FACTS 001 and Me

February 26, 2015

This post was written by Morenike Folayan, Coordinator with the New HIV Vaccine and Microbicide Advocacy Society and member of the CROI Community Liaison Subcommittee. This is the third in a series of community voice posts from CROI 2015. Read the others here and here.

I sat in the meeting room today listening to the results of the FACTS 001 study. I am sure a number of you must have received mails about what the FACTS study was and what the result of the study is.

AVAC states that: FACTS 001 was a trial of a tenofovir-based vaginal microbicide gel to be used before and after sex among young women in South Africa. The study found no effect for vaginal tenofovir gel overall in the trial. While it appeared that most of the participants used the product at some point, there was not enough correct and consistent use in the trial to provide significant levels of protection. There was a trend of modest protection among the small proportion of women in the trial who appeared to have used the product consistently. This was similar to trends seen in previous studies of tenofovir gel among women, but not enough to change the overall outcome of the trial.

I felt extremely disappointed with the results. I ask myself, where do we go from here? How come the FACTS study has no similitude of efficacy? Why does the result of this study not show any complimentary to the CAPRISA 004 study? How can the IRR be 1.0? How can that be if the women used it even some of the time?

I still remain very unclear about the answers to these questions. I think the answers may come as we move into the future. I know some answers may never come also. I hear that repeatedly during this meeting that FACTS, VOICE and Fem-PrEP studies seem to tell us something. I no longer hear that CAPRISA 004 told us something.

As the researchers meet and think about the interpretation of the results, I have one question for them as someone concerned about ethics? Why were study participants recruited from only (that is what it seems to me) from the low socio-economic strata? The PI seem to imply that the study participants were majorly unemployed (she noted this in a response to a question doing the session) and live in shacks and so may have had challenges with using the gel discretely. Microbicides would be used by women from all socioeconomic strata if found effective. Why is it that the livelihood of the young girls recruited from the study a reason to explain poor adherence. Why are studies not designed to fit into the lives of people; rather we expect the lives of people to fit into our research? Why does the recruitment of study participants into these trials not respect the principle of justice?

More questions I guess. I hope to look for answers as I move forward today. I hope my search does not generate more questions also as I face FACTS.