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02350 INTENTIONS TO BECOME PREGNANT: DATA FROM A FEASIBILITY STUDY FOR A PHASE III MICROBICIDE TRIAL Ouma, Joseph Introduction: Vaginal microbicides are being developed to increase options of preventing HIV transmission. While current products are being investigated for both local and systemic safety profiles in phase I/II clinical trials, there are also potential effects of microbicides use on pregnancy, which also need to be considered when an effectiveness trial is planned. We therefore are investigating the willingness of women to delay pregnancy in a feasibility study for phase III microbicide trials. Objective: To assess womens reported intentions to become pregnant, prevalence of pregnancy, and the willingness of women to delay pregnancy during a feasibility study for a phase III Microbicide trial in rural Uganda. Methods: A cohort of 101 couples (76 HIV sero-discordant and 25 HIV sero-negative concordant) in regular sexual relationships were identified in a serological survey and invited to participate in a feasibility study in preparation for a phase III microbicide trial. Information on pregnancy prevalence and intentions of future pregnancies was collected from all women during the baseline questionnaire survey. Results: Out of the 101 recruited couples, 98 women consented to individual interviews. Their median age was 32 years (range 17 63). 94 (96%) women had ever been pregnant. 14 (15%) reported to be currently pregnant and 5 (6%) were not sure. 65 (66%) of the women said they had no intentions to get pregnant within the next 2 years, 6 (7%) were not sure, while 22 (27%) intended to do so. Of those intending to become pregnant, 13 (60%) expected this to happen within the next 1 to 2 years, 3 (14%) in the next 3 months to one year and 6 (26%) within the next three months. 54 (68%) of the women not currently pregnant were not using any contraceptive because they were either breast-feeding, 13 (24%), or reached menopause 12 (22%), while 18 (33%) said they had no particular reason for using contraception and 11 (20%) wanted to become pregnant. Conclusion: Two thirds of the women in this population have no intentions of becoming pregnant within the next 1 to 2 years, a result that argues for conducting a phase III trial in this population with a follow-up duration of 2 years or less. However, it will be necessary to see how the proportion of actual pregnancies compares with reported intention during the ongoing feasibility study follow-up. Mr. Joseph Ouma |
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