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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 6000 HIV positive adolescents and young adults ages 10-24 years enrolled in HIV care, 900 caregivers of ALHIV, and 200 HCW 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.

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

Conditions
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Adolescent Behavior, Hiv

Intervention / Treatment
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* Behavioral: Data-informed Stepped Care (DiSC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Data-informed Stepped Care (DiSC) arm<br>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)<br>* 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<br>|
| No Intervention: Standard of care<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of retention in care | We will evaluate retention using a definition of missed visit. 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. We will also analyze retention using loss to follow-up which 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of viral load results showing viral non-suppression | We will calculate the overall proportion of viral load test 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 | 
| Rate of adherence | Adherence will be defined as the number of pills dispensed divided by the number of days between visits. A percentage greater than 80% will be classified as good adherence. The level of adherence during the past inter-visit interval will be assessed at each visit. | 12 months | 
| Proportion of adolescents enrolled in differentiated care services | The proportion of adolescents enrolled in differentiated care will be computed as participants who (1) have multi-month prescription refill intervals ≥3 months; and/or (2) are assigned to fast-track status. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stepped care