Scale-up of an Evidence-based Adolescent Transition Package to Support Transitional Care Among Youth Living With HIV

NCT06924073 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1920

Last updated 2025-11-14

No results posted yet for this study

Summary

Ending the HIV epidemic for youth living with HIV will require implementation and optimization of evidence-based interventions that address barriers to treatment. The proposed implementation study will test a youth-led data-driven implementation strategy to scale-up an evidence-based Adolescent Transition Package (ATP) aimed at improving transition processes and post-transition clinical outcomes for youth living with HIV in Kenya. Clinics will be randomized to receive standard of care implementation through trainer of trainers or the youth-led data-driven implementation strategy alongside trainer of trainers. We will study whether the enhanced implementation strategy improves the number of youth who receive the ATP, the number of providers that initially chose to use the ATP, and the consistency with which the ATP is used over time. We will also evaluate the cost of the ATP and whether the ATP improves health outcomes among youth living with HIV, including viral suppression and retention in care. Healthcare workers at study sites will complete surveys, focus group discussions, interviews, and participate in continuous quality improvement processes. Youth will participate in surveys and focus groups, and have their routine medical records abstracted.

Conditions

  • Adolescent HIV Infection
  • Transition to Adult Care
  • Implementation Science
  • Implementation Strategies

Interventions

OTHER

ATP-Youth Enhanced Strategy (ATP-YES)

ATP-YES is a multi-component youth led implementation strategy that incorporates data audits and feedback, cyclical small tests of change and learning collaboratives

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Kenyatta National Hospital

    collaborator OTHER_GOV
  • University of Nairobi, Kenya

    collaborator UNKNOWN
  • University of Washington

    lead OTHER

Principal Investigators

  • Kristin M Beima-Sofie, PhD, MPH · University of Washington

  • Irene Njuguna, MBChB, MPH, PhD · Kenyatta National Hospital

  • Grace John-Stewart, MD, PhD, MPH · University of Washington

  • Dalton Wamalwa, MBChB, MMed, MPH · University of Nairobi

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-16
Primary Completion
2029-01-30
Completion
2029-01-30

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06924073 on ClinicalTrials.gov