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

NCT ID: NCT06741241

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-01

Study Completion Date

2029-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants
Participants will complete surveys and receive virtual education sessions and not know if they are in control arm or intervention arm.

Study Groups

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eHealth Promotora

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 Type EXPERIMENTAL

eHealth Promotora

Intervention Type 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 Healthy Nutrition

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.

Group Type ACTIVE_COMPARATOR

eHealth Healthy Nutrition

Intervention Type 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.

Interventions

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eHealth Promotora

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.

Intervention Type BEHAVIORAL

eHealth Healthy Nutrition

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Florida A&M University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Florida A&M University

Tallahassee, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Professor

Role: CONTACT

Phone: 8505993214

Email: [email protected]

Facility Contacts

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Professor

Role: primary

Other Identifiers

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2U54MD007582-39

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2180042-1

Identifier Type: -

Identifier Source: org_study_id