Trial Outcomes & Findings for Supporting Treatment Outcomes Among PWID (NCT NCT04652804)
NCT ID: NCT04652804
Last Updated: 2025-04-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3000 participants
Primary outcome timeframe
Between 10 and 60 weeks after scheduled end of treatment.
Results posted on
2025-04-08
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
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.
|
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
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1022
|
684
|
342
|
157
|
320
|
475
|
|
Overall Study
COMPLETED
|
1019
|
684
|
341
|
157
|
319
|
474
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
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
|
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.
|
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.
|
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
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
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
Supporting Treatment Outcomes Among PWID
Baseline characteristics by cohort
| Measure |
Arm 1: Low Intensity Intervention (Minimal Risk)
n=1019 Participants
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
|
Arm 2: Medium Intensity Intervention (Minimal Risk)
n=684 Participants
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.
|
Arm 3: High Intensity Intervention (Minimal Risk)
n=341 Participants
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.
|
Arm 1: Low Intensity Intervention (Elevated Risk)
n=157 Participants
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
|
Arm 2: Medium Intensity Intervention (Elevated Risk)
n=319 Participants
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.
|
Arm 3: High Intensity Intervention (Elevated Risk)
n=474 Participants
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.
|
Total
n=2994 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31 years
n=93 Participants
|
30 years
n=4 Participants
|
32 years
n=27 Participants
|
28 years
n=483 Participants
|
27 years
n=36 Participants
|
27 years
n=10 Participants
|
29 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
998 Participants
n=93 Participants
|
670 Participants
n=4 Participants
|
334 Participants
n=27 Participants
|
157 Participants
n=483 Participants
|
319 Participants
n=36 Participants
|
474 Participants
n=10 Participants
|
2952 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
1019 Participants
n=93 Participants
|
684 Participants
n=4 Participants
|
341 Participants
n=27 Participants
|
157 Participants
n=483 Participants
|
319 Participants
n=36 Participants
|
474 Participants
n=10 Participants
|
2994 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Living with HIV
|
166 Participants
n=93 Participants
|
136 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
48 Participants
n=483 Participants
|
94 Participants
n=36 Participants
|
143 Participants
n=10 Participants
|
641 Participants
n=115 Participants
|
|
HCV viral load
|
271186 IU/ml
n=93 Participants
|
336331 IU/ml
n=4 Participants
|
250493 IU/ml
n=27 Participants
|
230803 IU/ml
n=483 Participants
|
413023 IU/ml
n=36 Participants
|
220090 IU/ml
n=10 Participants
|
286574 IU/ml
n=115 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1: Low Intensity Intervention (Minimal Risk)
n=1019 Participants
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
|
Arm 2: Medium Intensity Intervention (Minimal Risk)
n=684 Participants
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.
|
Arm 3: High Intensity Intervention (Minimal Risk)
n=341 Participants
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.
|
Arm 1 : Low Intensity Intervention (Elevated Risk)
n=157 Participants
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
|
Arm 2: Medium Intervention (Elevated Risk)
n=319 Participants
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.
|
Arm 3: High Intensity Intervention (Elevated Risk)
n=474 Participants
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.
|
|---|---|---|---|---|---|---|
|
Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated)
|
638 Participants
|
416 Participants
|
233 Participants
|
76 Participants
|
145 Participants
|
241 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1: Low Intensity Intervention (Minimal Risk)
n=1019 Participants
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
|
Arm 2: Medium Intensity Intervention (Minimal Risk)
n=684 Participants
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.
|
Arm 3: High Intensity Intervention (Minimal Risk)
n=341 Participants
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.
|
Arm 1 : Low Intensity Intervention (Elevated Risk)
n=157 Participants
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
|
Arm 2: Medium Intervention (Elevated Risk)
n=319 Participants
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.
|
Arm 3: High Intensity Intervention (Elevated Risk)
n=474 Participants
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.
|
|---|---|---|---|---|---|---|
|
HCV Treatment Completion
|
969 Participants
|
660 Participants
|
311 Participants
|
138 Participants
|
291 Participants
|
413 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1: Low Intensity Intervention (Minimal Risk)
n=1019 Participants
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
|
Arm 2: Medium Intensity Intervention (Minimal Risk)
n=684 Participants
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.
|
Arm 3: High Intensity Intervention (Minimal Risk)
n=341 Participants
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.
|
Arm 1 : Low Intensity Intervention (Elevated Risk)
n=157 Participants
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
|
Arm 2: Medium Intervention (Elevated Risk)
n=319 Participants
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.
|
Arm 3: High Intensity Intervention (Elevated Risk)
n=474 Participants
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.
|
|---|---|---|---|---|---|---|
|
Adherence >90% (Self-report)
|
860 Participants
|
595 Participants
|
284 Participants
|
105 Participants
|
239 Participants
|
372 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1: Low Intensity Intervention (Minimal Risk)
n=1019 Participants
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
|
Arm 2: Medium Intensity Intervention (Minimal Risk)
n=684 Participants
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.
|
Arm 3: High Intensity Intervention (Minimal Risk)
n=341 Participants
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.
|
Arm 1 : Low Intensity Intervention (Elevated Risk)
n=157 Participants
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
|
Arm 2: Medium Intervention (Elevated Risk)
n=319 Participants
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.
|
Arm 3: High Intensity Intervention (Elevated Risk)
n=474 Participants
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.
|
|---|---|---|---|---|---|---|
|
Adherence >90% (Medication Records)
|
755 Participants
|
541 Participants
|
234 Participants
|
99 Participants
|
233 Participants
|
305 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1: Low Intensity Intervention (Minimal Risk)
n=1019 Participants
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
|
Arm 2: Medium Intensity Intervention (Minimal Risk)
n=684 Participants
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.
