HIV and drug abuse is concentrated within the criminal justice system (CJS) resulting in 26% of all HIV+ prisoners nationally being released to the community annually. Therefore, the CJS is an important place to target and empirically test interventions that address the Seek, Test, Treat and Retain (STTR) strategy to reduce HIV transmission within the community. STTR requires that HIV is maximally suppressed, resulting in decreased infectiousness;HIV+ prisoners successfully achieve maximal suppression during incarceration. Three 3 months post-release, however, viral suppression is lost mostly as a consequence of relapse to opioids - opioid dependence (OD) is present in 50% of HIV+ prisoners nationally and 70-85% in the Northeast. Opioid relapse is associated with decreased HAART adherence, discontinuation of HAART and increased HIV risk behaviors in the setting of viral replication - the perfect storm for HIV transmission. Effectively treating OD interrupts this relationship and has great potential to improve HIV outcomes;our team has confirmed this benefit using buprenorphine. Opioid substitution therapy, especially methadone, has had limited uptake within the CJS due to philosophical, safety, regulatory and staffing concerns. Therefore, strategies examining the efficacy of naltrexone (NTX), an opioid antagonist, to improve adherence and retention in care, has great appeal to benefit the individual, but also to reduce HIV transmission within the community.
Our specific aim i s to conduct a placebo-controlled RCT of depot NTX (d-NTX) for HIV+ prisoners with OD who are transitioning to the community. The placebo-control methodology further strengthens any findings that should be demonstrated. HIV treatment (HIV-1 RNA levels, CD4 count, ART adherence, retention in care), substance abuse (time to relapse to opioid use, % opioid negative urines, opioid craving), adverse side effects and HIV risk behavior (sexual and drug-related risks) outcomes will be compared in 150 subjects within CJS in New Haven, Hartford and Springfield. Subjects will be randomized 2:1 to d-NTX or d-placebo for 6 months and observed for 12 months. This therapeutic approach has great appeal by the CJS, given the ease of monthly injections, lack of diversion, few side effects and no antagonistic philosophical concerns about its use. The strength of this proposal is the team of researchers experienced in HIV, addiction and the CJS, the novel use of treating OD as a means to improve HIV outcomes, over 20 years of conducting research in the CJS and the novelty of using d-NTX for the treatment of OD. If this placebo-controlled trial of d-NTX among released HIV+ CJS-involved persons with OD demonstrates efficacy and safety, it is likely to become an evidence-based intervention to intervene with released HIV+ prisoners. As such, the individual, our health care system and society have a high likelihood to benefit - especially on the reduction of HIV within the community.

Public Health Relevance

Using a randomized, placebo-controlled trial, HIV treatment, opioid treatment and HIV risk behavior outcomes are examined among HIV-infected prisoners with opioid dependence who are treated with depot- naltrexone as they are transitioning from the correctional to the community setting. The public health relevance is that outcomes from this study will establish the efficacy, safety and tolerability of pharmacological therapy using naltrexone treatment among HIV+s and establish depot-naltrexone treatment as an effective, evidence-based treatment for opioid dependence for released HIV+ prisoners - a population who shares a disproportionate burden of morbidity and mortality and has fared poorly using the existing standard of care.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA030762-04
Application #
8537883
Study Section
Special Emphasis Panel (ZRG1-AARR-G (50))
Program Officer
Aklin, Will
Project Start
2010-09-30
Project End
2015-08-31
Budget Start
2013-09-01
Budget End
2014-08-31
Support Year
4
Fiscal Year
2013
Total Cost
$769,553
Indirect Cost
$255,303
Name
Yale University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Vagenas, Panagiotis; Di Paola, Angela; Herme, Maua et al. (2014) An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone. J Subst Abuse Treat 47:35-40
Rich, Josiah D; DiClemente, Ralph; Levy, Judith et al. (2013) Correctional facilities as partners in reducing HIV disparities. J Acquir Immune Defic Syndr 63 Suppl 1:S49-53
Morano, Jamie P; Gibson, Britton A; Altice, Frederick L (2013) The burgeoning HIV/HCV syndemic in the urban Northeast: HCV, HIV, and HIV/HCV coinfection in an urban setting. PLoS One 8:e64321
Springer, Sandra A; Spaulding, Anne C; Meyer, Jaimie P et al. (2011) Public health implications for adequate transitional care for HIV-infected prisoners: five essential components. Clin Infect Dis 53:469-79
Rich, Josiah D; Wohl, David A; Beckwith, Curt G et al. (2011) HIV-related research in correctional populations: now is the time. Curr HIV/AIDS Rep 8:288-96