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Better dialogue needed among at-risk populations in HIV clinical trials
Newman PA. Am J Public Health. 2011;101:1749-1758.
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Public discourse on HIV vaccine research is needed to interpret complex clinical trial processes and outcomes regarding existing beliefs and experiences, and to support effective communication and meaningful community engagement among at-risk populations, according to Peter A. Newman, PhD, and colleagues.
Newman, of the University of Toronto Faculty of Social Work, and colleagues used qualitative methods and a community-based approach to assess how at-risk populations interpreted the HIV-1 Step Study and subsequent implications for willingness to participate in and community support for HIV vaccine research. The Step Study was terminated early.
“In order to find a vaccine for HIV, it’s essential to have the participation of those in at-risk communities for vaccine trials,” Newman said in a press release. “Our study shows that we’re not doing enough to adequately communicate the processes and outcomes of HIV vaccine trials to most at-risk populations. There is still a lot of misinformation, distrust and misunderstanding out there, which could ultimately lead to people in high-risk communities refusing to participate in trials.”
From September 2007 to September 2008, nine focus groups (n=72; six in Toronto and three in Ottawa) were conducted among ethnically and sexually diverse populations. The researchers also conducted six key informant interviews with community advocates and health care providers.
The researchers observed common themes in the aftermath of the Step Study:
- Fear of vaccine-induced infection;
- Targeted recruitment of vulnerable participants; and
- Mistrust and conspiracy.
“We found that there is a general altruism toward HIV vaccine trials in these communities, and a feeling that people should participate for the greater good,” Newman said. “But there is also a lot of overriding confusion and misunderstanding, which illustrates a clear need for medical researchers and health professionals to do a better job of communicating with at-risk communities before, during and after trials.” – by Ashley DeNyse
Disclosure: This research was supported in part by the Ontario HI Treatment Network (grant ROGB169) and the Canada Research Chairs Program.
The Step Study showed that the vaccine did not prevent HIV-1 or reduce viral load. The study was shutdown early, because vaccine recipients had a higher rate for infection. Many critics have opined a priori that failed HIV vaccine trials would negatively affect the ability to recruit subjects for future trials. This study of Canadian at-risk individuals provides valuable insight on their perceptions and views to the shutdown. According to the data, although the Step Study was well designed and investigators acted promptly to halt the trial, a deep rift has developed between the at-risk community and HIV vaccine researchers. It is not yet clear if the damage is permanent. Some participants felt an air of social injustice and even likened the Step Study to unethical medical research. On the other hand, some participants did understand the need to target vulnerable participants. To include study participants that are at high-risk for contracting HIV in an HIV vaccine trial may seem obvious to an investigator, but some participants viewed it as discriminatory and conspiring. However, it is encouraging to see that the shutdown did not alter some participants' support for HIV vaccine research. Many participants continued to express altruism as a motivator for participation in future research. Their unfaltering optimism is encouraging.
Future HIV vaccine research is a must and thus so is community support. One takeaway from 'Speaking the Dialect: Understanding Public Discourse in the Aftermath of an HIV Vaccine Trial Shutdown' is that increased discourse with participants in the pre-trial stage and more meaningful community engagement will help. Conversations to help participants understand vaccine design will make them feel less betrayed and mistrustful if an unforeseeable problem occurs. Also, future trial developers, noting the findings of unbalanced distrust in certain communities, can direct pre-trial education. The Step Study was scientifically a failure. However, some good can come from this. The researcher's insightful, qualitative analysis of individuals at high-risk for HIV acquisition will allow future trial designers to better educate and recruit subjects.
– Stephen M. Smith, MD
Infectious Disease News Editorial Board member
– Erin M. Murphy, PA-C, MMS, MPH
The Smith Center for Infectious Diseases and Urban Health
Disclosure: Drs. Smith and Murphy report no relevant financial disclosures.
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