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

基本信息

批准号：
10020441
负责人：
Susan Marie Graham
金额：
$ 44.18万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
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/10020441
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

项目摘要

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.

项目概要 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) 无法获得抗逆转录病毒治疗 (ART)，接受 ART 的 18% 的感染者病毒载量未受到抑制。缓释或长效注射抗逆转录病毒疗法（LAI ART）是一项重要的技术通过提供支持病毒载量的新选择，可以提高 ART 的采用和依从性迫切需要研究来了解推动最终用户接受度的因素，以便开发人员可以迭代地制定更理想的产品，资助者可以确定并优先考虑最有可能获得高吸收率和持续使用的产品本提案的目标如下： (1) 设计并试点测试离散选择实验 (DCE)，以确定与以下内容相关的产品和交付属性根据我们之前的工作和主要信息提供者，美国 (US) 患者对 LAI ART 的接受度 (2) 在西雅图招募 200 名 ART 新手和 500 名有 ART 经验的人员亚特兰大 DCE 评估 LAI ART 产品偏好并确定与以下相关的患者特征这两个关键潜在最终用户群体的可接受性；以及 (3) 设计并试点测试类似的 DCE 工具在肯尼亚使用，然后招募 200 名 ART 新手和 500 名 ART 经验丰富的人员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。拟议的研究包括重点开发新型 LAI ART 产品，纳入两名患者观点（即那些刚刚开始治疗的人和那些考虑转换的人），以及如何探索个人特征（包括先前的 ART 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大学和肯尼亚肯雅塔国家医院拟议的工作将于两点进行。艾滋病临床试验集团在美国的临床研究中心（即位于西雅图的威斯康星大学艾滋病临床试验中心和亚特兰大的庞塞德莱昂中心）以及内罗毕肯雅塔国家医院内的两个艾滋病毒诊所，已成为与华盛顿大学肯尼亚研究和培训项目合作研究超过 25 年的网站得到了正在进行的 UM1 项目开发 LAI ART 的一部分的初步研究的支持。（AI120176，Ho/Collier，NIAID 靶向长效联合抗逆转录病毒疗法），拟议工作将通过提供可接受性和患者的关键估计来推进 LAI ART 产品开发工作偏好，使资助者、产品开发商和政策制定者能够优化产品以获得最大利益摄取、粘附和长期病毒抑制的可能性。