PrEP Talk: PrEP Uptake With Young Black MSM and Their Close Friends

Status unconfirmed · Early Phase 1

Conditions studied: HIV Negative and Not Yet on PrEP

In brief

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.

Key facts

Study ID: NCT04601649
Run by: California State University, Dominguez Hills
People needed: 120
Starts: 2020-09-01
Expected to finish: 2024-12-31
Last updated by the study team: 2022-07-28

Who can join

Age: 18 and older, up to 29. Sex: any. Healthy volunteers: accepted.

You may qualify if…

age: Index and Close Friends: 18-29 Gender: male assigned at birth or identifies as male or gender queer/non-binary/gender non-conforming; Close Friend none Racial/Ethnic Background: Index: Black/African American or Multiracial and partially identifies as Black/African American' Close Friend: no racial/ethnic restriction Sexual Orientation: Index: self-identify as gay or bisexual; Close Friend: none HIV status: Index must be currently HIV negative; Close Friend: none Currently using PrEP: Index must be not currently using PrEP; Close Friend:none Index must have a close friend with whom they talk regularly about important topics such as sexual health. Close Friend: none.
Close Friend must have a close friend who is Black and gay or bisexual betwen the ages of 18-29.
Close Friend must be willing to support their friend on sexual health goals for HIV prevention.

You may not qualify if…

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

Where it is running

Matt Mutchler — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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