- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07826962
Developing and Testing a Method for Engagement in Research Using WhatsApp (WI-CARE)
WICARE: WhatsApp Immigrant-Centered Research Engagement
African immigrants are underrepresented in health research in the United States. Barriers to research participation may include limited access to culturally and linguistically appropriate information, concerns about privacy, distrust of research institutions, stigma, and difficulty participating in traditional in-person activities. WhatsApp is commonly used within African immigrant communities, but there is limited evidence about how it can support meaningful engagement throughout the research process.
This study will develop and test the WhatsApp Immigrant-Centered Research Engagement (WI-CARE) protocol. WI-CARE will provide researchers and community partners with structured guidance for using WhatsApp to engage African immigrants in research planning, recruitment, data collection, interpretation, and dissemination.
The study has three aims. First, the research team will conduct surveys and focus groups to identify the WhatsApp features and engagement practices that facilitate or hinder participation in research. Second, the study team and African immigrant partners will use these findings to develop and refine the WI-CARE protocol. Third, the protocol will be tested through structured scenarios that simulate activities conducted during different stages of research. Participants will provide feedback about the acceptability, usability, feasibility, cultural relevance, privacy, trustworthiness, and quality of engagement supported by WI-CARE.
The study will include adult African immigrants living in Connecticut, Maine, Massachusetts, Minnesota, Pennsylvania, and Rhode Island. Findings will be used to refine WI-CARE and inform the use of digital platforms to support equitable engagement of African immigrant communities in health research.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
African immigrants are one of the fastest-growing immigrant populations in the United States but remain underrepresented in clinical, public health, and patient-centered research. Barriers to engagement include distrust of research institutions, concerns about privacy and immigration status, language differences, stigma, limited research literacy, and a lack of culturally appropriate engagement approaches. These barriers may limit opportunities for African immigrants to influence the questions, methods, implementation, interpretation, and dissemination of research relevant to their communities.
WhatsApp is widely used by African immigrant communities for communication, information sharing, and social support. Although researchers have used WhatsApp for participant recruitment and data collection, less is known about how the platform can support sustained and meaningful engagement across the research lifecycle. There is also no standard protocol to guide researchers in using WhatsApp for research engagement with African immigrant communities.
This mixed-methods study will develop and pilot the WhatsApp Immigrant-Centered Research Engagement (WI-CARE) protocol. WI-CARE will provide structured guidance for using WhatsApp features to support culturally and linguistically appropriate communication, privacy, trust, inclusion, and participation in research. The study is guided by the Unified Theory of Acceptance and Use of Technology and measures of patient engagement in research.
Aim 1 will identify the WhatsApp features and engagement practices that facilitate or hinder research engagement. Adult African immigrants will complete a survey about their experiences with WhatsApp, preferences for research communication and participation, perceived barriers, trust, privacy, and factors affecting their willingness to use WhatsApp for research engagement. Focus groups will provide additional information about participants' experiences and recommendations.
Aim 2 will use findings from Aim 1 to develop the WI-CARE protocol through a participatory process led by the study team, which includes African immigrant partner organizations and academic researchers. The protocol will address onboarding, informed consent, communication, privacy and confidentiality, multilingual engagement, facilitation, technical support, data collection, interpretation of findings, and dissemination. African immigrant patients and other experts will review the draft protocol for feasibility, usability, cultural relevance, and adaptability. Their feedback will guide iterative revisions.
Aim 3 will pilot WI-CARE among adult African immigrants residing in Connecticut, Maine, Massachusetts, Minnesota, Pennsylvania, and Rhode Island. Approximately 300 participants will be enrolled in a centralized WhatsApp community. Participants will be invited to opt into structured scenarios based on their interests and availability. The scenarios will simulate activities conducted during different stages of research, including onboarding and consent, research planning, recruitment, data collection, interpretation of findings, and dissemination.
Within each scenario, trained facilitators will use the WI-CARE protocol to guide participants through research-related activities. Participants will then evaluate the clarity, accessibility, cultural relevance, privacy, and usability of the engagement process. WhatsApp activity metrics, surveys, and individual interviews will be used to assess participation, retention, task completion, engagement quality, trustworthiness, acceptability, usability, and feasibility. The study will also examine whether engagement experiences differ according to participant characteristics and geographic location.
Quantitative and qualitative findings will be integrated to identify areas of agreement, differences across participant groups, and aspects of the protocol requiring revision. The final WI-CARE protocol will provide an evidence-informed approach for using WhatsApp to engage African immigrant communities throughout the research process.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Chioma Nnaji, MPH, MEd
- Numer telefonu: 875-325-1489
- E-mail: cnnaji@mac-boston.org
Lokalizacje studiów
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02130
- Multicultural AIDS Coalition
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
Aim 1 survey and focus group participants:
- Aged 18 years or older
- Born in a sub-Saharan African country
- Currently residing in the United States
- Able to read and speak English, French, or Kiswahili
- Able and willing to provide informed consent
Aim 2 expert panel participants:
- Aged 18 years or older
- Currently residing in the United States
- Able to read and speak English, French, or Kiswahili
- Able and willing to provide informed consent
- Has relevant knowledge, professional experience, or lived experience related to African immigrant health or digital research engagement
Aim 3 pilot participants:
- Aged 18 years or older
- Born in a sub-Saharan African country
- Currently residing in Connecticut, Maine, Massachusetts, Minnesota, Pennsylvania, or Rhode Island
- Able to read and speak English, French, or Kiswahili
- Has access to an internet-connected device that can use WhatsApp
- Able and willing to join the WI-CARE WhatsApp Community and participate in study activities conducted through WhatsApp
- Able and willing to provide informed consent
Exclusion Criteria:
- Younger than 18 years of age
- Unable or unwilling to provide informed consent
- Does not meet the eligibility requirements for the applicable study component
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: WI-CARE Protocol
Participants will join the centralized WI-CARE WhatsApp Community and receive structured onboarding, communication, privacy, facilitation, and research-engagement procedures.
Participants will be invited to take part in six scenarios representing activities across the research lifecycle.
Scenario participation will be based on participants' interests and availability.
All participants will be considered part of the same study arm.
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WI-CARE is a culturally and linguistically tailored protocol for engaging African immigrants in research through WhatsApp.
The protocol provides structured procedures for onboarding and informed consent, communication, privacy and confidentiality, facilitation, technical support, and participation in research activities.
Trained facilitators will use WI-CARE to guide participants through scenarios representing research planning, recruitment, data collection, interpretation of findings, and dissemination.
Participants may communicate through text, voice notes, audio or video calls, surveys, polls, group discussions, and multimedia features.
Participants will provide feedback on the clarity, accessibility, cultural relevance, acceptability, usability, and trustworthiness of the engagement process.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Quality of Research Engagement
Ramy czasowe: 6 months
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Participant-reported quality of engagement will be assessed using the 22-item Patient Engagement in Research Scale (PEIRS-22).
Item responses will be scored according to the PEIRS-22 scoring guidance.
Higher scores indicate greater perceived quality of engagement.
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6 months
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Engagement Context
Ramy czasowe: 12 months
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Engagement context will be assessed using survey items based on the Unified Theory of Acceptance and Use of Technology.
Separate scores will be calculated for performance expectancy, effort expectancy, social influence, facilitating conditions, behavioral intention, and use behavior.
These constructs assess the acceptability, usability, feasibility, and perceived effectiveness of WI-CARE.
Each construct will be scored according to the final survey scoring procedures, with higher scores indicating a more favorable assessment of WI-CARE.
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12 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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WI-CARE Acceptability
Ramy czasowe: 6 months
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Acceptability will be assessed through exit-survey items measuring participants' satisfaction with WI-CARE and the extent to which they consider the protocol appropriate for engaging African immigrants in research.
Responses will be summarized using item-level frequencies and mean or median scores, as appropriate.
Higher ratings indicate greater acceptability.
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6 months
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WI-CARE Usability
Ramy czasowe: 6 months
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Usability will be assessed through survey items informed by the Unified Theory of Acceptance and Use of Technology.
Items will examine the ease of learning and using WI-CARE procedures and WhatsApp features, the clarity of scenario instructions, and the effort required to participate.
Responses will be combined according to the final survey scoring procedures.
Higher ratings indicate greater perceived usability.
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6 months
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Scenario Participation Rate
Ramy czasowe: 6 months
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The scenario participation rate will be calculated as the number of enrolled participants who enter and participate in each WI-CARE scenario divided by the number of enrolled participants invited to that scenario, multiplied by 100.
Rates will be reported for each scenario and across the pilot.
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6 months
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Scenario Task Completion Rate
Ramy czasowe: At the completion of each scenario, up to approximately 6 months after enrollment
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The task completion rate will be calculated as the number of participants who complete the required activity within each WI-CARE scenario divided by the number of participants who begin that scenario, multiplied by 100.
Activities may include completing a survey, participating in a group discussion, reviewing research findings, or providing feedback.
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At the completion of each scenario, up to approximately 6 months after enrollment
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Participant Retention Rate
Ramy czasowe: At the end of the WI-CARE pilot, approximately 6 months after enrollment
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The retention rate will be calculated as the number of enrolled participants who complete the final WI-CARE evaluation divided by the total number enrolled in the WI-CARE WhatsApp Community, multiplied by 100.
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At the end of the WI-CARE pilot, approximately 6 months after enrollment
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Trustworthiness of the Engagement Process
Ramy czasowe: At the end of the WI-CARE pilot, approximately 6 months after enrollment
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Participant perceptions of trustworthiness will be assessed through exit-survey items addressing transparency, respect, privacy, confidentiality, data security, and confidence in the WI-CARE engagement process.
Responses will be summarized using item-level frequencies and mean or median scores, as appropriate.
Higher ratings indicate greater perceived trustworthiness.
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At the end of the WI-CARE pilot, approximately 6 months after enrollment
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Frequency and Type of Participant Interactions
Ramy czasowe: During each WI-CARE scenario, up to 6 months after enrollment
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WhatsApp analytics will be used to calculate the number of participant interactions during each scenario.
Interactions will be summarized overall and by communication type, including group messages, one-on-one text messages, audio notes, and media sharing.
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During each WI-CARE scenario, up to 6 months after enrollment
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Gloria AIDOO-FRIMPONG, PhD, MPH, MA, University at Buffalo
Publikacje i pomocne linki
Publikacje ogólne
- Aidoo-Frimpong G, Turner D, Collins RL, Ajiboye W, Agbemenu K, Nelson LE. WhatsApp-propriate? Exploring "WhatsApp" as a Tool for Research Among Ghanaian Immigrants in the United States. J Racial Ethn Health Disparities. 2024 Aug;11(4):1956-1963. doi: 10.1007/s40615-023-01664-9. Epub 2023 Jun 7.
- Akyirem S, Ekpor E, Aidoo-Frimpong GA, Salifu Y, Nelson LE. Online interviews for qualitative health research in Africa: a scoping review. Int Health. 2024 Jan 2;16(1):4-13. doi: 10.1093/inthealth/ihad010.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STUDY00010689
- SOE-2024C3-42543 (Inny numer grantu/finansowania: PCORI)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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