RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Evaluating the Feasibility and Acceptability of "PrEP-Talk": A PrEP Uptake Intervention for Young Black MSM With Their Close Friends

Quick Facts

Study Start:2020-09-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04601649

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 29 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Matt G Mutchler, PhD
CONTACT
310-243-3274
mmutchler@csudh.edu

Study Locations (Sites)

Matt Mutchler
Los Angeles, California, 90230-4409
United States

Collaborators and Investigators

Sponsor: California State University, Dominguez Hills

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2020-09-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • HIV Negative and Not Yet on PrEP