Cervical Cancer, Uterine Cervical Neoplasms, Human Papillomavirus
Conditions
Keywords
Cervical cancer screening, HPV testing, Self-collection
Brief summary
This study will investigate whether cervical cancer screening completion among under-screened women could be improved by offering HPV (human papillomavirus) testing by at-home self-collection followed by screening invitation compared to screening invitation alone.
Detailed description
Invasive cervical cancer (ICC) is preventable through regular screening and treatment, but one fifth of US women report not receiving Pap testing at recommended intervals. More than half of ICC cases occur in these under-screened women. For women 30 years and older, the US Preventive Services Task Force recommends Pap smears alone every 3 years or physician-collected HPV testing with Pap smear (co-testing) every 5 years. The FDA approved primary HPV physician screening for US women 25 years and older. Self-collection for HPV testing is a valid and well-accepted method for detecting HPV infection with comparable sensitivity and specificity to physician-collection for detecting high-grade cervical lesions. This 2-arm randomized control trial of 510 women will investigate whether offering HPV testing by mailed at-home self-collection to under-screened women increases their likelihood of completing cervical cancer screening. All participants will received a screening invitation by phone: a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free screening at a study-affiliated clinic, if needed. Those randomized to the intervention arm will first be mailed a kit to self-collect a cervico-vaginal sample, return the sample for oncogenic HPV testing, and receive their results by phone. HPV negative women will be considered screening complete. HPV positive women will be invited to schedule an appointment for free follow-up in-clinic screening in the same call in which their results are delivered. The study endpoint of screening completion will be defined as completing in-clinic screening (control arm participants and HPV positive intervention arm participants) or receiving a negative HPV self-collection result (intervention arm). Aim 1. Determine whether at-home HPV self-collection increases completion of cervical cancer screening among under-screened women offered enhanced reminders. Aim 2. Examine possible mechanisms explaining the intervention's effect, or lack of an effect. Aim 3. Estimate the incremental cost per additional woman completing screening of adding at-home HPV self-collection to enhanced reminders.
Interventions
BEHAVIORALScreening invitation (with education)
The participant will be provided with brief education about the importance and effectiveness of cervical cancer screening, and invited to schedule an appointment for a free in-clinic screening
BEHAVIORALSelf-collection for HPV testing
Participant is provided with a kit to take a self-collected sample at home and return it by mail for HPV testing. Results are provided to participant by phone.
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * Aged 25 to 64 years old * Living at ≤250% of the federal poverty line * Eligible to receive cervical cancer screening from a study-associated clinic * Resides within the same or bordering county of a study-associated clinic
Exclusion criteria
* Completion of cervical Pap screening in preceding 4 years * Completion of HPV testing in preceding 6 years * Pregnant * History of hysterectomy * Private insurance * Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of participants that complete cervical cancer screening | Six months after enrollment | Completion of cervical cancer screening is defined as (a) testing HPV negative by self-collection, or (b) completing in-clinic screening by i. HPV/Pap co-testing or ii. Pap smear alone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of risk appraisal with regards to cervical cancer and screening | 1-5 weeks after completion of self-collection or screening invitation | Risk appraisal will include multiple components measured by post-intervention questionnaire: Worry; Likelihood; Severity; Embodiment of risk (2 measures); Gist risk; Anticipated regret, action; Anticipated regret, inaction |
| Costs to payers | Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation) | Incremental cost to payer (public or private) per additional woman screened |
| Level of intention to complete cervical cancer screening | 1-5 weeks after completion of self-collection or screening invitation | As measured in post-intervention questionnaire |
| Level of self-efficacy to complete cervical cancer screening | 1-5 weeks after completion of self-collection or screening invitation | As measured in post-intervention questionnaire |
| Percentage of participants who schedule a clinic appointment to get cervical cancer screening | 1-5 weeks after completion of self-collection or screening invitation | Percent of participants that agree to schedule a clinic appointment to get a Pap smear or Pap/HPV co-testing |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving primary outcome in different demographic categories | Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation) | We will assess whether there are differences in the percentage of patients that complete cervical cancer screening by categories of age (e.g., younger than 45 vs. 45+), income, race, and educational level, measures collected at baseline |
| Attitudes towards HPV, cervical cancer, and cervical cancer screening | 1-5 weeks after completion of self-collection or screening invitation | Attitudes will include multiple components measured by post-intervention questionnaire, including perceived barriers to screening, perceived benefits to screening, defensive processing of risk information, and subjective norms about screening |
| Prevalence of HPV mRNA (messenger ribonucleic acid) detection in self- and clinic-collected samples, abnormal cytology detected in clinic samples, and high-grade lesions (CIN2+) as detected in follow-up colposcopy screening (as indicated) | Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation) | Prevalence of HPV infection (as determined by presence of hrHPV mRNA in self- and clinic samples), abnormal cytology (ASCUS+ per NCI Bethesda system), and high-grade lesions (CIN2+, as determined by follow-up colposcopic inspection with biopsy as indicated) will be determined from medical records (as permitted by HIPAA authorization) and compared between the arms |
| Percentage of patients referred to and completing colposcopy | Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation) | Referral to and completion of colposcopy will be determined from medical records (as permitted by HIPAA authorization) and compared between the arms |
| Number of patients referred to and completing colposcopy | Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation) | Referral to and completion of colposcopy will be determined from medical records (as permitted by HIPAA authorization) and compared between the arms |
| Number of patients referred to and completing treatment | Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation) | Referral to and completion of treatment will be determined from medical records (as permitted by HIPAA authorization) and compared between the arms |
| Percentage of patients referred to and completing treatment | Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation) | Referral to and completion of treatment will be determined from medical records (as permitted by HIPAA authorization) and compared between the arms |
Countries
United States
Outcome results
None listed