One-Stop care may boost HIV and hep c treatment in drug users
NCT ID NCT03981445
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether providing HIV prevention (PrEP) and hepatitis C treatment together at one location works better than sending patients to separate clinics. About 446 people who inject drugs will be randomly assigned to either on-site integrated care or off-site referrals with patient navigation. The goal is to see which approach leads to better PrEP adherence and higher hepatitis C cure rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- patient navigation (behavioral intervention)
- What this could lead to
- If successful, this could show that offering HIV prevention and HCV treatment in one place works better than sending patients to different clinics, improving health outcomes for people who inject drugs.
- What could go wrong
- This is a behavioral study, not a drug trial, so results depend on patient engagement and local resources. The findings may not apply to all communities or healthcare systems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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446 people
The number who actually took part.
- Started
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Nov 2019
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Individuals must meet the following criteria to be eligible to participate in the RCT: 1. Be 18-64 years of age 2. report injection drug use in the past 6-months 3. be HIV negative 4. provide informed consent 5. complete a medical release form 6. report living in the vicinity and being able to return for follow-up over 18-months 7. be willing to use a medically acceptable form of contraception throughout the study duration (for women of childbearing potential) 8. be able to communicate in English or French (site dependent) 9. 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: 1. have completed the first 6 months of RCT follow up (RCT participant interviews); 2. provide informed consent; 3. have contributed to assessments/interviews, intervention and/or treatment follow-ups (staff interviews). Exclusion Criteria: Individuals will be excluded from the RCT if they: 1. 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. 2. 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. 3. have chronic renal failure 4. have or have history of decompensated cirrhosis 5. are HIV-positive or have symptoms of an acute HIV infection 6. are pregnant (verified via pregnancy test), are planning to be pregnant during the course of the study, or breastfeeding 7. have an allergy or contraindication to one of the study medications 8. 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) 9. are currently on PrEP and/or HCV treatment. 10. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Columbia University Irving Medical Center
New York, New York, 10032, United States
-
Miami
Miami, Florida, 33136, United States
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Montreal
Montreal, Quebec, Canada
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