PrEP Adherence Programs for HIV Prevention (C4+3MV Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Yale University

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this clinical trial is to learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM). The study will also explore the most effective ways to support participants in continuing their PrEP use over time. The main questions it aims to answer are: * Does the C4 program help participants take PrEP more regularly? * Does adding the 3MV intervention to C4 provide additional support for adherence? Researchers will compare two intervention strategies to see if they result in better PrEP adherence: * C4 Intervention: A program focused on individualized care coordination and addressing structural needs. * C4 + 3MV Intervention: A combination of care coordination with additional behavioral change sessions. Participants will: * Participate in PrEP education and counseling sessions. * Have their PrEP use monitored through dried blood spot (DBS) tests. * Complete questionnaires about their experiences and challenges with PrEP. Receive support sessions tailored to address individual barriers to PrEP adherence.

Eligibility Criteria

This trial is for Black men who have sex with men (MSM) interested in improving their adherence to PrEP, a medication regimen that helps prevent HIV. Participants should be willing to undergo education and counseling sessions, have their medication use monitored via blood tests, and complete questionnaires.

Inclusion Criteria

I identify as male.

I am 18 years old or older.

I have had sexual relations with men in the past 6 months.

I am eligible for or currently on PrEP medication.

Exclusion Criteria

I am currently diagnosed with HIV.

I am unable to understand and give consent for treatment.

Participant Groups

The study compares two strategies: the C4 Program focusing on personalized care coordination, and the C4 + 3MV Program which adds behavioral change sessions. The goal is to see which method better supports regular PrEP usage among participants.

2Treatment groups

Experimental Treatment

Group I: C4 InterventionExperimental Treatment1 Intervention

Participants in this arm will receive care coordination and support through the C4 intervention. This program focuses on addressing structural barriers, such as healthcare access and mental health, to improve PrEP adherence. Participants will also attend regular counseling sessions and have their PrEP use monitored through dried blood spot (DBS) tests.

Group II: C4 + 3MV InterventionExperimental Treatment1 Intervention

Participants in this arm will receive the C4 intervention, along with the 3MV (Many Men, Many Voices) behavioral intervention. The 3MV program aims to reduce stigma, promote safer behaviors, and increase self-efficacy. This arm integrates both structural and behavioral approaches to enhance PrEP adherence. Participants will complete counseling sessions, group activities, and DBS testing for monitoring adherence.