Abstract
BACKGROUND/AIMS: Globally, only 36% of people with hepatitis C are aware of their infection, and just 20% of those diagnosed receive treatment, highlighting a significant diagnosis and treatment gap. The World Health Organization recommends hepatitis C virus self-testing (HCVST) as an additional strategy to increase access to diagnosis. METHODS: From July 2023 to April 2024, we conducted a cross-sectional study nested within a larger cluster randomized control trial (RCT) (CTRI/2023/07/054590) in urban slums of Haridwar. A total of 465 participants were recruited from community and urban primary health center settings. Under observation, participants performed hepatitis C virus (HCV) self-testing, allowing assessment of usability by tracking errors using standardized checklists, user-reported difficulties, and inter-reader concordance (self vs. trained personnel interpretation). For acceptability, a pre-tested questionnaire collected socio-demographic data, risk factors for HCV, participant experiences, and responses to hypothetical test results. Additionally, 35 ELISA-positive individuals were recruited to assess the sensitivity and specificity of the self-testing kit. RESULTS: Participants, mostly aged 26-35 years with primary education, demonstrated high usability, over 90% correctly performed critical steps like finger pricking, and 96% interpreted results accurately. Participants with education beyond high school had better interpretation accuracy (98.8% vs. 94.4%, P = 0.02). The process was reported as significantly easier by males (85.2% vs. 71.9%), participants under 46 years (82.4% vs. 66.1%), and those with higher education (90.1% vs. 71.6%, P < 0.001). Satisfaction was high (94.2%), and 95.4% trusted the test's accuracy. Inter-reader concordance was 95.9% (Cohen's Kappa = 0.25; 95% confidence interval [CI]: 0.07-0.43). Sensitivity and specificity were 97.4% and 99.6%, respectively. CONCLUSION: The HCV self-testing was highly usable and acceptable among residents of urban slums. While participants valued privacy and convenience, challenges with blood collection, instructions, and the absence of counseling were noted. HCV self-testing, if scaled up through targeted rollout and linked to counselling and treatment services, could substantially narrow the diagnostic gap and accelerate India's progress toward HCV elimination.