Optimizing HIV Prevention for Highly Vulnerable Methamphetamine-using Sexual Minority Men
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Proportion of Participants with Verified PrEP or ART Use
研究概览
简要总结
This is a hybrid type I randomized controlled trial to test the effectiveness of contingency management (CM) alone versus CM with motivational interviewing (MI) for optimizing entry or re-entry into the HIV prevention or care continua. A total of 400 participants will be randomized to CM (n = 200) or MI+CM (n = 200), all delivered via telehealth. Monthly follow-up assessments will be completed over 12 months to examine effectiveness MI+CM for the primary outcome - filling a pre-exposure prophylaxis (PrEP) or anti-retroviral therapy (ART) prescription (verified using a digital photo). Secondary outcomes will include: self-reported PrEP or ART clinical evaluation by a provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Assigned male a birth
- •Self-reported methamphetamine use in the past 3 months
- •HIV-negative or unknown serostatus at baseline
- •Has not filled a PrEP prescription in the past 6 months
排除标准
- •Unwilling or unable to provide informed consent
研究组 & 干预措施
Contingency Management
Provides incentives for initiating PrEP or HIV care ($50) and filling a PrEP or ART prescription ($50) in the three months following randomization.
干预措施: Contingency Management (CM) (Behavioral)
MI+CM
Two session MI counseling intervention delivered in the three months after randomization with CM.
干预措施: Motivational Interviewing (MI) (Behavioral)
MI+CM
Two session MI counseling intervention delivered in the three months after randomization with CM.
干预措施: Contingency Management (CM) (Behavioral)
结局指标
主要结局
Proportion of Participants with Verified PrEP or ART Use
时间窗: 12 Months
The proportion of participants providing evidence of PrEP or ART use (i.e., a digital photo a medication bottle bearing their name OR evidence of receipt of medication from a medical record)
次要结局
- Clinical Cut Points for Self-Reported Methamphetamine Use Severity(12 Months)
- Proportion of Participants Reporting Insertive Condomless Anal Sex (CAS)(12 Months)
- Proportion of Participants Reporting Receptive Condomless Anal Sex (CAS)(12 Months)
- Proportion of Participants with Prevention Effective PrEP Use(12 Months)
- Median Time to Verified PrEP or ART Use(12 Months)
研究者
Adam Carrico, PhD
Professor
Florida International University