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

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.