Recruiting

Cabotegravir

Sponsor:

Massachusetts General Hospital

Code:

NCT07199335

Conditions

HIV

Substance Use Disorder (SUD)

Injection Drug Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

APRETUDE (cabotegravir)

Study Details

Brief 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.

Conditions

HIV

Substance Use Disorder (SUD)

Injection Drug Use

Study ID

NCT07199335

Start date

Feb 24, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

APRETUDE (cabotegravir)

All participants will be prescribed APRETUDE based on APRETUDE's FDA approved indication, which is sexual risk of HIV transmission.

Primary outcome measure

  • Persistence on CAB-LA [ Time Frame: 7 months ]

Central Contacts and Locations

Central contacts

Suzanne McCluskey, MD, MSc

617-726-9488SMCCLUSKEY@MGH.HARVARD.EDU

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Suzanne McCluskey, MD, MSc

617-726-9488SMCCLUSKEY@MGH.HARVARD.EDU

Principal Investigator:

Suzanne McCluskey, MD, MSc

Fenway Health

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Julia Fleming, MD, MHS

857-313-6984JFleming@fenwayhealth.org

Principal Investigator:

Julia Fleming, MD, MHS

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • HIV
  • Substance use
  • pre-exposure prophylaxis
  • cabotegravir
  • long-acting cabotegravir
  • PrEP
  • implementation science
  • PrEP navigator

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-19.