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Pilot Treatment as Prevention for HCV Among Persons Who Actively Inject Drugs

NCT02609893 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-10-22

No results posted yet for this study

Summary

This project is a randomized trial of two strategies to treat persons with genotype 1 HCV who currently inject drugs (PWIDs) with a once daily regime of ledipasvir-sofosbuvir (LDV-SOF) for 8 weeks. The study will enroll 30 participants and will assess the feasibility and acceptability of treating active PWIDs for HCV with LDV-SOF by modified directly observed therapy (mDOT) versus unobserved dosing, with motivational interviewing based adherence support; and assess through in-depth, semi-structured qualitative interviews, the challenges with time intensity required for mDOT and unobserved dosing interventions, and identify key factors affecting treatment adherence.

Conditions

  • Chronic Hepatitis C

Interventions

OTHER

modified directly observed therapy (mDOT)

OTHER

unobserved dosing

OTHER

Motivational Interviewing-based counseling

Motivational Interviewing-based risk reduction and medication adherence counseling

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Phillip Coffin, MD, MIA

    lead OTHER_GOV

Principal Investigators

  • Phillip O Coffin, M.D. · San Francisco Department of Public Health

  • Emily Behar, MS · San Francisco Department of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-04-30
Completion
2019-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02609893 on ClinicalTrials.gov