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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT02641158
Eligibility Criteria:
Inclusion Criteria:
By virtue of participating individuals being recruited from the CTN-0049 cohort, they will be:
1. HIV-infected and
2. 18 years of age or older
3. Be able to communicate in English
Additionally, to be eligible for Component 1 they must:
4. provide informed consent, which includes being willing to provide sufficient locator information and to be tested for anti-HCV antibodies and, if antibody positive, tested for active HCV infection
5. sign a HIPAA form / medical record release form to facilitate medical record abstraction
Finally, to continue on to Component 2, they must:
6. provide sufficient locator information
7. report living in the vicinity and being able to return for follow-up visits
8. complete the baseline assessments
9. complete the blood draw
10. test as HCV antibody positive via study Component 1 and,
11. agree to be randomized in Component 2
Exclusion Criteria:
Individuals will be excluded from participation if they:
1. have significant cognitive or developmental impairment
2. are terminated via Site Principal Investigator decision/discretion with agreement from study Lead Investigator
3. are currently in jail, prison or any inpatient overnight facility as required by court of law or have a pending legal action which may prevent an individual from completing the study
Additionally, individuals may participate in Component 1, but will be excluded from Component 2 if they:
4. are currently on HCV therapy/medications at baseline
5. have completed a course of HCV medications in the last 12 weeks based on self-report.
It should be noted that pregnancy is not an exclusion criterion. Therefore, sites may enroll pregnant women and/or follow-up with already enrolled women who become pregnant after enrollment in the study provided that they have local IRB approval to do so.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02641158
Study Brief:
Protocol Section:
NCT02641158