Challenges in the conduct of vaginal microbicide effectiveness trials in the developing world. COL 1492 study group

Challenges in the conduct of vaginal microbicide effectiveness trials in the developing world. COL 1492 study group

Ramjee, G., Medical Research Council, Durban, South Africa
Morar, N.S., Medical Research Council, Durban, South Africa
Alary, M., Centre Hospitalier affili universitaire de Qubec, Qubec, Canada
Mukenge-Tshibaka, L., Centre Hospitalier affili universitaire de Qubec, Qubec, Canada
Vuylsteke, B., Project RETRO-CI, Abidjan, Cote d'lvoire
Ettiegne-Traore, V., Project RETRO-CI, Abidjan, Cote d'lvoire
Verapol Chandeying, Assoc. Prof., D. of Obstetrics and Gynecology, F. of Medicine, PSU.
Karim, S.A., Medical Research Council, Durban, South Africa
Van Damme, L., Inst. of Tropical Medicine, Antwerp, Belgium
Corresponding e-mail: Ramjeeg@mrc.ac.za

Grant : UNAIDS
Published : AIDS 2000 Nov 10, 14(16) : 2553-7
Key words : COL 1492, microbicide, female commercial sex workers, HIV prevention

Conducting a phase III trial of a vaginal microbicide in a developing country poses several important and complex ethical challenges. As part of a process to bridge the gap between ethical theory and practice, we share our experiences in performing a phase III trial of COL 1492 (Advan- tage S) among female sex workers at four sites world-wide; Durban, Abidjan, Cotonou and Hat Yai. The ethical challenges included : (i) difficulties in obtaining informed consent. Participants were unable to grasp the concepts of a clinical trial for several weeks to months. In Cotonou, 30% of the women did not know the gel was tested for HIV prevention. Only 25% understood what a placebo was. In Durban, 70% of the women did not fully understand the study after 3 months; (ii) in sustain-ing the use of known HIV prevention strategies. Participants at the Durban site had difficulty in sustaining condom use due to financial and client preferences. Sex without condoms was worth more ($20) than sex with condoms ($10); (iii) in maintaining the confidentiality of the subjectÕs HIV status. Novel approaches such as role plays and emphasis on other exclusion criteria were needed to main- tain the confidentiality of women not included in the trial due to their HIV status; (iv) in providing care and support to the subjects who became infected with HIV during the trial. Women could only be offered routine sexually transmitted disease treatment and counselling. Anti-retrovirals were not offered. The successes and failures of the solutions attempted are described.

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