Trials
Volume 15, Issue 1, 2014

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 (Article) (Open Access)

Carrasquillo O.* , McCann S. , Amofah A. , Pierre L. , Rodriguez B. , Alonzo Y. , Ilangovan K. , Gonzalez M. , Trevil D. , Byrne M.M. , Koru-Sengul T. , Kobetz E.
  • a Departments of Medicine, University of Miami Miller School of Medicine, Locator code C223, 1120 NW 14th Street, Miami, FL 33136, United States, Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL 33136, United States, Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Miami, FL 33136, United States
  • b Health Choice Network, 9064 N.W. 13 Terrace, Miami, FL 33172, United States
  • c Health Choice Network, 9064 N.W. 13 Terrace, Miami, FL 33172, United States
  • d Center for Haitian Studies, 8260 NE 2nd Ave, Miami, FL 33138, United States
  • e Departments of Medicine, University of Miami Miller School of Medicine, Locator code C223, 1120 NW 14th Street, Miami, FL 33136, United States
  • f Departments of Medicine, University of Miami Miller School of Medicine, Locator code C223, 1120 NW 14th Street, Miami, FL 33136, United States
  • g Departments of Medicine, University of Miami Miller School of Medicine, Locator code C223, 1120 NW 14th Street, Miami, FL 33136, United States
  • h Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Miami, FL 33136, United States
  • i Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Miami, FL 33136, United States
  • j Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL 33136, United States, Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Miami, FL 33136, United States
  • k Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL 33136, United States, Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Miami, FL 33136, United States
  • l Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL 33136, United States, Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 1120 NW 14th Street, Miami, FL 33136, United States

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.Design: 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.Discussion: 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. Trial registration: Clinical Trials.gov # NCT02121548, registered April 21, 2014. © 2014 Carrasquillo et al.; licensee BioMed Central Ltd.

Author Keywords

Cervical cancer Hispanic Screening Immigrant Haitian human papilloma virus health disparities Minority Community-based participatory research

Index Keywords

patient care clinical protocol immigrant methodology Research Design health disparity randomized controlled trial (topic) human Self Report middle aged health belief controlled study randomized controlled trial Aged cancer screening knowledge Humans Hispanic female isolation and purification Outcome Assessment (Health Care) Article major clinical study adult uterine cervix cancer health education health care access structured interview Papillomaviridae Uterine Cervical Neoplasms sample size Papanicolaou Test outcome assessment participatory research Clinical Protocols health literacy Healthcare Disparities health care disparity
Link
https://www.scopus.com/inward/record.uri?eid=2-s2.0-84904534998&doi=10.1186%2f1745-6215-15-299&partnerID=40&md5=773db66495f12f25825f0a218b343de8
DOI: 10.1186/1745-6215-15-299
ISSN: 17456215
Cited by: 9
Original Language: English