CDC Determination: IRB Approval is Not Required

Print Date: 7/7/22

Title:

National HIV Behavioral Surveillance Brief HIV Biobehavioral Assessment project (NHBS-BHBA)

Project Id:

0900f3eb81f40989

Accession #:

NCHHSTP-BST-5/17/22-29c49

Project Contact:

Dafna Kanny

Organization:

NCHHSTP/DHP/BCSB/BST

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

01/01/2022

Estimated Completion Date:

12/31/2026

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

5/24/22

Dodson_Janella R. (jhd7) CIO HSC

6/1/22

Bonds_Constance (akj8) CTR OMB/PRA Coordinator

45 CFR 46.102(l)(2)

Description & Funding
Description
Priority:

Standard

Date Needed:

06/15/2022

Determination Start Date:

06/01/22

Description:

The National HIV Behavioral Surveillance system (NHBS) is a non-research surveillance system to monitor HIV prevention progress
(OMB #0920-0770, Exp. 01/31/2023). However, with efforts underway to end the HIV epidemic in the U.S., CDC#s Division of HIV
Prevention (DHP) recognized the need for additional rapid assessment data to inform local prevention efforts, especially in
geographic areas or populations which lack information on HIV risk behaviors. The National HIV Behavioral Surveillance system#s
Brief HIV Biobehavioral Assessment project (NHBS-BHBA) is designed to use mixed-methods assessments to meet this need. As
part of a new Notice of Funding Opportunity CDC-RFA-PS22-2201 to fund NHBS project areas (OMB #0920-0770, Exp. 01/31
/2023) (component 1), a new component (2) was awarded to 2 state health departments. An ICR packet has been submitted.
Funded state health departments for NHBS-BHBA will work with local entities to conduct brief bio-behavioral assessments (BHBA)
in priority populations throughout the state. Priority populations may include persons at highest risk for HIV: men who have sex with
men (MSM), persons who inject drugs (PWID), and heterosexually active persons at increased risk for HIV infection (HET), and
locally identified populations of interest (e.g., women who inject drugs and exchange sex, persons who use stimulants) or
geographic areas of interest (e.g., non-urban areas experiencing increased HIV incidence). The BHBA process includes 1)
identification of geographic areas/populations at risk, 2) formative assessment for operations, 3) brief mixed methods quantitative
and qualitative data collection and HIV testing, and 4) data analysis and dissemination, and development of grantee-developed
recommendations for state/local partners. NHBS-BHBA data may be used rapidly by public health officials and researchers to
develop specific and timely recommendations for state/local partners, respond to ongoing and emerging HIV hotspots, identify HIV
prevention and care needs, allocate prevention and treatment resources, and develop and improve prevention programs directed to
the populations of interest and their communities. Data will be shared with community partners and inform grantee-developed
recommendations for state and local public health partners.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected
The goal of this project is to conduct brief bio-behavioral surveillance using mixed-methods assessments among priority populations

Goals/Purpose

Objective:

in specified geographic areas of interest across funded states. This surveillance system provides the opportunity to fill knowledge
gaps about HIV prevention among populations in geographic areas where data are limited and capitalize on experience recruiting atrisk individuals from non-healthcare community settings using scientifically sound methodologies. Data from these brief biobehavioral surveillance using mixed-methods assessments will be used for HIV prevention program planning and evaluation at the
state and local levels.
The objectives of NHBS-BHBA are to conduct ongoing monitoring to assess prevention and risk behaviors and HIV-associated
health outcomes in populations at high-risk for HIV, especially in geographic areas and populations where behavioral data are
limited. These data are critical for tracking the epidemic, planning effective responses, and monitoring and evaluating those
responses. The specific objectives are as follows: 1) Identify geographic areas with populations at increased risk of HIV infection. 2)
Assess the size of populations at risk for HIV infection. 3) Assess the prevalence of HIV infection. 4) Assess the prevalence of STI
infection or viral hepatitis (where appropriate, if funding is available). 5) Assess the prevalence of risk behaviors and social
determinants of health that increase the risk of HIV acquisition and transmission, including sexual risk behaviors and drug-use risk
behaviors. 6) Describe utilization of HIV testing, linkage to care, and antiretroviral therapy. 7) Assess the access to and use of
prevention services, including SSPs and PrEP. 8) Identify gaps in prevention services and missed opportunities for prevention
interventions.

Does this project include interventions, services, or No
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Not Selected

Measuring Disparities:

Yes

Studying Social Determinants of Health (SDOH):

Yes

SDOH Economic Stability:

Yes

SDOH Education:

Yes

SDOH Health Care Access:

Yes

SDOH Neighborhood and Environment:

Yes

SDOH Social and Community Context:

Yes

SDOH Indices:

Not Selected

Other SDOH Topics:

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research and
Practice:

Yes

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other - Adults at high-risk for HIV in identified priority populations in specified geographic areas within

Tags/Keywords:

HIV ; bio-behavioral surveillance ; rapid assessments ; quantitative ; Qualitative Research ; mixed methods

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided

Method Categories:

Focus Group; Individual Interviews (Qualitative); Prevalence (Cross-sectional) Surveys; Other - HIV Testing/collection of biospecimens

Methods:

NHBS-BHBAs are brief mixed-methods bio-behavioral HIV assessments conducted in priority populations in specified geographic
areas of interest (BHBA populations). The process includes 1) identification of geographic areas/populations at risk, 2) formative
assessment for operations, 3) quantitative and qualitative data collection and HIV testing, and 4) data analysis and dissemination.
State needs assessment activities include examining a comprehensive list of existing data sources to assess HIV prevention
priorities and develop a process to prioritize at least two populations to conduct BHBAs for each year of data collection. Project staff
will also establish community partnerships to support the project at the state and local levels. Project areas will conduct formative
assessment for each BHBA to identify appropriate recruitment methods and develop operational procedures in the project area.
Project areas will also garner the support of the local community and identify questions of local interest for HIV prevention.
Formative assessment will precede data collection. NHBS-BHBAs will be conducted through mixed-methods quantitative and
qualitative data collection. Project areas will implement recruitment strategies that may include venue based, time-space sampling
(VBS), respondent-driven sampling (RDS), and other CDC-approved methods to recruit populations at high-risk for HIV infection.
Project areas will conduct brief standardized quantitative interviews with eligible participants to meet the target sample size (n=500)
total participants from at least two BHBAs per year in funding years 2-5. Project areas will offer usually anonymous HIV blood-based
rapid testing and supplemental testing to those who participate in quantitative interviews to assess HIV seroprevalence. HIV
screening results will be made available to participants, and those with preliminary positive test results will be linked to HIV care.
Pending funding availability, HIV testing may include the collection of dried blood spot specimens for long term storage to conduct
additional testing, e.g., testing for recent HIV infection, HIV viral load, presence of antiretroviral drugs or pre-exposure prophylaxis,
or drug resistance. Other biological specimens may be collected and tested (e.g., viral hepatitis, sexually transmitted infections
(STI)) when funds are available. NHBS-BHBA rapid qualitative data collection include at least two forms of primary data collections,
including observations, key informant interviews with community members and professionals familiar with the population, focus
groups and other activities to interpret standardized quantitative findings and inform grantee-developed recommendations for state
/local public health partners. Small stipends or vouchers will be given to those interviewed and tested for HIV (approximately $25 for
each). In cycles using RDS, additional incentives (approximately $10) are paid to those who successfully recruit others. Funded
states will analyze and triangulate BHBA data to identify emerging key themes and recommendations and share preliminary findings
with their core and local advisory group comprised of community organizations and institutions that serve populations at high-risk of
HIV infection. They will develop a summary report for each BHBA with integrated findings from quantitative and qualitative data and
recommendations for state/local partners to inform HIV treatment and prevention.
Participants will be administered an eligibility screener; those who are eligible and give consent will be interviewed about sex and
drug use behaviors and their past HIV testing experiences using a standard questionnaire. The quantitative survey is administered
by trained interviewers using computers; HIV testing is done by trained staff. Other tests (e.g., new HIV testing technologies,
biological testing for STIs or hepatitis) may be performed in states that are funded to perform these activities. All participants will
provide their informed consent to take part in the interview, HIV testing, and any additional testing. 500 eligible persons from each
NHBS-BHBA funded state will be interviewed each year. The qualitative survey is administered by trained interviewers and a
minimum of 20 participants per BHBA population is expected. All participants will be informed during the recruitment process of the
anonymous nature of the data including the interview, HIV testing, and any additional testing offered. For participants# convenience
or benefit, participants may have the option to provide contact information to project staff on a voluntary basis. Examples of
participant convenience include but are not limited to: providing a phone number for phone text reminders of appointments;
providing payment information so incentives can be provided electronically; providing an email address to facilitate video conference
interviews; or providing an address to receive self-collection or self-testing kits via mail. Examples of participant benefit include but
are not limited to: providing a phone number so that project staff can call participants when their HIV/additional test results are

