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

NCT07199335 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2025P002398
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV; Substance Use Disorder (SUD); Injection Drug Use

Keywords

HIV; Substance use; pre-exposure prophylaxis; cabotegravir; long-acting cabotegravir; PrEP; implementation science; PrEP navigator

Outcome Measures

Primary Outcomes (1)

• Persistence on CAB-LA

  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.

  7 months

Study Arms (1)

All participants

EXPERIMENTAL

All participants will receive long-acting injectable cabotegravir and a suite of support services, including PrEP navigation, transportation assistance, and financial incentives.

Drug: APRETUDE (cabotegravir)

Interventions

APRETUDE (cabotegravir) DRUG

All participants will be prescribed APRETUDE based on APRETUDE's FDA approved indication, which is sexual risk of HIV transmission.

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• ViiV Healthcare: collaborator
• Fenway Community Health: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Fenway Health

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

cabotegravir

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Suzanne McCluskey, MD, MSc

CONTACT

617-726-9488; SMCCLUSKEY@MGH.HARVARD.EDU

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is an implementation study, using long-acting injectable cabotegravir for its approved indication as HIV pre-exposure prophylaxis for people with sexual risk factors for HIV.

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Data can be made available upon request following completion of study.
• Access Criteria: IPD can be made available upon request to the principal investigator with proof of IRB approval and a fully executed data use agreement.

Locations

US (2)