Assessing the PrEP Care Cascade Among Black Men and Transwomen in the Southeastern US

March 19, 2023 updated by: Lisa Eaton, University of Connecticut

PrEP Connected Study

The proposed research aims to assess the multiple forms and paths of stigma and substance use as they relate to pre-exposure prophylaxis (PrEP) use for HIV prevention. How stigma and an evolving public health landscape impact PrEP use among Black sexual minorit men who use substances is unknown. The current application focuses on addressing critical and novel questions to improving the essential building blocks of biomedical prevention approaches by providing crucial information for enhancing interventions to lower HIV prevalence among substance using Black sexual minority men.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

HIV incidence among Black men who have sex with men (BMSM) in the southeastern United States is one of the highest in the world. Our research team has conducted studies with BMSM in Atlanta that have demonstrated 35% HIV prevalence and over 5% annual HIV incidence. Although PrEP is highly effective for preventing HIV transmission, it is not reaching BMSM. The failures in our ability to engage BMSM in PrEP use are highly problematic given the alarming rates of HIV transmission among this group. Of particular concern is the impact of substance use as a barrier in PrEP linkage, uptake, adherence, and persistence. Substance use is common among BMSM in our study, with 43% (n=204/474) reporting recent substance use. Further complicating PrEP use is the potential impact of COVID-19 on health care access, health care infrastructure, and sex behavior. The need to better understand PrEP use in the context of our new health care landscape is critical to making advances in PrEP use. At this point, assessing how substance use impacts PrEP use is challenging because PrEP implementation is so low among this group. The current study aims to provide substance using BMSM with evidence-based PrEP engagement counseling to address barriers to accessing PrEP (not for intervention testing, but for facilitating PrEP use) and to assess the multiple forms and paths of stigma and substance use as they relate to PrEP linkage, uptake, adherence, and persistence. The investigators propose using the HIV Stigma Framework as a conceptual model for investigating the intersecting pathways of stigma drivers and stigma mechanisms as they relate to PrEP use among substance using BMSM. Aim 1: Enroll a prospective cohort of N=500 BMSM who test HIV negative and test substance use positive on toxicology testing, and provide evidence-based PrEP engagement counseling to facilitate access to PrEP care. Aim 2: Conduct psychosocial and health care access assessments every 2-months for 18-months, and conduct HIV/STI testing and dried blood spot testing for TFV-DP every 3-months for 18-months. Aim 3: Using data collected from Aims 1 and 2, model stigma pathways of advancing and reverting along the PrEP cascade (i.e., linkage, uptake, adherence, persistence), with these pathways mediated by health care access and moderated by substance use. Achieving the aims will provide critical insight for translating and adapting interventions to enhance potency and durability for individuals at exceedingly elevated risk for HIV.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men (based on male sex assignment at birth)
  • Age 18 or older
  • Identify as Black, African-American, Afro-Brazilian, Afro-Carribean, or African diaspora,
  • Report condomless anal sex with man in past six months
  • Test HIV negative
  • Report recent (<3 months) substance use
  • Positive drug toxicology for substance use

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Stigma Counseling for PrEP Access
Behavioral counseling
Behavioral: Stigma counseling for PrEP use
This counseling consists of a single-session (45 minute) delivered by trained peer counselors. The primary aims and relevant content areas for counseling are: (1) Assessing and discussing factors known to be drivers of emotional barriers to accessing health care. This counseling aim has two main sub-components: (a) participants will be asked about their prior experiences with accessing health care and their concerns regarding future access, and (b) the counseling will focus on creating personal agency around needing to prioritize one's health. (2) Evaluating concerns around discussing PrEP with health care providers. The counseling combines motivational interviewing with medical decisional balance, which focuses on points to consider when evaluating PrEP. (3) Promoting resiliency beliefs and positive adaptation. For this objective the counselor works with the participant to establish PrEP use goals and problem-solving strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP Use
Time Frame: 12 months
TFV-DP (Tenofovir Diphosphate) biological testing for PrEP pill taking will be assessed. TFV-DP measured at >700 fmol will be interpreted as having taken ≥4 doses/week, and TFV-DP measured at >700 fmol over two consecutive time points will be interpreted as persistence to taking PrEP. The lower scale limit is 0 and upper scale limit is approximately around 2500. Higher values indicate greater medication adherence to PrEP pills.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP stigma
Time Frame: 12 months
Questionnaire to assess stigma related psychosocial variables will be used to assess secondary outcomes. This questionnaire is based measures provided in the HIV Stigma Framework for assessing HIV related stigma (i.e., prejudice, stereotypes, discrimination, enacted stigma, anticipated stigma, and internalized stigma). Responses to the scale items range from 1=strongly disagree to 6=strongly agree, with higher scores indicating a higher number of experiences of stigma.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Connecticut

Investigators

  • Principal Investigator: Lisa A Eaton, PhD, University of Connecticut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Anticipated)

February 4, 2026

Study Completion (Anticipated)

February 4, 2026

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 19, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H20-0117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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