HIV Digest	HIV Digest Archive

The Reality "female condom" was approved in the United States in 1992 for vaginal contraceptive use; it has two flexible polyurethane rings and a thin, loose-fitting polyurethane sheath, demonstrated in laboratory studies to be impermeable to viruses and less likely to rupture than latex condoms. The removable inner ring is used for insertion and to anchor the condom to the cervix; the non-removable ring at the open end of the sheath is designed to cover the external genitalia.

The present study compares Reality and male latex condoms for anal sex with respect to safety (breakage, slippage, rectal disruption, inflammation and bleeding) and acceptability in future partnerships.

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The study enrolled 56 monogamous HIV-seroconcordant MSM couples who had not regularly used condoms in the past three months for a crossover study of male and Reality condoms. At enrollment, couples were randomly assigned to an initial condom type, Reality or lubricated male latex condoms without nonoxynol-9, to use with anal sex during the subsequent six weeks. In the second six weeks, couples crossed over to the other condom type. Couples were instructed to remove the inner ring of the Reality condom to reduce potential rectal trauma and bleeding, based on previous reports of discomfort and rectal bleeding from the inner ring.

Safety outcomes included self-reported condom breakage, condom slippage, semen spillage, rectal bleeding, and pain or discomfort during condom use. Participants were instructed to examine used condoms for breakage and bleeding. Condom slippage was defined as the condom slipping off the penis either into or out of the rectum during use or withdrawal. Rectal epithelial disruption was assessed among receptive partners who consented to rectal biopsies at baseline and after each condom use phase.

The objective of this study was to determine whether the Reality condom was a safe and acceptable form of barrier prevention among men who have sex with men (MSM) who were not regular condom users. Slippage with removal was reported more frequently with Reality than male latex condoms. Receptive partners more frequently reported pain or discomfort and rectal bleeding with Reality condoms than with male condoms. For the 20 percent in this study who reported a preference for Reality condoms, the potential utility and equivalent breakage and inflammation rates are balanced by a need for further evaluation of rectal bleeding and the significance and sources of discomfort. Training is needed related to slippage and methods for avoiding semen spillage that might expose anal mucosa. Given recent increasing rates of HIV and STDs among MSM, effective and acceptable barrier protection methods for anal sex for MSM and heterosexuals who engage in anal sex must be identified.

Editor's Note: from AIDS