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

NCT05007717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1911

Last updated 2024-11-27

Study results available
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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.

Conditions

  • Adolescent Behavior
  • Hiv

Interventions

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Pamela K Kohler, RN, MPH, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2023-09-19
Completion
2023-11-30

Countries

  • Kenya

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05007717 on ClinicalTrials.gov