Hepatitis CNCT04033887
Evaluation Study of RDTs Detecting Antibodies Against HCV
An observational study of Hepatitis C, run by Foundation for Innovative New Diagnostics, Switzerland at 3 sites in 3 countries.
Trial summary
The study aims to evaluate 13 different HCV RDTs (10 on-market, 3 under development) for their diagnostic performance and operational characteristics in archived EDTA plasma samples, originating from patients from different geographical regions (Nigeria, Georgia, Cambodia, Belgium) and with or without HIV co-infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- 13 Rapid Diagnostic Tests and reference tests
- Type of treatment
- Injection or infusion
- How many people
- 1,710 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 21 Sep 2018to 15 Mar 2019
- Phase
- Observational
- 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
Study population: Samples tested in Belgium originate from Cambodia (80%) and Belgium (20%). Cambodian samples are leftovers from samples collected during a cross-sectional study of hepatitis C among people living with HIV (De Weggheleire, A. 2017); samples in Belgium were collected and archived during routine patient care visits to the HIV clinic. Samples in Nigeria originate from routine diagnostic activities at NIMR as well as the AIDS Prevention Initiative Nigeria (APIN) PEPFAR Program Sample/Data Bank setup at NIMR and the Lagos University Teaching Hospital. Samples tested in Georgia are leftover samples from a previous FIND HCV study (Reipold, E.I., 2019), as well as archived routine diagnostic samples from the site. Percent sample distribution per site: Belgium: 38% Nigeria: 41% Georgia: 21%
Who may be able to join
- Non-hemolytic plasma samples with EDTA used as anticoagulant
- Sample were frozen at -20°C or lower on the day of processing and stored at -20°C or lower until they are used in this study
- Samples pre-characterized for, HCV, HIV serology status using assays routinely used at the sites and approved for diagnostic use by a local health authority. If available, samples should also be characterized for HBV status.
- Samples taken from subjects aged ≥18 years
- Availability of informed consent to use the sample in future research
Who cannot join
- Samples not stored correctly
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Georgia1 site
National Center for Disease Control & Public Health/Lugar Center
Tbilisi, 0198
About this study
Official title: Evaluation Study of Rapid Diagnostic Tests (RDTs) Detecting Antibodies Against Hepatitis C Virus
The study aims to evaluate 13 different HCV RDTs (10 on-market, 3 under development) for their diagnostic performance and operational characteristics in archived EDTA plasma samples, originating from patients from different geographical regions (Nigeria, Georgia, Cambodia, Belgium) and with or without HIV co-infection.
Read the detailed description
Background and rationale:
Screening of past exposure to Hepatitis C Virus (HCV) infection is done by detection of HCV specific antibodies. In Low and Middle Income Countries (LMICs), where equipped laboratories and trained staff are limited, Rapid Diagnostic Tests (RDTs) are widely used for HCV screening. Although many RDTs are available on the market, only some of them received CE-IVD marking and only two have been validated by WHO Pre-Qualification (PQ). More quality-assured tests are needed to establish effective screening programmes in LMICs.
Furthermore, an important research gap is the lack of studies on the impact of HIV positivity on RDT performance, as it is estimated that 2-15% of people living with HIV are co-infected with HCV.
The evaluation of RDT performance on clinical samples collected in different geographic regions as well as from HIV co-infected individuals, would allow to identify tests with a performance meeting or having the potential to meet WHO quality standards.
Concept:
This is a multicenter laboratory evaluation study using archived, frozen plasma samples.
Sensitivity and specificity of RDTs will be measured against a composite reference standard that consists of two WHO prequalified Enzyme Immunoassays (EIAs) (Murex Anti-HCV EIA version 4.0, Fujirebio Innotest HCV Ab IV) and a Line Immunoassay (LIA) (MP Diagnostics HCV blot 3.0). Samples are assigned as anti-HCV negative or anti-HCV positive based on the results of all three assays.
RDT results will be read by three independent readers to evaluate inter-reader variability (differences in visual interpretation, i.e. presence or absence of test and control line).
For each RDT, two independently produced lots will be tested for each sample to assess lot-to-lot variability (differences in RDT result for the same sample). Furthermore, rate of invalid runs will be assessed and a technical appraisal is completed for each RDT.
