Hepatitis CNCT04971538
HCV Self-testing in Pakistan
A study testing OraQuick® HCV Self-Test in people with Hepatitis C and Diagnostic Self Evaluation, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Diagnostic Self Evaluation
- What is being tested?
- OraQuick® HCV Self-Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Nov 2021to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Residing in UC 9 or 10
- Eligible for inclusion in the larger AKU micro-elimination study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Randomized Controlled Study of Home-based Hepatitis C Self-testing in Karachi, Pakistan
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.
Read the detailed 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.
- Conditions
- Hepatitis C, Diagnostic Self Evaluation
- Being tested
- OraQuick® HCV Self-Test
- Keywords
- self-test, micro-elimination, house to house screening
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraQuick® HCV Self-TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| HCV self-testing | Experimental | 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. Receives: Diagnostic Test: OraQuick® HCV Self-Test |
| Referral to clinic for HCV RDT | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks to 2 months after enrollment
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%.
Measured: 2 weeks to 2 months after enrollment
Secondary outcomes (2)
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
Measured: 2 weeks to 2 months after enrollment
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
Measured: entire duration of study, estimated 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start29 Nov 2021
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a matched cluster randomized controlled study, the households in the intervention clusters will be left information on the importance of testing, an HCV self-test and instructions for use while the households in the control clusters will be left information on the importance of testing for HCV and information on how to get tested at the nearest facility.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University
- Responsible party
- Sponsor
- Investigators
- Saeed Hamid, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971538
- Sponsor's protocol ID
- HC023
- Status last verified
- Sep 2026
- First submitted
- 12 Jul 2021
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shilton S, Ali D, Hasnain A, Abid A, Markby J, Jamil MS, Luhmann N, Nabeta P, Ongarello S, Reipold EI, Hamid S. Protocol for a cluster randomised controlled trial of secondary distribution of hepatitis C self-testing within the context of a house-to-house hepatitis C micro-elimination programme in Karachi, Pakistan. BMC Public Health. 2022 Apr 9;22(1):696. doi: 10.1186/s12889-022-13125-9.
PubMed 35397544
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Controlled Study of Home-based Hepatitis C Self-testing in Karachi, Pakistan
- ClinicalTrials.gov ID
- NCT04971538
- Acronym / sponsor ID
- HC023
- Conditions
- Hepatitis C, Diagnostic Self Evaluation
- Keywords
- self-test, micro-elimination, house to house screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Aga Khan University
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a matched cluster randomized controlled study, the households in the intervention clusters will be left information on the importance of testing, an HCV self-test and instructions for use while the households in the control clusters will be left information on the importance of testing for HCV and information on how to get tested at the nearest facility.
| Arm | Type | Receives |
|---|---|---|
| HCV self-testing | Experimental | Diagnostic Test: OraQuick® HCV Self-Testthe 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. |
| Referral to clinic for HCV RDT | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Residing in UC 9 or 10
- Eligible for inclusion in the larger AKU micro-elimination study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OraQuick® HCV Self-TestThe 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. | Diagnostic test | HCV self-testing |
Primary outcome
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%.
2 secondary outcomes
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
To assess the cost of HCV self-testing
Time frame: entire duration of study, estimated 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Derived from this study: PubMed 35397544Shilton S, Ali D, Hasnain A, Abid A, Markby J, Jamil MS, Luhmann N, Nabeta P, Ongarello S, Reipold EI, Hamid S. Protocol for a cluster randomised controlled trial of secondary distribution of hepatitis C self-testing within the context of a house-to-house hepatitis C micro-elimination programme in Karachi, Pakistan. BMC Public Health. 2022 Apr 9;22(1):696. doi: 10.1186/s12889-022-13125-9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saeed Hamid principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OraQuick® HCV Self-Test in people with Hepatitis C and Diagnostic Self Evaluation, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04971538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.