Olveen Carrasquillo1,2,3, Julia Seay4,5, Anthony Amofah6, Larry Pierre7, Yisel Alonzo8, Shelia McCann6, Martha Gonzalez5, Dinah Trevil5, Tulay Koru-Sengul4,5, Erin Kobetz8,4,5. 1. Department of Medicine, Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. oc6@med.miami.edu. 2. Department of Medicine, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, USA. oc6@med.miami.edu. 3. Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA. oc6@med.miami.edu. 4. Department of Medicine, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, USA. 5. Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA. 6. Health Choice Network, Miami-Dade County, FL, USA. 7. Center for Haitian Studies, Miami-Dade County, FL, USA. 8. Department of Medicine, Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.
Abstract
BACKGROUND: Ethnic minority women are at increased risk of cervical cancer. Self-sampling for high-risk human papillomavirus (HPV) is a promising approach to increase cervical screening among hard-to-reach populations. OBJECTIVE: To compare a community health worker (CHW)-led HPV self-sampling intervention with standard cervical cancer screening approaches. DESIGN: A 26-week single-blind randomized pragmatic clinical trial. PARTICIPANTS: From October 6, 2011 to July 7, 2014, a total of 601 Black, Haitian, and Hispanic women aged 30-65 years in need of cervical cancer screening were recruited, 479 of whom completed study follow-up. INTERVENTIONS: Participants were randomized into three groups: (1) outreach by CHWs and provision of culturally tailored cervical cancer screening information (outreach), (2) individualized CHW-led education and navigation to local health care facilities for Pap smear (navigation), or (3) individualized CHW-led education with a choice of HPV self-sampling or CHW-facilitated navigation to Pap smear (self-swab option). MAIN MEASURES: The proportion of women in each group whom self-reported completion of cervical cancer screening. Women lost to follow-up were considered as not having been screened. KEY RESULTS: Of the 601 women enrolled, 355 (59%) were Hispanic, 210 (35%) were Haitian, and 36 (6%) were non-Haitian Black. In intent-to-treat analyses, 160 of 207 (77%) of women in the self-swab option group completed cervical cancer screening versus 57 of 182 (31%) in the outreach group (aOR 95% CI, p < 0.01) and 90 of 212 (43%) in the navigation group (aOR CI, p = 0.02). CONCLUSIONS: As compared to more traditional approaches, CHW-facilitated HPV self-sampling led to increased cervical cancer screening among ethnic minority women in South Florida. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT02121548.
RCT Entities:
BACKGROUND: Ethnic minority women are at increased risk of cervical cancer. Self-sampling for high-risk human papillomavirus (HPV) is a promising approach to increase cervical screening among hard-to-reach populations. OBJECTIVE: To compare a community health worker (CHW)-led HPV self-sampling intervention with standard cervical cancer screening approaches. DESIGN: A 26-week single-blind randomized pragmatic clinical trial. PARTICIPANTS: From October 6, 2011 to July 7, 2014, a total of 601 Black, Haitian, and Hispanic women aged 30-65 years in need of cervical cancer screening were recruited, 479 of whom completed study follow-up. INTERVENTIONS:Participants were randomized into three groups: (1) outreach by CHWs and provision of culturally tailored cervical cancer screening information (outreach), (2) individualized CHW-led education and navigation to local health care facilities for Pap smear (navigation), or (3) individualized CHW-led education with a choice of HPV self-sampling or CHW-facilitated navigation to Pap smear (self-swab option). MAIN MEASURES: The proportion of women in each group whom self-reported completion of cervical cancer screening. Women lost to follow-up were considered as not having been screened. KEY RESULTS: Of the 601 women enrolled, 355 (59%) were Hispanic, 210 (35%) were Haitian, and 36 (6%) were non-Haitian Black. In intent-to-treat analyses, 160 of 207 (77%) of women in the self-swab option group completed cervical cancer screening versus 57 of 182 (31%) in the outreach group (aOR 95% CI, p < 0.01) and 90 of 212 (43%) in the navigation group (aOR CI, p = 0.02). CONCLUSIONS: As compared to more traditional approaches, CHW-facilitated HPV self-sampling led to increased cervical cancer screening among ethnic minority women in South Florida. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT02121548.
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