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133rd Annual Meeting & Exposition December 10-14, 2005 Philadelphia, PA |
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Terri L. Walsh, MPH, Karen Peacock, MA, and Ron Frezieres, MSPH. Research Division, California Family Health Council, Inc, 3600 Wilshire Boulevard, Suite 600, Los Angeles, CA 90010, 213-386-5614, peacockk@cfhc.org
The dual public health imperative of preventing HIV infection while providing contraception has increased research efforts to develop a microbicide with spermicidal activity. At least 3 microbicides have reached Phase II-III clinical trials. The evaluation of the contraceptive efficacy of methods used at the time of intercourse is complicated by the many ways participants can fail to follow study instructions. These include having unprotected intercourse, substituting less effective methods (withdrawal), substituting more effective methods (condoms), and combining non-study methods (withdrawal, condoms). Since these behaviors can either increase or decrease the probability of pregnancy, it is difficult to assess the true contraceptive efficacy of the microbicide used alone. We present multiple strategies for meeting this challenge. We will show how study participation can be divided into menstrual cycles that are classified so as to avoid overestimating or underestimating typical-use and consistent-use pregnancy rates. We will also include examples of coital logs/diaries that contain sufficient detail to estimate the pregnancy risk for each menstrual cycle of microbicide use.
Learning Objectives: After attending the session, the participant will be able to
Presenting author's disclosure statement:
I wish to disclose that I have NO financial interests or other relationship with the manufactures of commercial products, suppliers of commercial services or commercial supporters.
The 133rd Annual Meeting & Exposition (December 10-14, 2005) of APHA