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 doubleblind 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. Conclusions and Global Health Implications:  Our positive experience will be of utility to other researchers globally. Our findings 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. Key words: Participant Enrollment • Recruitment • Genetic-Epigenetics • Socio-Ecological Model (SEM) • Clinical Trials • Retention • Challenges Copyright © 2015 Salihu et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited

Evaluation of an Evidence-based and Community-responsive Fatherhood Training Program: Providers’ Perspective

Background And Objectives: Studies on male involvement and pregnancy outcomes have often not incorporated the providers’ perspectives, which are potentially critical to understanding program context, evolution, perceived impact, and sustainability. We sought to evaluate the 24/7 Dad® program from the viewpoint of the program providers. Methods: We conducted purposive sampling of 24/7 Dad program facilitators and administrators who were involved in recruitment, training, and follow up of program participants within a federal Healthy Start program (REACHUP) in Tampa, Florida, USA. Using a snowballing approach, we recruited six key informants who had administered the program for at least four years. We elicited and evaluated factors impacting the performance of the father involvement program using content analysis. Results: Under program participation and perceived impact, most providers thought that the program had created a safe space previously unavailable for men in the community. The most useful recruitment strategy was building partnerships with other organizations. The key informants noted an important evolutionary trend in the father involvement program over time as well as the nature of linkages to partner organizations within the area. Threats to program sustainability included the continued reluctance and scepticism to invest funds to address male issues, sub-optimal retention of participants who were living transient lives as well as geographical/transportation barriers. Conclusion and Global Health Implications: The involvement of fathers during pregnancy has significant implications for healthy babies. Our study results provide a clarion call to augment capacity and infuse more resources to improve paternal involvement in order to attain the United Nations Sustainable Goal (2015-2030) of ensuring healthy lives and the promotion of well-being for all at all ages. Key words: • Fatherhood involvement • Fatherhood training • REACHUP • Childhood development • 24/7 Dad program   Copyright © 2020 Obure et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited

Book of Abstracts: 2019 Health Equity Summer Research Summit Organized by the Center of Excellence in Health Equity, Training and Research, Baylor College of Medicine, Houston, Texas 77030, USA on June 18th, 2019

Copyright © 2020 Harris. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited