Behavior & Clinical Trials Participation in HIV+ Latinos

Funded by the National Institute of Health, Grant # K01 MH072353-04; PI: María Luisa Zúñiga

The overall goal of this project was to understand ethnic-specific and culture-bound behaviors and beliefs about medical treatment and research in order to improve researcher support of minority participant recruitment and retention in clinical trials as well as to improve health outcomes. Recent studies indicated a disproportionately low number of Latinos and non-Latino Blacks enrolled in HIV/AIDS and other clinical research studies (Penzak SR, 2003, Gifford AL, et al., 2002; Hessol NA, et al., 2001). Proportionate representation of minority populations in research trials is necessary in order to improve research capacity to generalize results to other HIV+ populations and sub-populations, including assessment of potential differences in metabolism, effectiveness, dosage, and administration of new therapies and vaccine development (Feinberg M, 2003; Penzak SR, 2003;

Gifford, AL, et al., 2002; Hessol NA, et al., 2001). The aims of this study are:

  1. To describe and understand the attitudes, beliefs, cultural and social norms, and economic influences relating entry into clinical trials in HIV+ Mexican-origin Latinos.
  2. To conduct formative qualitative research with HIV+ Mexican-origin Latinos to generate testable hypotheses on clinical trials participation.
  3. Based on qualitative work, to create a social cognitive model of participation in clinical trials research and survey a sample of HIV+ Mexican-origin Latinos to test this model.
  4. To develop and pilot test and intervention for improving understanding and acceptance of HIV clinical trials participation by HIV+ Mexican-origin Latinos and their communities.

This study used the Behavioral Model of Health Services Use developed by Andersen, Aday and others (Phillips KA, et al. 1998; Andersen RM, 1995) as the theoretical framework of the study research design to explore and define factors associated with clinical trials participation in HIV+ Latino populations. The model served as an analysis framework to test hypotheses about clinical trials participation. The Behavioral Model of Health Services Use lends itself to incorporation of the unique features of this study’s target population and target behavior, as well as the cultural, binational health care and geographic contexts that are central to the study. Consideration of these unique features within the Model’s framework allowed for greater understanding of the role of patient, provider, system, and environmental-level characteristics of clinical trials participation in a U.S.-Mexico border-dwelling Latino population. This study lead to improved understanding of the pervasiveness and role HIV-related stigma as a barrier to HIV related care, including participation in clinical trials.