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

BackgroundIn 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.DesignThe 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.DiscussionSUCCESS 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 registrationClinical Trials.gov # NCT02121548, registered April 21, 2014.

Acceptability and Feasibility of Human Papilloma Virus Self-Sampling for Cervical Cancer Screening

“…30,31 In the United States, our team is currently finalizing a randomized study testing HPV self-sampling among minority women lacking adequate screening from community-based nonclinical settings. 32 However, given our experience in using this approach in community-based samples and proven success in other clinical settings in other countries, we hypothesized that HPV self-sampling may be a viable strategy for cervical cancer screening in clinical settings. In this study we assess the feasibility and acceptability of HPV self-sampling among patients and clinic staff in two such settings.…”

Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial

“…A vast majority (91%) of adults speak Spanish at home [29]. English language proficiency is limited for many, which constitutes a barrier to seeking timely cancer and control prevention information, including information about routine screening [24–29]. …”

“…1, poverty, low educational attainment, limited English language proficiency and limited access to care represent major challenges to public health initiatives that target cancer prevention. Additionally, sociopolitical histories that include discrimination and longstanding linguistic isolation further complicate access to routine cervical cancer screening by fostering communitywide distrust of medical authorities and research in general [7, 24]. Such distrust necessitates a responsive approach that works within the particular sociopolitical, linguistic, and cultural frameworks of these communities to promote cancer prevention [7, 24].…”

“…Additionally, sociopolitical histories that include discrimination and longstanding linguistic isolation further complicate access to routine cervical cancer screening by fostering communitywide distrust of medical authorities and research in general [7, 24]. Such distrust necessitates a responsive approach that works within the particular sociopolitical, linguistic, and cultural frameworks of these communities to promote cancer prevention [7, 24]. This approach thus demands guidance and collaboration with community partners from each site, as is consistent with community-based participatory research (CBPR).

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“…We have recently completed a randomized controlled trial of community health worker (CHW)-delivered, home-based HPV self-sampling among Haitian and Hispanic immigrant women living in South Florida, through our National Cancer Institute (NCI)-funded South Florida Center for Reducing Cancer Disparities (SUCCESS) [24]. When compared with both standard educational outreach, as well as CHW-guided navigation to Pap smear screening, HPV self-sampling was superior in increasing cervical cancer screening uptake.…”