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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 956
- Locations
- 7
- Primary Endpoint
- The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up.
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 24 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The proportion of children, adolescents and young people living with HIV that achieves viral suppression at 6 and 12 months of follow-up.
Time Frame: 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.
Time Frame: 36 months
The time between enrolment into the study and viral suppression.
The time between enrolment into the study and viral suppression.
Time Frame: 36 months
The time between enrolment into the study and viral suppression.
Secondary Outcomes
- 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)