title: Impact of Periodic Presumptive Treatment for Bacterial Vaginosis on the Vaginal Microbiome among Women Participating in the Preventing Vaginal Infections Trial.
abstract: Evidence suggests that specific vaginal bacteria associated with bacterial vaginosis (BV) may increase the risk of adverse health outcomes in women. Among women participating in a randomized, double-blinded trial, we assessed the effect of periodic presumptive treatment (PPT) on detection of select vaginal bacteria.
  
  
  
  High-risk women from the United States and Kenya with a recent vaginal infection received intravaginal metronidazole 750 mg plus miconazole 200 mg or placebo for 5 consecutive nights each month for 12 months. Vaginal fluid specimens were collected via polyester/polyethylene terephthalate swabs every other month and tested for bacteria, using quantitative polymerase chain reaction (PCR) assays targeting the 16S ribosomal RNA gene. The effect of PPT on bacterium detection was assessed among all participants and stratified by country.
  
  
  
  Of 234 women enrolled, 221 had specimens available for analysis. The proportion of follow-up visits with detectable quantities was lower in the PPT arm versus the placebo arm for the following bacteria: BVAB1, BVAB2, Atopobium vaginae, Leptotrichia/Sneathia, and Megasphaera. The magnitude of reductions was greater among Kenyan participants as compared to US participants.
  
  
  
  Use of monthly PPT for 1 year reduced colonization with several bacteria strongly associated with BV. The role of PPT to improve vaginal health should be considered, and efforts to improve the impact of PPT regimens are warranted.
authors.affiliation: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center , Seattle, Washington, USA.|Department of Global Health, University of Washington, Seattle, Washington, USA.|Department of Epidemiology, University of Washington, Seattle, Washington, USA.
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Balkus
authors.affiliation: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center , Seattle, Washington, USA.
authors.forename: Sujatha
authors.initials: S
authors.lastname: Srinivasan
authors.affiliation: Department of Medical Microbiology, University of Nairobi, Nairobi, Kenya.
authors.forename: Omu
authors.initials: O
authors.lastname: Anzala
authors.affiliation: University of Nairobi Institute for Tropical and Infectious Diseases, University of Nairobi, Kenya.
authors.forename: Joshua
authors.initials: J
authors.lastname: Kimani
authors.affiliation: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center , Seattle, Washington, USA.
authors.forename: Chloe
authors.initials: C
authors.lastname: Andac
authors.affiliation: Department of Medicine, University of Alabama, Birmingham, Alabama, USA.
authors.forename: Jane
authors.initials: J
authors.lastname: Schwebke
authors.affiliation: Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center , Seattle, Washington, USA.|Department of Medicine, University of Washington, Seattle, Washington, USA.
authors.forename: David N
authors.initials: DN
authors.lastname: Fredricks
authors.affiliation: Department of Global Health, University of Washington, Seattle, Washington, USA.|Department of Epidemiology, University of Washington, Seattle, Washington, USA.|University of Nairobi Institute for Tropical and Infectious Diseases, University of Nairobi, Kenya.|Department of Medicine, University of Washington, Seattle, Washington, USA.
authors.forename: R Scott
authors.initials: RS
authors.lastname: McClelland
mesh_terms: D039903:Actinobacteria / Q000187:drug effects / Q000302:isolation & purification; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007630:Kenya; D007778:Lactobacillus / Q000187:drug effects / Q000302:isolation & purification; D045183:Leptotrichia / Q000187:drug effects / Q000302:isolation & purification; D057230:Limit of Detection; D016014:Linear Models; D045851:Megasphaera / Q000187:drug effects / Q000302:isolation & purification; D008795:Metronidazole / Q000008:administration & dosage* / Q000627:therapeutic use; D008825:Miconazole / Q000008:administration & dosage* / Q000627:therapeutic use; D064307:Microbiota; D008875:Middle Aged; D013048:Specimen Handling; D014621:Vagina / Q000382:microbiology*; D016585:Vaginosis, Bacterial / Q000188:drug therapy* / Q000517:prevention & control; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; D008795:Metronidazole; D008825:Miconazole
keywords: Bacterial vaginosis; vaginal health interventions; vaginal microbiome; periodic presumptive treatment