the form.
An editorial change was made within the second footnote at the bottom of page 1 of the PCRF to remove the
comma after the word “maintained.” This update was made to align with the formatting of the same footnote
that is present on page 4 of the ACRF. In the Treatment/Services Referrals section, the formatting for the label
for “This child’s primary caretaker is” was modified to have the entire label on a single line rather than
spanning two lines.
Table 1. Proposed Modifications to the Adult HIV Confidential Case Report Form (ACRF) and Pediatric HIV
Confidential Case Report Form (PCRF)
Page, Section, Variable

Change Proposed

Reason for Change Proposed

ACRF and PCRF
Page 1, Section: Patient
Identification, Variable:
Address Type

Added two additional response options:
“Military” and “Other.”

To meet the needs of the geocoding
activities required under the
cooperative agreement PS18-1802:
Integrated HIV Surveillance and
Prevention Programs for Health
Departments.
To better reflect that the response
options for this field indicate the
event associated with the address
(e.g., residence at HIV diagnosis).

Page 1, Section: Residence
at Diagnosis, Variable:
Address Type (previous
label)/Address Event Type
(new label)
Page 1, Section: Residence
at Diagnosis, Variable:
New (Address Type)

Updated the label from “Address Type” to
“Address Event Type.” No changes were
made to the existing response options.
Added a new field labeled “Address Type.”
The response options aligned with the
response options for “Address Type” in the
Patient Identification section.
Page 2

To meet the needs of the geocoding
activities required under cooperative
agreement PS18-1802: Integrated HIV

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Surveillance and Prevention Programs
for Health Departments.
Page 3, Section:
Laboratory Data, Variable:
N/A

PCRF only
Page 1, Section: Second
footnote, Variable: N/A

Page 4, Section: Birth
History, Variable: Address
Type (new label)

Modified the instruction provided under the
Documentation of Tests heading. Changed
from "Complete the above only if none of the
following was positive: HIV-1 Western blot,
IFA, culture, viral load, or qualitative NAAT
[RNA or DNA] " to " 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 sequence."

To clarify when the field “Did
documented laboratory test results
meet approved HIV diagnostic
algorithm criteria?” needs to be
completed.

Removed the comma after the word
“maintained” in the second footnote at the
bottom of page 1.

To make the formatting consistent
with the same footnote that is present
on page 4 of the ACRF.

Added a new field labeled “Address Type.”
The response options aligned with the
response options for “Address Type” in the
Patient Identification sections of the ACRF
and PCRF.
Updated the formatting of the label to have
the entire label on a single line rather than
spanning two lines.

To be consistent with how other
address information on the form is
collected.

Page 4, Section:
To make the label easier to read and
Treatment/Services
to be consistent with the formatting
Referrals, Variable: This
used for other labels in this section of
child’s primary caretaker
the form.
is
Footnote. The revised Adult HIV Confidential Case Report Form (ACRF) is provided in Attachment 3(a) and the
revised Pediatric HIV Confidential Case Report Form (PCRF) is provided in Attachment 3(b)
Additional Data System Variables for Geocoding Activities
The Centers for Disease Control and Prevention (CDC) is committed to reducing health disparities and
promoting health equity and has adopted the social determinants of health (SDH) conceptual framework to
determine priorities and focus intervention efforts. Recognizing gaps in data regarding SDH and HIV, health
departments have incorporated geocoding of HIV surveillance data into routine surveillance practice and
analyze and display geocoded HIV surveillance data along with SDH indicators that may affect HIV
transmission. Although many jurisdictions have been conducting routine geocoding and data linkage (GDL) as
an optional activity and reporting those data to CDC, all funded HIV surveillance programs will be incorporating
GDL into routine surveillance activities as part of the new cooperative agreement PS18-1802.
We are proposing modifications of an existing currently OMB approved data system variable and the addition
of two new data system variables that may be used by health departments for GDL. Relevant changes are also
captured on the paper-based case report forms as described in the section above. However, since GDL
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activities occur after case reporting it is not necessary to include some of the information on the case report
forms. Inclusion of the following variables in eHARS in 2020 will allow information associated with GDL to be
collected in the HIV surveillance system (i.e. the enhanced HIV/AIDS Reporting System (eHARS)). We anticipate
that these changes will create efficiencies in management of geocoded data. Because address data already
being collected is used for geocoding activities, we do not anticipate a change in burden associated with these
variables.
The proposed variables for GDL are described in Table 2. The new variables addr_type_orig_cd and
geographic_level will be designated as required variables for collection.
Table 2. Proposed Variables for GDL
Variable Name
address_type_cd

