Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention

Study Overview
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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.

Official Title
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Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: SHE Project


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHE Project<br>Receives SHE Project Intervention during Week 1 of enrollment | Behavioral: SHE Project<br>* Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.<br>|
| Active Comparator: Wait-List Control<br>Receive SHE Project intervention during Week 2 of Enrollment | Behavioral: SHE Project<br>* Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |