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临床试验/NCT02945436
NCT02945436已完成不适用

Optimizing HIV Counseling and Testing and Referral Through an Adaptive Drug Use

University of Michigan2 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2017年4月7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
258
试验地点
2
主要终点
Increases in repeat HIV testing

研究概览

简要总结

A sample of 300 young (15-29) men who have sex with men (MSM) and transgender persons living in South-East Michigan's Detroit Metro Area (DMA) will be recruited through venue-based sampling and online ads to examine the efficacy of adding a substance use brief intervention (SUBI) to standard HIV prevention and care (SOC) for achieving gains in successful engagement in HIV care. The investigators will partner with Detroit-area AIDS Service Organizations (ASOs) to deliver the intervention.

详细描述

The research activities involve a prospective 4-arm factorial RCT (SOC-only, SOC+SUBI, SUBI+SOC, SUBI+SUBI) of approximately 300 ATOD-using high-risk YMSM aged 15-29 in the DMA. The intervention comprises of two intervention visits, at which time participants may get either standard of care only (SOC-only) or standard of care plus SUBI. All participants will receive standard of care (SOC; i.e., Comprehensive HIV Testing and Counseling) at each visit. The substance use brief intervention (SUBI) will be added to SOC within the experimental arms. At intervention visit one, standard of care is the same for all participants: standard of care is Counseling Testing and Referral (CTR).CTR is a standardized service in which counselors provide HIV testing, risk-related counseling and appropriate referrals (medical, social, prevention, and partner services) to clients. Hence at visit one, 150 YMSM will receive CTR and 150 YMSM will receive CTR+SUBI. The investigators expect approximately 10-15% of participants to test HIV positive at intervention visit one. For intervention visit two, standard of care is sero-status specific. For HIV-negatives standard of care remains CTR. For HIV-positives standard of care is case management, as offered routinely by each ASO, which involves counseling on linkage to care and the importance of care retention. To examine how the sequencing and dosing of interventions impacts efficacy, the investigators propose to randomize at baseline into a factorial randomized controlled trial. The control arm will receive SOC-only at both intervention visit one and two (SOC-only). Experimental arm one (SOC+SUBI) will receive SOC at visit one and SUBI at visit two. Experimental arm two (SUBI+SOC) will receive SUBI at visit one and SOC at visit two. Experimental arm three (SUBI+SUBI) will receive the intervention condition at visits one and two.

The RCT thus answers two important questions: 1) What is the impact of the addition of SUBI to SOC on HIV engagement in care and sexual and substance-related risk-taking behaviors among high-risk YMSM? and 2) What combination of services (SOC-only, SOC+SUBI, SUBI+SOC, SUBI+SUBI) has the greatest impact on engagement in HIV prevention? (where engagement in care is defined as routine HIV testing for sero-negative YMSM and linkage/retention in care for sero-positive MSM).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 29 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All participants must be ages 15-29
  • All participants must currently reside in the DMA (verified by zip code)
  • All participants must self-report as HIV sero-negative
  • All participants must report at least one sexual experience with a man in the previous 6 months
  • All participants must report either at least one binge-drinking episode and/or use of illicit substances in the previous 3 months
  • All participants must identify as either a man who has sex with men (MSM) or as transgender
  • All participants must speak English

排除标准

  • °Anyone not meeting all 6 inclusion criteria will be excluded from the study

结局指标

主要结局

Increases in repeat HIV testing

时间窗: 18 months

Increases in repeat HIV testing as measured by the "HIV Testing Questions" section of the questionnaires

次要结局

未报告次要终点

研究者

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

Robert Stephenson

Professor

University of Michigan

研究点 (2)

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