Cervical Cancer Screening Project Part C
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Minnesota Community Networks Center for Eliminating Cancer Disparities: Cervical Cancer Screening Project Part C Quantitative|
- Number of home vaginal bio-specimen collections compared to standard clinic-based Pap test [ Time Frame: Within 3 months after Enrollment ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Home based or clinic based HPV test (Pap) collection
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575444
|Contact: Rahel Ghebre, M.D.||firstname.lastname@example.org|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Rahel Ghebre, M.D. 612-626-5339 email@example.com|
|Principal Investigator: Rahel Ghebre, M.D.|
|Principal Investigator:||Rahel Ghebre, M.D.||Masonic Cancer Center, University of Minnesota|