Abstract
Objective: To determine if, by reducing depressive symptoms, combined psychotherapy and pharmacotherapy reduces HIV drug risk behavior compared to an assessment-only condition for active drug injectors over 9 months. Design: Randomized controlled trial. Setting: Outpatient academic research office. Patients: Active injection drug users with a DSM-IV diagnosis of major depression, dysthymia, substance-induced mood disorder with depressive features persisting for at least 3 months, or major depression plus dysthymia. In addition, participants had a Hamilton Rating Scale for Depression (MHRSD) score > 13. Intervention: Psychotherapy (8 sessions of cognitive behavioral therapy) plus antidepressant pharmacotherapy over 3 months. Main Outcome Measures: HIV Risk Assessment Battery (RAB) drug scale scores measured at three, six and nine months, and depression remission (MHRSD score ≤ 8). Results: Participants (n = 109) were 64% male, 82% Caucasian, with a mean baseline MHRSD score of 20.7. Depression subtypes included major depression only (63%), substance-induced depression (17%), and double-depression (17%). Overall, study retention at nine months was 89%. Reported HIV drug risk scores decreased sharply over the first 3 months and continued to decline throughout the follow-up period. Between group differences were not significant in the intention-to-treat analysis. However, highly adherent participants had significantly lower HIV drug risk scores at 3 months (p < 05), but not 6 and 9 months. Depression remission was significantly associated with lower HIV drug risk scores at follow-ups. Conclusions: Combined psychotherapy and pharmacotherapy did not produce a significant reduction in HIV drug risk beyond that seen in an assessment-only control group. The greatest declines in HIV drug risk were found in participants with high protocol adherence and those with depression remission.