Results of a safety and feasibility study of the diaphragm used with ACIDFORM Gel or K-Y Jelly

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.