Factors associated with enrollment of African Americans into a clinical trial: Results from the African American study of kidney disease and hypertension

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Abstract

Recruitment of diverse populations into clinical trials remains challenging but is needed to fully understand disease processes and benefit the general public. Greater knowledge of key factors among ethnic and racial minority populations associated with the decision to participate in clinical research studies may facilitate recruitment and enhance the generalizibility of study results. Therefore, during the recruitment phase of the African American Study of Kidney Disease and Hypertension (AASK) trial, we conducted a telephone survey, using validated questions, to explore potential facilitators and barriers of research participation among eligible candidates residing in seven U.S. locations. Survey responses included a range of characteristics and perceptions among participants and non-participants and were compared using bivariate and step-wise logistic regression analyses.

One-hundred forty-one respondents in the one-hundred forty (70 trial participants and 71 non-participants) completed the survey. Trial participants and non-participants were similar in multiple demographic characteristics and shared similar views on discrimination, physician mistrust, and research integrity. Key group differences were related to their perceptions of the impact of their research participation. Participants associated enrollment with personal and societal health benefits, while non-participants were influenced by the health risks. In a step-wise linear regression analysis, the most powerful significant positive predictors of participation were acknowledgement of health status as important in the enrollment decision (OR = 4.54, p = 0.006), employment (OR = 3.12, p = 0.05) and healthcare satisfaction (OR = 2.12, p < 0.01). Racially-based mistrust did not emerge as a negative predictor and subjects' decisions were not influenced by the race of the research staff.

In conclusion, these results suggest that health-related factors, and not psychosocial perceptions, have predominant influence on research participation among African Americans.

Introduction

Recruitment of representative numbers of minority participants into clinical research studies, including clinical trials, remains challenging [1]. Despite the National Institutes of Health Revitalization Act of 1993 [2] which emphasized recruitment of racial and ethnic minority subjects into government-sponsored clinical research studies, and a greater recognition of this issue among private sector supporters of clinical trials, there is a paucity of information on the factors that might influence the decision to participate in clinical trials. Moreover, some of the available evidence is conflicting. For example, mistrust has been identified as an important barrier to research participation among African Americans [3], [4], [5], [6], [7] in some studies, whereas in others African Americans have been shown to be willing to participate in clinical research investigations [8], [9], [10], [11] with enrollment rates similar to non-Hispanic whites [12]. A better understanding of factors that influence participation of ethnic and racial minority populations in clinical research studies may enable the development of more effective recruitment strategies, thereby enhancing the generalizability of the findings from these investigations.

The vast majority of studies to assess the willingness of African Americans to engage in research have been based on community surveys, hypothetical research questionnaires, focus groups, and among clinic populations [3], [4], [6], [7], [8], [10], [11], [13], [14], [15], [16] post-hoc analyses [12], [13] and pilot surveys [6], [11], [15]. These extremely different approaches may be responsible for limiting our understanding of the factors that may influence an individual's decision to participate in clinical research. As an example, evaluation of hypothetical willingness to participate has been demonstrated to be less accurate when compared to actual trial participation [17].

Although studies have focused on attitudes of African Americans toward research participation, in AIDS [17], cancer [5], [6], [15], [18], [19] and cardiovascular research [16], there remains an absence of information on what factors should be considered to enhance recruitment. A large randomized clinical trial which exclusively enrolled African Americans with chronic kidney disease, the African American Study of Kidney Disease and Hypertension (AASK), provided the opportunity to evaluate the perceptions of subjects eligible for the trial to identify those factors which either resulted in subjects enrolling or refusing to join the study.

Section snippets

AASK trial design

The design, recruitment experience, and results of the AASK Trial have been reported previously [20], [21], [22]. Briefly, African American men and women between the ages of 18 and 70 with hypertensive kidney disease and glomerular filtration rates between 20 and 65 ml/min were eligible for the AASK trial. Screening procedures for eligibility in AASK involved an informal discussion with staff followed by a separate formal screening examination. During the screening process, eligible candidates

Demographics/socioeconomic characteristics

The 70 participants and 71 non-participants were similar in age, gender, and education (Table 2). Notably, unemployment was high in both groups but was significantly higher among non-participants. Of the potential barriers to research participation related to socioeconomic factors, household income and childcare were not significantly different between groups. Transportation was noted to be a critical factor among only 4 (6%) non-participants.

Perceptions on healthcare and biomedical research

Both groups had equivalent access to primary

Discussion

Our observations provide evidence that practical considerations, more than emotional biases, have substantial influence on whether or not African Americans choose to participate in biomedical research. During the recruitment phase of the AASK trial, a longitudinal study of blood pressure management in African Americans with hypertensive nephropathy, eligible candidates who enrolled considered their health in their decision, had positive healthcare experiences and were more likely employed

Acknowledgements

Supported by cooperative agreements U01 DK48682 (University of Michigan), DK45381 (Case Western Reserve), DK48659 (Medical University of South Carolina), DK65473 (Meharry Medical College), DK48669 (University of Alabama, Birminghan), DK48645 (University of California, San Diego), DK45386 (University of Texas, Southwestern) from the National Institute of Diabetes and Digestive and Kidney Diseases. Additional support is provided by the National Center for Minority Health and Health Disparities

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