Overview

This trial is active, not recruiting.

Condition cervical cancer
Treatment she project
Sponsor Megha Ramaswamy, PhD, MPH
Collaborator National Cancer Institute (NCI)
Start date April 2014
End date March 2016
Trial size 261 participants
Trial identifier NCT02128659, 13559, R01CA181047-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Receives SHE Project Intervention during Week 1 of enrollment
she project
Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.
(Active Comparator)
Receive SHE Project intervention during Week 2 of Enrollment
she project
Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.

Primary Outcomes

Measure
Effectiveness of sexual health empowerment (SHE Project) intervention
time frame: Change from Baseline to 5 days

Secondary Outcomes

Measure
Long-term health behavior
time frame: 6 Months post-jail release
Long-term health behavior
time frame: 12 Months post-jail release
Long-term health behavior
time frame: 24 Months post-jail release
Long-term health behavior
time frame: 36 months post-jail release

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

Official title Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention
Principal investigator Megha Ramaswamy, PhD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.