Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT02190305
Eligibility Criteria:
Inclusion Criteria:
All subjects:
* 13 years of age or older
* able to sign consent form (or parent/guardian sign consent plus subject sign assent for ages 13-18)
* willing to complete the risk assessment questionnaire, and
* willing to provide blood samples: finger stick sample (2 drops), 1 serum separator tube, 2 anticoagulant (K2 EDTA) tubes.
Population 1 - Diagnostic Trial "At Risk" Group (n = 2000-3000)
Subjects must meet one or more of the following inclusion criteria to be enrolled in Population 1:
* Have at least one risk factor for infection with hepatitis B or C,
* Have at least one risk factor for infection with HIV,
* Present with signs and symptoms of hepatitis,
* Be a known HIV-positive individual (previous positive HIV test result, may comprise up to 500 individuals)
Population 1A - Additional known HIV-positive individuals (n = \~500)
Subjects must:
• be a known HIV-positive individual (previous positive HIV test result).
Population 1B - Additional known HBV-positive individuals (n = \~500)
Subjects must:
• be known to have current or past HBV infection, as evidenced by HBV serology results.
Population 1C - Additional known HCV-positive individuals (n = \~500)
Subjects must:
• be known to be infected with HCV, as evidenced by previous positive HCV test results.
Exclusion Criteria:
* Subjects do not meet the inclusion criteria
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT02190305
Study Brief:
Protocol Section:
NCT02190305