PrEP Readiness Interventions for Supporting Motivation in Stimulant-Using Sexual Minority Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Proportion of Participants Filling a Prescription for PrEP
研究概览
简要总结
The overarching goal of this formative research is to examine whether, and in what combination, contingency management (CM) and motivational interviewing (MI) can facilitate entry of stimulant-using men who have sex with men (MSM) into the pre-exposure prophylaxis (PrEP) care continuum.
详细描述
In Stage 1, participants will be randomized to receive either: 1) three months of CM; or 2) two sessions of MI. All participants will be assessed at three months post-randomization for non-response. In Stage 2, a second randomization where non-responders (i.e., those who have not filled a PrEP prescription) are assigned to: 1) Switch to sequentially receive the other intervention (i.e., CM+MI or MI+CM); or 2) Continue with assessments only (i.e., CM-Only or MI-Only). All participants will complete a final assessment at 6 months.
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
- •At least 18 years of age
- •Sexually active cisgender sexual minority man
- •Reports using stimulants in the past three months
- •HIV-negative serostatus
- •Meets Centers for Disease Control and Prevention (CDC) criteria for PrEP eligibility
排除标准
- •Currently prescribed PrEP
- •Unable to provide informed consent
- •Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to participate
研究组 & 干预措施
CM+MI
Non-responders CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription in Stage 1 that were randomized to receive two sessions of MI in Stage 2.
干预措施: Motivational Interviewing (MI) (Behavioral)
CM+MI
Non-responders CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription in Stage 1 that were randomized to receive two sessions of MI in Stage 2.
干预措施: Contingency Management (CM) (Behavioral)
MI+CM
Non-responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use in Stage 1 that were randomized to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription in Stage 2.
干预措施: Motivational Interviewing (MI) (Behavioral)
Contingency Management (CM) - Only (Non-Responder)
Non-responders to CM financial inancial incentives for PrEP clinical evaluation and filling a PrEP prescription in Stage 1 that were randomized to assessments only in Stage 2.
干预措施: Contingency Management (CM) (Behavioral)
Motivational Interviewing (MI) - Only (Non-Responder)
Non-responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use in Stage 1 that were randomized to assessments only in Stage 2
干预措施: Motivational Interviewing (MI) (Behavioral)
MI+CM
Non-responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use in Stage 1 that were randomized to receive CM financial incentives for PrEP clinical evaluation and filling a PrEP prescription in Stage 2.
干预措施: Contingency Management (CM) (Behavioral)
CM-Only (Responder)
Respnders to CM financial incentives for CM will include financial incentives for rEP clinical evaluation and filling a PrEP prescription in Stage 1.
干预措施: Contingency Management (CM) (Behavioral)
MI-Only (Responder)
Responders to two MI sessions focusing on stimulant use, sexual risk, and PrEP use will be delivered in Stage 1.
干预措施: Motivational Interviewing (MI) (Behavioral)
结局指标
主要结局
Proportion of Participants Filling a Prescription for PrEP
时间窗: 6 Months
The proportion of participants who provide evidence that they have filled a PrEP prescription
次要结局
- Proportion of Participants Who Self-report PrEP Clinical Evaluation by a Medical Provider(6 Months)
- Clinical Cut Points for Self-reported Methamphetamine Use Severity(6 months)
- Proportion of Participants Who Reported Receptive Condomless Anal Sex (Receptive CAS)(6 months)
- Proportion of Participants Who Reported Insertive Condomless Anal Sex (Insertive CAS)(6 months)
研究者
Adam Carrico, PhD
Professor and Chair
Florida International University