HCV Self-testing in Pakistan

Overview

To achieve the goal of elimination of hepatitis C infection in Pakistan, the strategy of elimination needs to be increasingly directed towards case finding through mass screening in rural or peri-urban communities to identify and treat those not yet aware of their infection. Self-testing (ST) with easy-to-use rapid diagnostic tests has been successfully used for diseases such as HIV. The availability of self-testing has been shown to increase testing rates and testing acceptability in diverse populations around the world, in large part due to its convenience and privacy advantages. In the present study we aim to evaluate the acceptability and impact of a program enabling home delivery of hepatitis C virus (HCV) self-testing in the Malir district, Karachi division, Pakistan.

Full Title of Study: “Cluster Randomized Controlled Study of Home-based Hepatitis C Self-testing in Karachi, Pakistan”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2021

Detailed Description

This study is a cluster randomized controlled study that will be nested within a larger micro-elimination study run by Aga Khan Univeristy (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 In both groups, if the previously missed person is home when the study staff visits, that person will be enrolled in the larger micro-elimination study and not this study, no self-testing will be done. Study staff will conduct onsite RDT testing and reflex blood draw for confirmatory HCV RNA testing and APRI staging if the RDT is reactive as per the larger study protocol. If the person has HCV viremia, they will be provided HCV tx delivered to their door by The Liver Foundation. An operational analysis and a costing analysis will also be done evaluating the costs associated with self-testing home delivery with regards to cost per test completed and cost per person diagnosed with HCV.

Interventions

  • Diagnostic Test: OraQuick® HCV Self-Test
    • The OraQuick® HCV Self-Test is a lateral flow rapid diagnostic that can detect anti-HCV antibodies in oral fluid. Instructions for Use (IFU) for OraQuick® HCV Rapid Antibody Self-Test have been developed in Georgian for the previous 2 studies conducted in Georgia using the OraQuick® HCV Rapid Antibody Self-Test. The IFU has been optimized taking in the feedback on the IFU resulting from the aforementioned studies. As this HCV test is not approved for self-test use in Georgia, all tests will be labelled as Research Use Only (RUO) and test results will not be used for patient management.

Arms, Groups and Cohorts

  • Experimental: HCV self-testing
    • the study staff will leave an HCV ST and instructions for use (IFU) 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, collect any testing results, and conduct a brief survey.
  • No Intervention: Referral to clinic for HCV RDT
    • the study staff will leave information on HCV testing and direct them to the nearest clinic with screening services, the participant will not be left a HCVST. 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, collect any testing results, and conduct a brief survey

Clinical Trial Outcome Measures

Primary Measures

  • To assess the impact of HCV self-testing home delivery on HCV antibody testing rates
    • Time Frame: 2 weeks to 2 months after enrollment
    • The number of participants who report completing the HCV antibody testing in the intervention group.
  • To assess the impact of HCV self-testing home delivery on HCV antibody testing rates
    • Time Frame: 2 weeks to 2 months after enrollment
    • To assess that the proportion of participants who report completing the HCV antibody testing in the intervention group is superior to that of the participants in the control group by a margin of 20%.

Secondary Measures

  • To assess the impact of HCV self-testing on the number of HCV antibody positive individuals who are aware of their status
    • Time Frame: 2 weeks to 2 months after enrollment
    • Number of HCV antibody positive participants made aware of their status in the intervention vs control group
  • To assess the cost of HCV self-testing
    • Time Frame: entire duration of study, estimated 6 months
    • Cost per test completed, cost per person diagnosed (serology, RNA) in the intervention vs control groups. The costs of each step on the testing pathway will be combined to determine the overall cost per person diagnosed with HCV viremia

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years of age or older – Residing in UC 9 or 10 – Eligible for inclusion in the larger AKU micro-elimination study Exclusion Criteria:

  • Known to be HCV antibody positive – Tested for HCV within the last 6 months – At home during the visit by AKU staff for this study and available to be tested by study staff with an onsite RDT

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Foundation for Innovative New Diagnostics, Switzerland
  • Collaborator
    • Aga Khan University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Saeed Hamid, Principal Investigator, Aga Khan University
  • Overall Contact(s)
    • Sonjelle Shilton, +41 (22) 710 05 90, Sonjelle.Shilton@finddx.org

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