Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM

Keywords

• HIV
• PrEP
• Black MSM
• Stigma Reduction
• Client Centered Care Coordination
• Many Men Many Voices
• Evidence-based Intervention

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Study arms

• Experimental
  C4 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.

  Behavioral: C4 Program

• Experimental
  C4 + 3MV 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.

  Behavioral: C4 + 3MV Program

Interventions

• BehavioralC4 Program

  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.

  Also known as: Client Centered Care Coordination

• BehavioralC4 + 3MV Program

  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.

  Also known as: Many Men Many Voices and Client Centered Care Coordination Integrated Intervention

Primary outcomes

1. 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

2. 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

1. 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

1. 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

2. 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

3. 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

4. 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

5. Depression (PHQ-9)

   Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-27. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety.

   Time frame: Baseline, 6 months, and 12 months

6. HIV Stigma Scale

   Intersectional stigma will be measured across four subscales: Enacted Stigma (10 items) Vicarious Stigma (10 items) Perceived Stigma (10 items) Internalized Stigma (10 items) Each subscale ranges from 10 to 50, with higher scores indicating more stigma experienced.

   Time frame: Baseline, 3, 6, 9, and 12 months

7. Quality Client Perception of Coordination Quality

   The Client Perception of Coordination Quality Questionnaire will assess participants' satisfaction with healthcare services. Scores range from 3 to 15, with higher scores indicating better care coordination.

   Time frame: Baseline, 6 months, and 12 months

Individual participant data

Plan to share: Yes — Investigators plan to share de-identified participant data, including information on PrEP usage, behavioral intervention participation, survey responses, and biological specimen results (e.g., dried blood spot test results). The shared data will support future research on HIV prevention and PrEP adherence, ensuring participant privacy throughout the process.

Supporting information: Study protocol, Sap, Icf