End-user research to optimize adherence to injectable HIV prevention approaches

最终用户研究以优化对注射艾滋病毒预防方法的依从性

• 批准号: 8991846
• 负责人: Elizabeth Trask Montgomery
• 金额: $ 61.38万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8991846
• 关键词: AIDS prevention; Adherence; Adoption; Adverse effects; Africa South of the Sahara; African; Anti-Retroviral Agents; Attitude; Biological Markers; Clinical Trials; Communities; Computer Assisted; Data; Development; Device or Instrument Development; Devices; Dose; Drug Formulations; Effectiveness; Ensure; Film; Foundations; Future; HIV; HIV Infections; Health; Health Technology; Individual; Injectable; Interview; Intramuscular; Intramuscular Injections; Measures; Methods; Microbicide Trials Network; Oral; Pharmaceutical Preparations; Phase; Polymers; Population; Prevention approach; Prophylactic treatment; Public Health; Questionnaires; Regimen; Reporting; Research; Research Personnel; Risk; Route; Shapes; South Africa; Staging; System; Target Populations; Techniques; Technology; United States Food and Drug Administration; Vaginal Ring; Woman; Work; Youth; aged; base; computerized; density; design; effectiveness trial; efficacy trial; experience; health care delivery; high risk; improved; intervention effect; meetings; men; novel; novel strategies; phase II trial; preference; product development; prophylactic; public health relevance; research clinical testing; research study; risk perception; social; technology development; tool; trial design; uptake; young man; young woman

 DESCRIPTION (provided by applicant): The proposed 3-year study will identify key product attributes, end-user preferences, and health service delivery determinants relevant to youth's adherence to sustained-release injectable pre-exposure prophylaxis (PrEP) for HIV, and to use these findings to inform product optimization and future research and programmatic activities. Youth constitute a key target population for injectable PrEP, and careful examination of these factors will inform the design of future efficacy and effectiveness trials and ensure development of a product that will achieve high uptake and use. HIV PrEP trials and demonstration projects have suffered from suboptimal adherence. Biomarker assessments of product use in several recent PrEP trials in sub-Saharan Africa indicate that youth experience the greatest challenges with adherence to daily PrEP. Our team has just commenced development of a thin-film polymer device (TFPD) for PrEP delivery; however, it is critical to examine end-user and health delivery system issues that may impact adherence in the early stages of product development and clinical testing. Although an injectable method will simplify product delivery and overcome many of the barriers to use of existing methods, uptake of and adherence to an injectable PrEP method by youth is not a foregone conclusion. Youth have distinct risk profiles and experience social and structural barriers that shape risk perception and adoption of HIV prevention practices. The proposed study will take place in Cape Town, South Africa, and will focus on men and women aged 18-24, who constitute one of the populations most at risk for HIV acquisition globally. The research will be led by an early-stage Investigator with extensive experience evaluating factors contributing to the acceptability and adherence to novel HIV prevention methods in this setting, in partnership with Investigators at the Desmond Tutu HIV Research Foundation in Cape Town, South Africa. In the first phase of the study, we will conduct qualitative in-depth interviews (IDI) with 60 young women and men who have completed injectable, vaginal ring, and oral PrEP studies, and are "PrEP-experienced." Using a socio-ecological framework, we will explore end- user factors at the individual, intrapersonal, and structural levels that influence uptake of and adherence to new health technologies (Aim 1). This formative data will then inform the design of a computerized, questionnaire-based, discrete-choice experiment (or choice-format conjoint analysis) that will be administered to 600 PrEP-naïve youth residing in a high-density township in Cape Town. We will determine the key product design and health delivery system attributes that are most preferable and salient to adherence for an injectable PrEP method for young people (Aim 2). Through dissemination meetings, research findings will be integrated into product development of our own team's TFPD development and clinical testing of existing and other novel sustained-release injectables.

 描述(由申请人提供)：拟议的为期3年的研究将确定与青年坚持艾滋病毒缓释注射暴露前预防(PrEP)相关的关键产品属性、最终用户偏好和卫生服务提供决定因素，并利用这些研究结果为产品优化和未来的研究和方案活动提供信息。青年是可注射PrEP的主要目标人群，仔细检查这些因素将为未来疗效和有效性试验的设计提供信息，并确保开发一种将实现高摄取率和使用率的产品。艾滋病毒-PrEP试验和示范项目的依从性不佳。在撒哈拉以南非洲最近的几项PrEP试验中，对产品使用的生物标记物评估表明，年轻人在坚持每日PrEP方面遇到了最大的挑战。我们的团队刚刚开始开发用于PrEP递送的薄膜聚合物设备(TFPD)；然而，在产品开发和临床测试的早期阶段，检查可能影响依从性的最终用户和健康递送系统问题至关重要。尽管可注射方法将简化产品交付，并克服使用现有方法的许多障碍，但年轻人接受和坚持可注射PrEP方法并不是必然的结果。青年有不同的风险特征，并经历了影响艾滋病毒预防做法的风险认知和采用的社会和结构性障碍。这项拟议的研究将在南非开普敦进行，重点是18-24岁的男性和女性，他们是全球艾滋病毒感染风险最高的人群之一。这项研究将由一名具有丰富经验的早期调查员领导，该调查员与南非开普敦德斯蒙德·图图艾滋病毒研究基金会的调查人员合作，评估在这种情况下有助于接受和遵守新的艾滋病毒预防方法的因素。在研究的第一阶段，我们将对60名年轻男女进行定性的深度访谈(IDI)，他们已经完成了注射、阴道环和口服PrEP研究，并具有PrEP经验。利用社会生态框架，我们将在个人、个人内部和结构层面探索影响对新卫生技术的接受和遵守的最终用户因素(目标1)。然后，这些形成的数据将用于设计一项计算机化的、基于问卷的离散选择实验(或选择格式联合分析)，该实验将对居住在开普敦一个高密度城镇的600名学前教育-幼稚青年进行。我们将确定年轻人可注射PrEP方法最可取和最值得坚持的关键产品设计和健康提供系统属性(目标2)。通过宣传会，研究成果将被整合到我们自己团队的TFPD开发的产品开发中，以及现有和其他新型缓释注射剂的临床测试中。