持续质量改进干预措施以改善刚果民主共和国在孕期或哺乳期开始接受抗逆转录病毒治疗的女性的长期治疗效果：一项开放标签、平行组随机试验的设计
Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized trial.
作者信息
Yotebieng Marcel, Behets Frieda, Kawende Bienvenu, Ravelomanana Noro Lantoniaina Rosa, Tabala Martine, Okitolonda Emile W
机构信息
Division of Epidemiology, The Ohio State University, College of Public Health, 304 Cunz Hall, 1841 Neil Avenue, Columbus, OH, 43210, USA.
Department of Epidemiology, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
出版信息
BMC Health Serv Res. 2017 Apr 26;17(1):306. doi: 10.1186/s12913-017-2253-9.
BACKGROUND
Despite the rapid adoption of the World Health Organization's 2013 guidelines, children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health (MCH) clinics. To achieve the UNAIDS goal of eliminating mother-to-child HIV transmission, multiple, adaptive interventions need to be implemented to improve adherence to the HIV continuum.
METHODS
The aim of this open label, parallel, group randomized trial is to evaluate the effectiveness of Continuous Quality Improvement (CQI) interventions implemented at facility and health district levels to improve retention in care and virological suppression through 24 months postpartum among pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic Republic of Congo. Prior to randomization, the current monitoring and evaluation system will be strengthened to enable collection of high quality individual patient-level data necessary for timely indicators production and program outcomes monitoring to inform CQI interventions. Following randomization, in health districts randomized to CQI, quality improvement (QI) teams will be established at the district level and at MCH clinics level. For 18 months, QI teams will be brought together quarterly to identify key bottlenecks in the care delivery system using data from the monitoring system, develop an action plan to address those bottlenecks, and implement the action plan at the level of their district or clinics.
DISCUSSION
If proven to be effective, CQI as designed here, could be scaled up rapidly in resource-scarce settings to accelerate progress towards the goal of an AIDS free generation.
TRIAL REGISTRATION
The protocol was retrospectively registered on February 7, 2017. ClinicalTrials.gov Identifier: NCT03048669 .
背景
尽管世界卫生组织2013年的指南已迅速得到采用，但由于母婴健康（MCH）诊所对艾滋病病毒连续护理的依从性欠佳，儿童仍会在围产期感染艾滋病病毒。为实现联合国艾滋病规划署消除母婴传播艾滋病病毒的目标，需要实施多种适应性干预措施，以提高对艾滋病病毒连续护理的依从性。
方法
这项开放标签、平行、组随机试验的目的是评估在设施和卫生区层面实施的持续质量改进（CQI）干预措施的有效性，以提高刚果民主共和国金沙萨母婴健康诊所中接受抗逆转录病毒治疗的孕妇和哺乳期妇女产后24个月的护理留存率和病毒学抑制率。在随机分组之前，将加强当前的监测和评估系统，以便收集高质量的个体患者层面数据，这些数据对于及时生成指标和监测项目结果以指导CQI干预措施是必要的。随机分组后，在随机分配到CQI的卫生区，将在区一级和母婴健康诊所一级组建质量改进（QI）团队。在18个月内，QI团队将每季度汇聚一次，利用监测系统的数据确定护理提供系统中的关键瓶颈，制定解决这些瓶颈的行动计划，并在其所在区或诊所层面实施该行动计划。
讨论
如果经证明有效，本文设计的CQI可在资源匮乏地区迅速扩大规模，以加速朝着无艾滋病一代的目标取得进展。
试验注册
该方案于2017年2月7日进行回顾性注册。ClinicalTrials.gov标识符：NCT03048669 。
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