Men and women of Hispanic American (HA) heritage are difficult to recruit to clinical trials. Multiple factors contribute to this circumstance, including differential access to health care and health education associated with individuals'socioeconomic and linguistic characteristics, unique environmental and social forces that interplay within this cultural group, and cultural differences in attitudes, responsibilities, and practices related to health and disease. The NCI developed a customized Clinical Trials Education Series for HAs (CTES) in Spanish to help address the difficulty of recruiting HA participants to clinical trials. However, this series has not been systematically evaluated for its efficacy, and focus groups found it to be too complex for lay audience applications. In response, fotonovelas were developed but lack content needed to promote shifts in knowledge, attitudes, and behaviors. This project will adapt the best program components of the CTES into a single linguistically- and culturally-aligned clinical trials education program in English and Spanish. This adapted program will serve as the centerpiece of a randomized controlled trial to assess the program's capacity to help raise HAs'scientific literacy and positively change their attitudes about clinical trials participation in the intervention group, and then to assess whether the increased scientific literacy and improved attitudes in that group mediate subsequent response to invitations to participate in research studies. Their responses will be compared to control group members'changes in literacy and attitudes, and responses to the same research study invitations. In addition, intervention versus control participants'responsiveness to an invitation to participate in the PI's Ambassadors for Clinical Trials Program (ACTP) will be compared (ACTP promotes participation in research studies by having Ambassadors help studies recruit other members of their community). Baseline data collection will also include validated demographic, health, cultural, and psychosocial instruments to allow the researchers to determine whether personal characteristics of the participants moderate response to the clinical trials education program. The overarching study goal is to determine whether the NCI's education program can be adapted and applied to begin the process of creating a shift in knowledge, attitudes, and behaviors within the HA community related to clinical trials participation. If this educational program is effective, there will be an immediate and long term public health benefit. The program will have the immediate effect of creating a positive shift in knowledge and attitudes toward research study participation within the HA community. This will subsequently benefit the region's research community by creating a pool of HA community members who can be directly invited to participate in research studies and who can help open the community's doors to the research community. Ultimately this will advance the health and well being of the HA community as greater participation in health research increases the generalizability of research findings to this community.
The program will have the immediate effect of creating a positive shift in knowledge and attitudes toward research study participation within the HA community and actual study participation. This will subsequently benefit the region's research community by creating a pool of HA community members who can be directly invited to participate in research studies and who can help open the community's doors to the research community. Ultimately this will advance the health and well being of the HA community as greater participation in health research increases the generalizability of research findings to this community.
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|Mills, Sarah D; Fox, Rina S; Malcarne, Vanessa L et al. (2014) The psychometric properties of the generalized anxiety disorder-7 scale in Hispanic Americans with English or Spanish language preference. Cultur Divers Ethnic Minor Psychol 20:463-8|