CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,911 enrolled
Drug / intervention
Data-informed Stepped Care (DiSC)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05007717
NCT05007717N/ACompleted

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

University of Washington·interventional·Posted Aug 16, 2021·Updated Nov 27, 2024

In Brief

A clinical study evaluating Data-informed Stepped Care (DiSC) for Adolescent Behavior and Hiv. Completed, enrolled 1,911 participants across 24 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesKenya

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 16, 2021
Enrollment StartApr 19, 2022
Primary CompletionSep 19, 2023
Study CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.9 years ago

Interventions

Data-informed Stepped Care (DiSC)behavioral

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