Clinical trial NCT01372605: Trial of Collaborative Depression Care Management for HIV Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
HIV
Keywords: Depression
HIV
Adherence
Collaborative care
Measurement-Based Care
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of North Carolina, Chapel Hill
name: University of Alabama at Birmingham
First posted: 2011-06-14
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Antiretroviral Medication Adherence
timeFrame: Six months post-enrollment
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: Six months
measure: Antiretroviral Medication Adherence
timeFrame: 12 months
measure: Health Care Costs
timeFrame: 12 months
measure: Appointment Adherence
timeFrame: 12 months
measure: Number of Participants With Viral Load Below Detection
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
measure: Self Reported Adherence
timeFrame: 6 months
measure: Self-reported Adherence
timeFrame: 12 months
measure: Safety Endpoint
timeFrame: 12 months
measure: Depression-free Days
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham 1917 Clinic
state: Alabama
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals Infectious Diseases Clinic
state: North Carolina
city: Durham
country: United States
facility: Duke University Clinic 2J
state: North Carolina
city: Henderson
country: United States
facility: Northern Outreach Clinic
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brian W Pence, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Bradley N Gaynes, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pence BW, Gaynes BN, Williams Q, Modi R, Adams J, Quinlivan EB, Heine A, Thielman N, Mugavero MJ. Assessing the effect of Measurement-Based Care depression treatment on HIV medication adherence and health outcomes: rationale and design of the SLAM DUNC Study. Contemp Clin Trials. 2012 Jul;33(4):828-38. doi: 10.1016/j.cct.2012.04.002. Epub 2012 Apr 20.
citation: Adams JL, Gaynes BN, McGuinness T, Modi R, Willig J, Pence BW. Treating depression within the HIV "medical home": a guided algorithm for antidepressant management by HIV clinicians. AIDS Patient Care STDS. 2012 Nov;26(11):647-54. doi: 10.1089/apc.2012.0113.
citation: Bess KD, Adams J, Watt MH, O'Donnell JK, Gaynes BN, Thielman NM, Heine A, Zinski A, Raper JL, Pence BW. Providers' attitudes towards treating depression and self-reported depression treatment practices in HIV outpatient care. AIDS Patient Care STDS. 2013 Mar;27(3):171-80. doi: 10.1089/apc.2012.0406. Epub 2013 Feb 26.
citation: Edwards M, Quinlivan EB, Bess K, Gaynes BN, Heine A, Zinski A, Modi R, Pence BW. Implementation of PHQ-9 depression screening for HIV-infected patients in a real-world setting. J Assoc Nurses AIDS Care. 2014 May-Jun;25(3):243-52. doi: 10.1016/j.jana.2013.05.004. Epub 2013 Oct 5.
citation: Bengtson AM, Pence BW, O'Donnell J, Thielman N, Heine A, Zinski A, Modi R, McGuinness T, Gaynes B. Improvements in depression and changes in quality of life among HIV-infected adults. AIDS Care. 2015;27(1):47-53. doi: 10.1080/09540121.2014.946386. Epub 2014 Aug 8.
citation: Pence BW, Quinlivan EB, Heine A, Edwards M, Thielman NM, Gaynes BN. When "need plus supply" does not equal demand: challenges in uptake of depression treatment in HIV clinical care. Psychiatr Serv. 2015 Mar 1;66(3):321-3. doi: 10.1176/appi.ps.201400132. Epub 2014 Dec 1.