Cervical Cancer Screening Project Part C

University of Minnesota (UMN)

Status: Terminated

Conditions: Cervical Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01575444

2010NTLS097

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

10 participants in 2 patient groups

Home Based Vaginal Collection

Description:

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

Description:

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.