A Multi-Center Assessment of an Intervention to Provide Long-Acting Cabotegravir Injectable Pre-Exposure Prophylaxis to People Who Inject Drugs
Massachusetts General Hospital
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.
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 who inject drugs. All enrollees will be prescribed CAB-LA based on CAB-LA's FDA approved indication, which is sexual risk of HIV transmission. Investigators will recruit participants from two sites in Boston, Massachusetts. The target study sample size is 100 participants. Recruitment will be primarily by clinician referrals and medical records review at each site. The study team will screen pote…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 bre…
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 HospitalBoston, Massachusetts
- Fenway HealthBoston, Massachusetts