NCT03981445Active, not recruiting
Integrated HIV Prevention and HCV Care for PWID
A Multi-site Multi-Setting Randomized Controlled Trial (RCT) of Integrated HIV Prevention and HCV Care for People Who Inject Drugs (PWID)
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 446 (actual)
- First submitted
- 6 Jun 2019
- Start date
- 14 Nov 2019
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Columbia University
- Diseases
- HIV
- NCT number
- NCT03981445
What you commit to
- Study type: Interventional
- Participants enrolled: 446
- From 14 Nov 2019 to the primary completion date, 30 Sept 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
- have an allergy or contraindication to one of the study medications
Lab values
- 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.
Other
- Individuals will be excluded from the RCT if they:
- are pregnant (verified via pregnancy test), are planning to be pregnant during the course of the study, or breastfeeding
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.