跳至主要内容
临床试验/NCT02056106
NCT02056106已完成4 期

Task Shifting Model of Depression Treatment to Unleash HIV Public Health Benefits

RAND1 个研究点 分布在 1 个国家目标入组 1,252 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
RAND
入组人数
1,252
试验地点
1
主要终点
Depression diagnostic evaluation

研究概览

简要总结

This study compares two models for implementing antidepressant treatment in 10 HIV clinics in Uganda. Using a cluster randomization, 5 clinics implement a task-shifting, protocolized model, and 5 others rely on clinical acumen. The protocolized model includes (1) routine depression screening at each clinic visit for all adult patients by trained expert patients at triage, (2) training nurses to diagnose depression and prescribe and monitor antidepressant treatment using an algorithm-based protocol, and (3) monthly supervision and monitoring by hired study psychiatrists. The clinical acumen model also includes routine depression screening and ongoing supervision, but it relies on the clinical acumen of trained primary care providers to further evaluate and treat patients who show signs of depression at screening, as opposed to a structured protocol. The primary aim is to test the hypothesis that the nurse-driven protocolized model will result in greater uptake of antidepressant treatment and better quality of depression care outcomes. The study will also test the hypotheses that treatment of depression results in improved HIV treatment adherence, work functioning and consistent condom use.

详细描述

The study evaluates a task-shifting approach to depression treatment that uses an algorithm-based, nurse-driven model for managing antidepressant treatment in 10 Ugandan HIV clinics. The model will include (1) case identification facilitated by routine depression screening at each clinic visit for all patients, (2) training nurses to assist primary care providers in implementing antidepressant treatment by performing the initial evaluation, monitoring symptoms and side effects, and making algorithm-based dose recommendations, and (3) layers of supervision and monitoring by psychiatric specialists to ensure safety and quality of care. This model will be implemented at 5 randomly selected clinics (protocolized arm), while 5 other clinics will be selected to also use routine depression screening but will rely on primary care providers to decide whether to further evaluate and treat depression (clinical acumen arm). At each site, random samples of 150 patients (total n=1500) who have screened positive for possible depression will be followed for 12 months. We will compare the two arms on depression evaluation, uptake of antidepressant treatment, and change in depression (treatment response). We will also examine the relationship between change in depression and key economic and public health outcomes (e.g. work status, condom use, HIV treatment adherence).

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 years or above
  • screens positive for depression (scores > 2 on PHQ-2)
  • medically stable
  • client at the HIV clinic (and hence, HIV positive)

排除标准

  • active acute opportunistic infection
  • about to start HIV antiretroviral therapy or started antiretroviral therapy within past 4 weeks

研究组 & 干预措施

Clinical acumen

Active Comparator

Depression diagnosis and antidepressant treatment provided based on clinical acumen of primary care providers trained to provide depression care.

干预措施: antidepressant therapy (Drug)

Protocolized Arm

Active Comparator

Structured, algorithm-based protocol that guides depression diagnosis and antidepressant treatment

干预措施: antidepressant therapy (Drug)

结局指标

主要结局

Depression diagnostic evaluation

时间窗: baseline, Month 6, Month 12

Whether or not the Patient Health Questionnaire (PHQ-9) was administered to assess severity of depression

Antidepressant prescription

时间窗: baseline, Month 6, Month 12

Whether or not antidepressants were prescribed; this variable will be analyzed among the subset of patients categorized as depressed based on PHQ-9 \> 9

Depressive symptoms

时间窗: past 2 weeks at Month 6 and Month 12

depressive symptoms present at Month 6 and Month 12 (in comparison to baseline) to assess treatment response; PHQ-9 will be used to measure depressive symptoms

次要结局

  • Consistent condom use(past 6 months prior to baseline, Month 6, Month 12)
  • ART adherence(past month prior to baseline, Month 6 and Month 12)

研究者

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

Glenn Wagner

Senior Behavioral Scientist

RAND

研究点 (1)

Loading locations...

相似试验