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

June 2, 2019 updated by: Megha Ramaswamy, PhD, MPH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Kansas City, Kansas, United States, 66101
        • Wyandotte County Detention Center
    • Missouri
      • Kansas City, Missouri, United States, 64106
        • Jackson County Detention/Regional Correctional Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from Baseline to 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 Months post-jail release
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)
12 Months post-jail release
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)
24 Months post-jail release
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)
36 months post-jail release

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Megha Ramaswamy, PhD, MPH

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Megha Ramaswamy, PhD, MPH, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

May 31, 2019

Study Registration Dates

First Submitted

April 29, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (ESTIMATE)

May 1, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 2, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13559
  • R01CA181047-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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