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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06316089

Enrollment

100

Registered

2024-03-18

Start date

2025-01-31

Completion date

2027-06-30

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv, Substance Use Disorders

Keywords

HIV, Substance Use Disorders, Injection Drug Use, Incarceration

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.

Interventions

BEHAVIORALPrEPared 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
PrEP initiation	Rapid, within 7 days	Initiation of PrEP usage

Secondary

Measure	Time frame	Description
Adherence to PrEP	At least 30 days	Appropriate use of PrEP postinitiation
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026