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NCT Number: NCT06741241

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

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.

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Key information

Conditions

Cervical Cancer Screening

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 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.

Primary outcomes

  1. Cervical cancer screening uptake

    Time frame: 6 months

    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.

Secondary outcomes

  1. Cervical cancer screening self-efficacy

    Time frame: 6 months

    The 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.

  2. Cervical cancer knowledge

    Time frame: 6 months

    A 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Professor

CONTACT

[email protected]

8505993214

Sponsors and collaborators

Lead sponsor

Florida A&M University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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