Therapy Targeting Depression and HIV Treatment Adherence (The TRIAD Study)

• changes in HIV medication adherence, as measured by electronic medication event monitoring system (MEMS) pill-cap scores [ Time Frame: Measured at each visit - baseline, interim visits, and after 4, 8, and 12 months ] [ Designated as safety issue: No ]
  HIV medication adherence is assessed more frequently during the acute study period (baseline to post-treatment), and then at the follow up major visits.
  
  

• changes in Severity of depression, as assessed on the Montgomery-Asberg Depression Rating Scale (MADRS) by a blinded independent assessor [ Time Frame: Measured at baseline and after 4, 8, and 12 months ] [ Designated as safety issue: No ]
  
• changes in depression, as measured by the blinded assessor CGI rating [ Time Frame: Measured at baseline and after 4, 8, and 12 months ] [ Designated as safety issue: No ]
  
• changes in RNA viral load [ Time Frame: Measured at baseline and after 4, 8, and 12 months ] [ Designated as safety issue: No ]
  
• changes in CD4 cell count [ Time Frame: Measured at baseline and after 4, 8, and 12 months ] [ Designated as safety issue: No ]
  
• changes in self-reported depression (CESD) [ Time Frame: Measured at each visit ] [ Designated as safety issue: No ]
  This is measured more frequently during the acute phase (pretreatment to post-treatment) then at the follow up assessments.
  
  

People infected with HIV are more likely to suffer from depression than those not infected, with studies finding anywhere from 20% to 50% of HIV-infected individuals having significant depressive symptoms. Depression, in addition to causing persistent sadness and inability to feel pleasure, is related to a lack of HIV treatment adherence. Treatment adherence (making sure to take every pill as prescribed by doctors) is critically important to successful treatment of HIV, because missing even a few doses gives the HIV virus an opportunity to develop immunity to the medication. Poor adherence is related to worse medical outcomes, but even a small, 10% improvement rate in adherence may improve these outcomes. This study will test the efficacy of cognitive behavioral therapy (CBT) that addresses both depression and treatment adherence for HIV-infected people.

Participation in this study will last 1 year, including follow-up visits. All participants will complete an initial one-visit intervention addressing treatment adherence. Then after 2 weeks, participants will be randomly assigned to one of three conditions: CBT for HIV medication adherence and depression (CBT-AD), information and supportive psychotherapy for HIV medication adherence and depression (ISP-AD), or enhanced treatment as usual (ETAU). Participants receiving CBT-AD and ISP-AD will complete 12 therapy sessions over 4 months and will be asked to report any changes to their psychological or HIV treatments. CBT-AD will involve learning to identify and change problematic patterns of thought and behavior, while ISP-AD will involve education and supportive psychotherapy. Participants receiving ETAU will receive only the initial session on HIV medication adherence and will be asked about their psychological and HIV treatment every other week for 4 months.

Major study assessments will take place at baseline and after 4, 8, and 12 months. Assessments will include completing diagnostic interviews and questionnaires, measuring medication adherence through an electronic pill cap, and determining CD4 cell count and viral load (indicators of HIV treatment effectiveness).