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NCT03221309 · ClinicalTrials.gov registry record

Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior

A clinical trial of HCV and PrEP, sponsored by University of Maryland, Baltimore.

Active
Registry status
198
Enrollment target
2
Study locations

NCT03221309: Active study of HCV and PrEP, sponsored by University of Maryland, Baltimore.

NCT03221309 is a study of HCV and PrEP that is active but no longer recruiting, run by University of Maryland, Baltimore. The registered enrollment target is 198 participants, above the 174-participant average among 8 other HCV trials with a reported enrollment target (14% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03221309, a study of HCV and PrEP, is active but no longer recruiting, sponsored by University of Maryland, Baltimore.

ACTIVE NOT RECRUITING
Registry status
198 participants
Enrollment target
2
Study locations

Study Summary

This is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis C in people with ongoing injection drug use. Participants will be treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly be offered pre-exposure prophylaxis for HIV prevention and buprenorphine for treatment of opioid use disorder when clinically indicated.

Primary Outcome

Undetectable HCV viral load 12 weeks after the end of treatment

Interventions

  • OTHER Evaluate model of care for HCV-infected adults with on-going opioid misuse

Study Locations (2)

District of Columbia

  • HIPS - Washington D.C.

Maryland

  • University of Maryland Drug Treatment Center - Baltimore

Trial Details

FieldValue
Enrollment Target 198 participants
Start Date 2017-05-01
Est. Completion 2026-01
University of Maryland, Baltimore

560 total trials

What the registry record for NCT03221309 still lists

NCT03221309 is an observational study that tracks outcomes without assigning an intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, above the 174-participant average among 8 other HCV trials with a reported enrollment target (14% higher).

The record links to 3 conditions, with HCV appearing as the primary indexed condition, and to 1 intervention - of which Evaluate model of care for HCV-infected adults with on-going opioid misuse is the first listed.

NCT03221309 reports a single indexed study location in District of Columbia, Maryland.

Frequently Asked Questions

What is clinical trial NCT03221309 about?

NCT03221309 is a clinical study titled "Hepatitis C Treatment to Prevent HIV, Initiate Opioid Substitution Therapy, and Reduce Risky Behavior". This is an open label, non-randomized, observational pilot study to evaluate a model of care for treatment of hepatitis C in people with ongoing injection drug use. Participants will be treated with direct-acting antivirals (DAA) as per standard of care and will concomittantly be offered pre-exposur...

What is the current status of trial NCT03221309?

This trial is currently active not recruiting. The enrollment target is 198 participants. The study started on 2017-05-01. Estimated completion is 2026-01.

What conditions does trial NCT03221309 study?

This clinical trial studies the following conditions: HCV, PrEP, Buprenorphine.

What interventions are being tested in trial NCT03221309?

The interventions under investigation include: Evaluate model of care for HCV-infected adults with on-going opioid misuse (OTHER).

Who is sponsoring clinical trial NCT03221309?

This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03221309 being conducted?

This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for HCV

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03221309's enrollment target sits among peer trials

198 4th of 8 higher than 5 of 8 other HCV trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HCV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03221309, the US trial registry maintained by the National Library of Medicine. NCT03221309 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.