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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04971538
Other study ID # HC023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 29, 2021
Est. completion date April 2022

Study information

Verified date February 2022
Source Foundation for Innovative New Diagnostics, Switzerland
Contact Sonjelle Shilton
Phone +41 (22) 710 05 90
Email Sonjelle.Shilton@finddx.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date April 2022
Est. primary completion date March 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Pakistan Aga Khan University Karachi Sindh

Sponsors (2)

Lead Sponsor Collaborator
Foundation for Innovative New Diagnostics, Switzerland Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the impact of HCV self-testing home delivery on HCV antibody testing rates The number of participants who report completing the HCV antibody testing in the intervention group. 2 weeks to 2 months after enrollment
Primary To assess the impact of HCV self-testing home delivery on HCV antibody testing rates 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%. 2 weeks to 2 months after enrollment
Secondary To assess the impact of HCV self-testing on the number of HCV antibody positive individuals who are aware of their status Number of HCV antibody positive participants made aware of their status in the intervention vs control group 2 weeks to 2 months after enrollment
Secondary To assess the cost of HCV self-testing 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 entire duration of study, estimated 6 months
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