Understanding the Role of Social Science Research in Clinical Trials
What can researchers learn from studying communities in preparation for AIDS vaccine clinical trials?
Volunteers are an essential component of AIDS vaccine clinical trials. Without the many individuals who are willing to participate in clinical studies, researchers would not be able to test candidate vaccines and determine if they are safe and effective. Recruiting thousands of volunteers for large Phase III efficacy trials is a daunting task. One way to effectively reach and engage potential volunteers for clinical trials is to gain a better understanding of the communities in which trials will take place. This is sometimes accomplished by conducting social science research.
Social science research, as its name implies, involves the study of human behavior and relationships. While more subjective than virology or immunology, social science research can include behavioral, health policy, and health systems research, as well as social epidemiology.
Social scientists have been studying HIV since the beginning of the epidemic. HIV is most often transmitted through sexual activity or injection drug use, and so developing a better understanding of the societal impact and drivers of the pandemic has been crucial to understanding HIV, particularly with regard to prevention. Social science research can also be used to collect information that can help ensure that AIDS vaccine clinical trials are conducted successfully.
Supporting volunteer recruitment and retention
If a trial is designed to show whether a particular candidate vaccine is effective at preventing HIV infection, individuals who participate in the trial must be at risk of HIV infection through natural exposure to the virus (see VAX May 2008Primer on Understanding the Recruitment of Volunteers at Risk of HIV Infection). Importantly, volunteers in a vaccine trial are never purposely exposed to HIV and the vaccine candidates cannot cause HIV infection.
To ensure that at-risk volunteers are included, clinical trials are often conducted in areas where the rate of new HIV infections or incidence is highest. It is also in these areas or specific populations—such as men who have sex with men (MSM) or commercial sex workers—that a vaccine is needed most and would ultimately offer the greatest benefit, and so it is therefore important that these individuals are part of the clinical process.
Social scientists have employed in-depth interviews, focus groups, and anonymous surveys to gain information about these at-risk populations. To make sure the tools being used to collect the data—such as a questionnaire—are scientifically rigorous enough, social scientists will sometimes use independent auditors to review the language in the questionnaire and the method and settings in which the questions are asked.
The information collected from these surveys or interviews helps researchers identify factors that may impede recruitment, enrollment, and retention of at-risk individuals in clinical studies. There are different factors within these populations that affect a person’s vulnerability with regard to HIV, and understanding these factors can help make the recruitment and enrollment process for clinical trials run more smoothly.
Several groups involved in AIDS vaccine research and development are currently engaged in social science research, including IAVI, the Kenya AIDS Vaccine Initiative, the Uganda Virus Research Institute, the Desmond Tutu HIV Foundation, the Aurum Institute, and the US National Institute of Allergy and Infectious Diseases, as well as many others. This research is helping to determine, for example, if certain populations are suitable for upcoming vaccine trials. Other research is focused on identifying barriers and opportunities for involving MSM or transgendered communities in HIV prevention research.
Gender issues
One particularly important avenue of social science research has focused on the role of gender in the HIV pandemic, and in AIDS vaccine research and development more specifically. Biological distinctions between men and women may impact the efficacy of a vaccine. Also, because HIV prevalence is so high among women, particularly in southern Africa, it is important that AIDS vaccine candidates be tested in adequate numbers of female volunteers (see VAXMarch 2008 Primer on Understanding the Recruitment and Retention of Women in Clinical Trials).
Social science research can help assess the barriers that discourage women in developing countries from participating in clinical trials. This knowledge can enable researchers to develop strategies that are aimed specifically at enrolling women. For instance, in a Kenyan study conducted by IAVI and the International Center for Research on Women, social scientists discovered that women were more vulnerable to HIV stigma than men, which may have affected their willingness to participate in a clinical trial. The study found that while men and women were both concerned that participating in a trial could potentially damage their personal relationships, the concern loomed larger for women, who are more likely to be dependent on a relationship for economic reasons.
By building a better understanding about the fears women and men have about clinical trials and HIV/AIDS and how their decision making processes may differ, researchers can hopefully strengthen outreach, recruitment, retention, and support systems within the context of AIDS vaccine clinical trials.