Trial of Collaborative Depression Care Management for HIV Patients

Not Applicable

Completed

• Conditions: Depression; HIV
• Interventions: Other: Measurement-Based Care collaborative depression management; Other: Enhanced Usual Care

• Registration Number: NCT01372605
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-06-12
• Study First Submitted QC: 2011-06-12
• Study First Posted: 2011-06-14
• Primary Completion: 2014-04
• Study Completion: 2014-06
• Results First Submitted: 2016-04-11
• Results First Submitted QC: 2016-08-25
• Status Verified: 2016-10
• Results First Posted: 2016-10-19
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

• Age 18-65
• HIV-positive
• Patient Health Questionnaire-9 (PHQ-9) total score >= 10
• Confirmed current major depressive episode
• English-speaking

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collaborative depression care	Measurement-Based Care collaborative depression management	Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.
Enhanced usual care	Enhanced Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Antiretroviral Medication Adherence	Six months post-enrollment	Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor

Secondary Outcome Measures

Name	Time	Method
Safety Endpoint	12 months	Psychiatric hospitalizations
Antiretroviral Medication Adherence	12 months	Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor
Self-reported Adherence	12 months	Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).
Health Care Costs	12 months	Total health care costs over 12 months
Appointment Adherence	12 months	Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment
Number of Participants With Viral Load Below Detection	6 months	HIV RNA viral load below the limit of detection at 6 months
Quality of Life	6 months	Short Form-12 Mental Composite score. Scores range from 0-100, with 50 corresponding to the mean and 10 points to the standard deviation in a normative US population. Higher scores indicate better health.
Self Reported Adherence	6 months	Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).
Depression-free Days	12 months	Total depression-free days over 12 months as calculated from Hamilton Rating Scale for Depression scores at baseline and 3, 6, 9, and 12 months
Depressive Symptoms	Six months	Hamilton Rating Scale for Depression (HAMD) symptom score at 6 months, assessed by blinded assessor. Possible score ranges from 0 to 50. Higher scores indicate worse depressive symptoms.

Trial Locations

Locations (4)

Duke University Clinic 2J; 🇺🇸 Durham, North Carolina, United States

Northern Outreach Clinic; 🇺🇸 Henderson, North Carolina, United States

University of North Carolina Hospitals Infectious Diseases Clinic; 🇺🇸 Chapel Hill, North Carolina, United States

University of Alabama at Birmingham 1917 Clinic; 🇺🇸 Birmingham, Alabama, United States