Project Mix: Behavioral Intervention to Reduce Sexual Risk Behavior of Substance-Using (Non-Injection) Men Who Have Sex With Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,686
- 试验地点
- 6
- 主要终点
- Decrease in the number of unprotected anal sex partners (and acts) while under the influence of AOD as reported at 3-, 6-, and 12-month follow-up assessments compared to baseline assessments.
研究概览
简要总结
The purpose of this project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk for HIV infection among non-injection, substance-using men who have sex with men (SUMSM). The primary goal of the intervention is to reduce HIV transmission by reducing the incidence of unprotected anal sex while under the influence of alcohol and other drugs (AOD).
详细描述
Men who have sex with men (MSM) continue to be the largest risk category for incident and prevalent cases of HIV and AIDS in the U.S. Studies of MSM have established an association between alcohol and other drug (AOD) use and risky sexual behaviors. Although studies have assessed and confirmed the association of AOD use and unsafe sex, few have focused specifically on reducing sexual risk of SUMSM.
Sexual risk reduction interventions for MSM identified in the published scientific literature have demonstrated that they are generally effective at reducing sexual risk behaviors among MSM. However, none of these interventions specifically targeted non-injecting SUMSM. Thus, a gap exists in prevention efforts to reduce HIV transmission among SUMSM.
The primary aim of the Project Mix overall is to develop and evaluate a practical intervention strategy that is specifically tailored to the needs of non-injecting SUMSM. The intent of the intervention is to decrease the number of unprotected anal sex partners (and acts) while under the influence of AOD and in general.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •be 18 years of age or older;
- •self-identify as male;
- •understand and read English;
- •live within the metropolitan area;
- •report being drunk or "buzzed" on alcohol 2 or more times or high on non-injection drugs at least once during (or two hours before) anal sex in the past six months;
- •have had at least one unprotected anal sex episode in the past six months with a male partner of unknown or different HIV-status than their own (i.e., DUA)
排除标准
- •report only marijuana, only Viagra or only marijuana and Viagra use during anal sex (current research shows that marijuana use is not associated with sexual risk behavior);
- •report injecting drugs (eligible if only methamphetamine, steroids, hormones and/or prescribed medications) in the past six months;
- •have known their HIV-positive status for less than six months (this is done to allow for psychological and behavioral adjustment following an initial HIV diagnosis and this time frame coincides with our screening window); these men (if they so desire) will be put on a wait list and contacted after 6 months have passed since their first HIV-positive test result;
- •are currently involved in another HIV behavioral intervention study for MSM [local study site identifies a list of such studies in their community at the time of the trial];
- •have a specific plan to move from the metropolitan area within the next 15 months;
- •participated in the pilot phase of the project;
- •other reasons that the investigators deem would make participation either detrimental to the participant or to the study.
研究组 & 干预措施
Control
Waitlist control
Intervention
Behavioral discussion sessions focused on reducing substance use and sexual risk behavior
干预措施: Discussion Group (Behavioral)
Comparison
Video discussion on health issues unrelated to HIV prevention and substance use
干预措施: Video Discussion Group (Behavioral)
结局指标
主要结局
Decrease in the number of unprotected anal sex partners (and acts) while under the influence of AOD as reported at 3-, 6-, and 12-month follow-up assessments compared to baseline assessments.
时间窗: 3 months
Decrease in the number of unprotected anal sex partners (and acts) as reported at 3-, 6-, and 12-month follow-up assessments compared to baseline assessments.
时间窗: 3 months
次要结局
未报告次要终点
研究者
Gordon Mansergh
Project Officer/Senior Scientist
Centers for Disease Control and Prevention