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

von Mollendorf, Claire E.; Van Damme, Lut.; Moyes, Jocelyn A.; Rees, Vera Helen; Callahan, Marianne M.; Mauck, Christine K.; Puren, Adrian J.; Tweedy, Kathryn; Taylor, Doug

doi:10.1016/j.contraception.2009.10.011

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Volume 81, Issue 3 , Pages 232-239, March 2010

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

Claire E. von Mollendorf
- Reproductive Health and HIV Research Unit (RHRU), University of the Witwatersrand, Hugh Solomon Building, Hillbrow Health Precinct, Johannesburg, 2001, South Africa
- Corresponding author. Tel.: +27 11 358 5500; fax: +27 11 358 5400.
Lut. Van Damme
- Family Health International (FHI), Research Triangle Park, NC 27713, USA
Jocelyn A. Moyes
- Reproductive Health and HIV Research Unit (RHRU), University of the Witwatersrand, Hugh Solomon Building, Hillbrow Health Precinct, Johannesburg, 2001, South Africa
Vera Helen Rees
- Reproductive Health and HIV Research Unit (RHRU), University of the Witwatersrand, Hugh Solomon Building, Hillbrow Health Precinct, Johannesburg, 2001, South Africa
Marianne M. Callahan
- CONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA
Christine K. Mauck
- CONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA
Adrian J. Puren
- Specialized Molecular Diagnostics Unit, National Institute for Communicable Diseases (NICD), Modderfontein Road, Sandringham, Johannesburg 2131, South Africa
Kathryn Tweedy
- Family Health International (FHI), Research Triangle Park, NC 27713, USA
Doug Taylor
- Family Health International (FHI), Research Triangle Park, NC 27713, USA

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.

Keywords: Diaphragm, ACIDFORM Gel, K-Y® Jelly