Depression, HIV
Conditions
Keywords
Depression, HIV, Adherence, Collaborative care, Measurement-Based Care
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.
Interventions
OTHERMeasurement-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
OTHEREnhanced Usual Care
Sponsors
National Institute of Mental Health (NIMH)
University of North Carolina, Chapel Hill
University of Alabama at Birmingham
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral Medication Adherence | Six months post-enrollment | Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral Medication Adherence | 12 months | Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor |
| 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 |
| 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. |
| 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). |
| 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). |
| Safety Endpoint | 12 months | Psychiatric hospitalizations |
| 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 |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 149 |
| 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. | 155 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Changed medical home | 2 | 0 |
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Moved | 3 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 7 |
Baseline characteristics
| Characteristic | Collaborative Depression Care | Total | Enhanced Usual Care |
|---|---|---|---|
| Age, Continuous | 42.8 years STANDARD_DEVIATION 10.3 | 43.9 years STANDARD_DEVIATION 10.1 | 44.9 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 13 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 140 Participants | 291 Participants | 151 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 86 Participants | 193 Participants | 107 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 58 Participants | 101 Participants | 43 Participants |
| Region of Enrollment United States | 149 participants | 304 participants | 155 participants |
| Sex/Gender, Customized Female | 35 participants | 87 participants | 52 participants |
| Sex/Gender, Customized Male | 112 participants | 212 participants | 100 participants |
| Sex/Gender, Customized Transgender | 2 participants | 5 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 149 | 37 / 155 |
| serious Total, serious adverse events | 1 / 149 | 2 / 155 |
Outcome results
Primary
Antiretroviral Medication Adherence
Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor
Time frame: Six months post-enrollment
Population: All those completing a 6-month pill count which resulted in a valid adherence measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Depression Care | Antiretroviral Medication Adherence | 89.2 observed pills taken as % of expected | Standard Deviation 21.8 |
| Enhanced Usual Care | Antiretroviral Medication Adherence | 87.6 observed pills taken as % of expected | Standard Deviation 22.9 |
Secondary
Antiretroviral Medication Adherence
Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Depression Care | Antiretroviral Medication Adherence | 86.3 Percentage of expected pills | Standard Deviation 22.5 |
| Enhanced Usual Care | Antiretroviral Medication Adherence | 94.5 Percentage of expected pills | Standard Deviation 12.4 |
Secondary
Appointment Adherence
Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Depression Care | Appointment Adherence | 81.3 Percent of appts that were kept | Standard Deviation 23.9 |
| Enhanced Usual Care | Appointment Adherence | 80.1 Percent of appts that were kept | Standard Deviation 26.1 |
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
Time frame: 12 months
Population: All participants with at least one depression measure contributed to this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Depression Care | Depression-free Days | 160 days | Standard Deviation 9.9 |
| Enhanced Usual Care | Depression-free Days | 136 days | Standard Deviation 9.3 |
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.
Time frame: Six months
Population: All those completing a 6-month outcomes interview which resulted in a valid HAMD measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Depression Care | Depressive Symptoms | 13.5 units on a scale | Standard Deviation 7.6 |
| Enhanced Usual Care | Depressive Symptoms | 17.2 units on a scale | Standard Deviation 8.5 |
Secondary
Health Care Costs
Total health care costs over 12 months
Time frame: 12 months
Population: All participants were analyzed using all available time points, with multiple imputation used to address missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Depression Care | Health Care Costs | 4611 dollars | Standard Error 151 |
| Enhanced Usual Care | Health Care Costs | 4535 dollars | Standard Error 148 |
Secondary
Number of Participants With Viral Load Below Detection
HIV RNA viral load below the limit of detection at 6 months
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Collaborative Depression Care | Number of Participants With Viral Load Below Detection | 68 participants |
| Enhanced Usual Care | Number of Participants With Viral Load Below Detection | 75 participants |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Depression Care | Quality of Life | 41.6 units on a scale | Standard Deviation 12.4 |
| Enhanced Usual Care | Quality of Life | 37.6 units on a scale | Standard Deviation 12.6 |
Secondary
Safety Endpoint
Psychiatric hospitalizations
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Collaborative Depression Care | Safety Endpoint | 2 participants |
| Enhanced Usual Care | Safety Endpoint | 4 participants |
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).
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Depression Care | Self-reported Adherence | 91.6 units on a scale | Standard Deviation 16.4 |
| Enhanced Usual Care | Self-reported Adherence | 94.1 units on a scale | Standard Deviation 14.7 |
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).
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Depression Care | Self Reported Adherence | 92.7 units on a scale | Standard Deviation 12.3 |
| Enhanced Usual Care | Self Reported Adherence | 93.9 units on a scale | Standard Deviation 15 |