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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

26 Years
65 Years
Not Enrolling
Cervical Intraepithelial Neoplasia, Human Papillomavirus

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Trial Information

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

We have been conducting a study of self-collected cervicovaginal specimens and carcinogenic
human papillomavirus (HPV) DNA testing for cervical cancer screening of women living in the
Mississippi Delta, who have disproportionately high rates of cervical cancer. To date, we
have noted high levels of participation as well as high percentages of completion and return
of the home self-collection. Although we have recruited some under-screened women into our
study, it was clinic-based (i.e., under-screened women were still required to come to the
health department clinic), using Mississippi State Department of Health district clinics. In
reality, women who get cervical cancer in the Mississippi Delta are unlikely to come to
clinics except perhaps for giving birth, years before they are diagnosed with cancer. Thus,
as an ancillary study to our work in Mississippi, we are proposing an outreach study to
determine whether under-screened women, if approached via door-to-door recruitment, would
participate (get screened) by one of two community outreach-based cervical cancer screening
modalities, home-based self-collection and HPV testing or clinic-based cytology screening,
and which of the two modalities they prefer. We will recruit door-to-door 400
under-screened, eligible women aged 26-65 years living in the Mississippi Delta. Consenting,
eligible women will be given a choice of taking and using a self-collection kit on their own
or coming to the local Health Department clinic for cervical cytology screening. Under the
assumption that only 5% of this under-screened population would choose to undergo screening
without intervention, recruitment of 400 women into the study will permit us to detect a
2-fold increase in participation in screening (defined as completing screening) with 90%
power (alpha = 0.05). In this scenario, we will be able to detect with 90% power (alpha =
0.05) a 25% preference for one of the screening methods (75% vs. 50% (no preference)).

Inclusion Criteria


- Women who are age 26-65 years, not pregnant currently or in the past 8 weeks, who
have an intact cervix, no history of cancer, have not been screened for cervical
cancer in the last 3 years, and able and competent to provide informed consent will
be considered eligible for the study.


- Women under 26 or over 65 years of age.

- Pregnant women or women who have given birth to a child in the past 8 weeks. To
insure women included in the study are not pregnant, we will ask women during the
consenting process if they are pregnant or gave recently given birth. Women who
answer yes for either query will be excluded.

- Women who have had a total hysterectomy.

- History of cervical cancer

- Screened for cervical cancer in the last 3 years.

- Other reasons to exclude women include the inability to speak English, the appearance
of mental incompetence, or refusal to participate or sign the informed consent form.

Type of Study:


Study Design:

Time Perspective: Prospective


United States: Federal Government

Study ID:




Start Date:

December 2009

Completion Date:

April 2011

Related Keywords:

  • Cervical Intraepithelial Neoplasia
  • Human Papillomavirus
  • Cervical Cancer Screening
  • Cervical Precancer
  • Self-Collection
  • Cytology
  • Human Papilloma Virus (HPV)
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ



National Cancer Institute (NCI), 9000 Rockville PikeBethesda, Maryland  20892