Misperceptions regarding HIV protection in vaginal microbicide clinical trials

A number of vaginal microbicides that could decrease the rate of HIV transmission are currently under development and in different clinical trial phases. There are a number of different issues with how to run these trials, ranging from the women who participate being perceived as sex workers or ‘loose,’ to whether it is ethical to stop providing treatment once a trial is over for people who sero-convert during the trial, to whether including contraceptive properties as part of the microbicide will affect the utilization, and finally to whether the use of microbicides will cause a drop in condom use.

One of the reasons for developing vaginal microbicides is to provide women with a tool for protecting themselves when their partners refuse to use condoms. One of the difficulties in developing vaginal microbicides is addressing many different cultures’ requirements; people in some countries prefer ‘dry sex’ (little lubrication), others prefer more lubricated sex; some would avoid a vaginal microbicide that includes contraception, while others would welcome it. A number of different studies have been performed, just to examine and address preferences like these.[1]^,[2],[3]

In a study that evaluated participants’ perceptions of a candidate microbicide product, a disturbing trend was noted.[4] In this study, though the participants were counseled on what the microbicide could do and did not do, and how important it was to use condoms, the participants’ perception was that by using the gel, they were doing something for their health, regardless of the microbicide’s actual efficacy. In fact, in this particular trial, the microbicide was demonstrated to be ineffective, but there was a persistent belief that it was effective nonetheless, leading to a decreased reliance on condoms.

In many of the cited studies, preferences have been expressed that participants would rather use the microbicide than a condom, even when it has been explained that both are needed for optimum safety.

This is something that people who are running current and future trials need to be intimately aware of; the perception that the gel is so efficacious that condoms do not need to be used, even when it has been carefully explained otherwise, is so strong that if careful steps are not taken, the participants may endanger themselves more than the microbicide can protect them.

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[1] Bentley ME, et al. Acceptability of a microbicide among women and their partners in a 4-country phase I trial. Am J Public Health. 2004; 94(7): 1159 – 1164.

[2] Braunstein S, van de Wijgert J. Preferences and practices related to vaginal lubrication: Implications for microbicide acceptability and clinical testing. J Women’s Health. 2005; 14(5): 424 – 433.

[3] Ramjee G, et al. Accetability of Carraguard, a candidate microbicide and methyl cellulose placebo vaginal gels among HIV-positive women and men in Durban, South Africa. AIDS Research & Therapy. 2007; 4:20.

[4] Mantell JE, Morar NS, Meyer L, Ramjee G. “We have our protector”: Misperceptions of protection against HIV among participants in a microbicide efficacy trial. Am J Public Health. 2006; 96(6): 1073 – 1077.