addr_type_orig_cd

Description
Existing address type variable in
eHARS. Includes categories that
represent the address event type.
Will be modified to include two new
response options for “Military” and
“Other.”

Valid Values
BAD - Bad address
COR - Correctional facility
CUR - Current
FOS - Foster home
HML - Homeless
POS - Postal
RAD - Residence at death
RBI - Residence at birth
Also collected on the paper-based
RES - Residential
forms.
RHE - Residence at perinatal
exposure
RSR - Residence at pediatric
seroreversion
RSA - Residence at diagnosis of
stage 3 HIV infection (AIDS)
RSH - Residence at diagnosis of
HIV infection
SHL - Shelter
TMP - Temporary
To be determined - Military
To be determined - Other
Additional field for address type
BAD - Bad address
information when the
COR - Correctional facility
address_type_cd captures an
FOS - Foster home
address event type (i.e., current,
HML - Homeless
residence at death, residence at
POS - Postal
birth, residence at perinatal
RES - Residential
exposure, residence at pediatric
SHL - Shelter
seroreversion, residence at diagnosis TMP - Temporary
of stage 3 HIV infection (AIDS), and
To be determined - Military
residence at diagnosis of HIV
To be determined - Other
infection)
Also collected on the paper-based
forms.

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geographic_level

Geographic level to which the
address was geocoded.

1=Census tract
2=Zip code
3=County
4=Insufficient

Additional Estimated Burden Investigation Reporting and Evaluation
In 2017, additional variables were requested and approved for monitoring and evaluation of data-to-care not
in care investigations of persons identified to be not-in-care and cluster investigations and subsequently added
to eHARS.
Health departments are now using the absence of reported test results to HIV surveillance programs to
identify persons who may be not in care and may be in need of HIV medical care or other services and link
those individuals to needed services. This revision includes additional estimated burden for health
departments reporting of monitoring and evaluation variables for surveillance initiated investigations of
persons identified as not-in-care and interventions to link them to care. We anticipate that information will
primarily be imported electronically from other data systems used to manage these activities in the health
departments. More information on the Data to Care strategy of using HIV surveillance to facilitate linkage to
care can be found at
https://effectiveinterventions.cdc.gov/en/HighImpactPrevention/PublicHealthStrategies/DatatoCare.aspx.
The surveillance data collected through NHSS are used to monitor and characterize trends in HIV to guide
public health action at the federal, state, and local levels, to identify growing HIV clusters, and to identify
people for engagement in care efforts to improve health outcomes and prevent transmission. HIV sequence
data that are generated from drug resistance testing performed as part of routine HIV medical care are
routinely reported to health departments. Using methodology developed by CDC, HIV genetic sequence data
can be analyzed to identify clusters of recent and rapid transmission, and ultimately guide the implementation
of prevention efforts. In addition to using genetic sequence data, transmission clusters can be identified
through analysis of HIV surveillance data (e.g., time-space clusters represent an increase in the number of
diagnoses of HIV infection in a particular geographic area above levels expected given previous patterns),
notification by partner services staff, or notification by astute clinical providers or frontline staff at health
departments. We are including burden for reporting and monitoring of cluster investigations; using the
variables in 2019 will allow results of transmission cluster analyses to be documented for cases in eHARS. We
anticipate that these variables will create efficiencies in management of transmission cluster investigations and
will be electronically importable from other systems that may be used by health departments. We have
included burden reporting for the estimated subset of persons identified and investigated as part of
transmission clusters identified. The additional estimated burden for both cluster investigations and data to
care investigations are included in the burden table below under Investigation Reporting and Evaluation.
Cluster Report Form
Clusters of HIV are groups of persons related by recent, rapid transmission, for which rapid response is needed
in order to intervene to interrupt ongoing transmission and prevent future HIV infections. Health departments
may detect clusters through multiple means, including through routine analyses of data reported to the
National HIV Surveillance System. It is necessary and important for CDC to collect this information to monitor
cluster detection and response activities that are required of all 59 jurisdictions funded under PS18 1802.

