HPV Self-Sampling for Cervical Cancer Screening Among Ethnic Minority Women in South Florida: a Randomized Trial
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.
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