PrEP Intervention in Prince George's County, Maryland

September 26, 2025 updated by: George Mason University

A Community-based Intervention to Increase PrEP Initiation in Prince George's County, Maryland: Reducing HIV Stigma and Increasing Social Support

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 in PG county is extremely limited.

Internalized stigma is an important and understudied factor that can deter PrEP use among BSMM, similar to the well documented associations between internalized stigma and several HIV risk behaviors among SMM. Research has consistently shown the impact of stigma 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. Internalized stigma and peer social support are potentially modifiable factors that may directly impact PrEP acceptability and PrEP stigma; the associations between internalized stigma and PrEP use are still notably understudied. Despite this, interventions promoting PrEP use have largely not addressed internalized stigma as a potential barrier to uptake.

The goal of the proposed research is to design a peer-based community intervention focused on addressing HIV stigma, HIV knowledge, and peer BSMM support to increase PrEP initiation 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 through the use of peer-led activities and discussions, often in a drop-in center. There have been several successful adaptations of the MPowerment model in different settings. The investigators are adapting the model to focus on improving PrEP initiation through focusing on peer support, and reducing internalized stigma, including 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 in two ongoing MPowerment programs, one in Falls Church, VA (suburban) and the other in Washington, DC (urban).

Aim 2. Conduct 32 in depth interviews to inform adapting an MPowerment intervention to reduce internalized stigma 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 in PG County, based on the MPowerment model, with a focus on reducing internalized HIV stigma and increasing social support and resilience.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MPowerment PrEP Promotion Intervention
This is the arm engaging in the stigma-reduction and support-increasing activities aimed to increase PrEP use.
Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
George Mason University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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