NCT06924073

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,920

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Oct 2025Jan 2029

First Submitted

Initial submission to the registry

April 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

October 16, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2029

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

3.3 years

First QC Date

April 4, 2025

Last Update Submit

November 12, 2025

Conditions

Adolescent HIV InfectionTransition to Adult CareImplementation ScienceImplementation Strategies

Keywords

Adolescent HIVTransition to Adult CareScale-upImplementation scienceimplementation strategy

Outcome Measures

Primary Outcomes (4)

  • Reach

    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

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

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

  • Effectiveness: Retention

    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

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

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

Secondary Outcomes (5)

  • Effectiveness: Transition Readiness

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

  • Effectiveness: Viral Suppression

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

  • Implementation: Fidelity to ATP

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

  • Implementation: Fidelity to ATP-YES

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

  • Maintenance

    From study end (36 months) through 6 months post study end (42 months)

Other Outcomes (2)

  • Reach

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

  • Effectiveness: Disclosure

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

Study Arms (2)

Training of trainers

NO INTERVENTION

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

Youth Enhanced Implementation Strategy (ATP-YES)

EXPERIMENTAL

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)

Interventions

ATP-Youth Enhanced Strategy (ATP-YES)OTHER

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

Youth Enhanced Implementation Strategy (ATP-YES)

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Awendo Sub County Hospital

Awendo, Kenya

RECRUITING

Uriri Sub County Hospital

Awendo, Kenya

RECRUITING

Gatundu Level 5 Hospital

Gatundu, Kenya

RECRUITING

Kiambu County Referral Hospital

Kiambu, Kenya

RECRUITING

Wangige Sub-County Hospital

Kiambu, Kenya

RECRUITING

Kikuyu (PCEA) Hospital

Kikuyu, Kenya

RECRUITING

Nazareth Hospital

Limuru, Kenya

RECRUITING

Arombe Dispensary

Migori, Kenya

RECRUITING

Dede Health Centre

Migori, Kenya

RECRUITING

Migori County Referral Hospital

Migori, Kenya

RECRUITING

St Joseph Mission Hospital (Ombo)

Migori, Kenya

RECRUITING

Baraka Dispensary (Nairobi)

Nairobi, Kenya

RECRUITING

Embakasi Health Centre

Nairobi, Kenya

RECRUITING

Kenyatta National Hospital/University of Nairobi

Nairobi, Kenya

NOT YET RECRUITING

Mama Lucy Kibaki Hospital

Nairobi, Kenya

RECRUITING

Mbagathi District Hospital

Nairobi, Kenya

RECRUITING

Mukuru Health Centre

Nairobi, Kenya

RECRUITING

Pumwani Maternity Hospital

Nairobi, Kenya

RECRUITING

Tabitha Medical Clinic

Nairobi, Kenya

RECRUITING

Umoja Health Center

Nairobi, Kenya

RECRUITING

Rongo Sub County Hospital

Rongo, Kenya

RECRUITING

Verna Health Centre

Rongo, Kenya

RECRUITING

Ruiru Sub-County Hospital

Ruiru, Kenya

RECRUITING

Kiandutu Health Centre

Thika, Kenya

RECRUITING

Thika Level 5 Hospital

Thika, Kenya

RECRUITING

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin M Beima-Sofie, PhD, MPH

CONTACT

206-685-8332beimak@uw.edu

Irene Njuguna, MBChB, MPH, PhD

CONTACT

irenen@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

April 4, 2025

First Posted

April 11, 2025

Study Start

October 16, 2025

Primary Completion (Estimated)

January 30, 2029

Study Completion (Estimated)

January 30, 2029

Last Updated

November 14, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Locations

KE(25)