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.
