Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT07199335
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07199335
Study Brief:
Protocol Section:
NCT07199335