HIV, Buprenorphine, and the Criminal Justice System (STRIDE)

• HIV-1 RNA levels [ Time Frame: baseline ] [ Designated as safety issue: No ]
  Monitor change in percent Viral Load <400, change in CD4 count, change in retention in care, and change in HIV risk behaviors
  
  
• HIV-1 RNA levels [ Time Frame: week 13 ] [ Designated as safety issue: No ]
  Monitor change in percent Viral Load <400, change in CD4 count, change in retention in care, and change in HIV risk behaviors
  
  
• HIV-1 RNA levels [ Time Frame: week 27 ] [ Designated as safety issue: No ]
  Monitor change in percent Viral Load <400, change in CD4 count, change in retention in care, and change in HIV risk behaviors
  
  
• HIV-1 RNA levels [ Time Frame: week 40 ] [ Designated as safety issue: No ]
  Monitor change in percent Viral Load <400, change in CD4 count, change in retention in care, and change in HIV risk behaviors
  
  

• Improved opioid treatment outcomes [ Time Frame: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 52 ] [ Designated as safety issue: No ]
  Monitor relapse to opioid use, retention on Buprenorphine or placebo, percent days using opioids, lower addiction severity, lower craving, between baseline and subsequent follow-up visits. Monitor urine toxicology screens on every visit for approximately one year.
  
  
• Improved criminal justice outcomes [ Time Frame: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52 ] [ Designated as safety issue: No ]
  Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.
  
  

The purpose of this study is to determine whether treatment with BUP will help to reduce opioid dependence in HIV + inmates and improve their health outcomes with regard to substance dependence and HIV, as well as reduce their criminal justice involvement. In this study, which will take place in Washington D.C., we will examine whether among HIV+ opioid dependent prisoners, undergoing treatment with BUP will result in improved HIV-related outcomes (VL, CD4, retention in care, HIV risk behaviors), improved opioid treatment outcomes (relapse to opioid use, retention on BUP or placebo, percent days using opioids, lower addiction severity, lower craving), and improved criminal justice outcomes (time to reincarceration, number of days reincarcerated, crime days) over the following 12 months. In order to determine if BUP is effective in altering in these outcomes, we will follow all participants and schedule regular interviews to understand their progress in treatment. This will also enable us to look at the opioid use in the subject's system and the amount of virus in the participant's blood, and conduct other tests such as liver function tests to monitor for adverse side effects.