Evaluation of Behavioral Intervention for HIV Positive Prisoners in NC and TX (imPACT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01629316|
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : June 11, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Behavioral: Text reminders, counseling, and link coordination Behavioral: Standard of care - control arm||Not Applicable|
For Aims 2 and 3:
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:
- 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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||381 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||CID 1007 - Randomized Controlled Trial of an Augmented Test, Treat, Link & Retain Model for NC and TX Prisoners (imPACT Study)|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Experimental: Text reminders, counseling, link coordinator
Text reminders, counseling, link coordination
Behavioral: Text reminders, counseling, and link coordination
This is an intervention with text reminders, counseling that involves motivational interviewing, and link coordination
|Active Comparator: Standard of care - control arm||
Behavioral: Standard of care - control arm
The control arm is standard of care for each subject.
- HIV RNA level (Viral Load) [ Time Frame: Week 24 post-release from prison ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629316
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27514|
|United States, Texas|
|Texas Christian University|
|Fort Worth, Texas, United States, 76129|
|Principal Investigator:||David A Wohl, MD||University of North Carolina, Chapel Hill|
|Principal Investigator:||Carol Golin, MD||University of North Carolina, Chapel Hill|