title: Vaginal Self-Sampling for Human Papillomavirus Infection as a Primary Cervical Cancer Screening Tool in a Haitian Population.
abstract: BACKGROUND
  Human papillomavirus (HPV) testing as primary cervical cancer screening has not been studied in Caribbean women. We tested vaginal self-collection versus physician cervical sampling in a population of Haitian women.
  
  
  METHODS
  Participants were screened for high-risk HPV with self-performed vaginal and clinician-collected cervical samples using Hybrid Capture 2 assays (Qiagen, Gaithersburg, MD). Women positive by either method then underwent colposcopy with biopsy of all visible lesions. Sensitivity and positive predictive value were calculated for each sample method compared with biopsy results, with κ statistics performed for agreement. McNemar tests were performed for differences in sensitivity at ≥cervical intraepithelial neoplasia (CIN)-I and ≥CIN-II.
  
  
  RESULTS
  Of 1845 women screened, 446 (24.3%) were HPV positive by either method, including 105 (5.7%) only by vaginal swab and 53 (2.9%) only by cervical swab. Vaginal and cervical samples were 91.4% concordant (κ = 0.73 [95% confidence interval, 0.69-0.77], P < 0.001). Overall, 133 HPV-positive women (29.9%) had CIN-I, whereas 32 (7.2%) had ≥CIN-II. The sensitivity of vaginal swabs was similar to cervical swabs for detecting ≥CIN-I (89.1% vs. 87.9%, respectively; P = 0.75) lesions and ≥CIN-II disease (87.5% vs. 96.9%, P = 0.18). Eighteen of 19 cases of CIN-III and invasive cancer were found by both methods.
  
  
  CONCLUSIONS
  Human papillomavirus screening via self-collected vaginal swabs or physician-collected cervical swabs are feasible options in this Haitian population. The agreement between cervical and vaginal samples was high, suggesting that vaginal sample-only algorithms for screening could be effective for improving screening rates in this underscreened population.
authors.affiliation: From the *Duke Global Health Institute, Duke University, Durham, NC; †Department of Medicine, Duke University Health System, Durham, NC; ‡Family Health Ministries, Durham, NC; §PathForceDx, Seattle, WA; ¶University of Miami Health System, Miami, FL; ∥University of Notre Dame-Haiti School of Medicine, Port-au-Prince, Haiti; and **Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.
authors.forename: Joel C
authors.initials: JC
authors.lastname: Boggan
authors.forename: David K
authors.initials: DK
authors.lastname: Walmer
authors.forename: Gregory
authors.initials: G
authors.lastname: Henderson
authors.forename: Nahida
authors.initials: N
authors.lastname: Chakhtoura
authors.forename: Schatzi H
authors.initials: SH
authors.lastname: McCarthy
authors.forename: Harry J
authors.initials: HJ
authors.lastname: Beauvais
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Smith
mesh_terms: D000293:Adolescent; D000328:Adult; D004279:DNA, Viral; D055088:Early Detection of Cancer / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006205:Haiti / Q000453:epidemiology; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis*; D011237:Predictive Value of Tests; D012648:Self Care; D012680:Sensitivity and Specificity; D013048:Specimen Handling / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology
chemical_list: D004279:DNA, Viral