NCT02916238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

September 24, 2016

Last Update Submit

November 29, 2016

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

  • Remission of Depression

    PHQ-9 less than 5

    6 months

Secondary Outcomes (3)

  • ART adherence - viral suppression

    6 months

  • ART adherence - immune functioning

    6 months

  • Total treatment cost from the health center perspective

    6 months

Study Arms (2)

Measurement Based Care

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Usual Care

Interventions

FluoxetineDRUG

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.

Also known as: Prozac
Measurement Based Care
Enhanced Usual CareBEHAVIORAL

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

Enhanced Usual Care

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (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);

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GHESKIO Centers

Port-au-Prince, Haiti

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Jessy G. Dévieux, Ph.D.

    Florida International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 24, 2016

First Posted

September 27, 2016

Study Start

February 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 1, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Locations

HA(1)