A Mobile Web App Intervention to Promote Cervical Cancer Screening

NCT07574190 | Not Yet Recruiting

• 1 other identifier: University of South Dakota
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cervical Cancer Screening

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Secondary Outcomes (6)

• Cervical Cancer Knowledge

  Measured at baseline and 1 week post-intervention.

• Health Beliefs and Attitudes Toward Cervical Cancer Screening

  Measured at baseline and 1 week post-intervention.

• Self-Efficacy for Cervical Cancer Screening

  Measured at baseline and 1 week post-intervention.

• Intent to Undergo Cervical Cancer Screening

  Measured at baseline and 1 week post-intervention.

• Participant Satisfaction With the Intervention

  Measured at 1 week post-intervention.

Study Arms (2)

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.

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.

Interventions

wPap Mobile Web App Intervention BEHAVIORAL

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.

Experimental: Intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Dakota: lead

Study Sites (1)

Yankton Sioux Tribe

Lake Andes, South Dakota, 57356, United States

Location

Study Officials

• Soonhee Roh, PhD

  University of South Dakota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soonhee Roh, PhD

CONTACT

16053571593; Soonhee.Roh@usd.edu

Sasheen T Stone, BA

CONTACT

1-605-469-6180; sstone@yanktonsiouxtribe.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are unaware of which group they have been assigned to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 arms randomized clinical trial with control and intervention group

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)