Comparison of HIV Clinic-Based Treatment With Buprenorphine Versus Referred Care in Heroin-Dependent Participants

• Retention to substance abuse treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  

• Visit attendance with primary medical provider [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• Urine drug screen positivity for opioids and other drugs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• Use of and adherence to highly active antiretroviral therapy (HAART) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• HIV RNA changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• CD4 cell count changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• Self-reported HIV transmission risk behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• Costs and resource utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  

We, the investigators at Johns Hopkins University, propose to enroll and randomize 120 opioid-dependent, HIV-infected participants, who receive care in the Johns Hopkins HIV Clinic to either:

• clinic-based care with buprenorphine (clinic-based BPN/NX arm); or
• case management and referral to an opioid treatment program for opioid agonist-based therapy (case management and referral arm).

The study interventions and follow-up will last 12 months. Participants will be enrolled over a 3-year period. Participants who are assigned to the clinic-based BPN/NX arm will receive BPN/NX (Suboxone®), individual counseling from a nurse interventionist, and group therapy sessions. Participants who are assigned to the case management and referral arm will be enrolled in an established case management and adherence program in the Johns Hopkins HIV Clinic (Project LINK). LINK provides intensive case management, education, and support by a team that includes a social worker, a nurse, a pharmacist educator, and peer advocates. In addition to providing counseling and linkage to needed services, LINK will expedite intake at licensed opioid treatment programs that provide agonist-based therapy for opioid dependence. The clinic-based BPN intervention is a new strategy that was developed in a pilot project over the past 6 months. The case-management and referral arm represents standard-of-care in our clinic, which has been enhanced and codified for this trial. Study outcome visits will be performed at baseline, 1 month, 3 months, 6 months, 9 months, and 12 months.

Comparisons:

• Retention to substance abuse treatment;
• Urine drug screens;
• Adherence to HIV primary care provider visits;
• Use of and adherence to highly active antiretroviral therapy (HAART);
• HIV RNA levels and CD4 cell counts;
• HIV transmission risk behaviors (e.g., injection, sharing of drug paraphernalia, sexual behaviors);
• Costs and resource utilization.