Support for Adolescents Living With HIV in South Africa (NCT06035445) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Support for Adolescents Living With HIV in South Africa
South Africa570 participantsStarted 2024-02-02
Plain-language summary
This is a cluster randomized controlled trial determining the effectiveness of in-person or mHealth-based adolescent-friendly transition interventions compared to standard care on retention in care and viral suppression among adolescents living with HIV who have low transition readiness. Participants are adolescents living with HIV ages 15 to 19 years old in KwaZulu-Natal, South Africa.
Who can participate
Age range
15 Years – 19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Adolescent Participants:
* Aged 15 to 19 years at enrollment
* Living with perinatally-acquired HIV
* Receiving ART for at least 6 months
* Aware of their HIV status
* Scoring low to intermediate on transition readiness assessment (intervention cohort only)
Inclusion Criteria for Healthcare Providers:
* Profession as a healthcare provider
* Working at one of the designated clinics
* Involvement with adolescents before, during or after transition to adult care
Exclusion Criteria for all participants:
* Inability to read and/or speak English or Zulu
* Severe mental or physical illness preventing participation in informed consent activities
* Anticipated move out of clinic area in the next 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Retained in Care
Timeframe: After the 9 month intervention (Month 9 or Month 18)
2
Change in Number of Participants with Viral Suppression
Timeframe: Baseline, After the 9 month intervention (Month 9 or Month 18)