Preparing for clinical trials with vaginal rings that protect women from HIV and unintended pregnancy (THE RING PLUS PROJECT)

On the eve of the introduction of long-term combination HIV prevention/contraception vaginal rings in Africa, we need to improve our knowledge about the attitude of women in Africa towards the ring and to assess the effect of the ring on the vaginal microbiome.

The overall aim of this trial is to provide data on the acceptability of the vaginal ring in Rwanda and on the effects of such ring on the vaginal microbiome. A clinical trial will be conducted among two groups of study participants: one group will use a contraceptive vaginal ring for three weeks followed by one week off (intermittent users); the other group will use each contraceptive vaginal ring for three weeks and insert a new contraceptive vaginal ring immediately (continuous users). Both groups will use the contraceptive vaginal ring during a period of three menstrual cycles. Specimens will be analysed to characterize the vaginal microbiome. The vaginal rings will be collected after use and analysed for bacterial adherence and potential biofilm formation.

Women’s’ acceptability and adherence will be assessed using a mixed methods approach. The results of this project will inform the possible, future introduction of a combination HIV prevention/contraception vaginal ring in African women.