Bacterial vaginosis (BV), the most common bacterial vaginal infection in women of reproductive ages, has been linked to female HIV-1 acquisition and infection in both cross sectional and prospective studies. Women in sub-Saharan Africa have the highest prevalence of BV, approximately 40-50 percent in Uganda and Kenya. Thus with such a high prevalence and approximately a 2-fold increased risk of HIV acquisition in women with BV, the attributable risk percent for HIV infection associated with BV is high, and treatment and prevention of prevalent and recurrent BV in African women could potentially have a substantial impact on reducing female HIV-1 acquisition. Although treatment of women with BV using metronidazole successfully eliminates symptoms and signs of vaginal discharge, recurrence rates are high. Clinical trials of treating male partners of women with BV targeting anaerobic bacteria have not reduced the risk of BV recurrence. However, our preliminary work has demonstrated BV- associated morphotypes in the urethra of male partners of women with BV significantly more often than in the urethra of male partners of women without BV. Poor male genital hygiene was also associated with BV in the female partners. We hypothesize that poor genital hygiene in men represents an important risk factor for BV, and that improved male genital hygiene or antisepsis, especially among uncircumcised men, and/or antibiotic treatment of the male partners with broad-spectrum antibiotics (active not only against anaerobes but also against facultative microorganisms) will reduce the frequency of recurrence of BV in women ffter initial treatment, as compared to antibiotic treatment of the women only. We propose a pilot (phase 2) study to determine the impact of topical antimicrobial/antiseptic use of women undergoing treatment for BV and of their male partners on the risk of recurrence of BV after treatment. We will screen 1000 couples attending two STD clinics in Nairobi, Kenya for BV and other reproductive tract infections, and (to confirm our preliminary studies) to collect smears from the male urethra and subprepuce (from uncircumcised men) to detect BV-associated bacterial morphotypes. Of the 40 percent (N= 400) of women expected to be diagnosed with BV and enrolled in our treatment trial, 380 will have male partners who will agree to be randomized to use of antisepsis or control; and within those 2 arms, the male partners will be evenly randomized to either metronidazole plus azithromycin or placebo. Female participants will be followed at monthly intervals for 3 months, repeating vaginal Gram stains to ascertain cure versus recurrence or persistence of BV. We will also monitor the acceptability and adverse effects with the use of genital topical antisepsis, and occurrence of symptoms or signs of any adverse effects of antiseptic use among the men.
| Bukusi, Elizabeth; Thomas, Katherine K; Nguti, Rosemary et al. (2011) Topical penile microbicide use by men to prevent recurrent bacterial vaginosis in sex partners: a randomized clinical trial. Sex Transm Dis 38:483-9 |
| Matu, Martin N; Orinda, George O; Njagi, Eliud N M et al. (2010) In vitro inhibitory activity of human vaginal lactobacilli against pathogenic bacteria associated with bacterial vaginosis in Kenyan women. Anaerobe 16:210-5 |
