Hepatitis C, HIV Coinfection
Conditions
Keywords
Patient Navigation, Treatment Adherence, People who inject drugs (PWID), Directly Observed Therapy (DOT), India
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALLow 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
BEHAVIORALMedium 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.
BEHAVIORALHigh 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.
Sponsors
YR Gaitonde Centre for AIDS Research and Education
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated) | Between 10 and 60 weeks after scheduled end of treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence >90% (Self-report) | Measured at the end of prescribed course of treatment (12 or 24 weeks) | The percentage of participants who self-report taking \>90% of doses during treatment. |
| HCV Treatment Completion | Measured at the end of prescribed course of treatment (12 or 24 weeks) | 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. |
| Adherence >90% (Medication Records) | Measured at the end of prescribed course of treatment (12 or 24 weeks) | The percentage of participants in possession of \>90% of doses during treatment based on medication refills and pill counts. |
| Adherence Level (Self-report) | Measured at the end of prescribed course of treatment (12 or 24 weeks) | The percentage of doses taken during treatment as self-reported by the participant. |
| Adherence Level (Medication Records) | Measured at the end of prescribed course of treatment (12 or 24 weeks) | The percentage of doses participants had in their possession during treatment based on medication refills and pill counts. |
| HCV Reinfection | Measured at 6 month intervals after confirmation of SVR for up to 36 months. | The percentage of participants who test positive for HCV Core Antigen after achieving SVR. |
| HIV Viral Suppression Among HIV/HCV Coinfected Participants | After assessment of SVR for up to 36 months. | The percentage of HIV/HCV co-infected participants with HIV RNA less than LLOQ after the SVR assessment. HCV RNA abstracted from chart reviews. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Outcome Measure: Quality of Life | Measured at 6 month intervals at the SVR visit and post SVR for up to 36 months. | Self-reported quality of life score based on self-report |
| Exploratory Outcome Measure: Mortality | Measured from Entry visit to post SVR for up to 36 months. | Mortality rate per person years |
| Exploratory Outcome Measure: Cost Effectiveness of Tailored Support Options (Low, Medium and High Intensity) | Measured at weekly intervals starting from Entry visit to SVR visit (up to 12 weeks after treatment completion). | Incremental cost effectiveness ratios calculated between an intervention and its next least costly comparator and assessed against per capita Gross Domestic Product (GDP) |
| Exploratory Outcome Measure: Acceptability of Low, Medium and High Intensity Interventions | Qualitative interviews will be conducted between the end of treatment visit and the SVR visit (up to 12 weeks after treatment completion). | Measured by in-depth qualitative interviews with integrated care clinic staff and clients post intervention. |
| Exploratory Outcome Measure: Medication for Opioid Use Disorder Retention | Measured daily from Entry Visit to post SVR for up to 36 months | Consistent MOUD use post randomization |
| Exploratory Outcome Measure: Medication for Opioid Use Disorder (MOUD) Initiation | Measured daily from Entry Visit to post SVR for up to 36 months | Rate of MOUD Initiation post randomization |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1,019 |
| 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. | 684 |
| 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. | 341 |
| 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 | 157 |
| 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. | 319 |
| 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. | 474 |
| Total | 2,994 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Ineligible post randomization | 1 | 0 | 1 | 0 | 1 | 1 |
| Overall Study | Missing SVR lab results | 2 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm 1: Low Intensity Intervention (Minimal Risk) | Arm 2: Medium Intensity Intervention (Minimal Risk) | Arm 3: High Intensity Intervention (Minimal Risk) | Arm 1: Low Intensity Intervention (Elevated Risk) | Arm 2: Medium Intensity Intervention (Elevated Risk) | Arm 3: High Intensity Intervention (Elevated Risk) | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 31 years | 30 years | 32 years | 28 years | 27 years | 27 years | 29 years |
| HCV viral load | 271186 IU/ml | 336331 IU/ml | 250493 IU/ml | 230803 IU/ml | 413023 IU/ml | 220090 IU/ml | 286574 IU/ml |
| Living with HIV | 166 Participants | 136 Participants | 54 Participants | 48 Participants | 94 Participants | 143 Participants | 641 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1019 Participants | 684 Participants | 341 Participants | 157 Participants | 319 Participants | 474 Participants | 2994 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 21 Participants | 14 Participants | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 42 Participants |
| Sex: Female, Male Male | 998 Participants | 670 Participants | 334 Participants | 157 Participants | 319 Participants | 474 Participants | 2952 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 9 / 1,022 | 3 / 684 | 3 / 342 | 4 / 157 | 9 / 320 | 7 / 475 |
| other Total, other adverse events | 1 / 1,022 | 1 / 684 | 2 / 342 | 1 / 157 | 0 / 320 | 1 / 475 |
| serious Total, serious adverse events | 14 / 1,022 | 5 / 684 | 4 / 342 | 7 / 157 | 10 / 320 | 11 / 475 |
Outcome results
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.
