Recruiting

Cervical Cancer Education

Sponsor:

Florida A&M University

Code:

NCT06741241

Conditions

Cervical Cancer Screening

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

eHealth Promotora

eHealth Healthy Nutrition

Study Details

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

Study ID

NCT06741241

Start date

Sep 3, 2026

Status verified date

Sep, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

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.

Primary outcome measure

  • Cervical cancer screening uptake [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Professor

8505993214tanise.jackson@famu.edu

Locations

Florida A&M University

Recruiting

Tallahassee, Florida, United States, 32307

Contacts

Professor

8505612054john.luque@famu.edu

More Information

Sponsor

Florida A&M University

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Florida A&M University on 2026-09-11.