Recruiting

PrEP Intervention

Sponsor:

George Mason University

Code:

NCT06141408

Conditions

Hiv

Mental Health Issue

Support, Family

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

MPowerment PrEP Promotion Intervention

Study Details

Brief summary:

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

Conditions

Hiv

Mental Health Issue

Support, Family

Study ID

NCT06141408

Start date

Mar 31, 2022

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: MPowerment PrEP Promotion Intervention

This is the arm engaging in the stigma-reduction and support-increasing activities aimed to increase PrEP use.

no intervention: Standard of Care

This is the arm not engaging in the stigma-reduction and support-increasing activities. This arm will receive standard referreals to PrEP knowledge resources and providers.

Interventions

MPowerment PrEP Promotion Intervention

In-person events will focus on five specific goals: Fostering a sense of community acceptance and social connection, promoting self-acceptance of sexual identity, teaching skills for navigating healthcare, reducing PrEP stigma, and providing education on HIV risk. In accordance with the MPowerment model, In collaboration with the PI, the core group and volunteers would lead the development, implementation, and evaluation of all intervention events. Both peer leaders and the primary investigator 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 activities focused on the aforementioned goals.

Primary outcome measure

  • Number of participants with a PreP prescription within one month of intervention completion. [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Rodman Turpin, PhD

2024651249rturpin@gmu.edu

Locations

George Mason University

Recruiting

Fairfax, Virginia, United States, 22030

Contacts

More Information

Sponsor

George Mason University

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Keywords

  • HIV
  • Stigma
  • Support
  • PrEP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Mason University on 2025-10-01.