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

Browse trials for

• Uterine Cervical Neoplasms 1,881

Keywords

• cervical cancer
• screening
• human papillomavirus
• cervical intraepithelial neoplasia

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 19,851 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Study arms

• 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.

  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.

  Other: Usual care

Interventions

• BehavioralMailed in-home high-risk HPV testing kit
• OtherUsual care

Primary outcomes

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

   Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse

   Time frame: 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

   Time frame: Assessed for up to 18 months post-randomization

Secondary outcomes

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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

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

Baseline characteristics

Publications

• 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 ↗

Study documents

• Protocol and statistical analysis plan · Mar 17, 2015

Documents are hosted by the registry — open the source record to download them.