CDC Determination: IRB Approval is Not Required

Print Date: 9/14/21

Title:

National HIV Behavioral Surveillance among Transgender Women (NHBS-Trans)

Project Id:

0900f3eb81dafa47

Accession #:

NCHHSTP-BST-8/25/21-afa47

Project Contact:

Dafna Kanny

Organization:

NCHHSTP/DHAP/BCSB/BST

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

01/01/2022

Estimated Completion Date:

12/31/2026

CDC/ATSDR HRPO/IRB Protocol #:

N/A

OMB Control #:

0920-1262 Exp. 04/30/2022

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

8/30/21

Dodson_Janella R. (jhd7) CIO HSC

8/31/21

Bonds_Constance (akj8) CTR OMB/PRA Coordinator

45 CFR 46.102(l)(2)

HRPO:
Concur

ICRO:
PRA Applies

OMB Approval date: 4/24/19
OMB Expiration date: 4/30/21

9/13/21

Bass_Micah (zgi7) HRPO Reviewer

8/31/21

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

09/10/2021

Determination Start Date:

08/25/21

Description:

The purpose of this request is to amend the original project determination (PD) which was approved on 09/29/2017 before STARS
and is being entered into STARS for the first time. This project was approved by OMB (#0920-1262; exp date 4/30/2022). The
original PD received an HSR determination that the activity is surveillance and not human subject research. CDC does not require
project sites to submit NHBS-Trans to their local IRB(s) for review and approval. Nevertheless, sites must still adhere to their local
policies for human subjects protection. These policies may require sites to submit NHBS-Trans to their local IRB(s) for a research
determination or for an expedited or full review. The primary intent of NHBS-Trans is to collect data in an ongoing and systematic
manner on HIV risk behaviors, HIV testing, exposure and access to HIV prevention programs, and HIV seroprevalence and
incidence among transgender (trans) women. NHBS-Trans is a combined qualitative and quantitative project wherein project areas
conduct formative assessment activities before implementing the NHBS survey for trans women, with qualitative data collection
activities including professional and community key informant interviews, focus groups, and quantitative data collection activities
including a behavioral assessment survey and optional HIV testing made available to those who consent to the survey and testing.
NHBS-Trans conducted its first data collection cycle in 2019-20, an important public health contribution as data on trans women in
the US are limited. NHBS-Trans uses a culturally appropriate survey instrument specifically designed for capturing and assessing
the needs and HIV risk behaviors of trans women. Ongoing behavioral surveillance among trans women is needed for HIV
prevention program planning and evaluation at the national and local levels. The findings from NHBS-Trans will be used to develop
local HIV prevention programs and to evaluate existing programs and services by assessing exposure to and use of prevention
services over time, and determining gaps in provision of, access to, or use of HIV prevention services. In particular, the extent of
unrecognized HIV infection, measured through unawareness of HIV status among persons whose NHBS-Trans test result is
positive, can be used to target testing services and evaluate testing guidelines. NHBS-Trans will be conducted in up to 10
Metropolitan Statistical Areas (MSA) with high HIV prevalence.

IMS/CIO/Epi-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

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The goal of this project is to conduct ongoing bio-behavioral surveillance among trans women. This surveillance system provides
the opportunity to capitalize on experience recruiting at-risk individuals from non-healthcare community settings using scientifically
sound methodologies. Data from the bio-behavioral surveillance system will be used for HIV prevention program planning and
evaluation at the national and local levels.

Objective:

The objectives of this project are to conduct ongoing monitoring to ascertain the prevalence of and trends in HIV risk behaviors and
HIV infection among trans women at high risk for HIV infection for use in developing and directing national and local prevention
services and programs; and to evaluate the impact of HIV prevention services. Specific objectives include the following: 1) To
estimate the prevalence of HIV risk behaviors and HIV testing behaviors among trans women in MSAs with high HIV prevalence. 2)
To assess the exposure to and use of HIV prevention services among trans women. 3) To measure trends in HIV seroprevalence,
HIV incidence, and the prevalence of other sexually transmitted infections (STIs) among trans women. 4) To use the data collected
to target HIV prevention activities and evaluate HIV prevention programs locally. 5) To detect changes over time in HIV risk
behaviors among trans women. 6) To evaluate the surveillance system periodically to ensure that it is meeting its goals and to make
recommendations for improving its methods, quality, efficiency, and usefulness.

Does this project include interventions, services, or Yes
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:

Not Selected

Before starting quantitative data collection, project areas will engage in a period of formative research. Project areas will work with
ethnographers and community-based organizations in their jurisdiction to conduct formative assessment. Within the context of
NHBS-Trans, formative assessment allows project areas to gain insight into the context of HIV risk behavior within certain settings

Other:

and among sub-populations of the specific groups at risk in their community. Formative assessment activities include a review of
existing data on the population of interest specific to the MSA, qualitative data collection, garnering the support of community
stakeholders, and development of questions that measure local prevention activities.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Female ; Transgender

Tags/Keywords:

Transgender women ; HIV ; Bio-behavioral surveillance

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:

The overall strategy for NHBS-Trans is to conduct surveillance among trans women who may be at high risk for HIV acquisition or
transmission. Surveillance activities include formative assessment, a behavioral assessment survey, and HIV testing. These
surveillance activities will be conducted in MSAs with high HIV prevalence over time to provide information on trends in behaviors
and use of prevention programs. Formative Assessment (Qualitative) Project areas will work with ethnographers and communitybased organizations in their jurisdiction to conduct formative assessment. Within the context of NHBS-Trans, formative assessment
allows project areas to gain insight into the context of HIV risk behavior within certain settings and among sub-populations of the
specific groups at risk in their community. Formative assessment activities include a review of existing data on the population of
interest specific to the MSA, qualitative interviews with professional and community key informants, garnering the support of
community stakeholders, and development of questions that measure local prevention activities. Each NHBS-Trans site should
follow local requirements regarding informed consent for focus groups and key informant interviews. Three model consent forms are
provided (Appendices A, B, and C in NHBS-Trans Model Protocol_August 2021) and are only modified to meet local IRB
requirements. To protect the anonymity of those interviewed, consent to participate shall only be provided verbally by participants
and no data collection activities will be video- or audio-taped. Please refer to approved NHBS core project determination (project ID:
0900f3eb81bae32c, OMB Control # 0920-0770) for more details on formative assessment activities. Behavioral Assessment Survey
(Quantitative) Respondent-driven sampling (RDS) starts with a limited number of #seeds,# who are chosen by referrals from people
who know the local risk group well, or by staff doing outreach in areas identified through the formative assessment. These seeds
complete an interview and are then asked to recruit up to 5 people they know who also meet the eligibility criteria for the cycle.
Participants are provided an incentive for the interview and HIV testing, and for recruiting others. Recruiters and recruits are linked
using coded coupons and tracked using a coupon manager software program. After confirming eligibility and obtaining informed
consent (Appendix E_Model Consent Form Trans), participants are asked to complete an interviewer-administered survey lasting
approximately 40 minutes. Also, after eligibility and consent, participants will be asked if they wish to receive HIV testing in
conjunction with the survey, which they may refuse with no effect on participation in the survey. However, HIV testing is only
available through NHBS-Trans to persons who respond to the survey. Persons who do not consent to participate in the survey will
be directed to other HIV testing resources upon request.
The project#s target population is trans women within racial and ethnic minority populations. Eligibility for NHBS-Trans will be
limited to trans women as assessed by the #two-step# approach measure of gender identity recommended by GenIUSS Group
report: #Best Practices for Asking Questions to Identify Transgender and Other Gender Minority Respondents on Population-Based
Surveys# (http://williamsinstitute.law.ucla.edu/wp-content/uploads/geniuss-report-sep-2014.pdf). To be eligible for the NHBS-Trans
behavioral assessment survey, participants must report an assigned male sex at birth AND their gender as #woman# or
#transgender woman.# Additionally, eligibility will be limited using the standard NHBS eligibility criteria (age ?18 years, resident of
participating city, and ability to complete interview in English or Spanish). Participants will be recruited and 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 survey is administered by trained interviewers using portable computers; HIV

Collection of Info, Data or Biospecimen:

