Pre-exposure Prophylaxis of HIV Infection Among Men Who Have Sex With Men (MSM) and Transgender Women (TG) in Suburban Yangon, Myanmar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Uptake rate of PrEP
研究概览
简要总结
HIV is concentrated among key populations in Myanmar. Globally, HIV-prevalence among transgender (TG) women is one of the highest; laboratory-confirmed prevalence is reported up to 40%. In September 2015, WHO recommended the use of Pre-Exposure Prophylaxis (PrEP) for people at substantial risk of HIV as part of a combination HIV prevention strategy. A demonstration project will take place to implement and evaluate the uptake and effectiveness of PrEP among MSM, and TG women in a clinic in Hlaingtharyar township, Yangon. The aim is to describe PrEP uptake, as well as HIV-seroconversion and STI infection rates among those who use PrEP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-negative
- •No suspicion of acute HIV infection
- •Substantial risk of HIV infection
- •Creatinine clearance is more than 30 ml/min
- •Willingness to use PrEP as prescribed, including periodic HIV testing
- •Willingness to sign informed consent
排除标准
- •Anyone who is not eligible with the inclusion criteria
研究组 & 干预措施
HIV-negative MSM/TG
Oral pre-exposure prophylaxis (PrEP) will be offered to HIV negative MSM, TG identified to be at substantial risk for HIV infection and those motivated to take daily PrEP.
干预措施: Tenofovir Disoproxil Fumarate (TDF) 300 mg (Drug)
结局指标
主要结局
Uptake rate of PrEP
时间窗: through study completion, an average of 1 year
The proportion of HIV-negative MSM and TG women who are taking PrEP among those who are eligible to take PrEP.
HIV seroconversion rate among PrEP user
时间窗: through study completion, an average of 1 year
The portion of PrEP taking HIV negative MSM and TG women who become HIV positive while he is taking PrEP among those who are taking PrEP.
STI infection rates among PrEP user(Syphilis test, Gram stain for gonorrhoea and Xpert CT/NG)
时间窗: through study completion, an average of 1 year
The number of positive episodes for either syphilis or gonorrhea or chlamydia infection among the PrEP taking MSM and Transgender women per number of testing among them.
次要结局
未报告次要终点