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

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


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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Anti-Infective Agents, Local / administration & dosage
  • Anti-Infective Agents, Local / adverse effects*
  • Cellulose / administration & dosage
  • Cellulose / adverse effects
  • Cellulose / analogs & derivatives*
  • Contraceptive Devices, Female / adverse effects*
  • Feasibility Studies
  • Female
  • Glycerol / administration & dosage
  • Glycerol / adverse effects*
  • HIV Infections / prevention & control*
  • Humans
  • Intention to Treat Analysis
  • Middle Aged
  • Patient Acceptance of Health Care
  • Patient Compliance
  • Patient Satisfaction
  • Phosphates / administration & dosage
  • Phosphates / adverse effects*
  • Propylene Glycols / administration & dosage
  • Propylene Glycols / adverse effects*
  • South Africa
  • Statistics, Nonparametric
  • Surveys and Questionnaires
  • Treatment Outcome


  • Anti-Infective Agents, Local
  • K-Y jelly
  • Phosphates
  • Propylene Glycols
  • Cellulose
  • Glycerol