Study Summary
This trial will test an expansion of an existing cervical cancer prevention intervention to a broader population to see if it is effective and sustainable.
Eligible Conditions
- Sexually Transmitted Infections (STIs)
- Cervical Cancer
- Birth Control
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
19 Primary · 0 Secondary · Reporting Duration: 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention
Month 36
Change in HPV Vaccination receipt
Month 36
Change in Beliefs related to Breast Cancer
Body Weight Changes
Change in Knowledge of Contraception
Change in Pap Knowledge
Change in attitudes related to condom use
Change in beliefs about acquisition and use of contraception
Change in beliefs about barriers to cervical cancer screening
Change in beliefs about susceptibility to cervical cancer.
Change in beliefs about the benefits of cervical cancer screening and cervical cancer
Change in beliefs in motivation for cervical cancer screening
Change in confidence in use of contraception
Change in confidence navigating health systems
Change in confidence using condoms
Change in knowledge of sexually transmitted diseases
Change in self-efficacy for cervical cancer screening
Change in the perception of seriousness of cervical cancer.
Up to date Pap screening
Up-to-date mammography for women age 50+
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment
279 Total Participants · 2 Treatment Groups
Primary Treatment: SHE-WOMEN · No Placebo Group · N/A
Intervention
Behavioral
Experimental Group · 1 Intervention: SHE-WOMEN · Intervention Types: BehavioralControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months post behavioral intervention, 24 months post behavioral intervention, 36 months post behavioral intervention
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
407 Previous Clinical Trials
159,884 Total Patients Enrolled
Megha Ramaswamy, PhD, MPHPrincipal Investigator - University of Kansas School of Medicine
University of Kansas Medical Center
1 Previous Clinical Trials
261 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Ramaswamy, Megha, Hsiang-Feng Chen, Karen L. Cropsey, Jennifer G. Clarke, and Patricia J. Kelly. 2015. “Highly Effective Birth Control Use Before and After Women's Incarceration”. Journal of Women's Health. Mary Ann Liebert Inc. doi:10.1089/jwh.2014.4942.
- Jaworski, Beth C., and Michael P. Carey. 2006. “Development and Psychometric Evaluation of a Self-administered Questionnaire to Measure Knowledge of Sexually Transmitted Diseases”. AIDS and Behavior. Springer Science and Business Media LLC. doi:10.1007/s10461-006-9168-5.
- Brafford, Linda J., and Kenneth H. Beck. 1991. “Development and Validation of a Condom Self-efficacy Scale for College Students”. Journal of American College Health. Informa UK Limited. doi:10.1080/07448481.1991.9936238.
- Ramaswamy, Megha, and Patricia J. Kelly. 2015. “Sexual Health Risk and the Movement of Women Between Disadvantaged Communities and Local Jails”. Behavioral Medicine. Informa UK Limited. doi:10.1080/08964289.2015.1024602.
- Fernández, María E., Alicia Gonzales, Guillermo Tortolero-Luna, Janet Williams, Monica Saavedra-Embesi, Wenyaw Chan, and Sally W. Vernon. 2009. “Effectiveness of cultivando La Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-income Hispanic Women”. American Journal of Public Health. American Public Health Association. doi:10.2105/ajph.2008.136713.
- Hogenmiller, Jette R., Jan R. Atwood, Ada M. Lindsey, David R. Johnson, Melody Hertzog, and Joseph C. Scott. 2007. “Self-efficacy Scale for Pap Smear Screening Participation in Sheltered Women”. Nursing Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.nnr.0000299848.21935.8d.
- Helweg-Larsen, Marie, and Barry E. Collins. 1994. “The UCLA Multidimensional Condom Attitudes Scale: Documenting the Complex Determinants of Condom Use in College Students.”. Health Psychology. American Psychological Association (APA). doi:10.1037/0278-6133.13.3.224.
- Haynes, Meagan Campol, Nessa Ryan, Mona Saleh, Abigail Ford Winkel, and Veronica Ades. 2017. “Contraceptive Knowledge Assessment: Validity and Reliability of a Novel Contraceptive Research Tool”. Contraception. Elsevier BV. doi:10.1016/j.contraception.2016.09.002.
- Melnick, Alan L., Rebecca E. Rdesinski, E. Dawn Creach, Dongseok Choi, and S. Marie Harvey. 2008. “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”. Women's Health Issues. Elsevier BV. doi:10.1016/j.whi.2008.07.011.
- Ramaswamy, Megha, and Patricia J. Kelly. 2015. ““the Vagina Is a Very Tricky Little Thing down There”: Cervical Health Literacy Among Incarcerated Women”. Journal of Health Care for the Poor and Underserved. Project Muse. doi:10.1353/hpu.2015.0130.
- Ramaswamy, Megha, Jaehoon Lee, Joi Wickliffe, Molly Allison, Amanda Emerson, and Patricia J. Kelly. 2017. “Impact of a Brief Intervention on Cervical Health Literacy: A Waitlist Control Study with Jailed Women”. Preventive Medicine Reports. Elsevier BV. doi:10.1016/j.pmedr.2017.04.003.
- Pickett, Michelle L., Molly Allison, Katelyn Twist, Jennifer R. Klemp, and Megha Ramaswamy. 2018. “Breast Cancer Risk Among Women in Jail”. Bioresearch Open Access. Mary Ann Liebert Inc. doi:10.1089/biores.2018.0018.
- Ramaswamy, Megha, Rebekah Simmons, and Patricia J. Kelly. 2014. “The Development of a Brief Jail-based Cervical Health Promotion Intervention”. Health Promotion Practice. SAGE Publications. doi:10.1177/1524839914541658.
- Guvenc, Gulten, Aygul Akyuz, and Cengiz Han Açikel. 2010. “Health Belief Model Scale for Cervical Cancer and Pap Smear Test: Psychometric Testing”. Journal of Advanced Nursing. Wiley. doi:10.1111/j.1365-2648.2010.05450.x.
- Kelly, Patricia J., Molly Allison, and Megha Ramaswamy. 2018. “Cervical Cancer Screening Among Incarcerated Women”. Edited by Andrea Knittel. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0199220.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Megha Ramaswamy, PhD, MPH 2019. "Sexual Health Empowerment for Women's Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03984695.
Frequently Asked Questions
How many participants are currently eligible for this research trial?
"Affirmative, clinicaltrials.gov reveals that recruitment has opened for this research project which was initially posted on the 11th of November 2019 and recently modified on the 2nd of February 2021. 200 applicants are sought from a single site." - Anonymous Online Contributor
Unverified Answer
Are there still opportunities to join this medical experiment?
"Affirmative. Data hosted on clinicaltrials.gov shows that this research is actively enrolling participants, with the study first advertised on November 11th 2019 and last edited today February 11th 2021. The trial seeks 200 patients from a single medical centre." - Anonymous Online Contributor
Unverified Answer