|
Arm 3: High Intensity Intervention (Minimal Risk)
n=341 Participants
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.
|
Arm 1 : Low Intensity Intervention (Elevated Risk)
n=157 Participants
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
|
Arm 2: Medium Intervention (Elevated Risk)
n=319 Participants
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.
|
Arm 3: High Intensity Intervention (Elevated Risk)
n=474 Participants
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.
|
|---|---|---|---|---|---|---|
|
Adherence Level (Self-report)
|
100 % of doses taken
Interval 98.7 to 100.0
|
100 % of doses taken
Interval 100.0 to 100.0
|
100 % of doses taken
Interval 100.0 to 100.0
|
100 % of doses taken
Interval 83.3 to 100.0
|
100 % of doses taken
Interval 90.0 to 100.0
|
100 % of doses taken
Interval 93.3 to 100.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1: Low Intensity Intervention (Minimal Risk)
n=1019 Participants
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
|
Arm 2: Medium Intensity Intervention (Minimal Risk)
n=684 Participants
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.
|
Arm 3: High Intensity Intervention (Minimal Risk)
n=341 Participants
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.
|
Arm 1 : Low Intensity Intervention (Elevated Risk)
n=157 Participants
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
|
Arm 2: Medium Intervention (Elevated Risk)
n=319 Participants
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.
|
Arm 3: High Intensity Intervention (Elevated Risk)
n=474 Participants
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.
|
|---|---|---|---|---|---|---|
|
Adherence Level (Medication Records)
|
96.5 Percentage of doses
Interval 89.4 to 98.8
|
96.6 Percentage of doses
Interval 91.3 to 98.8
|
95.2 Percentage of doses
Interval 87.4 to 98.8
|
93.3 Percentage of doses
Interval 85.6 to 97.6
|
95.5 Percentage of doses
Interval 89.2 to 98.8
|
92.9 Percentage of doses
Interval 84.9 to 97.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured daily from Entry Visit to post SVR for up to 36 monthsRate of MOUD Initiation post randomization
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured daily from Entry Visit to post SVR for up to 36 monthsConsistent MOUD use post randomization
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured from Entry visit to post SVR for up to 36 months.Mortality rate per person years
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1: Low Intensity Intervention (Minimal Risk)
Serious events: 14 serious events
Other events: 1 other events
Deaths: 9 deaths
Arm 2: Medium Intensity Intervention (Minimal Risk)
Serious events: 5 serious events
Other events: 1 other events
Deaths: 3 deaths
Arm 3: High Intensity Intervention (Minimal Risk)
Serious events: 4 serious events
Other events: 2 other events
Deaths: 3 deaths
Arm 1: Low Intensity Intervention (Elevated Risk)
Serious events: 7 serious events
Other events: 1 other events
Deaths: 4 deaths
Arm 2: Medium Intensity Intervention (Elevated Risk)
Serious events: 10 serious events
Other events: 0 other events
Deaths: 9 deaths
Arm 3: High Intensity Intervention (Elevated Risk)
Serious events: 11 serious events
Other events: 1 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Arm 1: Low Intensity Intervention (Minimal Risk)
n=1022 participants at 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
|
Arm 2: Medium Intensity Intervention (Minimal Risk)
n=684 participants at 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.
|
Arm 3: High Intensity Intervention (Minimal Risk)
n=342 participants at 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.
|
Arm 1: Low Intensity Intervention (Elevated Risk)
n=157 participants at 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
|
Arm 2: Medium Intensity Intervention (Elevated Risk)
n=320 participants at 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.
|
Arm 3: High Intensity Intervention (Elevated Risk)
n=475 participants at 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.
|
|---|---|---|---|---|---|---|
|
General disorders
Death
|
0.88%
9/1022 • Number of events 9 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
0.44%
3/684 • Number of events 3 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
0.88%
3/342 • Number of events 3 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
2.5%
4/157 • Number of events 4 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
2.8%
9/320 • Number of events 9 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
1.5%
7/475 • Number of events 7 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
|
General disorders
Event other than death
|
0.49%
5/1022 • Number of events 5 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
0.29%
2/684 • Number of events 2 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
0.29%
1/342 • Number of events 1 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
1.9%
3/157 • Number of events 3 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
0.31%
1/320 • Number of events 1 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
0.84%
4/475 • Number of events 4 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
Other adverse events
| Measure |
Arm 1: Low Intensity Intervention (Minimal Risk)
n=1022 participants at 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
|
Arm 2: Medium Intensity Intervention (Minimal Risk)
n=684 participants at 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.
|
Arm 3: High Intensity Intervention (Minimal Risk)
n=342 participants at 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.
|
Arm 1: Low Intensity Intervention (Elevated Risk)
n=157 participants at 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
|
Arm 2: Medium Intensity Intervention (Elevated Risk)
n=320 participants at 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.
|
Arm 3: High Intensity Intervention (Elevated Risk)
n=475 participants at 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.
|
|---|---|---|---|---|---|---|
|
General disorders
Event other than death
|
0.10%
1/1022 • Number of events 1 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
0.15%
1/684 • Number of events 1 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
0.58%
2/342 • Number of events 2 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
0.64%
1/157 • Number of events 1 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
0.00%
0/320 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
0.21%
1/475 • Number of events 1 • 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: * All grade ≥ 3 AEs * All AEs that led to a change in treatment/intervention regardless of grade * All AEs meeting SAE definition or expedited adverse event (EAE) reporting requirement All AEs that were reported had their severity graded as per Division of AIDS guidelines. Serious adverse events (SAE) was reported within 7 days of when the site staff were notified.
|
Additional Information
Shruti H. Mehta
Johns Hopkins Bloomberg School of Public Health
Phone: 443-287-3837
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place