A Mobile Web App Intervention to Promote Cervical Cancer Screening

Официальное название

A Mobile Web App Intervention to Promote Cervical Cancer Screening Among Indigenous Women

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое wPap 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.

Первичные конечные точки

• Receipt of Cervical Cancer Screening [Срок оценки: 6 months]

Вторичные конечные точки (6)

• Cervical Cancer Knowledge [Срок оценки: Measured at baseline and 1 week post-intervention.]
• Health Beliefs and Attitudes Toward Cervical Cancer Screening [Срок оценки: Measured at baseline and 1 week post-intervention.]
• Self-Efficacy for Cervical Cancer Screening [Срок оценки: Measured at baseline and 1 week post-intervention.]
• Intent to Undergo Cervical Cancer Screening [Срок оценки: Measured at baseline and 1 week post-intervention.]
• Participant Satisfaction With the Intervention [Срок оценки: Measured at 1 week post-intervention.]
• Participant Acceptance of the Intervention [Срок оценки: Measured at 1 week post-intervention.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Yankton Sioux Tribe — Lake Andes

Идентификаторы

NCT: NCT07574190 · University of South Dakota

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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