eHealth Intervention for Cervical Cancer Screening

Overseen By Professor

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Florida A&M University

Disqualifiers: Age, Non-Hispanic, Up-to-date screening

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

Compensation: Varies

Number of Visits: 7

170 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational sessions about cervical cancer screening and nutrition.

What data supports the effectiveness of the eHealth Healthy Nutrition and eHealth Promotora treatment for cervical cancer screening?

Research shows that using eHealth tools, like videos and online education, can significantly increase women's knowledge about cervical cancer and nearly double the number of women who go for screening. This suggests that eHealth interventions can effectively encourage more women to participate in cervical cancer screening. ^{1 2 3 4 5}

How does the eHealth Promotora treatment for cervical cancer screening differ from other treatments?

The eHealth Promotora treatment is unique because it uses digital health technologies, like mobile apps and online platforms, to educate and encourage women to participate in cervical cancer screening. This approach is particularly effective in increasing screening rates by providing accessible information and support, which is different from traditional methods that rely on in-person visits and paper-based information. ^{1 4 6 7 8}

What is the purpose of this trial?

This study will test the effectiveness of an eHealth promotora (lay health advisor) outreach strategy to increase cervical cancer screening in Hispanic women. The investigators will recruit 160 Hispanic women ages 21-65 who are not up to date with cervical cancer screening or have never been screened, with the goal to evaluate screening knowledge, behavior, and intervention effects on cervical cancer screening outcomes. The study will utilize a two-arm, cluster randomized trial design, and participants will be randomly assigned to the cervical cancer education intervention or a nutrition education control group. The cervical cancer education arm will utilize a promotora to deliver an educational session virtually to encourage cervical cancer screening and receive a resource list for screening sites. The control group will participate in an educational session virtually about the importance of healthy nutrition. The primary study outcome is receipt of cervical cancer screening measured six months following receiving the intervention. The secondary outcomes will include cervical cancer screening knowledge and self-efficacy (confidence to receive cervical cancer screening). The research objective is to test the eHealth promotora intervention effectiveness for promoting cervical cancer screening in an under-screened Hispanic population.

Eligibility Criteria

Hispanic women aged 21-65 who are not current with cervical cancer screenings or have never been screened, and have no history of cervical cancer or a hysterectomy. The trial aims to increase screening uptake in this group.

Inclusion Criteria

Identify as Hispanic

I haven't had a cervical cancer screening in over 3 years.

I am between 21 and 65 years old.

Exclusion Criteria

I have had a hysterectomy.

Do not identify as Hispanic

Up-to-date with cervical cancer screening (last Pap test < 3 years - based on U.S. Preventive Services Task Force guidelines)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive an eHealth promotora group education session on cervical cancer screening or a control session on healthy nutrition

1 session

1 virtual session

Follow-up

Participants are monitored for cervical cancer screening uptake and self-efficacy

6 months

Baseline and 6-month follow-up surveys

Treatment Details

Interventions

• eHealth Healthy Nutrition
• eHealth Promotora

Trial Overview The study is testing if an eHealth promotora can boost cervical cancer screening rates among Hispanic women. Participants will be randomly placed into two groups: one receives virtual education on cervical cancer, the other on healthy nutrition.

Participant Groups

Group I: eHealth Promotora Experimental Treatment 1 Intervention

Intervention arm participants will participate in a eHealth promotora group education session to receive a presentation on cervical cancer screening education, view an educational video, and complete baseline and 6-month follow-up surveys.

Group II: eHealth Healthy Nutrition Active Control 1 Intervention

Control group participants will participate in an eHealth group education session to receive a presentation on healthy nutrition information, view an educational video, and complete baseline and 6-month surveys.

Who Is Running the Clinical Trial?

Florida A&M University

Lead Sponsor

Trials

8

Recruited

5,100+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Empirical investigation of e-health intervention in cervical cancer screening: A systematic literature review. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

Educational interventions for cervical cancer prevention: a scoping review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of an Electronic Health Record Decision Support Alert to Decrease Excess Cervical Cancer Screening. [2022]

4. Poland pubmed.ncbi.nlm.nih.gov

[The use of interactive medical data transfer to increase effectiveness of a mass screening program]. [2018]

5. Ireland pubmed.ncbi.nlm.nih.gov

Factors predicting intermediate endpoints of cervical cancer and exposure to human papillomavirus (HPV) infections in young women screened as potential targets for prophylactic HPV vaccination in south of Brazil. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of mobile Health (mHealth) application on cervical cancer prevention knowledge and screening among women social support groups with low-socioeconomic status in Mysuru city, Southern India. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Developing SMS Content to Promote Papanicolaou Triage Among Women Who Performed HPV Self-collection Test: Qualitative Study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Mobile Technologies and Cervical Cancer Screening in Low- and Middle-Income Countries: A Systematic Review. [2021]