Improvement of Vaginal Health for Kenyan Women at Risk for Acquisition of Human Immunodeficiency Virus Type 1: Results of a Randomized Trial

Background. Vaginal infections are common and have been associated with increased risk for acquisition of human immunodeficiency virus type 1 (HIV-1). Methods. We conducted a randomized trial of directly observed oral treatment administered monthly to reduce vaginal infections among Kenyan women at...

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Bibliographic Details
Published in:The Journal of infectious diseases 2008-05, Vol.197 (10), p.1361-1368
Main Authors: McClelland, R. Scott, Richardson, Barbra A., Hassan, Wisal M., Chohan, Vrasha, Lavreys, Ludo, Mandaliya, Kishorchandra, Kiarie, James, Jaoko, Walter, Ndinya-Achola, Jeckoniah O., Baeten, Jared M., Kurth, Ann E., Holmes, King K.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Anti-Infective Agents - administration & dosage
Anti-Infective Agents - therapeutic use
Antifungal Agents - administration & dosage
Antifungal Agents - therapeutic use
Candidiasis, Vulvovaginal - epidemiology
Candidiasis, Vulvovaginal - prevention & control
Female
Fluconazole - administration & dosage
Fluconazole - therapeutic use
HIV Infections - epidemiology
HIV Infections - prevention & control
HIV Infections - virology
HIV-1 - isolation & purification
Human immunodeficiency virus 1
Humans
Incidence
Kenya - epidemiology
Lactobacillus
Lactobacillus - growth & development
Metronidazole - administration & dosage
Metronidazole - therapeutic use
Middle Aged
Placebos - administration & dosage
Sex Work
Trichomonas Vaginitis - epidemiology
Trichomonas Vaginitis - prevention & control
Vagina - microbiology
Vagina - parasitology
Vagina - physiology
Vaginosis, Bacterial - epidemiology
Vaginosis, Bacterial - prevention & control
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Summary:Background. Vaginal infections are common and have been associated with increased risk for acquisition of human immunodeficiency virus type 1 (HIV-1). Methods. We conducted a randomized trial of directly observed oral treatment administered monthly to reduce vaginal infections among Kenyan women at risk for HIV-1 acquisition. A trial intervention of 2 g of metronidazole plus 150 mg of fluconazole was compared with metronidazole placebo plus fluconazole placebo. The primary end points were bacterial vaginosis (BV), vaginal candidiasis, trichomoniasis vaginalis (hereafter, “trichomoniasis”), and colonization with Lactobacillus organisms. Results. Of 310 HIV-1-seronegative female sex workers enrolled (155 per arm), 303 were included in the primary end points analysis. A median of 12 follow-up visits per subject were recorded in both study arms (P = .8). Compared with control subjects, women receiving the intervention had fewer episodes of BV (hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.49–0.63) and more frequent vaginal colonization with any Lactobacillus species (HR, 1.47; 95% CI, 1.19–1.80) and H2O2-producing Lactobacillus species (HR, 1.63; 95% CI, 1.16–2.27). The incidences of vaginal candidiasis (HR, 0.84; 95% CI, 0.67–1.04) and trichomoniasis (HR, 0.55; 95% CI, 0.27–1.12) among treated women were less than those among control subjects, but the differences were not statistically significant. Conclusions. Periodic presumptive treatment reduced the incidence of BV and promoted colonization with normal vaginal flora. Vaginal health interventions have the potential to provide simple, female-controlled approaches for reducing the risk of HIV-1 acquisition.
ISSN:0022-1899
1537-6613
DOI:10.1086/587490