Primary objective:
1.1 Evaluation of sensitivity and specificity of anti-HCV RDTs in archived plasma samples, collected from HCV-infected and HCV-uninfected individuals not co-infected with HIV, measured against the composite reference standard composed of two Enzyme Immunoassays (EIAs) and a Line Immunoassay (LIA).
1.2 Evaluation of sensitivity and specificity of anti-HCV RDTs in archived plasma samples, collected from HCV-infected and HCV-uninfected individuals who are all co-infected with HIV, measured against the composite reference standard composed of two EIAs and a LIA.
Secondary objectives:
2.1 Evaluation of sensitivity and specificity of anti-HCV RDTs in archived plasma samples, collected from HCV-infected and HCV-uninfected individuals, both co-infected and not with HIV, measured against the composite reference standard composed of two EIAs and a LIA.
2.2 Evaluation of operational characteristics of anti-HCV RDTs: inter-reader variability; lot-to-lot variability; rate of invalid runs 2.3 Technical appraisal of each RDT product per manufacturer
- Conditions
- Hepatitis C
- Being tested
- 13 Rapid Diagnostic Tests and reference tests
- Keywords
- Diagnosis, HIV coinfection, Rapid diagnostic test
- Medical subject headings
- Hepatitis C, Disease, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13 Rapid Diagnostic Tests and reference testsDiagnostic test
Rapid diagnostic tests:
- HCV antibody test (under development); bioLytical Laboratories
- DPP® HCV (under development); Chembio Diagnostic Systems
- HCV-Ab Rapid Test; Beijing Wantai Biological Pharmacy Enterprise
- Rapid Anti-HCV Test; InTec
- First Response HCV Card Test; Premire Medical Corporation
- Signal HCV Ver 3.0; Arkray healthcare
- TRI DOT HCV; J. Mitra \& Co
- Triplex HIV, HCV, HBsAg; Biosynex SA
- Standard Q HCV Ab; SD Biosensor
- HCV Hepatitis Virus Antibody Test; Artron Laboratories
- SD Bioline HCV; Abbott Diagnostics
- OraQuick HCV; OraSure
- Care Start HCV Rapid Test (under development); Access Bio
Reference tests:
Enzyme Immunoassays (EIAs): Murex Anti-HCV EIA version 4.0; Fujirebio Innotest HCV Ab IV
Line Immunoassay (LIA): MP Diagnostics HCV blot 3.0
| Study group | Role | What they receive |
|---|---|---|
| HCV-only infected | Archived frozen plasma samples from individuals that were characterised to be HCV-antibody positive or HCV-antibody negative ("HCV-only infected"). These samples are characterised for their HIV status (negative). Receives: Diagnostic Test: 13 Rapid Diagnostic Tests and reference tests | |
| HCV/HIV co-infected | Archived frozen plasma samples from HCV-positive or HCV-negative individuals who are HIV infected ("HCV/HIV co-infected"). Receives: Diagnostic Test: 13 Rapid Diagnostic Tests and reference tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point estimates of sensitivity and specificity, with 95% confidence intervals, of RDTs for the detection of anti-HCV antibodies in individuals not co-infected with HIV.
Point estimates of sensitivity and specificity, with 95% confidence Intervals based on Wilson's score method, will be computed for all samples HCV+ve/HIV-ve and HCV-ve/HIV-ve; the calculation was performed for all RDT manufacturers and individually for each lot. The estimates were calculated on the overall sample population.
Measured: 6 months
Point estimates of sensitivity and specificity, with 95% confidence intervals, of RDTs for the detection of anti-HCV antibodies in HIV co-infected individuals.
Point estimates of sensitivity and specificity, with 95% confidence Intervals based on Wilson's score method, were computed for all samples HCV+ve/HIV+ve and HCV-ve/HIV+ve; the calculation was performed for all RDT manufacturers and individually for each lot. The estimates were calculated on the overall sample population.
Measured: 6 months
Secondary outcomes (3)
Point estimates of sensitivity and specificity, with 95% confidence intervals, of RDTs for the detection of anti-HCV antibodies in the overall sample population.
