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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AI145555-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| YR Gaitonde Centre for AIDS Research and Education | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
The primary objective is to evaluate whether the intensity of treatment adherence support affects sustained virologic response rates in HCV mono- and HIV/HCV co-infected participants receiving HCV direct-acting antivirals (DAA) in PWID-focused centers. Secondary objectives are: 1. To evaluate whether the intensity of treatment adherence support affects HCV treatment completion rates. 2. To evaluate whether the intensity of treatment adherence support affects HCV treatment adherence. 3. To estimate the incidence and correlates of HCV reinfection among HCV mono- and HIV/HCV coinfected PWID who achieve HCV cure. 4. To evaluate the impact of HCV cure on HIV viral suppression among HIV/HCV coinfected PWID.
Investigators will evaluate this via a 3-arm, individual-level randomized clinical trial, in which treatment assignment probabilities vary according to participants' estimated propensity for treatment failure at baseline (precision randomization). An estimated 3,000 persons will be enrolled and randomized at 7 community-based integrated care centers (ICCs) across India across a duration of 18 - 24 months. Data from these 7 ICCs on early HIV treatment refills/viral suppression (3-6 months after antiretroviral therapy (ART) initiation) will be used to develop and validate an algorithm to predict propensity for HCV treatment failure. Prior to treatment initiation, each participant will undergo a questionnaire to capture information on barriers/ facilitators to treatment adherence identified in the prediction model in order to determine the propensity for HCV treatment failure (minimal or elevated risk). Individuals will be preferentially randomized to the support level that matches their failure risk. Those at elevated risk for treatment failure will be randomized at an allocation ratio of 3:2:1 for Arm 3 (high intensity support), Arm 2 (medium intensity support) and Arm 1 (low intensity support), respectively. Conversely, those at minimal risk will be randomized at a ratio of 1:2:3 to Arm 3 (high intensity support), Arm 2 (medium intensity support) and Arm 1 (low intensity support), respectively. Participants and study staff will be blinded to the risk classification (minimal, elevated) but, because of the nature of the interventions, blinding to intervention assignment is not possible.
Persons will be treated for HCV according to the standard of care in India. Minimal laboratory monitoring will be used except when clinically indicated. Participants with decompensated cirrhosis will be excluded from treatment.
All HIV/HCV co-infected participants and those HCV monoinfected participants who achieve SVR will be followed post-treatment. These individuals will be followed every six months after the SVR assessment to assess HCV reinfection and HIV viral suppression (among HIV/HCV coinfected participants) for up to 30 months after SVR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Low Intensity Intervention | Active Comparator | 4 weeks dispensation + standard adherence counseling |
|
| Arm 2: Medium Intensity Intervention | Active Comparator | 4 weeks dispensation + support from patient navigator |
|
| Arm 3: High Intensity Intervention | Active Comparator | Directly Observed Therapy with flexible dispensing and support from patient navigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity HCV treatment adherence support | Behavioral | A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements |
| Measure | Description | Time Frame |
|---|---|---|
| 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). HCV RNA < lower limit of quantification (LLOQ, 30 IU/ml) was measured 12 weeks (range 10 - 60 weeks) after treatment completion. | Between 10 and 60 weeks after scheduled end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| HCV Treatment Completion | The percentage of participants who completed the prescribed course of treatment (12 or 24 weeks). Participants with compensated cirrhosis and genotype 3 infection would have received 24 weeks of treatment. All other participants would have received treatment for 12 weeks. All participants in this study received 12 weeks of treatment. | Measured at the end of prescribed course of treatment (12 or 24 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Exploratory Outcome Measure: Medication for Opioid Use Disorder Retention |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Sunil S Solomon, PhD MBBS MPH | Johns Hopkins University School of Medicine and Y.R. Gaitonde Centre for AIDS Research and Education | Principal Investigator |
| Shruti H Mehta, PhD MPH | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YR Gaitonde Centre for AIDS Research and Education | Chennai | Tamil Nadu | 600010 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42379314 | Derived | Solomon SS, Srikrishnan AK, McFall AM, Baishya J, Gunaratne MP, Kedar A, Amrose P, Balakrishnan R, Boobalan J, Evans J, Lau BM, Ehrhardt S, Sulkowski MS, Thomas DL, Lucas GM, Suresh Kumar M, Mehta SH. A precision randomized trial of hepatitis C treatment support among people who inject drugs in India: The STOP-C Trial. J Hepatol. 2026 Jun 30:S0168-8278(26)02683-8. doi: 10.1016/j.jhep.2026.06.034. Online ahead of print. | |
| 39572371 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Low Intensity Intervention (Minimal Risk) | 4 weeks dispensation + standard adherence counseling Low intensity Hepatitis C Virus (HCV) treatment adherence support: A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements |
| FG001 | Arm 2: Medium Intensity Intervention (Minimal Risk) | 4 weeks dispensation + support from patient navigator Medium intensity HCV treatment adherence support: The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. |
| FG002 | Arm 3: High Intensity Intervention (Minimal Risk) | Directly Observed Therapy (DOT) with flexible dispensing and support from patient navigator High intensity HCV treatment adherence support: The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. |
