14th International AIDS Conference Barcelona, Spain - July 7-12, 2002

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbOr23)

Gabbay M, Thomas J, Gibbs A
University of Liverpool, Liverpool, United Kingdom

BACKGROUND: Condom failures potentially expose couples to 255M pregnancies & STIs each year worldwide, acting as a disincentive to their use. Our large RCT investigated the impact of additional spermicide on condom failure.

METHOD: Adult heterosexual condom users in stable relationships were randomized using a crossover control design. Data were collected by self-completion questionnaires. Failures were classified using the recommended taxonomy. Main outcome analyses used an intention to treat approach comparing couples' proportional failure rates (to account for inter-subject variation) during additional spermicide & control arms.

RESULTS: 175 couples used 12,530 condoms, 145 completing both trial arms with 67 clinical and 102 non-clinical failures. Unadjusted overall failure rates were 44/6463 (0.7%) in the additional lubrication arm & 113/6067 (1.9%) in the control arm. There was a significant reduction in overall condom failure rate for couples when using additional lubrication (Wilcoxon signed ranks test Z = -2.36, P = 0.017), and fewer clinical failures (Z= -1.9, P = 0.056). Couples with a history of condom failure also had significantly fewer clinical failures (Mann-Whitney Z = -2.18, P = 0.02). The only evidence of adverse events was a mild risk of irritation with spermicide (13 v 2 subjects, McNemar's P = 0.013). Whilst some couples preferred condoms alone, citing lubricant as an additional interruption or messy, a significant proportion considered sex with additional spermicide to be more pleasurable, and many preferred it (Wilcoxon's Z = -4.2, P = 0.0005 for men, & -2.8, P = 0.006 for women).

CONCLUSION: The low failure rate in this RCT concurs with recent findings. Additional spermicide reduced condom failure, and was popular with some users, but not others. Acceptable and effective additional lubrication will boost condom popularity, reduce failure and hence HIV transmission.

020707
LbOr23

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