Clinical trial NCT05007717: Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)
Official title: Data-informed Stepped Care (DiSC) to Improve Adolescent HIV Outcomes (UH3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Hiv
Keywords: stepped care
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-08-16
Enrollment: 1911
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Proportion of Missed Visits
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of Viral Load Results Showing Viral Non-suppression
timeFrame: 12 months
measure: Proportion of Visit Intervals With Good Adherence
timeFrame: 12 months
measure: Incidence Rate of Loss to Follow-up
timeFrame: 12 months
measure: Proportion of Visits Enrolled in Differentiated Care Services (Fast-track Visits)
timeFrame: 12 months
measure: Proportion of Visits Enrolled in Differentiated Care Services (Multi-month Refills)
timeFrame: 12 months
Other outcomes:
Locations:
city: Homa Bay
country: Kenya
facility: Asumbi Health Centre
city: Homa Bay
country: Kenya
facility: Homa Hills Health Centre
city: Homa Bay
country: Kenya
facility: Kendu Adventist Hospital
city: Homa Bay
country: Kenya
facility: Marindi Sub County Referral Hospital
city: Homa Bay
country: Kenya
facility: Mbita District Hospital
city: Homa Bay
country: Kenya
facility: Rachuonyo District Hospital
city: Homa Bay
country: Kenya
facility: Rangwe Sub-District Hospital
city: Homa Bay
country: Kenya
facility: Shirikisho Health Centre
city: Homa Bay
country: Kenya
facility: Suba District Hospital
city: Kisumu
country: Kenya
facility: Nyabondo Mission Hospital
city: Kisumu
country: Kenya
facility: Nyahera Sub County Hospital
city: Kisumu
country: Kenya
facility: Nyang'oma Health Centre
city: Kisumu
country: Kenya
facility: Rabour Health Centre
city: Kisumu
country: Kenya
facility: St. Elizabeth Chiga
city: Migori
country: Kenya
facility: Awendo Sub County Hospital
city: Migori
country: Kenya
facility: Dede Health Centre
city: Migori
country: Kenya
facility: Godkwer
city: Migori
country: Kenya
facility: Macalder Mission Hospital
city: Migori
country: Kenya
facility: Migori County Mission Hospital
city: Migori
country: Kenya
facility: Nyamaraga Health Centre
city: Migori
country: Kenya
facility: Rongo Sub County Hospital
city: Migori
country: Kenya
facility: Sony Medical Centre
city: Migori
country: Kenya
facility: St. Joseph's Mission Hospital
city: Migori
country: Kenya
facility: Uriri Sub County Hospital
Study officials:
affiliation: University of Washington
name: Pamela K Kohler, RN, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohler P, Agot K, Njuguna IN, Dyer J, Badia J, Jiang W, Beima-Sofie K, Chhun N, Inwani I, Shah SK, Richardson BA, Chaktoura N, John-Stewart G. Data-informed stepped care to improve youth engagement in HIV care in Kenya: a protocol for a cluster randomised trial of a health service intervention. BMJ Open. 2022 Oct 31;12(10):e062134. doi: 10.1136/bmjopen-2022-062134.