Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care… (NCT05841810) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
United States398 participantsStarted 2024-08-20
Plain-language summary
This study will optimize, implement, and test the impact of our multicomponent health program that includes three primary implementation strategies (Cultural Weavers and co-creation, mHealth strategies using culturally meaningful text and voice messages, and care coordination). The investigators will use a participatory approach to engage community members in co-creating and optimizing our mHealth outreach and enhanced care coordination program components. The investigators will use a hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial (SMART) design to assess the impact of our multicomponent health program on implementation and outcome measures.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years or older.
* Speaks Spanish, Arabic and/or Vietnamese.
* Current San Ysidro Health patient and receives care at select clinics in study locations (Escondido, El Cajon, Community Heights).
Exclusion Criteria:
* Not able to provide informed consent.
* \< 18 years old
* Does not speak Spanish, Arabic or Vietnamese
* Is not a current San Ysidro Health patient or is a current San Ysidro Health patient but does not receive care at select clinics in study locations (Escondido, El Cajon, Community Heights).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
COVID-19 vaccination rate
Timeframe: 8 months after starting the 1st stage intervention to determine response vs non-response for 2nd stage randomization.
2
COVID-19 vaccination rate
Timeframe: 12 months after 2nd stage randomization
3
COVID-19 vaccination rate
Timeframe: 24 months after 2nd stage randomization
4
COVID-19 vaccination rate
Timeframe: 36 months after 2nd stage randomization