NCT07199335 Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
| NCT ID | NCT07199335 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts General Hospital |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-02-24 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2026-02-24 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07199335 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07199335 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07199335 currently recruiting?
Yes, NCT07199335 is actively recruiting participants. Contact the research team at SMCCLUSKEY@MGH.HARVARD.EDU for enrollment information.
Where is the NCT07199335 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT07199335 clinical trial?
NCT07199335 is sponsored by Massachusetts General Hospital. The trial plans to enroll 100 participants.
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