TY - JOUR
T1 - Data-informed stepped care to improve youth engagement in HIV care in Kenya
T2 - a protocol for a cluster randomised trial of a health service intervention
AU - Kohler, Pamela
AU - Agot, Kawango
AU - Njuguna, Irene N.
AU - Dyer, Jessica
AU - Badia, Jacinta
AU - Jiang, Wenwen
AU - Beima-Sofie, Kristin
AU - Chhun, Nok
AU - Inwani, Irene
AU - Shah, Seema K.
AU - Richardson, Barbra A.
AU - Chaktoura, Nahida
AU - John-Stewart, Grace
N1 - Funding Information:
This work was supported through the PATC3H consortium, funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health under grant UG3/UH3 HD096906.
Publisher Copyright:
© 2022 BMJ Publishing Group. All rights reserved.
PY - 2022/10/31
Y1 - 2022/10/31
N2 - Introduction Adolescents and youth living with HIV (AYLHIV) have lower retention in care, adherence to treatment, and viral suppression compared with adults. Stepped care is a process by which clients are assigned to increasingly intensive services or 'steps' according to level of need. Differentiated care, in which stable clients access less frequent services, can be combined with stepped care to align needs and preferences of youth to promote optimal engagement in care. Methods and analysis This hybrid type I effectiveness implementation cluster randomised trial aims to evaluate a data-informed stepped care (DiSC) intervention for AYLHIV. AYLHIV ages 10-24 receiving care at 24 HIV treatment facilities in Kisumu, Homabay and Migori counties in Kenya will be enrolled. Twelve facilities will be randomised to the DiSC intervention, and 12 will provide standard care. A clinical assignment tool developed by the study team will be used at intervention sites to assign AYLHIV to one of four steps based on risk for loss to follow-up: differentiated care, standard care, counselling services or intensive support services. The primary clinical outcome is retention in care, specifically missed visits (failure to return within 30 days for any visit) and 12-month loss to follow-up. Implementation outcomes are based on the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Proportions of missed visits will be compared using mixed effect models clustered by facility and participant. Ethics and dissemination This study has been approved by the University of Washington Institutional Review Board (STUDY00011096), Maseno University Ethical Review Committee (MUERC/00917/20) and the Kenya National Commission for Science, Technology and Innovation (444824). AYLHIV provide written informed consent when legally permitted, or assent with caregiver permission for minors. Study staff will work with a Community Advisory Board, including youth members, to disseminate results via discussions, presentations, journal publications and local or international conferences. Trial registration number NCT05007717.
AB - Introduction Adolescents and youth living with HIV (AYLHIV) have lower retention in care, adherence to treatment, and viral suppression compared with adults. Stepped care is a process by which clients are assigned to increasingly intensive services or 'steps' according to level of need. Differentiated care, in which stable clients access less frequent services, can be combined with stepped care to align needs and preferences of youth to promote optimal engagement in care. Methods and analysis This hybrid type I effectiveness implementation cluster randomised trial aims to evaluate a data-informed stepped care (DiSC) intervention for AYLHIV. AYLHIV ages 10-24 receiving care at 24 HIV treatment facilities in Kisumu, Homabay and Migori counties in Kenya will be enrolled. Twelve facilities will be randomised to the DiSC intervention, and 12 will provide standard care. A clinical assignment tool developed by the study team will be used at intervention sites to assign AYLHIV to one of four steps based on risk for loss to follow-up: differentiated care, standard care, counselling services or intensive support services. The primary clinical outcome is retention in care, specifically missed visits (failure to return within 30 days for any visit) and 12-month loss to follow-up. Implementation outcomes are based on the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Proportions of missed visits will be compared using mixed effect models clustered by facility and participant. Ethics and dissemination This study has been approved by the University of Washington Institutional Review Board (STUDY00011096), Maseno University Ethical Review Committee (MUERC/00917/20) and the Kenya National Commission for Science, Technology and Innovation (444824). AYLHIV provide written informed consent when legally permitted, or assent with caregiver permission for minors. Study staff will work with a Community Advisory Board, including youth members, to disseminate results via discussions, presentations, journal publications and local or international conferences. Trial registration number NCT05007717.
KW - Clinical trials
KW - Community child health
KW - HIV & AIDS
KW - Paediatric intensive & critical care
KW - Quality in health care
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U2 - 10.1136/bmjopen-2022-062134
DO - 10.1136/bmjopen-2022-062134
M3 - Article
C2 - 36316073
AN - SCOPUS:85140940135
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 10
M1 - e062134
ER -
