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: 10678651
• 负责人: Susan Marie Graham
• 金额: $ 36.74万
• 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/10678651
• 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; Experimental Designs; Experimental Models; Formulation; Frequencies; Goals; HIV; Health; Hospitals; Individual; Injectable; Injections; International; Interview; Kenya; Learning; 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; Resources; Sampling; Scientist; Site; Social Behavior; Tablets; Technology; Testing; Training Programs; Treatment outcome; United States; Universities; Viral; Viral Load result; Washington; Work; antiretroviral therapy; clinical research site; design; experience; experimental study; improved; individual patient; informant; innovation; instrument; multidisciplinary; novel; pandemic disease; patient population; pill; pilot test; 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，联合国艾滋病规划署估计，23%的确诊艾滋病毒感染者（PLWH）没有获得 抗逆转录病毒治疗（ART），18%的PLWH服用ART有未抑制的病毒载量。的发展 持续释放或长效注射抗逆转录病毒治疗（LAIART）是一种重要的技术， 通过提供支持病毒载量的新选择，可以增加ART的吸收和依从性 镇压迫切需要进行研究，以了解推动最终用户接受的因素， 开发人员可以迭代地制定更理想的产品，资助者可以识别并优先考虑 最有可能高吸收和持续使用的产品。这项建议的目的如下：（1） 设计和试点测试离散选择实验（DCE），以确定产品和交付属性相关的 根据我们之前的工作和关键知情人，美国（US）患者对LAI ART的可接受性 （2）在西雅图招募200名ART初治者和500名ART经验者， Atlanta的DCE，以估计LAI ART产品偏好并识别与以下相关的患者特征： 这两个主要潜在最终用户群体之间的可接受性;以及（3）设计和试点测试类似的DCE 然后在肯尼亚招募200名未接受过抗逆转录病毒治疗个体和500名有抗逆转录病毒治疗经验的个体， 内罗毕，了解受艾滋病毒流行影响最严重的地区的患者偏好。的创新 拟议的研究包括关注开发中的新型LAI ART产品，包括两名患者 视角（即，那些刚刚开始治疗和那些考虑转换），并探索如何 个体特征，包括先前的ART依从性和治疗结果，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家， 来自华盛顿大学（UW）、RTI International和Emory的DCE设计和建模专业知识 美国的肯雅塔大学和肯尼亚的肯雅塔国立医院。拟议的工作将在两个 艾滋病临床试验组在美国的临床研究地点（即，位于西雅图的华盛顿大学艾滋病临床试验中心， 亚特兰大的庞塞德莱昂中心）和内罗毕肯雅塔国家医院内的两个艾滋病毒诊所， 一直是一个网站的合作研究与华盛顿大学的肯尼亚研究和培训计划超过25 年作为正在进行的开发LAI ART的UM 1项目的一部分进行的初步研究的支持 （AI 120176，Ho/Collier，NIAID靶向长效联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， 优惠，使资助者，产品开发商和政策制定者能够优化产品， 摄取、依从和长期病毒抑制的可能性。