Effect of Human Papillomavirus Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3

Cervical Cancer Clinical Trial

— MBMT-3  

Official title:

Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651883
• Other study ID #: 14-3042
• Secondary ID: 1R01CA183891-01A
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: April 10, 2020

Study information

• Verified date: December 2022
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 665
• Est. completion date: April 10, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Human Papillomavirus
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Screening 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
• Self-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.

Locations

Country	Name	City	State
United States	University of North Carolina Gillings School of Public Health	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of participants achieving primary outcome in different demographic categories	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	Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
Other	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)	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	Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
Other	Percentage of patients referred to and completing colposcopy	Referral to and completion of colposcopy will be determined from medical records (as permitted by HIPAA authorization) and compared between the arms	Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
Other	Number of patients referred to and completing colposcopy	Referral to and completion of colposcopy will be determined from medical records (as permitted by HIPAA authorization) and compared between the arms	Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
Other	Number of patients referred to and completing treatment	Referral to and completion of treatment will be determined from medical records (as permitted by HIPAA authorization) and compared between the arms	Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
Other	Percentage of patients referred to and completing treatment	Referral to and completion of treatment will be determined from medical records (as permitted by HIPAA authorization) and compared between the arms	Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
Other	Attitudes towards HPV, cervical cancer, and cervical cancer screening	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	1-5 weeks after completion of self-collection or screening invitation
Primary	Percent of participants that complete cervical cancer screening	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.	Six months after enrollment
Secondary	Levels of risk appraisal with regards to cervical cancer and screening	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	1-5 weeks after completion of self-collection or screening invitation
Secondary	Costs to payers	Incremental cost to payer (public or private) per additional woman screened	Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
Secondary	Level of intention to complete cervical cancer screening	As measured in post-intervention questionnaire	1-5 weeks after completion of self-collection or screening invitation
Secondary	Level of self-efficacy to complete cervical cancer screening	As measured in post-intervention questionnaire	1-5 weeks after completion of self-collection or screening invitation
Secondary	Percentage of participants who schedule a clinic appointment to get cervical cancer screening	Percent of participants that agree to schedule a clinic appointment to get a Pap smear or Pap/HPV co-testing	1-5 weeks after completion of self-collection or screening invitation