Supporting Treatment Outcomes Among PWID

NACompletedINTERVENTIONAL
Enrollment

3,000

Participants

Timeline

Start Date

January 21, 2021

Primary Completion Date

December 30, 2023

Study Completion Date

December 31, 2024

Conditions
Hepatitis CHIV Coinfection
Interventions
BEHAVIORAL

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

BEHAVIORAL

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.

BEHAVIORAL

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.

Trial Locations (1)

600010

YR Gaitonde Centre for AIDS Research and Education, Chennai

All Listed Sponsors
collaborator

YR Gaitonde Centre for AIDS Research and Education

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Johns Hopkins University

OTHER

NCT04652804 - Supporting Treatment Outcomes Among PWID | Biotech Hunter | Biotech Hunter