RecruitingPhase 4NCT07199335

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

A Multi-Center Assessment of an Intervention to Provide Long-Acting Cabotegravir Injectable Pre-Exposure Prophylaxis to People Who Inject Drugs

Sponsor

Massachusetts General Hospital

Enrollment

100 participants

Start Date

Feb 24, 2026

Study Type

INTERVENTIONAL

Conditions

HIV Substance Use Disorder (SUD)Injection Drug Use

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria5

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

Interventions

DRUGAPRETUDE (cabotegravir)

All participants will be prescribed APRETUDE based on APRETUDE's FDA approved indication, which is sexual risk of HIV transmission.

Locations(2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Fenway Health

Boston, Massachusetts, United States

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NCT07199335

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