Point estimates of sensitivity and specificity, with 95% confidence intervals based on Wilson's score method, were computed for all samples: HCV+ve/HIV-ve, HCV-ve/HIV-ve, HCV+ve/ HIV+ve and HCV-ve/HIV+ve; the was performed for all RDT manufacturers and individually for each lot. The estimates were calculated on the overall sample population.
Measured: 6 months
Operational characteristics
Inter-reader variability: Fleiss Kappa Coefficient (κ) of inter-reader variability per RDT; manufacturer lot Lot-to-lot variability: coefficient of lot-to-lot variability (percentage agreement) per RDT manufacturer Rate of invalid runs: Percent of invalid runs per manufacturer lot
Measured: 6 months
Technical appraisal rating on kit instructions, packaging, labelling and test conduct, on a Likert scale
Averages of likert-scale scores will be calculated and serve to understand the user-friendliness of the RDT; there is no expected outcome, the scale rating is used to collect consistent feedback from users; scale scores are as follows: 1=poor, 2=needs improvement, 3=satisfactory, 4=good, 5=excellent
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start21 Sep 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,710 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium, Nigerian Institute of Medical Research, Richard Lugar Centre for Public Health Research, Georgia
- Responsible party
- Sponsor
- Investigators
- Ranga Sampath, PhD, Study director, Foundation for Innovative New Diagnostics, Geneva, SwitzerlandRosemary Audu, PhD, Principal investigator, Nigerian Institute of Medical Research, Lagos, NigeriaKatrien Fransen, PhD, Principal investigator, Institute of Tropical Medicine, Antwerp, BelgiumMaia Alkhazashvili, Masters, Principal investigator, NCDC Lugar Centre, Tbilisi, Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033887
- Sponsor's protocol ID
- 8162-2/1
- Status last verified
- Jul 2019
- First submitted
- 18 Mar 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Weggheleire A, An S, De Baetselier I, Soeung P, Keath H, So V, Ros S, Teav S, Smekens B, Buyze J, Florence E, van Griensven J, Thai S, Francque S, Lynen L. A cross-sectional study of hepatitis C among people living with HIV in Cambodia: Prevalence, risk factors, and potential for targeted screening. PLoS One. 2017 Aug 23;12(8):e0183530. doi: 10.1371/journal.pone.0183530. eCollection 2017.
PubMed 28832660Reipold, E.I., Evaluation of the diagnostic performance of the Xpert® Fingerstick HCV Viral Load (VL) Assay. Manuscript in preparation 2019
Vetter BN, Reipold EI, Ongarello S, Audu R, Ige FA, Alkhazashvili M, Chitadze N, Vanroye F, De Weggheleire A, An S, Fransen K. Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study. J Infect Dis. 2022 Aug 26;226(3):420-430. doi: 10.1093/infdis/jiaa389.
PubMed 32614451
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Study of Rapid Diagnostic Tests (RDTs) Detecting Antibodies Against Hepatitis C Virus
- ClinicalTrials.gov ID
- NCT04033887
- Acronym / sponsor ID
- 8162-2/1
- Conditions
- Hepatitis C
- Keywords
- Diagnosis, HIV coinfection, Rapid diagnostic test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,710 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium, Nigerian Institute of Medical Research, Richard Lugar Centre for Public Health Research, Georgia
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 26 Jul 2019 (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.
The study aims to evaluate 13 different HCV RDTs (10 on-market, 3 under development) for their diagnostic performance and operational characteristics in archived EDTA plasma samples, originating from patients from different geographical regions (Nigeria, Georgia, Cambodia, Belgium) and with or without HIV co-infection.
Detailed description
Background and rationale:
Screening of past exposure to Hepatitis C Virus (HCV) infection is done by detection of HCV specific antibodies. In Low and Middle Income Countries (LMICs), where equipped laboratories and trained staff are limited, Rapid Diagnostic Tests (RDTs) are widely used for HCV screening. Although many RDTs are available on the market, only some of them received CE-IVD marking and only two have been validated by WHO Pre-Qualification (PQ). More quality-assured tests are needed to establish effective screening programmes in LMICs.
Furthermore, an important research gap is the lack of studies on the impact of HIV positivity on RDT performance, as it is estimated that 2-15% of people living with HIV are co-infected with HCV.
