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A Mobile Web App Intervention to Promote Cervical Cancer Screening (wPap)

19 maja 2026 zaktualizowane przez: University of South Dakota

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.

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

120

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Experimental: Intervention
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.
Behawioralne: 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.
Brak interwencji: Control group
Participants are randomized to control arm where they are give an education brochure. There are pre and post tests to complete.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Receipt of Cervical Cancer Screening
Ramy czasowe: 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 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Intent to Undergo Cervical Cancer Screening
Ramy czasowe: 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.
Measured at baseline and 1 week post-intervention.
Participant Acceptance of the Intervention
Ramy czasowe: 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.
Measured at 1 week post-intervention.
Cervical Cancer Knowledge
Ramy czasowe: 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.
Measured at baseline and 1 week post-intervention.
Health Beliefs and Attitudes Toward Cervical Cancer Screening
Ramy czasowe: 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.
Measured at baseline and 1 week post-intervention.
Self-Efficacy for Cervical Cancer Screening
Ramy czasowe: 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.
Measured at baseline and 1 week post-intervention.
Participant Satisfaction With the Intervention
Ramy czasowe: 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.
Measured at 1 week post-intervention.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of South Dakota

Śledczy

  • Główny śledczy: Soonhee Roh, PhD, University of South Dakota

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

1 listopada 2026

Ukończenie studiów (Szacowany)

15 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

1 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 maja 2026

Pierwszy wysłany (Rzeczywisty)

7 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • University of South Dakota

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Not sharing IPD with other researchers

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Badania przesiewowe w kierunku raka szyjki macicy

Badania kliniczne na wPap Mobile Web App Intervention

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