title: The effectiveness of Carraguard, a vaginal microbicide, in protecting women against high-risk human papillomavirus infection.
abstract: BACKGROUND
  A randomised, double-blind, placebo-controlled trial found the vaginal microbicide Carraguard unable to prevent HIV infection. A substudy assessed the association of genital high-risk human papillomavirus (HR-HPV) in women at study end with Carraguard use.
  
  
  METHODS
  Participants received Carraguard gel or placebo plus condoms, and were instructed to use gel plus condoms during each act of vaginal intercourse. HR-HPV detection on cervical samples from 1,723 women was by Digene Hybrid Capture 2 analysis. Poisson regression analysis assessed the prevalence of genital HR-HPV for individuals receiving Carraguard relative to individuals receiving placebo.
  
  
  RESULTS
  In the Carraguard arm (n=875) the end trial unadjusted HR-HPV prevalence was 23.5% (95% CI 20.8-26.3) and 23.0% (95% CI 20.2-25.8) in placebo arm (n=843). Significant risk factors for HR-HPV infection were younger age, being single, an abnormal pap smear, multiple sexual partners and promiscuous behaviour without the use of a condom. There were 348 compliant women (174 Carraguard, 174 placebo users), with relatively high adherence to gel use, who inserted 80% of their opened, returned applicators of test product with the proportion of applicator insertions to sex acts >30%. After adjusting for risk factors, these compliant Carraguard users were 0.62 as likely to be classified HR-HPV positive (95% CI 0.41-0.94) as compliant placebo users.
  
  
  CONCLUSIONS
  The prevalence of HR-HPV infection was lower in compliant Carraguard users than compliant placebo users. To our knowledge, this is the first report showing a negative association of HPV infection with a vaginal microbicide.
authors.affiliation: Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Dianne
authors.initials: D
authors.lastname: Marais
authors.forename: Daniel
authors.initials: D
authors.lastname: Gawarecki
authors.forename: Bruce
authors.initials: B
authors.lastname: Allan
authors.forename: Khatija
authors.initials: K
authors.lastname: Ahmed
authors.forename: Lydia
authors.initials: L
authors.lastname: Altini
authors.forename: Nazira
authors.initials: N
authors.lastname: Cassim
authors.forename: Felicity
authors.initials: F
authors.lastname: Gopolang
authors.forename: Margaret
authors.initials: M
authors.lastname: Hoffman
authors.forename: Gita
authors.initials: G
authors.lastname: Ramjee
authors.forename: Anna-Lise
authors.initials: AL
authors.lastname: Williamson
mesh_terms: D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002351:Carrageenan / Q000008:administration & dosage / Q000627:therapeutic use*; D015897:Comorbidity; D017280:Condoms; D016172:DNA Fingerprinting; D004279:DNA, Viral; D004311:Double-Blind Method; D005260:Female; D006678:HIV / Q000502:physiology; D015658:HIV Infections / Q000453:epidemiology / Q000635:transmission / Q000821:virology; D006801:Humans; D027383:Papillomaviridae / Q000187:drug effects* / Q000502:physiology; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission / Q000821:virology; D015995:Prevalence; D012307:Risk Factors; D012725:Sexual Behavior; D013019:South Africa / Q000453:epidemiology; D014621:Vagina / Q000187:drug effects / Q000821:virology; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000890:Anti-Infective Agents; D004279:DNA, Viral; D014622:Vaginal Creams, Foams, and Jellies; D002351:Carrageenan