A youth-led program to help young people with HIV move from pediatric to adult care
Scale-up of an Evidence-based Adolescent Transition Package to Support Transitional Care Among Youth Living With HIV
This project will test whether a youth-led, data-driven approach helps clinics deliver a transition package that improves care for young people living with HIV (ages 10–24) in Kenya.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1920 (estimated) |
| Ages | 10 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 25 sites (Awendo and 24 other locations) |
| Trial ID | NCT06924073 on ClinicalTrials.gov |
What this trial studies
This cluster randomized implementation trial compares standard trainer-of-trainers rollout to an enhanced youth-led, data-driven implementation strategy delivered alongside trainer-of-trainers across 32 Kenyan health facilities. The intervention is an Adolescent Transition Package (ATP), a toolkit delivered by healthcare workers to teach youth the skills needed for independent adult HIV care, adapted from prior evidence and tested previously in the ATTACH trial. Primary outcomes use the RE-AIM framework to measure reach, provider adoption, delivery consistency over time, clinical outcomes (including viral suppression and retention), and cost-effectiveness. The study will also analyze factors influencing implementation and the budget impact of scaling the ATP.
Who should consider this trial
Good fit: Young people living with HIV aged about 10–24 who receive care at one of the participating Kenyan clinics and attend at least one visit after the intervention is offered are the intended participants.
Not a fit: People who do not receive care at the participating clinics, who are outside the age range, or who do not attend clinic after the intervention is introduced are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the approach could increase the number of youth who receive structured transition support and improve post-transition retention and viral suppression.
How similar studies have performed: The ATP itself improved transition-related outcomes in the prior ATTACH randomized trial, though the youth-led scale-up implementation strategy is a new test of how best to expand the intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Healthcare providers * ≥18 years of age * Employed at one of the 32 facilities in the RCT * Provides HIV services to adolescents affiliated within their clinic Adolescents and youth living with HIV * Between 15-24 years of age (focus group discussions, surveys) or between 10-24 years of age (offered the intervention) * Receives HIV clinical care at one of the clinics included in the study * Attended clinic ≥1 time following intervention implementation Exclusion Criteria: Any individual who meets the following criteria will be excluded from participation in this study: \- Conditions that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
Where this trial is running
Awendo and 24 other locations
- Awendo Sub County Hospital — Awendo, Kenya (Recruiting)
- Uriri Sub County Hospital — Awendo, Kenya (Recruiting)
- Gatundu Level 5 Hospital — Gatundu, Kenya (Recruiting)
- Kiambu County Referral Hospital — Kiambu, Kenya (Recruiting)
- Wangige Sub-County Hospital — Kiambu, Kenya (Recruiting)
- Kikuyu (PCEA) Hospital — Kikuyu, Kenya (Recruiting)
- Nazareth Hospital — Limuru, Kenya (Recruiting)
- Arombe Dispensary — Migori, Kenya (Recruiting)
- Dede Health Centre — Migori, Kenya (Recruiting)
- Migori County Referral Hospital — Migori, Kenya (Recruiting)
- St Joseph Mission Hospital (Ombo) — Migori, Kenya (Recruiting)
- Baraka Dispensary (Nairobi) — Nairobi, Kenya (Recruiting)
- Embakasi Health Centre — Nairobi, Kenya (Recruiting)
- Kenyatta National Hospital/University of Nairobi — Nairobi, Kenya (Not_yet_recruiting)
- Mama Lucy Kibaki Hospital — Nairobi, Kenya (Recruiting)
- Mbagathi District Hospital — Nairobi, Kenya (Recruiting)
- Mukuru Health Centre — Nairobi, Kenya (Recruiting)
- Pumwani Maternity Hospital — Nairobi, Kenya (Recruiting)
- Tabitha Medical Clinic — Nairobi, Kenya (Recruiting)
- Umoja Health Center — Nairobi, Kenya (Recruiting)
- Rongo Sub County Hospital — Rongo, Kenya (Recruiting)
- Verna Health Centre — Rongo, Kenya (Recruiting)
- Ruiru Sub-County Hospital — Ruiru, Kenya (Recruiting)
- Kiandutu Health Centre — Thika, Kenya (Recruiting)
- Thika Level 5 Hospital — Thika, Kenya (Recruiting)
Study contacts
- Principal investigator: Kristin M Beima-Sofie, PhD, MPH — University of Washington
- Study coordinator: Kristin M Beima-Sofie, PhD, MPH
- Email: beimak@uw.edu
- Phone: 206-685-8332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.