Neuroinflammation and Modulating Factors in Depression and HIV

Study Overview
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Brief Summary
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Determine if depression, which persists after depression treatment at 26 weeks, is associated with increased innate inflammation in a prospective cohort of HIV-infected Ugandans receiving SSRIs in which group psychotherapy is initiated.

Detailed Description
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Depression in HIV is a complex co-morbidity with both social factors such as stigma as well as biologic components. Disruptions in neurotransmitters such as serotonin and catecholamines are known to cause depression. Inflammation caused by diseases such as stroke, diabetes, and HIV is associated with higher rates of depression. HIV causes inflammation throughout the body, but since the virus can cross the blood-brain-barrier, HIV can replicate in and target the brain causing neuroinflammation which predisposes depression. However the pathophysiology of the role of inflammation in comorbid depression and HIV is poorly understood. Among depressed HIV-infected Ugandans, determine if the resolution of depression at 26 weeks of HIV therapy is improved with group psychotherapy. In the same population determine if persistent depression is associated with higher levels of innate inflammation. Also, compare baseline and follow up inflammation among depressed compared to non-depressed control group. Evaluate if viral suppression levels at 26 weeks are improved by group psychotherapy.

Official Title
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Neuroinflammation and Modulating Factors in Depression and HIV: The Growth Study-Group Therapy in HIV for Depression IN Uganda

Conditions
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HIV, Depression

Intervention / Treatment
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* Behavioral: Group Pyschotherapy
* Other: Depression Standard of Care
* Other: HIV Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the depressed patient arm, Newly-presenting clinic patients (<3 months) Mild to Moderately-Severe Depressive Symptoms with PHQ-9 score >5 but <20 Not suicidal (PHQ-9 question 9 score >2) Not receiving antiretroviral therapy (ART) at screening Outpatient, not requiring hospitalization For the non-depressed patient arm, Newly-presenting clinic patients (<3 months) Not suicidal (PHQ-9 question 9 score >2) Not receiving antiretroviral therapy (ART) at screening Outpatient, not requiring hospitalization Exclusion Criteria: - No additional exclusion criteria

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>The first 100 participants with HIV and depression will receive standard of care including SSRI therapy. | Other: Depression Standard of Care<br>* Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).<br>Other: HIV Standard of Care<br>* Standard clinical care for HIV<br>|
| Experimental: Standard of Care + Group Support Psychotherapy<br>The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy. | Behavioral: Group Pyschotherapy<br>* Group psychotherapy<br>Other: Depression Standard of Care<br>* Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).<br>Other: HIV Standard of Care<br>* Standard clinical care for HIV<br>|
| Active Comparator: Standard of Care (Non-Depressed)<br>100 participants with HIV and without depression will receive standard of care therapy for HIV and no depression treatment. | Other: HIV Standard of Care<br>* Standard clinical care for HIV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire (PHQ)-9 | The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. | Baseline, 26 weeks | 
| Change in Plasma Interleukin (IL)-6 Concentration | Plasma concentration of IL-6 will be measured using Luminex magnetic bead technology and reported in ng/ml. | Baseline, 26 weeks | 
| Change in Morning Plasma Cortisol Concentration | Plasma cortisol concentration will be measured with enzyme-linked immunosorbant assay (ELISA) and reported in ng/ml. | Baseline, 26 weeks |