An Intervention to Improve HIV Pre-exposure Prophylaxis Initiation, Adherence and Linkage to Care for Recently Incarcerated Men Who Inject Drugs.

Lifespan

Status: Not yet enrolling

Conditions: Substance Use Disorders; Hiv

Treatments: Behavioral: PrEPared for Release

Study type: Interventional

Funder types: Other

Identifiers

NCT06316089

K23DA054003

Details and patient eligibility

About

Pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection among people who inject drugs (PWID) yet studies suggest that its use is low among this population which is particularly vulnerable to HIV infection. The criminal justice (CJ) system, at the intersection of increased risk of HIV infection and substance use, presents a unique opportunity to engage PWID in HIV prevention care that incudes PrEP. The study will characterize the facilitators and barriers to PrEP initiation, adherence and linkage to care among male PWID that are experiencing incarceration and develop the "PrEPare-for-Release" intervention to promote PrEP initiation, adherence and linkage to care upon release from incarceration into the community.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Incarcerated at the Rhode Island Department of Corrections
• Identifies as male
• Reports a history of injection drug use
• Meets CDC clinical criteria for PrEP use
• Able to provide written and verbal consent in either English or Spanish

Exclusion criteria

• Unable to provide written and/or verbal consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

PrEPared For Release

Experimental group

Description:

Intervention arm

Treatment:

Behavioral: PrEPared for Release

Standard of Care

No Intervention group

Description:

Control arm