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Presenter: Guédou F. A. MD, MSc, PhD

Is bacterial vaginosis just the tip of the iceberg as to the risk of HIV related to vaginal flora abnormalities ?. Presenter: Guédou F. A. MD, MSc, PhD Co-authors: Van Damme L, Mirembe F, Solomon S, Becker M, Deese J, Crucitti T, Taylor D, Alary M. Afri-Can Forum

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Presenter: Guédou F. A. MD, MSc, PhD

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  1. Is bacterial vaginosis just the tip of the iceberg as to the risk of HIV related to vaginal flora abnormalities ? Presenter: Guédou F. A. MD, MSc, PhD Co-authors: Van Damme L, Mirembe F, Solomon S, Becker M, Deese J, Crucitti T, Taylor D, Alary M Afri-Can Forum Entebbe 17-19 January 2013

  2. Overview • Background • Objectives • Methods and materials • Results • Discussion • Conclusion

  3. Background(1) • Bacterial Vaginosis (BV) is a polymicrobial infection resulting from the replacement of lactobacilli of the normal vaginal flora by a variety of bacteria, predominantly anaerobic • The main challenge of BV to date is that of the identification of its causative agent so that the current consensus is that a polymicrobial infection

  4. Background (2) Conventionally, BV is diagnosed: • Clinically on Amsel’s criteria; • Biologically with Nugent’score: • normal flora (NS = 0-3); • intermediate flora (NS = 4-6); • BV (NS = 7-10)

  5. Background (3) • BV = most common genital infection worldwide • Higher prevalence in developing countries (DC): between 9% and 50%; 70% among female sex workers (FSW)

  6. Background (4) • But what justifies the present work is that the role of BV in HIV acquisition or transmission has been strongly suggested by some studies • Since BV has such a high prevalence among FSWs, even a modest RR substantial attributable risk for HIV

  7. Background (5) • This is of uppermost interest when considering the role of core group played by FSWs in the dynamic of HIV epidemics in DC and particularly in Sub-Saharan Africa • In addition, most studies that have examined this association have classified “BV” as (BV vs. non-BV) • Very little attention has been paid to the possible role of intermediate vaginal flora (IVF) in this association

  8. Objectives • To investigate the association between HIV and respectively IVF and BV, among FSW screened prior to enrolment in the Cellulose sulfate trial • To compare the strengths of these two associations

  9. Chennai Mudhol/Jhamkandi (India): (2) Benin Uganda Kampala (Uganda): (1) Cotonou (Benin): (1) Durban (South Africa): (1) Materials and Methods (1) Settings: Sites of the CS trial

  10. Materials and Methods (2) Participants selection: Eligibility criteria: • Potential participant in the SC trial • 18 years or older • HIV high risk woman (≥ 3 different sexual partners in the last 3 months and ≥ 3 sexual acts/week) • Data available for both BV and HIV • Informed consent for screening

  11. Materials and Methods (3) Data collection • Interview: socio-demo. and behavioral data • Gynecological Exam: clinical data • Blood and cervico-vaginal swabs: • HIV: HIV antibodies test • BV: Gram and Nugent score (NS) • Gonorrhea and Chlamydia: SDA (Strand DNA Amplification) • Syphilis: RPR confirmed with TPHA • Trichomoniasis (TV) and Candidiasis: Wet mount

  12. Materials and Methods(4) Statistical analyses • Log binomial regression to model HIV prevalencewith respect to vaginal floraabnormalities: • 2 categories: BV vs. Non-BV • 3 categories : normal (reference), IVF and BV (Comparison of BV and IVF prevalence ratios) • Bivariate analyses (controlling for site) • Multivariate analyses (adjustment)

  13. Results: (1)

  14. Results (2)

  15. Discussion (1) • The aPR obtained using women with NVF as reference was substantially higher than that obtained using women without BV as reference • This is due to the fact that HIV prevalence among women with IVF was significantly higher than that of women with NVF: aPR = 1.56 (95% CI = 1.22-1.98, p = 0.0003) • The use of all women without BV (NVF/IVF) as a reference to measure the increase in HIV risk associated with BV could lead to its underestimation

  16. Discussion (2) • In addition, the strength of the association obtained with IVF was similar to that obtained with the BV (p = 0.6347) • This is in contrast with the trend of monotonic increase found in most studies that have examined the association between HIV and vaginal flora abnormalities

  17. Discussion (3): Direction of the association? • BV may increase the risk of HIVMobilization of HIV target cellsWeakening of the vaginal epithelial barrier • HIV may increase the risk of BVImmunosuppression? But no significant association between HIV and other STIs! • A risk factor common to HIV and BV (not / insufficiently controlled by analysis)

  18. Discussion (4): the study limits • Cross-sectional design • 124 eligible FSW excluded (lack of data on BV) • Inability to control for HSV-2, alcohol • Possibility of inaccuracy for some data: • Vaginal douching (quantification) • Number of sexual partners (memory) • Condom use (social desirability)

  19. Discussion (5): Strenghts of the study • Clinical trial settings: • Large sample size • An international quality control system • Use of the current gold standard for BV diagnosis • Use of log-binomial regression: which enabled a better approximation of the relative risk

  20. Conclusions • The results of this study suggest that: • BV represents only a part of the vaginal flora abnormalities associated with an increased risk of HIV; • IVF is associated with HIV as stronger as BV • Need of prospective studies to confirm findings • Implication for HIV prevention: Controlling vaginal flora abnormalities (not just BV) among FSWs may be an untapped strategy to curb HIV epidemic, particularly in countries with concentrated epidemic

  21. Acknowledgments (1) • Trial participants • Cotonou Team (Benin): • Clinical team: I. Minani; N. Geraldo; G. Ainan; C. Assogba; C. Gbenafa • Lab team: M. Loembe; E. Goma; G. Ahotin; L. Djossou; N. Tata • Sociology team: O. Azonnadou, J. Agonmounon, F. Mito-Yobo • Field team: G. Batona et coll. • Canada Team(CHU of Quebec) :M. Belleau, J. Leroux, J. Begin, L. Pagé • Other sites: • Lusaka (Ouganda): F. Mirembe et al. • Chennai (Inde): S. Solomon et al. • Mudhol/Jhamkandi (Inde): M. Becker et al.

  22. Aknowledgments (2) • International Team: • CONRAD (VA, USA): L. Van Damme (PI); • FHI (NC, USA): J. Deese; D. Taylor; • ITM (Antwerrp, Belgium) : T. Crucitti • Sponsor: CONRAD (USA) • Funders: • USAID • Fondation Bill Gates & Melinda

  23. Thanks for your kind attention

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