Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05007717 |
| Other study ID # |
STUDY00011096 |
| Secondary ID |
UH3HD096906 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 19, 2022 |
| Est. completion date |
November 30, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
