Cervical Cancer
Conditions
Keywords
cervical cancer, screening, human papillomavirus, cervical intraepithelial neoplasia
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.
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.
Interventions
BEHAVIORALMailed in-home high-risk HPV testing kit
OTHERUsual care
Sponsors
Kaiser Permanente
University of Texas Southwestern Medical Center
National Cancer Institute (NCI)
University of California, Davis
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
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.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse | 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 | Assessed for up to 18 months post-randomization | Receipt of treatment for cervical intraepithelial neoplasia grade 2 or worse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Completed Uptake of Cervical Cancer Screening | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 9,843 |
| 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 | 9,891 |
| Total | 19,734 |
Baseline characteristics
| Characteristic | In-home HPV Screening | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9843 Participants | 9891 Participants | 19734 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 486 Participants | 8761 Participants | 9247 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8710 Participants | 480 Participants | 9190 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 647 Participants | 650 Participants | 1297 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 147 Participants | 145 Participants | 292 Participants |
| Race (NIH/OMB) Asian | 893 Participants | 880 Participants | 1773 Participants |
| Race (NIH/OMB) Black or African American | 438 Participants | 431 Participants | 869 Participants |
| Race (NIH/OMB) More than one race | 285 Participants | 283 Participants | 568 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 151 Participants | 139 Participants | 290 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 911 Participants | 902 Participants | 1813 Participants |
| Race (NIH/OMB) White | 7018 Participants | 7111 Participants | 14129 Participants |
| Region of Enrollment United States | 9843 participants | 9891 participants | 19734 participants |
| Sex: Female, Male Female | 9843 Participants | 9891 Participants | 19734 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9,960 | 0 / 9,891 |
| other Total, other adverse events | 5 / 9,960 | 0 / 9,891 |
| serious Total, serious adverse events | 0 / 9,960 | 0 / 9,891 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| In-home HPV Screening | Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse | 12 Participants |
| Usual Care | Number of Participants Diagnosed With Cervical Epithelial Neoplasia Grade 2 or Worse | 8 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| In-home HPV Screening | Number of Participants That Received Treatment for Cervical Intraepithelial Neoplasia Grade 2 or Worse | 12 Participants |
| Usual Care | Number of Participants That Received Treatment for Cervical Intraepithelial Neoplasia Grade 2 or Worse | 7 Participants |
Secondary
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
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| In-home HPV Screening | Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results | Kit HPV positive and interviewed | 46 Participants |
| In-home HPV Screening | Experiences and Attitudes Associated With Follow-up of Positive In-home HPV Testing Results | Kit HPV positive and not-interviewed | 29 Participants |
Secondary
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| In-home HPV Screening | Experiences and Attitudes Associated With In-home HPV Testing Uptake | Kit returner and responded | 116 Participants |
| In-home HPV Screening | Experiences and Attitudes Associated With In-home HPV Testing Uptake | Kit returner and did not respond | 156 Participants |
| In-home HPV Screening | Experiences and Attitudes Associated With In-home HPV Testing Uptake | Kit non-returner and responded | 119 Participants |
| In-home HPV Screening | Experiences and Attitudes Associated With In-home HPV Testing Uptake | Kit non-returner and did not respond | 964 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| In-home HPV Screening | Number of Participants That Completed Uptake of Cervical Cancer Screening | 2618 Participants |
| Usual Care | Number of Participants That Completed Uptake of Cervical Cancer Screening | 1719 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| In-home HPV Screening | Number of Participants With an Abnormal Screening Result | 225 Participants |
| Usual Care | Number of Participants With an Abnormal Screening Result | 114 Participants |