Enhancing HIV Prevention Among HIV Infected Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up
研究概览
简要总结
This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management in promoting safer sex practices in HIV-infected men.
详细描述
In recent years, the spread of HIV and other STDs has increased, especially among men who have sex with men. This increase signifies continued sexual risk taking within this population. In order to curb the increase of HIV infections, prevention programs are needed. A standard prevention case management program has been developed; however, new programs that further improve outcomes are needed. This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management (PCM) in promoting safer sex practices in HIV-infected men.
Participants in this 1-year open-label study will be randomly assigned to receive either PCM alone or a behavioral intervention called Project Enhance, in addition to PCM. The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. PCM will entail standard case management, as well as referrals to specific services that each individual may need. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
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
- •HIV infected
- •Receives primary health care at Fenway Community Health
- •Identifies as a man who has sex with men
- •Has engaged in unprotected anal or vaginal intercourse within 3 months of study enrollment
排除标准
- •All episodes of unprotected anal intercourse occurred with only a single primary partner who is also HIV infected
- •Plans to relocate over the upcoming year
结局指标
主要结局
Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up
时间窗: Measured at Months 3, 6, 9, and 12
次要结局
- Incidence of sexually transmitted diseases(Measured at Months 3, 6, 9, and 12)
- Higher risk-reduction self-efficacy(Measured at Months 3, 6, 9, and 12)
- Increased behavioral intentions to engage in safer behaviors(Measured at Months 3, 6, 9, and 12)
- Increased risk-reduction strategies (other than condom use)(Measured at Months 3, 6, 9, and 12)