Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)

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.

Study Overview

• Status: Completed
• Conditions: Hiv; Adolescent Behavior
• Intervention / Treatment: Behavioral: Data-informed Stepped Care (DiSC)

Detailed Description

UNAIDS '95-95-95' targets cannot be achieved without additional support for adolescents living with HIV (ALHIV) to increase retention in care and to support viral suppression. Risk prediction tools as well as a stepped care approach to care can support differentiation of ALHIV to different risk groups, and tailor care based on risk.

The investigators have conducted informative work with ALHIV, caregivers, healthcare workers (HCW) and policy makers, and has developed a clinical prediction tool to identify ALHIV at highest risk of not being retained in care and poor viral suppression that could be adapted to identify adolescents who may need more support in their care. Understanding how best to use the risk prediction tool as well as how to tailor services based on risk may ultimately result in more efficient HIV care services, as well as adequate support for ALHIV at highest risk of poor outcomes.

Building on that informative work, in this protocol, the investigators will conduct a Phase III cluster randomized controlled trial (cRCT) by implementing a data-informed stepped care (DiSC) intervention of ALHIV HIV treatment management in high-volume HIV clinics in Kenya.

The cRCT will be conducted at up to 24 HIV care and treatment facilities located in Kisumu, Homabay, Migori county in Western Kenya, in which approximately 2000 HIV positive adolescents and young adults ages 10-24 years enrolled in HIV care will be recruited in this study.

Clinics randomized to the DiSC intervention arm will use a data-driven system to assign ALHIV to different levels of care depending on their current and anticipated health care needs. The intervention will be delivered at the individual level by HCW providing routine care during routine HIV clinic visits. Clinics 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.

As secondary objectives, this study also aims to evaluate the effectiveness of the DiSC intervention on ALHIV cascade outcomes (adherence, viral non-suppression) and receiving differentiated HIV care based on health status evaluation.

• Study Type: Interventional
• Enrollment (Actual): 1911
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Homa Bay, Kenya
    • 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
  • Kisumu, 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
  • Migori, 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• HIV-positive
• Enrolled in HIV care
• Provision of informed consent
• Willing and able to give informed consent

Exclusion Criteria:

- Not able or willing to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Data-informed Stepped Care (DiSC) arm; At 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.	Behavioral: Data-informed Stepped Care (DiSC); 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
No Intervention: Standard of care; Sites 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Viral Load Results Showing Viral Non-suppression	We will evaluate viral load test results and calculate the proportion of results that show non-suppression. Viral non-suppression will be defined as having HIV RNA viral loads (VL) >1,000 copies per milliliter. Each VL test result will be classified as VL suppressed vs. unsuppressed.	12 months
Proportion of Visit Intervals With Good Adherence	We will evaluate adherence by calculating the number of pills dispensed divided by the number of days during an inter-visit interval. A proportion of adherence greater than 0.8 will be classified as good adherence. The level of adherence during the past inter-visit interval will be assessed at each visit.	12 months
Incidence Rate of Loss to Follow-up	We will also analyze retention using loss to follow-up (LTFU). LTFU will be defined as a participant not seen within 30 days of a scheduled visit and not return to care within the 12-month study period. The incidence rate of LTFU is the ratio of the number of new cases of LTFU to the total time the study participants was at risk of LTFU. The denominator is the sum of the time each participant (person-year) was observed, totaled for all participants.	12 months
Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits)	We will calculate the proportion of visits enrolled in differentiated care using two definitions. The first is fast-track visit, which evaluates if participants are assigned to fast-track status during visits. Each visit will be assessed as enrolled in differentiated care (assigned to fast-track) or not.	12 months
Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills)	We will calculate the proportion of visits enrolled in differentiated care using two definitions. The second is multi-month prescription refills, which evaluates if participants are given multi-month refill intervals more than 3 months. Each visit will be assessed as enrolled in differentiated care (given multi-month refills) or not.	12 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Pamela K Kohler, RN, MPH, PhD, University of Washington

Publications and helpful links

General Publications

• Kohler 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Actual): September 19, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: stepped care
• Other Study ID Numbers: STUDY00011096; UH3HD096906 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share all IPD that underlie results in the primary publication after deidentification procedures.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing 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)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No