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Anna Wald, MD,MPH; Andria G. M. Langenberg, MD; Katherine Link, MS; Allen E. Izu, MS; Rhoda Ashley, PhD; Terri Warren, ARNP; Stephen Tyring, MD,PhD; John M. Douglas, Jr, MD; Lawrence Corey, MD

JAMA. 2001;285:3100-3106.

Context  Herpes simplex virus type 2 (HSV-2) is one of the most common sexually transmitted infections in the United States. No prospective study has shown the ability of condoms to reduce transmission of HSV-2.

Objective  To evaluate risk factors for HSV-2 acquisition and efficacy of condoms in prevention of HSV-2 transmission.

Design  Analysis of data from a randomized, double-blind, placebo-controlled trial conducted December 13, 1993, to June 28, 1996, of an ineffective candidate HSV-2 vaccine with 18 months of follow-up.

Setting  Eighteen clinical trial centers in the United States.

Participants  A total of 528 monogamous couples discordant for HSV-2 infection, including an HSV-2–susceptible population of 261 men and 267 women.

Main Outcome Measure  Acquisition of HSV-2 infection by susceptible partners, compared with those remaining free of HSV-2 with regard to demographic characteristics, sexual activity, and condom use.

Results  Twenty-six women (9.7%) vs 5 men (1.9%) acquired HSV-2, for a rate per 10 000 sex acts (episodes of sexual intercourse) of 8.9 vs 1.5, respectively (P<.001). In multivariable analysis, younger age (adjusted hazard ratio [HR] per 5 years, 1.57; 95% confidence interval [CI], 1.22-2.04), seropositivity for HSV-1 and HSV-2 vs HSV-2 alone in the source partner (adjusted HR, 2.34; 95% CI, 1.14-4.82), and more frequent sexual activity (adjusted HR per additional sex act per week, 1.10; 95% CI, 1.01-1.19) were associated with higher risk of HSV-2 acquisition. Condom use during more than 25% of sex acts was associated with protection against HSV-2 acquisition for women (adjusted HR, 0.085; 95% CI, 0.01-0.67) but not for men (adjusted HR, 2.02; 95% CI, 0.32-12.50). Risk of HSV-2 transmission declined from 8.5 per 100 person-years in the initial 150-day interval to 0.9 per 100 person-years in the final 150-day interval (P = .002 for trend), concurrent with a decrease in sexual activity and proportion of sex acts occurring when the source partner had genital lesions.

Conclusions  Condom use offers significant protection against HSV-2 infection in susceptible women. Changes in sexual behavior, correlated with counseling about avoiding sex when a partner has lesions, were associated with reduction in HSV-2 acquisition over time. These data suggest that identification of discordant couples can reduce transmission of HSV-2, especially for heterosexual couples in which the male partner has HSV-2 infection.

Author Affiliations: Departments of Medicine (Drs Wald and Corey), Epidemiology (Dr Wald), and Laboratory Medicine (Ms Link and Drs Ashley and Corey), University of Washington, Seattle; Chiron Corp, Emeryville, Calif (Dr Langenberg and Mr Izu); Westover Heights Clinic, Portland, Ore (Ms Warren); Departments of Microbiology, Immunology, Dermatology, and Pediatrics, University of Texas, Medical Branch, Galveston (Dr Tyring); Department of Public Health, Denver, Colo (Dr Douglas); and Program in Infectious Diseases, Fred Hutchinson Cancer Research Center, Seattle, Wash (Dr Corey).

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