SHE-WOMEN Program for Cervical Cancer Prevention

(SHE-WOMEN Trial)

Overseen By Joi L Wickliffe, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Intoxication, Severe psychological distress

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to expand a program that helps women understand and prevent cervical cancer by offering health education and support, especially to vulnerable women, to enhance their overall health knowledge. Participants will receive either a booklet with support from a health educator or an electronic health literacy intervention as part of the SHE-WOMEN program. The trial seeks women who are about to leave jail and are not experiencing severe psychological issues or intoxication. As an unphased trial, it provides valuable health insights and support without the risks linked to early-phase drug testing.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the SHE-WOMEN program is safe for cervical cancer prevention?

Research has shown that the SHE-WOMEN program builds on a previous project called the Sexual Health Empowerment (SHE) project, which aimed to educate women about preventing cervical cancer. Since the SHE-WOMEN program does not introduce new drugs or medical procedures, no evidence suggests physical health risks.

The program delivers health education through text messages and online content. It is designed to be easy to understand and particularly helpful for women recently released from jail. The main goal is to increase knowledge and awareness about preventing cervical cancer. By using educational materials instead of medical treatments, the program is generally considered safe for participants.

Participants can feel at ease joining this program, as it primarily involves receiving information and advice from health educators. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional cervical cancer prevention methods, which often rely on regular in-person screenings and HPV vaccinations, the SHE-WOMEN program offers a unique, multimedia approach to health literacy. This program is delivered through a text-Web format, allowing for personalized and continuous engagement with participants who have recently been released from jail. Researchers are excited because this digitally-driven intervention could improve accessibility and adherence to cervical cancer prevention measures, particularly for vulnerable populations with limited access to traditional healthcare resources.

What evidence suggests that the SHE-WOMEN program is effective for cervical cancer prevention?

Research has shown that the Sexual Health Empowerment (SHE) program can help women better understand cervical health. In a previous study, a more intensive version of the SHE program led 53.4% of women to get pap tests, compared to 38.7% with a less intensive version. Pap tests are crucial for early detection and prevention of cervical cancer. This trial will compare the SHE-WOMEN program, based on the SHE program and delivered via a text-Web intervention, with a control group receiving a health education booklet. This comparison suggests that the SHE-WOMEN program might effectively encourage women to take preventive health steps. ^{6 7 8 9 10}

Who Is on the Research Team?

Jason Glenn, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for women who are scheduled to leave jail within the next three days and are interested in improving their knowledge about sexual health, including cervical and breast cancer prevention, birth control, and preventing sexually transmitted infections. Women showing severe psychological distress or those actively intoxicated cannot participate.

Inclusion Criteria

-Scheduled to leave jail within 3 days

Exclusion Criteria

You are not experiencing serious mental or emotional distress.

You cannot currently be under the influence of drugs or alcohol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the SHE-Women intervention in text-Web format over approximately a 5-day period

1 week

Content delivered electronically

Follow-up

Participants are monitored for health literacy, screening, and risk reduction practices at multiple intervals

36 months

Assessments at 5 days, 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• SHE-WOMEN

Trial Overview The SHE-WOMEN intervention is being tested to see if it can help reduce health disparities by educating vulnerable populations of women on various aspects of sexual health. The study aims to create a sustainable model for disseminating this information effectively.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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.

Group II: Control Active Control 1 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

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10249153/

Protocol for the formative phase of a trial (SHE-CAN) to test co ... The quality and outcomes of existing screening services, readiness to transition to HPV-based screening, challenges in providing and ...

2. cancercontrol.cancer.gov cancercontrol.cancer.gov/sites/default/files/2020-06/SGA_8704096.pdf

Sexual Health Empowerment for Cervical Health Literacy and ... The primary objective of this project is to assess the effectiveness of a sexual health empowerment. (SHE Project) intervention to improve cervical health ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5293604/

Results of a Randomized Controlled Trial to Increase ... At seven months post-randomization, significantly more women in the high intensity arm received a pap test (53.4%) compared to the low intensity arm (38.7%), ...

4. nature.com nature.com/articles/s41591-023-02600-4

Benefits, harms and cost-effectiveness of cervical ... Outcomes included reduction in cancer incidence and mortality, number of pre-cancer treatments needed to prevent a cervical cancer death (NNT), ...

5. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7406a4.htm

Trends in Cervical Precancers Identified Through ... During 2008–2022, cervical precancer incidence decreased 79% and higher-grade precancer incidence decreased 80% among screened women aged 20–24 years.

6. withpower.com withpower.com/trial/phase-sexually-transmitted-diseases-10-2019-2fdde

SHE-WOMEN Program for Cervical Cancer Prevention The purpose of this study is to expand the reach of an existing cervical cancer literacy and prevention intervention- the Sexual Health Empowerment (SHE) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10570451/

Cervical cancer screening programs for female sex workers Among the 403 women screened, 24% were FSWs, and 27.8% of them had positive Visual Inspection with Acetic Acid (VIA) results, reflecting changes in the cervix ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6314678/

Cervical Cancer Burden and Opportunities for Prevention ... Of 419 women with cervical cancer, more than half (58%) were stage 2B or higher at diagnosis and 40% were uninsured. Most (69%) had no prior healthcare system ...

9. hrsa.gov hrsa.gov/office-womens-health/improving-cervical-cancer-care/resources

Federal Cervical Cancer Collaborative Resources The Federal Cervical Cancer Collaborative (FCCC) develops resources to advance cervical cancer prevention, screening, and management in safety-net settings.

10. hsrd.research.va.gov hsrd.research.va.gov/for_researchers/cyber_seminars/archives/video_archive.cfm?SessionID=4113

Cervical Cancer Screening in VA: Unique individual and ... A cyberseminar reviewing the latest research in cervical cancer prevention in VA. Dr. Elisheva Danan will summarize the current standards for screening.