This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Recent legislation and the FDA approval of buprenorphine and buprenorphine/naloxone (BPN/NX, trade name: Suboxone ) have opened the door to medical-clinic-based treatment of opioid-dependent individuals. There are compelling reasons why the assimilation of BPN-based substance abuse treatment and primary HIV care should take a high public health priority. First, substance abuse in general and opioid dependence in particular, are highly prevalent in HIV clinics, particularly those located in poor urban areas. For example, 51% of the patients in the Johns Hopkins HIV Clinic have a history of injection drug use and 30% report active heroin use in confidential surveys. Second, prior work from our group, as well as from others, has shown that active drug use is strongly associated with missed outpatient clinic visits, underutilization of antiretroviral therapy (ART), and higher rates of HIV disease progression, compared to non-drug-use. Third, HIV-infected individuals who continue to use drugs pose an ongoing HIV-transmission risk to others through shared injection paraphernalia, exchange of sex for drugs, and other behaviors. We propose to conduct a randomized controlled trial of clinic-based care with BPN/NX (clinic-based BPN/NX arm) versus case management and referral to a opioid treatment program for opioid agonist-based therapy (case management and referral arm) in 120 treatment-seeking opioid-dependent patients who receive primary medical care in the Johns Hopkins HIV Clinic. Participants assigned to the case management and referral arm will be managed by a case management team that includes a social worker, a nurse, and peer advocates, and will be referred to a licensed opioid treatment program, where therapy with methadone and/or BPN/NX and are available. The two study arms will be compared with respect to: 1) retention to and progress in substance abuse treatment, 2) access of HIV care and changes in viral loads and CD4 cell counts, 3) HIV transmission risk behaviors, 4) resource utilization and costs. We will also assess changes in the perceptions of clinic-based treatment of opioid dependence in physician and non-physician medical care providers in the Johns Hopkins HIV Clinic by administering a written survey in years 1 and 5 of the protocol. Our study was 1 of 10 funded by HRSA Special Projects of National Significance to examine the integration of BPN/NX into HIV primary care clinics. While the study designs and aims at the 10 sites are not identical, core data from the sites will be pooled and analyzed by a coordinating site, The New York Academy of Medicine
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