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

Erin Kobetz, Julia Seay, Anthony Amofah, Larry Pierre, Jordan Baeker Bispo, Dinah Trevil, Martha Gonzalez, Martine Poitevien, Tulay Koru-Sengul, Olveen Carrasquillo, Erin Kobetz, Julia Seay, Anthony Amofah, Larry Pierre, Jordan Baeker Bispo, Dinah Trevil, Martha Gonzalez, Martine Poitevien, Tulay Koru-Sengul, Olveen Carrasquillo

Abstract

Background: Underserved 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.

Design: We 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.

Discussion: Our 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 registration: ClinicalTrials.gov, NCT02202109 . Registered on 9 July 2014.

Keywords: Cervical cancer; HPV; Haitian; Hispanic; Immigrant; Screening.

Figures

Fig. 1
Fig. 1
Cervical cancer incidence and sociodemographic characteristics in intervention communities

References

    1. Solomon D, Breen N, McNeel T. Cervical cancer screening rates in the United States and the potential impact of implementation of screening guidelines. CA Cancer J Clin. 2007;57(2):105–11. doi: 10.3322/canjclin.57.2.105.
    1. Sanghavi Goel M, Wee CC, McCarthy EP, Davis RB, NgoMetzger Q, Phillips RS. Racial and ethnic disparities in cancer screening: the importance of foreign birth as a barrier to care. J Gen Intern Med. 2003;18:1028–35. doi: 10.1111/j.1525-1497.2003.20807.x.
    1. Pierce Campbell CM, Menezes LJ, Paskett ED, Giuliano AR. Prevention of invasive cervical cancer in the United States: past, present, and future. Cancer Epidemiol Biomarkers Prev. 2012;21(9):1402-8.
    1. Sambamoorthi U, McAlpine D. Racial, ethnic, socioeconomic, and access disparities in the use of preventive services among women. Prev Med. 2003;37:475–84. doi: 10.1016/S0091-7435(03)00172-5.
    1. Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010–2020. J Natl Cancer Inst. 2011;103(2):117–28. doi: 10.1093/jnci/djq495.
    1. Herzog TJ, Wright JD. The impact of cervical cancer on quality of life—the components and means for management. Gynecol Oncol. 2007;107(3):572–7. doi: 10.1016/j.ygyno.2007.09.019.
    1. Kobetz E, Menard J, Barton B, Pierre L, Diem J, Auguste PD. Patnè en Aksyon: addressing cancer disparities in Little Haiti through research and social action. Am J Public Health. 2009;99(7):1163–5. doi: 10.2105/AJPH.2008.142794.
    1. CDC NCfHS. US Mortality Files. 2009.
    1. Institute NC. The Surveillance, Epidemiology, and End Results (SEER) Program. 2009.
    1. Babu S. Florida Annual Cancer Report: 2005 Incidence and Mortality. Tallahassee: Florida Department of Health, 2009.
    1. Seay JS, Carrasquillo O, Campos NG, McCann S, Amofah A, Pierre L, et al. Cancer screening utilization among immigrant women in Miami, Florida. Prog Community Health Partnersh. 2015;9(Suppl):11–20. doi: 10.1353/cpr.2015.0029.
    1. Kathleen FB, Michael CC, Joseph L, Lora EF, Leonidas GK. Disparities in survival among women with invasive cervical cancer. Cancer. 2009;115(1):166–78. doi: 10.1002/cncr.24007.
    1. Akers AY, Newmann SJ, Smith JS. Factors underlying disparities in cervical cancer incidence, screening, and treatment in the United States. Curr Probl Cancer. 2007;31(3):157–81. doi: 10.1016/j.currproblcancer.2007.01.001.
    1. McDougall JA, Madeleine MM, Daling JR, Li CI. Racial and ethnic disparities in cervical cancer incidence rates in the United States, 1992–2003. Cancer Causes Control. 2007;18(10):1175–86. doi: 10.1007/s10552-007-9056-y.
    1. Newmann SJ, Garner EO. Social inequities along the cervical cancer continuum: a structured review. Cancer Causes Control. 2005;16(1):63–70. doi: 10.1007/s10552-004-1290-y.
    1. Carrasquillo O, Lantigua RA, Shea S. Preventive services among Medicare beneficiaries with supplemental coverage versus HMO enrollees, medicaid recipients, and elders with no additional coverage. Med Care. 2001;39(6):616–26. doi: 10.1097/00005650-200106000-00009.
    1. DeLaet DE, Shea S, Carrasquillo O. Receipt of preventive services among privately insured minorities in managed care versus fee-for-service insurance plans. J Gen Intern Med. 2002;17(6):451–7. doi: 10.1046/j.1525-1497.2002.10512.x.
    1. Echeverria SE, Carrasquillo O. The roles of citizenship status, acculturation, and health insurance in breast and cervical cancer screening among immigrant women. Med Care. 2006;44(8):788–92. doi: 10.1097/01.mlr.0000215863.24214.41.
    1. Verdoodt F, Jentschke M, Hillemanns P, Racey CS, Snijders PJ, Arbyn M. Reaching women who do not participate in the regular cervical cancer screening programme by offering self-sampling kits: a systematic review and meta-analysis of randomised trials. Eur J Cancer. 2015;51(16): 2375-85.
    1. Arbyn M, Verdoodt F, Snijders PJ, Verhoef VM, Suonio E, Dillner L, et al. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014;15(2):172–83. doi: 10.1016/S1470-2045(13)70570-9.
    1. Belinson JL, Du H, Yang B, Wu R, Belinson SE, Qu X, et al. Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing. Int J Cancer. 2012;130(8):1855–60. doi: 10.1002/ijc.26202.
    1. Racey CS, Withrow DR, Gesink D. Self-collected HPV testing improves participation in cervical cancer screening: a systematic review and meta-analysis. Can J Public Health. 2013;104(2):e159–66.
    1. Castle PE, Rausa A, Walls T, Gravitt PE, Partridge EE, Olivo V, et al. Comparative community outreach to increase cervical cancer screening in the Mississippi Delta. Prev Med. 2011;52(6):452–5. doi: 10.1016/j.ypmed.2011.03.018.
    1. Carrasquillo O, McCann S, Amofah A, Pierre L, Rodriguez B, Alonzo Y, et al. Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial. Trials. 2014;15:299. doi: 10.1186/1745-6215-15-299.
    1. SaintJean G, Crandall LA. Sources and barriers to health care coverage for Haitian immigrants in MiamiDade County, Florida. J Health Care Poor Underserved. 2005;16:29–41. doi: 10.1353/hpu.2005.0016.
    1. United States Census Bureau; 2013 American Community Survey 5-year estimates. Tables B01003, B19013, B1503, S1701, S2701, S1601; generated using American FactFinder. . Accessed 9 Aug 2016.
    1. HRSA. Shortage designation: HPSAs, MUAs & MUPs. . Accessed 9 Aug 2016.
    1. SaintJean G, Crandall LA. Utilization of preventive care by Haitian immigrants in Miami, Florida. J Immigr Health. 2005;7(4):283–92. doi: 10.1007/s10903-005-5125-z.
    1. United States Census Bureau; 2014 American Community Survey 5-year estimates. Tables B01003, B19013, B1503, S1701, S2701, S1601; generated using American FactFinder; . Accessed 9 August 2016.
    1. Stokols D. Translating social ecological theory into guidelines for community health promotion. Am J Health Promot. 1996;10(4):282–98. doi: 10.4278/0890-1171-10.4.282.
    1. ACOG Practice Bulletin 109. Cervical cytology screening. Obstet Gynecol. 2009;114:1409–20. doi: 10.1097/AOG.0b013e3181c6f8a4.
    1. Smith RA, Cokkinides V, Brawley OW. Cancer screening in the United States, 2009: a review of current American Cancer Society guidelines and issues in cancer screening. CA Cancer J Clin. 2009;59(1):27–41. doi: 10.3322/caac.20008.
    1. Final Update Summary: Cervical Cancer: Screening. U.S. Preventive Services Task Force. July 2015. . Accessed 9 Aug 2016.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner