Clinical trials for an HIV cure need a comprehensive, transparent engagement plan that includes educating all possible stakeholders, said Jessica Salzwedel of AVAC during a recent Stakeholder Engagement webinar based on the CUREiculum, a set of tools developed by a number of HIV organizations that provide information on HIV cure research. Salzwedel distinguished between good clinical practice (GCP), which governs the relationship between a researcher and a clinical trial participant, and good participatory practice (GPP), which guides how research teams interact with clinical trial stakeholders.
Stakeholders include not only those funding clinical research, ministries of health and the like, but also the trial participants' families and the staff at the trial site, said webinar speakers. Participating in a clinical trial is not an isolated event, but must be seen in the context of other issues the participant may be facing, such as discrimination or a lack of stable housing. Salzwedel called this set of possibly competing priorities the "landscape of engagement." Good engagement not only focuses on the medical issues surrounding the trial but is a dialog between the participants and research staff, said a webinar participant identified as Ebony. That dialog must be characterized by respect, mutual understanding, integrity, transparency, accountability and community stakeholder autonomy, Salzwedel added. Possible social harm to trial participants, such as loss of employment due to absences for frequent trial site visits, must also be taken into account.
Another problem with informing stakeholders and the general public about HIV cure research is the erosion of trust that may result from inaccurate headlines in "fast media," very quick news media coverage of stories developing online. A cautionary tale here is the experience with a 2009 microbicide trial in Zambia, whose flat results were inaccurately commented on by a blogger, which in turn was picked up by local media and started a storm of rumors about this particular trial, resulting in significant difficulties in obtaining permission for further clinical trials.
Such coverage is sometimes compounded by HIV advocates themselves, who focus on slogans rather than on health literacy, Ebony emphasized. For example, the distinction between having an undetectable viral load (Magic Johnson) and being cured of HIV (Timothy Brown) may be lost in the media coverage surrounding these two men.
This is why an engagement plan is needed for a clinical trial, Salzwedel said. It should include not only a communication component that spells out policies and strategies for disseminating research information, but also an educational component that promotes "research literacy" -- understanding the basic vocabulary used by researchers, as well as the implications of the trial for oneself and the wider public. To this end, the process for obtaining informed consent must also assess the trial participants' comprehension of these issues in a locally appropriate form and may also need to include consent from their partners.
The next two webinars in this series will focus on early antiretroviral therapy and the ethics of HIV cure research.