A Mobile Web App Intervention to Promote Cervical Cancer Screening (wPap)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Soonhee Roh, PhD
- Número de teléfono: 16053571593
- Correo electrónico: Soonhee.Roh@usd.edu
Copia de seguridad de contactos de estudio
- Nombre: Sasheen T Stone, BA
- Número de teléfono: 1-605-469-6180
- Correo electrónico: sstone@yanktonsiouxtribe.net
Ubicaciones de estudio
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South Dakota
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Lake Andes, South Dakota, Estados Unidos, 57356
- Yankton Sioux Tribe
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Contacto:
- Soonhee Roh, PhD
- Número de teléfono: 6053571593
- Correo electrónico: Soonhee.Roh@usd.edu
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Contacto:
- Sasheen T Stone, BA
- Número de teléfono: 605-469-6180
- Correo electrónico: sstone@yanktonsiouxtribe.net
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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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.
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Sin intervención: Control group
Participants are randomized to control arm where they are give an education brochure.
There are pre and post tests to complete.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Receipt of Cervical Cancer Screening
Periodo de tiempo: 6 months
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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).
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intent to Undergo Cervical Cancer Screening
Periodo de tiempo: Measured at baseline and 1 week post-intervention.
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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.
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Measured at baseline and 1 week post-intervention.
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Participant Acceptance of the Intervention
Periodo de tiempo: Measured at 1 week post-intervention.
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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.
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Measured at 1 week post-intervention.
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Cervical Cancer Knowledge
Periodo de tiempo: Measured at baseline and 1 week post-intervention.
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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.
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Measured at baseline and 1 week post-intervention.
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Health Beliefs and Attitudes Toward Cervical Cancer Screening
Periodo de tiempo: Measured at baseline and 1 week post-intervention.
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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.
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Measured at baseline and 1 week post-intervention.
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Self-Efficacy for Cervical Cancer Screening
Periodo de tiempo: Measured at baseline and 1 week post-intervention.
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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.
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Measured at baseline and 1 week post-intervention.
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Participant Satisfaction With the Intervention
Periodo de tiempo: Measured at 1 week post-intervention.
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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.
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Measured at 1 week post-intervention.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Soonhee Roh, PhD, University of South Dakota
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
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Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- University of South Dakota
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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