Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1

• Percent Medication Adherence at 3-month Follow-up Assessment [ Time Frame: 3-month assessment ] [ Designated as safety issue: No ]
  Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.
  
  
• Percent Medication Adherence at 12-month Follow-up Assessment [ Time Frame: 12-month follow-up assessment ] [ Designated as safety issue: No ]
  Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.
  
  

• Clinician-assessed Depression Rating at 3 Month Follow-up Assessment [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
  Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.
  
  
• HIV Viral Load at 12-month Follow-up Assessment [ Time Frame: 12-month follow-up assessment ] [ Designated as safety issue: No ]
  HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.
  
  
• CD4+ Lymphocyte Count at 12-month Follow-up Assessment. [ Time Frame: 12-month follow-up assessment ] [ Designated as safety issue: No ]
  CD4+ lymphocyte cell count at 12-month follow-up assessment.
  
  
• Clinician-assessed Depression at 12-month Follow-up Assessment [ Time Frame: 12-month follow-up assessment ] [ Designated as safety issue: No ]
  Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.
  
  
• HIV Viral Load at 3-month Follow-up Assessment [ Time Frame: 3-month assessment ] [ Designated as safety issue: No ]
  HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.
  
  
• CD4+ Lymphocyte Count at 3-month Follow-up Assessment. [ Time Frame: 3-month assessment ] [ Designated as safety issue: No ]
  CD4+ lymphocyte cell count at 3-month follow-up assessment.
  
  

Symptoms of depression (i.e. low motivation, poor concentration, loss of interest, sad mood, suicidal ideation) that occur in the context of substance abuse or dependence can interfere with self-care behaviors necessary for maintaining HIV care, as well as interfere with potential benefit from an intervention that focuses on adherence alone. We hypothesize that teaching skills to cope with depression will improve the outcome from an adherence intervention to promote healthier living with HIV, in HIV+ opioid dependent individuals in methadone maintenance treatment.

Overview of Research Plan. Patients who are HIV positive and who are receiving methadone maintenance for opioid dependence will be randomized to treatment with either: (1) CBT, a combination of CBT for depression and HIV medication adherence, including a single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments or (2) the single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments. Participants will be followed for one-year post-randomization.