Rationale: HIV can infect several cell types found in womens' genital tracts, including cells found in high concentrations in the cervix (the opening to the uterus). Protecting the cervix from exposure to HIV is therefore a potential HIV risk-reduction strategy. To test this hypothesis, the MIRA trial looked at whether the use of the contraceptive diaphragm, which covers the cervix, reduced the risk of HIV infection in women via vaginal sex.
Study Questions: The study was designed to measure the effectiveness of the Ortho All-Flex® diaphragm used with Replens® lubricant gel in reducing risk of HIV infection among women.
Participants: 4,500 HIV-negative women
Countries: South Africa and Zimbabwe
Trial sponsors and collaborators: Bill & Melinda Gates Foundation, University of California at San Francisco
When were results released? Results were announced July 2007. There was no evidence of benefit, nor any difference in rates of infection between the two groups. However, even though women who received the diaphragm plus the standard prevention package (treatment for sexually transmitted infections, condoms, and behavior change counseling) reported less frequent condom use than women who received the standard prevention package alone, the two groups had similar rates of HIV infection. Some researchers have suggested that this may mean that a diaphragm plus the standard prevention package can provide a level of protection that's comparable to that seen in women using condoms plus the standard prevention package.
To learn more visit:
http://www.thelancet.com/journals/lancet/article/PIIS0140673607609507/fulltext?iseop=true
http://www.avac.org/pdf/mira_carraguard.pdf