Collection of Info, Data or Biospecimen:

Expected Use of Findings/Results and their impact:

ready; providing contact information to help participants with linkage to HIV care or other services they may need. In all cases,
participants will be provided information and instructions for how to participate without providing contact information. This
surveillance activity is funded through cooperative agreements with participating health departments. All data will be collected
locally by grantees. No contact information will be sent to CDC. Project areas will keep contact information separately from all
NHBS-BHBA data and destroy contact information immediately upon completion of its intended use. Contact information will be
stored securely in a separate document from any NHBS-BHBA test result data, paper or electronic. In most cases, contact
information will not be linkable to any NHBS-BHBA data. In rare circumstance, contact information may need to be indirectly linkable
to limited NHBS-BHBA data, for example NHBS-BHBA project area staff cannot return test results by phone without both a phone
number and test result. A generated survey ID number will be used to link test results data or test kits for the purpose of returning
test results to participants or contacting participants to ensure a test kit is completed and returned. Consent forms, questionnaires,
lab forms, and other NHBS-BHBA data collection forms will be maintained in confidential secure environments and any hard copies
stored in locked filing cabinets. Only authorized persons will have access to NHBS-BHBA files. Audio recordings of qualitative
interviews and focus groups will be kept in a secure location that only authorized project staff can access and will be destroyed once
the information is transcribed and checked. Audio files will not be submitted to CDC.
Dissemination of findings is critical to the success of the project and funded states should use the data to inform and improve local
program efforts. Both quantitative and qualitative data should be analyzed, and findings, along with grantee-developed
recommendations, should be disseminated to local partners with the support of the core and local advisory groups. Funded states
will create a dissemination plan for each BHBA, including at least one data product or report and at least one presentation to
community partners. Funded states will have principal responsibility for analyzing their local quantitative and qualitative data and
developing tailored recommendations. NHBS-BHBA project areas and CDC may collaborate on articles and reports when
appropriate. Funded states will contribute to national reporting of data collection outcomes such as surveillance reports and other
publications by reviewing analysis notifications, concept proposals, table shells and manuscript drafts within specified timelines and
participating in discussions during monthly conference calls and annual meetings. CDC may disseminate reports, e.g., CDC HIV
Surveillance Special Reports and other CDC reports, the Morbidity and Mortality Weekly Report (MMWR), and peer-reviewed
journals. CDC may also present results at national conferences and meetings.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

Yes

Does CDC have access to the identifiers (including
coded data)?:

No

Is this project covered by an Assurance of
Confidentiality?

Yes

Assurances of Confidentiality associated with this
project:

NCHHSTP - AIDS and HIV Surveillance

Does this activity meet the criteria for a Certificate
of Confidentiality (CoC)?

No

Is there a formal written agreement prohibiting the
release of identifiers?

Yes, see supporting info

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

CDC Cooperative Agreement

National HIV Behavioral Surveillance (NHBS)

