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

March 12, 2024 updated by: Matthew Murphy, Rhode Island Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PrEPared For Release
Intervention arm
Behavioral: 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.
No Intervention: Standard of Care
Control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP initiation
Time Frame: Rapid, within 7 days
Initiation of PrEP usage
Rapid, within 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to PrEP
Time Frame: At least 30 days
Appropriate use of PrEP postinitiation
At least 30 days
Linkage to PrEP care in the community
Time Frame: Within 30 days post-incarceration
Linkage to a community PrEP care provider for participants post-release from incarceration
Within 30 days post-incarceration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23DA054003 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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