An effectiveness-implementation trial protocol to evaluate PrEP initiation among U.S. cisgender women using eHealth tools vs. standard care.
An effectiveness-implementation trial protocol to evaluate PrEP initiation among U.S. cisgender women using eHealth tools vs. standard care.
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DOI：
10.3389/frph.2023.1196392
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发表时间：
2023
影响因子：
--
通讯作者：
Coleman, Jenell S
中科院分区：
文献类型：
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作者：
Izadi, Lillee H;Mmeje, Okeoma;Drabo, Emmanuel F;Perin, Jamie;Martin, Stephen;Coleman, Jenell S
美国(U.S.)结束艾滋病毒流行的倡议旨在减少艾滋病毒高流行地区新的艾滋病毒感染。尽管国家努力降低艾滋病毒发病率，但在美国，顺性妇女仍然占大约五分之一的新艾滋病毒诊断病例。采取暴露前预防(PrEP)是一种有效的艾滋病毒预防战略；然而，在顺性妇女中启动PrEP是次优的，2019年只有10%的符合条件的妇女接受PrEP处方。我们设计了一项试验，以测试增加PrEP启动的干预措施的有效性，同时评估在马里兰州巴尔的摩的七家妇产科(OB/GYN)诊所(两家联邦合格的医疗中心，三家社区卫生中心，两家学术诊所)的实施策略(混合型II试验)。共有42名妇产科提供者将被纳入并随机(1：1：1)进入三个临床试验分支(标准护理、患者水平干预或多水平干预)之一。登记提供者的合格患者将在预约前通过电子健康记录(EHR)的患者门户网站接受性健康调查问卷。调查问卷将被分成三个等级(低、中、高)来评估艾滋病毒风险。低风险患者将只接受艾滋病毒检测，而那些得分中等或高风险的患者将被包括在临床试验中，并被分配到与其提供者相关的临床试验部门。我们的主要结果，PrEP启动的差异，将使用带有Logistic回归的广义线性混合效应模型来分析。我们将根据观察到的军队之间的人口统计学差异调整结果，并检查按患者和提供者的种族和民族分层的PrEP启动。此外，还将对每一种干预进行全面的经济分析。我们假设，以电子方式收集有关敏感性行为的信息，以可理解和可关联的形式向患者和妇产科提供者传达艾滋病毒风险，并部署EHR警报，将增加PrEP启动和艾滋病毒检测。该试验于2022年6月9日在ClinicalTrials.gov(NCT05412433)注册。Https://clinicaltrials.gov/ct2/show/NCT05412433?term=NCT05412433&draw=2&rank=1.
The United States' (U.S.) initiative to End the HIV Epidemic aims to reduce new HIV infections in areas of high HIV prevalence. Despite national efforts to reduce HIV incidence, cisgender women continue to represent approximately one out of every five new HIV diagnoses in the U.S. Taking pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy; however, PrEP initiation among cisgender women is suboptimal, with only 10% of eligible women receiving PrEP prescriptions in 2019. We designed a trial to test the effectiveness of interventions to increase PrEP initiation, while evaluating the implementation strategy (hybrid type II trial) in seven obstetrics and gynecology (OB/GYN) clinics (two federally qualified health centers, three community-based, and two academic) in Baltimore, Maryland. A total of 42 OB/GYN providers will be enrolled and randomized (1:1:1) into one of three clinical trial arms (standard of care, patient-level intervention, or multi-level intervention). Eligible patients of enrolled providers will receive a sexual health questionnaire before their appointment through the electronic health record’s (EHR) patient portal. The questionnaire will be scored in three tiers (low, moderate, and high) to assess HIV risk. Patients at low risk will be offered an HIV test only, while those who score medium or high risk will be included in the clinical trial and assigned to the clinical trial arm associated with their provider. Differences in PrEP initiation, our primary outcome, across the three arms will be analyzed using generalized linear mixed-effect models with logistic regression. We will adjust results for demographic differences observed between arms and examine PrEP initiation stratified by patient’s and provider’s race and ethnicity.Additionally, a comprehensive economic analysis for each intervention will be conducted. We hypothesize that gathering information on sensitive sexual behaviors electronically, communicating HIV risk in an understandable and relatable format to patients and OB/GYN providers, and deploying EHR alerts will increase PrEP initiation and HIV testing. The trial is registered with ClinicalTrials.gov (NCT05412433) on 09 June 2022. https://clinicaltrials.gov/ct2/show/NCT05412433?term=NCT05412433&draw=2&rank=1.
DOI：
10.3390/healthcare9111419
发表时间：
2021-10-22
期刊：
Healthcare (Basel, Switzerland)
影响因子：
--
作者：
Sendi P;Matter-Walstra K;Schwenkglenks M
通讯作者：
Schwenkglenks M
影响因子：
15.8
作者：
Holtgrave DR
通讯作者：
Holtgrave DR