Hepatitis C, ChronicHEAD-StartNCT03594838
Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia
A study testing HCV viremia testing approaches in people with Hepatitis C, Chronic, run by Foundation for Innovative New Diagnostics, Switzerland at 8 sites in Georgia.
Trial summary
This study will evaluate two novel approaches to improve access to Hepatitis C virus (HCV) confirmatory viremia testing. Both approaches are "Harm reduction site-based (HRS)" because HCV viremia testing will be initiated and test results will be provided at the HRSs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- HCV viremia testing approaches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,672 participants
- Where
- 8 sitesGeorgia
- Study dates
- 21 May 2018to 21 Jul 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any history of injection drug use (IDU)
- Age ≥18 years
- Anti-HCV-positive on rapid diagnostic test performed at the HRS
- Eligible for the Georgia HCV State Program
- Living in the catchment area served by the HRS
- No plans to move out of the catchment area during the next 6 months
Show all 10Show fewer
- Willing and able to give informed consent
- Provide HCV services at HRS from screening through linkage to care.
- Laboratory staff performing HCV viremia testing at the HRSs, Lugar Centre and Treatment centres:
- Perform HCV viremia testing
Who cannot join
- Tested HCV RNA-positive from April 2015
- Pregnancy (self-report)
- Currently on treatment for hepatitis C
- Unable to provide a blood sample
- HRS staff involved in HCV testing and care:
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Georgia8 sites
Imedi Harm Reduction Site
Batumi
Step to the Future Harm Reduction Site
Gori
New Way Harm Reduction Site
Kutaisi
New Vector Harm Reduction Site
Rustavi
Akeso Harm Reduction Site
Tbilisi
New Vector Harm Reduction Site
Tbilisi
New Way Harm Reduction Site
Tbilisi
Xenon Harm Reduction Site
Zugdidi
About this study
Official title: Feasibility, Acceptability, Effectiveness and Cost-analysis of Models of HCV Viremia Testing for Confirmation and Cure Among People Who Inject Drugs (PWID): the HEAD*-Start Trial in Georgia
This study will evaluate two novel approaches to improve access to Hepatitis C virus (HCV) confirmatory viremia testing. Both approaches are "Harm reduction site-based (HRS)" because HCV viremia testing will be initiated and test results will be provided at the HRSs. These approaches will be compared to the current standard of care (control) in which anti-HCV-positive individuals must travel to a HCV treatment centre for HCV viremia testing. The investigators hypothesize that improving access to viremia testing improves linkage to care and reduces loss to follow-up among those who screen anti-HCV-positive.
Read the detailed description
A major step in identifying HCV infected individuals in Georgia has already been implemented by providing rapid anti-HCV testing for people who inject drugs (PWID) at HRS. However, access to HCV confirmatory viremia testing remains limited as PWID must be referred to treatment centers for testing.
Two novel approaches to improve access to HCV viremia testing will be evaluated.
In the first approach, participants with a positive anti-HCV test will have blood drawn and HCV RNA test performed at the HRS. Test results will be provided the same day (or the following day if the participant is unable to wait for results) at the HRS.
In the second approach participants with a positive anti-HCV test will have blood drawn at the HRS. The blood will be processed on site and a plasma sample shipped to a central laboratory for viremia testing. Test results will be communicated to the participants by HRS staff at a follow-up visit as soon as the results are available.
In both groups, participants who test positive will be referred to a treatment centre for further assessments and subsequent treatment initiation.
