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Making it last: A randomized, controlled trial of a home care system to promote persistence in PrEP care

让它持久：一项随机对照家庭护理系统试验，以促进 PrEP 护理的持久性

基本信息

批准号：
10191050
负责人：
KENNETH H MAYER
金额：
$ 114.1万
依托单位：
EMORY UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-08-25 至 2023-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10191050
关键词：
AIDS prevention Address Adherence Adult Behavior assessment Behavioral Biological Markers Boston CDC7 gene Caring Centers for Disease Control and Prevention (U.S.)Clinic Cohort Studies Continuity of Patient Care Cost Analysis Cost Savings Counseling Creatinine Diphosphates Dose Drops Effectiveness Effectiveness of Interventions HIV HIV Infections HIV/STD Healthcare Healthcare Systems Home Home visitation Hospitals Hour Intervention Interview Label Laboratories Measurable Measures Mediator of activation protein Medical Methods Minority Monitor Participant Patient Self-Report Patients Persons Pharmaceutical Preparations Population Provider Public Health Randomized Randomized Controlled Trials Research Residual state Risk Risk Reduction Sampling Self Efficacy Self Medication Services Site Subgroup Support System Surveys System Technology Tenofovir Testing Theoretical model Time United States Visit aged arm base black men who have sex with men care systems cohort cost effectiveness cost utility analysis demographics effectiveness trial efficacy trial follow-up high risk high risk men mathematical model men who have sex with men opportunity cost patient home care pill pre-exposure prophylaxis primary outcome recruit sample collection scale up secondary analysis secondary outcome seroconversion standard of care transmission process trial comparing young man

项目摘要

PROJECT SUMMARY/ABSTRACT HIV pre-exposure prophylaxis (PrEP) has been shown in efficacy and effectiveness trials to achieve high levels of protection, with over 95% protection among those with measurable levels of medication that indicate adherence. This provides a substantial public health opportunity, with the US Centers for Disease Control and Prevention (CDC) estimating that approximately 1.2 million US adults are eligible for PrEP, including 492,000 MSM. PrEP prescriptions are growing exponentially, with over 79,000 prescriptions between 2012 and 2015 in the US. Guidance issued by CDC and by WHO calls for quarterly follow-up visits for those on PrEP, to include behavioral and laboratory assessments, and treatment or counseling as needed. Currently, those on PrEP must have in-person visits with their medical provider for such services, a system that places a large burden on both providers and patients. If PrEP were to be scaled up to cover eligible, high-risk MSM in the United States, we estimate over 1.5 million yearly patient visits would be required, a substantial burden on clinics seeking to bring PrEP to scale. A related problem with bringing PrEP to scale is that patients may not persist in PrEP care over time. This is particularly concerning because those patients in demographics with highest risk for HIV acquisition, young and Black MSM, have been observed to be more likely to not persist in PrEP care over time. The proposed research seeks to make PrEP scale-up more feasible and to increase persistence in PrEP care, by developing a home-based monitoring and support system that would alleviate the need for quarterly, in- person provider visits. We propose to conduct a randomized, controlled trial to determine whether participants (half Black, half aged 18-34) randomized to the home care PrEP system have higher levels of retention in PrEP care relative to standard of care control participants, as determined by biomarker and self-report. The trial will be conducted at sites in Atlanta, GA, Boston, MA, Jackson, MS, and St. Louis, MO. We will also conduct a mixed-methods assessment of trial results, and assess the cost-effectiveness of the home care system.

项目概要/摘要 HIV 暴露前预防 (PrEP) 已在疗效和有效性试验中显示可达到高水平的保护，在那些具有可测量药物水平的人中，超过 95% 的保护表明坚持。这提供了巨大的公共卫生机会，美国疾病控制中心和预防 (CDC) 估计大约 120 万美国成年人有资格接受 PrEP，其中 492,000 人男同性恋者。 PrEP 处方呈指数级增长，2012 年至 2015 年间有超过 79,000 个处方美国。 CDC 和 WHO 发布的指南要求对 PrEP 患者进行季度随访，包括行为和实验室评估，以及根据需要进行治疗或咨询。目前，PrEP 患者必须亲自拜访他们的医疗提供者才能获得此类服务，这一系统给他们带来了很大的负担提供者和患者。如果要扩大 PrEP 覆盖范围以覆盖美国符合条件的高风险 MSM，我们估计每年需要超过 150 万名患者就诊，这对寻求医疗服务的诊所来说是一个沉重的负担扩大 PrEP 规模。扩大 PrEP 规模的一个相关问题是患者可能不会坚持接受 PrEP 护理随着时间的推移。这尤其令人担忧，因为人口统计中感染艾滋病毒风险最高的患者据观察，随着时间的推移，年轻和黑人 MSM 的感染者更有可能不会坚持 PrEP 护理。拟议的研究旨在使 PrEP 扩大规模更加可行，并提高 PrEP 护理的持久性，通过开发一个基于家庭的监测和支持系统，该系统将减轻对季度、内部监测的需求人员提供者拜访。我们建议进行一项随机对照试验，以确定参与者是否（一半黑人，一半年龄 18-34 岁）随机分配到家庭护理 PrEP 系统，其保留率较高 PrEP 护理相对于护理对照参与者的标准，由生物标志物和自我报告确定。这试验将在佐治亚州亚特兰大、马萨诸塞州波士顿、密西西比州杰克逊和密苏里州圣路易斯进行。我们还将对试验结果进行混合方法评估，并评估家庭护理的成本效益系统。

项目成果

期刊论文数量（25）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Law Everywhere: A Causal Framework for Law and Infectious Disease.

无处不在的法律：法律与传染病的因果框架。

DOI：
10.1177/0033354920912991
发表时间：
2020
期刊：
Public health reports (Washington, D.C. : 1974)
影响因子：
0
作者：
Siegler,AaronJ;Komro,KelliA;Wagenaar,AlexanderC
通讯作者：
Wagenaar,AlexanderC

Assessing the performance of international pre-exposure prophylaxis (PrEP) eligibility guidelines in a cohort of Chinese MSM, Beijing, China 2009 to 2016.

DOI：
10.1002/jia2.25653
发表时间：
2020-12
期刊：
Journal of the International AIDS Society
影响因子：
6
作者：
Hall EW;Wang L;Huang X;Sullivan PS;Siegler AJ
通讯作者：
Siegler AJ

PrEParing for long-acting injectable PrEP in the South: perspectives from healthcare providers in Georgia.

DOI：
10.1080/09540121.2020.1810616
发表时间：
2021-06
期刊：
AIDS care
影响因子：
1.7
作者：
Xavier Hall CD;Smith JC;Driggers RA;Stoller B;Khan Z;Li J;Ignatius EH;Siegler AJ
通讯作者：
Siegler AJ

The PrEP Laboratory Service Gap: Applying Implementation Science Strategies to Bring PrEP Coverage to Scale in the United States.