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Long-acting Cabotegravir for People Who Inject Drugs

This study is looking at how well long-acting injectable cabotegravir (APRETUDE) works to prevent HIV in adults who inject non-prescription drugs and are also at risk for HIV through sexual activity. All participants will receive APRETUDE, which is an FDA-approved medication. To join, you must be at least 18 years old, have injected non-prescribed drugs in the last 6 months, and test negative for HIV. The main goal is to see how consistently people use APRETUDE over 7 months. This study plans to enroll 100 participants, but its current status is unclear.

Study design
This is an open-label study, meaning everyone knows they are receiving APRETUDE. It aims to enroll 100 participants.
What's involved
You will have an initial medical evaluation, complete a survey, and receive your first APRETUDE injection. You will then continue to receive injections according to the medication's instructions.
Compensation
Not stated in the trial record.
Follow-up
The study will track how consistently you use APRETUDE for 7 months.

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NCT07199335

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

Recruiting
PHASE4Ages 18+InterventionalPrevention
Massachusetts General Hospital
~100 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:APRETUDE (cabotegravir)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Persistence on CAB-LA
Measured over 7 months

Conditions

HIV
Substance Use Disorder (SUD)
Injection Drug Use

Explore related trials

HIV InfectionSubstance use disorder

Where it's being run

2 sites across 1 states
Massachusetts2

Who to contact

Suzanne McCluskey, MD, MSc
[email protected]
617-726-9488
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Persistence on CAB-LA7 months

    For the primary analysis, investigators will calculate the proportion of study participants who achieve PrEP persistence at 7 months post-initiation. Investigators will then calculate 95% confidence intervals around the proportion.