Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)
2 other identifiers
interventional
1,911
1 country
24
Brief Summary
The investigators will conduct a Phase III cluster randomized controlled trial (cRCT) to evaluate the effectiveness of the implementation of a data-informed stepped care (DiSC) intervention for HIV treatment management among adolescents living with HIV (ALHIV) in high-volume HIV clinics in Kenya. The DiSC intervention is comprised of a system to assign ALHIV to care based on their health needs and the different levels of care for each assignment group. The primary outcome will be ALHIV retention, and the secondary outcomes will include adherence, viral non-suppression, and receipt of differentiated care among ALHIV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
24 active sites
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
First Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
August 16, 2021
CompletedStudy Start
First participant enrolled
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedResults Posted
Study results publicly available
November 27, 2024
CompletedNovember 27, 2024
November 1, 2024
1.4 years
July 13, 2021
September 20, 2024
November 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Missed Visits
We will evaluate retention using a definition of missed visit and calculate the proportion of scheduled visits that are missed. Missed visits will be defined as a participant not seen within 30 days after each scheduled visit. Each scheduled visit will be classified as missed versus not missed.
12 months
Secondary Outcomes (5)
Proportion of Viral Load Results Showing Viral Non-suppression
12 months
Proportion of Visit Intervals With Good Adherence
12 months
Incidence Rate of Loss to Follow-up
12 months
Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits)
12 months
Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills)
12 months
Study Arms (2)
Data-informed Stepped Care (DiSC) arm
EXPERIMENTALAt intervention sites, HCW will assign ALHIV to different levels or intensity of HIV services depending on their current and anticipated health care needs. The stepped care framework is designed to be flexible, to accommodate variable individual and social support services available at each facility.
Standard of care
NO INTERVENTIONSites randomized to the control arm will continue with standard of care approaches for adolescent clinic visits (usually 1-3 monthly visits) regardless of health care needs and additional support as needed.
Interventions
The DiSC intervention is comprised of a data-driven system to assign adolescents to care based on their health needs and the different levels of care for each assignment group. The trajectory of services moves from a relative position of ALHIV autonomy to more intensive service provision. Intervention steps start with 1) multi-month refills or community treatment delivery (differentiated care); 2) a standard of care level for those with medical needs such as pregnancy or opportunistic infections or patient choice; 3) patient reminders/tracking and counseling and referral services for mental health needs; 4) case management of unsuppressed individuals, including enhanced counseling and case conference problem-solving
Eligibility Criteria
You may qualify if:
- HIV-positive
- Enrolled in HIV care
- Provision of informed consent
- Willing and able to give informed consent
You may not qualify if:
- \- Not able or willing to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Asumbi Health Centre
Homa Bay, Kenya
Homa Hills Health Centre
Homa Bay, Kenya
Kendu Adventist Hospital
Homa Bay, Kenya
Marindi Sub County Referral Hospital
Homa Bay, Kenya
Mbita District Hospital
Homa Bay, Kenya
Rachuonyo District Hospital
Homa Bay, Kenya
Rangwe Sub-District Hospital
Homa Bay, Kenya
Shirikisho Health Centre
Homa Bay, Kenya
Suba District Hospital
Homa Bay, Kenya
Nyabondo Mission Hospital
Kisumu, Kenya
Nyahera Sub County Hospital
Kisumu, Kenya
Nyang'oma Health Centre
Kisumu, Kenya
Rabour Health Centre
Kisumu, Kenya
St. Elizabeth Chiga
Kisumu, Kenya
Awendo Sub County Hospital
Migori, Kenya
Dede Health Centre
Migori, Kenya
Godkwer
Migori, Kenya
Macalder Mission Hospital
Migori, Kenya
Migori County Mission Hospital
Migori, Kenya
Nyamaraga Health Centre
Migori, Kenya
Rongo Sub County Hospital
Migori, Kenya
Sony Medical Centre
Migori, Kenya
St. Joseph's Mission Hospital
Migori, Kenya
Uriri Sub County Hospital
Migori, Kenya
Related Publications (2)
Chhun N, Mangale DI, Agot K, Owade WA, Kadima J, Badia J, Kibugi JK, Kohler PK, John-Stewart G, Beima-Sofie K. Determinants of implementation of a stepped care intervention for adolescents and youth living with HIV in Kenya: a qualitative evaluation. BMC Health Serv Res. 2025 May 15;25(1):702. doi: 10.1186/s12913-025-12875-7.
PMID: 40369586DERIVEDKohler P, Agot K, Njuguna IN, Dyer J, Badia J, Jiang W, Beima-Sofie K, Chhun N, Inwani I, Shah SK, Richardson BA, Chaktoura N, John-Stewart G. Data-informed stepped care to improve youth engagement in HIV care in Kenya: a protocol for a cluster randomised trial of a health service intervention. BMJ Open. 2022 Oct 31;12(10):e062134. doi: 10.1136/bmjopen-2022-062134.
PMID: 36316073DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Data Analyst
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela K Kohler, RN, MPH, PhD
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor: School of Nursing; Associate Professor: Public Health/Global Health
Study Record Dates
First Submitted
July 13, 2021
First Posted
August 16, 2021
Study Start
April 19, 2022
Primary Completion
September 19, 2023
Study Completion
November 30, 2023
Last Updated
November 27, 2024
Results First Posted
November 27, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Beginning 3 months and ending 5 years following article publication.
- Access Criteria
- The final public-facing repository for clinical data and/or biospecimen information will be the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH)
We plan to share all IPD that underlie results in the primary publication after deidentification procedures.