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ACTIVE NOT RECRUITING

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

NCT03221309 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

University of Maryland, Baltimore

559 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03221309

The ClinicalTrials.gov registry entry for NCT03221309 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 198 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 559 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03221309 reports 2 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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, Buprenorphine, PreP. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03221309?

This trial is sponsored by University of Maryland, Baltimore, which has 559 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial