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Measurement-based Care for Depression in Resource-Poor Settings

NCT02916238 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2016-12-01

No results posted yet for this study

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.

Conditions

Interventions

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.

BEHAVIORAL

Enhanced Usual Care

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

Sponsors & Collaborators

  • Florida International University

    lead OTHER

Principal Investigators

  • Jessy G. Dévieux, Ph.D. · Florida International University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Haiti

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02916238 on ClinicalTrials.gov