PrEP Intervention Among Black Sexual Minority Men

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141408
• Other study ID #: GeorgeMU
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: George Mason University
• Contact: Rodman Turpin, PhD
• Phone: 2024651249
• Email: rturpin[@]gmu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Mental Health Issue

Intervention

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.

Locations

Country	Name	City	State
United States	George Mason University	Fairfax	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
George Mason University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Bavinton BR, Grulich AE. HIV pre-exposure prophylaxis: scaling up for impact now and in the future. Lancet Public Health. 2021 Jul;6(7):e528-e533. doi: 10.1016/S2468-2667(21)00112-2. Epub 2021 Jun 2. — View Citation

Calabrese SK. Understanding, Contextualizing, and Addressing PrEP Stigma to Enhance PrEP Implementation. Curr HIV/AIDS Rep. 2020 Dec;17(6):579-588. doi: 10.1007/s11904-020-00533-y. Epub 2020 Sep 23. — View Citation

Dangerfield DT 2nd, Lipson A, Anderson JN. HIV PrEP Clinician Communication Preferences Among Black Sexual Minority Men. AIDS Educ Prev. 2022 Apr;34(2):168-181. doi: 10.1521/aeap.2022.34.2.168. — View Citation

Golub SA. PrEP Stigma: Implicit and Explicit Drivers of Disparity. Curr HIV/AIDS Rep. 2018 Apr;15(2):190-197. doi: 10.1007/s11904-018-0385-0. — View Citation

Hillis A, Germain J, Hope V, McVeigh J, Van Hout MC. Pre-exposure Prophylaxis (PrEP) for HIV Prevention Among Men Who Have Sex with Men (MSM): A Scoping Review on PrEP Service Delivery and Programming. AIDS Behav. 2020 Nov;24(11):3056-3070. doi: 10.1007/s10461-020-02855-9. — View Citation

Johnson J, Radix A, Copeland R, Chacon G. Building Racial and Gender Equity into a National PrEP Access Program. J Law Med Ethics. 2022;50(S1):55-59. doi: 10.1017/jme.2022.37. — View Citation

Sullivan PS, Mena L, Elopre L, Siegler AJ. Implementation Strategies to Increase PrEP Uptake in the South. Curr HIV/AIDS Rep. 2019 Aug;16(4):259-269. doi: 10.1007/s11904-019-00447-4. — View Citation

Sullivan PS, Siegler AJ. Getting pre-exposure prophylaxis (PrEP) to the people: opportunities, challenges and emerging models of PrEP implementation. Sex Health. 2018 Nov;15(6):522-527. doi: 10.1071/SH18103. — View Citation

Sun Z, Gu Q, Dai Y, Zou H, Agins B, Chen Q, Li P, Shen J, Yang Y, Jiang H. Increasing awareness of HIV pre-exposure prophylaxis (PrEP) and willingness to use HIV PrEP among men who have sex with men: a systematic review and meta-analysis of global data. J Int AIDS Soc. 2022 Mar;25(3):e25883. doi: 10.1002/jia2.25883. — View Citation

Touger R, Wood BR. A Review of Telehealth Innovations for HIV Pre-Exposure Prophylaxis (PrEP). Curr HIV/AIDS Rep. 2019 Feb;16(1):113-119. doi: 10.1007/s11904-019-00430-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a PreP prescription within one 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.
Primary	Number of participants with a positive blood spot test for PrEP 6 months following the 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.