HIV Prevention
Conditions
Keywords
HIV, PrEP, Black MSM, Stigma Reduction, Client Centered Care Coordination, Many Men Many Voices, Evidence-based Intervention
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 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.
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.
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.
Sponsors
Yale University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP adherence- self report | 0, 3, 6, 9, 12 months | 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. |
| PrEP adherence- biomarker validation | 0, 6, and 12 months | PrEP adherence will be assessed through biomarker validation using dried blood samples. A tenofovir disoproxil fumarate (TFV-DF) level \>700 fmol/punch confirms adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Testing Frequency | Every 3 months for 12 months | 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 |
Countries
United States
Contacts
CONTACTRaquel Ramos, PhD, MBA, MSN, FNYAM, FAHA
CONTACTLaRon Nelson, PhD, RN, FNP, FNAP, FNYAM, FAA
Outcome results
None listed