Clinical trial NCT06924073: Scale-up of an Evidence-based Adolescent Transition Package to Support Transitional Care Among Youth Living With HIV
Official title: Scale-up of an Evidence-based Adolescent Transition Package to Support Transitional Care Among Youth Living With HIV
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adolescent HIV Infection
Transition to Adult Care
Implementation Science
Implementation Strategies
Keywords: Adolescent HIV
Transition to Adult Care
Scale-up
Implementation science
implementation strategy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Kenyatta National Hospital
name: University of Nairobi, Kenya
First posted: 2025-04-11
Enrollment: 1920
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: The proposed project extends the team's previously conducted cluster randomized controlled trial, the Adolescent Transition to Adult Care (ATTACH) study (NIH R01HD089850-01; PI John-Stewart). This new R01 tests an implementation strategy to improve scale up of an Adolescent Transition Package (ATP), developed during the previous clinical trial, within health facilities in Kenya and evaluate the cost-effectiveness and budget impact of the implementation strategy. Primary outcomes include measuring intervention uptake and delivery outcomes using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, factors influencing implementation, clinical outcomes, and cost.

The ATP is a healthcare worker (HCW) delivered toolkit that supports the transition from pediatric to independent care for youth living with HIV (YLH). The ATP was developed by the ATTACH study, working in partnership with the Kenya Ministry of Health and other key collaborators leading treatment and care provision in Kenya. The ATP is designed to support transition to adult care for YLH and provide YLH with the knowledge and skills needed to independently manage HIV. The ATP combined two evidence-based interventions from other contexts (Namibia and the United States) and adapted them to better meet Kenyan patient, provider and health system needs. The ATP was tested in a randomized controlled trial of 20 clinics in 4 counties in Kenya (ATTACH study), and shown to significantly improve readiness to transition among YLH in intervention sites compared to those in the control. HCWs and YLH appreciated the content and design of the ATP as they found it feasible and acceptable for routine clinic use.

During this scale up focused R01, the ATP will be administered at the clinic level by existing HCWs during routine YLH clinic visits, as in the original trial. In all participating clinics, all eligible adolescents aged 10-24 years will have medical record data abstracted, and older YLH (ages 15-24) will be offered the opportunity to participate in surveys and qualitative data collection. HCWs from participating clinics will provide feedback on implementation throughout the study and work to optimize delivery of the ATP within their clinic settings.

The ATTACH-Scale study includes implementation of the ATP in 32 clinics. The 32 study sites for this R01 will be selected from a large list of eligible facilities, and specific clinics will be selected by prioritizing high HIV volume clinics (\>50 YLH per clinic), existing collaborations (ex: ATTACH study sites), and MoH priorities. Selection of intervention and control sites will be done using stratified randomization, balancing for county and model of HIV care in the clinic, by a biostatistician based at the University of Washington. The units of analysis vary by study aim, and are either at the level of the HCW, YLH, or clinic, depending on the specific aim and outcome being assessed.

Specific details for each study aim are described below.

Aim 1 (SCALE-UP): Using an effectiveness-implementation hybrid III design, the study will test the impact of ATP scale-up using the Kenya MoH standard of care (SoC) implementation strategy (Trainer of Trainers \[ToT\]) versus an enhanced scale-up implementation strategy that includes the SoC plus youth-led data- driven intervention adaptations (ATP-YES). ATP-YES is a multi-component youth led package that incorporates weekly data assessments, data review and adaptation meetings, and cross collaborative learning across intervention sites. In total, 32 HIV clinics (4 counties, 8 per county) will be randomized 1:1 to 36 months of ATP-YES or SoC alone. The Reach, Effectiveness, Adoption, Implementation and Maintenance \[RE-AIM\] framework will be used to evaluate and compare ATP implementation and guide real-time ATP adaptations. Specifically, ATP reach (YLH exposed to ATP), effectiveness (intervention effect on transition readiness, viral suppression and retention), adoption (proportion of HCWs implementing the ATP), implementation (fidelity to ATP processes), and maintenance (continued use post-trial) will be measured at each study site and compared between intervention and control arms. The Consolidated Framework for Implementation Research (CFIR) will be used to understand the role of context on how and why the ATP-YES strategy is or is not successful. The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) will be used to systematically study adaptations to the ATP and ATP-YES implementation strategy.

Aim 2 (COSTING): Simultaneously with Aim 1, program costs will be captured and the budget impact of ATP-YES will be compared between intervention and control sites. Micro costing, involving HCW interviews and time and motion observations, will be used to estimate the incremental costs of implementing the ATP-YES strategy and develop a model to project the health impact (HIV deaths and morbidity averted) and financial costs of ATP-YES compared to SoC.

Impact: The study will determine whether the ATP-YES can be used to effectively and affordably support implementation of the ATP in Kenya. The study team hypothesizes that this implementation strategy will improve uptake, integration, and delivery of the ATP within existing YLH clinics.

Alongside study aims, this project will engage communities, build capacity for IS research among youth, program implementers and policy-makers, and participate in collaborative science. The project includes collaboration with MOH in Kenya to ensure transition tools and implementation processes align with and integrate MOH priorities and strategies. The study also includes creation of a youth advisory board and engagement of policy-makers, HCWs, program implementers and other key stakeholders throughout the entirety of the study. Finally, the study supports youth to gain research skills and build capacity for conducting research through their leadership roles in ATP-YES, involvement in youth mentorship programs, and the youth advisory board.

Eligibility criteria: Inclusion Criteria:

Healthcare providers

* ≥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)
* Receives HIV clinical care at one of the clinics included in the study
* Attended clinic ≥1 time following intervention implementation

Exclusion Criteria:

Any individual who meets the following criteria will be excluded from participation in this study:

- Conditions that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study

Primary outcomes:
measure: Reach
timeFrame: From enrollment through 6 months post study end (42 months)
measure: Effectiveness: Successful Transfer
timeFrame: From enrollment through 6 months post study end (42 months)
measure: Effectiveness: Retention
timeFrame: From enrollment through 6 months post study end (42 months)
measure: Adoption
timeFrame: From enrollment through 6 months post study end (42 months)
Secondary outcomes:
measure: Effectiveness: Transition Readiness
timeFrame: From enrollment through 6 months post study end (42 months)
measure: Effectiveness: Viral Suppression
timeFrame: From enrollment through 6 months post study end (42 months)
measure: Implementation: Fidelity to ATP
timeFrame: From enrollment through 6 months post study end (42 months)
measure: Implementation: Fidelity to ATP-YES
timeFrame: From enrollment through 6 months post study end (42 months)
measure: Maintenance
timeFrame: From study end (36 months) through 6 months post study end (42 months)
Other outcomes:
measure: Reach
timeFrame: From enrollment through 6 months post study end (42 months)
measure: Effectiveness: Disclosure
timeFrame: From enrollment through 6 months post study end (42 months)
Locations:
city: Nairobi
country: Kenya
facility: Kenyatta National Hospital/University of Nairobi
Study officials:
affiliation: University of Washington
name: Kristin M Beima-Sofie, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenyatta National Hospital
name: Irene Njuguna, MBChB, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Grace John-Stewart, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nairobi
name: Dalton Wamalwa, MBChB, MMed, MPH
role: PRINCIPAL_INVESTIGATOR
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