Challenges in the conduct of vaginal microbicide effectiveness trials in the developing world

Conducting a phase III trial of a vaginal microbicide in a developing count ry poses several important and complex ethical challenges. As part of a pro cess to bridge the gap between ethical theory and practice, we share our ex periences in performing a phase III trial of Col 1492 (Advantage S) among f emale sex workers at four sites worldwide; Durban, Abidjan, Cotonou and Hat Yai. The ethical challenges included: (i) difficulties in obtaining inform ed consent. Participants were unable to grasp the concepts of a clinical tr ial 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 w as. In Durban, 70% of the women did not fully understand the study after 3 months; (ii) in sustaining the use of known HIV prevention strategies. Part icipants 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 th e subject's HIV status. Novel approaches such as role plays and emphasis on other exclusion criteria were needed to maintain the confidentiality of wo men not included in the trial due to their HIV status; (iv) in providing ca re and support to the subjects who became infected with HIV during the tria l. Women could only be offered: routine sexually transmitted disease treatm ent and counselling. Anti-retrovirals were not offered. The successes and f ailures of the solutions attempted are described. (C) 2000 Lippincott Willi ams & Wilkins.