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15 May 2008

Volume 197, Number 10
The Journal of Infectious Diseases 2008;197:1361–1368
© 2008 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2008/19710-0003$15.00
DOI: 10.1086/587490
MAJOR ARTICLE

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

R. Scott McClelland,1,2,6

Barbra A. Richardson,3

Wisal M. Hassan,2

Vrasha Chohan,6

Ludo Lavreys,2,6

Kishorchandra Mandaliya,8

James Kiarie,7

Walter Jaoko,6

Jeckoniah O. Ndinya‐Achola,6

Jared M. Baeten,1

Ann E. Kurth,5 and

King K. Holmes1,4

Departments of 1Medicine, 2Epidemiology, 3Biostatistics, and 4Global Health and 5School of Nursing, University of Washington, Seattle; and Departments of 6Medical Microbiology and 7Obstetrics and Gynecology, University of Nairobi, Nairobi, and 8Coast Provincial General Hospital, Mombasa, Kenya

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 ( ). 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.

Received 3 October 2007; accepted 27 November 2007; electronically published 9 April 2008.

  • (See the editorial commentary by Shin and Kaul on pages 1355–7.)

Reprints or correspondence: Dr. R. Scott McClelland, International AIDS Research and Training Program, Univ. of Washington, Box 359909, 325 Ninth Ave., Seattle, WA 98104 ().

Cited by

Kwame Owusu-Edusei, Mehul N. Tejani, Thomas L. Gift, Charlotte K. Kent, Guoyu Tao. (2009) Estimates of the Direct Cost Per Case and Overall Burden of Trichomoniasis for the Employer-Sponsored Privately Insured Women Population in the United States, 2001 to 2005. Sexually Transmitted Diseases 36:6, 395-399
Online publication date: 1-Jul-2009.
CrossRef
Ruanne V. Barnabas, Judith N. Wasserheit. (2009) Riddle of the Sphinx Revisited: The Role of STDs in HIV Prevention. Sexually Transmitted Diseases 36:6, 365-367
Online publication date: 1-Jul-2009.
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Janneke H. H. M. van de Wijgert, Charles S. Morrison, Joelle Brown, Cynthia Kwok, Barbara Van Der Pol, Tsungai Chipato, Josaphat K. Byamugisha, Nancy Padian, Robert A. Salata. (2009) Disentangling Contributions of Reproductive Tract Infections to HIV Acquisition in African Women. Sexually Transmitted Diseases 36:6, 357-364
Online publication date: 1-Jul-2009.
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R. Scott McClelland, Barbra A. Richardson, Wisal M. Hassan, Susan M. Graham, James Kiarie, Jared M. Baeten, Kishorchandra Mandaliya, Walter Jaoko, Jeckoniah O. Ndinya‐Achola, and King K. Holmes. (2009) Prospective Study of Vaginal Bacterial Flora and Other Risk Factors for Vulvovaginal Candidiasis. The Journal of Infectious Diseases 199:12, 1883-1890
Online publication date: 15-Jun-2009.
Abstract-Full Text-PDF Version (92 kB)
Jared M. Baeten. (2008) New biomedical strategies for HIV-1 prevention in women. Current Infectious Disease Reports 10:6, 490-498
Online publication date: 1-Dec-2008.
CrossRef
Lucy Y. Shin and Rupert Kaul. (2008) Stay It with Flora: Maintaining Vaginal Health as a Possible Avenue for Prevention of Human Immunodeficiency Virus Acquisition. The Journal of Infectious Diseases 197:10, 1355-1357
Online publication date: 15-May-2008.
Citation-Full Text-PDF Version (51 kB)

  • Potential conflicts of interest: none reported.

    Presented in part: 17th International Society for Sexually Transmitted Disease Research Conference, 31 July–3 August 2007, Seattle, WA (abstract O‐102).

    Financial support: National Institutes of Health (grant K23‐AI52480) and Fogarty International Center (grant D43‐TW00007 to W.M.H.).

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