Youth-focused Strategies to Promote Adherence to Pre-exposure Prophylaxis Among Youth At-risk for HIV in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- PrEP Adherence
研究概览
简要总结
A randomized controlled clinical trial looking at the effect of use of a mobile phone application in addition to standard care compared to standard care alone at a youth-friendly clinic in young men who have sex with men and transgender women aged between 15-19 years at risk of HIV on PrEP adherence.
详细描述
OBJECTIVES
Primary Objectives:
To study PrEP adherence in adolescent MSM who are at high risk of HIV acquisition.
Secondary Objectives:
To study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Adolescent men who have sex with men
- •At high risk of HIV infection (have at least one of the following)
- •More than 1 sexual partner in the last 6 months
- •Irregular condom use during sexual intercourse
- •HIV positive sexual partner
- •Age 15 to under 20 years old
- •A desire to take PrEP to prevent HIV infection
- •Tested HIV negative within 1 month of enrolment
- •Able to provide written consent or assent to take part in the clinical trial
排除标准
- •Signs or symptoms of acute retroviral syndrome that cannot be confirmed to be due to alternate causes, including unremitting fevers, headaches, myalgia, fatigue, and lymphadenopathy
结局指标
主要结局
PrEP Adherence
时间窗: Weekly self-reported adherence for a period of 6 months following randomization
Self-Reported Adherence
PrEP Adherence at 3 months
时间窗: Measured at month 3 (measure of 17 day half life of TDF-DP)
Measured Serum TDF-DP Level (from dried blood spots)
PrEP Adherence at 6 months
时间窗: Measured at month 6 (measure of 17 day half life of TDF-DP)
Measured Serum TDF-DP Level (from dried blood spots)
次要结局
- Rates of Urethral Chlamydia trachomatis(duration of study (6 months))
- HIV infection rates(duration of study (6 months))
- Behaviour Risk-Taking(duration of study (6 months))
- Rates of Anal Chlamydia trachomatis(duration of study (6 months))
- Rates of Syphilis Infection(duration of study (6 months))
- Rates of Hepatitis B infection(At initial project visit (month 0))
- Rates of Urethral Neisseria gonorrhea(duration of study (6 months))
- Rates of Anal Neisseria gonorrhea(duration of study (6 months))
研究者
Wipaporn Natalie Songtaweesin, MD.
Principal Investigator, Clinical Researcher
Chulalongkorn University