Results of a safety and feasibility study of the diaphragm used with ACIDFORM Gel or K-Y® Jelly
Received 14 April 2009; received in revised form 15 October 2009; accepted 27 October 2009. published online 23 November 2009.
Abstract
Background
New strategies are needed for preventing HIV infection in women. One potential approach is female-initiated use of an effective topical microbicidal gel in combination with a cervical barrier such as the diaphragm.
Study design
Randomized, placebo-controlled safety and feasibility trial of diaphragm with vaginal gel during 6 months of use among 120 HIV-negative sexually active women in Johannesburg, South Africa.
Results
Pelvic event rates were 338.3 and 247.1 per 100 women-years in the ACIDFORM gel (plus diaphragm) and K-Y® Jelly (plus diaphragm) groups, respectively, with a rate ratio of 1.37 (95% CI: 0.89–2.11). Most women found diaphragm with gel use acceptable.
Conclusion
There was a trend towards more safety events in the ACIDFORM plus diaphragm group, although no primary comparisons achieved statistical significance. Adding an effective microbicidal gel to a mechanical barrier may still prove to be an important and acceptable combination method to help prevent pregnancy and HIV/sexually transmitted infection transmission.
aReproductive Health and HIV Research Unit (RHRU), University of the Witwatersrand, Hugh Solomon Building, Hillbrow Health Precinct, Johannesburg, 2001, South Africa
bFamily Health International (FHI), Research Triangle Park, NC 27713, USA
cCONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA
dSpecialized Molecular Diagnostics Unit, National Institute for Communicable Diseases (NICD), Modderfontein Road, Sandringham, Johannesburg 2131, South Africa
ABSTRACT