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Contraception. 2010 Mar;81(3):232-9. doi: 10.1016/j.contraception.2009.10.011. Epub 2009 Nov 22.

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

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1
Reproductive Health and HIV Research Unit, University of the Witwatersrand, Hugh Solomon Building, Hillbrow Health Precinct, Johannesburg, South Africa. cvonmollendorf@rhru.co.za

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(R) 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.

[Indexed for MEDLINE]

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