NCT02609893

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Phillip Coffin, MD, MIA · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
OTHER	modified directly observed therapy (mDOT)
OTHER	unobserved dosing
OTHER	Motivational Interviewing-based counseling	Motivational Interviewing-based risk reduction and medication adherence counseling

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-04-01
• Completion: 2019-08-01
• First posted: 2015-11-20
• Last updated: 2020-10-22

Locations

1 site across 1 country: United States