Implementation of Point of Care HIV Viral Load Monitoring to Improve Viral Load Suppression Among Children, Adolescents and Young People Living With HIV in East Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 956
- 试验地点
- 7
- 主要终点
- The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up.
研究概览
简要总结
The purpose of EAPoC-VL project is to examine the feasibility, acceptability, and effectiveness of using point of care viral load (PoC VL) monitoring to improve viral load suppression among children, adolescents and young people (age ≤24 years) living with HIV in Kenya, Rwanda, Tanzania and Uganda.
详细描述
Main Study Aims:
i) To determine the effectiveness of PoC VL monitoring in improving viral suppression among children, adolescents and young people living with HIV in East Africa.
ii) To evaluate feasibility and acceptability of using PoC VL monitoring among children, adolescents and young people living with HIV in East Africa.
iii) To understand the psychosocial life of children, adolescents and young people living with HIV in East Africa and how they predict adherence and viral load suppression
Objectives of Aim 1:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6 months - 24 years
- •Documented evidence of HIV infection
- •Receiving ART for treatment of HIV infection for at least 6 months.
- •Has had a detectable VL of >1000 copies/ml in the last 6 months.
- •Guardian, parent or legal representative able and willing to give voluntary consent and sign/mark an informed consent document.
- •Willing and able to comply with protocol requirements/study procedures.
排除标准
- •Any medical conditions that require pausing of ART for more than three months.
- •Potential participant already enrolled in another study which may interfere with the study outcome or participation as per investigator's judgement.
- •Child, adolescent or young person already enrolled and completed follow up in the current study.
- •Any medical or other condition in the potential participant or their parent/ guardian that precludes provision of informed consent/ assent or that may hinder achieving study objectives as per investigator's judgement.
结局指标
主要结局
The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up.
时间窗: 36 months
The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up
The time between enrolment into the study and viral suppression.
时间窗: 36 months
The time between enrolment into the study and viral suppression.
The time between enrolment into the study and viral suppression.
时间窗: 36 months
The time between enrolment into the study and viral suppression.
次要结局
- The proportion of children, adolescents and young people living with HIV that experiences virological rebound after initial suppression within 6 and 12 months of follow-up(36 months)
- The time between enrolment into the study and initiation of intensive adherence counselling following virological failure.(36 months)
- The proportion of children, adolescents and young people living with HIV that experiences change of ART regimen within 6 and 12 months of follow-up(36 months)
- The proportion of children, adolescents and young people living with HIV that is retained in care at 6 and 12 months.(36 months)
- The time between enrolment into the study and initiation of intensive adherence counselling following virological failure.(36 months)