Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial.
Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial.
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DOI：
10.1186/s13063-021-05601-1
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发表时间：
2021-09-16
期刊：
影响因子：
2.5
通讯作者：
Wagner G
中科院分区：
文献类型：
--
作者：
McBain RK;Mwale O;Ruderman T;Kayira W;Connolly E;Chalamanda M;Kachimanga C;Khongo BD;Wilson J;Wroe E;Raviola G;Smith S;Coleman S;Kelly K;Houde A;Tebeka MG;Watson S;Kulisewa K;Udedi M;Wagner G
马拉维是撒哈拉以南非洲的一个低收入国家，资源有限，无法应对包括艾滋病毒/艾滋病在内的重大疾病负担。此外，抑郁症是该国残疾的主要原因，但在很大程度上仍未得到诊断和治疗。缺乏经济有效、可扩展的解决方案是扩大抑郁症治疗的根本障碍。在此背景下，一项重大成功是扩大了由700多家艾滋病毒诊所组成的网络，有50多万患者参加了抗逆转录病毒疗法(ART)。作为一个拥有专门人力资源和基础设施的慢性护理系统，这为整合抑郁症护理提供了一个战略平台，并回应了概述抑郁症和艾滋病毒结果的双向的强有力的证据基础。我们将对马拉维Neno区420名患有中度/重度抑郁症的成年人进行分级抑郁症护理模式的评估，该模式结合了基于团体的问题管理+(Group PM+)和抗抑郁药物治疗(ADT)，通过患者健康问卷9(PHQ-9)和迷你国际神经精神病学访谈(MINI)进行衡量。推广将遵循阶梯式楔形群组随机设计，其中14家卫生机构被随机分配，在15个月的时间内分五步实施该模型。主要结果(抑郁症状、功能障碍和总体健康)和次要结果(例如，HIV：病毒载量、抗逆转录病毒治疗依从性；糖尿病：A1C水平、治疗依从性；高血压：收缩压、治疗依从性)将通过12个月的随访每3个月测量一次。我们还将评估该模型的成本效益，量化为与没有干预模型的基线慢性护理服务相比的增量成本效益比(ICER)。这项研究将进行阶梯式楔形整群随机试验，以比较循证抑郁症护理模式与常规护理在抑郁症症状缓解以及慢性护理条件下的身体健康结果方面的效果。如果被确定为具有成本效益，这项研究将提供一个模式，将抑郁症护理纳入马拉维其他地区和其他艾滋病毒流行率较高的低资源地区的艾滋病毒诊所。临床试验.政府NCT04777006.注册日期：2021年3月1日
Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease—including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes. We will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model’s cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model. This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence. ClinicalTrials.govNCT04777006. Registered on 1 March, 2021
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影响因子：
4.5
作者：
Crabb J;Stewart RC;Kokota D;Masson N;Chabunya S;Krishnadas R
通讯作者：
Krishnadas R
影响因子：
3.7
作者：
Gaynes BN;Pence BW;Atashili J;O'Donnell JK;Njamnshi AK;Tabenyang ME;Arrey CK;Whetten R;Whetten K;Ndumbe P
通讯作者：
Ndumbe P
影响因子：
4.6
作者：
Castillo-Mancilla JR;Haberer JE
通讯作者：
Haberer JE
DOI：
10.1097/qai.0000000000000803
发表时间：
2016-01-01
期刊：
Journal of acquired immune deficiency syndromes (1999)
影响因子：
--
作者：
Brown LK;Kennard BD;Emslie GJ;Mayes TL;Whiteley LB;Bethel J;Xu J;Thornton S;Tanney MR;Hawkins LA;Garvie PA;Subramaniam GA;Worrell CJ;Stoff LW;Adolescent Trials Network for HIVAIDS Interventions
通讯作者：
Adolescent Trials Network for HIVAIDS Interventions
影响因子：
7.6
作者：
Betancourt, Theresa S.;McBain, Ryan;Brennan, Robert T.
通讯作者：
Brennan, Robert T.