Trial Outcomes & Findings for Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women (NCT NCT02005510)

NCT ID: NCT02005510

Last Updated: 2020-09-16

Results Overview

Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 19851 participants
• Primary outcome timeframe: Assessed for up to 12 months post-randomization
• Results posted on: 2020-09-16

Participant Flow

Participant milestones

Measure	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. Mailed in-home high-risk HPV testing kit Usual care	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. Usual care
Randomized (Round 1) STARTED	8120	8111
Randomized (Round 1) COMPLETED	8120	8111
Randomized (Round 1) NOT COMPLETED	0	0
Rerandomized (Round 2) STARTED	1631	1585
Rerandomized (Round 2) COMPLETED	1631	1585
Rerandomized (Round 2) NOT COMPLETED	0	0
Rerandomized (Round 3) STARTED	209	195
Rerandomized (Round 3) COMPLETED	209	195
Rerandomized (Round 3) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	In-home HPV Screening n=9843 Participants 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. Mailed in-home high-risk HPV testing kit Usual care	Usual Care n=9891 Participants 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. Usual care	Total n=19734 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9843 Participants n=5 Participants	9891 Participants n=7 Participants	19734 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9843 Participants n=5 Participants	9891 Participants n=7 Participants	19734 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	486 Participants n=5 Participants	8761 Participants n=7 Participants	9247 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8710 Participants n=5 Participants	480 Participants n=7 Participants	9190 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	647 Participants n=5 Participants	650 Participants n=7 Participants	1297 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	147 Participants n=5 Participants	145 Participants n=7 Participants	292 Participants n=5 Participants
Race (NIH/OMB) Asian	893 Participants n=5 Participants	880 Participants n=7 Participants	1773 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	151 Participants n=5 Participants	139 Participants n=7 Participants	290 Participants n=5 Participants
Race (NIH/OMB) Black or African American	438 Participants n=5 Participants	431 Participants n=7 Participants	869 Participants n=5 Participants
Race (NIH/OMB) White	7018 Participants n=5 Participants	7111 Participants n=7 Participants	14129 Participants n=5 Participants
Race (NIH/OMB) More than one race	285 Participants n=5 Participants	283 Participants n=7 Participants	568 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	911 Participants n=5 Participants	902 Participants n=7 Participants	1813 Participants n=5 Participants
Region of Enrollment United States	9843 participants n=5 Participants	9891 participants n=7 Participants	19734 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed for up to 12 months post-randomization

Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or worse

Outcome measures

Measure	In-home HPV Screening n=9960 Participants 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. Mailed in-home high-risk HPV testing kit Usual care	Usual Care n=9891 Participants 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. Usual care
Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse	12 Participants	8 Participants

PRIMARY outcome

Timeframe: Assessed for up to 18 months post-randomization

Receipt of treatment for cervical intraepithelial neoplasia grade 2 or worse

Outcome measures

Measure	In-home HPV Screening n=9960 Participants 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. Mailed in-home high-risk HPV testing kit Usual care	Usual Care n=9891 Participants 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. Usual care
Number of Participants That Received Treatment for Cervical Intraepithelial Neoplasia Grade 2 or Worse	12 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	In-home HPV Screening n=9960 Participants 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. Mailed in-home high-risk HPV testing kit Usual care	Usual Care n=9891 Participants 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. Usual care
Number of Participants That Completed Uptake of Cervical Cancer Screening	2618 Participants	1719 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	In-home HPV Screening n=9960 Participants 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. Mailed in-home high-risk HPV testing kit Usual care	Usual Care n=9891 Participants 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. Usual care
Number of Participants With an Abnormal Screening Result	225 Participants	114 Participants

SECONDARY outcome

Timeframe: Survey invitation mailed 6 months post-randomization

Population: A subset of intervention arm participants who do and do not return the in-home HPV kit will be invited to complete a survey.

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.

Outcome measures

Measure	In-home HPV Screening n=1355 Participants 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. Mailed in-home high-risk HPV testing kit Usual care	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. Usual care
Experiences and Attitudes Associated With In-home HPV Testing Uptake Kit non-returner and did not respond	964 Participants	—
Experiences and Attitudes Associated With In-home HPV Testing Uptake Kit returner and responded	116 Participants	—
Experiences and Attitudes Associated With In-home HPV Testing Uptake Kit returner and did not respond	156 Participants	—
Experiences and Attitudes Associated With In-home HPV Testing Uptake Kit non-returner and responded	119 Participants	—

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Measure	In-home HPV Screening n=75 Participants 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. Mailed in-home high-risk HPV testing kit Usual care	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. Usual care
Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results Kit HPV positive and interviewed	46 Participants	—
Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results Kit HPV positive and not-interviewed	29 Participants	—

Adverse Events

In-home HPV Screening

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	In-home HPV Screening n=9960 participants at risk 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. Mailed in-home high-risk HPV testing kit Usual care	Usual Care n=9891 participants at risk 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. Usual care
General disorders Light bleeding	0.02% 2/9960 • Number of events 2 • Up to 6 months	0.00% 0/9891 • Up to 6 months
General disorders Discomfort	0.03% 3/9960 • Number of events 3 • Up to 6 months	0.00% 0/9891 • Up to 6 months

Additional Information

Dr. Rachel Winer

University of Washington

Phone: 2066165081

Email: rlw@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place