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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06741241
Enrollment
170
Registered
2024-12-18
Start date
2026-09-03
Completion date
2029-09-30
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer Screening

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.

Interventions

BEHAVIORALeHealth 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.

BEHAVIORALeHealth 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.

Sponsors

Florida A&M University
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Masking description

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

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cervical cancer screening uptake6 monthsProportion 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.

Secondary

MeasureTime frameDescription
Cervical cancer screening self-efficacy6 monthsThe 10-item cervical cancer screening self-efficacy scale is scored on a 5-item Likert scale ranging from 1 (very unsure) to 5 (very sure) (α = 0.88). Questions include asking participants to rate their confidence in having a discussion with their doctor about the Pap test, scheduling and keeping appointments, getting a Pap test despite being worried about pain, and overcoming embarrassment.
Cervical cancer knowledge6 monthsA 15-item cervical cancer knowledge instrument measures educational content of the intervention with 10 True/False questions and 5 multiple choice questions to produce a knowledge score ranging from 0 to 15.

Countries

United States

Contacts

CONTACTProfessor
tanise.jackson@famu.edu8505993214

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026