Site-Randomized Controlled Trial of a Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression Among Youth Living with HIV in the United States.

Background Depression is frequent among youth living with HIV (YLWH). Studies suggest that manualized treatment guided by symptom measurement is more efficacious than usual care. Setting This study evaluated manualized, measurement-guided depression treatment among YLWH, ages 12-24 years at thirteen United States sites of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). Methods Using restricted randomization, sites were assigned to either a 24-week, combination cognitive behavioral therapy and medication management algorithm (COMB-R) tailored for YLWH or to Enhanced Standard of Care (ESC), which provided standard psychotherapy and medication management. Eligibility included diagnosis of nonpsychotic depression and current depressive symptoms. Arm comparisons used t-tests on site-level means. Results Thirteen sites enrolled 156 YLWH, with a median of 13 participants per site (range 2-16). At baseline there were no significant differences between arms on demographic factors, severity of depression, or HIV status. The average site-level participant characteristics were: mean age of 21 years; 45% male, 61% Black, and 53% acquired HIV through perinatal transmission. At Week 24, youth at COMB-R sites, compared to ESC sites, reported significantly fewer depressive symptoms on the Quick Inventory for Depression Symptomatology Self-Report (QIDS-SR score 6.7 vs. 10.6, p=0.01) and a greater proportion in remission (QIDS-SR score ≤ 5; 47.9% vs.17.0%, p=0.01). The site mean HIV viral load and CD4 T-cell level were not significantly different between arms at Week 24. Conclusions A manualized, measurement-guided psychotherapy and medication management algorithm tailored for YLWH significantly reduced depressive symptoms compared to standard care at HIV clinics.