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.
Clinical trials
Community child health
HIV & AIDS
Paediatric intensive & critical care
Quality in health care
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
31 10 2022
31 10 2022
Historique:
entrez:
31
10
2022
pubmed:
1
11
2022
medline:
3
11
2022
Statut:
epublish
Résumé
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. 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. 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. NCT05007717.
Identifiants
pubmed: 36316073
pii: bmjopen-2022-062134
doi: 10.1136/bmjopen-2022-062134
pmc: PMC9628651
doi:
Banques de données
ClinicalTrials.gov
['NCT05007717']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
e062134Subventions
Organisme : NICHD NIH HHS
ID : UH3 HD096906
Pays : United States
Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
AIDS. 2021 Dec 1;35(15):2503-2511
pubmed: 34870930
J Int AIDS Soc. 2017 May 16;20(Suppl 3):21577
pubmed: 28530042
BMC Infect Dis. 2012 Jan 25;12:21
pubmed: 22273267
J Acquir Immune Defic Syndr. 2009 May 1;51(1):65-71
pubmed: 19282780
Prev Med. 1993 Mar;22(2):237-60
pubmed: 8483862
AIDS. 2007 May 31;21(9):1185-97
pubmed: 17502729
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941
Am J Orthopsychiatry. 2004 Oct;74(4):545-58
pubmed: 15554814
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
J Adolesc Health. 2007 Jan;40(1):96-8
pubmed: 17185215
Psychiatry Res. 2007 Aug 30;152(2-3):293-7
pubmed: 17459488
Psychol Serv. 2017 Nov;14(4):428-442
pubmed: 29120201
J Acquir Immune Defic Syndr. 2020 Dec 15;85(5):606-611
pubmed: 32897936
J Int AIDS Soc. 2016 Apr 27;19(1):20683
pubmed: 27125320
Implement Sci. 2017 Aug 29;12(1):108
pubmed: 28851459
Qual Health Res. 2005 Nov;15(9):1277-88
pubmed: 16204405
AIDS Res Hum Retroviruses. 2013 Jun;29(6):892-900
pubmed: 23373540
Implement Sci Commun. 2021 Jul 19;2(1):80
pubmed: 34281614
BMJ. 2015 Nov 23;351:h6127
pubmed: 26597263
Trop Med Int Health. 2016 Mar;21(3):325-33
pubmed: 26681359
Clin Infect Dis. 2017 Mar 15;64(6):751-758
pubmed: 28034882
J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e16-23
pubmed: 26473798
J Health Soc Behav. 1995 Mar;36(1):1-10
pubmed: 7738325
Implement Sci. 2020 Mar 12;15(1):17
pubmed: 32164692
Implement Sci. 2009 Aug 07;4:50
pubmed: 19664226
Clin Infect Dis. 2010 Mar 1;50(5):779-86
pubmed: 20121574
AIDS. 2014 Nov 28;28(18):2729-38
pubmed: 25493599
AIDS Res Hum Retroviruses. 2007 Oct;23(10):1208-14
pubmed: 17961106
Trials. 2018 Dec 29;19(1):710
pubmed: 30594223
JAMA. 2017 Jun 06;317(21):2196-2206
pubmed: 28586888
J Acquir Immune Defic Syndr. 2016 Jul 1;72(3):333-43
pubmed: 26918545
BMC Public Health. 2018 Aug 22;18(1):1048
pubmed: 30134880
Implement Sci. 2019 Jun 6;14(1):58
pubmed: 31171014
J Acquir Immune Defic Syndr. 2015 Nov 1;70(3):e110-9
pubmed: 26470034
J Int AIDS Soc. 2017 Nov;20 Suppl 7:
pubmed: 29171180
AIDS. 2018 Jan 2;32(1):17-23
pubmed: 29112073
N Engl J Med. 2011 Aug 11;365(6):493-505
pubmed: 21767103
J Acquir Immune Defic Syndr. 2012 Aug 1;60(4):421-7
pubmed: 22487585
J Int AIDS Soc. 2016 Dec 01;19(1):21484
pubmed: 27914186
Am J Public Health. 1999 Sep;89(9):1322-7
pubmed: 10474547
BMC Public Health. 2019 Jan 28;19(1):117
pubmed: 30691425
J Int AIDS Soc. 2021 Apr;24(4):e25695
pubmed: 33838007
Can J Psychiatry. 2012 Apr;57(4):210-5
pubmed: 22480585
J Acquir Immune Defic Syndr. 2014 Jul 1;66 Suppl 2:S144-53
pubmed: 24918590
J Acquir Immune Defic Syndr. 2017 Sep 1;76(1):e15-e18
pubmed: 28394821
Sex Transm Dis. 2009 Sep;36(9):547-55
pubmed: 19707108
Psychol Med. 2015 Jan;45(2):231-46
pubmed: 25065653
J Pers Assess. 1990 Winter;55(3-4):610-7
pubmed: 2280326
Addiction. 2002 Sep;97(9):1183-94
pubmed: 12199834
BMC Public Health. 2020 Dec 1;20(1):1841
pubmed: 33261566
AIDS. 2014 Feb 20;28(4):559-68
pubmed: 24076661
J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):339-47
pubmed: 23187945
J Behav Med. 2007 Oct;30(5):359-70
pubmed: 17588200
PLoS Med. 2022 Jan 5;19(1):e1003887
pubmed: 34986170
AIDS. 2017 Jan 2;31(1):61-70
pubmed: 27677163