Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention

Cervical Cancer Clinical Trial

— SHE Project  

Official title:

Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128659
• Other study ID #: 13559
• Secondary ID: R01CA181047-01A1
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: May 31, 2019
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• SHE Project
Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.

Locations

Country	Name	City	State
United States	Jackson County Detention/Regional Correctional Center	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Wyandotte County Detention Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Megha Ramaswamy, PhD, MPH	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	6 Months post-jail release
Secondary	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)	12 Months post-jail release
Secondary	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)	24 Months post-jail release
Secondary	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)	36 months post-jail release

External Links

•   Study website