Abstract
BackgroundUnderserved ethnic minority women experience significant disparities in cervical cancer incidence and mortality, mainly due to lack of cervical cancer screening. Barriers to Pap smear screening include lack of knowledge, lack of health insurance and access, and cultural beliefs regarding disease prevention. In our previous SUCCESS trial, we demonstrated that HPV self-sampling delivered by a community health worker (CHW) is efficacious in circumventing these barriers. This approach increased screening uptake relative to navigation to Pap smear screening. SUCCESS trial participants, as well as our community partners, provided feedback that women may prefer the HPV self-sampler to be delivered through the mail, such that they would not need to schedule an appointment with the CHW. Thus, our current trial aims to elucidate the efficacy of the HPV self-sampling method when delivered via mail.DesignWe are conducting a randomized controlled trial among 600 Haitian, Hispanic, and African-American women from the South Florida communities of Little Haiti, Hialeah, and South Dade. Women between the ages of 30 and 65 years who have not had a Pap smear within the past 3 years are eligible for the study. Women are recruited by CHWs and complete a structured interview to assess multilevel determinants of cervical cancer risk. Women are then randomized to receive HPV self-sampling delivered by either the CHW (group 1) or via mail (group 2). The primary outcome is completion of HPV self-sampling within 6 months post enrollment.DiscussionOur trial is among the first to examine the efficacy of the mailed HPV self-sampling approach. If found to be efficacious, this approach may represent a cost-effective strategy for cervical cancer screening within underserved and underscreened minority groups.Trial registrationClinicalTrials.gov, NCT02202109. Registered on 9 July 2014.
Highlights
Underserved ethnic minority women experience significant disparities in cervical cancer incidence and mortality, mainly due to lack of cervical cancer screening
Our trial is among the first to examine the efficacy of the mailed human papilloma virus (HPV) self-sampling approach
Our project addresses the excess burden of cervical cancer experienced by Little Haiti, Hialeah, and South Dade, three medically underserved communities within the Miami metropolitan area [2,3,4,5,6,7,8,9,10,11,12,13,14]
Summary
Our project addresses the excess burden of cervical cancer experienced by Little Haiti, Hialeah, and South Dade, three medically underserved communities within the Miami metropolitan area [2,3,4,5,6,7,8,9,10,11,12,13,14]. Using a CBPR approach, we will determine the efficacy of CHW versus mail-delivered HPV self-sampling among 600 women from our target communities. While HPV testing has been shown to demonstrate greater sensitivity and negative predictive value than the Pap smear, it is not yet standard-of-care practice for primary cervical cancer screening [21]. Our prior work indicates that many women within our target communities experience significant barriers to Pap smear screening that may be circumvented by HPV self-sampling. In our previous SUCCESS trial, many women who were not amenable to Pap smear screening elected to self-sample, and through their engagement with our study, eventually were able to connect with the formalized health care system. As with our prior trial, all women in the current study are given information and referrals to community health centers where they may receive low-cost Pap smear screening.
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