Cervical Cancer Screening Project Part C

Study Overview
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Brief Summary
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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
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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.

Official Title
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Minnesota Community Networks Center for Eliminating Cancer Disparities: Cervical Cancer Screening Project Part C Quantitative

Conditions
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Cervical Cancer

Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Home Based Vaginal Collection<br>Somali women who are randomized for Home based Vaginal Collection will be given a kit to perform the vaginal sample collection for HPV analysis, with detailed written instructions. | |
| Clinic Based Pap Test Collection<br>30 Somali women who are randomized for Standard Clinic Pap Group will be given a list of clinics that they can attend for cervical cancer screening using pap test. Follow-up will be done on test completion with the clinic at 3 months after enrollment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of home vaginal bio-specimen collections compared to standard clinic-based Pap test | 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. | Within 3 months after Enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pap test, HPV testing, cervical cancer