Actively Recruiting
Scale-up of an Evidence-based Adolescent Transition Package to Support Transitional Care Among Youth Living With HIV
Led by University of Washington · Updated on 2025-11-14
1920
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to improve care for youth living with HIV in Kenya by scaling up an evidence-based Adolescent Transition Package (ATP). The study evaluates how well a youth-led, data-driven implementation strategy (ATP-YES) supports the transition from pediatric to adult HIV care compared to the standard of care. It focuses on improving youth readiness to transition, viral suppression, retention in care, and overall health outcomes using a cluster randomized controlled trial design involving 32 clinics across four counties. The study compares two approaches: standard of care implementation using a trainer of trainers (ToT) method and an enhanced ATP-YES strategy that includes youth-led data audits, feedback, and collaborative learning cycles. Existing healthcare workers at clinics will deliver the ATP during routine visits over a 36-month intervention period. Youth aged 10-24 will be offered the ATP, with those aged 15-24 invited to participate in surveys and focus groups. Clinics are randomized 1:1 to either intervention or control arms. Participants will be involved in surveys, focus groups, and routine medical record reviews. Healthcare workers will provide feedback through interviews and continuous quality improvement activities. The study tracks outcomes such as ATP reach, adoption by providers, fidelity of implementation, viral suppression, retention, and transition readiness over 42 months. Costs and budget impacts of the ATP-YES strategy will also be evaluated. The project includes youth advisory boards and collaboration with Kenyan health authorities to ensure alignment with national priorities.
CONDITIONS
Brief Title
Scale-up of an Evidence-based Adolescent Transition Package to Support Transitional Care Among Youth Living With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthcare providers aged 18 years or older
- Employed at one of the 32 participating facilities
- Provides HIV services to adolescents at their clinic
- Adolescents and youth living with HIV between 10 and 24 years old
- Receives HIV clinical care at a participating clinic
- Attended at least one clinic visit after intervention implementation
- Youth aged 15 to 24 years invited to participate in surveys and focus groups
You will not qualify if you...
- Individuals with conditions that increase risk or prevent full compliance with the study
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 36 months
Participants receive support through an adolescent transition package delivered by healthcare workers during routine clinic visits to help youth living with HIV transition from pediatric to adult care.
Routine clinic visits for HIV care during the 36-month intervention period
Duration - 6 months
Participants are observed for continued use and impact of the transition package after the intervention period ends.
Follow-up visits occurring up to 6 months after the 36-month study period
Trial Site Locations
Total: 25 locations
1
Awendo Sub County Hospital
Awendo, Kenya
Actively Recruiting
2
Uriri Sub County Hospital
Awendo, Kenya
Actively Recruiting
3
Gatundu Level 5 Hospital
Gatundu, Kenya
Actively Recruiting
4
Kiambu County Referral Hospital
Kiambu, Kenya
Actively Recruiting
5
Wangige Sub-County Hospital
Kiambu, Kenya
Actively Recruiting
6
Kikuyu (PCEA) Hospital
Kikuyu, Kenya
Actively Recruiting
7
Nazareth Hospital
Limuru, Kenya
Actively Recruiting
8
Arombe Dispensary
Migori, Kenya
Actively Recruiting
9
Dede Health Centre
Migori, Kenya
Actively Recruiting
10
Migori County Referral Hospital
Migori, Kenya
Actively Recruiting
11
St Joseph Mission Hospital (Ombo)
Migori, Kenya
Actively Recruiting
12
Baraka Dispensary (Nairobi)
Nairobi, Kenya
Actively Recruiting
13
Embakasi Health Centre
Nairobi, Kenya
Actively Recruiting
14
Kenyatta National Hospital/University of Nairobi
Nairobi, Kenya
Not Yet Recruiting
15
Mama Lucy Kibaki Hospital
Nairobi, Kenya
Actively Recruiting
16
Mbagathi District Hospital
Nairobi, Kenya
Actively Recruiting
17
Mukuru Health Centre
Nairobi, Kenya
Actively Recruiting
18
Pumwani Maternity Hospital
Nairobi, Kenya
Actively Recruiting
19
Tabitha Medical Clinic
Nairobi, Kenya
Actively Recruiting
20
Umoja Health Center
Nairobi, Kenya
Actively Recruiting
21
Rongo Sub County Hospital
Rongo, Kenya
Actively Recruiting
22
Verna Health Centre
Rongo, Kenya
Actively Recruiting
23
Ruiru Sub-County Hospital
Ruiru, Kenya
Actively Recruiting
24
Kiandutu Health Centre
Thika, Kenya
Actively Recruiting
25
Thika Level 5 Hospital
Thika, Kenya
Actively Recruiting
Research Team
K
Kristin M Beima-Sofie, PhD, MPH
I
Irene Njuguna, MBChB, MPH, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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