Clinical trial NCT06141408: PrEP Intervention Among Black Sexual Minority Men
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Mental Health Issue
Support, Family
Keywords: HIV
Stigma
Black
Sexuality
Support
PrEP
Lead sponsor: George Mason University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with a PreP prescription within one month of intervention completion.
timeFrame: Within 1 month of intervention completion.
measure: Number of participants with a positive blood spot test for PrEP 6 months following the intervention.
timeFrame: 6 months post-intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: George Mason University
state: Virginia
Study officials:
affiliation: George Mason University
name: Rodman Turpin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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