Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)
- Conditions
- Adolescent BehaviorHiv
- Interventions
- Behavioral: Data-informed Stepped Care (DiSC)
- Registration Number
- NCT05007717
- Lead Sponsor
- University of Washington
- Brief 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.
- Detailed 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 2000 HIV positive adolescents and young adults ages 10-24 years enrolled in HIV care 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1911
- HIV-positive
- Enrolled in HIV care
- Provision of informed consent
- Willing and able to give informed consent
- Not able or willing to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Data-informed Stepped Care (DiSC) arm Data-informed Stepped Care (DiSC) 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.
- Primary Outcome Measures
Name Time Method Proportion of Missed Visits 12 months We will evaluate retention using a definition of missed visit and calculate the proportion of scheduled visits that are missed. Missed visits will be defined as a participant not seen within 30 days after each scheduled visit. Each scheduled visit will be classified as missed versus not missed.
- Secondary Outcome Measures
Name Time Method Proportion of Viral Load Results Showing Viral Non-suppression 12 months We will evaluate viral load test results and calculate the proportion of results that show non-suppression. Viral non-suppression will be defined as having HIV RNA viral loads (VL) \>1,000 copies per milliliter. Each VL test result will be classified as VL suppressed vs. unsuppressed.
Proportion of Visit Intervals With Good Adherence 12 months We will evaluate adherence by calculating the number of pills dispensed divided by the number of days during an inter-visit interval. A proportion of adherence greater than 0.8 will be classified as good adherence. The level of adherence during the past inter-visit interval will be assessed at each visit.
Incidence Rate of Loss to Follow-up 12 months We will also analyze retention using loss to follow-up (LTFU). LTFU will be defined as a participant not seen within 30 days of a scheduled visit and not return to care within the 12-month study period. The incidence rate of LTFU is the ratio of the number of new cases of LTFU to the total time the study participants was at risk of LTFU. The denominator is the sum of the time each participant (person-year) was observed, totaled for all participants.
Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits) 12 months We will calculate the proportion of visits enrolled in differentiated care using two definitions. The first is fast-track visit, which evaluates if participants are assigned to fast-track status during visits. Each visit will be assessed as enrolled in differentiated care (assigned to fast-track) or not.
Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills) 12 months We will calculate the proportion of visits enrolled in differentiated care using two definitions. The second is multi-month prescription refills, which evaluates if participants are given multi-month refill intervals more than 3 months. Each visit will be assessed as enrolled in differentiated care (given multi-month refills) or not.
Trial Locations
- Locations (24)
Mbita District Hospital
🇰🇪Homa Bay, Kenya
Kendu Adventist Hospital
🇰🇪Homa Bay, Kenya
Awendo Sub County Hospital
🇰🇪Migori, Kenya
Dede Health Centre
🇰🇪Migori, Kenya
Rongo Sub County Hospital
🇰🇪Migori, Kenya
St. Elizabeth Chiga
🇰🇪Kisumu, Kenya
Rachuonyo District Hospital
🇰🇪Homa Bay, Kenya
Suba District Hospital
🇰🇪Homa Bay, Kenya
Homa Hills Health Centre
🇰🇪Homa Bay, Kenya
Nyahera Sub County Hospital
🇰🇪Kisumu, Kenya
Macalder Mission Hospital
🇰🇪Migori, Kenya
Rangwe Sub-District Hospital
🇰🇪Homa Bay, Kenya
Shirikisho Health Centre
🇰🇪Homa Bay, Kenya
St. Joseph's Mission Hospital
🇰🇪Migori, Kenya
Nyang'oma Health Centre
🇰🇪Kisumu, Kenya
Godkwer
🇰🇪Migori, Kenya
Nyamaraga Health Centre
🇰🇪Migori, Kenya
Uriri Sub County Hospital
🇰🇪Migori, Kenya
Asumbi Health Centre
🇰🇪Homa Bay, Kenya
Marindi Sub County Referral Hospital
🇰🇪Homa Bay, Kenya
Rabour Health Centre
🇰🇪Kisumu, Kenya
Nyabondo Mission Hospital
🇰🇪Kisumu, Kenya
Migori County Mission Hospital
🇰🇪Migori, Kenya
Sony Medical Centre
🇰🇪Migori, Kenya