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

NCT01629316 | Completed DMC

• 2 other identifiers: CID 1007 - UNC IRB 10-1183R01DA030793-01
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infection

Keywords

HIV; prisoners; test; treat; link coordination; retain; behavioral; intervention; text reminders; motivational interviewing; medication adherence

Outcome Measures

Primary Outcomes (1)

• HIV RNA level (Viral Load)

  Week 24 post-release from prison

Study Arms (2)

Text reminders, counseling, link coordinator

EXPERIMENTAL

Text reminders, counseling, link coordination

Behavioral: Text reminders, counseling, and link coordination

Standard of care - control arm

ACTIVE COMPARATOR

Behavioral: Standard of care - control arm

Interventions

Text reminders, counseling, and link coordination BEHAVIORAL

This is an intervention with text reminders, counseling that involves motivational interviewing, and link coordination

Text reminders, counseling, link coordinator

Standard of care - control arm BEHAVIORAL

The control arm is standard of care for each subject.

Standard of care - control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Texas Christian University

Fort Worth, Texas, 76129, United States

Location

Related Publications (14)

• 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.

  PMID: 19038438 BACKGROUND

• 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.

  PMID: 18498241 BACKGROUND

• 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.

  PMID: 19509386 BACKGROUND

• 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.

  PMID: 19907649 BACKGROUND

• 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.

  PMID: 12032974 BACKGROUND

• 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.

  PMID: 15227623 BACKGROUND

• 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.

  PMID: 19244192 BACKGROUND

• 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.

  PMID: 15736336 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16464271 BACKGROUND

• 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.

  PMID: 11398956 BACKGROUND

• 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.

  PMID: 14621414 BACKGROUND

• 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.

  PMID: 10159709 BACKGROUND

• 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.

  PMID: 27596559 DERIVED

Related Links

• 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

MeSH Terms

Conditions

HIV Infections; Behavior; Medication Adherence

Interventions

Counseling

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• David A Wohl, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Carol Golin, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 27, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 11, 2015

Record last verified: 2015-06

Locations

US (2)