The purpose of this study is to conduct a two-arm effectiveness trial in Cape Town, South Africa of a Xhosa-adapted, nurse-delivered, cognitive behavioral therapy (CBT) treatment for depression and adherence, integrated into the HIV care setting in patients with HIV who did not achieve viral suppression from first-line treatment. The CBT treatment will be compared to enhanced usual care (Enhanced Treatment As Usual - ETAU) on study endpoints (as described in study endpoints section below).
Clinical Clinical depression is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent. Depression, in the context of HIV, leads to poor self-care behavior such as non-adherence to ART and worse retention in care, which are critical for treatment success. Based on our prior work, and given that CBT is an evidenced-based treatment for depression, this is a two-arm effectiveness randomized controlled trial of nurse-delivered cognitive behavioral therapy for depression and adherence integrated into the HIV primary care setting in S. Africa. To ensure that those who need this intervention the most will receive it, participants will be patients with HIV who did not achieve viral suppression from their first line ART, and have a unipolar depressive mood disorder.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
161
This treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.
University of Miami
Miami, Florida, United States
The General Hospital Corp dba Massachusetts General Hospital
Boston, Massachusetts, United States
University of Cape Town
Cape Town, South Africa
Changes in HIV medication adherence throughout intervention phase
Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device
Time frame: Assessed between baseline and the 4 month assessment
Depression scores as assessed by an independent (blind assessor) after intervention.
Hamilton Depression Rating Scale The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.
Time frame: 4 month assessment
HIV viral load
Percentage of patients with a detectable viral load at the 12 month assessment
Time frame: 12-month assessment
CD4
Mean CD4 cell counts at the 12 month assessment
Time frame: 12-month assessment
HIV medication adherence over follow-up
Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device
Time frame: Aggregate across 4,8, and 12-month assessment
Depression scores as assessed by an independent (blind assessor) over follow-up
Hamilton Depression Rating Scale The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.
Time frame: Aggregate across 4,8, and 12-month assessment
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