Finding studies
Finding studies
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Raquel Ramos, PhD, MBA, MSN, FNYAM, FAHA
CONTACT
LaRon Nelson, PhD, RN, FNP, FNAP, FNYAM, FAA
CONTACT
Lead
Yale University
With
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 New York City. 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 (Texas n=150 and NYC n=350); 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.
Age
18–any
Sex
MALE
Healthy volunteers
Accepted