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

NCT02005510 | Completed Results

• 2 other identifiers: 44731R01CA168598
• Study Type: interventional
• Target: 19,851
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer

Keywords

cervical cancer; screening; human papillomavirus; cervical intraepithelial neoplasia

Outcome Measures

Primary Outcomes (2)

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

  Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse

  Assessed for up to 12 months post-randomization

• 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

  Assessed for up to 18 months post-randomization

Secondary Outcomes (4)

• Number of Participants That Completed Uptake of Cervical Cancer Screening

  Assessed for up to 6 months post-randomization

• Number of Participants With an Abnormal Screening Result

  Assessed for up to 6 months post-randomization

• Experiences and Attitudes Associated With In-home HPV Testing Uptake

  Survey invitation mailed 6 months post-randomization

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

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

Study Arms (2)

In-home HPV Screening

EXPERIMENTAL

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.

Behavioral: Mailed in-home high-risk HPV testing kit; Other: Usual care

Usual Care

PLACEBO COMPARATOR

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.

Other: Usual care

Interventions

Mailed in-home high-risk HPV testing kit BEHAVIORAL

In-home HPV Screening

Usual care OTHER

In-home HPV Screening; Usual Care

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• Kaiser Permanente: collaborator
• University of Texas Southwestern Medical Center: collaborator
• National Cancer Institute (NCI): collaborator
• University of California, Davis: collaborator

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (2)

• 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.

  PMID: 36449291 DERIVED

• 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.

  PMID: 31693128 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

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; Precancerous Conditions

Results Point of Contact

• Title: Dr. Rachel Winer
• Organization: University of Washington

rlw@uw.edu

2066165081

Study Officials

• Rachel L Winer, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: February 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Locations

US (1)