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

Primary Purpose

HIV Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text reminders, counseling, and link coordination
Standard of care - control arm
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infection focused on measuring HIV, prisoners, test, treat, link coordination, retain, behavioral, intervention, text reminders, motivational interviewing, medication adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of North Carolina at Chapel Hill
  • Texas Christian University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Text reminders, counseling, link coordinator

Standard of care - control arm

Arm Description

Text reminders, counseling, link coordination

Outcomes

Primary Outcome Measures

HIV RNA level (Viral Load)

Secondary Outcome Measures

Full Information

First Posted
June 4, 2012
Last Updated
June 9, 2015
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01629316
Brief Title
Evaluation of Behavioral Intervention for HIV Positive Prisoners in NC and TX
Acronym
imPACT
Official Title
CID 1007 - Randomized Controlled Trial of an Augmented Test, Treat, Link & Retain Model for NC and TX Prisoners (imPACT Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV, prisoners, test, treat, link coordination, retain, behavioral, intervention, text reminders, motivational interviewing, medication adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text reminders, counseling, link coordinator
Arm Type
Experimental
Arm Description
Text reminders, counseling, link coordination
Arm Title
Standard of care - control arm
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Text reminders, counseling, and link coordination
Intervention Description
This is an intervention with text reminders, counseling that involves motivational interviewing, and link coordination
Intervention Type
Behavioral
Intervention Name(s)
Standard of care - control arm
Intervention Description
The control arm is standard of care for each subject.
Primary Outcome Measure Information:
Title
HIV RNA level (Viral Load)
Time Frame
Week 24 post-release from prison

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Wohl, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carol Golin, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Texas Christian University
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76129
Country
United States

12. IPD Sharing Statement

Citations:
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19038438
Citation
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PubMed Identifier
19509386
Citation
Dieffenbach CW, Fauci AS. Universal voluntary testing and treatment for prevention of HIV transmission. JAMA. 2009 Jun 10;301(22):2380-2. doi: 10.1001/jama.2009.828. No abstract available.
Results Reference
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PubMed Identifier
19907649
Citation
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Citation
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Citation
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Results Reference
derived

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

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