Hepatitis C Clinical Trial
— STOP-COfficial title:
A Precision Randomized Trial to Evaluate the Impact of Tailored Hepatitis C Virus (HCV) Treatment Adherence Support on HCV Treatment Outcomes in HIV/HCV Co-infected and HCV Mono-infected People Who Inject Drugs (PWID) in India.
Verified date | May 2024 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 3000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
India | YR Gaitonde Centre for AIDS Research and Education | Chennai | Tamil Nadu |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute of Allergy and Infectious Diseases (NIAID), YR Gaitonde Centre for AIDS Research and Education |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory Outcome Measure: Medication for Opioid Use Disorder (MOUD) Initiation | Rate of MOUD Initiation post randomization | Measured daily from Entry Visit to post SVR for up to 36 months | |
Other | Exploratory Outcome Measure: Medication for Opioid Use Disorder Retention | Consistent MOUD use post randomization | Measured daily from Entry Visit to post SVR for up to 36 months | |
Other | Exploratory Outcome Measure: Quality of Life | Self-reported quality of life score based on self-report | Measured at 6 month intervals at the SVR visit and post SVR for up to 36 months. | |
Other | Exploratory Outcome Measure: Mortality | Mortality rate per person years | Measured from Entry visit to post SVR for up to 36 months. | |
Other | Exploratory Outcome Measure: Cost effectiveness of tailored support options (low, medium and high intensity) | Incremental cost effectiveness ratios calculated between an intervention and its next least costly comparator and assessed against per capita Gross Domestic Product (GDP) | Measured at weekly intervals starting from Entry visit to SVR visit (up to 12 weeks after treatment completion). | |
Other | Exploratory Outcome Measure: Acceptability of low, medium and high intensity interventions | Measured by in-depth qualitative interviews with integrated care clinic staff and clients post intervention. | Qualitative interviews will be conducted between the end of treatment visit and the SVR visit (up to 12 weeks after treatment completion). | |
Primary | Sustained virologic response (SVR) by intervention group stratified by defined risk for treatment failure (minimal vs elevated) | The percentage of participants who achieved SVR defined as HCV RNA < lower limit of quantification (LLOQ) | Between 10 and 60 weeks after scheduled end of treatment | |
Secondary | HCV treatment completion | The percentage of participants who completed the prescribed course of treatment (12 or 24 weeks) | Measured at end of prescribed course of treatment (12 or 24 weeks) | |
Secondary | Adherence >90% (self-report) | The percentage of participants who self-report taking >90% of doses during treatment. | Measured at 4 week intervals over 12 weeks for those on 12 weeks of treatment and over 24 weeks for those on 24 weeks of treatment. | |
Secondary | Adherence >90% (medication records) | The percentage of participants in possession of >90% of doses during treatment based on medication refills and pill counts. | Measured at each medication dispensation (1 week intervals for high intensity participants and 4 week intervals for low/medium intensity over 12 weeks for those on 12 weeks of treatment and over 24 weeks for those on 24 weeks of treatment). | |
Secondary | Adherence level (self-report) | The percentage of doses taken during treatment as self-reported by the participant. | Measured at 4 week intervals over 12 weeks for those on 12 weeks of treatment and over 24 weeks for those on 24 weeks of treatment. | |
Secondary | Adherence level (medication records) | The percentage of doses participants had in their possession during treatment based on medication refills and pill counts. | Measured at each medication dispensation (1 week intervals for high intensity participants and 4 week intervals for low/medium intensity over 12 weeks for those on 12 weeks of treatment and over 24 weeks for those on 24 weeks of treatment). | |
Secondary | HCV reinfection | The percentage of participants who test positive for HCV Core Antigen after achieving SVR. | Measured at 6 month intervals after confirmation of SVR for up to 36 months. | |
Secondary | HIV viral suppression among HIV/HCV coinfected participants | The percentage of HIV/HCV co-infected participants with HIV RNA less than LLOQ after the SVR assessment. HCV RNA abstracted from chart reviews. | After assessment of SVR for up to 36 months. |
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