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Cervical CancerNCT02005510

Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women

A study testing Mailed in-home high-risk HPV testing kit in people with Cervical Cancer, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this trial is to determine whether mailing in-home human papillomavirus (HPV) screening kits is effective in increasing uptake of cervical cancer screening and early detection and treatment of cervical neoplasia in underscreened women. Read more about this study

Who is it for?
Ages 30 to 64 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Mailed in-home high-risk HPV testing kit
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19,851 participants
Where
1 siteUnited States
Study dates
Feb 2014to Feb 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 64 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Currently pregnant
  • Language interpreter needed
  • On "do not contact list" for research studies

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kaiser Permanente Washington Health Research Institute

    Seattle, Washington, 98101

Other trials in United States

About this study

The purpose of this trial is to determine whether mailing in-home human papillomavirus (HPV) screening kits is effective in increasing uptake of cervical cancer screening and early detection and treatment of cervical neoplasia in underscreened women.

Read the detailed description

Over half of all cervical cancers in the U.S. are diagnosed in unscreened or underscreened 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. 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. 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 high-risk human papillomavirus (hrHPV) screening kit. We will randomize eligible women to the in-home hrHPV screening arm or the usual care arm. 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.

Conditions
Cervical Cancer
Being tested
Mailed in-home high-risk HPV testing kit, Usual care
Keywords
cervical cancer, screening, human papillomavirus, cervical intraepithelial neoplasia
Medical subject headings
Uterine Cervical Neoplasms, Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mailed in-home high-risk HPV testing kitBehavioural

  • Usual careOther

Study groups in NCT02005510
Study groupRoleWhat they receive
In-home HPV ScreeningExperimentalUsual 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.
Receives: Behavioral: Mailed in-home high-risk HPV testing kit; Other: Usual care
Usual CarePlacebo comparatorUsual 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.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse

    Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse

    Measured: Assessed for up to 12 months post-randomization

  2. Number of Participants That Received Treatment for Cervical Intraepithelial Neoplasia Grade 2 or Worse

    Receipt of treatment for cervical intraepithelial neoplasia grade 2 or worse

    Measured: Assessed for up to 18 months post-randomization

Secondary outcomes (4)

  1. Number of Participants That Completed Uptake of Cervical Cancer Screening

    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.

    Measured: Assessed for up to 6 months post-randomization

  2. Number of Participants With an Abnormal Screening Result

    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.

    Measured: Assessed for up to 6 months post-randomization

  3. Experiences and Attitudes Associated With In-home HPV Testing Uptake

    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.

    Measured: Survey invitation mailed 6 months post-randomization

  4. Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results

    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.

    Measured: Interview invitation mailed after all recommended clinical follow-up complete OR study follow-up window complete, up to 12 months post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator
Enrolment
19,851 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02005510
Sponsor's protocol ID
44731
Other IDs
R01CA168598
Status last verified
Aug 2020
First submitted
3 Dec 2013
Last updated
16 Sep 2020
Data monitoring committee
No

Publications

  • Winer RL, Lin J, Tiro JA, Miglioretti DL, Beatty T, Gao H, Kimbel K, Thayer C, Buist DSM. Effect of Patient Characteristics on Uptake of Screening Using a Mailed Human Papillomavirus Self-sampling Kit: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2244343. doi: 10.1001/jamanetworkopen.2022.44343.

    PubMed 36449291

  • Winer RL, Lin J, Tiro JA, Miglioretti DL, Beatty T, Gao H, Kimbel K, Thayer C, Buist DSM. Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: A Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914729. doi: 10.1001/jamanetworkopen.2019.14729.

    PubMed 31693128

Questions about this trial

What is this clinical trial studying?

A study testing Mailed in-home high-risk HPV testing kit in people with Cervical Cancer, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse (time frame: Assessed for up to 12 months post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02005510, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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