Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women
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ClinicalTrials.gov Identifier: NCT02005510 |
Recruitment Status :
Completed
First Posted : December 9, 2013
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cervical Cancer | Behavioral: Mailed in-home high-risk HPV testing kit Other: Usual care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19851 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Eligibility is assessed weekly over 2.5 years. Study participants are assigned to the control arm or to the intervention arm. After follow-up is complete, control arm participants are re-assessed for eligibility and re-randomization. |
Masking: | Single (Investigator) |
Primary Purpose: | Screening |
Official Title: | Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women |
Actual Study Start Date : | February 2014 |
Actual Primary Completion Date : | February 2018 |
Actual Study Completion Date : | February 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: In-home HPV Screening
Usual care PLUS a mailed in-home high-risk HPV testing kit (accompanied by an invitational letter, research information sheet, and illustrated instructions for using the kit). "Usual care" consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.
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Behavioral: Mailed in-home high-risk HPV testing kit Other: Usual care |
Placebo Comparator: Usual Care
Usual care. "Usual care" consists of patient-, provider-, clinic- and systems-level services to promote adherence to Pap screening, including an annual birthday letter with Pap screening reminders, telephone outreach from primary care providers, and automatic alerts in the electronic medical record for overdue women.
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Other: Usual care |
- Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse [ Time Frame: Assessed for up to 12 months post-randomization ]Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse
- Number of Participants That Received Treatment for Cervical Intraepithelial Neoplasia Grade 2 or Worse [ Time Frame: Assessed for up to 18 months post-randomization ]Receipt of treatment for cervical intraepithelial neoplasia grade 2 or worse
- Number of Participants That Completed Uptake of Cervical Cancer Screening [ Time Frame: Assessed for up to 6 months post-randomization ]
Uptake of cervical cancer screening is defined as either: [1] receipt of a Pap or co-test; [2] self-sample hrHPV-positive (16/18-negative) OR unsatisfactory AND receipt of follow-up diagnostic testing (Pap or co-test or colposcopy); [3] self-sample HPV16/18-positive; or [4] self-sample hrHPV-negative)
Using an intent-to-treat approach, we will use log-binomial regression to estimate the relative risk for cervical cancer screening uptake for the in-home HPV screening arm versus the usual care arm.
We will also use log-binomial regression to estimate the effects of EMR-derived patient characteristics (e.g. age, race/ethnicity, geocoded socioeconomic status, geocoded distance form primary care clinic, insurance type, time since last Pap test, tobacco use, obesity, and Charlson comorbidity score) on cervical cancer screening uptake, stratified subdivided by randomization arm.
- Number of Participants With an Abnormal Screening Result [ Time Frame: Assessed for up to 6 months post-randomization ]
Screening result that warrants repeat testing, surveillance, or immediate colposcopy (per current guidelines) before returning to a routine screening schedule
Using an intent-to-treat approach, we will use log-binomial regression to estimate the relative risk for an abnormal screening result for the in-home HPV screening arm versus the usual care arm.
- Experiences and Attitudes Associated With In-home HPV Testing Uptake [ Time Frame: Survey invitation mailed 6 months post-randomization ]Experiences and attitudes will be measured with online surveys. A subset of intervention arm participants who do and do not return the in-home HPV kit will be invited to complete a survey (target n=200). We will examine psychosocial factors (e.g., cervical cancer/HPV knowledge, attitudes toward screening), experiences, and reactions to kits. We will compare responses in women who do versus do not return a mailed HPV kit.
- Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results [ Time Frame: Interview invitation mailed after all recommended clinical follow-up complete OR study follow-up window complete, up to 12 months post-randomization ]Intervention arm participants who return in-home HPV kits and test positive for HPV will be invited to complete an in-depth semi-structured interview (target n=50). We will explore patient perspectives following a positive human papillomavirus (HPV) self-sampling result to describe experiences and information needs for this home-based screening modality.
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Ages Eligible for Study: | 30 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female
- 30 to 64 years of age
- Have a primary care provider at Group Health
- Received annual "birthday letter" with Pap screening reminder 5 months earlier
- No Pap test in the past 3.4 years
- Continuously enrolled at Group Health for at least 3.4 years
- No hysterectomy
Exclusion Criteria:
- Currently pregnant
- Language interpreter needed
- On "do not contact list" for research studies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005510
United States, Washington | |
Kaiser Permanente Washington Health Research Institute | |
Seattle, Washington, United States, 98101 |
Principal Investigator: | Rachel L Winer, PhD, MPH | University of Washington |
Documents provided by Rachel Winer, University of Washington:
Responsible Party: | Rachel Winer, Associate Professor, University of Washington |
ClinicalTrials.gov Identifier: | NCT02005510 |
Other Study ID Numbers: |
44731 R01CA168598 ( U.S. NIH Grant/Contract ) |
First Posted: | December 9, 2013 Key Record Dates |
Results First Posted: | September 16, 2020 |
Last Update Posted: | September 16, 2020 |
Last Verified: | August 2020 |
cervical cancer screening human papillomavirus cervical intraepithelial neoplasia |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases |