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A Comparison Study of Two Community Outreach-Based Approaches to Increase Participation of Women Living in the Mississippi Delta in Cervical Cancer Screening

NCT01058148 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2017-07-02

No results posted yet for this study

Summary

Background:

* 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.

Objectives:

\- 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.

Eligibility:

\- 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.

Design:

* 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....

Conditions

  • Cervical Intraepithelial Neoplasia
  • Human Papillomavirus

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Eligibility

Min Age
26 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-22
Completion
2011-04-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01058148 on ClinicalTrials.gov