Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

说明(由申请人提供)：意义：尽管抗逆转录病毒疗法(ART)在撒哈拉以南非洲取得了早期成功，但结构性和非结构性障碍通常会造成遵守方面的挑战。无法克服这些障碍并维持第一线的抗逆转录病毒治疗对个人和公共健康以及成本都有重大影响。拟议的研究将使用 短信和现有的社会支持网络，以开发对医疗系统负担最小的实时依从性干预。创新：1)使用实时依从性监测和干预，2)基于个体依从性行为的有针对性的干预，3)参与社会支持网络提供个性化支持，4)确定短信和社会支持的作用机制，从而使设计和测试基于证据的干预成为可能。方法：拟议的干预基于一个概念性框架，在该框架中，短信触发社会支持以提高遵从性，以及直接克服遵守障碍。在一组开始接受抗逆转录病毒治疗并使用Wisepill进行监测的HIV感染者中，我们将连续测试1)每日短信提醒，2)每周短信提醒，3)与错过剂量的实时检测相关的短信提醒，以及4)短信提醒加上对其社会支持网络成员的短信通知-两者都与错过剂量的实时检测相关联。我们将进行定性访谈，以了解参与者及其社会支持网络成员使用每种类型短信的经验。这种在单一队列中分阶段进行的方法将使我们能够充分了解和比较以短信为基础的干预措施的相加效应和可接受性。我们还将确定行为效应机制，以及比较每种类型的短信与只接受Wisepill监测的对照人群对依从性和HIV RNA的影响。我们提出了以下目标：目的1.开发一种基于短信提醒的ART依从性干预措施，用于实时检测错过的剂量，并评估其可接受性、可行性和对依从性和HIV RNA抑制的初步影响。目的2.开发一种基于社会支持的ART依从性干预方法，并结合依从性实时监测，评估其可接受性、可行性以及对依从性和HIV RNA抑制的初步影响。研究人员：Haberer博士(Pi)是实时ART依从性监测的新兴学术领袖，特别是在资源有限的环境中。Musiimenta博士在乌干达农村地区艾滋病毒/艾滋病相关信息系统的混合方法评估方面提供了重要经验。威尔博士是一位具有丰富经验的医学人类学家，在撒哈拉以南非洲地区对抗逆转录病毒治疗的坚持行为进行了定性访谈。邦斯伯格博士是国际公认的坚持抗逆转录病毒治疗的领导者，也是哈贝勒博士的主要导师。

DESCRIPTION (provided by applicant): Significance: Despite early success with antiretroviral therapy (ART) in sub-Saharan Africa, structural and non-structural barriers commonly cause adherence challenges. Inability to overcome these barriers and sustain first line ART has significant implications individual and public health, as well as cost. The proposed study will use SMS texting and existing social support networks to develop a real-time adherence intervention with minimal burden on healthcare systems. Innovation: The proposed study is innovative in 1) its use of real-time adherence monitoring and intervention, 2) targeted intervention based on an individual's adherence behavior, 3) engagement of social support networks for provision of individualized support, and 4) determination of mechanisms of effect of SMS and social support, thus making it possible to design and test evidence-based interventions. Approach: The proposed intervention is based on a conceptual framework in which SMS trigger social support for improved adherence, as well as directly overcome adherence barriers. In a cohort of HIV-infected individuals starting ART and monitored with Wisepill, we will serially test 1) daily SMS reminders, 2) weekly SMS reminders, 3) SMS reminders linked to real-time detection of missed doses, and 4) SMS reminders plus SMS notifications to members of their social support networks- both linked to real-time detection of missed doses. We will conduct qualitative interviews to learn the experiences of participants and members of their social support networks with each type of SMS. This staged approach in a single cohort will allow us to fully understand and compare the additive effects and acceptability of SMS-based interventions. We will also determine behavioral effect mechanisms, as well as compare the impact of each type of SMS with a control population receiving only Wisepill monitoring on adherence and HIV RNA. We propose the following aims: Aim 1. Develop an ART adherence intervention based on SMS reminders linked to real-time detection of missed doses, and assess its acceptability, feasibility and preliminary impact on adherence and HIV RNA suppression. Aim 2. Develop an ART adherence intervention based on social support linked to real-time adherence monitoring and assess its acceptability, feasibility and preliminary impact on adherence and HIV RNA suppression. Investigators: Dr. Haberer (PI) is the emerging academic leader of real-time ART adherence monitoring, particularly in resource-limited settings. Dr. Musiimenta provides key experience in mixed method evaluation of HIV/AIDS-related information systems in rural Uganda. Dr. Ware is a medical anthropologist with extensive experience conducting qualitative interviews on ART adherence behavior in sub-Saharan Africa. Dr. Bangsberg is an internationally recognized leader in adherence to ART and Dr. Haberer's primary mentor.