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

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ClinicalTrials.gov Identifier: NCT01629316

Recruitment Status : Completed

First Posted : June 27, 2012

Last Update Posted : June 11, 2015

Sponsor:

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

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.

Condition or disease	Intervention/treatment	Phase
HIV Infection	Behavioral: Text reminders, counseling, and link coordination Behavioral: Standard of care - control arm	Not Applicable

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	381 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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)
Study Start Date :	March 2012
Actual Primary Completion Date :	May 2015
Actual Study Completion Date :	May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

HIV RNA level (Viral Load) [ Time Frame: Week 24 post-release from prison ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

Granich RM, Gilks CF, Dye C, De Cock KM, Williams BG. Universal voluntary HIV testing with immediate antiretroviral therapy as a strategy for elimination of HIV transmission: a mathematical model. Lancet. 2009 Jan 3;373(9657):48-57. doi: 10.1016/S0140-6736(08)61697-9. Epub 2008 Nov 27.

Lima VD, Johnston K, Hogg RS, Levy AR, Harrigan PR, Anema A, Montaner JS. Expanded access to highly active antiretroviral therapy: a potentially powerful strategy to curb the growth of the HIV epidemic. J Infect Dis. 2008 Jul 1;198(1):59-67. doi: 10.1086/588673.

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.

Spaulding AC, Seals RM, Page MJ, Brzozowski AK, Rhodes W, Hammett TM. HIV/AIDS among inmates of and releasees from US correctional facilities, 2006: declining share of epidemic but persistent public health opportunity. PLoS One. 2009 Nov 11;4(11):e7558. doi: 10.1371/journal.pone.0007558.

Leukefeld CG, Staton M, Hiller ML, Logan TK, Warner B, Shaw K, Purvis RT. A descriptive profile of health problems, health services utilization, and HIV serostatus among incarcerated male drug abusers. J Behav Health Serv Res. 2002 May;29(2):167-75.

Springer SA, Pesanti E, Hodges J, Macura T, Doros G, Altice FL. Effectiveness of antiretroviral therapy among HIV-infected prisoners: reincarceration and the lack of sustained benefit after release to the community. Clin Infect Dis. 2004 Jun 15;38(12):1754-60. Epub 2004 May 26.

Baillargeon J, Giordano TP, Rich JD, Wu ZH, Wells K, Pollock BH, Paar DP. Accessing antiretroviral therapy following release from prison. JAMA. 2009 Feb 25;301(8):848-57. doi: 10.1001/jama.2009.202.

Stephenson BL, Wohl DA, Golin CE, Tien HC, Stewart P, Kaplan AH. Effect of release from prison and re-incarceration on the viral loads of HIV-infected individuals. Public Health Rep. 2005 Jan-Feb;120(1):84-8.

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

Stephenson BL, Wohl DA, McKaig R, Golin CE, Shain L, Adamian M, Emrick C, Strauss RP, Fogel C, Kaplan AH. Sexual behaviours of HIV-seropositive men and women following release from prison. Int J STD AIDS. 2006 Feb;17(2):103-8.

Grinstead O, Zack B, Faigeles B. Reducing postrelease risk behavior among HIV seropositive prison inmates: the health promotion program. AIDS Educ Prev. 2001 Apr;13(2):109-19.

Best A, Stokols D, Green LW, Leischow S, Holmes B, Buchholz K. An integrative framework for community partnering to translate theory into effective health promotion strategy. Am J Health Promot. 2003 Nov-Dec;18(2):168-76. Review.

Stokols D. Translating social ecological theory into guidelines for community health promotion. Am J Health Promot. 1996 Mar-Apr;10(4):282-98. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Golin CE, Knight K, Carda-Auten J, Gould M, Groves J, L White B, Bradley-Bull S, Amola K, Fray N, Rosen DL, Mugavaro MJ, Pence BW, Flynn PM, Wohl D. Individuals motivated to participate in adherence, care and treatment (imPACT): development of a multi-component intervention to help HIV-infected recently incarcerated individuals link and adhere to HIV care. BMC Public Health. 2016 Sep 6;16:935. doi: 10.1186/s12889-016-3511-1.


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 ( U.S. NIH Grant/Contract )
First Posted:	June 27, 2012 Key Record Dates
Last Update Posted:	June 11, 2015
Last Verified:	June 2015

Keywords provided by David A Wohl, MD, 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

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