| FG003 | Arm 1: Low Intensity Intervention (Elevated Risk) | 4 weeks dispensation + standard adherence counseling Low intensity HCV treatment adherence support: A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements |
| FG004 | Arm 2: Medium Intensity Intervention (Elevated Risk) | 4 weeks dispensation + support from patient navigator Medium intensity HCV treatment adherence support: The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. |
| FG005 | Arm 3: High Intensity Intervention (Elevated Risk) | Directly Observed Therapy with flexible dispensing and support from patient navigator High intensity HCV treatment adherence support: The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data are stratified by risk stratum and arm. 2048 participants were assigned to the minimal risk stratum, and 952 were assigned to the elevated risk stratum.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Low Intensity Intervention (Minimal Risk) | 4 weeks dispensation + standard adherence counseling Low intensity HCV treatment adherence support: A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median (Inter-Quartile Range) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). HCV RNA < lower limit of quantification (LLOQ, 30 IU/ml) was measured 12 weeks (range 10 - 60 weeks) after treatment completion. | Posted | Count of Participants | Participants | Between 10 and 60 weeks after scheduled end of treatment. |
|
From date of randomization up to the expected Sustained Virologic Response (SVR) 12 week visit date
All AEs that occurred after the entry visit and up to SVR evaluation were recorded if any of the following criteria were met:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Low Intensity Intervention (Minimal Risk) | 4 weeks dispensation + standard adherence counseling Low intensity HCV treatment adherence support: A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Event other than death | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shruti H. Mehta | Johns Hopkins Bloomberg School of Public Health | 443-287-3837 | smehta@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2022 | Jan 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2024 | Jan 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D015658 | HIV Infections |
| D000074822 | Treatment Adherence and Compliance |
| D023801 | Directly Observed Therapy |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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This is a 3-arm, individual-level randomized clinical trial, in which treatment assignment probabilities vary according to participants' estimated propensity for treatment failure at baseline (precision randomization). Minimal risk individuals have a higher likelihood of being allocated to lower intensity intervention and elevated risk individuals have higher likelihood of being allocated to higher intensity intervention.
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|
| Medium intensity HCV treatment adherence support | Behavioral | The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. |
|
| High intensity HCV treatment adherence support | Behavioral | The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. |
|
| Adherence >90% (Self-report) | The percentage of participants who self-report taking >90% of doses during treatment. | Measured at the end of prescribed course of treatment (12 or 24 weeks) |
| 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 the end of prescribed course of treatment (12 or 24 weeks) |
| Adherence Level (Self-report) | The percentage of doses taken during treatment as self-reported by the participant. | Measured at the end of prescribed course of treatment (12 or 24 weeks) |
| Adherence Level (Medication Records) | The percentage of doses participants had in their possession during treatment based on medication refills and pill counts. | Measured at the end of prescribed course of treatment (12 or 24 weeks) |
| 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. |
| 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. |
Consistent MOUD use post randomization |
| Measured daily from Entry Visit to post SVR for up to 36 months |
| 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. |
| Exploratory Outcome Measure: Mortality | Mortality rate per person years | Measured from Entry visit to post SVR for up to 36 months. |
| 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). |
| 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). |
| Mehta SH, Lau BM, Ehrhardt S, McFall A, Gunaratne MP, Baishya J, Kedar A, Srikrishnan AK, Evans J, Loeb T, Pradeep A, Kumar MS, Thomas DL, Lucas GM, Solomon SS. A precision randomized trial to evaluate the impact of tailored hepatitis C treatment adherence support on HCV treatment outcomes among people who inject drugs in India: design and baseline characteristics of the STOP-C trial. Am J Epidemiol. 2025 Oct 7;194(10):2986-2998. doi: 10.1093/aje/kwae430. |
| Missing SVR lab results |
|
| BG001 | Arm 2: Medium Intensity Intervention (Minimal Risk) | 4 weeks dispensation + support from patient navigator Medium intensity HCV treatment adherence support: The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. |
| BG002 | Arm 3: High Intensity Intervention (Minimal Risk) | Directly Observed Therapy with flexible dispensing and support from patient navigator High intensity HCV treatment adherence support: The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. |
| BG003 | Arm 1: Low Intensity Intervention (Elevated Risk) | 4 weeks dispensation + standard adherence counseling Low intensity HCV treatment adherence support: A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements |
| BG004 | Arm 2: Medium Intensity Intervention (Elevated Risk) | 4 weeks dispensation + support from patient navigator Medium intensity HCV treatment adherence support: The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. |
| BG005 | Arm 3: High Intensity Intervention (Elevated Risk) | Directly Observed Therapy with flexible dispensing and support from patient navigator High intensity HCV treatment adherence support: The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. |
