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Background: Low-dose nonoxynol-9 products have a potential advantage of reduced toxicity. However, little is known about their efficacy in reducing the incidence of sexually transmitted diseases (STDs)., Goal: To determine the effect that an intravaginal gel containing 52.5 mg of nonoxynol-9 has on the acquisition of STDs in a cohort of HIV-1-seronegative female sex workers in Mombasa, Kenya., Study Design: A randomized double-blind placebo controlled trial was performed., Results: In this study, 139 women were randomized to the nonoxynol-9 group and 139 to the placebo group. No significant differences were found between the two study groups in terms of safety outcomes and reported symptoms, except for a lower incidence of vaginal erythema in the nonoxynol-9 group. There was a significantly higher incidence of gonorrhea in the nonoxynol-9 group than in the placebo group. No significant differences were observed between the groups for acquisition of Candida, trichomonas, bacterial vaginosis, C trachomatis, syphilis, or HIV-1, although the statistical power to detect differences for some of these STDs was limited., Conclusions: In this randomized placebo-controlled trial of a low-dose nonoxynol-9 gel, a significantly higher incidence of gonorrhea was found in the nonoxynol-9 group, but no significant differences between the groups were found for Candida, trichomonas, bacterial vaginosis, C trachomatis, syphilis, or HIV-1.

Objective: To evaluate the safety and toxicity of once-daily administration of Advantage-24 (Columbia Research Laboratories, Inc., Rockville Centre, NY), a vaginal gel containing 52.5 mg of nonoxynol-9 (N-9), including the effects of this gel on the vaginal and cervical epithelium., Study Design: Randomized, placebo-controlled, double-blind crossover trial, with a 2-week product application period and a 2-week washout period., Methods: Female sex workers in Mombasa, Kenya were randomized to one of two sequences, N-9 followed by placebo, or vice versa. Women were instructed to apply one applicator of N-9 or placebo gel vaginally once each day. During each of the two product periods, subjects were evaluated by questionnaire and physical examination, including colposcopy, after 7 and 14 days of product use. The primary outcome was genital epithelial disruption., Results: Sixty subjects were randomized, of whom 52 (87%) had complete follow-up. There were four episodes of epithelial disruption, three of which occurred during the placebo period and one during the N-9 period. The estimated risk of epithelial disruption associated with N-9 use was 0.33 (95% confidence interval, 0.03-3.26). There was no increased frequency of other, nondisruptive epithelial lesions during N-9 use., Conclusions: No genital epithelial toxicity of N-9 vaginal gel was observed. This safety profile suggests that this N-9 product is appropriate for evaluation for human immunodeficiency virus type 1 prevention in a phase III efficacy trial.

Background and Objectives: To determine the prevalence, correlates, and incidence of Haemophilus ducreyi antibodies, a cohort of East African trucking company employees was evaluated., Study Design: Human immunodeficiency virus (HIV)-1-seronegative men working in six trucking companies in Mombasa, Kenya, were evaluated with a questionnaire and serologic testing for antibodies to H. ducreyi and other sexually transmitted pathogens. Men who were initially H. ducreyi seronegative were retested at 1 year of follow-up., Results: The H. ducreyi seroprevalence among 501 men at enrollment was 26.5%. Seropositivity was significantly associated with older age, married status, years of active sex life, number of sex partners in the past year, history of unprotected sex with a prostitute in the past year, and history of alcohol intake (all P values < 0.01). Occupational travel for more than 14 days per month was also significantly associated with H. ducreyi seropositivity (odds ratio [OR] 2.1, 95% confidence interval [CI] 1.3-3.2). Using multivariate analysis, H. ducreyi seropositivity was independently associated with age, married status, history of sex with a prostitute, and history of alcohol intake. Presence of H. ducreyi antibodies was significantly associated with seropositivity to the other major genital ulcerative pathogens, Treponema pallidum (OR 4.3, 95% CI 2.2-8.3), herpes simplex virus type 2 (OR 4.9, 95% CI 2.0-11.5), and Chlamydia trachomatis (OR 3.2, 95% CI 1.5-6.9). These associations remained significant after adjusting for demographic and exposure variables. The incidence of seroconversion to H. ducreyi antibodies was 3.6 per 100 person years., Conclusions: Serologic evidence of H. ducreyi infection was common among male trucking company employees. H. ducreyi seropositivity is an objective marker of high-risk behavior and is associated with serologic evidence of other ulcerative sexually transmitted diseases.

To evaluate the impact of human immunodeficiency virus (HIV) on human papillomavirus (HPV) and cervical intraepithelial neoplasia (CIN), a study was conducted of 147 HIV-seropositive and 51 HIV-seronegative prostitutes in Nairobi, Kenya. Among the women infected with HIV, 10 (7%) had signs or symptoms of significant HIV-related disease, and the remaining 93% were asymptomatic. The prevalence of cervical HPV DNA was 37% among HIV-seropositive women and 24% in HIV-seronegative women (odds ratio [OR] 1.7, 95% confidence intervals [CI] 0.8, 3.6, after adjusting for potential confounding factors). Genital warts, cervical HPV DNA, and cytologic findings consistent with CIN were all significantly associated with younger age and fewer years of prostitution, but were unrelated or weakly related to number of sexual partners per week or frequency of condom use. In a subset of 63 women with evaluable Papanicolaou smears, CIN was found in 50% of the women with HPV but only in 8% of those without HPV (adjusted OR 7.2, 95% CI 1.6, 32.1, P = 0.006). However, CIN was unrelated to HIV seropositivity (prevalence of 26% among HIV-seropositive women and 24% in HIV-seronegative women). Among women with cervical HPV DNA, HIV infection was not associated with an increased prevalence of CIN (47% prevalence among women with HIV versus 57% prevalence among women without HIV). Thus, in this population of HIV-seropositive women, most of whom had CDC Stage II or III infection, there was no demonstration of an adverse impact of HIV on CIN.