Original articleRecruitment of Hispanic women to the Women's Health Initiative: the case of Embajadoras in Arizona
Introduction
By 2010, Hispanics are expected to become the largest ethnic/racial population in the United States, and will account for 42% of this country's new population growth 1, 2. Along with this boom comes a parallel increase in certain health-related problems, some simply due to growth in the lower socioeconomic strata, some triggered by acculturation of immigrants to less healthy lifestyle behaviors and some reflecting the secular trends for increasing rates of certain diseases 3, 4, 5, 6.
The National Institutes of Health recently called for one particular strategy to address the growing health problems with minority populations in general: to increase the number of minorities as subjects in clinical research trials. Both ethical and research-related premises are cited for inclusion [7]. Factors that contribute to recruitment success in the general population have shown that the characteristics of the study (i.e., perceived as worthwhile research, minimal demands) as well as the ways in which it is promoted (i.e., mail, phone, newspaper) influence accrual, but these same issues have been less systematically studied in minority populations 8, 9, 10, 11, 12, 13. Specific strategies need to be developed to improve enrollment of special populations taking into account everything from the research design to the cultural appropriateness of the recruitment methods 14, 15.
As with participation of any underrepresented minority group, ensuring that Hispanics participate in clinical treatment and prevention research trials is necessary to produce results that help us understand the effects of agents and behavioral strategies when applied in these groups 16, 17. National Cancer Institute-sponsored and other clinical trials have gained substantial minority participation in recent years 18, 19, 20. For cancer prevention trials, the data are less promising on Hispanics. For example, Hispanics accounted for only 2–3% of the total participants in the National Surgical Breast and Bowel Project's Breast Cancer Prevention Trial [21] and only 3% in the Southwest Oncology Group's Prostate Cancer Prevention Trial [22].
Critical factors that shape health-seeking behavior among Hispanics, and correspondingly may affect exposure and enrollment in research trials, are poor access to care, lack of transportation, need for child care, costs related to the patient's lost time at work, competing family responsibilities, and the lack of culturally appropriate or language-matched care 23, 24, 25. Published research on reaching Hispanics generally prescribes strategies that take into account cultural barriers (such as anxiety about raising negative health topics) and the strong emphasis in Hispanic culture on family and smooth, trusting relationships 26, 27, 28, 29. Consequently, recommended cultural adaptations to recruitment methods include face-to-face communication by supportive community health advisors, practical assistance for keeping appointments (such as transportation and child care) and family-oriented decision making 27, 30, 31.
Section snippets
Recruitment of Hispanic women into the Women's Health Initiative in Arizona
The Women's Health Initiative (WHI) is a nationwide 15-year longitudinal study targeting cardiovascular disease, cancer, and osteoporosis among postmenopausal women aged 50–79 years at the time of recruitment [32]. The Arizona WHI Clinical Center committed to overrecruit minority women so that 60%, or 2172 of the 3620 targeted enrollments would be of minority status. Hispanics are by far the largest ethnic minority group in Arizona and represent 25% of the population [33]. Thus, the lion's
Selection of participants
Screening criteria were determined for identifying eligible Hispanic women to be randomized to either the training group or control. These criteria included (1) a positive attitude toward the study measured with a set of questions concerning the perceived importance and relevance of the WHI (WHI Attitude Survey) and (2) a minimum required number of social contacts as measured by listing and rating social closeness to acquaintances in the Network Linkages Index (may be obtained from first
Referral and enrollment
To examine the main hypothesis of the study, referral and enrollments lists were assessed at the end of the recruitment period to evaluate the success of the Embajadoras as compared to control group women (see Table 1). A referral was counted if a potential participant sent or brought in to the clinic site a referral card clipped from a brochure. Enrollment was defined as having completed the eligibility and consent process to the point of being randomized into the study.
In the following
Enrollment
Enrollment (“any” vs. “none”) was significantly associated with intervention (two-sided Fisher's Exact Test: χ2=14.35, p=0.001). To determine which groups differed in enrollment success, the 2×3 table was stratified into three 2×2 tables (one for each pairwise comparison) and Fisher's Exact Test was performed for each table (since each had at least one cell with an expected frequency of <5). The alpha level used for each test was that determined by using a Bonferroni correction (i.e.,
Discussion
The main point of this study was to examine the effectiveness of a lay advocacy program among Hispanic women. The program included training volunteer study participants and providing regular contact to encourage their activities. Implementing the intervention required moderate resources, including the technical assistance of a half-time Hispanic student, several investigators to plan and oversee educational sessions and evaluation, and the collaboration of on-site WHI clinic staff.
Compared to a
Conclusions
Lay advocacy for recruitment to clinical trials is being recommended and used increasingly within minority populations [30]. Yet very little is known about the factors that contribute to the success of such programs. This study formally examined an advocacy intervention and showed positive results with a strong program of educating Hispanic lay advocates and providing ongoing contact and support. Further studies that assess other explanatory variables related to messages and promotional
Acknowledgements
Dr. Larkey wishes to thank WHI recruiters, Orlando Romero and Bertha Fest, and LeAnn Barrett for assistance in tracking Embajadora program outcomes. This research was supported in part by National Cancer Institute, grant #1RO3 CA73255 and by National Institutes of Health, Women's Health Initiative grant #WHI32115.
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