Evaluation of Behavioral Intervention for HIV Positive Prisoners in NC and TX (imPACT)
This study is currently recruiting participants.
Verified March 2013 by University of North Carolina, Chapel Hill
Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Information provided by (Responsible Party):
David A Wohl, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01629316
First received: June 4, 2012
Last updated: March 15, 2013
Last verified: March 2013
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Purpose
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 | Intervention |
|---|---|
|
HIV Infection |
Behavioral: Text reminders, counseling, and link coordination Behavioral: Standard of care - control arm |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- HIV RNA level (Viral Load) [ Time Frame: Week 24 post-release from prison ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Text reminders, counseling, link coordinator |
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.
|
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:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented HIV infection
- Incarcerated in the NCDOC at a facility within a 3 hour drive from Chapel Hill OR incarcerated in the TDCJ at a facility within a 3 hour drive from Ft. Worth
- Age 18 years or older
- Receiving ART for at least 90 days in prison prior to enrollment
- Plasma HIV RNA level of <400 c/mL within 90 days prior to enrollment
- English speaking
- Able and willing to provide informed consent
- Willing to participate in post-release study activities
- For NC - planning to remain in state after release and returning to a community within a 3 hour drive of Chapel Hill
- For TX - returning to one of the following areas: Houston, Dallas, and Ft. Worth (including their suburbs)
- Scheduled for release from prison
Exclusion Criteria:
- Conviction for offenses that includes sexual assault or death or serious injury to a victim or is otherwise found, in the opinion of the investigators, to be at high risk for injury to staff (this criterion is designed to minimize risk to study personnel who will conduct study-related visits with participants in the communities to which they return and may be informed by input from correctional staff)
- Pending charges that would likely lead to transfer of custody or other condition which would otherwise prevent or significantly delay release from custody.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629316
Contacts
| Contact: Jessica Carda-Auten, MPH | 919-966-7759 | jessica_carda-auten@med.unc.edu |
Locations
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| Contact: Debra Henninger, PhD 919-966-7759 debra_henninger@med.unc.edu | |
| Principal Investigator: David Wohl, MD | |
| Principal Investigator: Carol Golin, MD | |
| Sub-Investigator: Becky White, MD, MPH | |
| Sub-Investigator: Peter Leone, MD | |
| Sub-Investigator: Stephen Cole, PhD | |
| Sub-Investigator: David Rosen, MD, PhD | |
| Sub-Investigator: Roger Akers, PhD | |
| Sub-Investigator: Catherine Fogel, PhD, RNC | |
| Sub-Investigator: Sonia Napravnik, PhD | |
| Sub-Investigator: Kimberly Powers, MSPH | |
| United States, Texas | |
| Texas Christian University | Recruiting |
| Fort Worth, Texas, United States, 76129 | |
| Contact: Michele Gould, MPH 817-257-5926 m.gould@tcu.edu | |
| Principal Investigator: Patrick Flynn, PhD | |
| Principal Investigator: Kevin Knight, PhD | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
| Principal Investigator: | David A Wohl, MD | University of North Carolina, Chapel Hill |
| Principal Investigator: | Carol Golin, MD | University of North Carolina, Chapel Hill |
More Information
Additional Information:
Publications:
| Responsible Party: | David A Wohl, MD, Clinical Associate Professor, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01629316 History of Changes |
| Other Study ID Numbers: | CID 1007 - UNC IRB 10-1183, R01DA030793-01 |
| Study First Received: | June 4, 2012 |
| Last Updated: | March 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
HIV prisoners test treat link coordination retain |
behavioral intervention text reminders motivational interviewing medication adherence |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013