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

Recruiting now · Phase 4

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

In brief

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.

Key facts

Study ID

NCT07199335

Run by

Massachusetts General Hospital

People needed

100

Starts

2026-02-24

Expected to finish

2028-12-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Fenway Health — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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