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The following studies are listed in reverse chronological order based on the start date of the study. Contraceptive Effectiveness and Safety Study of the SILCS Diaphragm: The Pivotal Study Providers' Perceptions of the Diaphragm in Southern Africa and the United States An Exploratory, Non-Blinded, Single Center, Randomized, Cross-Over MRI Study of the Delivery of Microbicide by the SILCS Diaphragm Location: University of Pennsylvania, United States Started in 2009, the primary objective of this study is to assess the feasibility of the SILCS diaphragm as a microbicide delivery system and to assess overall user acceptability. Secondary objectives include assessing the gel coverage of the upper vagina (above the pelvic diaphragm) and the entire vagina using three methods of application, assessing distribution of the gel before and after simulated intercourse (immediately after and 6 hours after), and assessing the initial acceptability of the SILCS microbicide delivery system as opposed to pre-filled applicators. Nine women will participate in this study and BufferGel® will be used with the SILCS diaphragm. This study is being conducted by PATH; the University of Pennsylvania Women’s Health Clinical Research Center; and The Miriam Hospital/Brown University Centers for Behavioral & Preventive Medicine, and is funded by USAID. A Randomized, Cross-Over, Couples’ Use Acceptability Study of the SILCS Diaphragm Microbicide Delivery System Location: Los Angeles, United States Started in 2009, the primary objective of this study is to assess the feasibility and acceptability of the SILCS diaphragm as a microbicide delivery system compared to microbicide delivered by a vaginal applicator when used during sexual intercourse. Secondary objectives include assessing preference for applying microbicide gel via the SILCS diaphragm or the microbicide applicator, assessing the relationship between gel application technique and impact on user acceptability, and assessing user perspective of additive value of using SILCS diaphragm to deliver microbicide gel for dual protection. Thirty-six women will participate in this study and BufferGel® will be used with the SILCS diaphragm. This study is being conducted by PATH and the California Family Health Council and is funded by USAID. An Acceptability and Safety Study of BufferGel Duet® among African Women in Relation to its Possible Future Use to Prevent HIV Infection Location: Zimbabwe The BufferGel Duet® Acceptability and Safety Study is an open-label crossover study conducted in Zimbabwe among 100 healthy, sexually active women. The study aims to assess the acceptability and safety of Duet® used as a delivery method of the candidate microbicide BufferGel for the prevention of HIV infection. Two approaches to using BufferGel Duet® are investigated: coital use and daily use. Questionnaires and qualitative interviews will be used to assess acceptability and preference for either daily or coital use and safety will also be assessed. Information from this study will be used to inform the design of future effectiveness trials. Data collection was completed in June 2009. Key Findings: Expected September – December, 2009. This study is being conducted by RTI International (San Francisco Project Office) and the University of Zimbabwe – University of California, San Francisco Collaborative Programme. Contraceptive Effectiveness and Safety Study of the SILCS Diaphragm: The Pivotal Study Location: United States The contraceptive diaphragm was widely used in the United States in the mid 20th century but use has decreased in recent years. Novel female-controlled barrier methods with dual method potential are essential contraceptive options for women. A single-size diaphragm available over-the-counter would be an ideal microbicide delivery systems for HIV/STI prevention. In 1994, PATH, an international nonprofit organization based in Seattle, began the development of a single-size silicone contraceptive diaphragm with extensive input from users and clinicians to identify and address necessary improvements over the currently available and approved diaphragms. The SILCS diaphragm was developed based on user evaluations in multiple sites in the US. Additional testing was performed in South Africa, Thailand, and the Dominican Republic to confirm user acceptance. Recent results of a study using magnetic resonance imaging to evaluate the fit of the SILCS in vivo indicate that the device fits women of varying parities and body sizes (See Yang et al. 2007 below). In a postcoital study enrolling 20 couples, the SILCS diaphragm used with nonoxynol-9 during intercourse prevented progressively motile sperm from reaching cervical mucus. A study designed to determine the contraceptive effectiveness of the SILCS device in 450 sexually active couples began enrolling in February 2008 at six different sites in the United States. This study is being conducted by CONRAD, a nonprofit organization that operates within the Eastern Virginia Medical School, with funds provided by the United States Agency for International Development (USAID). Participants in the study are randomly assigned to use one of two gels (either BufferGel®, which is currently in development as a contraceptive; or Gynol II®, which is an FDA-approved contraceptive gel) along with the SILCS diaphragm for a period of six months and at least six menstrual cycles. All 450 couples have been enrolled as of February 2009, and the study is expected to be completed by 2010. Related Publications: Yang C, Maravilla KR, Kilbourne-Brook M, Austin G. Magnetic resonance imaging of SILCS diaphragm: anatomical considerations and corroboration with clinical fit. Contraception 76:3 (2007) 238-244. Providers' Perceptions of the Diaphragm in Southern Africa and the United States Key Informant Interview and Survey Study Location: United States, South Africa, and Zimbabwe Started in 2004, the objective of this ongoing study is to evaluate providers’ perceptions of the diaphragm and their counseling practices for HIV and pregnancy prevention. Approximately 3,600 physicians and nurses are being enrolled in this study. Participants are residents in training, retired, or holding research-only positions, as well as reproductive endocrinologists and maternal-fetal medicine specialists. Key Findings: This study is not yet completed. Results are expected in 2009. This study is being conducted by researchers at the University of California, San Francisco and Ibis Reproductive Health and is funded by NICHD.
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