Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Behavioral: SHE Project

• Registration Number: NCT02128659
• Lead Sponsor: Megha Ramaswamy, PhD, MPH

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.

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-05-01
• Primary Completion: 2016-03
• Study Completion: 2019-05-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-02
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 261

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHE Project	SHE Project	Receives SHE Project Intervention during Week 1 of enrollment
Wait-List Control	SHE Project	Receive SHE Project intervention during Week 2 of Enrollment

Primary Outcome Measures

Name	Time	Method
Effectiveness of sexual health empowerment (SHE Project) intervention	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

Name	Time	Method
Long-term health behavior	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)

Trial Locations

Locations (3)

Wyandotte County Detention Center; 🇺🇸 Kansas City, Kansas, United States

Jackson County Detention/Regional Correctional Center; 🇺🇸 Kansas City, Missouri, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States