Trial of Collaborative Depression Care Management for HIV Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Depression, HIV

Intervention / Treatment
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* Other: Measurement-Based Care collaborative depression management
* Other: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative depression care<br>Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. | Other: Measurement-Based Care collaborative depression management<br>* Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications<br>|
| Other: Enhanced usual care<br>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. | Other: Enhanced Usual Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiretroviral Medication Adherence | Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor | Six months post-enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptoms | 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. | Six months | 
| Antiretroviral Medication Adherence | Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor | 12 months | 
| Health Care Costs | Total health care costs over 12 months | 12 months | 
| Appointment Adherence | Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment | 12 months | 
| Number of Participants With Viral Load Below Detection | HIV RNA viral load below the limit of detection at 6 months | 6 months | 
| Quality of Life | 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. | 6 months | 
| Self Reported Adherence | 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). | 6 months | 
| Self-reported Adherence | 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). | 12 months | 
| Safety Endpoint | Psychiatric hospitalizations | 12 months | 
| Depression-free Days | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Depression, Adherence, Collaborative care, Measurement-Based Care