The criminal justice system (CJS) is disproportionately impacted by people with HIV and substance use disorders, such that one quarter of all HIV+ persons nationally cycle through the CJS annually. The CJS is therefore an important place to seek and empirically test interventions that address the Seek, Test, Treat and Retain (STTR) strategy to reduce community-wide HIV transmission. STTR requires that HIV is maximally suppressed, thereby resulting in decreased infectiousness. HIV+ prisoners maximally suppress HIV replication during incarceration. Unfortunately, viral suppression is lost within 3 months post-release, mostly as a consequence of relapse to opioids. Opioid dependence (OD) is present in 50% of all HIV+ prisoners nationally and 70-85% in the Northeast - OD is therefore a significant co-morbid condition requiring effective treatment. 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 and reduce community-wide transmission. Our team has confirmed for the first time that treating OD with buprenorphine (BPN) results in sustained viral suppression over the vulnerable 3-month post-release period. Adoption of methadone, despite its confirmed benefit, is minimal within the CJS due to philosophical, safety, regulatory and staffing concerns. BPN, a partial opioid agonist, is a more attractive option due to its safer profile and reduced regulation. Generic formulation now makes it affordable. Therefore, strategies examining the efficacy of BPN 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 aims are: 1) to conduct a placebo-controlled RCT of BPN for HIV+ prisoners with OD who are transitioning to the community and 2) to model the impact of BPN treatment on reducing HIV transmission. In the RCT, 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), and HIV risk behaviors (sexual and drug-related risks) outcomes will be compared in 152 released prisoners and followed for 12 months. We bring together the strengths of seasoned researchers who have conducted research in the CJS for two decades in the areas of HIV treatment and adherence, Addiction Medicine and mathematical modeling. BPN, as a medication-assisted therapy, has great appeal within CJS due to lack of stigma, its documented safety in HIV+ patients, its unique pharmacology, lack of stringent regulation and its recently reduced cost. If this placebo-controlled trial of BPN among released HIV+ prisoners with OD demonstrates efficacy and safety, it is likely to become more widely adopted. As such, the individual, our health care system and society have a high likelihood to benefit - especially on reducing HIV transmission within the community.

Public Health Relevance

HIV and substance use disorders, especially opioid dependence, is concentrated within the American criminal justice system (CJS). The period after release from CJS is extremely vulnerable and associated with worsening outcomes from HIV treatment, increased relapse to opioids and increased HIV risk behaviors - a perfect storm for an explosive community-wide epidemic. This proposal intends to improve health to the individual and to the community during the crucial period during transition from the prison to the community.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA030768-03
Application #
8288900
Study Section
Special Emphasis Panel (ZRG1-AARR-G (50))
Program Officer
Jones, Dionne
Project Start
2010-09-30
Project End
2015-06-30
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
3
Fiscal Year
2012
Total Cost
$782,808
Indirect Cost
$308,988
Name
Yale University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
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Haddad, Marwan S; Zelenev, Alexei; Altice, Frederick L (2013) Integrating buprenorphine maintenance therapy into federally qualified health centers: real-world substance abuse treatment outcomes. Drug Alcohol Depend 131:127-35
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