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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01681-42 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| ANRS, Emerging Infectious Diseases | OTHER_GOV |
| Gilead Sciences | INDUSTRY |
| Roche Pharma AG | INDUSTRY |
| Mairie de Paris |
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This is a pilot, monocentric, prospective, randomized control trial looking at the use of rapid tests as a part of normal care. The investigators will be testing for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). Testing will be proposed to all persons seeking care at the Centre d'Accueil, de Soins et d'Orientation from the organization Médecin du Monde (CASO, MDM).
Infection status of participants will be determined by either the standard test (ELISA) or rapid test. The choice between tests will be determined randomly.
The overall goal is to determine the general acceptability and feasibility of rapid tests and to see if they can help individuals increase their awareness of infection status when compared to longer, routine methods of testing. In addition, results from these tests will allow the medical doctor to guide participants to appropriate care. All positive tests will be confirmed at a specialized hospital (Hôptial Saint-Antoine, Paris, France) and health-specific information will be obtained four months after testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard testing with ELISA | Active Comparator | HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA). |
|
| Rapid testing | Experimental | HBV, HCV, and HIV infection status determined by a rapid test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELISA | Other | Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Accessibility of Testing Results | The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals. | Evaluated once, up to 4 months after testing |
| Measure | Description | Time Frame |
|---|---|---|
| Access to Care | The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals. | Evaluated once, up to 4 months after testing |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Participating | The number of individuals accepting to participate in the study divided by the total number of individuals proposed. | At testing |
| Proportion of Rapid Test Failures | The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm). |
Inclusion Criteria:
Exclusion Criteria:
Currently under physician's care for viral hepatitis (HBV/HCV-specific) or HIV
Already has been tested (must give any of the following as evidence):
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| Name | Affiliation | Role |
|---|---|---|
| Julie Bottero, MD | Hôpital Saint-Antoine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consultation d'Accueil, de Soins et d'Orientation (CASO) de Médecins du Monde (MDM) | Paris | 75011 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23183527 | Background | Bottero J, Boyd A, Gozlan J, Lemoine M, Carrat F, Collignon A, Boo N, Dhotte P, Varsat B, Muller G, Cha O, Picard O, Nau J, Campa P, Silbermann B, Bary M, Girard PM, Lacombe K. Performance of rapid tests for detection of HBsAg and anti-HBsAb in a large cohort, France. J Hepatol. 2013 Mar;58(3):473-8. doi: 10.1016/j.jhep.2012.11.016. Epub 2012 Nov 23. | |
| 26668814 |
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Data will be shared under the following conditions: (1) interested parties must submit a request for data access to the principal investigator and (2) the request is approved by the Scientific Committee.
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554 participants were initially screened for eligibility. 150 did not meet inclusion criteria, 16 had a medical condition requiring immediate referral to a specialist, and 61 declined to participate. A total of 327 were randomized.
Volunteers were recruited from an innercity clinic for persons without healthcare coverage ("Médecins du Monde", Paris, France). From February 25, 2013 to June 21, 2013, individuals seeking care at the center were asked to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Testing With ELISA | HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA). ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days). |
| FG001 | Rapid Testing | HBV, HCV, and HIV infection status determined by a rapid test Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Testing With ELISA | HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA). ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accessibility of Testing Results | The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals. | Posted | Number | proportion of participants | Evaluated once, up to 4 months after testing |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Testing With ELISA | HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA). ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days). |
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Single-center pilot study, possibly reducing generalizability; small number of participants and infected individuals may have decreased power to detect differences in linkage-to-care; not all rapid tests were approved for routine use in France.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Bottero | Service des maladies infectieuses et tropicales - Hôpital Saint-Antoine | +33 1 49 28 04 24 | julie.bottero@aphp.fr |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006526 | Hepatitis C |
| D006528 | Carcinoma, Hepatocellular |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D004797 | Enzyme-Linked Immunosorbent Assay |
| D000092025 | Rapid Diagnostic Tests |
| ID | Term |
|---|---|
| D007124 | Immunoenzyme Techniques |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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| UNKNOWN |
| BioMérieux | INDUSTRY |
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| Rapid Test | Other | A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day. |
|
|
| At testing |
| Bottero J, Boyd A, Gozlan J, Carrat F, Nau J, Pauti MD, Rougier H, Girard PM, Lacombe K. Simultaneous Human Immunodeficiency Virus-Hepatitis B-Hepatitis C Point-of-Care Tests Improve Outcomes in Linkage-to-Care: Results of a Randomized Control Trial in Persons Without Healthcare Coverage. Open Forum Infect Dis. 2015 Oct 26;2(4):ofv162. doi: 10.1093/ofid/ofv162. eCollection 2015 Dec. |
| RT failure and no follow-up ELISA |
|
| BG001 |
| Rapid Testing |
HBV, HCV, and HIV infection status determined by a rapid test Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| HBV prevalence of birth country | Number | participants |
|
| No health insurance plan | Number | participants |
|
|
|
|
| Secondary | Access to Care | The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals. | Analysis includes only participants with positive HIV, HBV, and/or HCV results. | Posted | Number | proportion of participants | Evaluated once, up to 4 months after testing |
|
|
|
|
| Other Pre-specified | Proportion Participating | The number of individuals accepting to participate in the study divided by the total number of individuals proposed. | Posted | Number | proportion of participants | At testing |
|
|
|
| Other Pre-specified | Proportion of Rapid Test Failures | The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm). | Only patients randomized to the rapid testing arm. | Posted | Number | proportion of participants | At testing |
|
|
|
| 0 |
| 162 |
| 0 |
| 162 |
| EG001 | Rapid Testing | HBV, HCV, and HIV infection status determined by a rapid test Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day. | 0 | 162 | 0 | 162 |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D015658 | HIV Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D007163 |
| Immunosorbent Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000067716 | Point-of-Care Testing |
| D019095 | Point-of-Care Systems |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |