Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs (NCT07199335) | Clinical Trial Compass
RecruitingPhase 4
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
United States100 participantsStarted 2026-02-24
Plain-language summary
The goal of this study is to determine the feasibility and impact of delivering long-acting injectable cabotegravir HIV pre-exposure prophylaxis and suite of support services to adults who inject non-prescription drugs who are risk for HIV through known sexual risk.
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:
* HIV Ab/Ag test (lab-based or rapid) negative at time of enrollment
* ≥18 years old
* Able to provide informed consent
* Have injected non-prescribed drugs within the past 6 months
* No prior history of receiving cabotegravir (Note: prior or active use of non-CAB PrEP (\[FTC/TDF or FTC/TAF\]) at screening is allowed, but participant will need to indicate that they prefer to switch to injectable PrEP).
* PrEP provider deems cabotegravir use to be appropriate per the applicable prescribing information prior to enrollment in the study.
Exclusion Criteria:
* Pregnant or breastfeeding people. Should a participant become pregnant, the treating physician will discuss with the participant whether to continue study medication, taking into consideration the risks and benefits of continuing cabotegravir compared with the risk of switching to an alternative recommended PrEP regimen.
* Has not had vaginal or anal sex in the past 6 months
* HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP
* Already diagnosed with HIV
* Taking any of the following medications: Carbamazepine, Rifampin, Oxcarbazepine, Rifapentine, Phenobarbital, Phenytoin
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.