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Background:
PWID bear highest burden of HCV and due to multiple barriers suffer from suboptimal access to accessing treatment. There is insufficient evidence on HCV integration in harm reduction from low-middle income countries, where HCV burden among PWID is most significant.This study seeks to contribute evidence to global efforts in combating HCV among PWID, by identifying effective strategies to overcome barriers to testing/treatment, and advancing goals of WHO’s global hepatitis strategy to eliminate HCV. Aim of the study is to assess acceptability and effectiveness of integrating HCV testing and treatment within community-based harm reduction programs for PWID in low-resource countries,and identify key factors and implementation options associated with improved outcomes.
Description of program:
The study is implemented within the Innovate, Involve, Inspire Project and will test a Community-based Simplified HCV Testing and Treatment Algorithm (CBSA), implemented at community harm reduction sites. All participants with positive anti-HCV test will undergo diagnostics including HCV-RNA testing at community.Those eligible for CBSA will be prescribed a combination tablet:sofosbuvir/daclatasvir. Sustained virologic response (SVR) will be assessed 12 weeks after treatment completion.Those achieving SVR will be tested for HCV_RNA at 6 and 12 months after SVR12.
Effectiveness:
Study is implemented at harm reduction sites in Egypt, Kyrgyzstan, and Nigeria where HCV prevalence in PWID reaches 20, 50,and 10% respectively. Expected sample size across three countries is 1,454 PWID with confirmed HCV. Recruitment of study participants starts in March with baseline data collected in April 2025.
Conclusion and next steps:
Primary outcomes are based on HCV cascade:(a)Completing the pre-treatment evaluation;(b) Initiating and completing the full DAA course;(c)Achieving SVR12;(d)Re-infection rate at six and 12 months after SVR12. Secondary outcomes include treatment motivation, adherence, quality of life, and treatment satisfaction. Qualitative component explores client-level, provider-level, organizational, community-level,and structural factors influencing integration of CBSA into harm reduction programs.
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