Enhancing Recruitment and Retention of Underrepresented Pregnant Hispanic Women in a Phase III Randomized Clinical Trial

目前的提案没有改变我们正在进行的随机对照试验(R01)的最初范围、目标或研究设计 HD083292；ClinicalTrials.gov ID：NCT02626299)，旨在确定高DHA与低DHA 孕期摄入可以成功地减少早产。相反，这项提案指向了额外的 评估以社区为基础的参与性研究战略的资源，以招聘和保留 少数族裔代表不足，特别是怀孕的西班牙裔妇女。我们寻求1)确定怀孕障碍 拉美裔妇女在接受临床护理时面临的问题，2)确定她们对参与临床研究的看法 因为它关系到他们的怀孕和未出生的孩子的健康，以及3)增加注册和保留 西班牙裔妇女在我们的临床试验中实现了具有全国代表性的抽样。一个新成立的 与多语种、文化相宜的中心进行跨学科协作，并在以下方面取得成功 拉美裔社区的参与将指导我们的努力。结果数据将包括西班牙裔美国人的人数 登记并完成我们临床试验的参与者以及改进的描述性方法 代表人数不足的少数群体对未来研究的承诺。

The current proposal does not change the original scope, aims or research design of our ongoing RCT (R01 HD083292; ClinicalTrials.gov ID: NCT02626299) which seeks to determine whether high versus low DHA intake during pregnancy can successfully reduce early preterm birth. Instead this proposal directs additional resources to evaluate community based participatory research strategies for the recruitment and retention of underrepresented minorities, specifically pregnant Hispanic women. We seek to 1) identify barriers pregnant Hispanic women face when accessing clinical care, 2) identify their perception of clinical research participation as it relates to the health of their pregnancy and unborn child and 3) increase enrollment and retention of Hispanic women in our clinical trial to achieve a nationally representative sampling. A newly formed interdisciplinary collaboration with a multilingual, culturally appropriate center with a successful track record of Hispanic community engagement will guide our efforts. Outcome data will include the number of Hispanic participants who enroll into and complete our clinical trial as well as descriptive methods to improve commitment of underrepresented minorities for future studies.