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临床试验/NCT04205487
NCT04205487已完成不适用

PrEP Readiness Interventions for Supporting Motivation in Stimulant-Using Sexual Minority Men

Florida International University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Carrico, PhD

Professor and Chair

Florida International University

研究点 (2)

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