HPV Self-Sampling for Cervical Cancer Screening Among Ethnic Minority Women in South Florida: a Randomized Trial
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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.
To compare a community health worker (CHW)-led HPV self-sampling intervention with standard cervical cancer screening approaches.
A 26-week single-blind randomized pragmatic clinical trial.
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.
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).
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.
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).
As compared to more traditional approaches, CHW-facilitated HPV self-sampling led to increased cervical cancer screening among ethnic minority women in South Florida.
Clinical Trials.gov Identifier: NCT02121548
We wish to thank our study team staff having a critical role in ensuring completion of the study. These include our community health workers, Valentine Cesar (center for Haitian Studies), Maria Azqueta (Citrus Health), and Linabell Lopez (Community Health Inc.); data management and analysis team including Carmen Linarte and Feng Miao; and prior project coordinator Brendaly Rodriguez.
This work was supported by the National Cancer Institute Community Networks Program Center Grant U54 CAI53705.
Compliance with Ethical Standards
The study was approved by the University of Miami Institutional Review Board and registered at clinialtrials.gov (NCT02121548). During this visit, participants provided free and voluntary informed consent in their primary language (English, Spanish, or Haitian Creole) and had all of their questions answered prior to signing.
Conflict of Interest
The authors declare that they do not have a conflict of interest.
- 1.U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2013 Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2016. Available at: www.cdc.gov/uscs. Accessed February 2, 2018.
- 8.National Cancer Institute. Research-tested Intervention Programs (RTIPs): cervical cancer Available from: https://rtips.cancer.gov/rtips/programSearch.do Accessed February 2, 2018
- 9.Community Preventive Services Task Force. Updated recommendations for client- and provider-oriented interventions to increase breast, cervical, and colorectal cancer screening. Am J Prev Med 2012;43:760–4.Google Scholar
- 12.US Food and Drug Administration. Meeting materials of the microbiology devices panel. 12 March 2014. FDA, Bethesda, MD. https://wayback.archive-it.org/7993/20170113191702/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/UCM388564.pdf. Accessed February 2, 2018.
- 16.Verdoodt F, Jentschke M, Hillemanns P, Racey CS, Snijders PJ, Arbyn M. Reaching women who do not participate in the regular cervical cancer screening program by offering self-sampling kits: a systematic review and meta-analysis of randomized trials. Eur J Cancer. 2015;51:2375–85.CrossRefPubMedGoogle Scholar