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（由适用提供）：拟议的3年研究将确定关键的产品属性，最终用户的偏好和卫生服务提供确定与青年人对HIV的持续释放预先暴露前预防（PREP）相关的艾滋病毒，并使用这些发现来为产品优化和未来的研究和程序化活动提供信息。青年构成了可注射准备的关键目标人群，仔细检查这些因素将为未来有效性和有效性试验的设计提供信息，并确保开发将获得高吸收和使用的产品。艾滋病毒预科试验和示范项目遭受了次优的依从性。在撒哈拉以南非洲最近的几项PREP试验中，生物标志物评估产品的使用评估表明，青年经历了最大的挑战，并遵守日常准备。我们的团队刚刚开始开发薄膜聚合物设备（TFPD）进行准备。但是，检查最终用户和健康输送系统问题可能会影响产品开发和临床测试早期的依从性。尽管一种可注射的方法可以简化产品的传递并克服使用现有方法的许多障碍，但青年人对可注射的准备方法的吸收和遵守并不是定局的结论。青年具有独特的风险特征，并经历社会和结构性障碍，这些障碍会影响风险感知并采用艾滋病毒预防实践。拟议的研究将在南非开普敦举行，并将集中于18-24岁的男女，他们构成了最有艾滋病毒在全球范围内获得艾滋病毒风险的人群之一。这项研究将由一名早期研究人员领导，其经验丰富的经验评估了因素，这是有助于在这种环境中与新型HIV预防方法的可接受性和遵守，并与南非开普敦Desmond Tutu HIV研究基金会的研究人员合作。在研究的第一阶段中，我们将对60名已完成注射式，阴道环和口腔预备研究的年轻男女进行定性的深入访谈（IDI），并“预先经验丰富”。使用社会生态框架，我们将探索影响摄取和遵守新健康技术的个人，人际和结构水平的最终用户因素（AIM 1）。然后，此形成性数据将为一项基于计算机化问卷的离散选择实验（或Choice-Format联合分析）的设计提供信息，该实验将对居住在开普敦高密度乡镇的600名预先预期青年进行管理。我们将确定关键的产品设计和健康输送系统属性，这些属性最喜欢，并且是对年轻人的可注射准备方法的依从性（AIM 2）。通过传播会议，研究结果将集成到我们自己团队的TFPD开发以及对现有和其他新型持续释放注射剂的临床测试的产品开发中。