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Sexual Health Empowerment for Women's Health (SHE-WOMEN)

Primary Purpose

Cervical Cancer, Breast Cancer, Contraceptive Usage

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SHE-WOMEN

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring Jail, Vulnerable Populations, STD Screening, unintended pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

-Scheduled to leave jail within 3 days

Exclusion Criteria:

not actively intoxicated
not show severe psychological distress

Sites / Locations

Jackson County Correctional Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

15 minute discharge planning session with health educator Health education booklet containing SHE-Women intervention content in print form(N~100) access to health educator via text message

Deliver text-Web intervention to (N ~100) women Researchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of ~10 hours pushed to participants over approximately a 5-day period.

Outcomes

Primary Outcome Measures

Change in Pap Knowledge

--Pap Knowledge Scale (PMID: 19299678) True, False. Mean increase in scoring equals an increase in Pap (cervical cancer) Knowledge

Change in beliefs about the benefits of cervical cancer screening and cervical cancer

--Health belief model scale for cervical cancer and Pap smear test (PMID:20946564) ..increased mean score = more perceived benefits to screening

Change in beliefs about barriers to cervical cancer screening

--Health belief model scale for cervical cancer and Pap smear test (PMID:20946564) ..increased mean score = more perceived barriers to screening

Change in the perception of seriousness of cervical cancer.

--Health belief model scale for cervical cancer and Pap smear test (PMID:20946564) Perceived Seriousness: increased mean score = increased perception that cervical cancer is serious, i.e. cervical cancer would change life

Change in beliefs about susceptibility to cervical cancer.

--Health belief model scale for cervical cancer and Pap smear test (PMID:20946564) ..Susceptibility to cervical cancer: increased mean score = increased perception that risk of cervical cancer is high "strongly disagree to strongly agree"

Change in beliefs in motivation for cervical cancer screening

--Health belief model scale for cervical cancer and Pap smear test (PMID:20946564) ..Motivation for screening: increased mean score = increased engagement in activities that would improve health "strongly disagree to strongly to agree"

Change in self-efficacy for cervical cancer screening

Self-efficacy scale for Pap smear screening participation in sheltered women (PMID:18004183) Definitely, Very Likely, Probably, Unlikely, Definitely not. Mean increase in scoring equals an increase in self-efficacy for Pap screening participation ...

Change in confidence navigating health systems

Confidence navigating health systems scale (PMID: 28435785) Very confident, Confident, Neutral, Not very confident Not at all confident ...Mean score increase equals increase in confidence navigating systems

Change in Breast Cancer Knowledge

Items from revised Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) True/False questions. Increase in mean score equals increase in breast in breast cancer knowledge

Change in Beliefs related to Breast Cancer

...items from revised Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) disagree or agree options: higher mean score = higher perception of risk

Change in Knowledge of Contraception

-Contraceptive knowledge assessment (PMID:27621043) Mean increase in score = increase in change in knowledge

Change in beliefs about acquisition and use of contraception

-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree Beliefs of barriers: mean increase in score equals increased perceptions of barriers

Change in confidence in use of contraception

-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Very confident, Confident, Neutral, Not very confident, Not at all confident: Confidence using contraception: mean increase in score equals increased confidence

Change in knowledge of sexually transmitted diseases

-STD knowledge questionnaire (PMID: 17016760) True/False: mean increase in score equals increased knowledge.

Change in attitudes related to condom use

-Multidimensional condom attitudes scale (PMID: 8055858) Higher mean score indicate more positive attitudes toward condoms. Items were rated on a 7-point scale ranging from strongly disagree to strongly to agree.

Change in confidence using condoms

-Condom self-efficacy scale (PMID: 1783705) strongly disagree to strongly agree : higher mean scores equals increase in self efficacy

Up to date Pap screening

Health Information National Trends Survey-cervical cancer screening question . "Have you ever had a Pap smear or Pap test? "When was your last pap screen?"

Up-to-date mammography for women age 50+

-Health Information National Trends Survey-breast cancer screening questions Multiple choice question: "When did you have your most recent mammogram to check for breast cancer?

Change in HPV Vaccination receipt

Behavioral Risk Factor Surveillance System (BRFSS) Human papillomavirus (HPV) vaccine question Yes or no: have you ever had an HPV vaccination?

Secondary Outcome Measures

Full Information

NCT ID

NCT03984695

First Posted

May 13, 2019

Last Updated

April 3, 2023

Sponsor

University of Kansas Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03984695

Brief Title

Sexual Health Empowerment for Women's Health

Acronym

SHE-WOMEN

Official Title

Sexual Health Empowerment for Jail-Involved Women's Health Literacy and Prevention

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 11, 2019 (Actual)

Primary Completion Date

December 21, 2022 (Actual)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to expand the reach of an existing cervical cancer literacy and prevention intervention- the Sexual Health Empowerment (SHE) Project . As a logical extension of the investigators earlier work, the objective of this renewal is to expand reach of SHE to address women's health disparities more broadly to create a sustainable model for dissemination of health promotion interventions for vulnerable populations.

Detailed Description

Over the last 35 years, there has been a 700% increase in the number of women in prisons and jails. These women, mostly women of color, have pervasive trauma histories, mental health problems, and drug use, all of which compromise their ability to engage in preventive health behaviors. For the last eight years, the research team has studied women leaving jail and why they are 4-5 times more likely to develop cervical cancer, a disparity that has remained unchanged for over 50 years. The original objective of the Sexual Health Empowerment (SHE) for Cervical Health Literacy and Prevention program (R01 CA181047) was to assess the effectiveness of a jail-based intervention to increase cervical health literacy and screening. SHE increased jailed women's cervical health literacy and rates of cancer screening after the women left jail. While delivering SHE, researchers observed: 1) the cross-cutting nature of women's health risk factors, i.e. the risks that jailed women faced for cervical cancer also could lead to other women's health problems; and 2) opportunity for taking an evidence-based intervention, with a rich theoretical framing, to expand to other women's health issues faced by this group, around, not only cervical cancer prevention, but also breast cancer, unintended pregnancy, and STI prevention. While following women after release from jail (85% follow-up rate after 3 years), investigators also identified strategies for reaching this high-risk population through electronic communication. SHE participants were high users of mobile phones (88%), text (76%), Web (79%), and Facebook (70%). This renewal application presents an opportunity to holistically address health disparities experienced by women leaving jail and test new modalities for intervention delivery given use of electronic communication and social media. The first aim uses an RCT to test the effectiveness of SHE-Women with women leaving jail on increasing women's health literacy, screening, and risk reduction practices (for cervical, breast cancer, unintended pregnancy, and STIs) against a standard of care. The second aim will be to understand the role and impact of human interaction in electronic interventions by tracking participants and interviewing key stakeholders. Knowledge gained from this study will lead to an understanding of: 1) how a comprehensive women's health literacy intervention can narrow health disparities among justice-involved women and 2) the role of human interaction in successful electronic interventions, thereby creating a sustainable model for dissemination of health promotion interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer, Breast Cancer, Contraceptive Usage, Sexually Transmitted Diseases

Keywords

Jail, Vulnerable Populations, STD Screening, unintended pregnancy

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized clinical trial.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

279 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

15 minute discharge planning session with health educator Health education booklet containing SHE-Women intervention content in print form(N~100) access to health educator via text message

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

SHE-WOMEN

Intervention Description

SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections.

Primary Outcome Measure Information:

Title

Change in Pap Knowledge

Description

--Pap Knowledge Scale (PMID: 19299678) True, False. Mean increase in scoring equals an increase in Pap (cervical cancer) Knowledge

Time Frame