What side effects are associated with this type of intervention?

Common treatments for COVID-19 include pharmacotherapies like dexamethasone, which can cause psychiatric side effects such as depression, emotional lability, and psychosis. Hydroxychloroquine (HCQ) has been associated with an increased risk of adverse events compared to placebo. Behavioral interventions aimed at increasing vaccine uptake, such as the TT-C intervention, focus on addressing vaccine hesitancy, confidence, and knowledge, and do not have pharmacological side effects but may involve psychological and social factors.

What prior FDA approvals exist?

The FDA has granted emergency use authorization (EUA) for several treatments for COVID-19, including antiviral drugs like remdesivir and molnupiravir, which are used to treat mild to moderate cases. Additionally, vaccines such as the Pfizer-BioNTech and Moderna COVID-19 vaccines have received EUA to prevent COVID-19. While the TT-C intervention focuses on behavioral strategies to increase vaccine uptake by addressing hesitancy, confidence, and knowledge, the FDA has not specifically approved behavioral interventions for COVID-19 treatment. However, the importance of such interventions is recognized in increasing vaccine uptake and combating the pandemic.

What other types of research exist?

Promising, novel alternatives to the TT-C intervention for increasing COVID-19 vaccine uptake include: 1) Educational interventions delivered by trusted healthcare providers to combat misinformation, as seen in Canadian federal prisons. 2) Dialogue-based web interventions hosted by trusted community figures, such as those used in Black church congregations. 3) Training primary care clinicians to communicate effectively about COVID-19 vaccination plans with their patients. 4) Internet-based cognitive behavioral therapy (iCBT) to address health anxiety and improve vaccine uptake. These alternatives focus on building trust, providing accurate information, and leveraging trusted community figures and healthcare providers.

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Behavioral Intervention

Tough Talks COVID Intervention for Vaccine Uptake

N/A

Waitlist Available

Led By Lisa Hightow-Weidman, MD, MPH

Research Sponsored by Florida State University

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 3

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether a mobile app called TT-C can help increase COVID-19 vaccination rates among Black young adults in Alabama, Georgia, and North Carolina. The app provides information to boost confidence in vaccines. Participants receive either standard vaccine information or access to the TT-C app.

Who is the study for?

This trial is for African American young adults aged 18-29 who live in Alabama, Georgia, or North Carolina. They must be able to speak and read English, have access to a personal smartphone, and not yet received the full COVID vaccine series.

What is being tested?

The study compares two groups: one receives standard care while the other gets the Tough Talks COVID (TT-C) intervention. The goal is to see if TT-C increases COVID-19 vaccine uptake among participants more effectively than usual methods.

What are the potential side effects?

Since this trial focuses on increasing vaccine uptake through an educational intervention rather than testing a medical product directly, it does not involve typical drug side effects. However, there may be indirect effects related to changes in knowledge or attitudes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

COVID Vaccine Uptake at Month 1

COVID Vaccine Uptake at Month 3

Secondary study objectives

COVID Vaccine Confidence

COVID Vaccine Hesitancy

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: TT-C InterventionExperimental Treatment1 Intervention

Research staff will provide access to the TT-COVID app for one-month, which will provide knowledge about the COVID-19 vaccine, address mis-information, and include multi-media digital stories from study participant's peers.

Group II: Standard of Care (Control)Active Control1 Intervention

Research staff will provide COVID vaccine materials from the Centers for Disease Control (CDC) to those participants in the Standard of Care (SOC) arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tough Talks COVID

2023

N/A

~360

Do I qualify?Apply below to find out

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

Common treatments for COVID-19 include traditional Chinese medicine (TCM), convalescent plasma (CP), and behavioral interventions. TCM formulations are used to boost the immune system and alleviate symptoms, though their molecular mechanisms are not fully understood. CP involves transfusing plasma from recovered COVID-19 patients to provide passive immunity through antibodies. Behavioral interventions, like the TT-C trial, aim to increase vaccine uptake by addressing vaccine hesitancy, improving confidence, and enhancing knowledge about vaccines. This is crucial for COVID-19 patients as higher vaccine uptake can lead to greater community immunity, reducing the spread and severity of the disease.

A bibliometric analysis of research related Chinese Medicine in the prevention and treatment of corona virus disease 2019.How Are Emerging Data Translated Into Clinical Practice? A Mixed Methods Investigation of Coronavirus Disease 2019 Institutional Treatment Protocols.Neurological risks and benefits of cytokine-based treatments in coronavirus disease 2019: from preclinical to clinical evidence.