Safety and Acceptability of the Reality Condom for Anal Sex Among Men Who Have Sex With Men

Unprotected anal intercourse is the major mode of sexual transmission of HIV and other STDs between men and has been associated with increased heterosexual transmission risk. Latex male condoms are the main barrier method promoted for HIV and STD prevention but are associated with usage problems including breakage, slippage, latex allergies, and lack of control by receptive partners.

The Reality “female condom” was approved in the United States in 1992 for vaginal contraceptive use and has since been reported to reduce reinfection with trichomonas. The Reality condom 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.

Given the need to identify safe and acceptable alternatives to the male condom and the limited safety data available for Reality condoms for anal sex, 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.

The study enrolled 56 monogamous HIV-seroconcordant MSM couples who had not regularly used condoms in the past 3 months for a crossover study of male and Reality condoms. Participants were recruited from HIV clinics, advertisements, and outreach in Seattle, Wash., during 2001. Eligibility criteria were 18 years or older, relationship duration of 3 months or longer, and willingness to use each condom during anal sex up to 10 times (minimum of three uses each type). Each couple designated one partner as receptive and the other as insertive for anal sex.

Baseline information was obtained at screening with HIV counseling and testing. At enrollment, couples were randomly assigned to an initial condom type, 10 Reality or lubricated male latex condoms without nonoxynol-9, to use with anal sex during the subsequent 6 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. After each condom use, participants separately completed a structured diary sheet on safety outcomes. At the end of each period of 6 weeks, acceptability was assessed by willingness to use Reality or male condoms for anal sex in future partnerships of varying degrees of HIV risk. The primary acceptability outcome measure was strongly or somewhat preferring the Reality or male condom for anal sex with a new partner of unknown HIV status.

The objective of this study was to determine whether the Reality condom was a safe and acceptable form of barrier prevention among 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. Further work is warranted on design modifications, safety and acceptability of the Reality condom in HIV-negative MSM, as well as accelerated efforts to develop non-barrier methods such as rectal microbicides.

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