Integrated HIV Prevention and HCV Care for PWID

Running, not enrolling · Not applicable

Conditions studied: HIV Prevention, HCV, Opioid Use, Intravenous Drug Usage

In brief

The objective of this study is to compare and evaluate two strategies of delivering PrEP and Hepatitis C Virus (HCV) treatment to people who inject drugs to determine the best method of providing care. Participants will be randomized to one of two treatment arms: on-site integrated care or off-site referral to specialized care.

Key facts

Study ID

NCT03981445

Run by

Columbia University

People needed

446

Starts

2019-11-14

Expected to finish

2026-09-30

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Individuals must meet the following criteria to be eligible to participate in the RCT:
• Be 18-64 years of age
• report injection drug use in the past 6-months
• be HIV negative
• provide informed consent
• complete a medical release form
• report living in the vicinity and being able to return for follow-up over 18-months
• be willing to use a medically acceptable form of contraception throughout the study duration (for women of childbearing potential)
• be able to communicate in English or French (site dependent)
• be receiving services at an opioid agonist therapy clinic or a syringe access program
• Individuals must meet the following criteria to be eligible to participate in the qualitative interview:
• have completed the first 6 months of RCT follow up (RCT participant interviews);
• provide informed consent;
• have contributed to assessments/interviews, intervention and/or treatment follow-ups (staff interviews).

You may not qualify if…

• Individuals will be excluded from the RCT if they:
• have any disabling medical conditions as assessed by medical history, physical exam, vital signs, and/or laboratory assessments that in the opinion of the study physician preclude safe participation in the study or ability to provide fully informed consent.
• have any disabling mental conditions as assessed by medical history and clinical assessment that in the opinion of the study physician precludes safe participation in the study or ability to provide fully informed consent.
• have chronic renal failure
• have or have history of decompensated cirrhosis
• are HIV-positive or have symptoms of an acute HIV infection
• are pregnant (verified via pregnancy test), are planning to be pregnant during the course of the study, or breastfeeding
• have an allergy or contraindication to one of the study medications
• have prior HCV treatment failure with direct-acting antiviral (DAA) regimens (Except those who were treated, cured the virus, but were re-infected with a new virus)
• are currently on PrEP and/or HCV treatment.
• are currently in prison, in any inpatient overnight facility as required by court of law or have a pending legal action, which may prevent an individual from completing the study.

Where it is running

• Miami — Miami, Florida, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Montreal — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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