Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention
SHE Project
2 other identifiers
interventional
261
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 29, 2014
CompletedFirst Posted
Study publicly available on registry
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedJune 4, 2019
June 1, 2019
1.9 years
April 29, 2014
June 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Effectiveness of sexual health empowerment (SHE Project) intervention
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 Outcomes (4)
Long-term health behavior
6 Months post-jail release
Long-term health behavior
12 Months post-jail release
Long-term health behavior
24 Months post-jail release
Long-term health behavior
36 months post-jail release
Study Arms (2)
SHE Project
EXPERIMENTALReceives SHE Project Intervention during Week 1 of enrollment
Wait-List Control
ACTIVE COMPARATORReceive SHE Project intervention during Week 2 of Enrollment
Interventions
Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.
Eligibility Criteria
You may qualify if:
- Women sentenced or anticipate a sentence of one year or less
- Ability to follow participants post-jail release
- Able to read and understand English
You may not qualify if:
- Women who have been treated for cervical cancer with procedures that would obviate the need for regular screening
- Exhibit severe psychological distress
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Megha Ramaswamy, PhD, MPHlead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
Wyandotte County Detention Center
Kansas City, Kansas, 66101, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Jackson County Detention/Regional Correctional Center
Kansas City, Missouri, 64106, United States
Related Publications (9)
Pickett ML, Allison M, Twist K, Klemp JR, Ramaswamy M. Breast Cancer Risk Among Women in Jail. Biores Open Access. 2018 Sep 20;7(1):139-144. doi: 10.1089/biores.2018.0018. eCollection 2018.
PMID: 30250761BACKGROUNDKelly PJ, Emerson A, Fair C, Ramaswamy M. Assessing fidelity: balancing methodology and reality in jail interventions. BMC Womens Health. 2018 Jul 23;18(1):127. doi: 10.1186/s12905-018-0617-x.
PMID: 30037333BACKGROUNDEmerson AM. Narrative Inquiry Into Shelter-Seeking by Women With a History of Repeated Incarceration: Research and Nursing Practice Implications. ANS Adv Nurs Sci. 2018 Jul/Sep;41(3):260-274. doi: 10.1097/ANS.0000000000000216.
PMID: 29901467BACKGROUNDEmerson AM. Strategizing and Fatalizing: Self and Other in the Trauma Narratives of Justice-Involved Women. Qual Health Res. 2018 May;28(6):873-887. doi: 10.1177/1049732318758634. Epub 2018 Feb 24.
PMID: 29478403BACKGROUNDKelly PJ, Ramaswamy M. Closing the cervical cancer disparity gap. Public Health Nurs. 2017 May;34(3):195-196. doi: 10.1111/phn.12336. No abstract available.
PMID: 28493356BACKGROUNDRamaswamy M, Lee J, Wickliffe J, Allison M, Emerson A, Kelly PJ. Impact of a brief intervention on cervical health literacy: A waitlist control study with jailed women. Prev Med Rep. 2017 Apr 5;6:314-321. doi: 10.1016/j.pmedr.2017.04.003. eCollection 2017 Jun.
PMID: 28435785BACKGROUNDKelly PJ, Hunter J, Daily EB, Ramaswamy M. Challenges to Pap Smear Follow-up among Women in the Criminal Justice System. J Community Health. 2017 Feb;42(1):15-20. doi: 10.1007/s10900-016-0225-3.
PMID: 27449030BACKGROUNDRamaswamy M, Kelly PJ. "The Vagina is a Very Tricky Little Thing Down There": Cervical Health Literacy among Incarcerated Women. J Health Care Poor Underserved. 2015 Nov;26(4):1265-85. doi: 10.1353/hpu.2015.0130.
PMID: 26548678BACKGROUNDRamaswamy M, Simmons R, Kelly PJ. The development of a brief jail-based cervical health promotion intervention. Health Promot Pract. 2015 May;16(3):432-42. doi: 10.1177/1524839914541658. Epub 2014 Jul 25.
PMID: 25063589BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Megha Ramaswamy, PhD, MPH
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 29, 2014
First Posted
May 1, 2014
Study Start
April 1, 2014
Primary Completion
March 1, 2016
Study Completion
May 31, 2019
Last Updated
June 4, 2019
Record last verified: 2019-06