Measurement-based Care for Depression in Resource-Poor Settings
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Fluoxetine; Enhanced Usual Care
Intervention type(s): Drug; Behavioral
Intervention description(s): 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.; Depression symptoms monitored at 3 month intervals; results from PHQ-9 available to ART clinic physicians.
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment