Trial of Collaborative Depression Care Management for HIV Patients (SLAM DUNC)

Duke University

Status: Completed

Conditions: HIV; Depression

Treatments: Other: Measurement-Based Care collaborative depression management; Other: Enhanced Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01372605

Pro00019233

R01MH086362 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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 antiretroviral therapy (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.

Enrollment: 304 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-65
• HIV-positive
• Patient Health Questionnaire-9 (PHQ-9) 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

304 participants in 2 patient groups

Collaborative depression care

Experimental group

Description:

Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.

Treatment:

Other: Measurement-Based Care collaborative depression management

Enhanced usual care

Other group

Description:

Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.

Treatment:

Other: Enhanced Usual Care