Sexual Health Empowerment for Women's Health

Breast Cancer Clinical Trial

— SHE-WOMEN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03984695
• Other study ID #: STUDY00143316
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 279
• Est. completion date: March 31, 2024
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Scheduled to leave jail within 3 days

Exclusion Criteria:

• not actively intoxicated

• not show severe psychological distress

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Contraceptive Usage
• Sexually Transmitted Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Jackson County Correctional Facility	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Sexual Health Empowerment Team Website