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

NCT ID: NCT06316089

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2027-06-30

Brief Summary

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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

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Conditions

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Hiv Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PrEPared For Release

Intervention arm

Group Type EXPERIMENTAL

PrEPared for Release

Intervention Type BEHAVIORAL

A multilevel, behavioral and navigation intervention administered over two sessions to promote PrEP initiation, adherence and linkage to PrEP care in the community for incarcerated men with a history of injection drug use.

Standard of Care

Control arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PrEPared for Release

A multilevel, behavioral and navigation intervention administered over two sessions to promote PrEP initiation, adherence and linkage to PrEP care in the community for incarcerated men with a history of injection drug use.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthew Murphy

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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K23DA054003

Identifier Type: NIH

Identifier Source: org_study_id

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