PrEP Intervention Among Black Sexual Minority Men

November 15, 2023 updated by: George Mason University

A Community-based Intervention to Increase PrEP Initiation Among Black Sexual Minority Men in Prince George's County, Maryland: Reducing Internalized Stigma and Increasing Social Support

The goal of the proposed research is to design a peer-based community intervention focused on addressing internalized homophobia, internalized racism, HIV stigma, and peer BSMM support to increase PrEP initiation among BSMM in Prince George's County, MD. Participants will attend intervention events focused on stigma reduction and building community among Black queer men. Researchers will compare intervention and control group participants to see if there in a difference in PrEP initiation and adherence.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Black gay, bisexual, and other Black sexual minority men (BSMM) are a priority population and experience the highest rate of new HIV infections in the United States. Maryland (MD) is an HIV epicenter and ranks 4th in AIDS cases nationally; the state has several hotspots of HIV and AIDS cases in geographically distinct areas, including urban, suburban, and rural settings. Prince George's (PG) County is a majority Black suburban county (63% Black) bordering Washington, DC, with the highest per capita income for Black people in the nation, yet the second highest incidence and prevalence of HIV in the DC greater metropolitan area. It is an understudied region in the "Ending the Epidemic" initiative to end HIV in the United States. Despite the availability of PrEP for prevention and overall economic resources in this area, uptake among BSMM remains low. Greater understanding of factors impacting PrEP utilization among BSMM in this population and region of the U.S. are necessary for successful HIV prevention for BSMM. Additionally, extant literature specific to PrEP use among BSMM in PG county is extremely limited.

Internalized racism is an important and understudied factor that can deter PrEP use among BSMM, similar to the well documented associations between internalized homophobia and several HIV risk behaviors among SMM. Research has consistently shown the impact of racism and homophobia on several HIV-related outcomes among SMM, including HIV stigma that deters uptake of HIV prevention. In contrast, social support can facilitate HIV prevention behaviors among BSMM. Internalized racism/homophobia, HIV stigma, and peer social support are potentially modifiable factors that may directly impact PrEP acceptability and PrEP stigma among BSMM; the associations between internalized stigma and PrEP use among BSMM are still notably understudied. Despite this, interventions promoting PrEP use among BSMM have largely not addressed internalized stigma as a potential barrier to uptake. Notably, internalized racism/homophobia is more modifiable than experienced or anticipated racism/homophobia.

The goal of the proposed research is to design a peer-based community intervention focused on addressing internalized homophobia, internalized racism, HIV stigma, and peer BSMM support to increase PrEP initiation among BSMM in Prince George's County, MD. The investigators will adapt the MPowerment peer-based model: This is a CDC-developed evidence-based intervention originally designed to reduce sexual risk and improve peer support among SMM through the use of peer-led activities and discussions, often in a drop-in center that is a safe space for young BSMM.31,32 There have been several successful adaptations of the MPowerment model in different settings of SMM. The investigators are adapting the model to focus on improving PrEP initiation among BSMM, through focusing on peer BSMM support, and reducing internalized racism, homophobia, and HIV stigma through peer-led events and activities. The following are our aims:

Aim 1. Using ethnographic methods (participant and direct observation), study peer-peer interactions/exchanges and HIV prevention communications among BSMM in two ongoing MPowerment programs, one in Falls Church, VA (suburban) and the other in Washington, DC (urban). As the PI is a BSMM well connected to these organizations, he has unique advantages in conducting these ethnographies.

Aim 2. Conduct 32 in depth interviews to inform adapting an MPowerment intervention to reduce internalized racism/homophobia and increase PrEP uptake among BSMM in PG County. This would inform intervention site selection, promotion materials, and design of events and activities.

Aim 3. Pilot test a community-based pretest-posttest intervention (n=130) to increase PrEP uptake among BSMM in PG County, based on the MPowerment model, with a focus on reducing internalized racism/ homophobia/HIV stigma, and increasing social support and resilience.

Study Type

Interventional

Enrollment (Estimated)

120

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 Locations

  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Recruiting
        • George Mason University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male
  • Black
  • HIV-negative
  • 18 years of age or older
  • Either residing in Prince George's County Maryland, or having a sexual partner in Prince George's County Maryland within the past year.

Exclusion Criteria

  • HIV Positive
  • Refusal of HIV testing

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
This is the arm engaging in the stigma-reduction and support-increasing activities.
Behavioral: MPowerment Stigma-reduction Intervention
In-person events will focus on five specific goals: Fostering a sense of community acceptance and social connection among Black sexual minority men (BSMM), promoting self-acceptance of sexual identity, teaching skills for coping with experiences of racism, reducing PrEP stigma, and providing education on HIV risk. In accordance with the MPowerment model, In collaboration with the PI, the BSMM core group and volunteers would lead the development, implementation, and evaluation of all intervention events. Both peer leaders and the primary investigator (all BSMM) will collaborate to develop specific events ("M-Groups"), guided by the findings in both the quantitative and qualitative studies. M-Groups will be held once every month. Events will be 2 hour in-person activities focused on the aforementioned goals.
No Intervention: Comparison
This is the arm not engaging in the stigma-reduction and support-increasing activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with a PreP prescription within one month of intervention completion.
Time Frame: Within 1 month of intervention completion.
This is the number of participants who receive an initial prescription for Pre-exposure prophylaxis. Investigators will refer individuals participating in the intervention for PrEP use. Those who provide either a PrEP prescription, or a PrEP bottle with their prescription information, will be considered as initiating PrEP use.
Within 1 month of intervention completion.
Number of participants with a positive blood spot test for PrEP 6 months following the intervention.
Time Frame: 6 months post-intervention.
6 months following the intervention completion, investigators will mail a blood spot collection kit to participants, with return postage. When mailed back, investigators will test the dried blood spots for the presence of PrEP using a chemistry analyzer. Those who test positive will be considered as "PrEP adherent".
6 months post-intervention.

Collaborators and Investigators

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

Sponsor

George Mason University

Investigators

  • Principal Investigator: Rodman Turpin, PhD, George Mason University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 31, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Estimated)

November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GeorgeMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators are still working on developing a plan for data dissemination.

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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