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

January 8, 2026 updated by: Jason E Glenn, PhD, University of Kansas Medical Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64106
        • Jackson County Correctional Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

-Scheduled to leave jail within 3 days

Exclusion Criteria:

  • not actively intoxicated
  • not show severe psychological distress

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
  • 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
Experimental: Intervention

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.
Behavioral: SHE-WOMEN
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical Cancer Literacy
Time Frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment

Cervical Cancer Literacy Assessment Tool (C-CLAT) (PMID: 19299678) Adopted 16-items C-CLAT, the sum of scores on all 16 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 16 (maximum).

A higher score represents a higher level of cervical cancer literacy (i.e., better outcome).
Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment
Breast Cancer Literacy
Time Frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment

Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) Revised 22-items from B-CLAT (with an added item ask "At what age are most women supposed to start having mammograms?") The sum of scores on all 22 items reflects participants breast cancer literacy with a possible total score ranges from 0 (minimum) to 22 (maximum).

A higher score represents a higher level of cervical cancer literacy (i.e., better outcome).

...items from revised Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) disagree or agree options: higher mean score = higher perception of risk
Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment
Knowledge of Contraception
Time Frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment

-Contraceptive knowledge assessment (PMID:27621043) Adopted 8-items Contraceptive knowledge assessment, the sum of scores on all 8 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 8 (maximum).

A higher score represents a higher level of knowledge of contraception.
Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment
Beliefs About Acquisition and Use of Contraception
Time Frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.

-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Strongly Disagree) to 5 (Strongly Agree) A mean score of 10 items represent participants' beliefs of contraceptive barriers, ranges from 1 (minimum) to 5 (maximum).

A higher score represents a higher level of perceived barriers (i.e., worse outcome).
Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.
Confidence in Use of Contraception
Time Frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.

-Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Very confident) to 5 (Not at all confident).

A mean score of reverse-coded 6 items represent participants' beliefs of contraceptive self-efficacy, ranges from 1 (minimum) to 5 (maximum).

A higher score represents a higher level of contraceptive self-efficacy (i.e., better outcome).
Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.
Knowledge of Sexually Transmitted Diseases
Time Frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.

-STD knowledge questionnaire (PMID: 17016760) Adopted 8-items STD knowledge questionnaire , the sum of scores on all 8 items reflects participants STD knowledge level with a possible total score ranges from 0 (minimum) to 8 (maximum).

A higher score represents a higher level of knowledge of STD.
Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.
Confidence Using Condoms
Time Frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.

-Condom self-efficacy scale (PMID: 1783705) A mean score of 15 items were calculated with a possible range of 1 (minimum) to 7 (maximum).

Higher scores represent a higher level of condom self-efficacy.
Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.
Attitudes Related to Condom Use
Time Frame: Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.

-Multidimensional condom attitudes scale (PMID: 8055858) A mean score of 20-items was calculated with possible values range from 1 (minimum) to 7 (maximum).

Items were rated on a 7-point scale ranging from strongly disagree to strongly agree.

Higher mean score indicate more positive attitudes toward condoms.
Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV Vaccination Receipt
Time Frame: Only at baseline
Behavioral Risk Factor Surveillance System (BRFSS) Human papillomavirus (HPV) vaccine question: have you ever had an HPV vaccination? A dichotomized score reflects participants' HPV vaccination receipt with 0 (no) and 1 (yes).
Only at baseline
Up to Date Pap Screening
Time Frame: Only at baseline
Health Information National Trends Survey-cervical cancer screening question: "When was your last pap screen?" A categorical items with four levels: 1) never; 2) within the past 3 years; 3) between 3 to 5 years; 4) 5 or more years ago.
Only at baseline
Up to Date Mammography
Time Frame: Only at baseline
Health Information National Trends Survey-breast cancer screening question: "When did you have your most recent mammogram to check for breast cancer? The items is only asked for participants over 50 years old. A categorical outcome with five levels: 1) never had a mammogram; 2) a year ago or less; 3) more than 1, up to 2 years ago; 4) more than 2 but no more than 5 years ago; 5) more than 5 years ago
Only at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jason Glenn, PhD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2019

Primary Completion (Actual)

September 1, 2023

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (Actual)

June 13, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00143316
  • 5R01CA181047-10 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sexually Transmitted Diseases

Clinical Trials on SHE-WOMEN

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe