Reducing HIV Transmission Risk Behavior: a Trial of a Two Session Risk-Reduction Intervention With HIV-Positive Men Who Have Sex With Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 4
- 主要终点
- Reduction in HIV transmission risk behavior; measured 6 and 12 months following the initial counseling intervention
研究概览
简要总结
This study will evaluate the effectiveness of a specialized cognitive-behavioral counseling intervention in reducing sexual risk behaviors in men who are HIV-infected and report having unprotected sex with male partners who are either not HIV-infected or do not know if they are HIV-infected.
详细描述
Past research has shown that HIV-uninfected men who receive counseling regarding high-risk sexual behavior are less likely to engage in such behavior with other men. The rising rates of HIV infection among gay men suggest that some HIV-infected men are still engaging in high-risk sexual activity. There are several existing counseling interventions that focus on reducing high-risk sexual behavior, but the need exists for an intervention specifically targeted to HIV-infected men. This study will focus on the development of a specialized counseling intervention to help HIV-infected men identify and re-evaluate their "self-justifications," which are their thoughts, attitudes, and beliefs when deciding to engage in high-risk sexual activity with other men. In turn, this counseling may decrease the incidence of high-risk sexual behaviors, thereby reducing HIV infection rates among gay men. This study will evaluate the effectiveness of the specialized counseling intervention versus a standard risk-reduction counseling intervention in promoting safer sexual activity among HIV-infected men.
This study will consist of two phases. In Year 1, interviews will be conducted with 30 HIV-infected men who have engaged in high-risk unprotected sex within the previous 12 months with HIV-uninfected partners or partners with an unknown HIV status. The data resulting from these interviews will aid in the development of a specialized counseling intervention that is specifically geared for HIV-infected men. In Years 2 through 4, approximately 400 HIV-infected men will be randomly assigned to receive either the specialized counseling intervention or a standard counseling intervention. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later. Outcome measurements will be assessed at the second counseling session and again 6 months later, and will include self-reports of unprotected sex and laboratory testing for the presence of sexually transmitted diseases.
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
- Double (Participant, Investigator)
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
- •HIV-infected
- •Currently receiving HIV-specific primary medical care or mental health care
- •Reports at least one episode of unprotected sex (receptive or insertive) with a male partner who is either not infected or does not know if he is infected with HIV (within 12 months prior to study enrollment)
- •Plans to live in the San Francisco Bay Area for the next 12 months
排除标准
- •History of intercourse on a regular basis with only one person
- •Insufficient understanding of English
- •Cognitive disorder that may affect ability to give informed consent
- •Currently enrolled in any other behavioral or clinical HIV trials that could affect participation in this study
结局指标
主要结局
Reduction in HIV transmission risk behavior; measured 6 and 12 months following the initial counseling intervention
时间窗: Measured at Months 6 and 12
次要结局
未报告次要终点
研究者
James W. Dilley
Principal Investigator
University of California, San Francisco
