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

November 12, 2025 updated by: Kristin Beima-Sofie, University of Washington
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1920

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kristin M Beima-Sofie, PhD, MPH
  • Phone Number: 206-685-8332
  • Email: beimak@uw.edu

Study Contact Backup

Study Locations

  • Kenya
      • Awendo, Kenya
        • Recruiting
        • Awendo Sub County Hospital
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-723227477
          • Email: mnn3@uw.edu
      • Awendo, Kenya
        • Recruiting
        • Uriri Sub County Hospital
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-701969623
          • Email: mnn3@uw.edu
      • Gatundu, Kenya
        • Recruiting
        • Gatundu Level 5 Hospital
        • Contact:
      • Kiambu, Kenya
      • Kiambu, Kenya
        • Recruiting
        • Wangige Sub-County Hospital
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-723243427
          • Email: mnn3@uw.edu
      • Kikuyu, Kenya
      • Limuru, Kenya
      • Migori, Kenya
        • Recruiting
        • Dede Health Centre
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-727629677
          • Email: mnn3@uw.edu
      • Migori, Kenya
        • Recruiting
        • Migori County Referral Hospital
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-794456890
          • Email: mnn3@uw.edu
      • Migori, Kenya
        • Recruiting
        • Arombe Dispensary
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-797603497
          • Email: mnn3@uw.edu
      • Migori, Kenya
        • Recruiting
        • St Joseph Mission Hospital (Ombo)
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-723628148
          • Email: mnn3@uw.edu
      • Nairobi, Kenya
      • Nairobi, Kenya
        • Recruiting
        • Baraka Dispensary (Nairobi)
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-711639234
          • Email: mnn3@uw.edu
      • Nairobi, Kenya
        • Recruiting
        • Embakasi Health Centre
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-202318794
          • Email: mnn3@uw.edu
      • Nairobi, Kenya
        • Not yet recruiting
        • Kenyatta National Hospital/University of Nairobi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dalton Wamalwa, MBChB, MMed, MPH
        • Principal Investigator:
          • Irene Njuguna, MBChB, MPH, PhD
      • Nairobi, Kenya
        • Recruiting
        • Mama Lucy Kibaki Hospital
        • Contact:
      • Nairobi, Kenya
        • Recruiting
        • Mbagathi District Hospital
        • Contact:
      • Nairobi, Kenya
        • Recruiting
        • Mukuru Health Centre
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-710802246
          • Email: mnn3@uw.edu
      • Nairobi, Kenya
      • Nairobi, Kenya
        • Recruiting
        • Umoja Health Center
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-710628919
          • Email: mnn3@uw.edu
      • Rongo, Kenya
        • Recruiting
        • Rongo Sub County Hospital
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-713463946
          • Email: mnn3@uw.edu
      • Rongo, Kenya
        • Recruiting
        • Verna Health Centre
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-705574747
          • Email: mnn3@uw.edu
      • Ruiru, Kenya
      • Thika, Kenya
        • Recruiting
        • Kiandutu Health Centre
        • Contact:
          • Medical Supervisor
          • Phone Number: 254-720311498
          • Email: mnn3@uw.edu
      • Thika, Kenya
        • Recruiting
        • Thika Level 5 Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Training of trainers
Sites assigned to the standard of care (SoC) control arm will receive cascading training of trainers (ToTs) and cascade training to sites for supporting scale-up of the ATP
Experimental: Youth Enhanced Implementation Strategy (ATP-YES)
Sites assigned to the intervention arm will receive the ATP-YES implementation strategy, a multi-component youth led implementation strategy that incorporates data audits and feedback, cyclical small tests of change and learning collaboratives, to support scale-up of the ATP
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reach
Time Frame: From enrollment through 6 months post study end (42 months)
Proportion of youth living with HIV ages 15-24 years exposed to the ATP intervention
From enrollment through 6 months post study end (42 months)
Effectiveness: Successful Transfer
Time Frame: From enrollment through 6 months post study end (42 months)
Proportion of youth living with HIV who attend first adult clinic visit
From enrollment through 6 months post study end (42 months)
Effectiveness: Retention
Time Frame: From enrollment through 6 months post study end (42 months)
Number of scheduled clinic visits youth living with HIV attend in the year after transition to adult care
From enrollment through 6 months post study end (42 months)
Adoption
Time Frame: From enrollment through 6 months post study end (42 months)
Proportion of health providers in youth HIV clinics who deliver the ATP
From enrollment through 6 months post study end (42 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness: Transition Readiness
Time Frame: From enrollment through 6 months post study end (42 months)
Change in transition readiness scores
From enrollment through 6 months post study end (42 months)
Effectiveness: Viral Suppression
Time Frame: From enrollment through 6 months post study end (42 months)
Proportion of youth living with HIV who are virally suppressed 12 months after transition to adult clinics
From enrollment through 6 months post study end (42 months)
Implementation: Fidelity to ATP
Time Frame: From enrollment through 6 months post study end (42 months)
Proportion of facilities that deliver the ATP as designed
From enrollment through 6 months post study end (42 months)
Implementation: Fidelity to ATP-YES
Time Frame: From enrollment through 6 months post study end (42 months)
Proportion of facilities that deliver the ATP-YES as designed in intervention clinics
From enrollment through 6 months post study end (42 months)
Maintenance
Time Frame: From study end (36 months) through 6 months post study end (42 months)
Proportion of clinics that continue use the ATP as designed 6 months post study
From study end (36 months) through 6 months post study end (42 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reach
Time Frame: From enrollment through 6 months post study end (42 months)
Proportion of YLH who do not know their HIV status who are exposed to the disclosure intervention
From enrollment through 6 months post study end (42 months)
Effectiveness: Disclosure
Time Frame: From enrollment through 6 months post study end (42 months)
Proportion of YLH who know their HIV status
From enrollment through 6 months post study end (42 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)
Kenyatta National Hospital
University of Nairobi, Kenya

Investigators

  • Principal Investigator: Kristin M Beima-Sofie, PhD, MPH, University of Washington
  • Principal Investigator: Irene Njuguna, MBChB, MPH, PhD, Kenyatta National Hospital
  • Principal Investigator: Grace John-Stewart, MD, PhD, MPH, University of Washington
  • Principal Investigator: Dalton Wamalwa, MBChB, MMed, MPH, University of Nairobi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2025

Primary Completion (Estimated)

January 30, 2029

Study Completion (Estimated)

January 30, 2029

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00020373
  • 1R01MH136897 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The research community will have access to data when the award ends. De-identified individual and aggregate survey data (including raw and recoded data) will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates. As required by NDA, studies will also be created that contain the data used for every publication.

Documentation to be made publicly available to the research community will include PDF, Word, and Excel documents containing survey instruments, interview guides, data collection protocols, codebooks for surveys and qualitative analysis, and code used in survey data analyses.

Abstracted medical records will be used as secondary data and will not be shared. Transcripts from focus group discussions and interviews with providers, and voice recordings of focus groups or interviews from youth and providers will not be shared to protect participant privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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