Time frame: Between 10 and 60 weeks after scheduled end of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Low Intensity Intervention (Minimal Risk) | Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated) | 638 Participants |
| Arm 2: Medium Intensity Intervention (Minimal Risk) | Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated) | 416 Participants |
| Arm 3: High Intensity Intervention (Minimal Risk) | Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated) | 233 Participants |
| Arm 1 : Low Intensity Intervention (Elevated Risk) | Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated) | 76 Participants |
| Arm 2: Medium Intervention (Elevated Risk) | Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated) | 145 Participants |
| Arm 3: High Intensity Intervention (Elevated Risk) | Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated) | 241 Participants |
Comparison: Reference group: Low Intensity Intervention95% CI: [1, 1.19]
Comparison: Reference Group: Low Intensity Intervention95% CI: [0.9, 1.05]
Comparison: Reference group: High Intensity Intervention95% CI: [0.8, 1.15]
Comparison: Reference group: High Intensity Intervention95% CI: [0.77, 1.04]
Secondary
Adherence >90% (Medication Records)
The percentage of participants in possession of \>90% of doses during treatment based on medication refills and pill counts.
Time frame: Measured at the end of prescribed course of treatment (12 or 24 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Low Intensity Intervention (Minimal Risk) | Adherence >90% (Medication Records) | 755 Participants |
| Arm 2: Medium Intensity Intervention (Minimal Risk) | Adherence >90% (Medication Records) | 541 Participants |
| Arm 3: High Intensity Intervention (Minimal Risk) | Adherence >90% (Medication Records) | 234 Participants |
| Arm 1 : Low Intensity Intervention (Elevated Risk) | Adherence >90% (Medication Records) | 99 Participants |
| Arm 2: Medium Intervention (Elevated Risk) | Adherence >90% (Medication Records) | 233 Participants |
| Arm 3: High Intensity Intervention (Elevated Risk) | Adherence >90% (Medication Records) | 305 Participants |
Secondary
Adherence >90% (Self-report)
The percentage of participants who self-report taking \>90% of doses during treatment.
Time frame: Measured at the end of prescribed course of treatment (12 or 24 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Low Intensity Intervention (Minimal Risk) | Adherence >90% (Self-report) | 860 Participants |
| Arm 2: Medium Intensity Intervention (Minimal Risk) | Adherence >90% (Self-report) | 595 Participants |
| Arm 3: High Intensity Intervention (Minimal Risk) | Adherence >90% (Self-report) | 284 Participants |
| Arm 1 : Low Intensity Intervention (Elevated Risk) | Adherence >90% (Self-report) | 105 Participants |
| Arm 2: Medium Intervention (Elevated Risk) | Adherence >90% (Self-report) | 239 Participants |
| Arm 3: High Intensity Intervention (Elevated Risk) | Adherence >90% (Self-report) | 372 Participants |
Secondary
Adherence Level (Medication Records)
The percentage of doses participants had in their possession during treatment based on medication refills and pill counts.
