Population Council Research that makes a difference

Barbara Friedland

Ensuring informed consent and voluntary participation is one of the most complicated aspects of conducting any clinical trial. But what makes microbicides trials even more difficult is that we are dealing with HIV, which remains highly stigmatized in many of the countries where trials are being conducted. Microbicides trials also involve other sensitive issues like sexuality and gender-based power dynamics. And, because large-scale efficacy trials must be conducted in areas with high incidence of HIV, healthy volunteers must be recruited from populations that are economically vulnerable and at substantial risk of HIV infection. As researchers, we must do our best to protect participants by providing counseling on safer sex practices, while reinforcing that the efficacy of the test product is unknown, so that participants do not have a false sense of protection. 

A number of practical issues add to the complexity of the informed consent process in these settings. The concept and experience of informed consent—where a researcher gives information to a potential study participant so that he or she can make a decision about joining a trial—may be foreign to people in many places where microbicide trials are being conducted. Trial objectives and procedures are complex and can be difficult to understand, especially for people who are unfamiliar with medical research. A particularly challenging issue is the lack of translations for the research lexicon; many terms, such as "placebo," "randomization," and especially "microbicide" do not exist in local languages, which makes it a daunting task to translate informed consent forms and other educational materials and to effectively communicate concepts that are difficult to understand. 

For the past 12 years, starting when I was the study coordinator for Council microbicides trials in South Africa and Thailand, I have worked to equip people with information so they can make informed choices about trial participation, and present this information in a way that is meaningful to them. I conducted several studies to improve the informed consent form and process before, during, and after a Phase 2 trial of the Council’s candidate microbicide, Carraguard®, in South Africa. Based on results of these studies, I developed a study booklet and educational video for women participating in our Phase 3 Carraguard trial, also in South Africa. We created the video at the recommendation of trial participants, since many women had never had a pelvic exam prior to enrolling in the trial and they felt that seeing it in a video would have prepared them better. It was incredibly rewarding for me to hear from trial staff how this video gave women a starting point from which to ask questions—rather than the blank stares they used to get when they asked women if they had questions. The video has also been an effective tool for educating clinic staff—both for the Carraguard and other microbicides trials—and community groups. 

Building on the success of the Carraguard video, the Council and the International Partnership for Microbicides recently launched an educational video that can be used for microbicides trials in different countries and languages. Hope Against HIV: Microbicide Trials in Your Community is designed for use in Africa and introduces concepts that apply to all microbicides trials. The video is targeted to prospective trial participants, as well as community members, policymakers, and clinic personnel where products will be tested. It is my hope that this latest resource will be widely used and will help increase research literacy in the trial communities. Ideally, the video will help people understand that trial participation—whether for a microbicide or any other product—is an individual choice to be made after carefully weighing the risks and benefits of the study.