Cervical Cancer ScreeningNCT06741241
Effectiveness of an eHealth Intervention for Uptake of Cervical Cancer Screening in Hispanic Women
A study testing eHealth Promotora and eHealth Healthy Nutrition in people with Cervical Cancer Screening, run by Florida A&M University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- eHealth Promotora and eHealth Healthy Nutrition
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2026to 30 Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida A&M University
Tallahassee, Florida, 32307
Professor, 8505612054, john.luque@famu.edu
About this study
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
- Being tested
- eHealth Promotora, eHealth Healthy Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth PromotoraBehavioural
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 NutritionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: eHealth Healthy Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Cervical cancer screening self-efficacy
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.
Measured: 6 months
Cervical cancer knowledge
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start7 Oct 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741241
- Sponsor's protocol ID
- 2180042-1
- Other IDs
- 2U54MD007582-39
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No