Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorYale University

About 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

Qualifiers

Self-identify as male.

Self-Identify as Black people.

Aged 18 or older.

Self Report having sex with men in the past 6 months.

Disqualifiers

Currently diagnosed with HIV.

Unable to provide informed consent.

Unable to fully engage with the intervention due to health issues.

Participating in another clinical trial with conflicting outcomes.

Trial design

Treatments tested in this trial

  • C4 Program
  • C4 + 3MV Program

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator