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



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:March 2012
End Date:October 2014
Contact:Jessica Carda-Auten, MPH
Email:jessica_carda-auten@med.unc.edu
Phone:919-966-7759

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

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.

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:

1. 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

2. 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.

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.
We found this trial at
2
sites
Fort Worth, Texas 76129
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Chapel Hill, North Carolina 27599
(919) 962-2211
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Chapel Hill, NC
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