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临床试验/NCT00432926
NCT00432926已完成2 期

Behavior Change and Maintenance Intervention for HIV+ MSM Methamphetamine Users

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 429 人开始时间: 2007年2月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
429
试验地点
1
主要终点
Reduction of defined sexual risk behaviors

研究概览

简要总结

This study tests the effectiveness of a behavioral intervention to reduce sexual risk behavior in HIV-positive, methamphetamine-using men who have sex with men (MSM). It builds on the findings of a previous study (R01 DA012116, "Promoting safer sex in HIV+ homosexual and bisexual men who use methamphetamine"). That study achieved significant short-term results that eroded over time. Accordingly, this study hypothesizes that the addition of a maintenance component to the already proven counseling and educational components of the treatment model will result in longer-lasting positive effects.

详细描述

Methamphetamine use by MSM has been consistently associated with increased HIV transmission. In the previous funding period we demonstrated reductions in transmission risk behavior associated with participation in our behavioral intervention; however, these improvements eroded over time, underscoring the need to develop and test interventions designed to enhance longer-term behavior change. The objective of this study is to evaluate the efficacy of an intervention designed to maintain reductions in high-risk sexual practices achieved by methamphetamine-using HIV+ MSM. Three major questions addressed are: 1) Can methamphetamine-using HIV+ MSM modify their high-risk sexual practices over an extended (16-month) period? 2) Do "group maintenance sessions" result in less erosion of behavioral improvements? 3) Are the underlying mechanisms the same for acquisition and maintenance of behavior change? We will assign 450 sexually active HIV+ MSM who regularly use methamphetamine and who have had unprotected sex with an HIV-negative or unknown-status partner to one of three conditions: 1) an eight-session intervention, combining client-centered motivational interviewing and structured behavioral counseling to address five intervention domains (context of unsafe sex/drug use; condom use; safer sex negotiation; disclosure; and enhancement of social supports); 2) the same eight counseling sessions (i.e., identical to condition 1 above), plus eight group-format safer sex maintenance sessions, which utilize clinical strategies from relapse prevention to identify high-risk situations and develop effective coping strategies; or 3) an attention-control condition that is time-equivalent to condition 2 above, and addresses diet, exercise, and HIV. Thus we will determine whether longer-term maintenance of safer sex behaviors is possible among HIV+ methamphetamine-using MSM, a population that remains at very high risk of HIV transmission, and for which substitution therapies to promote cessation and risk reduction are not yet available.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
否

入选标准

  • •Used methamphetamine at least twice in last two months
  • •At least some recent sexual partners were male
  • •At least some recent sexual activity has been high-risk for transmission of HIV

排除标准

  • •Current major psychiatric diagnosis
  • •Only HIV+ sex partners in past two months
  • •Consistently protected sex with HIV- or serostatus-unknown partners in last two months
  • •Sexually inactive in last two months
  • •Found out about HIV+ status less than two months ago

研究组 & 干预措施

1

Experimental

Five-session behavior change intervention that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports).

干预措施: EDGE counseling, no maintenance (Behavioral)

2

Experimental

Five-session behavior change intervention (identical to Arm 1) that combines client-centered motivational interviewing and structured behavioral counseling (to address context of unsafe sex/drug use; condom use, safer sex negotiation; disclosure; and enhancement of social supports) PLUS eight group-format safer sex maintenance counseling sessions, which utilize clinical strategies from relapse prevention to identify high risk situations and develop effective coping strategies.

干预措施: EDGE counseling, plus maintenance (Behavioral)

3

Active Comparator

An attention-control condition that is time-equivalent to Arm 2, and addresses diet, exercise, and HIV.

干预措施: Attention control (Behavioral)

结局指标

主要结局

Reduction of defined sexual risk behaviors

时间窗: 18 months

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

Thomas L. Patterson

Principal Investigator

University of California, San Diego

研究点 (1)

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