Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1721-6) contains supplementary material, which is available to authorized users.

A randomized trial of mailed HPV self-sampling for cervical cancer screening among ethnic minority women in South Florida

“…All study procedures were conducted in the participants’ language of preference, either English, Spanish, or Haitian Creole. The study protocol has been described in detail elsewhere [17]. Prior to implementation, it was approved by the University of Miami Institutional Review Board and registered at clinialtrials.gov (NCT02202109).…”

“…Women were excluded if they had a history of hysterectomy or cervical cancer, were pregnant, or had ever been enrolled in any other cervical cancer prevention/outreach-related study, including the aforementioned trial comparing CHW-delivered HPV self-sampling to patient navigation. Based on a priori power analyses (see Kobetz et al, 2016), we sought to enroll 200 women from each neighborhood (n = 600 total) [17]. …”

“…Women were instructed to insert the swab until they meet resistance, turn the swab 5 times, withdraw the swab, and swirl the swab in liquid ThinPrep fixative 10 times before disposing of the swab. The ThinPrep vial was then sealed in a biohazard bag and returned to the CHW [17]. Participants then were provided the option to self-sample while the CHW waited, or to self-sample at a later time, and return their sample via US mail using a pre-addressed, pre-stamped envelope.…”

Cervical cancer screening in the era of HPV vaccination: A review of shifting paradigms in cytopathology

“…128 An ongoing randomized controlled trial is being conducted among 600 women of minority groups in South Florida that will assess completion of mailed HPV self-sampling in the US. 129 The impact of this approach of detection rates on validated HPV testing has yet to be determined. Self-sampling for other cervical cancer predictors such as FAM19A4 methylation has also been analyzed with promising results.…”

“…A meta‐analysis among large groups of women in 24 countries demonstrated a high level of acceptability to this approach . An ongoing randomized controlled trial is being conducted among 600 women of minority groups in South Florida that will assess completion of mailed HPV self‐sampling in the US . The impact of this approach of detection rates on validated HPV testing has yet to be determined.…”