Browsing by Author "Damme, Lut Van"

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    Behavioural and medical predictors of bacterial vaginosis recurrence among female sex workers: longitudinal analysis from a randomized controlled trial
    (BMC Infectious Diseases, 2013) Guédou, Fernand A.; Damme, Lut Van; Deese, Jennifer; Crucitti, Tania; Becker, Marissa; Mirembe, Florence; Solomon, Suniti; Alary, Michel
    Data 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. Methods: Trial’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. Results: 440 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. Conclusion: This 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.
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    Expanded Phase I safety and acceptability study of 6% cellulose sulfate vaginal gel
    (AIDS, 2005) Malonza, Isaac M.; Mirembe, Florence; Nakabiito, Clemensia; Odusoga, Lawrence O.; Osinupebi, Olubunmi A.; Hazari, Kamal; Chitlange, Shanta; Alia, Mohamed M.; Callahane, Marianne; Damme, Lut Van
    An expanded Phase I trial was performed to assess the safety and acceptability of 6% cellulose sulfate gel (CS) in comparison with K-Y Jelly. Sexually abstinent (cohort I) and sexually active (cohort II) women in India, Nigeria and Uganda applied 3.5 ml of either 6% CS gel or K-Y Jelly for seven consecutive days. Safety was assessed by symptoms and signs (including colposcopy) of genital irritation, review of adverse events, and by changes in vaginal health as assessed by microscopy.
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    Lack of Effectiveness of Cellulose Sulfate Gel for the Prevention of Vaginal HIV Transmission
    (New England Journal of Medicine, 2008) Damme, Lut Van; Govinden, Roshini; Mirembe, Florence M.; Guédou, Fernand; Solomon, Suniti; Becker, Marissa L.; Pradeep, B.S.; Krishnan, A.K.; Alary, Michel; Pande, Bina; Ramjee, Gita; Deese, Jennifer; Crucitti, Tania; Taylor, Doug
    Women make up more than 50% of adults living with human immunodeficiency virus (HIV) infection or the acquired immunodeficiency syndrome (AIDS) in sub-Saharan Africa. Thus, female-initiated HIV prevention methods are urgently needed. Methods We performed a randomized, double-blind, placebo-controlled trial of cellulose sulfate, an HIV-entry inhibitor formulated as a vaginal gel, involving women at high risk for HIV infection at three African and two Indian sites. The primary end point was newly acquired infection with HIV type 1 or 2. The secondary end point was newly acquired gonococcal or chlamydial infection. The primary analysis was based on a log-rank test of no difference in the distribution of time to HIV infection, stratified according to site.