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

NCT06316089 | Not Yet Recruiting

• 1 other identifier: K23DA054003
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hiv; Substance Use Disorders

Keywords

HIV; Substance Use Disorders; Injection Drug Use; Incarceration

Outcome Measures

Primary Outcomes (1)

• PrEP initiation

  Initiation of PrEP usage

  Rapid, within 7 days

Secondary Outcomes (2)

• Adherence to PrEP

  At least 30 days

• Linkage to PrEP care in the community

  Within 30 days post-incarceration

Study Arms (2)

PrEPared For Release

EXPERIMENTAL

Intervention arm

Behavioral: PrEPared for Release

Standard of Care

NO INTERVENTION

Control arm

Interventions

PrEPared for Release 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.

PrEPared For Release

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide written and/or verbal consent

Sponsors & Collaborators

• Rhode Island Hospital: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders

Interventions

Drainage

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 18, 2024

Record last verified: 2024-03