Evaluating the Acceptability of a Cervical Self-sampling Device among Black women residing in Miami, Florida: A Pilot Study

Investigator: Erin Kobetz

Institutional Protocol #: 20070197

National Clinical Trials Identifier: N/A

Funding Agency/Sponsor: Intramural

Division: Cancer Center

Therapeutic Area: Gynecologic Cancer

Phase: N/A

Enrolling Sites: University of Miami Hospital & Clinics, University of Miami Medical Group

Enrolling Since: 5/22/2012


Purpose/Abstract:

SCHEMA
In South Florida, Black women, especially Haitians experience a higher incidence of invasive cervical carcinoma than any other racial/ethnic group. The excess disease is largely a function of their underutilization of Pap smear screening. Black women including Haitian women are not screened by Pap smear for a myriad of reasons, including but not limited to: poverty; language difficulties; limited access to heath care; lack of knowledge about cancer and the importance of early detection; cancer fatalism or the belief that cancer implies death; and, cultural norms about what causes cancer and who is at risk of developing the disease. The proposed research aims to help Black women living in Miami, Florida overcome some of the barriers that preclude them from routine Pap smear screening and predispose them to increased risk of invasive cervical cancer. To accomplish this aim, we will implement a community-based intervention that uses a cervical self-sampling device as an alternative screening technique for the Pap smear. In contrast to the Pap smear, this device is self-administered, and enables women to be screened for cervical lesions and the Human Papilloma Virus (HPV), the primary risk factor for cervical carcinogenesis, within the privacy of their own homes. This approach circumvents access to care issues and socio-cultural concerns about modesty that are prevalent within the Miami Florida Black communites, particulary Little Haiti, Overtown and Liberty City.

PRIMARY HYPOTHESIS:
The cervical self-sampling device will provide an acceptable alternative to the Pap smear for Black women residing in Miami, Florida.

We anticipate that increased availability of a cervical self sampling device should improve utilization of cervical cancer screening, and ultimately, decrease rates of disease incidence and mortality among Black women. However, we are unable to test this hypothesis within the context of our pilot study.




Eligibility Criteria:

Inclusion Criteria:

3.1 Inclusion Criteria
Black women 18 years and older who speak English and/or Haitian Creole, and have no prior history of cervical cancer and/or hysterectomy and are not currently pregnat (determined by self-report) are eligible to participate in the study. Participants must be physically capable of performing the self-sampling themselves. Additionally, participants must understand and be willing to sign or verbally agree to the informed consent document. For the Liberty City Survey, men will also be included.

Exclusion Criteria:

3.2 Exclusion Criteria
Women who are actively menstruating, have a history of cervical cancer, and/or surgical hysterectomy will be excluded from study. Pregnant women, determined by self-report are also not eligible to participate.
Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Cancer Center Studies
1-866-574-5124

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