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

Tiro, Jasmin A.; Miglioretti, Diana L.; Thayer, Chris; Beatty, Tara; Lin, John; Gao, Hongyuan; Kimbel, Kilian; Buist, Diana S.M.

doi:10.1016/j.cct.2017.11.004

Cited by 25 publications

(42 citation statements)

References 50 publications

(57 reference statements)

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“…In the US, a recent randomized controlled trial was started in which underscreened women were offered either patient clinic reminders or the usual care plus home delivered hrHPV self-sampling kits ( 112 ). This trial is the first within the US to evaluate if self-screening could increase cervical cancer participation and be a part of future preventive care.…”

Section: More and More Countries Are Accepting Self-screening For Hpvmentioning

confidence: 99%

Self-Sampling for Human Papillomavirus Testing: Increased Cervical Cancer Screening Participation and Incorporation in International Screening Programs

Gupta¹,

Palmer²,

Bik³

et al. 2018

Front. Public Health

121

119

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In most industrialized countries, screening programs for cervical cancer have shifted from cytology (Pap smear or ThinPrep) alone on clinician-obtained samples to the addition of screening for human papillomavirus (HPV), its main causative agent. For HPV testing, self-sampling instead of clinician-sampling has proven to be equally accurate, in particular for assays that use nucleic acid amplification techniques. In addition, HPV testing of self-collected samples in combination with a follow-up Pap smear in case of a positive result is more effective in detecting precancerous lesions than a Pap smear alone. Self-sampling for HPV testing has already been adopted by some countries, while others have started trials to evaluate its incorporation into national cervical cancer screening programs. Self-sampling may result in more individuals willing to participate in cervical cancer screening, because it removes many of the barriers that prevent women, especially those in low socioeconomic and minority populations, from participating in regular screening programs. Several studies have shown that the majority of women who have been underscreened but who tested HPV-positive in a self-obtained sample will visit a clinic for follow-up diagnosis and management. In addition, a self-collected sample can also be used for vaginal microbiome analysis, which can provide additional information about HPV infection persistence as well as vaginal health in general.

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Section: More and More Countries Are Accepting Self-screening For Hpvmentioning

confidence: 99%

Self-Sampling for Human Papillomavirus Testing: Increased Cervical Cancer Screening Participation and Incorporation in International Screening Programs

Gupta¹,

Palmer²,

Bik³

et al. 2018

Front. Public Health

121

119

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“…We conducted semistructured telephone interviews with a subset of women who were randomized as part of a pragmatic trial to receive an unsolicited mailed hrHPV self-sampling kit, returned the kit, and tested positive. Trial details including intervention materials and follow-up protocols are described elsewhere 20 (ClinicalTrials.gov: NCT02005510). In brief, the trial evaluates whether mailed hrHPV kits to women overdue for screening are effective in increasing screening uptake, early detection, and treatment of cervical neoplasia compared with usual care.…”

Section: Study Population and Settingmentioning

confidence: 99%

“…Providers and staff were informed about the trial and on how to counsel patients. 20 Patient notification method depended on the result:…”

Section: Study Population and Settingmentioning

confidence: 99%

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Understanding Patients' Perspectives and Information Needs Following a Positive Home Human Papillomavirus Self-Sampling Kit Result

Tiro

Betts

Kimbel

et al. 2019

Journal of Women's Health

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Objective: We explored patient perspectives after a positive human papillomavirus (HPV) self-sampling result to describe experiences and information needs for this home-based screening modality. Materials and Methods: We recruited women who tested high-risk (hr) HPV positive during a pragmatic trial evaluating mailed hrHPV self-sampling kits as an outreach strategy for women overdue for Pap screening in a U.S. integrated health care system. Telephone interviews were conducted from 2014 to 2017. Five independent coders analyzed transcripts using iterative content analysis. Results: Forty-six women (61% of invited; median age 55.5 years) completed a semistructured interview. Six themes emerged: (1) convenience of home-based screening, (2) intense feelings and emotions after receiving positive kit results, (3) importance of seeing provider and discussing kit results, (4) information seeking from various sources, (5) confusion about purpose and meaning of HPV versus Pap tests, and (6) concern that HPV self-sampling is inaccurate when the subsequent Pap test is normal. Conclusions: Although women liked the kit's convenience, discussion about discordant home HPV and inclinic Pap results led them to question the accuracy of HPV self-sampling. Patient-provider communication around home HPV kits is more complex than for reflex or cotesting because clinician-collected Pap results are unknown at the time of the positive kit result. Patients need education about differences between HPV and Pap tests and how they are used for screening and follow-up. To reassure patients and keep them interested in selfsampling, education should be provided at multiple time points during the screening process.

