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

Not Applicable

Not yet recruiting

• Conditions: Hiv; Substance Use Disorders
• Interventions: Behavioral: PrEPared for Release

• Registration Number: NCT06316089
• Lead Sponsor: Rhode Island Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18
• Study Start: 2025-01
• Primary Completion: 2027-01
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PrEPared For Release	PrEPared for Release	Intervention arm

Primary Outcome Measures

Name	Time	Method
PrEP initiation	Rapid, within 7 days	Initiation of PrEP usage

Secondary Outcome Measures

Name	Time	Method
Linkage to PrEP care in the community	Within 30 days post-incarceration	Linkage to a community PrEP care provider for participants post-release from incarceration
Adherence to PrEP	At least 30 days	Appropriate use of PrEP postinitiation