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

Abstract

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.

FIGURE 1—

Stages of screening process for homeless and marginally housed participants with HIV and depression for controlled trial of directly observed fluoxetine treatment. Note. ART = antiretroviral therapy; BDI-II = Beck Depression Inventory-II; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; REACH = Research in Access to Care for the Homeless; SCID = Structured Clinical Interview for DSM-IV. Prescreening with self-report of depression; administration of 21-item BDI-II; structured clinical assessment of candidates with a BDI-II score > 13 to confirm diagnosis of major depressive disorder, minor depressive disorder, or dysthymia; and interview with study psychiatrist to confirm interest and psychiatric diagnosis, assess appropriateness of antidepressant medication treatment, and review coordination of care with potential participant’s primary care provider.

FIGURE 2—

Mean depression symptom severity by treatment and time among homeless and marginally housed participants with HIV and depression in controlled trial of directly observed fluoxetine treatment. Note. HAM-D = Hamilton Rating Scale for Depression. Error bars indicate 95% confidence intervals.