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Open Access Study protocol

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

Olveen Carrasquillo123*, Sheila McCann4, Antony Amofah4, Larry Pierre5, Brendaly Rodriguez1, Yisel Alonzo1, Kumar Ilangovan1, Martha Gonzalez3, Dinah Trevil3, Margaret M Byrne23, Tulay Koru-Sengul23 and Erin Kobetz23

Author Affiliations

1 Departments of Medicine, University of Miami Miller School of Medicine, Locator code C223, 1120 NW 14th Street, Miami, FL 33136, USA

2 Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, 10th floor, Miami, FL 33136, USA

3 Sylvester Comprehensive Cancer Center, University of Miami, Miller School of Medicine, Clinical Research Building, 3rd floor, 1120 NW 14th Street, Miami, FL 33136, USA

4 Health Choice Network, 9064 N.W. 13 Terrace, Miami, FL 33172, USA

5 Center for Haitian Studies, 8260 NE 2nd Ave, Miami, FL 33138, USA

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Trials 2014, 15:299  doi:10.1186/1745-6215-15-299

Published: 23 July 2014

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.

Keywords:
Cervical cancer; Community-based participatory research; Haitian; Health disparities; Hispanic; Human papilloma virus; Immigrant; Minority; Screening