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Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention (SHE Project)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02128659
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Megha Ramaswamy, PhD, MPH, University of Kansas Medical Center

Brief Summary:
The purpose of this study is to learn if a cervical health literacy program is a practical and helpful way of improving women's cervical health knowledge and improving cancer screening behaviors, and ultimately preventing cervical cancer.

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: SHE Project Not Applicable

Detailed Description:

Women in the criminal just system are 4-5 times more likely to have cervical cancer than non-incarcerated women. Little is known about how to close this gap. The few investigators that have studied cervical cancer risk and disease among women in jails and prisons have found that while many women get screened for cervical cancer, less than half get follow-up care.

The investigator's pilot research suggests the most important contributor to cervical cancer risk, and perhaps lack of follow-up, is incarcerated women's low health literacy about both cervical cancer and broader reproductive health issues. This study is testing a sexual health empowerment intervention (SHE Project) to see if it improves incarcerated women's reproductive health literacy.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention
Study Start Date : April 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SHE Project
Receives SHE Project Intervention during Week 1 of enrollment
Behavioral: SHE Project
Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.

Active Comparator: Wait-List Control
Receive SHE Project intervention during Week 2 of Enrollment
Behavioral: SHE Project
Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.




Primary Outcome Measures :
  1. Effectiveness of sexual health empowerment (SHE Project) intervention [ Time Frame: Change from Baseline to 5 days ]
    Changes in knowledge, beliefs, and self-efficacy pre- and post-intervention measured using data collection instruments (Pap Knowledge Scale, Health Belief Model Scale for Cervical Cancer and Pap Smear Test, Self-Efficacy Scale for Pap Smear Screening Participation, Investigator developed study specific survey specific to women with criminal justice involvement, 10-question satisfaction survey)


Secondary Outcome Measures :
  1. Long-term health behavior [ Time Frame: 6 Months post-jail release ]
    Participant screening behaviors (Paps or Sexually Transmitted Infections [STIs]), clinical follow-up of screening, and strategies for navigating health care encounters. Measured using self-report of screening and clinical follow-up survey, review of participant medical charts)

  2. Long-term health behavior [ Time Frame: 12 Months post-jail release ]
    Participant screening behaviors (Paps or STIs), clinical follow-up of screening, and strategies for navigating health care encounters. Measured using self-report of screening and clinical follow-up survey, review of participant medical charts)

  3. Long-term health behavior [ Time Frame: 24 Months post-jail release ]
    Participant screening behaviors (Paps or STIs), clinical follow-up of screening, and strategies for navigating health care encounters. Measured using self-report of screening and clinical follow-up survey, review of participant medical charts)

  4. Long-term health behavior [ Time Frame: 36 months post-jail release ]
    Participant screening behaviors (Paps or STIs), clinical follow-up of screening, and strategies for navigating health care encounters. Measured using self-report of screening and clinical follow-up survey, review of participant medical charts)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women sentenced or anticipate a sentence of one year or less
  • Ability to follow participants post-jail release
  • Able to read and understand English

Exclusion Criteria:

  • Women who have been treated for cervical cancer with procedures that would obviate the need for regular screening
  • Exhibit severe psychological distress

Information from the National Library of Medicine

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): NCT02128659


Locations
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United States, Kansas
Wyandotte County Detention Center
Kansas City, Kansas, United States, 66101
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Jackson County Detention/Regional Correctional Center
Kansas City, Missouri, United States, 64106
Sponsors and Collaborators
Megha Ramaswamy, PhD, MPH
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Megha Ramaswamy, PhD, MPH University of Kansas Medical Center

Additional Information:
Publications:

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Responsible Party: Megha Ramaswamy, PhD, MPH, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02128659     History of Changes
Other Study ID Numbers: 13559
R01CA181047-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female