PS22-2201

2022

5

HSC Review

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Budget Amount

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Name

FWA #

FWA Exp Date

IRB Title

IRB Exp Date

Florida Department of Health

Funding #
PS22-2201

Massachusetts Department of Public Health

FWA00000786

03/04/25

PS22-2201

Staff
Staff Member

SIQT
Exp. Date

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Statistician

404-6391956

BEHAVIORAL SURVEILLANCE TEAM

Amy Baugher

12/27
/2024

Catlainn Sionean

09/20
/2024

Program
Official

404-6392

BEHAVIORAL SURVEILLANCE TEAM

Christine Agnew
Brune

06/05
/2023

Project
Officer

404-7185478

BEHAVIORAL SURVEILLANCE TEAM

Cyprian Wejnert

02/22
/2025

Program
Lead

404-6396055

BEHAVIORAL AND CLINICAL
SURVEILLANCE BRANCH

Dita Broz

08/11
/2023

Program
Official

404-6395258

BEHAVIORAL SURVEILLANCE TEAM

Ebony Symone
Townsend

01/12
/2024

Project
Officer

404-4984180

BEHAVIORAL SURVEILLANCE TEAM

12/07

Project

404-718-

09/06/2021

02/07/2021

Elana Morris

/2024

Officer

8193

BEHAVIORAL SURVEILLANCE TEAM

Janet Burnett

06/08
/2023

Project
Officer

404-6390086

BEHAVIORAL SURVEILLANCE TEAM

Jeffery Todd

02/28
/2023

Project
Officer

404-7185389

BEHAVIORAL SURVEILLANCE TEAM

Johanna ChapinBardales

08/04
/2023

Statistician

404-7185879

BEHAVIORAL SURVEILLANCE TEAM

Kathryn Lee

08/10
/2023

Program
Official

404-6396110

BEHAVIORAL SURVEILLANCE TEAM

Lyssa Faucher

06/08
/2024

Project
Officer

404-7182086

BEHAVIORAL SURVEILLANCE TEAM

Paul Denning

08/11
/2023

Project
Officer

404-6393

BEHAVIORAL SURVEILLANCE TEAM

Rashunda Lewis

03/20
/2023

Program
Official

404-6392981

BEHAVIORAL SURVEILLANCE TEAM

Susan Cha

12/30
/2024

Project
Officer

404-7185486

BEHAVIORAL SURVEILLANCE TEAM

Taylor Robbins

06/14
/2023

Project
Officer

404-6390016

BEHAVIORAL SURVEILLANCE TEAM

Teresa Finlayson

01/03
/2023

Program
Official

404-6392083

BEHAVIORAL SURVEILLANCE TEAM

12/18/2018

08/16/2019

Data
DMP
Proposed Data Collection Start Date:

1/1/23

Proposed Data Collection End Date:

12/31/26

Proposed Public Access Level:

Restricted

Restricted Details:

Data Sharing Agreement

Data Use Type:
Data Use Type URL:
Data Use Contact:

[email protected]

Public Access Justification:

As a component of HIV/AIDS surveillance, NHBS data are protected by the Assurance of Confidentiality (Section 308(d) of the
Public Health Service Act, 42 U.S.C. 242 m(d)). This assurance prohibits the disclosure of any information that could be used to
directly or indirectly identify individuals. HIV and hepatitis surveillance data require additional protection. Therefore, data collection,
management and analysis for this project will be conducted in compliance with the Centers for Disease Control and Prevention#s
Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs:
Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action available at http://www.cdc.gov/nchhstp
/programintegration/docs/PCSIDataSecurityGuidelines.pdf

How Access Will Be Provided for Data:

Processes for accessing NHBS data are described in the NHBS Multi-site Data Sharing Guidance document (Attached).

Plans for Archival and Long Term Preservation:

Spatiality
Country

State/Province

United States

Massachusetts

United States

Florida

County/Region

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Current

Kanny_Dafna
(dkk3)
Project Contact

05/17/2022

NHSS Assurance packet, including
a non-disclosure agreement and
an agreement to abide by
restrictions of data release

Non Disclosure Agreement

NHSS_FTE-Packet_FinJuly2020-508_compliant.pdf

Current

Kanny_Dafna
(dkk3)
Project Contact

05/17/2022

NCHHSTP_PRA Determination
Form BHBA

Paperwork Reduction Act Form

NCHHSTP_PRA Determination Form BHBA_final.doc

Current

Kanny_Dafna
(dkk3)
Project Contact

05/17/2022

Model Qualitative FG Consent
Form

Consent Form

Appendix G Model Qualitative FG Consent Form-final.
docx

Current

Kanny_Dafna
(dkk3)
Project Contact

05/17/2022

Model Qualitative PKI Consent
Form

Consent Form

Appendix E Model Qualitative PKI Consent Form-final.
docx

Current

Kanny_Dafna
(dkk3)
Project Contact

05/17/2022

NHBS-BHBA Protocol

Protocol

Protocol_Full_20220517_STARS submit.docx

Current

Kanny_Dafna
(dkk3)
Project Contact

05/17/2022

Model Survey Consent Form

Consent Form

Appendix I Model Survey Consent Form-final.docx

Current

Kanny_Dafna
(dkk3)
Project Contact

05/17/2022

Model Qualitative CKI Consent
Form

Consent Form

Appendix F Model Qualitative CKI Consent Form-final.
docx

Current

Kanny_Dafna
(dkk3)
Project Contact

05/17/2022

NHBS Multi-site Data Sharing
Guidance

Data Use Agreement

NHBS Multi-site Data Sharing Guidance 04122022.pdf