A Multi-Level Integrated Strategy to Optimize PrEP Adherence for Black MSM and Accelerate Implementation at Scale
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- PrEP adherence- self report
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: C4 Program (Behavioral)
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.
干预措施: C4 + 3MV Program (Behavioral)
结局指标
主要结局
PrEP adherence- self report
时间窗: 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
时间窗: 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.
次要结局
- HIV Testing Frequency(Every 3 months for 12 months)