Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT07199335
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- HIV
- Injection Drug Use
- Substance Use Disorder (SUD)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- APRETUDE (cabotegravir) — DRUGAll participants will be prescribed APRETUDE based on APRETUDE's FDA approved indication, which is sexual risk of HIV transmission.
Study Details
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.
Key Dates
- Start date
- Feb 24, 2026
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: All participantsAll participants will receive long-acting injectable cabotegravir and a suite of support services, including PrEP navigation, transportation assistance, and financial incentives.
Primary Outcome Measure
Persistence on CAB-LA [ Time Frame: 7 months ]
Central Contacts
- Suzanne McCluskey, MD, MSc617-726-9488
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fenway Health | Boston | Massachusetts | 02215 | Julia Fleming, MD, MHS (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Suzanne McCluskey, MD, MSc (PRINCIPAL_INVESTIGATOR) |
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