About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥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)
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
ATP-Youth Enhanced Strategy (ATP-YES)
Other interventionATP-YES is a multi-component youth led implementation strategy that incorporates data audits and feedback, cyclical small tests of change and learning collaboratives
Treatment groups
Trial outcomes
Primary outcomes
Reach
Proportion of youth living with HIV ages 15-24 years exposed to the ATP intervention
Effectiveness: Successful Transfer
Proportion of youth living with HIV who attend first adult clinic visit
Effectiveness: Retention
Number of scheduled clinic visits youth living with HIV attend in the year after transition to adult care
Adoption
Proportion of health providers in youth HIV clinics who deliver the ATP
Secondary outcomes
Effectiveness: Transition Readiness
Change in transition readiness scores
Effectiveness: Viral Suppression
Proportion of youth living with HIV who are virally suppressed 12 months after transition to adult clinics
Implementation: Fidelity to ATP
Proportion of facilities that deliver the ATP as designed
Implementation: Fidelity to ATP-YES
Proportion of facilities that deliver the ATP-YES as designed in intervention clinics
Other outcomes
Reach
Proportion of YLH who do not know their HIV status who are exposed to the disclosure intervention
Effectiveness: Disclosure
Proportion of YLH who know their HIV status
Sponsors and contacts
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University of Washington
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Kenyatta National Hospital
Collaborator
University of Nairobi, Kenya
Collaborator