Supporting Treatment Outcomes Among PWID (NCT04652804) | Clinical Trial Compass
CompletedNot Applicable
Supporting Treatment Outcomes Among PWID
India3,000 participantsStarted 2021-01-21
Plain-language summary
The goal of this study is to improve HCV care continuum outcomes for people who inject drugs (PWID), reduce potential onward transmission to others and improve HIV outcomes among those who are HIV/HCV coinfected. The study will evaluate whether HCV treatment outcomes (sustained virologic response, treatment completion, adherence) and post treatment outcomes (HCV reinfection, HIV viral suppression) in HCV mono- and HIV/HCV co-infected PWID can be optimized by tailoring treatment support in 7 PWID-focused integrated HIV/HCV prevention and treatment centers in India.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated)
Timeframe: Between 10 and 60 weeks after scheduled end of treatment.