Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
Recruiting · NCT07199335 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
APRETUDE (cabotegravir)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Fenway Health - Boston, Massachusetts, United States