Next generation real-time monitoring for PrEP adherence in young Kenyan women

下一代实时监测肯尼亚年轻女性 PrEP 依从性

• 批准号: 9039397
• 负责人: Jared Baeten
• 金额: $ 76.1万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-22 至 2020-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9039397
• 关键词: AIDS prevention; Address; Adherence; African; Behavior; Behavioral; Blood; Cellular Phone; Clinical Trials; Cohort Studies; Coupled; Coupling; Data; Data Storage and Retrieval; Devices; Economics; Effectiveness; Electronics; Epidemiology; Feedback; HIV; HIV risk; Health; Individual; Intervention; Kenya; Knowledge; Life; Link; Measurement; Measures; Modeling; Modification; Monitor; Oral; Pattern; Perception; Pharmacy facility; Play; Policies; Population; Prevention; Prevention Measures; Prevention strategy; Prophylactic treatment; Qualitative Methods; Randomized; Records; Research Personnel; Resources; Risk; Risk Behaviors; Sampling; Science; Self-control as a personality trait; Sex Behavior; Spottings; Surveys; Technology; Tenofovir; Testing; Thinking; Time; Time and Motion Studies; Uganda; Uncertainty; Wireless Technology; Woman; Women' s Health; Work; antiretroviral therapy; base; behavioral economics; behavioral/social science; cohort; cost; data exchange; high risk; improved; innovation; mobile computing; next generation; open label; pill; placebo controlled study; pre-clinical trial; primary outcome; public health relevance; risk perception; sex risk; technological innovation; temporal measurement; therapy adherence; tool; usability; young woman

 DESCRIPTION (provided by applicant): Significance and Innovation: Real-time electronic monitoring is the optimal approach for understanding patterns of adherence, which are critical for determining if adherence to daily oral pre-exposure prophylaxis (PrEP) aligns with an individual's risk for HIV acquisition. Compared with earlier adherence measurement devices, next generation Wisepill technology offers significant innovations in data storage and transmission reliability, cost, and usability and is ready for implementation in resource-limited settings. Coupling Wisepill monitoring to SMS adherence feedback has great potential to support adherence at the precise time it is needed. Real-time strategies may be particularly important for young women- a population in need of self-controlled HIV prevention strategies, but one that has previously struggled with PrEP adherence. Triangulating real-time SMS measurement of sexual behavior with adherence may explain how PrEP can be used most effectively for HIV prevention (i.e., prevention-effective adherence). Approach: We propose a forward-thinking project that brings together key technologies to conduct optimized real-time adherence monitoring, adherence feedback, and measurement of sexual behavior to maximize PrEP adherence. We will establish a cohort of 314 young HIV-uninfected women initiating PrEP in Kenya, following them over two years: Aim 1. Use the next generation Wisepill device to a) measure real-time adherence and b) determine the impact of real-time SMS feedback on PrEP adherence. We will monitor adherence among all women with Wisepill. We will randomize half to receive weekly SMS feedback on Wisepill openings. The primary outcome will be execution and persistence of adherence, comparing the randomized groups. Aim 2. Determine the technical function, acceptability, cost, and validity of the next generation Wisepill device couple to SMS feedback among young African women. We will measure data transmission reliability, battery life, and other technical features; assess acceptability and usability; and estimate costs of use. Adherence validity will be determined by comparing Wisepill data with dried blood spot tenofovir levels. Aim 3. Triangulate Wisepill adherence data with real-time assessment of HIV risk behaviors and perceptions, to measure prevention-effective adherence. Through weekly SMS surveys about recent sexual behavior, use of alternate HIV prevention tools, and subjective HIV risk, we will explore the overlap of perceptions, behaviors, and PrEP adherence, which is critical for effective HIV prevention with PrEP. Investigators: This project brings together an established, internationally-recognized team of PrEP leaders with expertise in real-time adherence monitoring and intervention (Jessica Haberer), HIV prevention and epidemiology (Jared Baeten), women's health and HIV prevention in Kenya (Nelly Mugo and Elizabeth Bukusi), behavioral and social science (Kenneth Ngure), pharmacy science (Stella Nujugana), behavioral economics and risk behavior (Harsha Thirumurthy), and HIV modelling (Ruanne Barnabas).

 描述（由申请人提供）：意义和创新：实时电子监测是了解依从性模式的最佳方法，这对于确定每日口服暴露前预防 (PrEP) 的依从性是否与个人的 HIV 风险相符至关重要与早期的依从性测量设备相比，下一代 Wisepill 技术在数据存储和传输可靠性、成本和可用性方面提供了重大创新，并准备在资源有限的环境中实施。 Wisepill 监测短信遵守情况反馈具有巨大的潜力，可以在需要的精确时间支持遵守情况。实时策略对于年轻女性尤其重要，因为年轻女性需要自我控制的艾滋病毒预防策略，但以前一直在努力。将性行为的实时 SMS 测量与遵守情况进行三角测量可以解释如何最有效地使用 PrEP 来预防艾滋病毒（即预防有效的遵守情况） 方法：我们提出了一个汇集关键技术的前瞻性项目。进行优化的实时依从性监测、依从性反馈和性行为测量，以最大限度地提高 PrEP 依从性 我们将在肯尼亚建立一个由 314 名未感染 HIV 的年轻女性组成的队列，对她们进行为期两年的跟踪： 目标 1. 使用下一代 Wisepill 设备：测量实时依从性，b) 确定实时短信反馈对 PrEP 依从性的影响 我们将在所有使用 Wisepill 的女性中进行坚持监测 我们将随机抽取一半每周接收有关 Wisepill 开放的短信反馈。主要结果是比较随机分组的执行力和坚持程度。目标 2. 确定下一代 Wisepill 设备与短信反馈在非洲年轻女性中的技术功能、可接受性、成本和有效性。可靠性、电池寿命和其他技术特征；评估可接受性和可用性；并通过比较 Wisepill 数据与干血斑替诺福韦水平来确定依从性。实时评估艾滋病毒风险行为和认知的数据，通过每周对近期性行为、替代艾滋病毒工具的使用和主观艾滋病毒风险进行短信调查，我们将探索预防认知和行为的重叠。和 PrEP 依从性，这对于 PrEP 有效预防艾滋病毒至关重要：该项目汇集了国际公认的 PrEP 领导者团队，他们在实时依从性监测和干预（Jessica Haberer）、艾滋病毒预防和流行病学方面拥有专业知识。 （贾里德Baeten）、肯尼亚妇女健康和艾滋病毒预防（Nelly Mugo 和 Elizabeth Bukusi）、行为和社会科学（Kenneth Ngure）、药学科学（Stella Nujugana）、行为经济学和风险行为（Harsha Thirumurthy）以及艾滋病毒建模（Ruanne Barnabas） ））。