Cluster Randomized Controlled Study of Home-based Hepatitis C Self-testing in Karachi, Pakistan

This study is a cluster randomized controlled study that will be nested within a larger micro-elimination study run by Aga Khan University (AKU). This larger study has already completed house-to-house screening of Union Council (UC) 9 and 10 in the Malir district of Karachi, with a number of households still in need of follow-up, these households contained members who were not present during the house-to-house screening and were not able to be offered the HCV rapid diagnostic test (RDT). In this study AKU study staff will return to the households that had persons missed by the first round of house-to-house screening done during the CHIME study.

For randomization purposes, the neighborhoods in UC 9 and 10 will be grouped into clusters. The clusters will be matched in pairs based on similarity of geography (peri-urban or rural), population size, and age demographics. Each cluster within a matched pair will then be randomized to the intervention or control group.

In the intervention group, if the participant is not home the study staff will leave an HCV self test (HCV ST), instructions for use ( IFU), and supporting materials with the household. The study team will also explain the HCVST process to the most senior member of the household, as well as leave a mobile number for the participant to contact for help conducting the test. The study team will follow up with the participant to inquire about if testing was completed. If the HCV ST is reactive, study staff, over the phone, will also make an appointment to return to the house for enrolment into the larger AKU micro-elimination study, and after enrolment into the lager AKU micro-elimination study the participant will receive a blood draw for HCV RNA confirmatory testing and APRI staging. If the participant is HCV viraemic they will be provided treatment, delivered to their door by The Liver Foundation.

In the control group, if the participant is not home the study staff will leave both printed and verbal information on HCV testing and direct them to the nearest clinic with screening services. Study staff will also leave a mobile number for the participant to contact for further information on HCV testing. The study team will follow up with the participant to inquire about if testing was completed. If the HCV test is reactive, study staff, over the phone, will also make an appointment to return to the house for enrolment into the larger AKU micro-elimination study, and after enrolment into the lager AKU micro-elimination study the participant will receive a blood draw for HCV RNA confirmatory testing and Aspartate aminotransferase to Platelet Ratio Index (APRI) staging. If the participant is HCV viraemic they will be provided treatment, delivered to their door by The Liver Foundation.

In both groups result reporting of did the test and it was positive, did the test and it was negative and did the test and it was indeterminate/I don't know the result, and did not do the test will be incentivized with a 500-rupee phone credit voucher, for those participants who phone AKU and inform them of the results within one month of enrolment. The study team will follow up with a subsection of participants, n=60 in the intervention and n=60 in the control, conduct a brief survey on their perceptions of the testing process