PROMISE (Program Refinements to Optimize Model Impact and Scalability based on Evidence): a cluster-randomised, stepped-wedge trial assessing effectiveness of the revised versus original Ryan White Part A HIV Care Coordination Programme for patients with barriers to treatment in the USA
PROMISE (Program Refinements to Optimize Model Impact and Scalability based on Evidence): a cluster-randomised, stepped-wedge trial assessing effectiveness of the revised versus original Ryan White Part A HIV Care Coordination Programme for patients with barriers to treatment in the USA
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DOI：
10.1136/bmjopen-2019-034624
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发表时间：
2020-01-01
期刊：
影响因子：
2.9
通讯作者：
Nash, Denis
中科院分区：
文献类型：
--
作者：
Irvine, Mary K.;Levin, Bruce;Nash, Denis
越来越多的证据支持将社会、行为和生物医学战略结合起来，以加强艾滋病毒护理的连续性。然而，联合干预可能是资源密集型的，而且很难扩大规模。需要进行研究，以确定最大限度地吸收、参与和有效性的干预组成部分和交付模式。在纽约市，2009年在28个机构启动了一项由瑞安·怀特（Ryan White） a部分资助的多部分医疗病例管理干预措施，称为护理协调方案（CCP），以解决护理和治疗方面的障碍。根据2013年4月登记的7000名患者及其对照的有效性估计，CCP在短期和长期病毒抑制方面优于“常规护理”，有很大的改进空间。综合评估结果和CCP服务提供商和社区利益相关者对修改的意见，纽约市卫生局在2017年的提案请求中打包了一个护理协调重新设计（CCR）。经过竞争性重新招标，原来的执行方案机构中有17个获得了合同。这些机构在配对组中随机分组，立即或延迟实施CCR。将检查三个9个月期间（实施前、部分实施和完全实施）的数据，以比较CCR与CCP对新入组CCR/CCP的未抑制HIV病毒载量的个体的及时病毒抑制（TVS，入组4个月内）的影响。基于当前入组人数（n=933）和实施前结果概率（TVS=0.54）， 80%功效的可检测效应量OR为2.75（相对风险：1.41）。本研究由纽约市卫生和精神卫生部门机构审查委员会（IRB，协议18-009）和纽约城市大学综合IRB（协议018-0057）批准，并放弃知情同意。调查结果将通过出版物、会议、利益攸关方会议和咨询委员会与执行机构代表的会议进行传播。
Introduction Growing evidence supports combining social, behavioural and biomedical strategies to strengthen the HIV care continuum. However, combination interventions can be resource-intensive and challenging to scale up. Research is needed to identify intervention components and delivery models that maximise uptake, engagement and effectiveness. In New York City (NYC), a multicomponent Ryan White Part A-funded medical case management intervention called the Care Coordination Programme (CCP) was launched at 28 agencies in 2009 in order to address barriers to care and treatment. Effectiveness estimates based on >7000 clients enrolled by April 2013 and their controls indicated modest CCP benefits over 'usual care' for short-term and long-term viral suppression, with substantial room for improvement.Methods and analysis Integrating evaluation findings and CCP service-provider and community-stakeholder input on modifications, the NYC Health Department packaged a Care Coordination Redesign (CCR) in a 2017 request for proposals. Following competitive re-solicitation, 17 of the original CCP-implementing agencies secured contracts. These agencies were randomised within matched pairs to immediate or delayed CCR implementation. Data from three 9-month periods (pre-implementation, partial implementation and full implementation) will be examined to compare CCR versus CCP effects on timely viral suppression (TVS, within 4 months of enrolment) among individuals with unsuppressed HIV viral load newly enrolling in the CCR/CCP. Based on current enrolment (n=933) and the pre-implementation outcome probability (TVS=0.54), the detectable effect size with 80% power is an OR of 2.75 (relative risk: 1.41).Ethics and dissemination This study was approved by the NYC Department of Health and Mental Hygiene Institutional Review Board (IRB, Protocol 18-009) and the City University of New York Integrated IRB (Protocol 018-0057) with a waiver of informed consent. Findings will be disseminated via publications, conferences, stakeholder meetings, and Advisory Board meetings with implementing agency representatives.