Cervical Cancer Screening Project Part C

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01575444

Enrollment

Registered

2012-04-11

Start date

2012-06-30

Completion date

2014-05-31

Last updated

2017-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Pap test, HPV testing, cervical cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results