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


METHODS
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.


CONCLUSIONS
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.
Reproductive Health and HIV Research Unit, University of the Witwatersrand, Hugh Solomon Building, Hillbrow Health Precinct, Johannesburg, South Africa. cvonmollendorf@rhru.co.za
Claire E
CE
von Mollendorf
Lut
L
Van Damme
Jocelyn A
JA
Moyes
Vera Helen
VH
Rees
Marianne M
MM
Callahan
Christine K
CK
Mauck
Adrian J
AJ
Puren
Kathryn
K
Tweedy
Doug
D
Taylor
D000293:Adolescent; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage / Q000009:adverse effects*; D002482:Cellulose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003274:Contraceptive Devices, Female / Q000009:adverse effects*; D005240:Feasibility Studies; D005260:Female; D005990:Glycerol / Q000008:administration & dosage / Q000009:adverse effects*; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D057194:Intention to Treat Analysis; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010349:Patient Compliance; D017060:Patient Satisfaction; D010710:Phosphates / Q000008:administration & dosage / Q000009:adverse effects*; D011409:Propylene Glycols / Q000008:administration & dosage / Q000009:adverse effects*; D013019:South Africa; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000891:Anti-Infective Agents, Local; C042973:K-Y jelly; D010710:Phosphates; D011409:Propylene Glycols; D002482:Cellulose; D005990:Glycerol