Influences on HIV-positive individuals' decisions to participate in clinical research

INTRODUCTION: Quality healthcare is grounded in scientifically rigorous and ethically justifiable research. Access to participation in research is essential if research results are to be relevant and applicable to individuals and populations. Underserved minority and/or marginalized individuals with HIV are often underrepresented in HIV/AIDS clinical research, even though they are disproportionately affected by the disease. In a qualitative pilot study, we examined motivations for participating in hypothetical research among underserved minority individuals with or at risk for HIV. In this study, we examine influences on HIV-positive individuals' decisions to take part in actual HIV/AIDS clinical research.

METHODS: The study design is mixed methods, using a quantitative survey and qualitative interviews. This presentation provides preliminary results of the quantitative survey currently being conducted to describe and analyze factors affecting individuals' decisions to take part in clinical research. Using the Health Belief Model as a theoretical framework, we developed Likert-style survey questions to elicit views of 200 participants regarding the influence of illness severity, benefits, barriers, cues to action, and self-efficacy beliefs (defined as “belief in one's ability to control the research process to one's benefit”) on the decision to take part in a clinical research study. The survey will be administered using audio computer-assisted self-interviewing and will be pre-tested in March, 2009. Survey data collection and preliminary analysis will be completed by August, 2009.

ANALYSIS: Data analysis will include descriptive statistics for each variable, and correlations among relevant variables will be determined. Our pilot data have demonstrated that participants view pharmaceutical studies as involving greater risk than behavioral research; therefore, group comparisons of variables will be made between participants in pharmaceutical studies and those in behavioral studies. Multiple logistic regression analyses will determine relationships between independent variables (e.g., perception of illness severity, trust, health literacy, etc.) and the dependent variable of type of research.

CONCLUSION: We expect that decisions to participate in HIV/AIDS clinical trials will be influenced by individual evaluations of burdens, barriers, and cues to action. However, as demonstrated in studies of participation in cancer clinical trials, we hypothesize that individuals' perceptions of their disease severity will play an important additional role in decision-making. Studying decisions to participate can identify influences that promote and impede individuals' participation in clinical trials. Future research will identify interventions to enhance participation so that underserved individuals will have access to the same benefits of participating in research that others receive.