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

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ClinicalTrials.gov Identifier: NCT03984695
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Megha Ramaswamy, PhD, MPH, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Breast Cancer Contraceptive Usage Sexually Transmitted Diseases Behavioral: SHE-WOMEN Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Sexual Health Empowerment for Jail-Involved Women's Health Literacy and Prevention
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Pap Knowledge [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]
    --Pap Knowledge Scale (PMID: 19299678) True, False. Mean increase in scoring equals an increase in Pap (cervical cancer) Knowledge

  2. Change in beliefs about the benefits of cervical cancer screening and cervical cancer [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]

    --Health belief model scale for cervical cancer and Pap smear test (PMID:20946564)

    ..increased mean score = more perceived benefits to screening


  3. Change in beliefs about barriers to cervical cancer screening [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]

    --Health belief model scale for cervical cancer and Pap smear test (PMID:20946564)

    ..increased mean score = more perceived barriers to screening


  4. Change in the perception of seriousness of cervical cancer. [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]

    --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


  5. Change in beliefs about susceptibility to cervical cancer. [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]

    --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"


  6. Change in beliefs in motivation for cervical cancer screening [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]

    --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"


  7. Change in self-efficacy for cervical cancer screening [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]

    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

    ...


  8. Change in confidence navigating health systems [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]

    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


  9. Change in Breast Cancer Knowledge [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]
    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

  10. Change in Beliefs related to Breast Cancer [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]
    ...items from revised Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) disagree or agree options: higher mean score = higher perception of risk

  11. Change in Knowledge of Contraception [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]
    -Contraceptive knowledge assessment (PMID:27621043) Mean increase in score = increase in change in knowledge

  12. Change in beliefs about acquisition and use of contraception [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]
    -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

  13. Change in confidence in use of contraception [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]
    -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

  14. Change in knowledge of sexually transmitted diseases [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]
    -STD knowledge questionnaire (PMID: 17016760) True/False: mean increase in score equals increased knowledge.

  15. Change in attitudes related to condom use [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]
    -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.

  16. Change in confidence using condoms [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]
    -Condom self-efficacy scale (PMID: 1783705) strongly disagree to strongly agree : higher mean scores equals increase in self efficacy

  17. Up to date Pap screening [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]

    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?"


  18. Up-to-date mammography for women age 50+ [ Time Frame: Pre-Intervention, Immediately post behavioral intervention, 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]
    -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?

  19. Change in HPV Vaccination receipt [ Time Frame: 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention ]
    Behavioral Risk Factor Surveillance System (BRFSS) Human papillomavirus (HPV) vaccine question Yes or no: have you ever had an HPV vaccination?



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Scheduled to leave jail within 3 days

Exclusion Criteria:

  • not actively intoxicated
  • not show severe psychological distress

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984695


Contacts
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Contact: Megha Ramaswamy, PhD, MPH 913 588 1053 mramaswamy@kumc.edu
Contact: Joi L Wickliffe, MPH 913 588 2646 jwickliffe@kumc.edu

Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Megha Ramaswamy, PhD, MPH University of Kansas School of Medicine

Additional Information:
Publications:

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Responsible Party: Megha Ramaswamy, PhD, MPH, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03984695     History of Changes
Other Study ID Numbers: STUDY00143316
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Megha Ramaswamy, PhD, MPH, University of Kansas Medical Center:
Jail
Vulnerable Populations
STD Screening
unintended pregnancy

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Sexually Transmitted Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Infection
Virus Diseases
Genital Diseases, Male