Long-acting injectable cabotegravir for preventing HIV in people who inject drugs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Project SHIELD 2.0: Police Education to Support Public Health in Kentucky

  Aimed at police in Kentucky, this program tests whether SHIELD training given to officers, with health workers helping deliver it, can reduce drug-related arrests and steer people who use drugs toward MOUD and other health services.

  Recruiting Johns Hopkins Bloomberg School of Public Health · Lexington, Kentucky · NCT07804121

• Using metformin to improve immune function in people with a history of injection drug use

  This study is testing if the diabetes drug metformin can help improve the immune system and reduce inflammation in people aged 18-64 who have a history of using injection drugs.

  Recruiting Phase 4 University of Alabama at Birmingham · Birmingham, Alabama · NCT06829238

• New ways to diagnose lymphoma and multicentric Castleman disease in people living with HIV

  This study tests a quick, point-of-care nucleic acid test to help diagnose lymphoma and multicentric Castleman disease in people living with HIV in sub-Saharan Africa.

  Recruiting Indiana University · Lilongwe · NCT07793006

• Real-time fMRI Neurofeedback for Anhedonia in Methadone-Treated Opioid Use Disorder

  This feasibility study tests a real-time fMRI neurofeedback approach to see if it helps reduce anhedonia in people on methadone for opioid use disorder.

  Recruiting Yale University · New Haven, Connecticut · NCT07768007

• Bridge to Belonging: A Peer‑Led Program to Reduce Loneliness and Depression in older gay and bisexual men with HIV

  This program tests a peer-delivered, manualized approach to help men aged 50+ with HIV connect to LGBTQ+-affirming elder services to see if it reduces loneliness and depressive symptoms.

  Recruiting Fenway Community Health · Boston, Massachusetts · NCT07762066

• HIV vaccine test in healthy adults using CH505 nanoparticles and mRNA boosters

  This early-stage study will test the safety and immune responses of CH505 vaccine regimens in healthy adults to see if they can trigger HIV-specific immune protection.

  Recruiting at 2 sites Phase 1 National Institute of Allergy and Infectious Diseases (NIAID) · San Francisco, California and 7 other locations · NCT07757802

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.