| BG006 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Living with HIV | Count of Participants | Participants |
|
| HCV viral load | Median | Inter-Quartile Range | IU/ml |
|
| OG001 | Arm 2: Medium Intensity Intervention (Minimal Risk) | 4 weeks dispensation + support from patient navigator Medium intensity HCV treatment adherence support: The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. |
| OG002 | Arm 3: High Intensity Intervention (Minimal Risk) | Directly Observed Therapy with flexible dispensing and support from patient navigator High intensity HCV treatment adherence support: The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. |
| OG003 | Arm 1 : Low Intensity Intervention (Elevated Risk) | 4 weeks dispensation + standard adherence counseling Low intensity HCV treatment adherence support: A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements |
| OG004 | Arm 2: Medium Intervention (Elevated Risk) | 4 weeks dispensation + support from patient navigator Medium intensity HCV treatment adherence support: The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. |
| OG005 | Arm 3: High Intensity Intervention (Elevated Risk) | Directly Observed Therapy with flexible dispensing and support from patient navigator High intensity HCV treatment adherence support: The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. |
|
|
|
| Secondary | HCV Treatment Completion | The percentage of participants who completed the prescribed course of treatment (12 or 24 weeks). Participants with compensated cirrhosis and genotype 3 infection would have received 24 weeks of treatment. All other participants would have received treatment for 12 weeks. All participants in this study received 12 weeks of treatment. | Posted | Count of Participants | Participants | Measured at the 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. | Posted | Count of Participants | Participants | Measured at the end of prescribed course of treatment (12 or 24 weeks) |
|
|
|
| Secondary | Adherence >90% (Medication Records) | The percentage of participants in possession of >90% of doses during treatment based on medication refills and pill counts. | Posted | Count of Participants | Participants | Measured at the end of prescribed course of treatment (12 or 24 weeks) |
|
|
|
| Secondary | Adherence Level (Self-report) | The percentage of doses taken during treatment as self-reported by the participant. | Posted | Median | Inter-Quartile Range | % of doses taken | Measured at the end of prescribed course of treatment (12 or 24 weeks) |
|
|
|
| Secondary | Adherence Level (Medication Records) | The percentage of doses participants had in their possession during treatment based on medication refills and pill counts. | Posted | Median | Inter-Quartile Range | Percentage of doses | Measured at the end of prescribed course of treatment (12 or 24 weeks) |
|
|
|
| Secondary | HCV Reinfection | The percentage of participants who test positive for HCV Core Antigen after achieving SVR. | Not Posted | Measured at 6 month intervals after confirmation of SVR for up to 36 months. | Participants |
| 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. | Not Posted | After assessment of SVR for up to 36 months. | Participants |
| Other Pre-specified | Exploratory Outcome Measure: Medication for Opioid Use Disorder (MOUD) Initiation | Rate of MOUD Initiation post randomization | Not Posted | Measured daily from Entry Visit to post SVR for up to 36 months | Participants |
| Other Pre-specified | Exploratory Outcome Measure: Medication for Opioid Use Disorder Retention | Consistent MOUD use post randomization | Not Posted | Measured daily from Entry Visit to post SVR for up to 36 months | Participants |
| Other Pre-specified | Exploratory Outcome Measure: Quality of Life | Self-reported quality of life score based on self-report | Not Posted | Measured at 6 month intervals at the SVR visit and post SVR for up to 36 months. | Participants |
| Other Pre-specified | Exploratory Outcome Measure: Mortality | Mortality rate per person years | Not Posted | Measured from Entry visit to post SVR for up to 36 months. | Participants |
| Other Pre-specified | 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) | Not Posted | Measured at weekly intervals starting from Entry visit to SVR visit (up to 12 weeks after treatment completion). | Participants |
| Other Pre-specified | 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. | Not Posted | Qualitative interviews will be conducted between the end of treatment visit and the SVR visit (up to 12 weeks after treatment completion). | Participants |
| 9 |
| 1,022 |
| 14 |
| 1,022 |
| 1 |
| 1,022 |
| EG001 | Arm 2: Medium Intensity Intervention (Minimal Risk) | 4 weeks dispensation + support from patient navigator Medium intensity HCV treatment adherence support: The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. | 3 | 684 | 5 | 684 | 1 | 684 |
| EG002 | Arm 3: High Intensity Intervention (Minimal Risk) | Directly Observed Therapy with flexible dispensing and support from patient navigator High intensity HCV treatment adherence support: The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. | 3 | 342 | 4 | 342 | 2 | 342 |
| EG003 | Arm 1: Low Intensity Intervention (Elevated Risk) | 4 weeks dispensation + standard adherence counseling Low intensity HCV treatment adherence support: A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements | 4 | 157 | 7 | 157 | 1 | 157 |
| EG004 | Arm 2: Medium Intensity Intervention (Elevated Risk) | 4 weeks dispensation + support from patient navigator Medium intensity HCV treatment adherence support: The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks. | 9 | 320 | 10 | 320 | 0 | 320 |
| EG005 | Arm 3: High Intensity Intervention (Elevated Risk) | Directly Observed Therapy with flexible dispensing and support from patient navigator High intensity HCV treatment adherence support: The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed. | 7 | 475 | 11 | 475 | 1 | 475 |
| Event other than death | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |