一项随机对照疗效试验：行为激活对男男性行为者同时使用兴奋剂和艾滋病毒感染性风险的影响：项目 IMPACT 研究方案。
A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: project IMPACT study protocol.
机构信息
Center for Health Equity Research, Brown University, 121 South Main Street, Providence, RI, 02903, USA.
Departments of Behavioral & Social Health Sciences and Epidemiology, Brown University, School of Public Health, Providence, RI, USA.
出版信息
BMC Public Health. 2018 Jul 25;18(1):914. doi: 10.1186/s12889-018-5856-0.
BACKGROUND
In the United States, problematic stimulant use is a prevalent and difficult to treat problem among men who have sex with men (MSM), as well as a major driver of HIV transmission through the large number of sexual partners and concomitant condomless anal sex (CAS). Evidence-based behavioral studies that address problematic stimulant use in MSM at risk for HIV infection are also lacking. In this paper, we describe the design of a behavioral intervention trial to reduce sexual risk behavior and stimulant use in HIV-uninfected MSM.
METHODS
This study, funded by the National Institute on Drug Abuse (NIDA), is a randomized controlled trial (RCT) testing an integrated HIV risk reduction and behavioral activation counseling intervention (IMPACT) for HIV-uninfected, stimulant using MSM in Boston, MA, and Miami, FL. Participants are randomized (2:2:1) to either (1) the IMPACT intervention; (2) a relaxation condition, an active therapy time- and intensity-matched control; or (3) a standard of care risk reduction counseling comparison. At enrollment, all participants receive an HIV test and pre- and post-test counseling. The primary outcome is the difference in the rate of change in the number of self-reported condomless anal sex acts without the protection of consistent Pre-Exposure Prophylaxis (PrEP) use, as well as reductions in stimulant use during the prior 4-months. Major assessments are conducted at baseline, 4-, 8-, and 12-month follow-up visits.
DISCUSSION
Effective and sustainable behavioral interventions are sorely needed to reduce HIV acquisition in stimulant using MSM at risk for HIV infection. In this study, we will evaluate the evidence of efficacy of the IMPACT intervention to reduce HIV acquisition in HIV-uninfected, stimulant-using MSM. If found effective, the intervention tested here holds promise for being readily integrated into real-world clinical settings.
TRIAL REGISTRATION
ClinicalTrials.gov number NCT03175159 , registered June 5, 2017.
背景
在美国，性活跃的男男性行为者（MSM）中存在着普遍且难以治疗的问题性兴奋剂使用，这也是通过大量性伴侣和同时无保护肛交（CAS）导致 HIV 传播的主要驱动因素。缺乏针对有 HIV 感染风险的 MSM 中问题性兴奋剂使用的基于证据的行为研究。在本文中，我们描述了一项行为干预试验的设计，旨在减少未感染 HIV 的 MSM 中的性风险行为和兴奋剂使用。
方法
这项由国家药物滥用研究所（NIDA）资助的研究是一项随机对照试验（RCT），旨在测试针对未感染 HIV、使用兴奋剂的 MSM 的综合 HIV 风险降低和行为激活咨询干预（IMPACT），地点在马萨诸塞州波士顿和佛罗里达州迈阿密。参与者按 2:2:1 的比例随机分配到以下三组之一：（1）IMPACT 干预组；（2）放松条件组，一种与活性治疗时间和强度匹配的对照；或（3）标准护理风险降低咨询对照组。在入组时，所有参与者都接受 HIV 检测和入组前和入组后咨询。主要结局是自我报告的无保护肛交行为次数变化率的差异，以及在过去 4 个月内减少兴奋剂使用的差异，前提是持续使用一致的暴露前预防（PrEP）。主要评估在基线、4 个月、8 个月和 12 个月随访时进行。
讨论
迫切需要有效的和可持续的行为干预措施来减少有 HIV 感染风险的使用兴奋剂的 MSM 中 HIV 的获得。在这项研究中，我们将评估 IMPACT 干预减少 HIV 感染的有效性证据，针对未感染 HIV、使用兴奋剂的 MSM。如果被证明有效，那么这里测试的干预措施有望很容易地整合到现实世界的临床环境中。
试验注册
ClinicalTrials.gov 编号 NCT03175159，注册日期 2017 年 6 月 5 日。
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