PrEP Talk for HIV Prevention in Young Black MSM

(PrEP-Talk Trial)

Overseen By Matt G Mutchler, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: California State University, Dominguez Hills

Disqualifiers: Currently using PrEP, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called "PrEP Talk" to help young Black men who have sex with men (YBMSM) consider and adhere to using PrEP, a medication that prevents HIV. The goal is to reduce HIV rates by addressing concerns and barriers such as stigma, trust, and access. Participants will either join sessions with a counselor and a friend or receive standard care. This trial targets YBMSM who are HIV-negative, not currently on PrEP, and regularly discuss important topics with a close friend. As an Early Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to explore this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on increasing the use of PrEP for HIV prevention, so it's best to discuss your current medications with the trial team.

What prior data suggests that the PrEP Talk intervention is safe?

A previous study showed that PrEP (pre-exposure prophylaxis) is safe and effective for preventing HIV, especially when taken correctly. The FDA has already approved it for HIV prevention, indicating it has passed many safety tests in humans.

The "PrEP Talk" program is still under research, so limited information is available about its safety. However, since it primarily involves counseling and support to assist people in using PrEP, it is not expected to pose direct health risks. The program aims to help young Black men who have sex with men (YBMSM) feel more comfortable and supported in using PrEP. Therefore, the main safety concern is how well participants perceive the support and information they receive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PrEP Talk because it offers a fresh approach to HIV prevention by focusing on education and communication, rather than medication alone. Unlike traditional methods that primarily rely on antiretroviral drugs to prevent HIV, PrEP Talk engages young Black men who have sex with men (MSM) through interactive sessions designed to increase awareness and encourage the use of pre-exposure prophylaxis (PrEP). This method aims to empower participants with knowledge and skills, fostering a supportive community that could enhance adherence to preventive measures. By addressing both social and behavioral aspects, PrEP Talk has the potential to significantly improve PrEP uptake and effectiveness in this vulnerable population.

What evidence suggests that the PrEP Talk intervention could be effective for increasing PrEP uptake and adherence among young Black MSM?

Research has shown that PrEP (pre-exposure prophylaxis) can lower the risk of contracting HIV by over 90% when used correctly, making it highly effective for individuals at high risk through sexual contact. In this trial, participants in the intervention arm will engage in the "PrEP Talk" program, which aims to help young Black men who have sex with men understand and adhere to their PrEP regimen. Early results suggest that support from a friend and a counselor can facilitate starting and continuing PrEP. This approach could help reduce HIV rates in this group by increasing PrEP use. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for Black or multiracial males aged 18-29 who identify as gay, bisexual, gender queer/non-binary/gender non-conforming. They must be HIV negative and not currently using PrEP. Participants need a close friend willing to support their sexual health goals for HIV prevention.

Inclusion Criteria

HIV status: Index must be currently HIV negative

Sexual Orientation: Index: self-identify as gay or bisexual

I regularly discuss important topics like sexual health with a close friend.

Exclusion Criteria

Participants are ineligible if they do not meet eligibility requirements stated above.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the PrEP-Talk intervention, which includes 3 sessions over 4 weeks, with up to 3 booster sessions for those starting PrEP.

4 weeks

Follow-up

Participants are monitored for PrEP uptake and adherence, with assessments at baseline, 3 months, and 6 months post-baseline.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PrEP Talk

Trial Overview 'PrEP-Talk' is an intervention being tested to increase the uptake and adherence of PrEP among young Black men who have sex with men (YBMSM). It involves counseling from a PrEP Counselor and support from a close friend, assessed through focus groups and a pilot randomized controlled trial.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants will take part in the PrEP Talk intervention sessions.

Group II: Control Active Control 1 Intervention

Participants will receive standard care.

Who Is Running the Clinical Trial?

California State University, Dominguez Hills

Lead Sponsor

Trials

5

Recruited

360+

Citations

1. trialx.com trialx.com/clinical-trials/listings/257289/prep-talk-prep-uptake-with-young-black-msm-and-their-close-friends/

PrEP Uptake With Young Black MSM and Their Close ... This proposed study is significant because our intervention may increase PrEP uptake and adherence, which may help to reduce HIV incidence among ...

2. withpower.com withpower.com/trial/early-phase-1-8-2020-75481

PrEP Talk for HIV Prevention in Young Black MSM This proposed study is significant because our intervention may increase PrEP uptake and adherence, which may help to reduce HIV incidence among YBMSM. If ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06872307

NCT06872307 | Intervention to Enhance PrEP Persistence The investigators will conduct a fully powered randomized controlled trial (RCT) to test the effect of a patient navigation intervention for ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212144723000297

Development of an acceptance based PrEP intervention ... Development of an acceptance based PrEP intervention (ACTPrEP) to engage young black MSM in the South utilizing the Adaptome Model of intervention adaptation.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8091483/

How Can We PrEP? Exploring Black MSM's experiences ... Pre-exposure prophylaxis (PrEP) can reduce the risk of HIV infection by over 90% among those at high risk via sexual transmission. PrEP acceptance and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5799010/

PrEP Chicago: A randomized controlled peer change agent ... PrEP Chicago is a randomized controlled trial network intervention designed to increase PrEP uptake among young Black MSM living in Chicago.

7. researchprotocols.org researchprotocols.org/2025/1/e66326

An mHealth App–Based Social Capital Intervention (PrEP ... After the intervention, young, Black, sexual minority men will complete surveys electronically at 1 and 3 months (accompanied by HIV testing) on ...