The evaluation of RDT performance on clinical samples collected in different geographic regions as well as from HIV co-infected individuals, would allow to identify tests with a performance meeting or having the potential to meet WHO quality standards.
Concept:
This is a multicenter laboratory evaluation study using archived, frozen plasma samples.
Sensitivity and specificity of RDTs will be measured against a composite reference standard that consists of two WHO prequalified Enzyme Immunoassays (EIAs) (Murex Anti-HCV EIA version 4.0, Fujirebio Innotest HCV Ab IV) and a Line Immunoassay (LIA) (MP Diagnostics HCV blot 3.0). Samples are assigned as anti-HCV negative or anti-HCV positive based on the results of all three assays.
RDT results will be read by three independent readers to evaluate inter-reader variability (differences in visual interpretation, i.e. presence or absence of test and control line).
For each RDT, two independently produced lots will be tested for each sample to assess lot-to-lot variability (differences in RDT result for the same sample). Furthermore, rate of invalid runs will be assessed and a technical appraisal is completed for each RDT.
Primary objective:
1.1 Evaluation of sensitivity and specificity of anti-HCV RDTs in archived plasma samples, collected from HCV-infected and HCV-uninfected individuals not co-infected with HIV, measured against the composite reference standard composed of two Enzyme Immunoassays (EIAs) and a Line Immunoassay (LIA).
1.2 Evaluation of sensitivity and specificity of anti-HCV RDTs in archived plasma samples, collected from HCV-infected and HCV-uninfected individuals who are all co-infected with HIV, measured against the composite reference standard composed of two EIAs and a LIA.
Secondary objectives:
2.1 Evaluation of sensitivity and specificity of anti-HCV RDTs in archived plasma samples, collected from HCV-infected and HCV-uninfected individuals, both co-infected and not with HIV, measured against the composite reference standard composed of two EIAs and a LIA.
2.2 Evaluation of operational characteristics of anti-HCV RDTs: inter-reader variability; lot-to-lot variability; rate of invalid runs 2.3 Technical appraisal of each RDT product per manufacturer
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV-only infected | – | Diagnostic Test: 13 Rapid Diagnostic Tests and reference testsArchived frozen plasma samples from individuals that were characterised to be HCV-antibody positive or HCV-antibody negative ("HCV-only infected"). These samples are characterised for their HIV status (negative). |
| HCV/HIV co-infected | – | Diagnostic Test: 13 Rapid Diagnostic Tests and reference testsArchived frozen plasma samples from HCV-positive or HCV-negative individuals who are HIV infected ("HCV/HIV co-infected"). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples tested in Belgium originate from Cambodia (80%) and Belgium (20%). Cambodian samples are leftovers from samples collected during a cross-sectional study of hepatitis C among people living with HIV (De Weggheleire, A. 2017); samples in Belgium were collected and archived during routine patient care visits to the HIV clinic. Samples in Nigeria originate from routine diagnostic activities at NIMR as well as the AIDS Prevention Initiative Nigeria (APIN) PEPFAR Program Sample/Data Bank setup at NIMR and the Lagos University Teaching Hospital. Samples tested in Georgia are leftover samples from a previous FIND HCV study (Reipold, E.I., 2019), as well as archived routine diagnostic samples from the site. Percent sample distribution per site: Belgium: 38% Nigeria: 41% Georgia: 21%
Key inclusion criteria (5 listed)
- Non-hemolytic plasma samples with EDTA used as anticoagulant
- Sample were frozen at -20°C or lower on the day of processing and stored at -20°C or lower until they are used in this study
- Samples pre-characterized for, HCV, HIV serology status using assays routinely used at the sites and approved for diagnostic use by a local health authority. If available, samples should also be characterized for HBV status.
