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

在 III 期随机临床试验中加强对代表性不足的西班牙裔孕妇的招募和保留

基本信息

批准号：
9446350
负责人：
SUSAN E CARLSON
金额：
$ 11.37万
依托单位：
UNIVERSITY OF KANSAS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-01-19 至 2020-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9446350
关键词：
10 year old Acculturation Address Adherence Affect Age American Area Attitude Belief Birth Caring Censuses Clinic Clinical Clinical Research Clinical Trials Communities Community Health Data Decision Making Enrollment Ensure Face Family Family member First Pregnancy Trimester Focus Groups Funding Future Health Hispanics Immigrant Intake Knowledge Latina Latino Linguistics Methods Modeling Multilingualism National Institute of Child Health and Human Development Not Hispanic or Latino Outcome Participant Perception Persons Phase Phase III Clinical Trials Population Pregnancy Pregnant Women Premature Birth Prenatal care Procedures Process Randomized Clinical Trials Recruitment Activity Research Research Design Research Infrastructure Resources Sampling Strategic Planning Therapeutic Intervention Time Treatment Efficacy Trust Uncertainty Underrepresented Minority United States United States National Institutes of Health Woman Women&apos s Health base clinical care community based participatory research design health care availability health disparity improved innovation interdisciplinary collaboration pregnant reproductive unborn child

项目摘要

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.

当前的提案不会改变我们正在进行的随机对照试验（R01）的原始范围、目标或研究设计 HD083292； ClinicalTrials.gov ID：NCT02626299）旨在确定高 DHA 还是低 DHA 怀孕期间摄入可以成功减少早期早产。相反，该提案指示了额外的评估基于社区的参与性研究战略的资源，以招募和保留代表性不足的少数族裔，特别是怀孕的西班牙裔妇女。我们力求 1) 找出怀孕障碍西班牙裔女性在获得临床护理时面临的问题是，2) 确定她们对参与临床研究的看法因为这关系到怀孕和未出生孩子的健康，并且 3) 增加入学率和保留率我们的临床试验中的西班牙裔女性样本实现了全国代表性。一个新成立的与多语言、文化适宜的中心进行跨学科合作，该中心在以下方面拥有成功的记录：西班牙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人数注册并完成我们的临床试验的参与者以及改进的描述性方法代表性不足的少数群体对未来学习的承诺。