From rxpgnews.com
USAID awards cooperative agreement to CONRAD for multipurpose prevention study
By CONRAD,
Oct 13, 2011 - 4:00:00 AM
Arlington, VA -- USAID awarded CONRAD a five year project with a $2 million ceiling to focus on testing the safety and effectiveness of the SILCS diaphragm, the one-size-fits-most contraceptive barrier, combined with tenofovir gel -- the only topical product proven to prevent the acquisition of HIV and Herpes Simplex Virus (HSV). If shown to be safe, effective and acceptable, this combination of products would provide women with a non-hormonal contraceptive method under their own control that also delivers protection against HIV and HSV. This award supports Aim 2 of USAID's Biomedical Research for Reproductive Health: to fast track development of reproductive health technologies that can simultaneously prevent unintended pregnancy, HIV, and other sexually transmitted infections.
Results of the SILCS diaphragm contraceptive effectiveness study were announced last month and showed effectiveness rates similar to that of a traditional fitted diaphragm. The benefits of this single size diaphragm include eliminating the need for a pelvic exam to fit the diaphragm, and meeting the contraceptive needs of women unable or unwilling to use a hormonal method.
In a recent landmark effectiveness trial conducted by CAPRISA in South Africa, tenofovir gel was shown to reduce the risk of HIV infection by 39% and HSV by 51%. Confirmatory studies of the gel are ongoing and will support regulatory approval.
Dr. Henry Gabelnick, CONRAD's Executive Director said, We see an urgent need for multipurpose prevention technologies, including non-hormonal methods that are easy to use, and that can be combined with a product that reduces the risk of HIV and HSV infection. This type of reproductive health technology is particularly needed in areas of the world where women need easy to use methods that are within their control.
Almost half of all pregnancies worldwide, estimated to be over 100 million annually, are unintended. In 2008, this resulted in 43 million abortions, half of which were performed under unsafe conditions, leading to almost 100,000 maternal deaths and 5 million women left with temporary or permanent disabilities. The majority of these deaths occur in less developed countries where the AIDS epidemic is most prevalent.
The SILCS diaphragm was developed at PATH, an international nonprofit organization whose mission is to improve the health of people around the world. PATH and CONRAD have collaborated on the validation of the SILC diaphragm for regulatory approval as a contraceptive device. CONRAD has been developing new methods of contraception for men and women for 25 years, including hormonal methods and barrier devices such as the female condom and cervical caps.
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