Clinical trial NCT06661343: Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM
Official title: A Multi-Level Integrated Strategy to Optimize PrEP Adherence for Black MSM and Accelerate Implementation at Scale
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV Prevention
PrEP Adherence
HIV Risk Reduction
Keywords: HIV
PrEP
Black MSM
Adherence
HIV Prevention
Stigma Reduction
C4 Intervention
3MV Program
Behavioral Health
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-10-28
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study uses a stepped-wedge cluster randomized trial. Participants from multiple networks are introduced to the intervention in a sequential manner, with each cluster beginning in a control phase and transitioning into one of two intervention phases over time. This design allows for comparison between groups while also ensuring all participants eventually receive the intervention.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: This clinical trial aims to evaluate two intervention strategies-C4 and C4 + 3MV-to improve adherence to PrEP (pre-exposure prophylaxis) among Black men who have sex with men (MSM) in two metropolitan areas: Dallas/Fort Worth and Miami/Fort Lauderdale. The study addresses structural and behavioral barriers to PrEP adherence, aiming to reduce disparities in HIV prevention efforts.

Study Design and Methodology:

* Trial Type: Multi-site, staircase stepped-wedge randomized controlled trial (RCT)
* Duration: 24 months total, with 9-month intervention periods for each group
* Participants: 500 participants (250 at each site); Participants are recruited from community-based organizations and through network-based referrals

Randomization:

* 48 networks will be randomized into 8 sequences.
* Each network will experience a 3-month control period, followed by either the C4 intervention or the C4 + 3MV intervention.

Interventions:

* C4 Intervention: Focuses on care coordination, addressing participants' needs related to healthcare access, stigma, and mental health services. Uses individualized care plans and support systems to facilitate adherence.
* C4 + 3MV Intervention: Incorporates both care coordination and the 3MV (Many Men, Many Voices) behavioral change program. 3MV focuses on reducing stigma, promoting safe behaviors, and improving self-efficacy through group sessions.

Primary and Secondary Outcomes:

* Primary Outcome: PrEP adherence, measured through dried blood spot (DBS) assays to assess drug levels over time.
* Secondary Outcomes: Changes in HIV-related health-seeking behavior (e.g., frequency of HIV testing); Autonomy and social support, measured through validated scales; Reduction in stigma and mental health improvements

Data Collection and Monitoring:

* Data will be collected at multiple points using questionnaires, DBS tests, and counseling session evaluations.
* A Learn-as-You-Go (LAGO) adaptive analysis will be conducted every 6 months to optimize intervention delivery.

Eligibility criteria: Inclusion Criteria:

* Self-identify as male.
* Self-Identify as Black people.
* Aged 18 or older.
* Self Report having sex with men in the past 6 months.
* Eligible for PrEP or currently prescribed PrEP.
* Willing to participate in behavioral intervention sessions.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: PrEP adherence- self report
timeFrame: 0, 3, 6, 9, 12 months
measure: PrEP adherence- biomarker validation
timeFrame: 0, 6, and 12 months
Secondary outcomes:
measure: HIV Testing Frequency
timeFrame: Every 3 months for 12 months
Other outcomes:
measure: Perceived Competence for PrEP use
timeFrame: Baseline, 6 months, and 12 months
measure: PrEP Use Self-Regulation
timeFrame: Baseline, 6 months, and 12 months
measure: Basic Needs Satisfaction Scale
timeFrame: Every 3 months for 12 months
measure: Healthcare Climate Questionnaire
timeFrame: Baseline, 6, and 12 months
measure: Depression (PHQ-9)
timeFrame: Baseline, 6 months, and 12 months
measure: HIV Stigma Scale
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Quality Client Perception of Coordination Quality
timeFrame: Baseline, 6 months, and 12 months
Locations:
city: Lauderdale Lakes
country: United States
facility: South Florida Afro Pride Federation
state: Florida
city: Dallas
country: United States
facility: Abounding Prosperity, Inc.
state: Texas
Study officials:
References: