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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10+
SponsorUniversity of Washington

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 volunteers

Qualifiers

≥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

Design model

Parallel

Treatments tested in this trial

  • ATP-Youth Enhanced Strategy (ATP-YES)

    Other intervention

    ATP-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

1,920 Participants
are divided into 2 treatment groups
Group A: Training of trainersNo intervention 0 interventions
Group B: Youth Enhanced Implementation Strategy (ATP-YES)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Reach

Proportion of youth living with HIV ages 15-24 years exposed to the ATP intervention

Time frame
From enrollment through 6 months post study end (42 months)
2

Effectiveness: Successful Transfer

Proportion of youth living with HIV who attend first adult clinic visit

Time frame
From enrollment through 6 months post study end (42 months)
3

Effectiveness: Retention

Number of scheduled clinic visits youth living with HIV attend in the year after transition to adult care

Time frame
From enrollment through 6 months post study end (42 months)
4

Adoption

Proportion of health providers in youth HIV clinics who deliver the ATP

Time frame
From enrollment through 6 months post study end (42 months)

Secondary outcomes

1

Effectiveness: Transition Readiness

Change in transition readiness scores

Time frame
From enrollment through 6 months post study end (42 months)
2

Effectiveness: Viral Suppression

Proportion of youth living with HIV who are virally suppressed 12 months after transition to adult clinics

Time frame
From enrollment through 6 months post study end (42 months)
3

Implementation: Fidelity to ATP

Proportion of facilities that deliver the ATP as designed

Time frame
From enrollment through 6 months post study end (42 months)
4

Implementation: Fidelity to ATP-YES

Proportion of facilities that deliver the ATP-YES as designed in intervention clinics

Time frame
From enrollment through 6 months post study end (42 months)

Other outcomes

1

Reach

Proportion of YLH who do not know their HIV status who are exposed to the disclosure intervention

Time frame
From enrollment through 6 months post study end (42 months)
2

Effectiveness: Disclosure

Proportion of YLH who know their HIV status

Time frame
From enrollment through 6 months post study end (42 months)

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