CompletedNot Applicable

ADAPT for Adolescents Adolescents

Kenya880 participantsStarted 2021-04-06

Plain-language summary

Adolescents and young adults (AYA) with HIV face unique challenges to engagement in care and their ability to achieve optimal health outcomes. The investigators hypothesize that developmentally-tailored behavioral interventions will improve engagement in HIV care and viral suppression (per current MOH guidelines) among AYA with HIV in Kenya. This two stage study will initially randomize 880 AYA with HIV to either standard of care (SOC) or electronic navigation to prevent treatment lapse. Participants who have a lapse will be re-randomized to SOC, in-person peer navigation, or conditional cash transfers. Formative work will be conducted initially to tailor the interventions to AYA and then later to assess AYA perception, experience, and satisfaction with the interventions. We will evaluate the most effective and cost-effective intervention and sequence of interventions to inform HIV program managers, public policy makers, and other key stakeholders the best approaches to improve engagement of care of AYA with HIV.

Who can participate

Age range

14 Years – 24 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: * HIV-infection, on or initiating ART, * 14-24 years of age, * Living \> 6 months in Kisumu County, Kenya in previous year, * Capable of informed consent (\> 18 years) or with a legal caregiver available for consent (14-\<18 years), * Access to a cell phone, * Ability to read or be read short message service (SMS) messages, * Willingness to be contacted by clinic upon missed appointment, * For AYA who report phone sharing must have disclosed to the person sharing the phone. * Additionally, we will include AYA who are aware of their HIV status or whose caregivers agree to assisted disclosure. Exclusion Criteria: * AYA who participated in ADAPT-R, * Those planning to move out of Kisumu County, those acutely ill and requiring hospitalization, * Those who report sharing phones but have not disclosed to the person sharing the phone

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

Care engagement failure

Timeframe: 24 months

Re-engagement

Timeframe: 24 months

Sustained viral suppression and engagement in care

Timeframe: 24 months

Trial details

NCT IDNCT04432571

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-13

View on ClinicalTrials.gov More HIV/AIDS trials

Plain-language summary

Who can participate

Age range

14 Years – 24 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.