Identifying Ethical and Culturally Responsive Research Activities to Build Trust and Improve Participation of Black Sexual Minority Men in Pre-Exposure Prophylaxis Telehealth Clinical Trials: Qualitative Study.
Identifying Ethical and Culturally Responsive Research Activities to Build Trust and Improve Participation of Black Sexual Minority Men in Pre-Exposure Prophylaxis Telehealth Clinical Trials: Qualitative Study.
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DOI：
10.2196/28798
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发表时间：
2022-02-07
影响因子：
2.7
通讯作者：
Wylie C
中科院分区：
文献类型：
--
作者：
Dangerfield Ii DT;Wylie C
远程保健干预可以改善艾滋病毒高发病率群体（如年轻的黑人性少数男性）的暴露前预防（PrEP）的启动和依从性。然而，年轻的BSMM仍然对临床试验缺乏信任和代表性。因此，需要以符合伦理和文化的方式建立信任并提高他们对PrEP远程医疗临床试验的参与。为了弥补这一差距，本研究确定了伦理和文化响应活动，以建立信任并提高年轻BSMM在PrEP远程医疗临床试验中的参与度。我们获得了7个虚拟的、同步的焦点小组的数据，这些小组于2020年4月至8月进行，由28名18-34岁的BSMM组成。焦点小组包括通过Qualtrics在线发布的简短调查，随后通过Zoom进行的虚拟同步焦点小组持续50至75分钟。焦点小组按年龄分层（18至24岁的参与者和25至34岁的参与者），概述了一个示例PrEP远程医疗随机对照试验的组成部分，并包括有关研究设计领域的问题——研究动机、研究资助、招募活动、知情同意细节、随机化、随访和研究活动结束。参与者被问及有关研究的伦理和可信度以及研究人员如何通过PrEP远程医疗临床试验中使用的协议获得他们的信任的针对性问题。焦点小组包括2组18- 24岁的参与者和5组25- 34岁的参与者。参与者的平均年龄为27.2岁（SD 4.4岁）。在28名参与者中，10人（36%）表示学士学位是他们完成的最高教育水平，6人（21%）表示研究生学位或更高的学历是他们完成的最高教育水平。大多数参与者（16/ 28,57 %）报告说他们有全职工作，他们单身或没有固定的关系（21/ 28,75 %）。大多数参与者（24/ 28,86%）报告说，在研究前6个月，他们在性行为前至少使用过一种药物。所有参与者都报告说他们听说过PrEP， 36%（10/28）是目前的PrEP使用者。总体而言，焦点小组得出的主题与研究人员意图、研究资金、招募活动、知情同意细节、随机化以及研究团队在研究期间和之后对临床试验信任和参与的影响有关。医学和研究方面的不信任在BSMM中依然存在。本研究确定了几项伦理和文化响应活动，以建立信任并提高年轻BSMM在PrEP远程医疗临床试验中的参与度。未来的研究应评估实施这些发现对参与PrEP远程医疗临床试验的研究的相对影响。
Telehealth interventions could improve pre-exposure prophylaxis (PrEP) initiation and adherence in high HIV incidence groups such as young Black sexual minority men (BSMM). However, young BSMM remain distrustful of and underrepresented in clinical trials. Therefore, ethical and culturally responsive ways are needed to build trust and improve their participation in PrEP telehealth clinical trials. To bridge this gap, this study identified ethical and culturally responsive activities to build trust and improve participation of young BSMM in PrEP telehealth clinical trials. We obtained data from 7 virtual, synchronous focus groups that were conducted from April to August 2020 and consisted of 28 BSMM aged 18-34 years. Focus groups included a brief survey distributed online via Qualtrics followed by a virtual, synchronous focus group conducted via Zoom that lasted between 50 and 75 minutes. Focus groups were stratified by age (18- to 24-year-old participants and 25- to 34-year-old participants), outlined the components of an example PrEP telehealth randomized controlled trial, and included questions on domains of the study design—research motivations, study funding, recruitment activities, informed consent details, randomization, follow-up, and end of study activities. Participants were asked targeted questions regarding the ethics and trustworthiness of the study and ways in which researchers could gain their trust through the protocol used in the PrEP telehealth clinical trial. The focus groups included 2 groups of 18- to 24-year-old participants and 5 groups of 25- to 34-year-old participants. The mean age of participants was 27.2 years (SD 4.4 years). Of the 28 participants, 10 (36%) reported a bachelor’s degree to be their highest completed education level and 6 (21%) reported some graduate degree or higher to be their highest completed education level. Most participants (16/28, 57%) reported that they worked full-time and that they were single or not in a committed relationship (21/28, 75%). Most participants (24/28, 86%) reported that they used at least one drug before sex in the 6 months prior to the study. All participants reported that they heard about PrEP and 36% (10/28) were current PrEP users. Overall, the focus groups yielded themes related to the impact of researcher intentions, study funding, recruitment activities, informed consent details, randomization, and study team interactions during and after the study on trust and participation in the clinical trial. Medical and research mistrust persists among BSMM. This study identified several ethical and culturally responsive activities to build trust and improve participation of young BSMM in PrEP telehealth clinical trials. Future studies should assess the relative impact of implementing these findings on research participation in a PrEP telehealth clinical trial.