A public cervix announcement: CERVICAL BARRIERS in seven minutes Katy R. Backes Ibis Reproductive Health March 28, 2004 Microbicides Advocates Meeting

Cervical barriers (CBs) What are CBs? Cervical barriers (diaphragms and cervical caps) are latex or silicone cups that fit at the upper end of the vaginal tract, covering the cervix. CBs have a long history as contraceptives. When used with spermicide, they are 60-94% effective against pregnancy.

CBs and HIV/STI prevention The cervix is fragile Entrance lined with delicate cells This layer is only 1 cell thick Preferential site of infection for many STI Bacterial pathogens (gonorrhea, chlamydia) Human papilloma virus Concentration of HIV receptor sites Protection of the upper genital tract Limitations - No protection for the vulva, urethra, and vagina Some researchers are hopeful that cervical barriers may offer some degree of protection against HIV and other STIs. There is a large and growing body of evidence that supports their optimism. -First, the cervix is extremely fragile. The entrance to the cervix is lined with delicate cells which are only 1 layer thick. The vagina, on the other hand, is lined with a tough skin that is 30-40 cell layers thick. -Secondly, the cervix is the preferential site of infection for many STIs, including bacterial pathogens such as gonorrhea and chlamydia as well as human papilloma virus. -Also, new evidence shows a concentration of HIV receptor sites at the entrance to the cervix. -Finally, the cervix is the entryway to the upper genital tract (uterus and fallopian tubes), and covering the cervix will also protect these vulnerable areas from infection Moench T, Chipato T, Padian N. 2001. Preventing disease by protecting the cervix:  the unexplored promise of internal vaginal barrier devices.  AIDS, 15(13):1595-1602.

MIRA Trial What is it? A randomized, controlled trial to measure the effectiveness of the diaphragm used with lubricant gel in preventing HIV infection among women How does it work? All participants receive condoms, safe sex counseling, and STI treatment Half also receive a diaphragm and gel and counseling on use We will compare outcomes between these groups Where is it happening? South Africa and Zimbabwe When will we know the results? By 2007 Research is currently underway to investigate whether or not diaphragm use may reduce transmission of HIV and other STIs. This study is called the Methods for Improving Reproductive Health in Africa (MIRA) trial. Ibis is collaborating with UCSF, UZ, MRC, PHRU to work on this trial. (read responses to questions above)

Research on diaphragm acceptability United States Harvey SM et al. Who continues using the diaphragm and who doesn’t: implications for the acceptability of female-controlled HIV prevention methods. Women’s Health Matters. 2003; 13:185-93. Developing Countries Colombia, Turkey, Philippines Bulut A et al. Assessing the acceptability, service delivery requirements, and use-effectiveness of the diaphragm in Colombia, Philippines, and Turkey. Contraception. 2001 May;63(5):267-75. Brazil do Lago TD et al. Acceptability of the Diaphragm Among Low-Income Women in Sao Paulo, Brazil. International Family Planning Perspectives. 1995 Sep:21(3):114-118. India Ravindran TKS and Rao SS, Is the diaphragm a suitable method of contraception for low-income women: a user perspectives study, Madras India. Zimbabwe (UZ-UCSF) Research into the topic of diaphragm acceptability has been conducted both in the United States and in developing country contexts. In the US, Marie Harvey led a study on the acceptability of the diaphragm among current and former users. She concluded that product characteristics influence continued use and have implications for improving the acceptability of current and future female-controlled HIV prevention methods. Additionally, studies in developing countries such as Columbia, Turkey, Philippines, Brazil, and India have shown that many women find the diaphragm to be an acceptable contraceptive method. In Zimbabwe, the UZ-UCSF collaborative programme in Women's health conducted a study of diaphragm acceptability among sexually active urbanized women who were inconsistent condom users. Their study concluded that, if proven effective against STI/HIV, DA used alone or in combination with a microbicide could provide an acceptable alternative to male condoms in at risk Zimbabwean women. 

Products Diaphragms Cervical caps Other cervical barriers All-Flex, Coil Spring, Semina, Wide Seal Cervical caps Prentif, Oves, FemCap, (Vimule, Dumas) Other cervical barriers Lea’s Shield Female condom – protects against HIV/STI Sponges Products under development (SILCS, BufferGel cup)

**CBAS** The Cervical Barrier Advancement Society (CBAS) aims to raise the profile of cervical barriers both for preventing pregnancy and potentially HIV and other STIs Coming soon: www.cervicalbarriers.org To share information and connect people who are interested in cervical barrier methods, a new organization called the Cervical Barrier Advancement Society has been founded. CBAS aims to raise the profile of cervical barriers both for preventing pregnancy and potentially HIV and other STIs. We plan to launch the CBAS website (www.cervicabarriers.org) sometime in May. We hope that you will visit the site and consider joining the organization, if you are interested. The issue of female controlled HIV prevention is a critical policy issue as well as a critical personal issue. We look forward to continued research on microbicides and cervical barriers and hope that there will soon be more options for women who are at risk.