Gelling medical knowledge: innovative pharmaceuticals, experience, and perceptions of efficacy

Abstract

As new pharmaceutical products to combat the acquisition of HIV are produced, their clinical efficacy is determined through large-scale clinical trials. Trial participants, however, also independently evaluate the effectiveness of these technologies. During a phase III microbicide clinical trial in Johannesburg, South Africa, female participants acknowledged that although the gel had not yet been clinically proven to be efficacious, they believed that it was capable of healing infections, cleansing the vagina, increasing fertility, and preventing HIV. These responses were informed by experiences of gel use coupled with ideas regarding the flow of bodily fluids and the removal of dirt for bodily cleanliness and the maintenance of health. Examining participant responses to the gel provides insight into the relationship between knowledge and experience when utilizing previously unfamiliar biotechnologies.

Keywords:

• HIV/AIDS
• pharmaceuticals
• clinical trials
• South Africa

Acknowledgements

This study was funded by a grant from the UK Department for International Development (DFID), administered through the Medical Research Council's Clinical Trials Unit.

Research assistance was provided by Mdu Mntambo, Elisa Shikwane, Sello Seoka, and Florence Mathebula of the Reproductive Health and HIV Research Unit.

The authors acknowledge the assistance of the MDP Team and the participation of the women and men of the Johannesburg MDP301 site in the research.

The research was granted ethical clearance by the Human Research Ethic Committee (Medical) of the University of the Witwatersrand (Reference 050108) in November 2003.

Conflict of interest: none.

Notes

1. The information and conclusions that we generated were shared with the MDP 301 managers throughout the duration of the trial.

2. An abridged list of standard interview questions relating to the issues discussed in this paper can be found in the appendix.

3. Fourteen of the focus groups were with community residents not participating in the trial.

4. Although an anonymous reviewer suggested a discussion of the placebo effect, the trial is double blind and we are unaware which women actually received the placebo. While it is unlikely that every woman who claims to have an active gel does so, we cannot disprove their assertions. Consequently, we do not wish to dismiss all local experiences as simply ‘in the mind’ when, in fact, there could be some chemical basis for them.

5. A phase I study of PRO 2000 showed that a 4% concentration did produce higher rates of epithelial adverse events than lower dosages (van Damme et al. 2000).

6. In another microbicide trial, participants also reported believing that they thought that the placebo would be watery (Family Health International 2008).

7. There is no evidence to suggest that women who asserted that they were given the placebo used it less frequently when having intercourse than those who believed they were given an active gel.

8. Ukungcolo (isiZulu) and ditshila (seSotho) have been translated as ‘dirt’.

9. Out of an enrolment of approximately 1800 women, 229 pregnancies were reported.

10. Given the limited space, issues relating to rumours and sociality surround gel use, and narratives will be discussed in detail in a future publication.

11. We have no evidence that suggests that women used condoms less because they believed the gel was efficacious as an HIV prevention method.