120 Participants Needed

PrEP Talk for HIV Prevention in Young Black MSM

(PrEP-Talk Trial)

MG
Overseen ByMatt G Mutchler, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: California State University, Dominguez Hills
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Young Black MSM (YBMSM) are at critically high and disproportionate HIV risk. Reducing HIV incidence rates among YBMSM will likely require increased adoption of additional strategies such as pre-exposure prophylaxis (PrEP). PrEP is a FDA approved medication for HIV that also prevents HIV transmission when taken appropriately. Interventions are needed to address potential individual, social/cultural, and structural barriers to uptake and adherence of PrEP among YBMSM to help curb HIV infections. Our preliminary research suggests that some YBMSM feel concerned that PrEP is not effective or may be toxic, about being stigmatized for having HIV if they take PrEP, as well as concerns about access and side effects. For YBMSM, high levels of medical mistrust of HIV-related public health information and research may also be barriers. Therefore, we propose "PrEP-Talk", an intervention that will use a PrEP Counselor (PC) who can provide information and guidance to YBMSM as they weigh their options regarding HIV risk along with the inclusion of a close friend (CF) to support PrEP uptake and adherence. In order to address these critical and timely issues, we developed the following specific aims:1. To develop and manualize "PrEP-Talk," which aims to increase PrEP uptake and adherence among YBMSM. This will be done through qualitative formative research (3 focus groups with 12-18 YBMSM and CF dyads, N=24-36); partnering with a community advisory board (comprised of individuals knowledgeable about HIV work with YBMSM); and field tests of the intervention with 5 YBMSM and CF dyads (N=10).2. Examine feasibility, acceptability and indicators of preliminary efficacy of "PrEP-Talk" on PrEP uptake and adherence among YBMSM. This will be accomplished through a pilot randomized controlled trial (RCT) with 30 dyads (YBMSM and CFs) in the intervention and 30 YBMSM in the control (N=90). We will conduct assessments at baseline, 3-months and 6-months post-baseline. We will also assess PrEP uptake supportive communication at each intervention session and collect urine samples to measure a biomarker of PrEP uptake (initial adherence) from all YBMSM who report use of PrEP.This proposed study is significant because our intervention may increase PrEP uptake and adherence, which may help to reduce HIV incidence among YBMSM. If the proposed intervention shows promise, we will prepare to undertake a full-scale R01-funded RCT.

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.
See 12 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants will take part in the PrEP Talk intervention sessions.
Group II: ControlActive Control1 Intervention
Participants will receive standard care.

Find a Clinic Near You

Who Is Running the Clinical Trial?

California State University, Dominguez Hills

Lead Sponsor

Trials
5
Recruited
360+
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