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

Department of Medicine, University of Washington, Seattle, USA.
The Journal of Infectious Diseases (Impact Factor: 6). 06/2008; 197(10):1361-8. DOI: 10.1086/587490
Source: PubMed

ABSTRACT Vaginal infections are common and have been associated with increased risk for acquisition of human immunodeficiency virus type 1 (HIV-1).
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.
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 H(2)O(2)-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.
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.

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    • "The two studies which reported BV incidence as multiple events were sub-studies of the same trial that evaluated the effect of PPT on the incidence of vaginal infections [12]. The first study, which was a secondary analysis focusing on the placebo group only, found a BV incidence rate of 361/100 person-years over the trial period [24]. "
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    ABSTRACT: BackgroundData on risk factors of recurrent bacterial vaginosis (RBV) are still scarce. We used data from female sex workers (FSW) participating in a randomized controlled microbicide trial to examine predictors of BV recurrence.MethodsTrial’s participants with at least an episode of BV which was treated and/or followed by a negative BV result and at least one subsequent visit offering BV testing were included in the analysis. Behavioural and medical data were collected monthly while laboratory testing for STI and genital tract infections were performed quarterly. The Andersen-Gill proportional hazards model was used to determine predictors of BV recurrence both in bivariate and multivariate analyses.Results440 women were included and the incidence rate for RBV was 20.8 recurrences/100 person-months (95% confidence interval (CI) =18.1–23.4). In the multivariate analysis controlling for the study site, recent vaginal cleansing as reported at baseline with adjusted hazard-ratio (aHR)=1.30, 95% CI = 1.02-1.64 increased the risk of BV recurrence, whereas consistent condom use (CCU) with the primary partner (aHR=0.68, 95% CI=0.49-0.93) and vaginal candidiasis (aHR=0.70, 95% CI=0.53-0.93), both treated as time-dependent variables, were associated with decreased risk of RBV.ConclusionThis study confirms the importance of counselling high-risk women with RBV about the adverse effects of vaginal cleansing and the protective effects of condom use with all types of partners for the prevention of sexually transmitted infections, including BV. More prospective studies on risk factors of BV recurrence are warranted.Trial registrationTrial registration: NCT00153777
    BMC Infectious Diseases 05/2013; 13(1):208. DOI:10.1186/1471-2334-13-208 · 2.61 Impact Factor
  • The Journal of Infectious Diseases 06/2008; 197(10):1355-7. DOI:10.1086/587491 · 6.00 Impact Factor
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    ABSTRACT: Novel HIV-1 prevention strategies continue to be urgently needed. This article reviews the current state of biomedical prevention against HIV-1, focusing on recently completed and ongoing clinical trials of new prevention interventions, particularly those relevant to prevention of HIV-1 in women. Male circumcision, cervical barrier devices, suppressive therapy against herpes simplex virus type 2, treatment of vaginal infections and other vaginal health interventions, pre-exposure antiretroviral prophylaxis, and topical vaginal microbicides are discussed.
    Current Infectious Disease Reports 12/2008; 10(6):490-8. DOI:10.1007/s11908-008-0080-1 · 1.68 Impact Factor
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