Cervical Cancer Screening
Conditions
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.
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.
Interventions
BEHAVIORALwPap Mobile Web App Intervention
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.
Sponsors
University of South Dakota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants are unaware of which group they have been assigned to.
Intervention model description
2 arms randomized clinical trial with control and intervention group
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of Cervical Cancer Screening | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cervical Cancer Knowledge | Measured at baseline and 1 week post-intervention. | 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. |
| Health Beliefs and Attitudes Toward Cervical Cancer Screening | Measured at baseline and 1 week post-intervention. | 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. |
| Self-Efficacy for Cervical Cancer Screening | Measured at baseline and 1 week post-intervention. | 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. |
| Intent to Undergo Cervical Cancer Screening | Measured at baseline and 1 week post-intervention. | 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. |
| Participant Satisfaction With the Intervention | Measured at 1 week post-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. |
| Participant Acceptance of the Intervention | Measured at 1 week post-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. |
Countries
United States
Contacts
CONTACTSoonhee Roh, PhD
CONTACTSasheen T Stone, BA
PRINCIPAL_INVESTIGATORSoonhee Roh, PhD
University of South Dakota
Outcome results
None listed