Feasibility Study of a Community-Level, Multi-Component Intervention for Black 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
- 1,553
- 试验地点
- 14
- 主要终点
- Proportion of participants who agree to STI testing
研究概览
简要总结
It has been estimated that black men who have sex with men (MSM) account for one quarter of all new HIV infections in the US annually, yet little prevention work has been directed towards this population. The purpose of this study is to research and potentially design a new and better way to try and slow the spread of HIV among black MSM.
详细描述
In the US, men who have sex with men (MSM) comprise the largest proportion of new HIV infections, with black MSM being infected at significantly higher rates. Differences in sexual-risk behaviors and substance use do not explain the disproportionate HIV rates by race among MSM. The most likely explanations are low frequency of HIV testing, high HIV prevalence within sexual networks, high prevalence of other sexual transmitted infections (STIs), and barriers to health care access and HIV/STI treatment. These result in later diagnoses of HIV-infected men, more frequent STIs, and fewer HIV-infected men having access to care.
The purpose of this study is to gather information on the achievability and acceptability of the following interventions:
A.) Referral of up to five sexual partners by index participants for enrollment into the study B.) Counseling and testing for HIV C.) Counseling and testing for other STIs D.) Counseling and referral for care offered to participants for issues such as substance use and mental health.
E.) Engagement with peer health care system navigators (PHNs) to facilitate uptake of health care and other services.
These interventions are designed to impact several factors related to the HIV epidemic among black MSM. At the individual level, the interventions will address personal risk factors for either acquiring or transmitting HIV, including identifying undiagnosed HIV or STI infections, and helping participants to reduce risk-behaviors, such as those influenced by drugs and alcohol. The interventions are also designed to have an impact at the population level. If successful, they will lower the viral load in HIV-infected men by identifying those who qualify for HIV treatment and intervening to increase treatment and access to healthcare. Overall, the study investigators propose that by lowering both the proportion of men with undiagnosed HIV infection and those with chronic, untreated infection, the rates of HIV transmission will be reduced among the black MSM population. This is a feasibility study, designed to provide estimates about the potential effectiveness of these interventions. These estimates will then be used to determine whether a large-scale trial of the interventions would be successful.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Willing and able to provide informed consent
- •Black, African American, Caribbean Black, or multiethnic Black
- •At least one instance of unprotected anal intercourse (UAI) with a man in the past six months
- •Residing in the metropolitan area and do not plan to move away during the time of study participation
排除标准
- •Co-enrollment in any other HIV interventional research study or have been enrolled in an HIV vaccine trial in which they were either in the active arm or do not know the arm in which they were enrolled.
- •Would be enrolled as a community-recruited participant in a category that has already reached its enrollment cap
- •Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
结局指标
主要结局
Proportion of participants who agree to STI testing
时间窗: Throughout study
Proportion of participants who are newly diagnosed with HIV at enrollment
时间窗: At Study Entry
Number of participants enrolled at each city
时间窗: At 52 Weeks
Proportion of participants who use PHN
时间窗: Throughout study
Increase in condom use
时间窗: Study Entry to Week 52
Proportion of participants who agree to HIV testing
时间窗: Throughout study
Decrease in STI
时间窗: At Study Entry to Week 52
Decrease in viral load among HIV-infected participants who initiate HAART during their study participation
时间窗: At Week 52
次要结局
- Number of participants with recent HIV infection(At Study Entry)
- Number of participants with acute HIV infection(At Week 52)
- Type and frequency of anal intercourse(At Study Entry, and Weeks 26 and 52)
- Number of sex partners(At Study Entry, and Weeks 26 and 52)
- Number of seroconversions during follow-up among those who are HIV-uninfected(At Follow-up)
- Level of condom use(At Study Entry, and Weeks 26 and 52)
- Number of sero-discordant or sero-unknown partners(At Study Entry, and Weeks 26 and 52)
- As individually self-reported by participants: network size, composition, density, multiplexity, durability, and homogeneity(Throughout study)
- Overlap of participant's sexual network with his social network(Throughout study)
- Partner change rate(At Study Entry, and Weeks 26 and 52)
- Attitudes of black MSM toward other prevention interventions(Throughout study)