Sexual Health Empowerment for Women's Health

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: SHE-WOMEN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Scheduled to leave jail within 3 days Exclusion Criteria: not actively intoxicated not show severe psychological distress

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pap Knowledge | --Pap Knowledge Scale (PMID: 19299678) True, False. Mean increase in scoring equals an increase in Pap (cervical cancer) Knowledge | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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 | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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 | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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 | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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 | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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 | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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 ... | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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 | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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 | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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 | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| Change in Knowledge of Contraception | -Contraceptive knowledge assessment (PMID:27621043) Mean increase in score = increase in change in knowledge | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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 | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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 | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| Change in knowledge of sexually transmitted diseases | -STD knowledge questionnaire (PMID: 17016760) True/False: mean increase in score equals increased knowledge. | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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. | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| Change in confidence using condoms | -Condom self-efficacy scale (PMID: 1783705) strongly disagree to strongly agree : higher mean scores equals increase in self efficacy | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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? | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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? | Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 
| 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? | 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jail, Vulnerable Populations, STD Screening, unintended pregnancy