title: Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial.
abstract: Underserved ethnic minority women experience significant disparities in cervical cancer incidence and mortality, mainly due to lack of cervical cancer screening. Barriers to Pap smear screening include lack of knowledge, lack of health insurance and access, and cultural beliefs regarding disease prevention. In our previous SUCCESS trial, we demonstrated that HPV self-sampling delivered by a community health worker (CHW) is efficacious in circumventing these barriers. This approach increased screening uptake relative to navigation to Pap smear screening. SUCCESS trial participants, as well as our community partners, provided feedback that women may prefer the HPV self-sampler to be delivered through the mail, such that they would not need to schedule an appointment with the CHW. Thus, our current trial aims to elucidate the efficacy of the HPV self-sampling method when delivered via mail.
  
  
  
  We are conducting a randomized controlled trial among 600 Haitian, Hispanic, and African-American women from the South Florida communities of Little Haiti, Hialeah, and South Dade. Women between the ages of 30 and 65 years who have not had a Pap smear within the past 3 years are eligible for the study. Women are recruited by CHWs and complete a structured interview to assess multilevel determinants of cervical cancer risk. Women are then randomized to receive HPV self-sampling delivered by either the CHW (group 1) or via mail (group 2). The primary outcome is completion of HPV self-sampling within 6 months post enrollment.
  
  
  
  Our trial is among the first to examine the efficacy of the mailed HPV self-sampling approach. If found to be efficacious, this approach may represent a cost-effective strategy for cervical cancer screening within underserved and underscreened minority groups.
  
  
  
  ClinicalTrials.gov, NCT02202109 . Registered on 9 July 2014.
authors.affiliation: Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Room 610B, Miami, FL, 33136, USA. ekobetz@med.miami.edu.|Department of Medicine, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL, 33136, USA. ekobetz@med.miami.edu.|Health Choice Network, 9064 NW 13th Terrace, Miami, FL, 33172, USA. ekobetz@med.miami.edu.
authors.forename: Erin
authors.initials: E
authors.lastname: Kobetz
authors.affiliation: Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Room 610B, Miami, FL, 33136, USA.|Department of Medicine, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL, 33136, USA.
authors.forename: Julia
authors.initials: J
authors.lastname: Seay
authors.affiliation: Health Choice Network, 9064 NW 13th Terrace, Miami, FL, 33172, USA.
authors.forename: Anthony
authors.initials: A
authors.lastname: Amofah
authors.affiliation: Center for Haitian Studies, 8260 NE 2nd Avenue, Miami, FL, 33138, USA.
authors.forename: Larry
authors.initials: L
authors.lastname: Pierre
authors.affiliation: Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL, 33136, USA.
authors.forename: Jordan Baeker
authors.initials: JB
authors.lastname: Bispo
authors.affiliation: Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Room 610B, Miami, FL, 33136, USA.
authors.forename: Dinah
authors.initials: D
authors.lastname: Trevil
authors.affiliation: Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Room 610B, Miami, FL, 33136, USA.
authors.forename: Martha
authors.initials: M
authors.lastname: Gonzalez
authors.affiliation: Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Room 610B, Miami, FL, 33136, USA.
authors.forename: Martine
authors.initials: M
authors.lastname: Poitevien
authors.affiliation: Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL, 33136, USA.
authors.forename: Tulay
authors.initials: T
authors.lastname: Koru-Sengul
authors.affiliation: Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Room 610B, Miami, FL, 33136, USA.|Department of Medicine, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL, 33136, USA.
authors.forename: Olveen
authors.initials: O
authors.lastname: Carrasquillo
mesh_terms: D000328:Adult; D001741:Black or African American; D000368:Aged; D002985:Clinical Protocols; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D005431:Florida / Q000453:epidemiology; D006205:Haiti / Q000208:ethnology; D054624:Health Status Disparities; D054625:Healthcare Disparities / Q000208:ethnology; D006630:Hispanic or Latino; D006801:Humans; D008875:Middle Aged; D008913:Minority Groups; D054525:Minority Health; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000208:ethnology / Q000821:virology*; D010342:Patient Acceptance of Health Care / Q000208:ethnology; D011177:Postal Service; D011237:Predictive Value of Tests; D012107:Research Design; D013048:Specimen Handling; D013997:Time Factors; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000208:ethnology / Q000821:virology*; D035862:Vulnerable Populations; D016387:Women's Health
keywords: Cervical cancer; HPV; Haitian; Hispanic; Immigrant; Screening