An interventional study of WI-CARE Protocol in Patient Engagement, sponsored by State University of New York at Buffalo. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Other
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Among 154 studies in Patient Participation with a site in United States — 27 open to participants now, 31 under way, none of them phase 3. Patient Participation · United States.
Among the 154 studies in Patient Participation with a site in United States, this one is the 44th largest by planned enrollment of the 139 interventional ones that give a count, is one of 14 that started in 2026, is one of 132 with no phase, reaches primary completion later than 23 of the 30 other live ones, and was the 154th registered.
409 studies on the registry are indexed under Patient Participation; 100 are open to participants now.
Browse Patient Participation studies →27 of the 154 studies in Patient Participation with a site in United States are open now. Recruiting first, the newest first:
University of Utah · Sites in United States
Ages 18+ · Women only · Healthy volunteers
William Brandenburg, MD · Sites in United States
Ages 18+ · Healthy volunteers
University of Nebraska · Sites in United States
Ages 15–18
University of Washington · Sites in United States
Ages 14+ · Healthy volunteers
Columbia University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 48 Patient Participation studies recruiting now, 32 (67%) set no upper age limit and 9 (19%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
154 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 2 · Phase 4 1
First in 2002; this study’s year is marked. 14 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 300 is above the median of 128 across 322 interventional studies indexed under Patient Participation.
Median enrollment 130 across the 139 interventional studies, 257 across the 15 observational. Of the 114 that completed or were terminated, 41 (36%) have results posted.
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10 of 154 have an industry lead sponsor. The 10 most frequent:
State University of New York at Buffalo is the lead sponsor of 294 studies on the registry; 63 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
State University of New York at Buffalo has 2 studies filed under Patient Participation — fewer than ten, so there is no comparison to draw.
13 of the studies in Patient Participation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06989593Sarah SchlegelBreaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions | 2026-11 |
| NCT06246409University of FloridaModernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy | 2026-12 |
| NCT07489105Auburn UniversityForge AHEAD: Feasibility of Yoga to Improve Cognitive Function | 2026-12-31 |
| NCT06581484University of California, San FranciscoImproving Congenital Heart Disease Care | 2026-12-31 |
| NCT06358261Johns Hopkins UniversityStudy of a Diabetes Prevention Patient Activation Clinical Decision Support Tool | 2027-01-01 |
Add all 13 to your calendar (.ics) → With an account.
Among the 154 studies in Patient Participation with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aim 1 survey and focus group participants:
Aim 2 expert panel participants:
Aim 3 pilot participants:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: WI-CARE Protocol
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.
Quality of Research Engagement
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.
Time frame: 6 months
Engagement Context
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.
Time frame: 12 months
WI-CARE Acceptability
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.
Time frame: 6 months
WI-CARE Usability
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.
Time frame: 6 months
Scenario Participation Rate
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.
Time frame: 6 months
Scenario Task Completion Rate
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.
Time frame: At the completion of each scenario, up to approximately 6 months after enrollment
Participant Retention Rate
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.
Time frame: At the end of the WI-CARE pilot, approximately 6 months after enrollment
Trustworthiness of the Engagement Process
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.
Time frame: At the end of the WI-CARE pilot, approximately 6 months after enrollment
Frequency and Type of Participant Interactions
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.
Time frame: During each WI-CARE scenario, up to 6 months after enrollment
Plan to share: No — Individual participant data will not be shared with researchers outside the study team. The study includes qualitative data, WhatsApp engagement data, and information from members of relatively small and connected African immigrant communities. Even after removing direct identifiers, combining participants' demographic characteristics, migration histories, geographic locations, and narrative responses may create a risk of re-identification.
Start is estimated for Dec 2026; primary completion for Jul 2028, 19 months later.
Of 219 non-industry interventional studies with no phase under Patient Participation, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 19 months is close to that.
Counting every sponsor, half of 226 studies reached it within 20 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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State University of New York at Buffalo →