Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention

NCT ID: NCT02128659

Last Updated: 2019-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-05-31

Brief Summary

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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

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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.

Conditions

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Cervical Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SHE Project

Receives SHE Project Intervention during Week 1 of enrollment

Group Type EXPERIMENTAL

SHE Project

Intervention Type BEHAVIORAL

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

Wait-List Control

Receive SHE Project intervention during Week 2 of Enrollment

Group Type ACTIVE_COMPARATOR

SHE Project

Intervention Type BEHAVIORAL

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

Interventions

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SHE Project

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Megha Ramaswamy, PhD, MPH

OTHER

Sponsor Role lead

Responsible Party

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Megha Ramaswamy, PhD, MPH

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Megha Ramaswamy, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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Wyandotte County Detention Center

Kansas City, Kansas, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Jackson County Detention/Regional Correctional Center

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30250761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30037333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29901467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29478403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28493356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28435785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27449030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26548678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25063589 (View on PubMed)

Other Identifiers

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R01CA181047-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13559

Identifier Type: -

Identifier Source: org_study_id

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