N/A
N=1,911
Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)
Adolescent Behavior · Hiv
Bottom Line
View on ClinicalTrials.gov: NCT05007717 ↗Enrolled (actual)
1,911
Serious AEs
0.1%
Results posted
Nov 2024
Primary outcome: Primary: Proportion of Missed Visits — 406; 433 Scheduled visits — p=0.631
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Data-informed Stepped Care (DiSC) (Behavioral)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Missed Visits |
406; 433 | 0.631 |
| SECONDARY Proportion of Viral Load Results Showing Viral Non-suppression |
125; 184 | 0.237 |
| SECONDARY Proportion of Visit Intervals With Good Adherence |
4065; 4486 | 0.386 |
| SECONDARY Incidence Rate of Loss to Follow-up |
61; 73 | 0.991 |
| SECONDARY Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits) |
517; 520 | 0.037 sig |
| SECONDARY Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills) |
1939; 2180 | 0.276 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05007717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.