NCT06141408

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
8mo left

Started Mar 2022

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Mar 2022Dec 2026

Study Start

First participant enrolled

March 31, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

4.3 years

First QC Date

November 10, 2023

Last Update Submit

September 26, 2025

Conditions

Keywords

HIVStigmaSupportPrEP

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

MPowerment PrEP Promotion Intervention

EXPERIMENTAL

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

Behavioral: MPowerment PrEP Promotion Intervention

Standard of Care

NO INTERVENTION

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

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.

MPowerment PrEP Promotion Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Black
  • HIV-negative
  • 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.

You may not qualify if:

  • HIV Positive
  • Refusal of HIV testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Mason University

Fairfax, Virginia, 22030, United States

RECRUITING

Related Publications (10)

  • 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.

    PMID: 31177363BACKGROUND
  • 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.

    PMID: 35255193BACKGROUND
  • 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.

    PMID: 32274670BACKGROUND
  • 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.

    PMID: 29460223BACKGROUND
  • 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.

    PMID: 32965576BACKGROUND
  • 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.

    PMID: 35902091BACKGROUND
  • 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.

    PMID: 30701404BACKGROUND
  • 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.

    PMID: 35438541BACKGROUND
  • 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.

    PMID: 34087117BACKGROUND
  • 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.

    PMID: 30476461BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSocial Stigma

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSocial BehaviorBehavior

Study Officials

  • Rodman Turpin, PhD

    George Mason University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodman Turpin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 21, 2023

Study Start

March 31, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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

Locations