This clinical trial tests the usefulness and effectiveness of an electronic women's health literacy intervention, SHE-Women, in improving health literacy in the vulnerable group of women leaving jail. Women who have been part of the justice system may have a high risk of negative women’s health outcomes. This may be because of lifestyle risks or because of less access to things like health screenings, health care, and insurance. Sexual Health Empowerment (SHE)-Women is an integrated, multimedia electronic women’s health literacy intervention delivery program through a text and website (Web) platform. The SHE-Women program includes information on breast cancer, cervical cancer, sexually transmitted infections (STIs), and different forms of birth control. SHE-Women may be an effective way for women leaving jail to learn more about women's health and improve their health outcomes by increasing women’s health literacy, screening, and risk reduction practices.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03984695.
PRIMARY OBJECTIVES:
I. Assess feasibility and pilot effectiveness of SHE-Women, an electronic women’s health literacy intervention.
II. Test the effectiveness of SHE-Women on women’s health literacy, screening, and risk reduction practices against a standard of care discharge planning session using a randomized controlled trial.
III. Understand the role and impact of human interaction in electronic interventions by tracking participants and interviewing key stakeholders.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo a standard of care discharge planning session and receive a 10-page women's health education booklet that utilizes SHE-Women content at time of jail release. Participants may participate in text messaging with a health educator if they have questions and attend community-based women’s health group sessions.
ARM II: Participants undergo SHE-Women self-directed education through a text and website platform. Participants receive texts on days 1-5 with link to content on SHE-Women website, which includes videos, quizzes, and plain text. Participants may participate in text messaging with a health educator if they have questions and attend community-based women’s health group sessions.
After completion of study, participants are followed up immediately post-intervention and annually for 3 years with follow-up complete by year 5.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Kansas Cancer Center
Principal InvestigatorMegha Ramaswamy
