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Trial record 1 of 17 for:    screening | Recruiting Studies | Cervical Cancer | United States | Studies with Female Participants
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Effect of Human Papillomavirus Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3 (MBMT-3)

This study is currently recruiting participants.
Verified September 2017 by University of North Carolina, Chapel Hill
Sponsor:
ClinicalTrials.gov Identifier:
NCT02651883
First Posted: January 11, 2016
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
  Purpose
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 Intervention
Cervical Cancer Uterine Cervical Neoplasms Human Papillomavirus Behavioral: Screening invitation (with education) Behavioral: Self-collection for HPV testing

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • 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

  • 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

  • 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:
  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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


Estimated Enrollment: 510
Study Start Date: April 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 5 years
  • Pregnant
  • History of hysterectomy
  • Private insurance
  • Unable to provide informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651883


Contacts
Contact: Andrea Des Marais, MPH 919-966-7999 adesmara@email.unc.edu

Locations
United States, North Carolina
University of North Carolina Gillings School of Public Health Recruiting
Chapel Hill, North Carolina, United States, 27599
Sub-Investigator: Noel Brewer, PhD         
Sub-Investigator: Stephanie Wheeler, PhD         
Sub-Investigator: Michael Hudgens, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jennifer S Smith, PhD UNC Chapel Hill
  More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02651883     History of Changes
Other Study ID Numbers: 14-3042
1R01CA183891-01A1 ( U.S. NIH Grant/Contract )
First Submitted: January 4, 2016
First Posted: January 11, 2016
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
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