跳至主要内容
临床试验/NCT02916238
NCT02916238已完成4 期

Measurement-based Care for Depression in Resource-Poor Settings

Florida International University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
140
试验地点
1
主要终点
Remission of Depression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (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);

排除标准

  • (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.

研究组 & 干预措施

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.

干预措施: Fluoxetine (Drug)

Enhanced Usual Care

Active Comparator

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

干预措施: Enhanced Usual Care (Behavioral)

结局指标

主要结局

Remission of Depression

时间窗: 6 months

PHQ-9 less than 5

次要结局

  • ART adherence - immune functioning(6 months)
  • ART adherence - viral suppression(6 months)
  • Total treatment cost from the health center perspective(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

jessy g devieux

Associate Professor

Florida International University

研究点 (1)

Loading locations...

相似试验