Sexual Health Empowerment for Women's Health

NCT03984695 | Active Not Recruiting Results

• 2 other identifiers: STUDY001433165R01CA181047-10
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Jail; Vulnerable Populations; STD Screening; unintended pregnancy

Outcome Measures

Primary Outcomes (8)

• Cervical Cancer Literacy

  Cervical Cancer Literacy Assessment Tool (C-CLAT) (PMID: 19299678) Adopted 16-items C-CLAT, the sum of scores on all 16 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 16 (maximum). A higher score represents a higher level of cervical cancer literacy (i.e., better outcome).

  Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment

• Breast Cancer Literacy

  Breast Cancer Literacy Assessment Tool (B-CLAT) (PMID:23905580) Revised 22-items from B-CLAT (with an added item ask "At what age are most women supposed to start having mammograms?") The sum of scores on all 22 items reflects participants breast cancer literacy with a possible total score ranges from 0 (minimum) to 22 (maximum). A higher score represents a higher level of cervical cancer literacy (i.e., better outcome). ...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 assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment

• Knowledge of Contraception

  -Contraceptive knowledge assessment (PMID:27621043) Adopted 8-items Contraceptive knowledge assessment, the sum of scores on all 8 items reflects participants cervical cancer literacy with a possible total score ranges from 0 (minimum) to 8 (maximum). A higher score represents a higher level of knowledge of contraception.

  Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment

• Beliefs About Acquisition and Use of Contraception

  -Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Strongly Disagree) to 5 (Strongly Agree) A mean score of 10 items represent participants' beliefs of contraceptive barriers, ranges from 1 (minimum) to 5 (maximum). A higher score represents a higher level of perceived barriers (i.e., worse outcome).

  Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.

• Confidence in Use of Contraception

  -Beliefs about acquisition and use of contraceptive items from self-efficacy scale (PMID:18926726) Each item was on 5-point Likert scale range from 1 (Very confident) to 5 (Not at all confident). A mean score of reverse-coded 6 items represent participants' beliefs of contraceptive self-efficacy, ranges from 1 (minimum) to 5 (maximum). A higher score represents a higher level of contraceptive self-efficacy (i.e., better outcome).

  Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.

• Knowledge of Sexually Transmitted Diseases

  -STD knowledge questionnaire (PMID: 17016760) Adopted 8-items STD knowledge questionnaire , the sum of scores on all 8 items reflects participants STD knowledge level with a possible total score ranges from 0 (minimum) to 8 (maximum). A higher score represents a higher level of knowledge of STD.

  Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.

• Confidence Using Condoms

  -Condom self-efficacy scale (PMID: 1783705) A mean score of 15 items were calculated with a possible range of 1 (minimum) to 7 (maximum). Higher scores represent a higher level of condom self-efficacy.

  Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.

• Attitudes Related to Condom Use

  -Multidimensional condom attitudes scale (PMID: 8055858) A mean score of 20-items was calculated with possible values range from 1 (minimum) to 7 (maximum). Items were rated on a 7-point scale ranging from strongly disagree to strongly agree. Higher mean score indicate more positive attitudes toward condoms.

  Pre-Intervention assessment measured at baseline, Immediately post behavioral intervention assessment measured at 5 days after baseline, 12-month, 24-month, and 36-month follow-up assessments are measured accordingly after the baseline assessment.

Secondary Outcomes (3)

• HPV Vaccination Receipt

  Only at baseline

• Up to Date Pap Screening

  Only at baseline

• Up to Date Mammography

  Only at baseline

Study Arms (2)

Control

NO INTERVENTION

* 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

Intervention

EXPERIMENTAL

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

Interventions

SHE-WOMEN BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to leave jail within 3 days

You may not qualify if:

• not actively intoxicated
• not show severe psychological distress

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jackson County Correctional Facility

Kansas City, Missouri, 64106, United States

Location

Related Publications (15)

• 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.

  PMID: 26548678 BACKGROUND

• 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.

  PMID: 28435785 BACKGROUND

• 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.

  PMID: 29944694 BACKGROUND

• 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.

  PMID: 30250761 BACKGROUND

• 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.

  PMID: 25555175 BACKGROUND

• 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.

  PMID: 26332929 BACKGROUND

• 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.

  PMID: 25063589 BACKGROUND

• 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.

  PMID: 19299678 BACKGROUND

• 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.

  PMID: 20946564 BACKGROUND

• 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.

  PMID: 18004183 BACKGROUND

• 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.

  PMID: 27621043 BACKGROUND

• 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.

  PMID: 18926726 BACKGROUND

• 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.

  PMID: 17016760 BACKGROUND

• 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.

  PMID: 8055858 BACKGROUND

• 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.

  PMID: 1783705 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Breast Neoplasms; Contraception Behavior; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Reproductive Behavior; Behavior; Communicable Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jaime Caldwell
• Organization: KUMCRI

spa@kumc.edu

913-588-1261

Study Officials

• Jason Glenn, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial.

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: June 13, 2019
• Study Start: September 11, 2019
• Primary Completion: September 1, 2023
• Study Completion: March 31, 2026
• Last Updated: January 28, 2026
• Results First Posted: February 21, 2025

Record last verified: 2026-01

Locations

US (1)