Effectiveness of an EHealth Intervention for Uptake of Cervical Cancer Screening in Hispanic Women

NCT06741241 | Not Yet Recruiting

• 2 other identifiers: 2180042-12U54MD007582-39
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Cervical cancer screening uptake

  Proportion of participants who complete cervical cancer screening determined by cervical cancer screening measure which asks about the last Pap test completed confirmed by chart review if possible.

  6 months

Secondary Outcomes (2)

• Cervical cancer screening self-efficacy

  6 months

• Cervical cancer knowledge

  6 months

Study Arms (2)

eHealth Promotora

EXPERIMENTAL

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.

Behavioral: eHealth Promotora

eHealth Healthy Nutrition

ACTIVE COMPARATOR

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.

Behavioral: eHealth Healthy Nutrition

Interventions

eHealth Promotora BEHAVIORAL

Intervention participants attend an eHealth promotora-delivered educational session. Activities include an icebreaker, the completion of a baseline survey, an introduction to cervical cancer using a video and slide presentation, a cervical cancer knowledge pretest/posttest, and a dialogue activity to explore possible barriers and solutions to health care access. Main topics included in the slide presentation are: female anatomy; cervical cancer etiology and disease progression by stage; cancer prevention including diet, exercise, safe sex, cancer screening; human papillomavirus (HPV) vaccine recommendations; Pap test preparations, procedure, screening interval; and information about where to receive a Pap test and seek more information about cervical cancer.

eHealth Promotora

eHealth Healthy Nutrition BEHAVIORAL

Control group participants attend an eHealth educational session on healthy nutrition. Activities include an icebreaker, the completion of a baseline survey, an introduction to healthy eating using a video and a slide presentation, a cervical cancer knowledge pretest/posttest, and a dialogue activity to explore benefits and challenges to healthy eating.

eHealth Healthy Nutrition

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the age of 21 and 65 years
• identify as Hispanic
• not up-to-date with cervical cancer screening \[never screened or last Pap test ≥ 3 years - based on U.S. Preventive Services Task Force guidelines\]
• have no history of cervical cancer
• have not had a hysterectomy.

You may not qualify if:

• under the age of 21 or over the age of 65 years
• do not identify as Hispanic
• up-to-date with cervical cancer screening \[last Pap test \< 3 years - based on U.S. Preventive Services Task Force guidelines\]
• history of cervical cancer
• have had a hysterectomy.

Sponsors & Collaborators

• Florida A&M University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Florida A&M University

Tallahassee, Florida, 32307, United States

Location

Central Study Contacts

Professor

CONTACT

8505993214; tanise.jackson@famu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will complete surveys and receive virtual education sessions and not know if they are in control arm or intervention arm.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to the eHealth promotora intervention where they will participate in a group education session of cervical cancer screening or a control group where they will participate in a group education session on healthy nutrition.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 18, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

US (1)