Time frame: Measured at the end of prescribed course of treatment (12 or 24 weeks)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: Low Intensity Intervention (Minimal Risk) | Adherence Level (Medication Records) | 96.5 Percentage of doses |
| Arm 2: Medium Intensity Intervention (Minimal Risk) | Adherence Level (Medication Records) | 96.6 Percentage of doses |
| Arm 3: High Intensity Intervention (Minimal Risk) | Adherence Level (Medication Records) | 95.2 Percentage of doses |
| Arm 1 : Low Intensity Intervention (Elevated Risk) | Adherence Level (Medication Records) | 93.3 Percentage of doses |
| Arm 2: Medium Intervention (Elevated Risk) | Adherence Level (Medication Records) | 95.5 Percentage of doses |
| Arm 3: High Intensity Intervention (Elevated Risk) | Adherence Level (Medication Records) | 92.9 Percentage of doses |
Secondary
Adherence Level (Self-report)
The percentage of doses taken during treatment as self-reported by the participant.
Time frame: Measured at the end of prescribed course of treatment (12 or 24 weeks)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: Low Intensity Intervention (Minimal Risk) | Adherence Level (Self-report) | 100 % of doses taken |
| Arm 2: Medium Intensity Intervention (Minimal Risk) | Adherence Level (Self-report) | 100 % of doses taken |
| Arm 3: High Intensity Intervention (Minimal Risk) | Adherence Level (Self-report) | 100 % of doses taken |
| Arm 1 : Low Intensity Intervention (Elevated Risk) | Adherence Level (Self-report) | 100 % of doses taken |
| Arm 2: Medium Intervention (Elevated Risk) | Adherence Level (Self-report) | 100 % of doses taken |
| Arm 3: High Intensity Intervention (Elevated Risk) | Adherence Level (Self-report) | 100 % of doses taken |
Secondary
HCV Reinfection
The percentage of participants who test positive for HCV Core Antigen after achieving SVR.
Time frame: Measured at 6 month intervals after confirmation of SVR for up to 36 months.
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.
Time frame: Measured at the end of prescribed course of treatment (12 or 24 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: Low Intensity Intervention (Minimal Risk) | HCV Treatment Completion | 969 Participants |
| Arm 2: Medium Intensity Intervention (Minimal Risk) | HCV Treatment Completion | 660 Participants |
| Arm 3: High Intensity Intervention (Minimal Risk) | HCV Treatment Completion | 311 Participants |
| Arm 1 : Low Intensity Intervention (Elevated Risk) | HCV Treatment Completion | 138 Participants |
| Arm 2: Medium Intervention (Elevated Risk) | HCV Treatment Completion | 291 Participants |
| Arm 3: High Intensity Intervention (Elevated Risk) | HCV Treatment Completion | 413 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.
Time frame: After assessment of SVR for up to 36 months.
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.
Time frame: Qualitative interviews will be conducted between the end of treatment visit and the SVR visit (up to 12 weeks after treatment completion).
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)
Time frame: Measured at weekly intervals starting from Entry visit to SVR visit (up to 12 weeks after treatment completion).
Other Pre-specified
Exploratory Outcome Measure: Medication for Opioid Use Disorder (MOUD) Initiation
Rate of MOUD Initiation post randomization
Time frame: Measured daily from Entry Visit to post SVR for up to 36 months
Other Pre-specified
Exploratory Outcome Measure: Medication for Opioid Use Disorder Retention
Consistent MOUD use post randomization
Time frame: Measured daily from Entry Visit to post SVR for up to 36 months
Other Pre-specified
Exploratory Outcome Measure: Mortality
Mortality rate per person years
Time frame: Measured from Entry visit to post SVR for up to 36 months.
Other Pre-specified
Exploratory Outcome Measure: Quality of Life
Self-reported quality of life score based on self-report
Time frame: Measured at 6 month intervals at the SVR visit and post SVR for up to 36 months.