Actively Recruiting

Phase Not Applicable
Age: 10Years +
All Genders
Healthy Volunteers
ID06924073

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

Age: 10Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation of Transition Package

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

Post-study Follow-up

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

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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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