Cervical Cancer ScreeningwPapNCT07574190
A Mobile Web App Intervention to Promote Cervical Cancer Screening
A study testing wPap Mobile Web App Intervention in people with Cervical Cancer Screening, run by University of South Dakota at 1 site in United States.
Trial summary
The overarching goal of this study is to increase cervical cancer (CC) screening rates among Indigenous women in the U.S. Specifically, the study aims to develop and evaluate a culturally tailored, multilevel, multimedia mobile web app intervention (wPap) for women of the Yankton Sioux Tribe (YST) living on the YST… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- wPap Mobile Web App Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to 15 Nov 2026
- 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 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who are self-identified AI women of the YST in SD
- Women who are aged 25 to 65 years
- Women who have not received any of the following cervical cancer screening tests: a Pap test within the past 3 years, primary HPV testing within the past 5 years, or HPV/Pap co-testing within the past 5 years.
- Women who are willing to use their own mobile phone, iPad, tablets, and computers, or a mobile phone borrowed from the research team for the wPap intervention.
Who cannot join
- Women younger than 25 years or older than 65 years
- Women who are currently up to date with cervical cancer screening according to recommended guidelines (Pap test within the past 3 years, primary HPV testing within the past 5 years, or HPV/Pap co-testing within the past 5 years)
- Women with a prior diagnosis of cervical cancer
- Women who have had a total hysterectomy that included removal of the cervix, without a history of high-grade precancerous lesions
- Women with a previous colposcopy examination indicating abnormal cytology that requires more frequent screening than every 3 years
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
Yankton Sioux Tribe
Lake Andes, South Dakota, 57356
Soonhee Roh, PhD, 6053571593, Soonhee.Roh@usd.edu
Sasheen T Stone, BA, 605-469-6180, sstone@yanktonsiouxtribe.net
About this study
Official title: A Mobile Web App Intervention to Promote Cervical Cancer Screening Among Indigenous Women
The overarching goal of this study is to increase cervical cancer (CC) screening rates among Indigenous women in the U.S. Specifically, the study aims to develop and evaluate a culturally tailored, multilevel, multimedia mobile web app intervention (wPap) for women of the Yankton Sioux Tribe (YST) living on the YST Reservation in South Dakota.
The wPap intervention will be tested in a randomized clinical trial (RCT) involving 120 YST women aged 25-65. Participants will be randomly assigned to either: (a) the wPap intervention group (n = 60), receiving personalized, culturally tailored multilevel multimedia messages through a mobile web app along with health navigator support, or (b) a waitlist control group (n = 60), receiving printed educational materials on cervical cancer and screening guidelines along with health navigator support. The intervention will last seven days, with assessments conducted at baseline, one week post-intervention, and six months post-intervention via surveys and telephone follow-up.
Read more
The study tests the following hypotheses:
(H1) women in the wPap intervention group will achieve higher CC screening rates than the waitlist control group; (H2) the wPap group will demonstrate greater improvements in knowledge, attitudes/beliefs, self-efficacy, and intention to undergo CC screening; and (H3) the wPap group will report higher satisfaction and acceptance of the intervention compared with the waitlist control group. Findings will inform the feasibility, acceptability, and efficacy of mobile web app interventions tailored to Indigenous communities to improve CC screening.
Read the detailed description
This study aims to increase cervical cancer (CC) screening among Yankton Sioux Tribe (YST) women by testing a culturally tailored mobile web app intervention called wPap. We plan to enroll 120 eligible women aged 25-65 living on the YST Reservation, anticipating a 20% attrition rate (about 24 participants) by the six-month follow-up. This sample size is based on prior findings from our wMammogram study, which showed a medium effect size for screening interventions. Selecting 120 participants ensures sufficient power to detect meaningful differences between groups, even with attrition.
Participants will be randomly assigned to one of two groups: the wPap intervention group, which receives personalized, culturally tailored multimedia messages through a mobile web app along with health navigator support, or a waitlist control group, which receives printed educational materials and health navigator support. The intervention lasts seven days, and assessments will be conducted at baseline, one week post-intervention, and six months post-intervention.
Outcome Measures:
- Primary efficacy outcome: CC screening completion, verified by physician documentation, using any of the three ACS-recommended screening methods (primary HPV test, HPV/Pap co-test, or Pap test alone). Participants without verification will be considered unscreened.
- Secondary outcomes: Knowledge, attitudes/beliefs, self-efficacy, and intention to undergo CC screening.
- Feasibility measures: Participant satisfaction with wPap (4-point scale) and acceptance of the intervention, measured by willingness to recommend it to others.
Data Analysis: Descriptive statistics will summarize participant characteristics, outcomes, and retention. Group equivalence at baseline will be assessed using t-tests and chi-square tests. Chi-square tests and logistic regression will evaluate CC screening completion by intervention group, adjusting for socio-demographic factors. Analyses will be performed using STATA and R.
- Conditions
- Cervical Cancer Screening
- Being tested
- wPap Mobile Web App Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wPap Mobile Web App InterventionBehavioural
A seven-day mobile web app program providing culturally tailored educational modules on cervical cancer risk, screening guidelines, and health promotion strategies. Participants download the app, complete daily modules, and complete pre- and post-tests to assess knowledge, attitudes, self-efficacy, and intention to undergo cervical cancer screening. Health navigator support is provided throughout the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention | Experimental | Participants in this arm will receive a seven-day mobile web app intervention designed to promote cervical cancer (CC) screening. Participants are required to download the wPap mobile app and complete daily educational modules over the seven-day period. Each module includes information about CC risk factors, screening guidelines, and health promotion strategies tailored to the cultural context of the Yankton Sioux Tribe. Participants will complete pre- and post-tests to assess knowledge, attitudes, self-efficacy, and intent to undergo screening. The intervention encourages participants to increase awareness of CC screening needs and supports engagement with available health services. Receives: Behavioral: wPap Mobile Web App Intervention |
| Control group | No intervention | Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of Cervical Cancer Screening
Completion of one of the three recommended screening methods by the ACS: primary HPV testing, co-testing, or Pap test alone. Completion of screening will be assessed using physician-signed verification of CC screening (Yes, No).
Measured: 6 months
Secondary outcomes (6)
Cervical Cancer Knowledge
Cervical cancer knowledge will be assessed using Taylor et al.'s Cervical Cancer Knowledge Scale, a modified previously validated 15-item true/false instrument. Scores range from 0 to 15, with scores calculated as the total number of correctly answered items. Higher scores indicate greater cervical cancer knowledge and represent a better outcome.
Measured: Measured at baseline and 1 week post-intervention.
Health Beliefs and Attitudes Toward Cervical Cancer Screening
Health beliefs and attitudes toward cervical cancer screening will be assessed using selected domains from the Champion's Health Belief Model Scale. Four domains consisting of 19 items will be used: perceived susceptibility, perceived seriousness, perceived benefits, and perceived barriers. Scores on the Champion's Health Belief Model Scale range from 1 to 76, with scores calculated by summing item responses within each domain. Higher scores indicate stronger endorsement of the respective health belief construct. Higher scores for perceived susceptibility, perceived seriousness, and perceived benefits represent more favorable beliefs and attitudes toward cervical cancer screening and indicate a better outcome, whereas higher scores for perceived barriers represent less favorable beliefs toward cervical cancer screening and indicate a worse outcome.
Measured: Measured at baseline and 1 week post-intervention.
Self-Efficacy for Cervical Cancer Screening
Self-efficacy for cervical cancer screening will be assessed using a modified version of Frerichs et al.'s Colorectal Cancer Screening Self-Efficacy Scale, adapted for this study to evaluate participants' confidence in obtaining cervical cancer screening. Scores on the Cancer Screening Self-Efficacy Scale range from 1 to 32, with higher scores indicating greater self-efficacy for completing cervical cancer screening behaviors and representing a better outcome.
Measured: Measured at baseline and 1 week post-intervention.
Intent to Undergo Cervical Cancer Screening
Intent to undergo cervical cancer screening will be assessed using two items informed by the Transtheoretical Model stages of change, which reflect increasing commitment toward adoption of screening behavior (precontemplation, contemplation, and preparation). The items assess: (1) participants' plan to receive cervical cancer screening in the next 6 months (Yes/No), and (2) level of intention to undergo cervical cancer screening in the future, rated on a 4-point scale ranging from today or within 1 month to within 1 year. Higher scores indicate greater intention and readiness to undergo cervical cancer screening.
Measured: Measured at baseline and 1 week post-intervention.
Participant Satisfaction With the Intervention
Participant satisfaction with the intervention will be assessed using a single-item satisfaction measure rated on a 4-point Likert scale, with scores ranging from 1 (very dissatisfied) to 4 (very satisfied). Higher scores indicate greater satisfaction with the intervention and represent a better outcome.
Measured: Measured at 1 week post-intervention.
Participant Acceptance of the Intervention
Participant acceptance of the intervention will be assessed by a single-item measure evaluating willingness to recommend the intervention received to friends (Yes/No). A "Yes" response indicates acceptance and positive endorsement of the intervention.
Measured: Measured at 1 week post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study startMay 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completion15 Nov 2026 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms randomized clinical trial with control and intervention group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Dakota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soonhee Roh, PhD, Principal investigator, University of South Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574190
- Sponsor's protocol ID
- University of South Dakota
- Acronym
- wPap
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not sharing IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Web App Intervention to Promote Cervical Cancer Screening Among Indigenous Women
- ClinicalTrials.gov ID
- NCT07574190
- Acronym / sponsor ID
- wPap / University of South Dakota
- Conditions
- Cervical Cancer Screening
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of South DakotaUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 7 May 2026 (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.
The overarching goal of this study is to increase cervical cancer (CC) screening rates among Indigenous women in the U.S. Specifically, the study aims to develop and evaluate a culturally tailored, multilevel, multimedia mobile web app intervention (wPap) for women of the Yankton Sioux Tribe (YST) living on the YST Reservation in South Dakota.
The wPap intervention will be tested in a randomized clinical trial (RCT) involving 120 YST women aged 25-65. Participants will be randomly assigned to either: (a) the wPap intervention group (n = 60), receiving personalized, culturally tailored multilevel multimedia messages through a mobile web app along with health navigator support, or (b) a waitlist control group (n = 60), receiving printed educational materials on cervical cancer and screening guidelines along with health navigator support. The intervention will last seven days, with assessments conducted at baseline, one week post-intervention, and six months post-intervention via surveys and telephone follow-up.
The study tests the following hypotheses:
(H1) women in the wPap intervention group will achieve higher CC screening rates than the waitlist control group; (H2) the wPap group will demonstrate greater improvements in knowledge, attitudes/beliefs, self-efficacy, and intention to undergo CC screening; and (H3) the wPap group will report higher satisfaction and acceptance of the intervention compared with the waitlist control group. Findings will inform the feasibility, acceptability, and efficacy of mobile web app interventions tailored to Indigenous communities to improve CC screening.
Detailed description
This study aims to increase cervical cancer (CC) screening among Yankton Sioux Tribe (YST) women by testing a culturally tailored mobile web app intervention called wPap. We plan to enroll 120 eligible women aged 25-65 living on the YST Reservation, anticipating a 20% attrition rate (about 24 participants) by the six-month follow-up. This sample size is based on prior findings from our wMammogram study, which showed a medium effect size for screening interventions. Selecting 120 participants ensures sufficient power to detect meaningful differences between groups, even with attrition.
Participants will be randomly assigned to one of two groups: the wPap intervention group, which receives personalized, culturally tailored multimedia messages through a mobile web app along with health navigator support, or a waitlist control group, which receives printed educational materials and health navigator support. The intervention lasts seven days, and assessments will be conducted at baseline, one week post-intervention, and six months post-intervention.
Outcome Measures:
- Primary efficacy outcome: CC screening completion, verified by physician documentation, using any of the three ACS-recommended screening methods (primary HPV test, HPV/Pap co-test, or Pap test alone). Participants without verification will be considered unscreened.
- Secondary outcomes: Knowledge, attitudes/beliefs, self-efficacy, and intention to undergo CC screening.
- Feasibility measures: Participant satisfaction with wPap (4-point scale) and acceptance of the intervention, measured by willingness to recommend it to others.
Data Analysis: Descriptive statistics will summarize participant characteristics, outcomes, and retention. Group equivalence at baseline will be assessed using t-tests and chi-square tests. Chi-square tests and logistic regression will evaluate CC screening completion by intervention group, adjusting for socio-demographic factors. Analyses will be performed using STATA and R.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 arms randomized clinical trial with control and intervention group
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention | Experimental | Behavioral: wPap Mobile Web App InterventionParticipants in this arm will receive a seven-day mobile web app intervention designed to promote cervical cancer (CC) screening. Participants are required to download the wPap mobile app and complete daily educational modules over the seven-day period. Each module includes information about CC risk factors, screening guidelines, and health promotion strategies tailored to the cultural context of the Yankton Sioux Tribe. Participants will complete pre- and post-tests to assess knowledge, attitudes, self-efficacy, and intent to undergo screening. The intervention encourages participants to increase awareness of CC screening needs and supports engagement with available health services. |
| Control group | No intervention | –Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women who are self-identified AI women of the YST in SD
- Women who are aged 25 to 65 years
- Women who have not received any of the following cervical cancer screening tests: a Pap test within the past 3 years, primary HPV testing within the past 5 years, or HPV/Pap co-testing within the past 5 years.
- Women who are willing to use their own mobile phone, iPad, tablets, and computers, or a mobile phone borrowed from the research team for the wPap intervention.
Key exclusion criteria (5 listed)
- Women younger than 25 years or older than 65 years
- Women who are currently up to date with cervical cancer screening according to recommended guidelines (Pap test within the past 3 years, primary HPV testing within the past 5 years, or HPV/Pap co-testing within the past 5 years)
- Women with a prior diagnosis of cervical cancer
- Women who have had a total hysterectomy that included removal of the cervix, without a history of high-grade precancerous lesions
- Women with a previous colposcopy examination indicating abnormal cytology that requires more frequent screening than every 3 years
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 |
|---|---|---|
| wPap Mobile Web App InterventionA seven-day mobile web app program providing culturally tailored educational modules on cervical cancer risk, screening guidelines, and health promotion strategies. Participants download the app, complete daily modules, and complete pre- and post-tests to assess knowledge, attitudes, self-efficacy, and intention to undergo cervical cancer screening. Health navigator support is provided throughout the intervention. | Behavioural | Experimental: Intervention |
Primary outcome
Receipt of Cervical Cancer Screening
Time frame: 6 months
Completion of one of the three recommended screening methods by the ACS: primary HPV testing, co-testing, or Pap test alone. Completion of screening will be assessed using physician-signed verification of CC screening (Yes, No).
6 secondary outcomes
Cervical Cancer Knowledge
Time frame: Measured at baseline and 1 week post-intervention.
Health Beliefs and Attitudes Toward Cervical Cancer Screening
Time frame: Measured at baseline and 1 week post-intervention.
Self-Efficacy for Cervical Cancer Screening
Time frame: Measured at baseline and 1 week post-intervention.
Intent to Undergo Cervical Cancer Screening
Time frame: Measured at baseline and 1 week post-intervention.
Participant Satisfaction With the Intervention
Time frame: Measured at 1 week post-intervention.
Participant Acceptance of the Intervention
Time frame: Measured at 1 week post-intervention.
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 22 May 2026.
- Individual participant dataSharing planned: No. Not sharing IPD with other researchers
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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.
Soonhee Roh, PhD principal investigator
University of South Dakota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wPap Mobile Web App Intervention in people with Cervical Cancer Screening, run by University of South Dakota 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 4 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: opening soon, as of the sponsor's last update on 22 May 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 Soonhee Roh, PhD (16053571593, Soonhee.Roh@usd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of Cervical Cancer Screening (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 22 May 2026.