- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02916238
Measurement-based Care for Depression in Resource-Poor Settings (MBC)
November 29, 2016 updated by: jessy g devieux, Florida International University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Port-au-Prince, Haiti
- GHESKIO Centers
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
ACTIVE_COMPARATOR: Enhanced Usual Care
Depression symptoms monitored at 3 month interval; results from PHQ-9 available to ART clinic physicians.
|
Depression symptoms monitored at 3 month intervals; results from PHQ-9 available to ART clinic physicians.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remission of Depression
Time Frame: 6 months
|
PHQ-9 less than 5
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ART adherence - viral suppression
Time Frame: 6 months
|
Improvement in Viral Load measurements
|
6 months
|
ART adherence - immune functioning
Time Frame: 6 months
|
Improvement in CD4 measurements
|
6 months
|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (ACTUAL)
November 1, 2016
Study Completion (ACTUAL)
November 1, 2016
Study Registration Dates
First Submitted
September 24, 2016
First Submitted That Met QC Criteria
September 25, 2016
First Posted (ESTIMATE)
September 27, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
December 1, 2016
Last Update Submitted That Met QC Criteria
November 29, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- FIU101503WIRB20132233
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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