- Conditions
- Hepatitis C, Chronic
- Being tested
- HCV viremia testing approaches
- Keywords
- HCV viremia testing
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV viremia testing approachesOther
Blood draw and HCV viremia testing is done at point of service (Intervention A) Blood draw at point of service and HCV viremia testing at a centralized laboratory (Intervention B)
| Study group | Role | What they receive |
|---|---|---|
| Decentralized testing approach | Experimental | Harm reduction site HCV viremia testing approach A. Four HRS will conduct blood draw and point-of-service (decentralized) HCV RNA testing, and results will be provided at the HRS on the same or the following day. Receives: Other: HCV viremia testing approaches |
| Centralized testing approach | Experimental | Harm reduction site HCV viremia testing approach B. Two sites will collect blood samples on site and transport them to a reference (centralized) laboratory for HCV viremia testing. Results will be provided at a follow-up visit to the HRS as soon as results are available. Receives: Other: HCV viremia testing approaches |
| Standard of Care | No intervention | Current standard of care. Patients who screen anti-HCV positive at HRS will be referred to HCV treatment centers for HCV RNA testing, and results will be provided at a follow-up visit to the treatment center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV care cascade
1.1. Proportion of participants with a positive HCV viremia test who complete each subsequent step in the HCV care cascade
Measured: 6 months
HCV confirmatory viremia test result receipt
Proven superiority (with a margin of 10%) of the proportion of participants with a positive anti-HCV test who receive results of an HCV confirmation of viremia test in each intervention arm separately, compared to referral-based testing (SOC)
Measured: 1-30 days
Secondary outcomes (7)
Entry into HCV care
Proven superiority (with a margin of 10%) of the proportion of participants with positive anti-HCV test who submit a blood sample for viremia testing in each intervention arm separately, compared to referral based testing (SOC)
Measured: 1-14 days
Treatment Initiation Fraction
Proportion of participants with positive HCV viremia test who initiate hepatitis treatment
Measured: 4 weeks
HCV confirmatory viremia test result receipt by intervention
Proportion of participants with a positive anti-HCV test who receive results of an HCV confirmation of viremia test using decentralized HCV RNA testing compared to centralized HCV core antigen
Measured: 1-14 day
Cost of HCV confirmatory viremia testing approach
Costs of HCV viremia testing approaches from a health service and patient perspective
Measured: 6 months
Operational performance of HCV confirmatory viremia testing
Testing volumes at the harm reduction sites
Measured: 6 months
Uptake of HCV confirmatory viremia testing
Facilitators and barriers of getting an HCV confirmatory viremia test as perceived by participants and health care workers
Measured: 4-8 weeks
Attitudes and preferences of participants for HCV confirmatory viremia testing as assessed on a Likert scale
Willingness of participants to get HCV confirmatory viremia testing as assessed on the Likert Scale of 'strongly agree' (0), 'agree' (1), 'neither agree nor disagree' (2), 'disagree' (3), 'strongly disagree' (4)
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start21 May 2018
- Primary completion30 Sep 2019
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A non-randomized 3 arm-interventional study at eight HRSs to evaluate two novel approaches of HCV viremia testing and compare them to the current standard of care. The HRS will be assigned to one of three study arms. Six HRSs will provide HCV viremia testing on-site using one of two approaches as follows and two HRS will refer patients off-site for testing (current standard of care). The three arms will be compared to determine differences in the proportion of anti-HCV-positive patients that receive HCV viremia test results.
- Masking
- None (open label)
- Enrolment
- 1,672 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Disease control and Public Health, Health Research Union
- Responsible party
- Sponsor
- Investigators
- Sonjelle Shilton, Study director, FindIrma Khonelidze, Principal investigator, National Centre for Disease Control, Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594838
- Sponsor's protocol ID
- 8157-3/1
- Acronym
- HEAD-Start
- Status last verified
- Jul 2020
- First submitted
- 13 Jun 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, Effectiveness and Cost-analysis of Models of HCV Viremia Testing for Confirmation and Cure Among People Who Inject Drugs (PWID): the HEAD*-Start Trial in Georgia
- ClinicalTrials.gov ID
- NCT03594838
- Acronym / sponsor ID
- HEAD-Start / 8157-3/1
- Conditions
- Hepatitis C, Chronic
- Keywords
- HCV viremia testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,672 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- National Center for Disease control and Public Health, Health Research Union
- Study start
- 21 May 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 20 Jul 2018 (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.
This study will evaluate two novel approaches to improve access to Hepatitis C virus (HCV) confirmatory viremia testing. Both approaches are "Harm reduction site-based (HRS)" because HCV viremia testing will be initiated and test results will be provided at the HRSs. These approaches will be compared to the current standard of care (control) in which anti-HCV-positive individuals must travel to a HCV treatment centre for HCV viremia testing. The investigators hypothesize that improving access to viremia testing improves linkage to care and reduces loss to follow-up among those who screen anti-HCV-positive.
Detailed description
A major step in identifying HCV infected individuals in Georgia has already been implemented by providing rapid anti-HCV testing for people who inject drugs (PWID) at HRS. However, access to HCV confirmatory viremia testing remains limited as PWID must be referred to treatment centers for testing.
Two novel approaches to improve access to HCV viremia testing will be evaluated.
In the first approach, participants with a positive anti-HCV test will have blood drawn and HCV RNA test performed at the HRS. Test results will be provided the same day (or the following day if the participant is unable to wait for results) at the HRS.
In the second approach participants with a positive anti-HCV test will have blood drawn at the HRS. The blood will be processed on site and a plasma sample shipped to a central laboratory for viremia testing. Test results will be communicated to the participants by HRS staff at a follow-up visit as soon as the results are available.
In both groups, participants who test positive will be referred to a treatment centre for further assessments and subsequent treatment initiation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A non-randomized 3 arm-interventional study at eight HRSs to evaluate two novel approaches of HCV viremia testing and compare them to the current standard of care. The HRS will be assigned to one of three study arms. Six HRSs will provide HCV viremia testing on-site using one of two approaches as follows and two HRS will refer patients off-site for testing (current standard of care). The three arms will be compared to determine differences in the proportion of anti-HCV-positive patients that receive HCV viremia test results.
| Arm | Type | Receives |
|---|---|---|
| Decentralized testing approach | Experimental | Other: HCV viremia testing approachesHarm reduction site HCV viremia testing approach A. Four HRS will conduct blood draw and point-of-service (decentralized) HCV RNA testing, and results will be provided at the HRS on the same or the following day. |
| Centralized testing approach | Experimental | Other: HCV viremia testing approachesHarm reduction site HCV viremia testing approach B. Two sites will collect blood samples on site and transport them to a reference (centralized) laboratory for HCV viremia testing. Results will be provided at a follow-up visit to the HRS as soon as results are available. |
| Standard of Care | No intervention | –Current standard of care. Patients who screen anti-HCV positive at HRS will be referred to HCV treatment centers for HCV RNA testing, and results will be provided at a follow-up visit to the treatment center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Laboratory staff performing HCV viremia testing at the HRSs, Lugar Centre and Treatment centres:
- Perform HCV viremia testing
Key exclusion criteria (5 listed)
- HRS staff involved in HCV testing and care:
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 |
|---|---|---|
| HCV viremia testing approachesBlood draw and HCV viremia testing is done at point of service (Intervention A) Blood draw at point of service and HCV viremia testing at a centralized laboratory (Intervention B) | Other | Centralized testing approach, Decentralized testing approach |
Primary outcome
HCV care cascade
Time frame: 6 months
1.1. Proportion of participants with a positive HCV viremia test who complete each subsequent step in the HCV care cascade
HCV confirmatory viremia test result receipt
Time frame: 1-30 days
Proven superiority (with a margin of 10%) of the proportion of participants with a positive anti-HCV test who receive results of an HCV confirmation of viremia test in each intervention arm separately, compared to referral-based testing (SOC)
7 secondary outcomes
Entry into HCV care
Time frame: 1-14 days
Treatment Initiation Fraction
Time frame: 4 weeks
HCV confirmatory viremia test result receipt by intervention
Time frame: 1-14 day
Cost of HCV confirmatory viremia testing approach
Time frame: 6 months
Operational performance of HCV confirmatory viremia testing
Time frame: 6 months
Uptake of HCV confirmatory viremia testing
Time frame: 4-8 weeks
Attitudes and preferences of participants for HCV confirmatory viremia testing as assessed on a Likert scale
Time frame: 4-8 weeks
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 22 Jul 2020.
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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.
Sonjelle Shilton study director
Find
Irma Khonelidze principal investigator
National Centre for Disease Control, Georgia
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCV viremia testing approaches in people with Hepatitis C, Chronic, run by Foundation for Innovative New Diagnostics, Switzerland at 8 sites in Georgia.
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 10 inclusion and 5 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Georgia. 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?
HCV care cascade (time frame: 6 months). 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?
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 22 Jul 2020.