Trial studies likely to fail if community not actively involved in study set up
A recently published study about the failure of the Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial in the New England Journal of Medicine, argues that the negative outcome of the study was not associated with the non-effectiveness of the product, but the participants deceit and lack of compliance. The VOICE trial was abruptly stopped after independent safety monitors concluded that the women who were given the pills and vaginal gels containing antiretrovirals (ARVs) were becoming infected at the same rate as women who were given a placebo. The trial researchers are holding the study participants responsible for the disappointing results of the research, stating that the women did not always disclose that they had not used the interventions, and handed in pill bottles and applicators that appeared to have been used, even though blood testing did not show any traces of the drugs.
This surprising failure of a large clinical trial with a new HIV prevention method in Africa has opened debate of how to run trial research studies in resource limited countries. Researchers not related to the VOICE trail argue over whether the participants were to blame for the study failure, or if the research failed because of bad research design, which did not taking into account the complex social and behavioral aspects which are related to compliance in this specific study.
It is argued that to implement successful studies there must be an understanding of the daily routines and methods which work best for women in stressful daily conditions. The VOICE trial shows that women will not use the proposed product if it does not fit into their daily routine, and will continue to be at risk for HIV. In any clinical trial it is important that the researchers build trust and respect within the research population. The introduction of any new innovative treatment-based intervention also requires community involvement and rigorous assessment of the normal practices within the target group. That this is important is shown in the success of the CAPRISA 004 microbicide trial. This study reviews the normal practice of women first, before advising people how to use the product, and established an interactive feedback system to see if women were using the product. The VOICE triallacked sufficient community involvement.
What could be learned from the VOICE trial is that bottom-up research is needed to make studies successful. Although it is known that this will take time and cost money, it might be the key to making a trial a success or a failure. Donors and funders need to be aware of these challenges, a make a significant part of the budget available to invest in local participation. As we have learned from decades of HIV research, and as we recently experience with the Ebola outbreak, without ongoing community involvement, it is not possible to effectively address an epidemic.