Long-acting injectable cabotegravir for preventing HIV in people who inject drugs
A Multi-Center Assessment of an Intervention to Provide Long-Acting Cabotegravir Injectable Pre-Exposure Prophylaxis to People Who Inject Drugs
This project tries long-acting injectable cabotegravir plus support services to prevent HIV in adults who inject non-prescription drugs and have sexual exposure risk.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT07199335 on ClinicalTrials.gov |
What this trial studies
This open-label, single-arm Phase IV implementation project will prescribe FDA-approved long-acting injectable cabotegravir (CAB-LA) to HIV-negative adults who have injected non-prescribed drugs and report sexual risk, enrolling up to 100 participants at two Boston sites. Participants are screened with a 4th generation HIV Ab/Ag test and a confirmatory HIV-1 RNA test, then complete a medical evaluation and receive the first CAB-LA injection within 0–7 days of enrollment. Dosing follows the labeled schedule with a second injection at one month and then injections every two months for three additional doses, and the team will offer a suite of support services and follow-up visits. Recruitment relies primarily on clinician referrals and medical record review, and the study measures the feasibility and impact of delivering CAB-LA to this population in real-world clinic settings.
Who should consider this trial
Good fit: Adults 18 or older who are HIV-negative, have injected non-prescription drugs within the past six months, have had vaginal or anal sex in the past six months, can provide informed consent, and whose provider deems CAB-LA appropriate are the intended participants.
Not a fit: People who are HIV-positive or have indeterminate HIV tests, are pregnant or breastfeeding, have not had recent sexual exposure, or cannot attend regular in-person visits in Boston are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, it could lower HIV infections among people who inject drugs by offering a long-acting PrEP option that reduces the need for daily pills and improves adherence when paired with support services.
How similar studies have performed: Large randomized trials have shown CAB-LA prevents HIV more effectively than daily oral PrEP in men and transgender women, but implementation and outcome data specifically for people who inject drugs remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Fenway Health — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Suzanne McCluskey, MD, MSc
- Email: SMCCLUSKEY@MGH.HARVARD.EDU
- Phone: 617-726-9488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.