Trial of Collaborative Depression Care Management for HIV Patients

Status:	Completed
Conditions:	Depression, HIV / AIDS
Therapuetic Areas:	Immunology / Infectious Diseases, Psychiatry / Psychology
Healthy:	No
Age Range:	18 - 65
Updated:	11/30/2013
Start Date:	April 2010
End Date:	April 2014
Contact:	Brian W Pence, PhD
Email:	brian.pence@duke.edu
Phone:	919-613-5443

Strategies to Link Antidepressant and Antiretroviral Management at Duke, UAB and UNC

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.

Inclusion Criteria:

- Age 18-65

- HIV-positive

- PHQ9 total score >= 10

- Confirmed current major depressive episode

- English-speaking

Exclusion Criteria:

- History of bipolar disorder

- History of psychotic disorder

- Failure of adequate trials of two different antidepressants at effective doses in the
current depressive episode

- Current substance dependence requiring inpatient hospitalization

- Not mentally competent

- Acute suicidality or other psychiatric presentation requiring immediate
hospitalization

We found this trial at

sites

Duke University Clinic 2J

Durham, North Carolina

from

Durham, NC