Implementing Depression and Adherence Treatment in South Africa HIV Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Reach of depression treatment
研究概览
简要总结
The goal of this clinical trial is to compare a core set and enhanced set of implementation strategies in increasing the reach of evidence-based treatments to patients with HIV and depression. The main questions it aims to answer are:
What proportion of patients start an evidence-based treatment for depression (reach)? What percentage of patients show clinical improvement in depression and what percentage attain viral undetectability within one year (effectiveness)?
Researchers will compare high and low reach clinics to further inform tailored implementation strategies for uptake and maintenance.
Clinics will be randomized into one of two study arms: core versus enhanced strategies. In both arms, core strategies will be utilized. Enhanced clinics will also receive more resource-intensive training.
详细描述
Objectives:
Our primary objective is to compare a core set to an enhanced set of implementation strategies for extending the reach of evidence-based treatments for depression to patients with uncontrolled HIV in South Africa (SA) HIV care settings. Using RE-AIM as the implementation outcome framework, the primary outcome is reach, defined as the percent of patients who start an evidence-based treatment for depression (i.e., CBT-AD and/or psychopharmacotherapy).
To further inform optimal implementation strategies, we will also examine possible moderators and mediators of implementation outcomes including the hypothesized mechanisms of the Implementation Research Logic Model (IRLM) (e.g., clinic level variables, self-efficacy, capacity for training, intervention delivery).
Our secondary objectives are effectiveness focused in order to assess differences in patient-level depression and HIV outcomes when using the enhanced versus the core set of strategies.
Study Procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Clinics (the primary "participants"):
- •Clinics are eligible if they provide HIV primary care via the City of Cape Town (CoCT) Department of Health
- •Clinics will be assigned to the study upon notice of funding and before start up.
- •Inclusion Criteria for Patient-level Outcomes:
- •Although the unit of randomization is at the clinic level, the study will be looking at adult patient level data at each clinic. All patients engaged in care at one of the 10 primary care/HIV treatment clinics in the study will be included if they:
- •Are 18 years of age or older and
- •Have a detectable HIV viral load (operationalized as the lower limit of detection on the standard test is used at the local clinic), or presumed detectable viral load per clinic standards
- •Screen in for depression via the PHQ (following detection standards set in clinics)
排除标准
- •Children below the age of 18 will not be included in the proposed study for adults.
研究组 & 干预措施
Core
Clinics in this arm will receive strategies that involve capacity building for nurses and education on mental health.
干预措施: Core Implementation Strategies (Other)
Enhanced
Clinics in the enhanced arm will receive core strategies along with enhanced strategies that involve more intensive training on depression treatment.
干预措施: Core Implementation Strategies (Other)
Enhanced
Clinics in the enhanced arm will receive core strategies along with enhanced strategies that involve more intensive training on depression treatment.
干预措施: Enhanced Implementation Strategies (Other)
结局指标
主要结局
Reach of depression treatment
时间窗: 1 year
Proportion of patients who start an evidence-based treatment for depression out of patients identified with positive depression and a detectable viral load
次要结局
- Depression(1 year)
- Viral undetectability(1 year)
研究者
Steven Safren
Professor
University of Miami