Development of Real-Time Antiretroviral Therapy Adherence Intervention in Uganda

重要性：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导致依从性挑战。无法克服这些障碍和维持一线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，以开发一种实时的依从性干预，对医疗保健系统的负担最小。创新：该研究的创新之处在于：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干预; 3）参与社会支持网络以提供个性化支持; 4）确定SMS和社会支持的作用机制，从而可以设计和测试循证干预措施。方法：建议的干预措施是基于一个概念框架，其中短信触发社会支持，以提高依从性，以及直接克服依从性障碍。在开始ART并使用Wisepill进行监测的HIV感染者队列中，我们将连续测试1）每日短信提醒，2）每周短信提醒，3）与错过剂量实时检测相关的短信提醒，以及4）短信提醒加短信通知他们的社会支持网络成员-两者都与错过剂量的实时检测相关。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对每种类型短信的体验。这种在单一队列中的分阶段方法将使我们能够充分理解和比较基于SMS的干预措施的累加效应和可接受性。我们还将确定行为效应机制，并将每种类型的SMS与仅接受Wisepill监测的对照人群对依从性和HIV RNA的影响进行比较。我们提出以下目标：目标1。开发基于SMS提醒的ART依从性干预措施，与错过剂量的实时检测相关联，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。 目标二。开发基于社会支持的ART依从性干预措施，并将其与实时依从性监测联系起来，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。Haberer博士（PI）是实时ART依从性监测的新兴学术领导者，特别是在资源有限的环境中。Musiimenta博士提供了乌干达农村地区艾滋病毒/艾滋病相关信息系统混合方法评价的关键经验。Ware博士是一位医学人类学家，在撒哈拉以南非洲地区对ART依从行为进行定性访谈方面拥有丰富的经验。Bangsberg博士是国际公认的坚持ART的领导者，也是Haberer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.