Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- APRETUDE (cabotegravir)
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
ViiV Healthcare
Collaborator
Fenway Community Health
Collaborator
Source ClinicalTrials.gov