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Grant Details

Grant Number: 5R01CA168598-05 Interpret this number
Primary Investigator: Winer, Rachel
Organization: University Of Washington
Project Title: Randomized Trial of in-Home Cervical Cancer Screening in Underscreened Women
Fiscal Year: 2017


Abstract

DESCRIPTION (provided by applicant): Over half of all cervical cancers in the U.S. are diagnosed in unscreened or under screened women. New national guidelines identify increasing screening uptake as the number one priority for reducing cervical cancer-related morbidity and mortality. Innovative screening strategies that eliminate the need for clinic-based screening could be highly effective in improving screening compliance while maintaining high-quality care. There is growing interest in using high-risk (hr) HPV screening followed by cytology-based triage of women with hrHPV as a primary screening strategy, with studies suggesting that such a strategy could be both cost- effective and sensitive for detecting cervical neoplasia. If samples for hrHPV screening could be self-collected at home (with in-clinic follow-up of hrHPV-positive women), the need for in-clinic screening could be eliminated for a majority of women. We propose a large, pragmatic randomized controlled trial within Group Health (a large integrated health care delivery system in Washington State) to compare effectiveness of two programmatic approaches to increasing cervical cancer screening among overdue women aged 30-65 years. The first approach (control arm) is usual care at Group Health, which consists of patient- and provider-level services to promote adherence to Pap screening, and the second approach (intervention arm) includes usual care plus a mailed in-home hrHPV screening kit. Primary outcomes are early detection and treatment of cervical neoplasia and secondary outcomes are cervical cancer screening uptake, predictors of screening, and patient experiences and attitudes towards in-home hrHPV testing and follow-up of hrHPV+ results (measured through surveys and interviews). We will identify all 30 to 65 year old female enrollees who are overdue for routine Pap screening (no Pap test within the last 3.4 years). We will randomize 7,200 to in-home hrHPV screening and the remainder (~10,400) to usual care. Compared to usual care, we hypothesize that in-home hrHPV screening will enhance early detection and treatment of cervical neoplasia and improve compliance with screening. The trial will provide definitive evidence-based data on the impact of an in-home hrHPV screening program in a real-world clinical setting.



Publications

Out of reach? Correlates of cervical cancer underscreening in women with varying levels of healthcare interactions in a United States integrated delivery system.
Authors: Malone C. , Buist D.S.M. , Tiro J. , Barlow W. , Gao H. , Lin J. , Winer R.L. .
Source: Preventive medicine, 2021 04; 145, p. 106410.
EPub date: 2020-12-31.
PMID: 33388329
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Authors' response: Cost-effectiveness evidence for HPV self-sampling could be improved by giving greater attention to vulnerable populations.
Authors: Malone C. , Barnabas R.V. , Buist D.S.M. , Tiro J.A. , Winer R.L. .
Source: Preventive medicine, 2020 10; 139, p. 106081.
EPub date: 2020-04-04.
PMID: 32259531
Related Citations

Reactions of women underscreened for cervical cancer who received unsolicited human papillomavirus self-sampling kits.
Authors: Malone C. , Tiro J.A. , Buist D.S. , Beatty T. , Lin J. , Kimbel K. , Gao H. , Thayer C. , Miglioretti D.L. , Winer R.L. .
Source: Journal of medical screening, 2020 09; 27(3), p. 146-156.
EPub date: 2019-11-20.
PMID: 31744374
Related Citations

Cost-effectiveness studies of HPV self-sampling: A systematic review.
Authors: Malone C. , Barnabas R.V. , Buist D.S.M. , Tiro J.A. , Winer R.L. .
Source: Preventive medicine, 2020 03; 132, p. 105953.
EPub date: 2020-01-03.
PMID: 31911163
Related Citations

Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: A Randomized Clinical Trial.
Authors: Winer R.L. , Lin J. , Tiro J.A. , Miglioretti D.L. , Beatty T. , Gao H. , Kimbel K. , Thayer C. , Buist D.S.M. .
Source: JAMA network open, 2019-11-01; 2(11), p. e1914729.
EPub date: 2019-11-01.
PMID: 31693128
Related Citations

Improving the promise of embedded pragmatic trials: Surmountable barriers encountered in an evaluation of home-based HPV self-sampling to increase cervical cancer screening in overdue women.
Authors: Buist D.S.M. , Tiro J.A. , Thayer C. , Beatty T. , Miglioretti D.L. , Lin J. , Winer R.L. .
Source: Contemporary clinical trials communications, 2019 Sep; 15, p. 100413.
EPub date: 2019-07-19.
PMID: 31372572
Related Citations

Understanding Patients' Perspectives and Information Needs Following a Positive Home Human Papillomavirus Self-Sampling Kit Result.
Authors: Tiro J.A. , Betts A.C. , Kimbel K. , Buist D.S.M. , Mao C. , Gao H. , Shulman L. , Malone C. , Beatty T. , Lin J. , et al. .
Source: Journal of women's health (2002), 2019 03; 28(3), p. 384-392.
EPub date: 2018-11-27.
PMID: 30481121
Related Citations

Rationale and design of the HOME trial: A pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake and effectiveness in a U.S. healthcare system.
Authors: Winer R.L. , Tiro J.A. , Miglioretti D.L. , Thayer C. , Beatty T. , Lin J. , Gao H. , Kimbel K. , Buist D.S.M. .
Source: Contemporary clinical trials, 2018 01; 64, p. 77-87.
EPub date: 2017-11-04.
PMID: 29113956
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