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

University of Washington

Status: Active, not recruiting

Conditions: Hiv; Adolescent Behavior

Treatments: Behavioral: Data-informed Stepped Care (DiSC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05007717

STUDY00011096

UH3HD096906 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 1,911 patients

Sex: All

Ages: 10 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,911 participants in 2 patient groups

Data-informed Stepped Care (DiSC) arm

Experimental group

Description:

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.

Treatment:

Behavioral: Data-informed Stepped Care (DiSC)

Standard of care

No Intervention group

Description:

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.