Study to Determine the Effect of HIV Self-testing on the Uptake of and Retention in Pre-exposure Prophylaxis Service Among Older Adolescent Men Who Have Sex With Men and Transgender Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- Proportion of participants taking PrEP retaining in care among those who use and do not use HIVST
研究概览
简要总结
This will be a prospective study that will enroll up to 600 older adolescent MSM and TGW from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.
详细描述
All eligible participants will be followed up at month 3, 6, 9, and 12; month 6 and 12 will be mandatory clinic visits, while month 3 and 9 will be either clinic or a virtual visits. For participants accepting PrEP, additional follow-up visit at month 1, 2, 4, and 5 will be appointed; all visits will be either clinic or virtual visits.
Study Sites
The study will take place at the following community-based clinics:
- SWING DIC, Bangkok, Thailand
- RSAT DIC, Bangkok, Thailand
- SWING DIC, Chonburi, Thailand
- Sister DIC, Chonburi, Thailand
- Caremat DIC, Chiang Mai, Thailand
- MPlus DIC, Chiang Mai, Thailand
- RSAT DIC, Songkhla, Thailand
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
- 15 Years 至 19 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Thai nationality
- •Age 15-19 years old
- •Men or transgender women who have sex with men
- •HIV-negative at the time of screening
- •Have at least one of the following risks for HIV acquisition in the past 6 months:
- •Any unprotected receptive anal sex with a male partner
- •More than 5 male partners, regardless of condom use and serostatus
- •Has had a bacterial sexually transmitted infection (STI)
- •Any injected drug use
- •Calculated creatinine clearance (CrCl) ≥ 75 mL/min, as estimated by the Cockcroft- Gault equation
- •Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- •Have signed the informed consent form
排除标准
- •HIV-positive
- •Hepatitis B infection as indicated by positive hepatitis B surface antigen (HBsAg) test at time of screening
- •Known allergy/sensitivity to tenofovir or emtricitabine
结局指标
主要结局
Proportion of participants taking PrEP retaining in care among those who use and do not use HIVST
时间窗: 3 years
Proportion of participants starting PrEP among those who use and do not use HIVST
时间窗: 3 years
次要结局
未报告次要终点