title: Effect of Replens gel used with a diaphragm on tests for human papillomavirus and other lower genital tract infections.
abstract: OBJECTIVE
  Little is known about effects of vaginal lubricants with barrier contraceptives on detection of sexually transmissible infections. We hypothesized that Replens gel used with a diaphragm would neither inhibit human papillomavirus (HPV) detection in cervical samples and chlamydia (CT) and gonorrhea (GC) detection in urine samples, nor affect cervical cytology quality.
  
  
  METHODS
  After a clinician-collected cervical sample and a self-collected vaginal sample for HPV detection ("pregel" specimens), women placed a diaphragm containing Replens gel into the vagina. Participants (n = 77) removed the diaphragm after 6 hours and performed vaginal HPV self-sampling at several time points thereafter. Clinicians performed cervical cytology sampling and HPV testing ("postgel" specimens) 24 hours after diaphragm removal. Pregel and postgel specimens were analyzed with and without added SiHa cells (source of defined numbers of HPV16 genomes). HPV was detected by polymerase chain reaction using MY09/11 primers. Urine samples were obtained for CT and GC testing. Proportions of samples testing positive were compared using relative risk (RR) regression models.
  
  
  RESULTS
  Proportions with detectable HPV in the clinician-collected cervical pregel and postgel samples were not statistically different for samples with added SiHa cells (88.3% vs 93.2%, RR = 1.06, 95% confidence interval = 0.96-1.14) or for native HPV infection (32.9% vs 28.2%, RR = 0.87, 95% confidence interval = 0.71-1.06). In self-collected vaginal postgel samples, there was no trend for decreased HPV detection after gel exposure. Gel affected neither urine tests for CT and GC nor cytological quality.
  
  
  CONCLUSIONS
  Recent Replens gel use with a diaphragm does not inhibit cervical HPV testing, urine testing for CT and GC, or cervical cytology quality.
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA 94143-0128, USA. kmccune@cc.ucsf.edu
authors.forename: Karen K
authors.initials: KK
authors.lastname: Smith-McCune
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Tuveson
authors.forename: Mary M
authors.initials: MM
authors.lastname: Rubin
authors.forename: Maria M
authors.initials: MM
authors.lastname: Da Costa
authors.forename: Teresa M
authors.initials: TM
authors.lastname: Darragh
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Shiboski
authors.forename: Barbara
authors.initials: B
authors.lastname: Van Der Pol
authors.forename: Anna-Barbara
authors.initials: AB
authors.lastname: Moscicki
authors.forename: Joel M
authors.initials: JM
authors.lastname: Palefsky
authors.forename: George F
authors.initials: GF
authors.lastname: Sawaya
mesh_terms: D000293:Adolescent; D000328:Adult; D003274:Contraceptive Devices, Female / Q000706:statistics & numerical data*; D004279:DNA, Viral / Q000032:analysis; D003937:Diagnosis, Differential; D005260:Female; D005831:Genital Diseases, Female / Q000175:diagnosis* / Q000821:virology; D052162:Human papillomavirus 16 / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008055:Lipids / Q000627:therapeutic use; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D016133:Polymerase Chain Reaction; D012189:Retrospective Studies; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use*
chemical_list: D004279:DNA, Viral; D008055:Lipids; C085472:Replens; D014622:Vaginal Creams, Foams, and Jellies