Recommendations and guidance on hepatitis C virus self-testing: web annex E: hepatitis C virus self-testing: multi-country evidence on usability and acceptability

RECOMMENDATIONS AND GUIDANCE ON HEPATITIS C VIRUS SELF-TESTING July 2021 Web Annex E. Hepatitis C virus self-testing: multi-country evidence on usability and acceptability Elena Ivanova Reipold, Thi Thuy Van Nguyen, Gamal Shiha, Ketevan Stvilia, Aliza Monroe-Wise, Cheng Wang, Muhammad S. Jamil, Cheryl C. Johnson, Philippa Easterbrook Recommendations and guidance on hepatitis C virus self-testing. Web Annex E. Hepatitis C virus self-testing: multi-country evidence on usability and acceptability/ Elena Ivanova Reipold, Thi Thuy Van Nguyen, Gamal Shiha, Ketevan Stvilia, Aliza Monroe-Wise, Cheng Wang et al. ISBN 978-92-4-003118-0 (electronic version) © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 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Suggested citation. Ivanova Reipold E, Van Nguyen TT, Shiha G, Stvilia K, Monroe-Wise A, Wang C et al. Web Annex E. Hepatitis C virus self-testing: multi-country evidence on usability and acceptability. In: Recommendations and guidance on hepatitis C virus self-testing. Geneva: World Health Organization; 2021. Licence: CC BY-NC- SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. 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However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. The named authors alone are responsible for the views expressed in this publication. This publication forms part of the WHO guideline entitled Recommendations and guidance on hepatitis C virus self- testing. It is being made publicly available for transparency purposes and information, in accordance with the WHO handbook for guideline development, 2nd edition (2014). 1 Hepatitis C virus self-testing: multi-country evidence on usability and acceptability1 Elena Ivanova Reipold1, Thi Thuy Van Nguyen2, Gamal Shiha3, Ketevan Stvilia4, Aliza Monroe-Wise5, Cheng Wang6, Muhammad S. Jamil7, Cheryl C. Johnson7, Philippa Easterbrook7 1. FIND, Geneva, Switzerland 2. World Health Organization, Hanoi, Viet Nam 3. Mansoura University, Mansoura, Egypt 4. National Center for Disease Control, Tbilisi, Georgia 5. University of Washington, Seattle, WA, USA 6. Guangxi Medical University, Nanning, China 7. World Health Organization, Global HIV, Hepatitis and STI Programmes, Geneva, Switzerland Background: Globally, ≤ 20% of all persons with hepatitis C (HCV) infection have been tested and only one quarter of diagnosed persons have been treated. Self-testing for HCV antibodies (HCVST) may be an additional strategy to expand access to HCV testing and support elimination efforts. We undertook studies to assess usability and acceptability of HCVST in general population as well as key populations: men who have sex with men (MSM) and people who inject drugs (PWID). Methods: Observational studies were conducted in five countries: Egypt (general population); China (MSM); Kenya (PWID); Viet Nam and Georgia (PWID and MSM). Oral fluid OraQuick® HCV Rapid Antibody Test with Instructions for Use (IFU) adapted for ST was used as a prototype HCVST kit. Participants were provided written and pictorial IFU and then conducted ST in a private room with a trained observer. In Egypt, in addition to IFU, study personnel provided a one-to-one demonstration on how to use the test. Usability was evaluated through observer assessment of errors and difficulties during ST using a standardized checklist; and acceptability using a semi-structured questionnaire. HCVST results were read and interpreted by participants and then re-read by the observer. All participants were re-tested with a professional use OraQuick® HCV Test performed by a trained provider. Results: A total of 775 participants were enrolled across five studies. Participants completing all testing steps without any mistakes was greatest in Egypt and Georgia (> 70%) and lowest in PWID from Kenya (30%) and Viet Nam (46%). The most common error was incorrect sample collection. Inter-reader agreement ranged from 86% to 99%, and inter-operator agreement from 85% to 99%. The majority of PWID from Vietnam and Kenya required assistance in performing HCVST. The proportion of participants who found the kit very easy or easy to conduct ranged from 55% in Egypt and 66% in Kenya, to more than 80% in other countries. Acceptability was high with > 90% of participants in four countries willing to use HCVST again and who would recommend it to family and friends. Conclusion: These are the first studies globally to demonstrate high usability and acceptability of HCVST in both general and key populations. While most users self-tested with ease, assisted self-testing models are needed for some populations such as PWID. HCVST is an important strategy for further consideration as it may be a promising tool for increasing coverage and achieving elimination goals. 1 The abstract was previously presented at the Conference on Retroviruses and Opportunistic Infections, Boston, March 6-10, 2021. Accessed, https://www.natap.org/2021/CROI/croi_129.htm, 29 April 2021 Related manuscript: Nguyen LT, Nguyen VTT, Ai KAL, Truong MB, Tran TMT, Jamil MS et al. Acceptability and Usability of HCV Self-Testing in High Risk Populations in Vietnam. Diagnostics (Basel). 2021 Feb 23;11(2):377. doi: 10.3390/diagnostics11020377. https://pubmed.ncbi.nlm.nih.gov/33672241/ 2 Table C1. Summary of multi-country assessment HCVST usability and acceptability https://files.aievolution.com/prd/cro2101/abstracts/abs_2244/CROI_Reipold_Table.PNG