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
- primary care
Data availability statement
Data are available upon reasonable request.
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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).
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Competing interests None declared.
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