Acceptability of Sustained-Release Antiretrovirals for Treatment in the US and sub-Saharan Africa

美国和撒哈拉以南非洲地区缓释抗逆转录病毒药物治疗的可接受性

• 批准号: 10214487
• 负责人: Susan Marie Graham
• 金额: $ 54.85万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-17 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10214487
• 关键词: AIDS clinical trial group; AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adherence; Africa South of the Sahara; Age; Antiviral Agents; Behavioral; Benchmarking; Characteristics; Clinic; Clinical; Clinical Trials Cooperative Group; Clinical Trials Unit; Collaborations; Comprehension; Computers; Consult; Consultations; Country; Data; Development; Diagnosis; Dose; Effectiveness; Epidemic; Epidemiologist; Ethnic Origin; Formulation; Frequencies; Goals; HIV; Health; Hospitals; Individual; Injectable; Injections; International; Interview; Kenya; Learning; Modeling; National Institute of Allergy and Infectious Disease; Oral; Pain; Participant; Patient Preferences; Patient Recruitments; Patients; Performance; Persons; Physicians; Policy Maker; Public Health; Race; Reaction; Recording of previous events; Regimen; Research; Research Personnel; Research Training; Resources; Sampling; Scientist; Site; Social Behavior; Sustainable Development; Tablets; Testing; Training Programs; Treatment outcome; United States; Universities; Viral; Viral Load result; Washington; Work; antiretroviral therapy; base; clinical research site; design; experience; experimental study; improved; individual patient; informant; innovation; instrument; multidisciplinary; novel; pandemic disease; patient population; pill; preference; product development; recruit; response; service delivery; sex; side effect; therapy adherence; uptake; AIDS clinical trial group; AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adherence; Africa South of the Sahara; Age; Antiviral Agents; Behavioral; Benchmarking; Characteristics; Clinic; Clinical; Clinical Trials Cooperative Group; Clinical Trials Unit; Collaborations; Comprehension; Computers; Consult; Consultations; Country; Data; Development; Diagnosis; Dose; Effectiveness; Epidemic; Epidemiologist; Ethnic Origin; Formulation; Frequencies; Goals; HIV; Health; Hospitals; Individual; Injectable; Injections; International; Interview; Kenya; Learning; Modeling; National Institute of Allergy and Infectious Disease; Oral; Pain; Participant; Patient Preferences; Patient Recruitments; Patients; Performance; Persons; Physicians; Policy Maker; Public Health; Race; Reaction; Recording of previous events; Regimen; Research; Research Personnel; Research Training; Resources; Sampling; Scientist; Site; Social Behavior; Sustainable Development; Tablets; Testing; Training Programs; Treatment outcome; United States; Universities; Viral; Viral Load result; Washington; Work; antiretroviral therapy; base; clinical research site; design; experience; experimental study; improved; individual patient; informant; innovation; instrument; multidisciplinary; novel; pandemic disease; patient population; pill; preference; product development; recruit; response; service delivery; sex; side effect; therapy adherence; uptake

Project Summary In 2017, UNAIDS estimated that 23% of diagnosed persons living with HIV (PLWH) were not accessing antiretroviral therapy (ART), and 18% of PLWH taking ART had unsuppressed viral loads. The development of sustained-release or long-acting injectable antiretroviral therapy (LAI ART) is an important technological advance that could increase ART uptake and adherence by providing new options to support viral load suppression. Research is urgently needed to understand factors that will drive end-user acceptability, so that developers can iteratively formulate more desirable products and funders can identify and prioritize the products most likely to have high uptake and sustained use. This proposal has the following aims: (1) To design and pilot test a discrete choice experiment (DCE) to identify product and delivery attributes related to LAI ART acceptability among patients in the United States (US), based on our prior work and key informant interviews; (2) To recruit 200 ART naïve-individuals and 500 ART-experienced individuals in Seattle and Atlanta for a DCE to estimate LAI ART product preferences and identify patient characteristics associated with acceptability among these two key potential end-user groups; and (3) To design and pilot test a similar DCE instrument for use in Kenya, then recruit 200 ART naïve-individuals and 500 ART-experienced individuals in Nairobi to learn about patient preferences in the region most impacted by the HIV epidemic. Innovations in the proposed research include a focus on novel LAI ART products in development, inclusion of two patient perspectives (i.e., those just starting treatment and those considering a switch), and exploration of how individual characteristics including prior ART adherence and treatment outcomes influence patient preferences. Our multidisciplinary team includes clinical researchers, behavioral scientists, and health economists with expertise in DCE design and modeling from the University of Washington (UW), RTI International, and Emory University in the US, and from Kenyatta National Hospital in Kenya. The proposed work will take place at two AIDS Clinical Trials Group clinical research sites in the US (i.e., the UW AIDS Clinical Trials Unit in Seattle and the Ponce de Leon Center in Atlanta), and at two HIV clinics within Kenyatta National Hospital in Nairobi, which has been a site for collaborative research with the UW’s Kenya Research and Training Program for over 25 years. Supported by preliminary studies conducted as part of an ongoing UM1 project to develop LAI ART (AI120176, Ho/Collier, NIAID Targeted Long-Acting Combination Antiretroviral Therapy), the proposed work will advance LAI ART product development efforts by providing key estimates of acceptability and patient preferences, enabling funders, product developers, and policy makers to optimize products for the greatest likelihood of uptake, adherence, and long-term viral suppression.

项目摘要 2017年，UNAID估计有23％的艾滋病毒（PLWH）的被诊断患者无法访问 抗逆转录病毒疗法（ART）和18％的PLWH服用ART具有未抑制的病毒载量。发展的发展 持续释放或长效注射抗逆转录病毒疗法（LAI ART）是重要的技术 通过提供新的选择来支持病毒负荷，可以增加艺术吸收和遵守的进步 抑制。迫切需要进行研究以了解将推动最终用户可接受性的因素，以便 开发人员可以迭代地制定更多理想的产品，而资金可以识别和优先考虑 最有可能具有高吸收和持续使用的产品。该提议具有以下目的：（1） 设计和试点测试一个离散选择实验（DCE），以识别与 根据我们先前的工作和关键线人，美国患者（美国）的LAI艺术可接受性 访谈； （2）在西雅图招募200名幼稚的人和500名艺术经验的人 亚特兰大进行DCE，以估算LAI艺术产品的偏好并确定与患者特征有关 这两个关键的最终用户群体之间的可接受性； （3）设计和飞行员测试类似的DCE 在肯尼亚使用的仪器，然后招募200名幼稚的个人和500名艺术经验的人 内罗毕了解该地区的患者偏好受HIV流行影响最大。创新 拟议的研究包括关注开发中的新型LAI艺术产品，包括两名患者 观点（即刚开始治疗的观点和考虑转换的人），并探索如何 个人特征在内，包括先前的艺术依从性和治疗结果会影响患者的偏好。 我们的多学科团队包括临床研究人员，行为科学家和健康经济学 华盛顿大学（UW），RTI International和Emory的DCE设计和建模方面的专业知识 美国的大学以及肯尼亚国家医院的肯尼亚大学。拟议的工作将在两个 AIDS临床试验组在美国的临床研究站点（即，UW AIDS AIDS临床试验单元在西雅图和 亚特兰大的Ponce de Leon中心，在内罗毕的Kenyatta国家医院的两个HIV诊所 一直是与UW的肯尼亚研究与培训计划合作研究的网站，超过25 年。在开发LAI艺术的持续的UM1项目的一部分的初步研究的支持下 （AI120176，HO/Collier，NIAID靶向长效组合抗逆转录病毒疗法），拟议的工作 将通过提供可接受性和患者的关键估计来推动LAI艺术产品开发工作 偏好，使资金，产品开发人员和政策制定者能够为最大的产品优化产品 摄取，依从性和长期病毒抑制的可能性。