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) — DRUG
    All 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 participants
    All 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

Locations (2)

FacilityCityStateZIPSite coordinators
Fenway HealthBostonMassachusetts02215
Julia Fleming, MD, MHS
857-313-6984
Julia Fleming, MD, MHS (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Suzanne McCluskey, MD, MSc
617-726-9488
Suzanne McCluskey, MD, MSc (PRINCIPAL_INVESTIGATOR)

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