HivNCT06141408
PrEP Intervention in Prince George's County, Maryland
A study testing MPowerment PrEP Promotion Intervention in people with Hiv and Mental Health Issue, run by George Mason University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv, Mental Health Issue, Support, Family
- What is being tested?
- MPowerment PrEP Promotion Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- HIV Positive
- Refusal of HIV testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
George Mason University
Fairfax, Virginia, 22030
Rodman Turpin, 2024651249, rturpin@gmu.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Hiv, Mental Health Issue, Support, Family
- Being tested
- MPowerment PrEP Promotion Intervention
- Keywords
- HIV, Stigma, Support, PrEP
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPowerment PrEP Promotion InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MPowerment PrEP Promotion Intervention | Experimental | This is the arm engaging in the stigma-reduction and support-increasing activities aimed to increase PrEP use. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start31 Mar 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodman Turpin, PhD, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141408
- Sponsor's protocol ID
- GeorgeMU
- Status last verified
- Sep 2025
- First submitted
- 10 Nov 2023
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators are still working on developing a plan for data dissemination.
Publications
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.
PubMed 31177363Sun 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.
PubMed 35255193Hillis 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.
PubMed 32274670Golub 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.
PubMed 29460223Calabrese 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.
PubMed 32965576Johnson 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.
PubMed 35902091Touger 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.
PubMed 30701404Dangerfield 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.
PubMed 35438541Bavinton 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.
PubMed 34087117Sullivan 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.
PubMed 30476461
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Intervention to Increase PrEP Initiation in Prince George's County, Maryland: Reducing HIV Stigma and Increasing Social Support
- ClinicalTrials.gov ID
- NCT06141408
- Acronym / sponsor ID
- GeorgeMU
- Conditions
- Hiv, Mental Health Issue, Support, Family
- Keywords
- HIV, Stigma, Support, PrEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPowerment PrEP Promotion Intervention | Experimental | Behavioral: MPowerment PrEP Promotion InterventionThis is the arm engaging in the stigma-reduction and support-increasing activities aimed to increase PrEP use. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- HIV Positive
- Refusal of HIV testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPowerment PrEP Promotion InterventionIn-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. | Behavioural | MPowerment PrEP Promotion Intervention |
Primary outcome
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.
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".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 31177363Sullivan 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.
- Background: PubMed 35255193Sun 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.
- Background: PubMed 32274670Hillis 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.
- Background: PubMed 29460223Golub 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.
- Background: PubMed 32965576Calabrese 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.
- Background: PubMed 35902091Johnson 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.
- Background: PubMed 30701404Touger 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.
- Background: PubMed 35438541Dangerfield 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.
- Background: PubMed 34087117Bavinton 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.
- Background: PubMed 30476461Sullivan 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.
- Individual participant dataSharing planned: No. The investigators are still working on developing a plan for data dissemination.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodman Turpin, PhD principal investigator
George Mason University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPowerment PrEP Promotion Intervention in people with Hiv and Mental Health Issue, run by George Mason University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodman Turpin, PhD (2024651249, rturpin@gmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a PreP prescription within one month of intervention completion. (time frame: Within 1 month of intervention completion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06141408, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.