Bureau AIDS, TB, and STI, Thailand Ministry of Public Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Pre-Exposure Prophylaxis of HIV
研究概览
简要总结
This is a prospective observational cohort study that aims to enroll a total of 2000 Thai MSM and TG at five health facilities in four provinces of Thailand. Each participant will be followed for 18 months. Baseline and historical rates of HIV testing/re-testing, initial CD4 counts, retention in care, and ART adherence at the study clinics, at the study clinics combined, and national data (if available) will be compared with rates after implementation of the Test and Treat strategy. Analysis will also include an assessment of HIV prevalence and incidence. This study will use similar objectives, indicators, and procedures as those used in an ongoing Test and Treat study by the Thai Red Cross AIDS Research Centre in three tertiary care hospitals, and a study to be conducted with PEPFAR Key Populations Implementation Science (KPIS) funding through United States Agency for International Development (USAID), in community-based centers, allowing comparison of uptake and follow-up of MSM and TG using the Test and Treat strategy in a variety of settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Thai national
- •Age >18 year
- •Male or transgender women who reports anal intercourse with a man without using a condom at least one time in the past 6 months
- •Not known to be HIV-infected
- •Able to read and write Thai
- •Additional inclusion criteria for PrEP:
- •A negative HIV test result
- •No signs or symptoms of acute HIV infection (fever, sore throat, fatigue, rash, swollen glands, nausea, diarrhea, white spots in the mouth) during the previous month
- •Creatinine clearance >60 ml/min
- •No contraindication to PrEP medication
排除标准
- •Participating in community-based Test and Treat study
结局指标
主要结局
Pre-Exposure Prophylaxis of HIV
时间窗: 36 months
Participants must be Thai MSM or TG, aged 18 years or older, who report unprotected anal sex with a man during the previous 6 months, can read and write Thai, and are not known to be HIV-infected. To receive PrEP, participants must have a negative HIV test result, no signs or symptoms of acute HIV infection during the previous month, a creatinine clearance result \> 60 ml/min, and no contraindication to PrEP medication.
次要结局
未报告次要终点