Comparative Trial of Antidepressant Treatment Models in HIV Care in Uganda

Study Overview
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Brief Summary
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This study compares two models for implementing antidepressant treatment in 10 HIV clinics in Uganda. Using a cluster randomization, 5 clinics implement a task-shifting, protocolized model, and 5 others rely on clinical acumen. The protocolized model includes (1) routine depression screening at each clinic visit for all adult patients by trained expert patients at triage, (2) training nurses to diagnose depression and prescribe and monitor antidepressant treatment using an algorithm-based protocol, and (3) monthly supervision and monitoring by hired study psychiatrists. The clinical acumen model also includes routine depression screening and ongoing supervision, but it relies on the clinical acumen of trained primary care providers to further evaluate and treat patients who show signs of depression at screening, as opposed to a structured protocol. The primary aim is to test the hypothesis that the nurse-driven protocolized model will result in greater uptake of antidepressant treatment and better quality of depression care outcomes. The study will also test the hypotheses that treatment of depression results in improved HIV treatment adherence, work functioning and consistent condom use.

Detailed Description
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The study evaluates a task-shifting approach to depression treatment that uses an algorithm-based, nurse-driven model for managing antidepressant treatment in 10 Ugandan HIV clinics. The model will include (1) case identification facilitated by routine depression screening at each clinic visit for all patients, (2) training nurses to assist primary care providers in implementing antidepressant treatment by performing the initial evaluation, monitoring symptoms and side effects, and making algorithm-based dose recommendations, and (3) layers of supervision and monitoring by psychiatric specialists to ensure safety and quality of care. This model will be implemented at 5 randomly selected clinics (protocolized arm), while 5 other clinics will be selected to also use routine depression screening but will rely on primary care providers to decide whether to further evaluate and treat depression (clinical acumen arm). At each site, random samples of 150 patients (total n=1500) who have screened positive for possible depression will be followed for 12 months. We will compare the two arms on depression evaluation, uptake of antidepressant treatment, and change in depression (treatment response). We will also examine the relationship between change in depression and key economic and public health outcomes (e.g. work status, condom use, HIV treatment adherence).

Official Title
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Task Shifting Model of Depression Treatment to Unleash HIV Public Health Benefits

Conditions
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Depression

Intervention / Treatment
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* Drug: antidepressant therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or above screens positive for depression (scores > 2 on PHQ-2) medically stable client at the HIV clinic (and hence, HIV positive) Exclusion Criteria: active acute opportunistic infection about to start HIV antiretroviral therapy or started antiretroviral therapy within past 4 weeks

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 |
| --- | --- |
| Active Comparator: Clinical acumen<br>Depression diagnosis and antidepressant treatment provided based on clinical acumen of primary care providers trained to provide depression care. | Drug: antidepressant therapy<br> <br> |
| Active Comparator: Protocolized Arm<br>Structured, algorithm-based protocol that guides depression diagnosis and antidepressant treatment | Drug: antidepressant therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression diagnostic evaluation | Whether or not the Patient Health Questionnaire (PHQ-9) was administered to assess severity of depression | baseline, Month 6, Month 12 | 
| Antidepressant prescription | Whether or not antidepressants were prescribed; this variable will be analyzed among the subset of patients categorized as depressed based on PHQ-9 > 9 | baseline, Month 6, Month 12 | 
| Depressive symptoms | depressive symptoms present at Month 6 and Month 12 (in comparison to baseline) to assess treatment response; PHQ-9 will be used to measure depressive symptoms | past 2 weeks at Month 6 and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistent condom use | A single likert scale item will be used to assess condom use in the past month; a single item will also be used to assess whether condom was used during last event of sexual intercourse | past 6 months prior to baseline, Month 6, Month 12 | 
| ART adherence | single variable to rate adherence to ART over the past month on scale of 0-100 | past month prior to baseline, Month 6 and Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, Uganda, HIV, task-shifting, condom use, adherence