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Tytuł:
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Protocol for a cluster randomised controlled trial of secondary distribution of hepatitis C self-testing within the context of a house-to-house hepatitis C micro-elimination programme in Karachi, Pakistan.
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Autorzy:
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Shilton S; FIND, Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland. .
Ali D; Aga Khan University, Stadium Road, Karachi, Pakistan.
Hasnain A; Aga Khan University, Stadium Road, Karachi, Pakistan.
Abid A; Aga Khan University, Stadium Road, Karachi, Pakistan.
Markby J; FIND, Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.
Jamil MS; WHO Global HIV, Hepatitis & STI programmes, Avenue Appia 20, 1202, Geneva, Switzerland.
Luhmann N; WHO Global HIV, Hepatitis & STI programmes, Avenue Appia 20, 1202, Geneva, Switzerland.
Nabeta P; FIND, Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.
Ongarello S; FIND, Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.
Reipold EI; FIND, Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.
Hamid S; Aga Khan University, Stadium Road, Karachi, Pakistan.
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Źródło:
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BMC public health [BMC Public Health] 2022 Apr 09; Vol. 22 (1), pp. 696. Date of Electronic Publication: 2022 Apr 09.
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Typ publikacji:
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Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Original Publication: London : BioMed Central, [2001-
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MeSH Terms:
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Hepacivirus*
Hepatitis C*/diagnosis
Hepatitis C*/epidemiology
Hepatitis C*/prevention & control
Humans ; Pakistan/epidemiology ; Randomized Controlled Trials as Topic ; Self-Testing ; Serologic Tests
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References:
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BMC Public Health. 2021 Jun 22;21(1):1188. (PMID: 34158006)
Lancet Gastroenterol Hepatol. 2021 Feb;6(2):89-90. (PMID: 33444535)
BMC Infect Dis. 2018 Jun 19;18(1):281. (PMID: 29914381)
BMC Infect Dis. 2021 Jun 26;21(1):609. (PMID: 34171990)
Lancet HIV. 2020 Nov;7(11):e752-e761. (PMID: 33045193)
Diagnostics (Basel). 2021 Feb 23;11(2):. (PMID: 33672241)
Lancet. 2018 Mar 3;391(10123):834-835. (PMID: 29508739)
BMC Infect Dis. 2021 Oct 14;21(1):1064. (PMID: 34649503)
JAMA Netw Open. 2019 May 3;2(5):e193613. (PMID: 31074817)
Diagnostics (Basel). 2021 Mar 07;11(3):. (PMID: 33800060)
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Grant Information:
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001 International WHO_ World Health Organization
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Contributed Indexing:
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Keywords: Hepatitis C; Micro-elimination; Pakistan; Self-testing; Testing uptake
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Molecular Sequence:
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ClinicalTrials.gov NCT04971538
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Entry Date(s):
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Date Created: 20220410 Date Completed: 20220412 Latest Revision: 20220517
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Update Code:
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20240105
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PubMed Central ID:
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PMC8994067
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DOI:
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10.1186/s12889-022-13125-9
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PMID:
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35397544
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Background: Globally, just 21% of the estimated 58 million people living with hepatitis C virus (HCV) know their status. Thus, there is considerable need to scale-up HCV testing if the World Health Organization (WHO) 2030 hepatitis elimination goals are to be achieved. HCV self-testing may assist with this; however, there are currently no data on the real-world impact of HCV self-testing. With an estimated 5% of the general population living with HCV, Pakistan has the second highest HCV burden in the world. This study aims to evaluate the acceptability and impact of home delivery of HCV self-testing for secondary distribution in the context of a house-to-house HCV micro-elimination programme in Pakistan.
Methods: This is a parallel group, non-blinded, cluster randomised trial comparing secondary distribution of HCV self-testing with secondary distribution of information pamphlets encouraging individuals to visit a testing facility for HCV screening. The cluster allocation ratio is 1:1. Clusters will be randomised either to HCV self-testing distributed via study staff or control clusters where information on HCV will be given and the participant will be requested to attend their local hospital for HCV screening. In both clusters, only households with a member who has not yet been screened as part of the larger micro-elimination project will be included. The primary outcome is the number and proportion of participants who report completion of testing. Secondary outcomes include the number and proportion of participants who a) receive a positive result and are made aware of their status, b) are referred to and complete HCV RNA confirmatory testing, and c) start treatment. Acceptability, feasibility, attitudes towards HCV testing, and cost will also be evaluated. The target sample size is 2,000 participants.
Discussion: This study will provide the first ever evidence regarding secondary distribution of HCV self-testing. By comparing HCV self-testing with facility-based testing, we will assess whether HCV self-testing increases the uptake of HCV testing. The findings will inform micro-elimination programmes and determine whether HCV self-testing can enable individuals to be reached who may otherwise be missed.
Trial Registration: This study and was registered on clinicaltrials.gov ( NCT04971538 ) 21 July 2021.
(© 2022. The Author(s).)
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