- Samples taken from subjects aged ≥18 years
- Availability of informed consent to use the sample in future research
Key exclusion criteria (1 listed)
- Samples not stored correctly
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 |
|---|---|---|
| 13 Rapid Diagnostic Tests and reference testsRapid diagnostic tests: 1. HCV antibody test (under development); bioLytical Laboratories 2. DPP® HCV (under development); Chembio Diagnostic Systems 3. HCV-Ab Rapid Test; Beijing Wantai Biological Pharmacy Enterprise 4. Rapid Anti-HCV Test; InTec 5. First Response HCV Card Test; Premire Medical Corporation 6. Signal HCV Ver 3.0; Arkray healthcare 7. TRI DOT HCV; J. Mitra \& Co 8. Triplex HIV, HCV, HBsAg; Biosynex SA 9. Standard Q HCV Ab; SD Biosensor 10. HCV Hepatitis Virus Antibody Test; Artron Laboratories 11. SD Bioline HCV; Abbott Diagnostics 12. OraQuick HCV; OraSure 13. Care Start HCV Rapid Test (under development); Access Bio Reference tests: Enzyme Immunoassays (EIAs): Murex Anti-HCV EIA version 4.0; Fujirebio Innotest HCV Ab IV Line Immunoassay (LIA): MP Diagnostics HCV blot 3.0 | Diagnostic test | HCV-only infected, HCV/HIV co-infected |
Primary outcome
Point estimates of sensitivity and specificity, with 95% confidence intervals, of RDTs for the detection of anti-HCV antibodies in individuals not co-infected with HIV.
Time frame: 6 months
Point estimates of sensitivity and specificity, with 95% confidence Intervals based on Wilson's score method, will be computed for all samples HCV+ve/HIV-ve and HCV-ve/HIV-ve; the calculation was performed for all RDT manufacturers and individually for each lot. The estimates were calculated on the overall sample population.
Point estimates of sensitivity and specificity, with 95% confidence intervals, of RDTs for the detection of anti-HCV antibodies in HIV co-infected individuals.
Time frame: 6 months
Point estimates of sensitivity and specificity, with 95% confidence Intervals based on Wilson's score method, were computed for all samples HCV+ve/HIV+ve and HCV-ve/HIV+ve; the calculation was performed for all RDT manufacturers and individually for each lot. The estimates were calculated on the overall sample population.
3 secondary outcomes
Point estimates of sensitivity and specificity, with 95% confidence intervals, of RDTs for the detection of anti-HCV antibodies in the overall sample population.
Time frame: 6 months
Operational characteristics
Time frame: 6 months
Technical appraisal rating on kit instructions, packaging, labelling and test conduct, on a Likert scale
Time frame: 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 29 Jul 2019.
- Background: PubMed 28832660De Weggheleire A, An S, De Baetselier I, Soeung P, Keath H, So V, Ros S, Teav S, Smekens B, Buyze J, Florence E, van Griensven J, Thai S, Francque S, Lynen L. A cross-sectional study of hepatitis C among people living with HIV in Cambodia: Prevalence, risk factors, and potential for targeted screening. PLoS One. 2017 Aug 23;12(8):e0183530. doi: 10.1371/journal.pone.0183530. eCollection 2017.
- BackgroundReipold, E.I., Evaluation of the diagnostic performance of the Xpert® Fingerstick HCV Viral Load (VL) Assay. Manuscript in preparation 2019
- Derived from this study: PubMed 32614451Vetter BN, Reipold EI, Ongarello S, Audu R, Ige FA, Alkhazashvili M, Chitadze N, Vanroye F, De Weggheleire A, An S, Fransen K. Sensitivity and Specificity of Rapid Diagnostic Tests for Hepatitis C Virus With or Without HIV Coinfection: A Multicentre Laboratory Evaluation Study. J Infect Dis. 2022 Aug 26;226(3):420-430. doi: 10.1093/infdis/jiaa389.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Ranga Sampath, PhD study director
Foundation for Innovative New Diagnostics, Geneva, Switzerland
Rosemary Audu, PhD principal investigator
Nigerian Institute of Medical Research, Lagos, Nigeria
Katrien Fransen, PhD principal investigator
Institute of Tropical Medicine, Antwerp, Belgium
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Foundation for Innovative New Diagnostics, Switzerland at 3 sites in 3 countries.
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 5 inclusion and 1 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 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Georgia, Nigeria. 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?
Point estimates of sensitivity and specificity, with 95% confidence intervals, of RDTs for the detection of anti-HCV antibodies in individuals not co-infected with HIV. (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?
On the ClinicalTrials.gov record for NCT04033887, which also lists 3 linked publications.
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 29 Jul 2019.