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Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

NCT07199335

RecruitingPhase 4

Sponsor: Massachusetts General Hospital

Conditions: HIV, Substance Use Disorder (SUD), Injection Drug Use

Interventions: APRETUDE (cabotegravir)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (2)

Boston, Massachusetts, United States
Boston, Massachusetts, United States