Evaluation of Behavioral Intervention for HIV Positive Prisoners in NC and TX
NCT ID: NCT01629316
Last Updated: 2015-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
381 participants
INTERVENTIONAL
2012-03-31
2015-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Text reminders, counseling, link coordinator
Text reminders, counseling, link coordination
Text reminders, counseling, and link coordination
This is an intervention with text reminders, counseling that involves motivational interviewing, and link coordination
Standard of care - control arm
Standard of care - control arm
The control arm is standard of care for each subject.
Interventions
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Text reminders, counseling, and link coordination
This is an intervention with text reminders, counseling that involves motivational interviewing, and link coordination
Standard of care - control arm
The control arm is standard of care for each subject.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pending charges that would likely lead to transfer of custody or other condition which would otherwise prevent or significantly delay release from custody.
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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David A Wohl, MD
Clinical Associate Professor
Principal Investigators
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David A Wohl, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Carol Golin, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Texas Christian University
Fort Worth, Texas, United States
Countries
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References
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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. No abstract available.
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. doi: 10.1007/BF02287703.
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. doi: 10.1086/421392. 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. doi: 10.1177/003335490512000114.
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. doi: 10.1258/095646206775455775.
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. doi: 10.1521/aeap.13.2.109.19737.
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. doi: 10.4278/0890-1171-18.2.168.
Stokols D. Translating social ecological theory into guidelines for community health promotion. Am J Health Promot. 1996 Mar-Apr;10(4):282-98. doi: 10.4278/0890-1171-10.4.282.
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(1):935. doi: 10.1186/s12889-016-3511-1.
Related Links
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Maruschak LM, Beavers R. Bureau of justice statistics: HIV in prisons, 2007-08. U.S. Department of Justice: Bureau of Justice Statistics; 2009 12/09. Report No.: NCJ 228307. http://bjs.ojp.usdoj.gov/content/pub/pdf/hivp08.pdf
15\. Sabol WJ, West H and Cooper M. Bureau of justice statistics: Prisoners in 2008. U.S. Department of Justice: Bureau of Justice Statistics; 2009 12/09. Report No.: NCJ 228417. http://bjs.ojp.usdoj.gov/index.cfm?ty=pbdetail\&iid=1763
Other Identifiers
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CID 1007 - UNC IRB 10-1183
Identifier Type: -
Identifier Source: org_study_id
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