Supporting Treatment Outcomes Among PWID

NCT04652804 | Completed Results DMC

• 2 other identifiers: IRB002321255R01AI145555-02
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; HIV Coinfection

Keywords

Patient Navigation; Treatment Adherence; People who inject drugs (PWID); Directly Observed Therapy (DOT); India

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response (SVR) by Intervention Group Stratified by Defined Risk for Treatment Failure (Minimal vs Elevated)

  The percentage of participants who achieved SVR defined as HCV RNA \< lower limit of quantification (LLOQ). HCV RNA \< lower limit of quantification (LLOQ, 30 IU/ml) was measured 12 weeks (range 10 - 60 weeks) after treatment completion.

  Between 10 and 60 weeks after scheduled end of treatment.

Secondary Outcomes (7)

• HCV Treatment Completion

  Measured at the end of prescribed course of treatment (12 or 24 weeks)

• Adherence >90% (Self-report)

  Measured at the end of prescribed course of treatment (12 or 24 weeks)

• Adherence >90% (Medication Records)

  Measured at the end of prescribed course of treatment (12 or 24 weeks)

• Adherence Level (Self-report)

  Measured at the end of prescribed course of treatment (12 or 24 weeks)

• Adherence Level (Medication Records)

  Measured at the end of prescribed course of treatment (12 or 24 weeks)

Other Outcomes (6)

• Exploratory Outcome Measure: Medication for Opioid Use Disorder (MOUD) Initiation

  Measured daily from Entry Visit to post SVR for up to 36 months

• Exploratory Outcome Measure: Medication for Opioid Use Disorder Retention

  Measured daily from Entry Visit to post SVR for up to 36 months

• Exploratory Outcome Measure: Quality of Life

  Measured at 6 month intervals at the SVR visit and post SVR for up to 36 months.

Study Arms (3)

Arm 1: Low Intensity Intervention

ACTIVE COMPARATOR

4 weeks dispensation + standard adherence counseling

Behavioral: Low intensity HCV treatment adherence support

Arm 2: Medium Intensity Intervention

ACTIVE COMPARATOR

4 weeks dispensation + support from patient navigator

Behavioral: Medium intensity HCV treatment adherence support

Arm 3: High Intensity Intervention

ACTIVE COMPARATOR

Directly Observed Therapy with flexible dispensing and support from patient navigator

Behavioral: High intensity HCV treatment adherence support

Interventions

Low intensity HCV treatment adherence support BEHAVIORAL

A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements

Arm 1: Low Intensity Intervention

Medium intensity HCV treatment adherence support BEHAVIORAL

The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks.

Arm 2: Medium Intensity Intervention

High intensity HCV treatment adherence support BEHAVIORAL

The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed.

Arm 3: High Intensity Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• YR Gaitonde Centre for AIDS Research and Education: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

YR Gaitonde Centre for AIDS Research and Education

Chennai, Tamil Nadu, 600010, India

Location

Related Publications (1)

• Mehta SH, Lau BM, Ehrhardt S, McFall A, Gunaratne MP, Baishya J, Kedar A, Srikrishnan AK, Evans J, Loeb T, Pradeep A, Kumar MS, Thomas DL, Lucas GM, Solomon SS. A precision randomized trial to evaluate the impact of tailored hepatitis C treatment adherence support on HCV treatment outcomes among people who inject drugs in India: design and baseline characteristics of the STOP-C trial. Am J Epidemiol. 2025 Oct 7;194(10):2986-2998. doi: 10.1093/aje/kwae430.

  PMID: 39572371 DERIVED

MeSH Terms

Conditions

Hepatitis C; HIV Infections; Treatment Adherence and Compliance; Directly Observed Therapy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Health Behavior; Behavior; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care

Results Point of Contact

• Title: Shruti H. Mehta
• Organization: Johns Hopkins Bloomberg School of Public Health

smehta@jhu.edu

443-287-3837

Study Officials

• Sunil S Solomon, PhD MBBS MPH

  Johns Hopkins University School of Medicine and Y.R. Gaitonde Centre for AIDS Research and Education

  PRINCIPAL INVESTIGATOR

• Shruti H Mehta, PhD MPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 3, 2020
• Study Start: January 21, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2024
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)