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:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT04652804
Eligibility Criteria:
Inclusion Criteria:
* Registered for care at an Integrated Care Center (ICC) in one of the 7 field sites.
* Active HCV infection confirmed by a detectable HCV RNA by polymerase chain reaction (PCR) (HCV RNA ≥ 30 copies/ml) within 90 days prior to study entry.
* Liver disease stage defined as non-cirrhotic or compensated cirrhotic (metric/diagnostic criteria used for fibrosis staging) within 90 days prior to study entry.
i. Albumin \>3.0 g/L. ii. Hemoglobin \>8.0 g/dL for women; \>9.0 g/dL for men. iii. Platelet count \>50,000/mm3. iv. Calculated creatinine clearance (CrCl) using Cockcroft-Gault method \>30 mL/min. v. Aspartate aminotransferase (AST/SGOT) \<10 times the upper limit of the normal range (ULN). vi. Alanine aminotransferase (ALT/SGPT) \<10 times the ULN. vii. Total bilirubin \<1.5 times the ULN for participants not on atazanavir (ATV) and \<3 times the ULN for participants on ATV. viii. International normalized ratio (INR) \<1.5 times the ULN.
* Life expectancy greater than 1 year (as determined by study clinician)
* Willing to initiate HCV treatment
* Agree to be randomized to an adherence support strategy
* Ability and willingness to provide written informed consent
* Female participants of reproductive potential must not be pregnant
* All female participants of reproductive potential must agree not to participate in a conception process
* All female participants of reproductive potential must agree to use at least one reliable form of contraceptive while receiving protocol-specified medication, and for 6 weeks after stopping the medication.
Exclusion Criteria:
* Psychologically unfit to provide written informed consent.
* Planning to migrate within the next six months.
* Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
* Acute or serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry.
* In HIV positive participants, presence of active or acute AIDS-defining opportunistic infections within 30 days prior to study entry.
* Use of prohibited medications within the past 14 days prior to study entry.
* Evidence of decompensated liver disease on clinical exam.
* Evidence of active tuberculosis.
* Evidence of chronic hepatitis B infection (HBsAg positive).
* Currently on HCV treatment.
* Prior history of DAA-based HCV treatment
* Confirmed active SARS CoV-2 infection or suspected active SARS CoV-2 infection at enrollment.
* Currently nursing (breastfeeding).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04652804
Study Brief:
Protocol Section:
NCT04652804