Evaluation of Behavioral Intervention for HIV Positive Prisoners in NC and TX (imPACT)
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
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: June 9, 2015
Last verified: June 2015
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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:
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 ]
| Enrollment: | 381 |
| Study Start Date: | March 2012 |
| Study Completion Date: | May 2015 |
| Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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 (Adult, Senior) |
| 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 30 days
- Last recorded viral load (must be within 90 days of entry) <400 copies/mL
- 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629316
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629316
Locations
| 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 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
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:
Haley D, Scheyett A, Golin C, et al. Perceptions of Release among Incarcerated HIV-Infected Persons and Implications for Practice: The UNC Bridges to Good Health and Treatment (BRIGHT) Project Qualitative Substudy. Abstract THPE0717. International AIDS Conference, 2006
| 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: | June 9, 2015 |
| 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on September 27, 2016