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Measurement-based Care for Depression in Resource-Poor Settings (MBC)

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ClinicalTrials.gov Identifier: NCT02916238
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
jessy g devieux, Florida International University

Brief Summary:
Depression is often the most prevalent mental health problem among people living with HIV (PLWH) worldwide, and if not adequately treated, it may impair response to antiretroviral treatment (ART) and the ability of individuals to adhere to medications and healthy behavior. Most patients with depression receiving ART in the poorest countries of the world are left untreated because no systematic approach or expertise is available. This study adapts an evidence-based model of depression care (Measurement-Based Care - MBC) using auxiliary HIV clinic staff, and tests feasibility and assesses costs among HIV positive patients beginning ART in Port-au-Prince, Haiti.

Condition or disease Intervention/treatment Phase
Major Depression Drug: Fluoxetine Behavioral: Enhanced Usual Care Phase 4

Detailed Description:
This developmental and exploratory study develops and tests a scalable model for the diagnosis and treatment of depression among HIV-infected patients initiating antiretroviral therapy (ART) in resource-poor settings. The investigators conduct a pilot test of the measurement-based care (MBC) approach to intervening, task shifting, and managing depression, which was adapted for use with auxiliary personnel who support HIV physicians in algorithm-guided antidepressant treatment. This intervention is based on the MBC approach developed by Pence, and conducted in HIV clinical sites in the US and Africa. The investigators adapted and tested an auxiliary-driven model, MBC-Aux, which is the first study of this approach with auxiliary personnel in a resource- poor country and its ART system. The study was conducted at the GHESKIO Centers in Port-au-Prince, Haiti, which is responsible for 50% of the ART population in Haiti. The investigators conducted a formative study of psychosocial factors related to depression and antidepressant medication in Aim 1, adapted the MBC depression medication and monitoring algorithm for use by auxiliary personnel at GHESKIO in Aim 2 and conducted a pre-test of procedures, and piloted the resulting MBC-Aux adaptation in Aim 3 compared to Enhanced Usual Care. The investigators also evaluated feasibility and cost. Although they are very safe medications, use of antidepressants in MBC-Aux, like use of all pharmacologic agents, incurs some measurable risk of mild, moderate and rare but severe side effects. Risks were explained to participants receiving antidepressant treatment and MBC-Aux includes systematic monitoring of participants taking these medications. This R21 developmental and exploratory study will produce the first systematic formative work of psychosocial factors related to depression in Haiti, and is the first to apply and test the MBC approach with auxiliary personnel.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measurement-based Care for Depression in Resource-Poor Settings
Study Start Date : February 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Experimental: Measurement Based Care
Fluoxetine prescribed and dispensed beginning at 10 mg daily; side effects and symptoms monitored biweekly; dosage increased to 20 mg., then by 20 mg. increments according to protocol algorithm based on PHQ-9 score to a maximum dose of 60 mg.
Drug: Fluoxetine
Fluoxetine prescribed and dispensed beginning at 10 mg daily; side effects and symptoms monitored biweekly; dosage increased to 20 mg., then by 20 mg. increments according to protocol algorithm based on PHQ-9 score to a maximum dose of 60 mg.
Other Name: Prozac

Active Comparator: Enhanced Usual Care
Depression symptoms monitored at 3 month interval; results from PHQ-9 available to ART clinic physicians.
Behavioral: Enhanced Usual Care
Depression symptoms monitored at 3 month intervals; results from PHQ-9 available to ART clinic physicians.




Primary Outcome Measures :
  1. Remission of Depression [ Time Frame: 6 months ]
    PHQ-9 less than 5


Secondary Outcome Measures :
  1. ART adherence - viral suppression [ Time Frame: 6 months ]
    Improvement in Viral Load measurements

  2. ART adherence - immune functioning [ Time Frame: 6 months ]
    Improvement in CD4 measurements

  3. Total treatment cost from the health center perspective [ Time Frame: 6 months ]
    Inform a mental health intervention model for ART networks in low-and-middle income



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (1) >18, but <60 years of age; 2) able to provide informed consent; 3) documentation of HIV seropositivity; 4) ART-naïve scheduled to begin ART within 1 month; 5) total score of 10 or higher on the PHQ-9, indicating likely major depression; 6) confirmed for major depression on the MINI (Mini International Neuropsychiatric Interview);

Exclusion Criteria:

  • (7) currently cognitively impaired, as determined by the MINI, since cognitive impairment may compromise the ability to comprehend and participate in the assessment and intervention; 8) bipolar disorder, psychosis, or current need for inpatient psychiatric hospitalization; 9) currently pregnant or enrolled in the GHESKIO PMTCT (Prevention of mother to child transmission) program.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916238


Locations
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Haiti
GHESKIO Centers
Port-au-Prince, Haiti
Sponsors and Collaborators
Florida International University
Investigators
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Principal Investigator: Jessy G. Dévieux, Ph.D. Florida International University

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Responsible Party: jessy g devieux, Associate Professor, Florida International University
ClinicalTrials.gov Identifier: NCT02916238     History of Changes
Other Study ID Numbers: FIU101503WIRB20132233
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors