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

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...

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Autores principales: Kobetz, Erin, Seay, Julia, Amofah, Anthony, Pierre, Larry, Bispo, Jordan Baeker, Trevil, Dinah, Gonzalez, Martha, Poitevien, Martine, Koru-Sengul, Tulay, Carrasquillo, Olveen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5237204/
https://www.ncbi.nlm.nih.gov/pubmed/28086983
http://dx.doi.org/10.1186/s13063-016-1721-6
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author Kobetz, Erin
Seay, Julia
Amofah, Anthony
Pierre, Larry
Bispo, Jordan Baeker
Trevil, Dinah
Gonzalez, Martha
Poitevien, Martine
Koru-Sengul, Tulay
Carrasquillo, Olveen
author_facet Kobetz, Erin
Seay, Julia
Amofah, Anthony
Pierre, Larry
Bispo, Jordan Baeker
Trevil, Dinah
Gonzalez, Martha
Poitevien, Martine
Koru-Sengul, Tulay
Carrasquillo, Olveen
author_sort Kobetz, Erin
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1721-6) contains supplementary material, which is available to authorized users.
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spelling pubmed-52372042017-01-18 Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial Kobetz, Erin Seay, Julia Amofah, Anthony Pierre, Larry Bispo, Jordan Baeker Trevil, Dinah Gonzalez, Martha Poitevien, Martine Koru-Sengul, Tulay Carrasquillo, Olveen Trials Study Protocol 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1721-6) contains supplementary material, which is available to authorized users. BioMed Central 2017-01-13 /pmc/articles/PMC5237204/ /pubmed/28086983 http://dx.doi.org/10.1186/s13063-016-1721-6 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Kobetz, Erin
Seay, Julia
Amofah, Anthony
Pierre, Larry
Bispo, Jordan Baeker
Trevil, Dinah
Gonzalez, Martha
Poitevien, Martine
Koru-Sengul, Tulay
Carrasquillo, Olveen
Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial
title Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial
title_full Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial
title_fullStr Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial
title_full_unstemmed Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial
title_short Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial
title_sort mailed hpv self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5237204/
https://www.ncbi.nlm.nih.gov/pubmed/28086983
http://dx.doi.org/10.1186/s13063-016-1721-6
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