Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM

ConditionHIV Prevention

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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

C4 Program
Behavioral
The C4 intervention is a behavioral program designed to provide care coordination to address structural barriers to PrEP adherence among Black men who have sex with men (MSM). It includes personalized support services, focusing on healthcare access, mental health, and stigma reduction to promote consistent PrEP use. Participants will receive counseling sessions and follow-ups based on their individual needs.
C4 + 3MV Program
Behavioral
This intervention combines the C4 care coordination with the 3MV behavioral program. The 3MV program focuses on behavior change, addressing self-efficacy, stigma, and promoting healthy practices. Through this combination, participants receive both structural and behavioral support to maximize their adherence to PrEP.

Treatment groups

500 Participants

are divided into 2 treatment groups

Group A: C4 InterventionExperimental treatment 1 intervention

Group B: C4 + 3MV InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

PrEP adherence- self report

PrEP adherence will be assessed through self-report. Self-reported adherence is measured by doses taken in the past 30 days, with fewer missed doses indicating higher adherence.

Time frame

0, 3, 6, 9, 12 months

PrEP adherence- biomarker validation

PrEP adherence will be assessed through biomarker validation using dried blood samples. A tenofovir disoproxil fumarate (TFV-DF) level \>700 fmol/punch confirms adherence.

Time frame

0, 6, and 12 months

Secondary outcomes

HIV Testing Frequency

HIV testing frequency will be assessed by the number of tests taken in the past 90 days, with more tests indicating higher engagement in testing

Time frame

Every 3 months for 12 months

Other outcomes

Perceived Competence for PrEP use

Perceived Competence for PrEP Use Scale will measure participants' confidence in their ability to follow PrEP recommendations. Scores range from 9 to 45, with higher scores reflecting greater competence.

Time frame

Baseline, 6 months, and 12 months

PrEP Use Self-Regulation

PrEP Use Self-Regulation Questionnaire will assess participants' internalization of autonomous motivation to maintain adherence to PrEP. Scores range from 9 to 45, with higher scores indicating stronger self-regulation.

Time frame

Baseline, 6 months, and 12 months

Basic Needs Satisfaction Scale

The Basic Needs Satisfaction Scale (9 items) assesses participants' fulfillment of psychological needs (autonomy, competence, and relatedness) within social relationships, especially from close friends. Scores range from 9 to 45, with higher scores indicating greater satisfaction.

Time frame

Every 3 months for 12 months

Healthcare Climate Questionnaire

The Healthcare Climate Questionnaire (15 items) will measure participants' perception of their healthcare providers' support. Scores range from 15 to 75, with higher scores reflecting a more supportive healthcare environment.

Time frame

Baseline, 6, and 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: