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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an eHealth Intervention for Uptake of Cervical Cancer Screening in Hispanic Women
- ClinicalTrials.gov ID
- NCT06741241
- Acronym / sponsor ID
- 2180042-1
- Conditions
- Cervical Cancer Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Florida A&M UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 7 Oct 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| eHealth Promotora | Experimental | Behavioral: eHealth PromotoraIntervention 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. |
| eHealth Healthy Nutrition | Active comparator | Behavioral: eHealth Healthy NutritionControl 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth PromotoraIntervention 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. | Behavioural | eHealth Promotora |
| eHealth Healthy NutritionControl 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. | Behavioural | eHealth Healthy Nutrition |
Primary outcome
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.
2 secondary outcomes
Cervical cancer screening self-efficacy
Time frame: 6 months
Cervical cancer knowledge
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor (8505993214, tanise.jackson@famu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical cancer screening uptake (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.