Cervical Cancer Screening Project Part C

Terminated

• Conditions: Cervical Cancer

• Registration Number: NCT01575444
• Lead Sponsor: University of Minnesota

Brief Summary

This proposal has been developed through collaboration between the University of Minnesota and New American Community Services (NACS), and the research design is based on a needs assessment conducted by the community partner. The investigators will test the hypotheses that women who are offered home vaginal bio-specimen collection will have higher rate of cervical cancer screening completion than that of women referred for clinic-based Pap test. All participants will be given identical education materials on cervical cancer screening and HPV, currently in use by the Minnesota Sage Program.

Detailed Description

The trial will pilot text a protocol for home vaginal bio-specimen collection for human papillomavirus (HPV) testing for cervical cancer screening. The main objective is to estimate the successful screening completion rate among a sample of Somali women who have not undergone cervical cancer screening for three or more years. Women will be randomized to either home vaginal bio-specimen collection or referral to undergo a clinic-based Pap test.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-11
• Study Start: 2012-06
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-08
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Somali female age 25-70 years

  • have lived in the U.S. 10 years or less
  • have not had a Pap test (by self report) in the last 3 years

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Exclusion Criteria

• Women with a self reported past history of any of the following will not be eligible:

  • total hysterectomy
  • cervical cancer
  • active history of cervical dysplasia

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of home vaginal bio-specimen collections compared to standard clinic-based Pap test	Within 3 months after Enrollment	The main outcome will be successful completion of cervical cancer screening by 3 months after enrollment. For the Home Vaginal Biospecimen Collection Group, completion is defined as return of the HPV DNA self-sampling kit by the patient, with a sample suitable for laboratory analysis. In the Clinic Pap Test Group, completion is defined by documentation of Pap test result.

Trial Locations

Locations (1)

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States