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

• ClinicalTrials.gov Identifier: NCT02651883
• Recruitment Status: Completed
• First Posted: January 11, 2016
• Last Update Posted: December 2, 2022
• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): UNC Lineberger Comprehensive Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer; Uterine Cervical Neoplasms; Human Papillomavirus	Behavioral: Screening invitation (with education); Behavioral: Self-collection for HPV testing	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 665 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
• Study Start Date: April 2016
• Actual Primary Completion Date: April 10, 2020
• Actual Study Completion Date: April 10, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Screening invitation (with education); Participants will receive a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free cervical cancer screening at a study-affiliated clinic.	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; Other Names: Screening recall; Client reminder
Experimental: Self-collection for HPV testing; Participants in the intervention arm will receive a kit to self-collect a sample and return it for HPV testing. Participants will then receive a phone call providing their HPV results plus (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free cervical cancer screening at a study-affiliated clinic, if desired.	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; Other Names: Screening recall; Client reminder; Behavioral: 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.; Other Names: Self-testing; Self-sampling

Outcome Measures

Primary Outcome Measures :

1. Percent of participants that complete cervical cancer screening [ Time Frame: 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 Outcome Measures :

1. Levels of risk appraisal with regards to cervical cancer and screening [ Time Frame: 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
2. Costs to payers [ Time Frame: 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
3. Level of intention to complete cervical cancer screening [ Time Frame: 1-5 weeks after completion of self-collection or screening invitation ]
   As measured in post-intervention questionnaire
4. Level of self-efficacy to complete cervical cancer screening [ Time Frame: 1-5 weeks after completion of self-collection or screening invitation ]
   As measured in post-intervention questionnaire
5. Percentage of participants who schedule a clinic appointment to get cervical cancer screening [ Time Frame: 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 Outcome Measures:

1. Percentage of participants achieving primary outcome in different demographic categories [ Time Frame: 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
2. 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) [ Time Frame: 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
3. Percentage of patients referred to and completing colposcopy [ Time Frame: 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
4. Number of patients referred to and completing colposcopy [ Time Frame: 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
5. Number of patients referred to and completing treatment [ Time Frame: 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
6. Percentage of patients referred to and completing treatment [ Time Frame: 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
7. Attitudes towards HPV, cervical cancer, and cervical cancer screening [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 64 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, North Carolina

University of North Carolina Gillings School of Public Health

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

UNC Lineberger Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jennifer S Smith, PhD; UNC Chapel Hill

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Biddell CB, Spees LP, Smith JS, Brewer NT, Des Marais AC, Sanusi BO, Hudgens MG, Barclay L, Jackson S, Kent EE, Wheeler SB. Perceived Financial Barriers to Cervical Cancer Screening and Associated Cost Burden Among Low-Income, Under-Screened Women. J Womens Health (Larchmt). 2021 Sep;30(9):1243-1252. doi: 10.1089/jwh.2020.8807. Epub 2021 Apr 13.

Spees LP, Des Marais AC, Wheeler SB, Hudgens MG, Doughty S, Brewer NT, Smith JS. Impact of human papillomavirus (HPV) self-collection on subsequent cervical cancer screening completion among under-screened US women: MyBodyMyTest-3 protocol for a randomized controlled trial. Trials. 2019 Dec 27;20(1):788. doi: 10.1186/s13063-019-3959-2.

• Responsible Party: UNC Lineberger Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02651883
• Other Study ID Numbers: 14-3042; 1R01CA183891-01A1 ( U.S. NIH Grant/Contract )
• First Posted: January 11, 2016
• Last Update Posted: December 2, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by UNC Lineberger Comprehensive Cancer Center:

Cervical cancer screening; HPV testing; Self-collection

Additional relevant MeSH terms:

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases