Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention (SHE Project)
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHE Project
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer
Eligibility 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
Sites / Locations
- Wyandotte County Detention Center
- University of Kansas Medical Center
- Jackson County Detention/Regional Correctional Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SHE Project
Wait-List Control
Arm Description
Receives SHE Project Intervention during Week 1 of enrollment
Receive SHE Project intervention during Week 2 of Enrollment
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Long-term health behavior
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)
Long-term health behavior
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)
Long-term health behavior
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)
Long-term health behavior
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)
Full Information
NCT ID
NCT02128659
First Posted
April 29, 2014
Last Updated
June 2, 2019
Sponsor
Megha Ramaswamy, PhD, MPH
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02128659
Brief Title
Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention
Acronym
SHE Project
Official Title
Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Megha Ramaswamy, PhD, MPH
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHE Project
Arm Type
Experimental
Arm Description
Receives SHE Project Intervention during Week 1 of enrollment
Arm Title
Wait-List Control
Arm Type
Active Comparator
Arm Description
Receive SHE Project intervention during Week 2 of Enrollment
Intervention Type
Behavioral
Intervention Name(s)
SHE Project
Intervention Description
Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.
Primary Outcome Measure Information:
Title
Effectiveness of sexual health empowerment (SHE Project) intervention
Description
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)
Time Frame
Change from Baseline to 5 days
Secondary Outcome Measure Information:
Title
Long-term health behavior
Description
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)
Time Frame
6 Months post-jail release
Title
Long-term health behavior
Description
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)
Time Frame
12 Months post-jail release
Title
Long-term health behavior
Description
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)
Time Frame
24 Months post-jail release
Title
Long-term health behavior
Description
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)
Time Frame
36 months post-jail release
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megha Ramaswamy, PhD, MPH
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wyandotte County Detention Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66101
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Jackson County Detention/Regional Correctional Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30250761
Citation
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.
Results Reference
background
PubMed Identifier
30037333
Citation
Kelly 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.
Results Reference
background
PubMed Identifier
29901467
Citation
Emerson 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.
Results Reference
background
PubMed Identifier
29478403
Citation
Emerson 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.
Results Reference
background
PubMed Identifier
28493356
Citation
Kelly 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.
Results Reference
background
PubMed Identifier
28435785
Citation
Ramaswamy 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. Erratum In: Prev Med Rep. 2017 Dec 06;8:303-305.
Results Reference
background
PubMed Identifier
27449030
Citation
Kelly 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.
Results Reference
background
PubMed Identifier
26548678
Citation
Ramaswamy 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. Erratum In: J Health Care Poor Underserved. 2016;27(1):viii.
Results Reference
background
PubMed Identifier
25063589
Citation
Ramaswamy 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.
Results Reference
background
Links:
URL
http://www.kumc.edu/she
Description
Study website
Learn more about this trial
Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention
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