NCT01629316

Evaluation of Behavioral Intervention for HIV Positive Prisoners in NC and TX

CID 1007 - Randomized Controlled Trial of an Augmented Test, Treat, Link & Retain Model for NC and TX Prisoners (imPACT Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Purpose: The purpose of this study is to determine if a comprehensive intervention supporting seek-test-and-treat results in a significant reduction in the potential for HIV-infected prisoners to transmit their virus after release from prison. Aim 2: Compare the effect of standard prison test-and-treat (sTNT) with the TNT-imPACT (imPACT) intervention on viral load 24 weeks following prison release. Aim 3: Describe and model secondary outcomes, comparing them between sTNT and TNT-imPACT study arms. These outcomes include post-release HIV transmission risk behaviors, incident STIs, adherence to ART, medical care appointments, emergence of ART resistance mutations, and predicted HIV transmission events.

Detailed description

For Aims 2 and 3: Participants: We will enroll 400 HIV-infected men and women, age 18 years and older who are incarcerated in the NC Department of Correction (NCDOC) or the Texas Department of Criminal Justice (TDCJ) and scheduled for prison release in approximately 12 weeks, who are receiving ART and have an HIV RNA level that is below 400 copies/mL. Procedures (methods): Participants will be consented, enrolled, and then randomized 1:1 to one of two conditions: 1. standard test-and-treat (sTNT), which is the current standard of care, wherein following HIV testing, the DOC provides to HIV-infected inmates ART during incarceration and referral to community-based care and services by prison staff as well as a supply of antiretroviral medication (30 days in NC, 10 in TX) upon release, or 2. TNT-imPACT (imPACT),which includes the sTNT plus our integrated, multi-component intervention targeting multiple levels to enhance adherence to HIV therapy and linkage to and engagement in clinical care, to maintain viral suppression after release. All participants will be followed for up to 24 weeks post-release.

Conditions

• HIV Infection

Interventions

Type	Name	Description
BEHAVIORAL	Text reminders, counseling, and link coordination	This is an intervention with text reminders, counseling that involves motivational interviewing, and link coordination
BEHAVIORAL	Standard of care - control arm	The control arm is standard of care for each subject.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2012-06-27
• Last updated: 2015-06-11

Locations

2 sites across 1 country: United States