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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH086362 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| University of North Carolina, Chapel Hill | OTHER |
| University of Alabama at Birmingham | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collaborative depression care | Experimental | Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. |
|
| Enhanced usual care | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement-Based Care collaborative depression management | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Antiretroviral Medication Adherence | Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor | Six months post-enrollment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian W Pence, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Bradley N Gaynes, MD MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham 1917 Clinic | Birmingham | Alabama | United States | |||
| University of North Carolina Hospitals Infectious Diseases Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22542960 | Background | 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. | |
| 23134559 | Background | 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. |
| Label | URL |
|---|---|
| SLAM DUNC study website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Collaborative Depression Care | Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Collaborative Depression Care | Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antiretroviral Medication Adherence | Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor | All those completing a 6-month pill count which resulted in a valid adherence measure | Posted | Mean | Standard Deviation | observed pills taken as % of expected | Six months post-enrollment |
|
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Adverse events were collected without classification by specific Adverse Event Terms.
Per protocol, hospitalizations were considered other adverse events in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Collaborative Depression Care | Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment. Measurement-Based Care collaborative depression management: 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Immune system disorders | Systematic Assessment | Death by all causes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical hospitalization | Immune system disorders | Systematic Assessment | This is hospitalizations from all non-psychiatric causes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Pence | University of North Carolina-Chapel Hill | 9199667446 | bpence@unc.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Enhanced Usual Care | Other |
|
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 |
| Chapel Hill |
| North Carolina |
| 27516 |
| United States |
| Duke University Clinic 2J | Durham | North Carolina | United States |
| Northern Outreach Clinic | Henderson | North Carolina | 27536 | United States |
| 23442030 | Background | 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. |
| 24103743 | Background | 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. |
| 25105320 | Background | 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. |
| 25727123 | Background | 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. |
| Withdrawal by Subject |
|
| Moved |
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| Changed medical home |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 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. |
|
|
| Secondary | 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. | All those completing a 6-month outcomes interview which resulted in a valid HAMD measure | Posted | Mean | Standard Deviation | units on a scale | Six months |
|
|
|
| Secondary | Antiretroviral Medication Adherence | Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor | Includes all individuals who completed a 6-month pill count that could be linked to an earlier (usually, 5-month) pill count, so as to calculate adherence. Some individuals did not complete this data point but still continued in the study and contributed later data. | Posted | Mean | Standard Deviation | Percentage of expected pills | 12 months |
|
|
|
| Secondary | Health Care Costs | Total health care costs over 12 months | All participants were analyzed using all available time points, with multiple imputation used to address missing data. | Posted | Mean | Standard Error | dollars | 12 months |
|
|
|
| Secondary | Appointment Adherence | Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment | All participants with available medical chart data on appointment attendance were analyzed. Some participants did not complete the study but still contributed chart abstraction data. | Posted | Mean | Standard Deviation | Percent of appts that were kept | 12 months |
|
|
|
| Secondary | Number of Participants With Viral Load Below Detection | HIV RNA viral load below the limit of detection at 6 months | All participants with a viral load available at 6 months. Some individuals without a viral load at 6 months still continued in the study and provided later data. | Posted | Number | participants | 6 months |
|
|
|
| Secondary | 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. | All participants who completed a 6-month research interview contributed data to this endpoint. Some participants did not complete the 6-month interview but still continued in the study and contributed later data. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | 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). | All participants completing the 6-month interview and currently on antiretrovirals contributed to this analysis. Some participants did not complete the 6-month interview but still continued in the study and contributed to later data. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | 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). | All participants completing the 12-month interview contributed data to this analysis. Some participants did not complete the 12-month interview but still completed the study and contributed other data. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Safety Endpoint | Psychiatric hospitalizations | Posted | Number | participants | 12 months |
|
|
|
| Secondary | 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 | All participants with at least one depression measure contributed to this analysis. | Posted | Mean | Standard Deviation | days | 12 months |
|
|
|
| 1 |
| 149 |
| 37 |
| 149 |
| EG001 | 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. | 2 | 155 | 37 | 155 |
|
| Psychiatric hospitalization | Psychiatric disorders | Systematic Assessment |
|
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