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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infection

Intervention / Treatment
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* Behavioral: Text reminders, counseling, and link coordination
* Behavioral: Standard of care - control arm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text reminders, counseling, link coordinator<br>Text reminders, counseling, link coordination | Behavioral: Text reminders, counseling, and link coordination<br>* This is an intervention with text reminders, counseling that involves motivational interviewing, and link coordination<br>|
| Active Comparator: Standard of care - control arm<br> | Behavioral: Standard of care - control arm<br>* The control arm is standard of care for each subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV RNA level (Viral Load) |  | Week 24 post-release from prison | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, prisoners, test, treat, link coordination, retain, behavioral, intervention, text reminders, motivational interviewing, medication adherence