Status:
NOT_YET_RECRUITING
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
ViiV Healthcare
Fenway Community Health
Conditions:
HIV
Substance Use Disorder (SUD)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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-...
Detailed Description
This is a Phase IV open-label single arm implementation study of the on-label use of an FDA approved drug, cabotegravir, as long-acting, injectable HIV pre-exposure prophylaxis (CAB-LA) among people w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07199335
Start Date
November 1 2025
End Date
September 1 2027
Last Update
October 7 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Fenway Health
Boston, Massachusetts, United States, 02215