Evaluation of the Revised Versus Original Ryan White Part A HIV Care Coordination Program in a Cluster-Randomized, Stepped-Wedge Trial.
Evaluation of the Revised Versus Original Ryan White Part A HIV Care Coordination Program in a Cluster-Randomized, Stepped-Wedge Trial.
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DOI：
10.1097/qai.0000000000003139
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发表时间：
2023-04-01
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补充数字内容可在正文中找到。为了应对提供循证艾滋病毒护理协调计划(CCP)的挑战，纽约市卫生局启动了CCP的重新设计。我们进行了现场随机阶梯楔形试验，以评估修订后的模型与原始模型的有效性。CCP在纽约市的医院、社区卫生中心和社区组织中提供给艾滋病毒结局不佳或有不良结果风险的人。结果，及时病毒抑制(TVS)被定义为在未抑制病毒载量(≥200拷贝/毫升)的参与者中，在4个月内达到病毒载量200拷贝/毫升。17家原始CCP提供商机构在配对中被随机分配到修订模型实施的早期(2018年8月)或推迟(2019年5月)开始实施。检查了3个时期的数据，以比较修订后的CCP和原始CCP对电视的影响。对干预效果的初步分析采用了完全条件最大似然估计、精确的条件P值和精确的基于检验的95%可信区间。我们给每个试验参与者分配了他们网站的实施水平(基于三个组成部分的衡量标准)，并测试了与电视的关联性，并根据时段和学习臂进行了调整。在3个9个月的时间里，960人有资格参加试验纳入(意向治疗)。TVS与非TVS的优势比为0.88(95%CI：0.45，1.7)。因此，修订后的计划产生的TV略低，尽管其影响在统计学上并不显著。TVS与修订后的CCP实施水平无显著相关。无论实施程度如何，计划修订都不会增加电视转播率。
Supplemental Digital Content is Available in the Text. To address challenges with delivery of an evidence-based HIV care coordination program (CCP), the New York City Health Department initiated a CCP redesign. We conducted a site-randomized stepped-wedge trial to evaluate effectiveness of the revised versus the original model. The CCP is delivered in New York City hospitals, community health centers, and community-based organizations to people experiencing or at risk for poor HIV outcomes. The outcome, timely viral suppression (TVS), was defined as achievement of viral load <200 copies/mL within 4 months among enrollees with unsuppressed viral load (≥200 copies/mL). Seventeen original-CCP provider agencies were randomized within matched pairs to early (August 2018) or delayed (May 2019) starts of revised-model implementation. Data from 3 periods were examined to compare revised versus original CCP effects on TVS. The primary analysis of the intervention effect applied fully conditional maximum likelihood estimation together with an exact, conditional P-value and an exact test-based 95% CI. We assigned each trial enrollee the implementation level of their site (based on a three-component measure) and tested for association with TVS, adjusting for period and study arm. Over 3 nine-month periods, 960 individuals were eligible for trial inclusion (intention to treat). The odds ratio of TVS versus no TVS comparing revised with original CCP was 0.88 (95% CI: 0.45, 1.7). Thus, the revised program yielded slightly lower TVS, although the effect was statistically nonsignificant. TVS was not significantly associated with revised-CCP implementation level. Program revisions did not increase TVS, irrespective of the implementation level.