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Grant Details

Grant Number: 5R01CA183891-05 Interpret this number
Primary Investigator: Smith, Jennifer
Organization: Univ Of North Carolina Chapel Hill
Project Title: Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women
Fiscal Year: 2019


 DESCRIPTION (provided by applicant): This study will investigate whether cervical cancer screening among under-screened women could be improved with testing for human papillomavirus (HPV) using at-home self-collection kits delivered by mail. Invasive cervical cancer (ICC) is preventable through regular screening and treatment, but one fifth of US women report not receiving Pap testing at recommended intervals. More than half of ICC cases occur in these under-screened women. For women 30 years and older, the US Preventive Services Task Force recommends Pap smears alone every 3 years or physician-collected HPV testing with Pap smear (co-testing) every 5 years. Self-collection for HPV testing is a valid and well-accepted method for detecting HPV infection with comparable sensitivity and specificity to physician-collection for detecting high-grade cervical lesions. This 2-arm randomized control trial of 870 women will investigate whether offering HPV testing by mailed at-home self-collection to under-screened women increases their likelihood of completing cervical cancer screening. All participants will received an enhanced reminder by phone: a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free screening at a study- affiliated clinic, if needed. Those randomized to the intervention arm will be mailed kits to self-collect cervicovaginal samples, return the samples for oncogenic HPV testing, and receive their results during the enhanced reminder call. HPV negative women will be considered screening complete and not receive scheduling assistance for in-clinic screening. Screening completion will be defined as in-clinic screening or a negative HPV self-collection result. Aim 1. Determine whether at-home HPV self-collection increases completion of cervical cancer screening among under-screened women offered enhanced reminders. Activities: We will recruit 870 under-screened, low-income women ages 30-64; randomize them to intervention (self-collection plus enhanced reminders) or control (enhanced reminders alone); and compare cervical cancer screening completion between the arms. Aim 2. Examine possible mechanisms explaining the intervention's effect, or lack of an effect. Activities: We will compare in-clinic screening completion between women who receive HPV-positive self-collection results, those who do not return a kit, and the control arm. We will assess perceived risk of cervical cancer pre- and post-intervention in all women, and examine psychological mediators of completing in-clinic screening. Aim 3. Estimate the incremental cost per additional woman completing screening of adding at-home HPV self- collection to enhanced reminders. Activities: We will measure economic inputs for each arm and calculate the incremental cost of at-home HPV self-collection per additional woman completing screening. If at-home HPV self-collection increases screening among under-screened women, it has potential to influence future outreach and clinical practice. Increasing early detection and treatment of high-grade precancerous cervical lesions will have a major public health impact by reducing suffering and death from ICC nationwide.


Cervical Cancer Screening Knowledge, Perceptions, and Behaviors in a Multiracial Cohort of Low-Income, Underscreened Women in North Carolina.
Authors: Bukowski A. , Smith J.S. , Wheeler S.B. , Sanusi B. , McGuire F.H. , Zeno E. , Des Marais A.C. , Barclay L. , Hudgens M.G. , Jackson S. , et al. .
Source: Journal of women's health (2002), 2023 Sep; 32(9), p. 970-981.
EPub date: 2023-06-16.
PMID: 37327372
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Cost-effectiveness of Human Papillomavirus Self-collection Intervention on Cervical Cancer Screening Uptake among Underscreened U.S. Persons with a Cervix.
Authors: Spees L.P. , Biddell C.B. , Smith J.S. , Des Marais A.C. , Hudgens M.G. , Sanusi B. , Jackson S. , Brewer N.T. , Wheeler S.B. .
Source: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2023-08-01; 32(8), p. 1097-1106.
PMID: 37204419
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Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial.
Authors: Pretsch P.K. , Spees L.P. , Brewer N.T. , Hudgens M.G. , Sanusi B. , Rohner E. , Miller E. , Jackson S.L. , Barclay L. , Carter A. , et al. .
Source: The Lancet. Public health, 2023 Jun; 8(6), p. e411-e421.
EPub date: 2023-05-11.
PMID: 37182529
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Prevalence of High-Risk Human Papillomavirus by RNA Assay in Home Self-Collected Samples Among Underscreened People in North Carolina.
Authors: Lee F. , Bukowski A. , Spees L.P. , Wheeler S.B. , Brewer N.T. , Sanusi B. , Hudgens M.G. , Jackson S. , Barclay L. , Carter A. , et al. .
Source: Sexually transmitted diseases, 2022-03-01; 49(3), p. 244-249.
PMID: 34535615
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Perceived Financial Barriers to Cervical Cancer Screening and Associated Cost Burden Among Low-Income, Under-Screened Women.
Authors: Biddell C.B. , Spees L.P. , Smith J.S. , Brewer N.T. , Des Marais A.C. , Sanusi B.O. , Hudgens M.G. , Barclay L. , Jackson S. , Kent E.E. , et al. .
Source: Journal of women's health (2002), 2021 Sep; 30(9), p. 1243-1252.
EPub date: 2021-04-13.
PMID: 33851854
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Extended HPV Genotyping to Compare HPV Type Distribution in Self- and Provider-Collected Samples for Cervical Cancer Screening.
Authors: Rohner E. , Edelman C. , Sanusi B. , Schmitt J.W. , Baker A. , Chesko K. , Faherty B. , Gregory S.M. , Romocki L.S. , Sivaraman V. , et al. .
Source: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2020 Dec; 29(12), p. 2651-2661.
EPub date: 2020-09-17.
PMID: 32943435
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Impact of human papillomavirus (HPV) self-collection on subsequent cervical cancer screening completion among under-screened US women: MyBodyMyTest-3 protocol for a randomized controlled trial.
Authors: Spees L.P. , Des Marais A.C. , Wheeler S.B. , Hudgens M.G. , Doughty S. , Brewer N.T. , Smith J.S. .
Source: Trials, 2019-12-27; 20(1), p. 788.
EPub date: 2019-12-27.
PMID: 31881928
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Predictors of Cervical Cancer Screening Among Infrequently Screened Women Completing Human Papillomavirus Self-Collection: My Body My Test-1.
Authors: Lea C.S. , Perez-Heydrich C. , Des Marais A.C. , Richman A.R. , Barclay L. , Brewer N.T. , Smith J.S. .
Source: Journal of women's health (2002), 2019 Aug; 28(8), p. 1094-1104.
EPub date: 2019-03-15.
PMID: 30874477
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Epstein-Barr virus, but not human cytomegalovirus, is associated with a high-grade human papillomavirus-associated cervical lesions among women in North Carolina.
Authors: Kienka T. , Varga M.G. , Caves J. , Smith J.S. , Sivaraman V. .
Source: Journal of medical virology, 2019 Mar; 91(3), p. 450-456.
EPub date: 2018-10-31.
PMID: 30307626
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Home Self-Collection by Mail to Test for Human Papillomavirus and Sexually Transmitted Infections.
Authors: Des Marais A.C. , Zhao Y. , Hobbs M.M. , Sivaraman V. , Barclay L. , Brewer N.T. , Smith J.S. .
Source: Obstetrics and gynecology, 2018 Dec; 132(6), p. 1412-1420.
PMID: 30399091
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Preference for Human Papillomavirus Self-Collection and Papanicolaou: Survey of Underscreened Women in North Carolina.
Authors: Kilfoyle K.A. , Des Marais A.C. , Ngo M.A. , Romocki L. , Richman A.R. , Barclay L. , Brewer N.T. , Rahangdale L. , Smith J.S. .
Source: Journal of lower genital tract disease, 2018 Oct; 22(4), p. 302-310.
PMID: 30179994
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Acceptability and ease of use of mailed HPV self-collection among infrequently screened women in North Carolina.
Authors: Anderson C. , Breithaupt L. , Des Marais A. , Rastas C. , Richman A. , Barclay L. , Brewer N.T. , Smith J.S. .
Source: Sexually transmitted infections, 2018 Mar; 94(2), p. 131-137.
EPub date: 2017-09-02.
PMID: 28866635
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Mailed Human Papillomavirus Self-Collection With Papanicolaou Test Referral for Infrequently Screened Women in the United States.
Authors: Smith J.S. , Des Marais A.C. , Deal A.M. , Richman A.R. , Perez-Heydrich C. , Yen-Lieberman B. , Barclay L. , Belinson J. , Rinas A. , Brewer N.T. .
Source: Sexually transmitted diseases, 2018 Jan; 45(1), p. 42-48.
PMID: 28876298
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