What side effects are associated with this type of intervention?

The most common treatments for COVID-19 include vaccines, antiviral medications like remdesivir, and supportive care. Vaccines, such as mRNA vaccines (Pfizer-BioNTech and Moderna), can cause side effects like injection site pain, fatigue, headache, muscle pain, chills, fever, and nausea. Remdesivir, an antiviral used in hospitalized patients, may cause side effects such as nausea, elevated liver enzymes, and potential allergic reactions. Supportive care, which includes managing symptoms like fever and cough, generally has minimal side effects but may involve medications like acetaminophen or ibuprofen, which can cause gastrointestinal discomfort or allergic reactions in some individuals.

What prior FDA approvals exist?

The FDA has granted Emergency Use Authorization (EUA) and full approval for several treatments and vaccines for COVID-19. Vaccines such as Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) have received full approval, while others like Johnson & Johnson's Janssen vaccine have EUA. Treatments like remdesivir (Veklury) have been approved for hospitalized patients. Monoclonal antibody therapies, such as those from Regeneron and Eli Lilly, have also received EUAs for treating mild to moderate COVID-19 in high-risk patients. These interventions align with the goals of increasing vaccine uptake and managing COVID-19 effectively.

What other types of research exist?

Promising novel alternatives to Community-Centered Interventions for increasing vaccine uptake among COVID-19 patients in 2024 include: 1) Digital health interventions such as mobile health apps and telehealth platforms to provide personalized vaccine information and reminders. 2) Use of artificial intelligence and machine learning to identify and target individuals with high vaccine hesitancy. 3) Implementation of workplace and school-based vaccination programs to increase accessibility. 4) Enhanced public-private partnerships to leverage resources and outreach capabilities. 5) Development and deployment of next-generation vaccines with improved efficacy and easier administration (e.g., oral or nasal vaccines).

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Motivational Interviewing for COVID-19 Vaccination Acceptance (G2YMI Trial)

N/A

Waitlist Available

Led By Erica Marsh, M.D.

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Persons under the age of 18

Unable or unwilling to receive SMS/MMS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses community-focused methods to encourage COVID-19 vaccination among African American and Latinx communities in specific Michigan counties. By understanding and addressing vaccine hesitancy through local engagement, the study aims to increase vaccination rates in these disproportionately affected groups.

Who is the study for?

This trial is for adults over 18 in Michigan, particularly from African American and Latinx communities, who are vaccinated and boosted but want to help others get vaccinated (Champions), or those unvaccinated/unboosted willing to participate. They must be able to use SMS/MMS and read/write in English or Spanish.

What is being tested?

The study tests motivational interviewing via text messages and web content designed to increase COVID-19 vaccine uptake among groups facing disparities. It's based on community feedback within four Michigan counties with a history of lower vaccination rates.

What are the potential side effects?

Since the intervention involves informational content rather than medical treatment, traditional side effects aren't expected. However, participants may experience discomfort or anxiety related to discussions about vaccines.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Select...

I cannot or do not want to receive text messages.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self-reported COVID-19 Vaccine uptake

Secondary study objectives

Intention to uptake COVID-19 Vaccine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Enrolled study participants receive Motivational Interviewing based SMS/MMS messages to increase COVID-19 vaccine uptake, and complete Baseline and Follow-up surveys.

Group II: ControlActive Control1 Intervention

Enrolled study participants receive a simple website and complete a Baseline and Follow-up survey, after which they will receive the interventional Motivational Interviewing based SMS/MMS messages to increase COVID-19 vaccine uptake.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for the Coronavirus Pandemic include vaccines, antiviral medications, and supportive care. Vaccines work by stimulating the immune system to recognize and fight the virus, thereby preventing infection or reducing the severity of the disease. Antiviral medications inhibit the replication of the virus within the body, helping to reduce viral load and mitigate symptoms. Supportive care, such as oxygen therapy and hydration, helps manage symptoms and support the body's natural healing processes. These treatments are crucial for patients as they reduce the risk of severe illness, hospitalization, and death, and help control the spread of the virus within communities. Community-centered interventions, like those studied in the Community-Centered Interventions for Improved Vaccine Uptake (CIVIC) trial, are essential for increasing vaccine uptake and addressing vaccine hesitancy, particularly in populations disproportionately affected by COVID-19.

A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.The race to treat COVID-19: Potential therapeutic agents for the prevention and treatment of SARS-CoV-2.Research methodology and characteristics of journal articles with original data, preprint articles and registered clinical trial protocols about COVID-19.