Cervical Cancer Screening Project Part C

NCT01575444 | Terminated

• 1 other identifier: 2010NTLS097
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Pap test; HPV testing; cervical cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Home Based Vaginal Collection

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

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.

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Somali female - Participants may speak Somali or English as their primary language.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Home based or clinic based HPV test (Pap) collection

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Rahel Ghebre, M.D.

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 11, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

US (1)