Depression Clinical Trial
Official title:
SLAM DUNC: Strategies to Link Antidepressant and Antiretroviral Management at Duke University, University of Alabama at Birmingham, Northern Outreach Clinic (Henderson, NC), and University of North Carolina
This project will integrate a depression treatment and brief medication adherence counseling intervention into clinical care at three HIV clinics and will use a randomized controlled trial to assess whether, relative to usual care, the intervention leads to improved HIV medication adherence. The depression treatment intervention uses a model known as Measurement-Based Care which equips Depression Care Managers with systematic measurement tools, a decision algorithm, and psychiatric backup and trains them to provide decision support to HIV clinicians to implement, monitor, and adjust antidepressant therapy.
Our goal in this project is to conduct a randomized controlled trial of an evidence-based
depression treatment intervention known as Measurement-Based Care (MBC), combined with brief
Motivational Interviewing (MI) adherence counseling, in depressed people living with
HIV/AIDS to assess its impact on ART adherence and clinical outcomes. MBC employs Depression
Care Managers with expertise in depression management to screen for depression and help
non-psychiatric physicians implement guideline-concordant, algorithm-driven antidepressant
treatment. The Depression Care Manager use standardized metrics (depressive symptoms, side
effects) and an algorithm to monitor treatment response and recommend changes. Weekly
supervision from a psychiatrist ensures quality care. Biweekly contact between patients and
the Depression Care Manager will include brief MI adherence counseling.
We will recruit 390 people living with HIV/AIDS on ART with confirmed depression, and will
conduct a randomized trial of the MBC intervention versus enhanced usual care. Our aims are:
(1) to test whether MBC improves ART adherence and HIV clinical outcomes, (2) to assess the
cost-effectiveness of MBC, and (3) to collect process measures concerning MBC implementation
to inform replication at other sites. Since the Depression Care Manager role can be
effectively filled by a behavioral health provider or nurse given appropriate training and
supervision and the intervention has limited time requirements, this model is potentially
replicable to a wide range of resource-constrained HIV treatment settings.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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