MPrEP+ study protocol: a prospective cohort study assessing the feasibility and acceptability of an HIV pre-exposure prophylaxis (PrEP) strategy for male clients of female sex workers in Kisumu, Kenya.
HIV & AIDS
international health services
public health
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
04 11 2022
04 11 2022
Historique:
entrez:
4
11
2022
pubmed:
5
11
2022
medline:
9
11
2022
Statut:
epublish
Résumé
Male clients (MCs) are integral to sex work-driven HIV transmission dynamics as sexual partners of female sex worker (FSW). MCs contribute disproportionately to incident HIV globally and in sub-Saharan Africa, with 27% of new infections attributed to MCs of FSW and other partners of key populations. Gaps in coverage of HIV testing and prevention services for men, including MCs, are well-documented, yet research and innovative interventions to improve MC uptake of effective prevention services, including pre-exposure prophylaxis (PrEP), are scarce. MPrEP+ is a cohort study designed to assess the feasibility and acceptability of a PrEP-focused HIV prevention strategy providing daily oral tenofovir/emtricitabine (TDF/FTC) in combination with three adherence self-management interventions: (1) use of a validated point-of-care urine drug-level assay with real-time feedback and tailored self-management counselling; (2) frequent HIV self-testing; and (3) weekly one-way text messaging. This package of interventions is being delivered to 120 MCs enrolled in the study in Kisumu, Kenya over a 6-month period. The primary outcome is PrEP adherence at 6 months as measured by PrEP drug levels. Bivariate and multivariable regression models will be used to identify predictors of PrEP adherence. We will also explore associations of sociodemographic characteristics and PrEP beliefs with PrEP adherence. The study was approved by the Columbia University Irving Medical Center Institutional Review Board and the Maseno University Ethical Review Committee. Study enrolment was initiated in November 2021 with participant follow-up planned through August 2022. Study results will be submitted for publication in peer-reviewed journals. Summaries and infographics of study findings will be developed and distributed to MC, FSW and stakeholders working in HIV prevention and support for people who sell and buy sex, including Kenya's Ministry of Health. NCT04898699; Registered on 24 May 2021.
Identifiants
pubmed: 36332953
pii: bmjopen-2022-064037
doi: 10.1136/bmjopen-2022-064037
pmc: PMC9639093
doi:
Substances chimiques
Anti-HIV Agents
0
Emtricitabine
G70B4ETF4S
Banques de données
ClinicalTrials.gov
['NCT04898699']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
e064037Subventions
Organisme : NIAID NIH HHS
ID : T32 AI114398
Pays : United States
Organisme : NIMH NIH HHS
ID : P30 MH043520
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
Braz J Infect Dis. 2021 Jan-Feb;25(1):101037
pubmed: 33285137
PLoS Med. 2016 Nov 8;13(11):e1002166
pubmed: 27824882
Am J Public Health Nations Health. 1951 Jun;41(6):654-61
pubmed: 18017295
Lancet HIV. 2017 Jan;4(1):e5-e6
pubmed: 27864001
HIV Med. 2017 Jul;18(6):412-418
pubmed: 28444867
Am J Public Health. 2014 Aug;104(8):e25-31
pubmed: 24922170
PLoS Med. 2022 Jan 25;19(1):e1003861
pubmed: 35077459
N Engl J Med. 2012 Aug 2;367(5):423-34
pubmed: 22784038
Glob J Health Sci. 2016 Feb 02;8(9):55119
pubmed: 27157185
AIDS Care. 2016 Dec;28(12):1528-1532
pubmed: 27256543
N Engl J Med. 2010 Dec 30;363(27):2587-99
pubmed: 21091279
Psychol Bull. 1992 May;111(3):455-74
pubmed: 1594721
Curr HIV/AIDS Rep. 2020 Oct;17(5):487-498
pubmed: 32627120
Curr Clin Pharmacol. 2020;15(2):102-104
pubmed: 31713497
Qual Health Res. 2005 Nov;15(9):1277-88
pubmed: 16204405
Gates Open Res. 2020 Jul 29;4:117
pubmed: 32954217
PLoS One. 2020 Sep 4;15(9):e0238639
pubmed: 32886695
J Int AIDS Soc. 2015 Jul 20;18(4 Suppl 3):19949
pubmed: 26198341
Int J Behav Med. 2014 Feb;21(1):88-98
pubmed: 23385488
Am J Health Behav. 2006 Mar-Apr;30(2):158-66
pubmed: 16533100
Lancet Infect Dis. 2017 Jun;17(6):595-604
pubmed: 28262598
Curr Opin HIV AIDS. 2012 Nov;7(6):542-8
pubmed: 22964887
PLoS One. 2014 Jul 28;9(7):e103549
pubmed: 25068720
AIDS Behav. 2018 Feb;22(2):580-592
pubmed: 28540563
Sex Transm Infect. 2014 Nov;90(7):556-62
pubmed: 24812406
J Immigr Minor Health. 2015 Feb;17(1):172-80
pubmed: 23979714
J Int AIDS Soc. 2017 Feb 8;20(1):21234
pubmed: 28362073
Lancet Diabetes Endocrinol. 2018 Feb;6(2):130-142
pubmed: 28970034
N Engl J Med. 2012 Aug 2;367(5):399-410
pubmed: 22784037
J Acquir Immune Defic Syndr. 2019 Jul 1;81(3):311-318
pubmed: 30893125
Patient Prefer Adherence. 2021 Feb 05;15:259-269
pubmed: 33574659
Lancet HIV. 2016 Jun;3(6):e266-74
pubmed: 27240789
AIDS Care. 2016 Aug;28(8):1000-6
pubmed: 26754017
BMJ Open. 2021 May 18;11(5):e048585
pubmed: 34006558