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

ConditionsHIV Substance Use Disorder (SUD)Injection Drug Use

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorMassachusetts General Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: All participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

7 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

ViiV Healthcare

Collaborator

Fenway Community Health

Collaborator

Source ClinicalTrials.gov

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