Measurement-based Care for Depression in Resource-Poor Settings

NCT ID: NCT02916238

Last Updated: 2016-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-11-30

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.

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.

Conditions

Major Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fluoxetine

Intervention Type: DRUG

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.

Enhanced Usual Care

Depression symptoms monitored at 3 month interval; results from PHQ-9 available to ART clinic physicians.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: BEHAVIORAL

Depression symptoms monitored at 3 month intervals; results from PHQ-9 available to ART clinic physicians.

Interventions

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.

Intervention Type: DRUG

Enhanced Usual Care

Depression symptoms monitored at 3 month intervals; results from PHQ-9 available to ART clinic physicians.

Intervention Type: BEHAVIORAL

Other Intervention Names

Prozac

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

jessy g devieux

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessy G. Dévieux, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Locations

GHESKIO Centers

Port-au-Prince, , Haiti

Countries

Haiti

Other Identifiers

FIU101503WIRB20132233

Identifier Type: -

Identifier Source: org_study_id