Abstract
1- Introduction
2- Method
3- Discussion
4- Conclusion
References
Abstract
Recruitment and retention of low-income African Americans in clinical trials is challenging. This paper reports recruitment and retention strategies that yielded high rates for both in a clinical trial pilot to improve hypertension self-management among low-income African Americans. The study successfully recruited 96.7% (59 of 61 participants) within a seven month period. Retention rates for the 1, 3, and 6-month post-baseline assessment visits were 91.5%, 88.1%, and 83.1%, respectively. Recruitment and retention strategies include two grounded in previous literature: a culturally sensitive and diverse research team and use of incentives. Four additional strategies were developed for this study to meet the needs of the study site and participants, which included: study site collaboration; ongoing communications; responding to the clinical environment; and addressing participants’ health literacy levels. A discussion of key recruitment and retention strategies and suggestions for future studies focused on low-income African American participants ensues.
Introduction
Effective recruitment and retention strategies are essential to the overall success of clinical trials. Low recruitment and high attrition rates result in inequitable distribution of research risks and benefits and undermine the trial results [1]. Despite the well-established finding that health disparities in minority populations persist, minorities are underrepresented in health research. This creates barriers to meaningful research as it reduces analytic sample sizes, statistical power, generalizability, and consequently the validity of overall study outcomes. This negatively affects the validity of research and undermines the collection of evidence for eliminating health disparities [2–4]. Recruitment and retention of African American participants are major challenges in research. They are particularly daunting challenges for follow-up assessment monitoring behavior change [1,3,5]. Low levels of participation by minorities are often attributed to a lack of trust in researchers because of historical breeches of ethical research conduct [2,3]. Research exploring interventions designed to reduce the health disparities of hypertension and other chronic illnesses in low-income African Americans is needed [6]. Among all race/ethnicity subgroups in the US, African Americans have the highest hypertension prevalence (58.6% among men and 56.0% among women), which, when compared to the prevalence among whites (48.2% among men and 41.3% among women) [7], is a major disparity. There is a need to explore culturally appropriate strategies to improve recruitment and retention successes with African Americans. This would provide a stronger foundation for designing interventions that eradicate health disparities in hypertension for low-income African Americans [2,3,8]. Literature on promoting hypertension self-management in lowincome African Americans is scarce and lacks critical information on recruitment and retention strategies. In a thorough review of papers examining this, we found only a few intervention studies with hypertensive low-income African-Americans adults and all indicated recruitment and retention challenges [9–12]. We found one study specifically on hypertensive low-income African-Americans adults [13]. Although the study reported a high retention rate (100%) over 8 weeks, the strategies used were not described. Other studies reported recruitment and retention strategies designed to enhance participation of African Americans of all incomes in clinical trials on chronic diseases other than hypertension [8,14–16]. Strategies included benefits to participation, convenience of participation, safety assurances, and trust.