Salihu Hamisu M, Wilson Ronee E, King Lindsey M, Marty Phillip J, Whiteman Valerie E
Department of Family and Community Medicine, Baylor College of Medicine, 3701 Kirby Drive, Suite 600, Houston, Texas, 77098, USA.
Department of Epidemiology and Biostatistics, College of Public Health, University of South Florida, 13201 Bruce B Downs Blvd, MDC56, Tampa, Florida, 33612, USA.
Int J MCH AIDS. 2015;3(1):85-95.
Numerous barriers and challenges can hinder the successful enrollment and retention of study participants in clinical trials targeting minority populations. To conduct quality research, it is important to investigate these challenges, determine appropriate strategies that are evidence-based and continue seeking methods of improvement.
In this paper, we report such experiences in a registered clinical trial in an underserved minority population in the Southern part of United States. This research study is a randomized double-blind controlled clinical trial that tests the efficacy of higher-strength as compared to low-strength/standard of care folic acid to prevent fetal body and brain size reduction in pregnant women who smoke. A unique approach in this socio-behavioral, genetic-epigenetic clinical trial is that we have adopted the socio-ecological model as a functional platform to effectively achieve and maintain high participant recruitment and retention rates.
We highlight the barriers we have encountered in our trial and describe how we have successfully applied the socio-ecological model to overcome these obstacles.
Our positive experience will be of utility to other researchers globally. Our fi ndings have far-reaching implications as the socio-ecological model approach is adaptable to developed and developing regions and has the potential to increase recruitment and retention of hard-to-reach populations who are typically under-represented in clinical trials.
众多障碍和挑战可能会阻碍针对少数族裔人群的临床试验成功招募和留住研究参与者。为了开展高质量研究，调查这些挑战、确定基于证据的适当策略并持续寻求改进方法非常重要。
在本文中，我们报告了在美国南部一个服务不足的少数族裔人群中进行的一项注册临床试验的此类经验。这项研究是一项随机双盲对照临床试验，旨在测试与低强度/标准护理叶酸相比，高强度叶酸预防吸烟孕妇胎儿身体和大脑尺寸减小的疗效。在这项社会行为、基因-表观遗传学临床试验中的一种独特方法是，我们采用社会生态模型作为一个功能平台，以有效实现并维持高参与者招募率和留存率。
我们强调了在试验中遇到的障碍，并描述了我们如何成功应用社会生态模型来克服这些障碍。
我们的积极经验将对全球其他研究人员有用。我们的研究结果具有深远影响，因为社会生态模型方法适用于发达和发展中地区，并且有可能增加在临床试验中代表性不足的难以接触人群的招募和留存。
