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

NCT04601649 | Unknown Early Phase 1

• 1 other identifier: PrEP Talk with Friends
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

HIV Negative and Not Yet on PrEP

Outcome Measures

Primary Outcomes (1)

• Decision to Begin PrEP

  The primary outcome is evidence that the participant has decided to begin PrEP

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will take part in the PrEP Talk intervention sessions.

Behavioral: PrEP Talk

Control

NO INTERVENTION

Participants will receive standard care.

Interventions

PrEP Talk BEHAVIORAL

The study is designed to provide education, support, and referrals for PrEP.

Intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: The index participants must be self-identified as male or male gender expression. Their close friends (whom they choose) may be any gender or gender expression.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• California State University, Dominguez Hills: lead

Study Sites (1)

Matt Mutchler

Los Angeles, California, 90230-4409, United States

RECRUITING

Central Study Contacts

Matt G Mutchler, PhD

CONTACT

310-243-3274; mmutchler@csudh.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None; this is a feasibility study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 30 friendship dyads (N=60) will be assigned to a control group and 30 friends dyads (N=60) will be assigned to the intervention group to collect feasibility and acceptability data.

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: We intend to comply fully with the NIH policy on Data Sharing. Data resulting from the proposed research will be shared with external researchers who request them. Our results will be available to other researchers, public health workers, healthcare professionals, and community leaders who are interested in adherence interventions among PLWHA. Constraints imposed by human research subjects protection regulations (e.g., HIPAA Protected Health Information) and RAND's IRB will be recognized as allowed by NIH. External researchers interested in investigator data, survey instruments, and other research methodology and procedures will obtain this information through collaborative agreements (e.g., data use agreements) with the Principal Investigator and Co-Investigators, as required by NIH's data sharing policy.
• Access Criteria: We intend to comply fully with the NIH policy on Data Sharing. Data resulting from the proposed research will be shared with external researchers who request them. Our results will be available to other researchers, public health workers, healthcare professionals, and community leaders who are interested in adherence interventions among PLWHA. Constraints imposed by human research subjects protection regulations (e.g., HIPAA Protected Health Information) and RAND's IRB will be recognized as allowed by NIH. External researchers interested in investigator data, survey instruments, and other research methodology and procedures will obtain this information through collaborative agreements (e.g., data use agreements) with the Principal Investigator and Co-Investigators, as required by NIH's data sharing policy.

Locations

US (1)