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-2susceptible 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.
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