title: Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  In the United States certain minority groups, such as racial/ethnic immigrant women, are less likely than non-Hispanic White women to be screened for cervical cancer. Barriers to such care include health insurance, cost, knowledge, attitudes, health literacy, and cultural norms and practices. Among the most promising approaches to increase screening in these groups are patient navigators that can link women to sources of appropriate care. Another recent promising approach is using human papilloma virus (HPV) self-sampling. In this manuscript, we describe our National Cancer Institute-sponsored study testing such approaches among immigrant minority women.
  
  
  METHODS
  The South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS) is conducting a three-arm randomized trial among Hispanic, Haitian, and African American women in Miami-Dade County. Community health workers (CHW) based in each of three communities are recruiting 200 women at each site (600 total). Eligibility criteria include women aged 30-65 years who have not had a Pap smear test in the last 3 years. Prior to randomization, all women undergo a standardized structured interview. Women randomized to public health outreach, Group 1, receive culturally tailored educational materials. Women in Group 2 receive an individualized comprehensive cervical cancer CHW-led education session followed by patient navigation to obtain the Pap smear test at community-based facilities. Women in Group 3 have the option of navigation to a Pap smear test or performing HPV self-sampling. The primary outcome is self-report of completed screening through a Pap smear test or HPV self-sampling within 6 months after enrollment.
  
  
  CONCLUSIONS
  SUCCESS is one of the first trials testing HPV self-sampling as a screening strategy among underserved minority women. If successful, HPV self-sampling may be an important option in community outreach programs aimed at reducing disparities in cervical cancer.
  
  
  BACKGROUND
  Clinical Trials.gov # NCT02121548, registered April 21, 2014.
authors: Departments of Medicine, University of Miami Miller School of Medicine, Locator code C223, 1120 NW 14th Street, Miami, FL 33136, USA. oc6@med.miami.edu.
authors: Olveen
authors: O
authors: Carrasquillo
authors: Sheila
authors: S
authors: McCann
authors: Antony
authors: A
authors: Amofah
authors: Larry
authors: L
authors: Pierre
authors: Brendaly
authors: B
authors: Rodriguez
authors: Yisel
authors: Y
authors: Alonzo
authors: Kumar
authors: K
authors: Ilangovan
authors: Martha
authors: M
authors: Gonzalez
authors: Dinah
authors: D
authors: Trevil
authors: Margaret M
authors: MM
authors: Byrne
authors: Tulay
authors: T
authors: Koru-Sengul
authors: Erin
authors: E
authors: Kobetz
mesh_terms: D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D005260:Female; D054625:Healthcare Disparities; D006801:Humans; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D027383:Papillomaviridae / Q000302:isolation & purification; D012107:Research Design; D018401:Sample Size; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control*