Prospective Study of Study to Evaluate the Feasibility of Universal HIV Testing and Antiretroviral Treatment Regardless of CD4 Count Using the Test and Treat Strategy Among Men Who Have Sex With Men and Transgender Women in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Primary endpoints
研究概览
简要总结
Objectives
- To determine the uptake of universal HIV testing among Thai men who have sex with men (MSM) and transgender women (TG)
- To determine the uptake of antiretroviral treatment (ART) regardless of CD4 count among Thai MSM/TG who test positive for HIV
Subject population:. Men or transgender women who have sex with men,Thai nationals, age ≥18 years old, Have engaged in anal intercourse with a man without using a condom at least one time in the last 6 months or have had at least 3 male sex partners in the last 6 months,Not known to be HIV-positive (either have never been tested for HIV or have had a previous negative HIV test)
Number of participants:2000 Thai MSM and TG with approximately 76%-90% in Bangkok, 5%-12% in Lampang and 5-12% in Ubonratchathani.
详细描述
All participants will receive HIV testing at baseline. The frequency of study visits to determine HIV status in HIV-negative participants will be every 6 months for a total follow up time of 24 months. Once HIV-positive status is confirmed, participants will be offered ART immediately regardless of CD4 count. Those who accept ART will be seen more frequently following ART initiation, at 2 weeks, 4 weeks, 2 months, 3 months and every 3 months thereafter until completion of 24 months of follow-up. Those who deny immediate ART will have clinic visits every 6 months to monitor HIV disease. HIV-negative participants will be asked to come for HIV re-testing every 6 months or sooner if they feel exposed to risk
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Thai nationals
- •Age >18 years
- •Men or transgender women who have sex with men
- •Have engaged in anal intercourse with a man without using a condom at least one time in the last 6 months or have had at least 3 male sex partners in the last 6 months
- •Not known to be HIV-positive (either have never been tested for HIV or have had a previous negative HIV test)
- •Have signed the consent form
排除标准
- •Known HIV-positive serostatus
结局指标
主要结局
Primary endpoints
时间窗: December 1, 2015
* Proportion of MSM who present for testing who have not previously had an HIV test * Proportion of HIV-negative participants who have HIV re-testing over the study period * Proportion of HIV-positive participants who accept ART regardless of CD4 count
次要结局
未报告次要终点