Socio-ecological Model as a Framework for Overcoming Barriers and Challenges in Randomized Control Trials in Minority and Underserved Communities.
BACKGROUND
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.


METHODS
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.


RESULTS
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.
Department of Family and Community Medicine, Baylor College of Medicine, 3701 Kirby Drive, Suite 600, Houston, Texas, 77098, USA.
Hamisu M
HM
Salihu
Department of Epidemiology and Biostatistics, College of Public Health, University of South Florida, 13201 Bruce B Downs Blvd, MDC56, Tampa, Florida, 33612, USA.
Ronee E
RE
Wilson
Department of Epidemiology and Biostatistics, College of Public Health, University of South Florida, 13201 Bruce B Downs Blvd, MDC56, Tampa, Florida, 33612, USA.
Lindsey M
LM
King
University of South Florida Health, Associate Vice Dean for Research, Tampa, Florida, 33612, USA.
Phillip J
PJ
Marty
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, College of Medicine, University of South Florida, Tampa, Florida 33612, USA.
Valerie E
VE
Whiteman
Challenges; Clinical Trials; Genetic-Epigenetics; Participant Enrollment; Recruitment; Retention; Socio-Ecological Model (SEM)