NCT04601649: PrEP-Talk

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

Status unknown EARLY_PHASE1 Last updated 28 July 2022

What this trial tests

EARLY_PHASE1 trial testing PrEP Talk in HIV Negative and Not Yet on PrEP in 120 participants. Status unknown.

Timeline

1 September 2020

Primary endpoint
31 December 2022

31 December 2024

Quick facts

Lead sponsor	California State University, Dominguez Hills
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	120
Start date	1 September 2020
Primary completion	31 December 2022
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

• PrEP Talk

Conditions studied

• HIV Negative and Not Yet on PrEP — all drugs for HIV Negative and Not Yet on PrEP →

Sponsor

California State University, Dominguez Hills

Who can join

Adults 18 to 29, any sex, with HIV Negative and Not Yet on PrEP. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.