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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06316089
• Other study ID #: K23DA054003
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP initiation	Initiation of PrEP usage	Rapid, within 7 days
Secondary	Adherence to PrEP	Appropriate use of PrEP postinitiation	At least 30 days
Secondary	Linkage to PrEP care in the community	Linkage to a community PrEP care provider for participants post-release from incarceration	Within 30 days post-incarceration