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Gastroenterology and hepatology
Original research
Assessing the impact of simplified HCV care on linkage to care amongst high-risk patients at primary healthcare clinics in Malaysia: a prospective observational study
  1. Jessica Markby1,
  2. Sonjelle Shilton1,
  3. Xiaohui Sem1,
  4. Huan Keat Chan2,
  5. Rosaida Md Said3,
  6. Sasikala Siva4,
  7. Zalwani Zainuddin5,
  8. Norasiah Abu Bakar6,
  9. Haniza Omar7,
  10. Ryan Jose III Ruiz1,
  11. Mary Gaeddert8,
  12. Alexander Tyshkovskiy9,10,
  13. Madeline Adee11,
  14. Jagpreet Chhatwal11,
  15. Suresh Kumar12,
  16. Jean-Michel Piedagnel4,
  17. Rozainanee Mohd Zain13,
  18. Caroline Menétrey4,
  19. Fazidah Yuswan14,
  20. Nazrila Hairizan Nasir15,
  21. Isabelle Andrieux-Meyer4,
  22. Fatanah Ismail15,
  23. Rozita Zakaria15,
  24. Ruziaton Hasim15,
  25. Shahnaz Murad4,
  26. Philippa Easterbrook16,
  27. Muhammad Radzi Abu Hassan2
  1. 1FIND, Geneva, Switzerland
  2. 2Clinical Research Centre, Hospital Sultanah Bahiyah, Alor Setar, Malaysia
  3. 3Hospital Ampang, Ampang Jaya, Malaysia
  4. 4Drugs for Neglected Diseases initiative, Geneva, Switzerland
  5. 5Hospital Sultanah Bahiyah, Alor Setar, Malaysia
  6. 6Hospital Raja Perempuan Zainab II, Kota Bharu, Malaysia
  7. 7Hospital Selayang, Batu Caves, Malaysia
  8. 8Division of Clinical Tropical Medicine, Center of Infectious Diseases, University Hospital Heidelberg, Heidelberg, Germany
  9. 9Division of Genetics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA
  10. 10Belozersky Institute of Physico-Chemical Biology, Moscow State University, Moscow, Russia
  11. 11Institute for Technology Assessment, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
  12. 12Hospital Sungai Buloh, Sungai Buloh, Malaysia
  13. 13Institute for Medical Research, Kuala Lumpur, Malaysia
  14. 14Disease Control Division, Ministry of Health, Putrajaya, Malaysia
  15. 15Family Health Development Division, Ministry of Health, Putrajaya, Malaysia
  16. 16Global HIV, Hepatitis & STI Programmes, World Health Organization, Geneva, Switzerland
  1. Correspondence to Sonjelle Shilton; sonjelle.shilton{at}finddx.org

Abstract

Introduction To achieve the elimination of hepatitis C virus (HCV), substantial scale-up in access to testing and treatment is needed. This will require innovation and simplification of the care pathway, through decentralisation of testing and treatment to primary care settings and task-shifting to non-specialists. The objective of this study was to evaluate the feasibility and effectiveness of decentralisation of HCV testing and treatment using rapid diagnostic tests (RDTs) in primary healthcare clinics (PHCs) among high-risk populations, with referral of seropositive patients for confirmatory viral load testing and treatment.

Methods This observational study was conducted between December 2018 and October 2019 at 25 PHCs in three regions in Malaysia. Each PHC was linked to one or more hospitals, for referral of seropositive participants for confirmatory testing and pretreatment evaluation. Treatment was provided in PHCs for non-cirrhotic patients and at hospitals for cirrhotic patients.

Results During the study period, a total of 15 366 adults were screened at the 25 PHCs, using RDTs for HCV antibodies. Of the 2020 (13.2%) HCV antibody-positive participants, 1481/2020 (73.3%) had a confirmatory viral load test, 1241/1481 (83.8%) were HCV RNA-positive, 991/1241 (79.9%) completed pretreatment assessment, 632/991 (63.8%) initiated treatment, 518/632 (82.0%) completed treatment, 352/518 (68.0%) were eligible for a sustained virological response (SVR) cure assessment, 209/352 (59.4%) had an SVR cure assessment, and SVR was achieved in 202/209 (96.7%) patients. A significantly higher proportion of patients referred to PHCs initiated treatment compared with those who had treatment initiated at hospitals (71.0% vs 48.8%, p<0.001).

Conclusions This study demonstrated the effectiveness and feasibility of a simplified decentralised HCV testing and treatment model in primary healthcare settings, targeting high-risk groups in Malaysia. There were good outcomes across most steps of the cascade of care when treatment was provided at PHCs compared with hospitals.

  • public health
  • hepatology
  • primary care

Data availability statement

Data are available upon reasonable request.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/bmjopen-2021-055142

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • JM and SS are joint first authors.

    • Contributors JM designed data collection tools, implemented the study, monitored data collection for the study, cleaned and analysed the data, and drafted and revised the paper. She is guarantor. SShilton initiated the collaborative project, designed the study and data collection tools, implemented the study, monitored data collection for the study and drafted and revised the paper. She is guarantor. XHS designed data collection tools, implemented the study, monitored data collection for the study, cleaned and analysed the data, and revised the draft paper. CHK revised the draft paper. RMS, ZZ, NAB, HO, SK and RH implemented the study and monitored data collection for the study. SSiva designed the study and data collection tools, implemented the study, monitored data collection for the study and revised the draft paper. RJR implemented the study and monitored data collection for the study. MG and AT wrote the statistical analysis plan, cleaned and analysed the data, and revised the draft paper. MA and JC analysed the data and revised the draft paper. J-MP initiated the collaborative project, implemented the study, and revised the draft paper. RMZ initiated the collaborative project, designed and implemented the study, and monitored data collection for the study. CM implemented the study, monitored data collection for the study, and revised the draft paper. FY, NHN, FI and RZ implemented the study. IA-M initiated the collaborative project, designed and implemented the study, and revised the draft paper. SM initiated the collaborative project and implemented the study. PE drafted and revised the paper. MRAH initiated the collaborative project, designed and implemented the study, monitored data collection for the study and revised the draft paper. All authors revised the paper critically for intellectual content and approved the final version.

    • Funding This study was funded by Unitaid as part of HEAD-Start (Hepatitis Elimination through Access to Diagnostics).

    • Map disclaimer The inclusion of any map (including the depiction of any boundaries therein), or of any geographic or locational reference, does not imply the expression of any opinion whatsoever on the part of BMJ concerning the legal status of any country, territory, jurisdiction or area or of its authorities. Any such expression remains solely that of the relevant source and is not endorsed by BMJ. Maps are provided without any warranty of any kind, either express or implied.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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    © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.