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.
Results of this supplement will directly address objective 3.9 of the NIH Strategic Plan for Research on Women?s Health, which in part seeks to examine health disparities resulting from discrepant access to therapeutic interventions. It will provide new evidence of successful approaches to enroll underrepresented minorities in innovative clinical trials and encourage continued studies in this area, ultimately closing the gap in care.
|Carlson, Susan E; Gajewski, Byron J; Valentine, Christina J et al. (2017) Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol. BMC Pregnancy Childbirth 17:62|