Directly observed antidepressant medication treatment and HIV outcomes among homeless and marginally housed HIV-positive adults: a randomized controlled trial.

Objectives. We assessed whether directly observed fluoxetine treatment reduced depression symptom severity and improved HIV outcomes among homeless and marginally housed HIV-positive adults in San Francisco, California, from 2002 to 2008. Methods. We conducted a nonblinded, randomized controlled trial of once-weekly fluoxetine, directly observed for 24 weeks, then self-administered for 12 weeks (n=137 persons with major or minor depressive disorder or dysthymia). Hamilton Depression Rating Scale score was the primary outcome. Response was a 50% reduction from baseline and remission a score below 8. Secondary measures were Beck Depression Inventory-II (BDI-II) score, antiretroviral uptake, antiretroviral adherence (measured by unannounced pill count), and HIV-1 RNA viral suppression (<50 copies/mL). Results. The intervention reduced depression symptom severity (b=-1.97; 95% confidence interval [CI]=-0.85, -3.08; P<.001) and increased response (adjusted odds ratio [AOR]=2.40; 95% CI=1.86, 3.10; P<.001) and remission (AOR=2.97; 95% CI=1.29, 3.87; P<.001). BDI-II results were similar. We observed no statistically significant differences in secondary HIV outcomes. Conclusions. Directly observed fluoxetine may be an effective depression treatment strategy for HIV-positive homeless and marginally housed adults, a vulnerable population with multiple barriers to adherence. (Am J Public Health. 2013;103:308-315. doi:10.2105/AJPH.2011.300422)