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“…Mailed self-sample HPV testing has been evaluated in multiple trials, particularly in international settings, where it has been used as an additive strategy to increase primary screening participation among screening non-attendees of organized population-based screening programs (13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23). To our knowledge, In the U.S., the HOMES study in the Kaiser Northwest System has been the only published trial to evaluate mailed self-sample HPV testing in the analogous setting of an integrated health system (28). However, to date, no randomized controlled trials have been conducted in safety net healthcare systems nor in a predominantly racially/ethnically minority patient population.…”

Section: Background and Rationalementioning

confidence: 99%

Mailed Self-Sample HPV Testing Kits to Improve Cervical Cancer Screening in a Safety Net Health System: Protocol for a Hybrid Type 2 Randomized Effectiveness-Implementation Trial

Montealegre

Anderson²,

Hilsenbeck

et al. 2020

Preprint

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Background. Almost 20% of U.S. women (particularly low-income, racial/ethnic minorities) remain at risk for cervical cancer due to their inability or unwillingness to participate in periodic clinic-based screening. Self-sampling has been shown to be an effective strategy for screening women for high-risk human papillomavirus (HR-HPV) infection in specific contexts. However, its effectiveness among medically underserved women in safety net health systems has not been evaluated. Furthermore, it is also unclear whether implementation strategies such as patient navigation can be used to improve the success of self-sample screening programs by addressing patient-level barriers to participation.Methods/Design. The Pr ospective E valuation of S elf- T esting to I ncrease S creening (PRESTIS) trial is a hybrid type 2 effectiveness-implementation pragmatic randomized controlled trial of mailed self-sample HPV testing. The aim is to assess the effectiveness of mailed self-sample HPV testing kits to improve cervical cancer screening participation among patients in a safety net health system who are overdue for clinic-based screening, while simultaneously assessing patient navigation as an implementation strategy. Its setting is a large, urban safety net health system that serves a predominantly racial/ethnic minority patient population. The trial targets recruitment of 2,268 participants randomized to telephone recall (enhanced usual care, n=756), telephone recall with mailed self-sample HPV testing kit (intervention, n=756), or telephone recall with mailed self-sample HPV testing kit and patient navigation (intervention + implementation strategy, n=756). The primary effectiveness outcome is completion of primary screening, defined as completion and return of mailed self-sample kit or completion of a clinic-based Pap test. Secondary effectiveness outcomes are predictors of screening and attendance for clinical follow-up among women with a positive screening test. Implementation outcomes are reach, acceptability, fidelity, adaptations, and cost-effectiveness.Discussion. Hybrid designs are needed to evaluate the clinical effectiveness of self-sample HPV testing in specific populations and settings, while incorporating and evaluating methods to optimize its real-world implementation. The current manuscript describes the rationale and design of a hybrid type 2 trial of self-sample HPV testing in a safety net health system. Trial findings are expected to provide meaningful data to inform the equitable delivery of screening to at-risk populations and ultimately realize the global goal of eliminating cervical cancer.Trial registration: ClinicalTrials.gov NCT03898167. Registered 01 April 2019. https://clinicaltrials.gov/ct2/show/NCT03898167

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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

Cited by 25 publications

References 50 publications

Self-Sampling for Human Papillomavirus Testing: Increased Cervical Cancer Screening Participation and Incorporation in International Screening Programs

Self-Sampling for Human Papillomavirus Testing: Increased Cervical Cancer Screening Participation and Incorporation in International Screening Programs

Understanding Patients' Perspectives and Information Needs Following a Positive Home Human Papillomavirus Self-Sampling Kit Result

Mailed Self-Sample HPV Testing Kits to Improve Cervical Cancer Screening in a Safety Net Health System: Protocol for a Hybrid Type 2 Randomized Effectiveness-Implementation Trial

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