A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: project IMPACT study protocol.
A randomized controlled efficacy trial of behavioral activation for concurrent stimulant use and sexual risk for HIV acquisition among MSM: project IMPACT study protocol.
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DOI：
10.1186/s12889-018-5856-0
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发表时间：
2018-07-25
影响因子：
4.5
通讯作者：
Safren SA
中科院分区：
文献类型：
--
作者：
Mimiaga MJ;Pantalone DW;Biello KB;Glynn TR;Santostefano CM;Olson J;Pardee DJ;Hughto JMW;Garcia Valles J;Carrico AW;Mayer KH;Safren SA
在美国，有问题的兴奋剂使用是男男性行为者（MSM）中普遍存在且难以治疗的问题，也是通过大量性伴侣和伴随的无安全套肛交（CAS）传播艾滋病毒的主要驱动因素。也缺乏以证据为基础的行为研究，以解决有艾滋病毒感染风险的男男性行为者使用兴奋剂的问题。在本文中，我们描述了一个行为干预试验的设计，以减少艾滋病毒未感染的男男性接触者的性风险行为和兴奋剂的使用。本研究由美国国家药物滥用研究所（NIDA）资助，是一项随机对照试验（RCT），在马萨诸塞州波士顿和佛罗里达州迈阿密对未感染艾滋病毒的MSM使用兴奋剂进行综合的艾滋病毒风险降低和行为激活咨询干预（IMPACT）。参与者随机（2：2：1）接受（1）IMPACT干预;（2）放松条件，积极治疗时间和强度匹配对照;或（3）护理标准风险降低咨询比较。在注册时，所有参与者都接受艾滋病毒检测和检测前和检测后咨询。主要结果是自我报告的无安全套肛交行为数量变化率的差异，而没有一致的暴露前预防（PrEP）使用的保护，以及前4个月内兴奋剂使用的减少。在基线、4个月、8个月和12个月随访访视时进行主要评估。迫切需要有效和可持续的行为干预，以减少艾滋病毒感染的风险，在刺激使用MSM艾滋病毒的收购。在这项研究中，我们将评估IMPACT干预措施在减少HIV未感染、使用兴奋剂的MSM中HIV感染的有效性证据。如果发现有效，这里测试的干预措施有望很容易地融入现实世界的临床环境。ClinicalTrials.gov编号NCT 03175159，注册日期为2017年6月5日。
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. 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. 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. ClinicalTrials.gov number NCT03175159, registered June 5, 2017.
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DOI：
10.1080/09540120500038058
发表时间：
2005-08-01
影响因子：
1.7
作者：
Amico, KR;Toro-Alfonso, J;Fisher, JD
通讯作者：
Fisher, JD
DOI：
10.1093/jurban/jti027
发表时间：
2005-03-01
影响因子：
6.6
作者：
Fern치ndez, MI;Perrino, T;Bowen, GS
通讯作者：
Bowen, GS
影响因子：
4.4
作者：
Halkitis PN;Mukherjee PP;Palamar JJ
通讯作者：
Palamar JJ
影响因子：
5
作者：
Colfax, G;Vittinghoff, E;Coates, TJ
通讯作者：
Coates, TJ
影响因子：
2.6
作者：
Halkitis, PN;Parsons, JT;Stirratt, MJ
通讯作者：
Stirratt, MJ