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

 描述（由申请人提供）：拟议的3年研究将确定关键产品属性、最终用户偏好和与青少年坚持使用缓释可注射暴露前预防（PrEP）治疗艾滋病毒相关的卫生服务提供决定因素，并使用这些发现为产品优化和未来的研究和计划活动提供信息。青少年是注射PrEP的关键目标人群，对这些因素的仔细检查将为未来疗效和有效性试验的设计提供信息，并确保开发出能够实现高吸收和使用的产品。艾滋病毒PrEP试验和示范项目的遵守情况欠佳。最近在撒哈拉以南非洲地区进行的几项PrEP试验中，对产品使用的生物标志物评估表明，青少年在坚持每日PrEP方面面临最大的挑战。我们的团队刚刚开始开发用于PrEP输送的薄膜聚合物设备（TFPD）;然而，在产品开发和临床试验的早期阶段，检查可能影响依从性的最终用户和健康输送系统问题至关重要。虽然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，但年轻人对注射PrEP方法的吸收和坚持并不是必然的结论。青年有着独特的风险状况，并经历着影响风险认知和采取艾滋病毒预防做法的社会和结构性障碍。拟议的研究将在南非开普敦进行，重点是18-24岁的男女，他们是全球感染艾滋病毒风险最高的人群之一。该研究将由一位具有丰富经验的早期研究者领导，该研究者将与南非开普敦Desmond Tutu HIV研究基金会的研究者合作，评估在这种情况下促进新的HIV预防方法的可接受性和依从性的因素。在研究的第一阶段，我们将对60名已经完成注射、阴道环和口服PrEP研究的年轻女性和男性进行定性深入访谈（IDI），并且是“PrEP经验丰富的”。“使用社会生态框架，我们将探讨最终用户因素在个人，个人内部和结构层面影响吸收和坚持新的健康技术（目标1）。然后，这些形成性数据将为设计一个计算机化的、基于选择的、离散选择实验（或选择格式联合分析）提供信息，该实验将对居住在开普敦一个高密度乡镇的600名PrEP初治青年进行管理。我们将确定关键的产品设计和健康输送系统属性，这些属性对于年轻人注射PrEP方法的依从性是最优选和最突出的（目标2）。通过传播会议，研究结果将被整合到我们自己团队的TFPD开发和现有和其他新型缓释注射剂的临床测试的产品开发中。

 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.