CARE: Comprehensive Assessment of Real-world Effectiveness of F/TAF in Persons Who Use Drugs (PWUD) (NCT07385183) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
CARE: Comprehensive Assessment of Real-world Effectiveness of F/TAF in Persons Who Use Drugs (PWUD)
200 participantsStarted 2026-02
Plain-language summary
This study looks at how to help people who use drugs start and keep taking medicine that can prevent HIV. The medicine is called PrEP (pre-exposure prophylaxis). The study investigators will use a pill called Descovy (F/TAF), which is already approved by the FDA for HIV prevention.
People who come to the emergency department (ED) and test negative for HIV may join the study. Some participants will start taking PrEP and will be followed for one year. Other participants will only do an interview about their thoughts on PrEP. The study investigators will also talk to doctors and peer support workers in the ED to learn what makes it easier or harder to offer PrEP.
The main goal is to see how well PrEP can be started and continued for people who use drugs. The study investigators will look at how many people start PrEP, how many keep taking it, and what helps or makes it hard to stay on PrEP. The study investigators will also learn about the best ways to connect people to care after they leave the ED.
This study does not test if the medicine works to prevent HIV-that is already known. Instead, it looks at real-life challenges and solutions for using PrEP in this group. The study may help improve HIV prevention and health care for people who use drugs.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Prep Initiation Inclusion: 18 years of age or older; Communicate in English; Confirmatory test of HIV-negative; Documented or identified history of injection drug use within the last six-months or have documented or identified general drug use within the last twelve months; Be able to provide at least one contact person including name and phone number where participant can be reached for follow-up
* Clinician Interview Inclusion: At least 18 years of age; Healthcare provider or peer navigator, a person with lived experience in substance use disorder who will help navigate the patient through care, currently employed in TGH ED
* Interview Inclusion: At least 18 years of age; Communicate in English; Confirmatory test of HIV-negative; Documented or identified history of injection drug use within the last six-months or have documented or identified general drug use within the last twelve months;
Exclusion Criteria:
* PrEP Initiation Exclusion: Under 18 years of age; Determined to be HIV-positive following confirmatory testing; Have a CrCl of less than 30ml/min, making them only eligible for long-acting injectable PrEP if CrCl is a limiting factor for oral PrEP; Have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent; Are currently incarcerated or have pending legal action that may prevent an individual from completing the study; Pregnant.
* Clinician Interview Exclusion: Under 18 years of age; …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adherence and Persistence Rates of Oral PrEP (F/TAF) Among Persons Who Use Drugs Over 12 Months
Timeframe: From enrollment through 12 months for patients who use PrEP. For the interview only group and clinician group, this information is collected at a single point in time when they are interviewed.