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These data will be collected through quarterly cluster report forms that will be completed by jurisdictions for
clusters that they have identified and for which they are actively conducting response activities. The ‘initial
cluster report form’ will be completed in the quarter a cluster is first identified. This form includes questions
about the means of cluster detection, data reviewed to assess the cluster, the size of the cluster and outcomes
of routine public health investigations (‘partner services’), key findings about the cluster from existing data
review, and the jurisdiction’s assessment of their level of concern for the cluster. The ‘cluster follow up form’
will be completed each quarter in which the cluster response remains active. This form includes questions
about the current cluster size, outcomes of HIV testing conducted in response to the cluster, and the
jurisdiction’s updated assessment of their current level of concern for the cluster. The ‘cluster close-out form’
will be completed when cluster response activities are closed, or at annual intervals while cluster response
remains active. This form includes questions on summary outcome measures of response activities, including
HIV testing conducted in response to the cluster, PrEP referral, and linkage-to-care efforts. It includes
additional questions on activities conducted in response to the cluster, and key findings and impacts of the
response.
Changes in the Standards Evaluation Report (SER)
The Standards Evaluation Report (SER) is used by CDC and Health Departments to improve data quality,
interpretation, usefulness, and surveillance system efficiency, as well as to monitor progress toward meeting
surveillance program objectives. The information collected for the SER includes a brief set of questions about
evaluation outcomes and the collection of laboratory data that will be reported one time a year by each 59
health departments. A revised Standards Evaluation Report (SER) is provided in Attachment 3(e) and changes
from the last version are outlined in Table 3. Changes are related to the transition from cooperative
agreement PS13-1302 to cooperative agreement PS18-1802, automation of processes and outcome measures
that were previously captured manually, and the addition of outcome measures that were not available for
Year 1 due to data collection limitations. The proposed form will be provided to jurisdictions in January 2020
to report their 2018 outcomes, and each January thereafter for the following three years. It is anticipated that
the burden to complete the new proposed SER will not change.

Table 3. Summary of Changes to the Standards Evaluation Report (SER)
Currently
approved SER
Form
Page 3, Section
C. Pediatric/
Perinatal

Proposed SER
Form

Changed Proposed

Page 3, Section
C. Pediatric/
Perinatal

Added outcome measure
“Perinatal HIV Exposure
Reporting”.

Page 4, Section
E, Submission of
Required SAS
Outcome Tables

Page 3, Section
D, Geocoding
and Data
Linkage
Page 4, Section
F, Submission of
Required SAS
Outcome Tables

Page 4, Section
E, Table below

Page 5, Section
F, Table below

Added one question with a Yes/No
checkbox to determine if
geocoded data was sent to CDC
per our joint MOU.
Rows with Yes/No checkboxes
indicating whether SAS outcome
tables were attached were added
in lines 4, 9, and 10, reading
“Cumulative Interstate Duplicate
Review”, “Geocoding”, and “Viral
suppression for cluster members”.
Rows with “Measure”, “Standard”
and “Result” were added in lines

NA

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Reason for Change Proposed
Re-alignment with the
requirements of the new
cooperative agreement PS181802.
CDC is not able to view
geocoded data by the time the
SER is due so the question is
asked of the jurisdiction.
Re-alignment with the
requirements of the new
cooperative agreement PS181802.

Re-alignment with the
requirements of the new
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the Yes/No
checkboxes

the Yes/No
checkboxes

4, 13, and 15, reading “Cumulative
Interstate Duplicate Review”,
“Geocoding”, and “Viral
suppression for cluster members”.

NA

Page 6, Section
Section G is new.
G, Submission of
Required
Outcome
Standards
without SAS
Tables

cooperative agreement PS181802. These tables run
automatically with CDC
developed software thus
jurisdiction burden is not
impacted.
Re-alignment with the
requirements of the new
cooperative agreement PS181802.

Changes in Estimates of Annualized Burden Hours
We estimate an overall increase in total estimated annualized burden hours for this ICR from 48,026 to 58,131
hours resulting primarily from changes in program activities and refinements made to our burden calculations.
This increase is largely due to addition of new surveillance activities that are required to be carried out by
grantees under cooperative agreement PS18-1802: Integrated HIV Surveillance and Prevention Programs for
Health Departments. Specifically, we have included burden for Investigation Reporting and Evaluation for data
to care and cluster investigations. We have also added burden for reporting of a cluster report form to monitor
cluster detection and response activities. We also have revised our burden estimate calculations to better
estimate the number of electronic laboratory updates resulting in an increased number of responses and
reducing time per response to account for improvements in electronic laboratory reporting capacity and
computing power and increased efficiencies of established data systems. We have also separated out
deduplication activities from case report evaluations to accommodate both Routine Interstate Deduplication
Review (RIDR) activities and new Cumulative Interstate Deduplication Review (CIDR), adjusting the time per
response to 10 minutes based on feedback from health departments on time for completion of these activities.
In addition to these additional data collection activities that increase burden, there are some activities that
have been discontinued or changed resulting in reductions in burden. The number of health departments
collecting information on the Perinatal HIV Exposure Report (PHER) form was reduced from 35 to 16 to reflect
the 16 areas required to report under the new NOFO reducing burden hour for this activity. HIV incidence
surveillance has been discontinued as a separate activity and incidence is now being estimated via statistical
methods (i.e., incidence estimation using a CD4 Depletion model) by CDC, lifting the burden off the grantees.
Finally, Molecular HIV Surveillance has been incorporated into routine surveillance activities and the burden is
now reflected under laboratory updates and other case report updates for reporting of the genotype sequence
and testing history information. The revised estimate of burden hours is provided in table 12.A.

Exhibit 12.A Estimate of Annualized Burden Hours.

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Form Name

Adult HIV Case
Report(att
3a,3c,4a)
Pediatric HIV
Case Report
(att 3b,3c,4b)
Case Report
Evaluations
(att 3a,3b,3c)
Case Report
Updates (att
3a,3b,3c,4a,4b)
Laboratory
Updates (att
3a,3b,3c,4a,4b)
Deduplication
Activities (att
4c)
Investigation
Reporting and
Evaluation (att
3c,4d,4e)
Initial Cluster
Report Form
(att 3f,4f)
Cluster Followup Form (att
3g,4f)
Cluster Closeout Form (att
3h, 4e)
Perinatal HIV
Exposure
Reporting
(PHER) (att
3c,3d,4b)
Annual
Reporting:
Standards
Evaluation
Report
(SER)(att 3e)

Avg.
Total
No. of
Burden
Total No.
Annual
Responses
per
No. of
of Annual
Burden
Respondents
per
Response
Responses
(in
Respondent
(in
hours)
hours)
59

854

50,386

20/60

16,795

59

3

177

20/60

59

59

86

5,074

20/60

1,691

59

2353

138,827

2/60

4,628

59

9410

555,190

0.5/60

4,627

59

2741

161,719

10/60

26,953

59

901

53,159

1/60

886

59

2.5

148

1

148

59

5

295

30/60

148

59

2.5

148

1

148

16

197

3,152

30/60

1,576

59

1

59

8

472

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58,131

Total Burden

Note: The estimates of total annualized burden hours are based on the estimated total number of case
reports (i.e., Total No. Annual Responses) expected to be completed by state and local health
departments each year (see narrative for description).

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