Sexual Health Empowerment for Women’s Health

Overview

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.

Full Title of Study: “Sexual Health Empowerment for Jail-Involved Women’s Health Literacy and Prevention”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 21, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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
  • 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”
  • 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”
  • 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 …
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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
  • 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?”
  • 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?
  • 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?

Participating in This Clinical Trial

Inclusion Criteria

-Scheduled to leave jail within 3 days Exclusion Criteria:

  • not actively intoxicated – not show severe psychological distress

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Kansas Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Megha Ramaswamy, PhD, MPH, Associate Professor – University of Kansas Medical Center
  • Overall Official(s)
    • Megha Ramaswamy, PhD, MPH, Principal Investigator, University of Kansas School of Medicine

References

Ramaswamy M, Kelly PJ. "The Vagina is a Very Tricky Little Thing Down There": Cervical Health Literacy among Incarcerated Women. J Health Care Poor Underserved. 2015 Nov;26(4):1265-85. doi: 10.1353/hpu.2015.0130. Erratum In: J Health Care Poor Underserved. 2016;27(1):viii.

Ramaswamy M, Lee J, Wickliffe J, Allison M, Emerson A, Kelly PJ. Impact of a brief intervention on cervical health literacy: A waitlist control study with jailed women. Prev Med Rep. 2017 Apr 5;6:314-321. doi: 10.1016/j.pmedr.2017.04.003. eCollection 2017 Jun. Erratum In: Prev Med Rep. 2017 Dec 06;8:303-305.

Kelly PJ, Allison M, Ramaswamy M. Cervical cancer screening among incarcerated women. PLoS One. 2018 Jun 26;13(6):e0199220. doi: 10.1371/journal.pone.0199220. eCollection 2018.

Pickett ML, Allison M, Twist K, Klemp JR, Ramaswamy M. Breast Cancer Risk Among Women in Jail. Biores Open Access. 2018 Sep 20;7(1):139-144. doi: 10.1089/biores.2018.0018. eCollection 2018.

Ramaswamy M, Chen HF, Cropsey KL, Clarke JG, Kelly PJ. Highly Effective Birth Control Use Before and After Women's Incarceration. J Womens Health (Larchmt). 2015 Jun;24(6):530-9. doi: 10.1089/jwh.2014.4942. Epub 2015 Jan 2.

Ramaswamy M, Kelly PJ. Sexual Health Risk and the Movement of Women Between Disadvantaged Communities and Local Jails. Behav Med. 2015;41(3):115-22. doi: 10.1080/08964289.2015.1024602.

Ramaswamy M, Simmons R, Kelly PJ. The development of a brief jail-based cervical health promotion intervention. Health Promot Pract. 2015 May;16(3):432-42. doi: 10.1177/1524839914541658. Epub 2014 Jul 25.

Fernandez ME, Gonzales A, Tortolero-Luna G, Williams J, Saavedra-Embesi M, Chan W, Vernon SW. Effectiveness of Cultivando la Salud: a breast and cervical cancer screening promotion program for low-income Hispanic women. Am J Public Health. 2009 May;99(5):936-43. doi: 10.2105/AJPH.2008.136713. Epub 2009 Mar 19.

Guvenc G, Akyuz A, Acikel CH. Health Belief Model Scale for Cervical Cancer and Pap Smear Test: psychometric testing. J Adv Nurs. 2011 Feb;67(2):428-37. doi: 10.1111/j.1365-2648.2010.05450.x. Epub 2010 Oct 15.

Hogenmiller JR, Atwood JR, Lindsey AM, Johnson DR, Hertzog M, Scott JC Jr. Self-efficacy scale for Pap smear screening participation in sheltered women. Nurs Res. 2007 Nov-Dec;56(6):369-77. doi: 10.1097/01.NNR.0000299848.21935.8d.

Haynes MC, Ryan N, Saleh M, Winkel AF, Ades V. Contraceptive Knowledge Assessment: validity and reliability of a novel contraceptive research tool. Contraception. 2017 Feb;95(2):190-197. doi: 10.1016/j.contraception.2016.09.002. Epub 2016 Sep 9.

Melnick AL, Rdesinski RE, Creach ED, Choi D, Harvey SM. The influence of nurse home visits, including provision of 3 months of contraceptives and contraceptive counseling, on perceived barriers to contraceptive use and contraceptive use self-efficacy. Womens Health Issues. 2008 Nov-Dec;18(6):471-81. doi: 10.1016/j.whi.2008.07.011. Epub 2008 Oct 15.

Jaworski BC, Carey MP. Development and psychometric evaluation of a self-administered questionnaire to measure knowledge of sexually transmitted diseases. AIDS Behav. 2007 Jul;11(4):557-74. doi: 10.1007/s10461-006-9168-5. Epub 2006 Oct 3.

Helweg-Larsen M, Collins BE. The UCLA Multidimensional Condom Attitudes Scale: documenting the complex determinants of condom use in college students. Health Psychol. 1994 May;13(3):224-37. doi: 10.1037//0278-6133.13.3.224.

Brafford LJ, Beck KH. Development and validation of a condom self-efficacy scale for college students. J Am Coll Health. 1991 Mar;39(5):219-25. doi: 10.1080/07448481.1991.9936238.

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