Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial.
Depression & mood disorders
HEALTH ECONOMICS
HIV & AIDS
MENTAL HEALTH
PUBLIC HEALTH
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
05 12 2022
05 12 2022
Historique:
entrez:
28
12
2022
pubmed:
29
12
2022
medline:
30
12
2022
Statut:
epublish
Résumé
Non-adherence to antiretroviral therapy (ART) is the main cause of viral non-suppression and its risk is increased by depression. In countries with high burden of HIV, there is a lack of trained professionals to deliver depression treatments. This paper describes the protocol for a 2-arm parallel group superiority 1:1 randomised controlled trial, to test the effectiveness and cost effectiveness of the TENDAI stepped care task-shifted intervention for depression, ART non-adherence and HIV viral suppression delivered by lay interventionists. Two hundred and ninety people living with HIV aged ≥18 years with probable depression (Patient Health Questionnaire=>10) and viral non-suppression (≥ 1000 HIV copies/mL) are being recruited from HIV clinics in towns in Zimbabwe. The intervention group will receive a culturally adapted 6-session psychological treatment, Problem-Solving Therapy for Adherence and Depression (PST-AD), including problem-solving therapy, positive activity scheduling, skills to cope with stress and poor sleep and content to target barriers to non-adherence to ART. Participants whose score on the Patient Health Questionnaire-9 remains ≥10, and/or falls by less than 5 points, step up to a nurse evaluation for possible antidepressant medication. The control group receives usual care for viral non-suppression, consisting of three sessions of adherence counselling from existing clinic staff, and enhanced usual care for depression in line with the WHO Mental Health Gap intervention guide. The primary outcome is viral suppression (<1000 HIV copies/mL) at 12 months post-randomisation. The study and its tools were approved by MRCZ/A/2390 in Zimbabwe and RESCM-18/19-5580 in the UK. Study findings will be shared through the community advisory group, conferences and open access publications. NCT04018391.
Identifiants
pubmed: 36576191
pii: bmjopen-2021-057844
doi: 10.1136/bmjopen-2021-057844
pmc: PMC9723911
doi:
Substances chimiques
Anti-Retroviral Agents
0
Banques de données
ClinicalTrials.gov
['NCT04018391']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
e057844Informations 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
J Acquir Immune Defic Syndr. 2002 Apr 15;29(5):484-94
pubmed: 11981365
J Health Psychol. 2018 May;23(6):776-787
pubmed: 27121977
Acta Psychiatr Scand. 1983 Jun;67(6):361-70
pubmed: 6880820
N Engl J Med. 2011 Aug 11;365(6):493-505
pubmed: 21767103
Stat Med. 2005 Apr 15;24(7):993-1007
pubmed: 15570623
Br J Psychiatry. 2006 Sep;189:241-6
pubmed: 16946359
AIDS. 2015 Sep 24;29(15):1975-86
pubmed: 26134881
Lancet HIV. 2016 Nov;3(11):e529-e538
pubmed: 27658881
J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57
pubmed: 9881538
AIDS Care. 2015;27(1):59-62
pubmed: 25303372
J Psychosom Res. 2002 Oct;53(4):877-81
pubmed: 12377297
AIDS Behav. 2011 Jul;15(5):949-58
pubmed: 20853023
BMJ. 2000 Apr 29;320(7243):1197-200
pubmed: 10784550
Lancet Psychiatry. 2018 Nov;5(11):867-869
pubmed: 30314854
BMJ Glob Health. 2016 Dec 30;1(4):e000125
pubmed: 28588979
World Psychiatry. 2015 Oct;14(3):270-7
pubmed: 26407772
AIDS. 2005 Sep 2;19(13):1367-74
pubmed: 16103767
AIDS Care. 2017 Apr;29(4):418-422
pubmed: 27535297
Stat Med. 2000 Dec 15;19(23):3219-36
pubmed: 11113956
J Int AIDS Soc. 2021 Jun;24 Suppl 2:e25748
pubmed: 34164925
Popul Health Metr. 2003 Dec 16;1(1):11
pubmed: 14678566
J Int Assoc Provid AIDS Care. 2017 Jan/Feb;16(1):91-97
pubmed: 28084190
Behav Res Ther. 2015 Jun;69:11-21
pubmed: 25847276
Glob Ment Health (Camb). 2015 Jan;2:
pubmed: 26435843
Trials. 2022 Jan 10;23(1):27
pubmed: 35012627
Int J Ment Health Syst. 2016 May 11;10:39
pubmed: 27175215
Lancet Psychiatry. 2022 Mar;9(3):190-191
pubmed: 34895478
Curr HIV/AIDS Rep. 2020 Oct;17(5):529-546
pubmed: 32776179
BMJ Open. 2018 Jan 21;8(1):e019680
pubmed: 29358446
J Infect Dis. 2008 May 15;197 Suppl 3:S272-8
pubmed: 18447613
Psychon Bull Rev. 2016 Apr;23(2):640-7
pubmed: 26374437
JMIR Res Protoc. 2020 Feb 3;9(2):e14200
pubmed: 32012114
AIDS Behav. 2016 Nov;20(11):2700-2708
pubmed: 27098408
JAMA. 2016 Dec 27;316(24):2618-2626
pubmed: 28027368
J Subst Abuse Treat. 2015 Jun;53:52-9
pubmed: 25682718
Lancet. 2005 Apr 30-May 6;365(9470):1591-5
pubmed: 15866314
Curr Dev Nutr. 2018 Jul 20;2(9):nzy062
pubmed: 30191202
BMJ Open. 2021 Jun 30;11(6):e046032
pubmed: 34193491
BMJ. 2013 Mar 25;346:f1049
pubmed: 23529982
AIDS Behav. 2020 Jun;24(6):1752-1764
pubmed: 31720956
Springerplus. 2013 May 14;2(1):222
pubmed: 23853744
J Affect Disord. 2016 Jul 1;198:50-5
pubmed: 27011359
J Int AIDS Soc. 2021 Jun;24 Suppl 2:e25722
pubmed: 34164926
Trop Med Int Health. 2015 Jul;20(7):903-13
pubmed: 25754063
AIDS Behav. 2018 Jan;22(1):86-101
pubmed: 28063075
Psychosomatics. 2002 Nov-Dec;43(6):478-85
pubmed: 12444231
J Health Psychol. 2017 Sep;22(10):1265-1276
pubmed: 26893295
Behav Res Ther. 2001 Oct;39(10):1151-62
pubmed: 11579986
Ann Thorac Surg. 2016 May;101(5):1644-5
pubmed: 27106412