A Comparison Study of Two Community Outreach-Based Approaches to Increase Participation of Women Living in the Mississippi Delta in Cervical Cancer Screening
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|ClinicalTrials.gov Identifier: NCT01058148|
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : July 2, 2017
- The Mississippi Delta (which includes the counties along the Mississippi River) is one of the poorest areas in the United States. Women living in the Mississippi Delta have disproportionately high rates of cervical cancer, but they are unlikely to come to clinics except perhaps for giving birth, years before they are diagnosed with cancer.
- To improve rates of screening, researchers are attempting an outreach study to see whether under-screened women, if approached by door-to-door recruitment, would get screened by one of two methods (home-based self-collection and testing, or a clinic exam) and which method they would prefer.
- To assess/measure increased participation of under-screened women living in the Mississippi Delta in cervical cancer screening by offering women the opportunity to get screened by one of two possible community outreach-based cervical cancer screening modalities, self-collection and HPV testing or clinic-based cytology screening, the current standard of care.
- Women between 26 and 65 years of age, who are not pregnant currently or in the past 8 weeks, have an intact cervix, have no history of cancer, and have not been screened for cervical cancer in the past 3 years.
- Researchers will recruit participants on a door-to-door basis. Researchers will recruit all eligible women within a household. Recruitment will be done only during daylight hours but at the end of the working day to maximize the chances of finding women at home.
- Eligible women willing to participate will complete a questionnaire with demographic and medical information.
- Participants will be asked to choose the screening method of their preference. If they choose self-collection with HPV testing, they will be given a self-collection kit and asked to perform the self-collection and return the kit within 1 month. Participants who choose to have cytology screening will be provided with the phone number and location of the local health department clinic and will be encouraged to schedule their screening within the following month.
- Women who do not complete their participation within 1 month will be considered noncompliant with their chosen intervention. Researchers will re-contact noncompliant women to offer them participation in the study, including permitting them to refuse to participate or to choose the alternative intervention....
|Condition or disease|
|Cervical Intraepithelial Neoplasia Human Papillomavirus|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||A Comparison Study of Two Community Outreach-Based Approaches to Increase Participation of Women Living in the Mississippi Delta in Cervical Cancer Screening|
|Study Start Date :||December 22, 2009|
|Study Completion Date :||April 13, 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058148
|United States, Maryland|
|National Cancer Institute (NCI), 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|