NCT07199335RecruitingPhase 4
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for 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
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 22 Sept 2025
- Start date
- 24 Feb 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- HIV
- NCT number
- NCT07199335
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 24 Feb 2026 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP
- Taking any of the following medications: Carbamazepine, Rifampin, Oxcarbazepine, Rifapentine, Phenobarbital, Phenytoin
Other illness
- Already diagnosed with HIV
Other
- Has not had vaginal or anal sex in the past 6 months
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fenway Health Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.