Expected Use of Findings/Results:

testing is done by trained staff. A minimum of 300 eligible persons from each site will be interviewed during NHBS-Trans. All
participants will be explicitly assured during the recruitment process of the anonymous nature of the data including the interview,
HIV testing, and any additional testing offered. All participants will provide their informed consent to take part in the interview and
HIV testing. For participants# convenience or benefit, participants may have the option to provide contact information to project staff
on a voluntary basis. Examples of participants providing contact information for convenience include but are not limited to: providing
a phone number for phone text reminders of interview 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 participants providing contact information for participant benefit include but are not limited
to: providing telephone contact information so that project staff can call participants when their HIV/additional test results are ready;
providing contact information to help participants with linkage to HIV care or other services they may need. Provision of contact
information will be optional. In all cases, participants also will be provided information and instructions for how to participate fully
without providing contact information. Please refer to approved NHBS core project determination (project ID: 0900f3eb81bae32c,
OMB Control # 0920-0770) for more details on collection of contact information.
CDC will have principal responsibility for analyzing and disseminating multi-site survey data. CDC will also have principal
responsibility for analyzing multi-site data on HIV prevalence. The CDC analyses will focus primarily on questions related to the
objectives of this project described above (Objective). To examine the key behavioral outcomes, data will be weighted when
possible to account for the complex sampling design. NHBS-Trans project areas are required to produce at least one report (fact
sheets, epidemiologic profiles, surveillance reports, peer-reviewed manuscripts or other formats as appropriate) and conduct at
least one presentation to community partners and stakeholders. Project areas are encouraged to establish Community Advisory
Boards (CABs) or other organizations to transmit project findings to the community and stakeholders within the community. CDC will
disseminate the information through: 1) DHAP surveillance reports, presentations, and publications and 2) providing assistance to
project areas for their local dissemination efforts. NHBS-Trans collaborators will disseminate findings from project activities through
presentations, reports, and publications to community, public health, and scientific partners at local and national levels.

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?

No

Is this project covered by an Assurance of
Confidentiality?

Yes

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

Budget
Amount

CDC Cooperative
Agreement

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STDS AND TB PREVENTION National HIV
Behavioral Surveillance (NHBS)

CDC-RFAPS22-2201

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
Population - Minors
Population - Prisoners
Population - Pregnant Women
Population - Emancipated Minors

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

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

0.00

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
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp. Date

Catlainn
Sionean

12/14
/2021

Cyprian
Wejnert

03/25
/2022

Dafna
Kanny

04/26
/2024

Dita Broz

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

Staff Role

Email

Phone

Organization

Program
Official

ziq9@cdc.
gov

404639-2

BEHAVIORAL SURVEILLANCE TEAM

02/07/2021

Principal
Investigator

dwy7@cdc.
gov

4046396055

BEHAVIORAL AND CLINICAL
SURVEILLANCE BRANCH

09/13/2021

Data Use
Contact

dkk3@cdc.
gov

7704885411

BEHAVIORAL SURVEILLANCE TEAM

08/11
/2023

Program
Official

iga4@cdc.
gov

4046395258

BEHAVIORAL SURVEILLANCE TEAM

Kathryn
Lee

08/10
/2023

CoInvestigator

hgi2@cdc.
gov

4046396110

BEHAVIORAL SURVEILLANCE TEAM

Teresa
Finlayson

01/03
/2023

Statistician

taj4@cdc.
gov

4046392083

BEHAVIORAL SURVEILLANCE TEAM

Data
DMP
Proposed Data Collection Start Date:

1/1/22

Proposed Data Collection End Date:

12/31/23

Proposed Public Access Level:

Restricted

CITI Good Clinical
Practice Exp. Date

Restricted Details:
Data Use Type:

Data Sharing Agreement

Data Use Type URL:

https://www.cdc.gov/hiv/statistics/systems/nhbs/index.html

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 is housed at CDC.
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-Trans data are described in the NHBS Multi-site Data Sharing Guidance document (Attached). The
purpose of this guidance is to ensure that the data collected by NHBS are used and disseminated widely and that NHBS
investigators can fairly participate in the process of publishing multi-site findings. In accordance with the Data Security and
Confidentiality Guidelines, multi-site analysis of NHBS data may only be conducted on CDC premises. This current policy limits the
ability of NHBS investigators outside of CDC to lead multi-site publications. This data sharing guidance outlines procedures for
health departments to conduct NHBS multi-site data analyses off-CDC premises utilizing NHBS restricted use datasets.

Plans for Archival and Long Term Preservation:

Spatiality
Country

State/Province

County/Region

United States

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date