- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06128928
Connecting Friends and Health Workers to Boost COVID-19 Vaccination in Latino Communities (REDES)
REDES: a Peer Network and mHealth Community Health Worker (CHW) Model to Improve COVID-19 Vaccination Among Latinos
The goal of this clinical trial is to find out which approach works better in getting more of the friends and connections of Latino adults get vaccinated against COVID-19.
The main questions this study aims to answer are:
- Can teaching people to use motivational interviewing help more friends and connections of Latino adults get the COVID-19 vaccine compared to just giving information about the vaccine?
- What are the things that make it easier or harder for Latinos and networks to get the COVID-19 vaccine?
- How does this intervention work in practice so that it can be made available to more people in the future
The researchers will compare the vaccine rates of the friends and connections of Latinos who have been trained in motivational interviewing with those who have only been given information about the COVID-19 vaccine. This will help figure out which method works best to encourage more people to get vaccinated.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kathleen R Page, MD
- Phone Number: (410) 321-0909
- Email: kpage2@jhmi.edu
Study Contact Backup
- Name: Adrianna Moore, MSW
- Phone Number: 410-321-0909
- Email: adrianna.moore@jhmi.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University
-
Contact:
- Kathleen Page, MD
- Phone Number: 410-321-0909
- Email: kpage2@jhmi.edu
-
Contact:
- Adrianna Moore, MSW
- Phone Number: (410) 321-0909
- Email: adrianna.moore@jhmi.edu
-
Principal Investigator:
- Kathleen Page, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Eligibility criteria for index participants (eligibility for index participants is intended to select participants who are less vaccine hesitant):
- Age 18 years or older, and
- Self-identifies as Hispanic/Latino, and
- Living in Maryland, and
- Has received at least one COVID-19 vaccine/booster in the last 12 months.
Eligibility criteria for primary and secondary network members (peers):
Eligibility for peers is intended to select for participants who are more vaccine hesitant (e.g. unvaccinated, or have not received at least one COVID-19 vaccine/booster in the last 12 months)
- 18 years old or older, and
- Self-identifies as Hispanic/Latino, and
- Living in Maryland, and
- Provide a study coupon to verify that they were referred by an index or a primary network member, and
- Has not received at least one COVID-19 vaccine/booster in the last 12 months.
Exclusion Criteria:
- Previously participated in the study
- Lacks capacity to consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: REDES: Motivational interviewing training
Participants in this arm will receive training on motivational interviewing (MI) to promote vaccine acceptance and uptake with their networks.
The training will be led by community health workers on how to use MI to address vaccine hesitancy using a guiding approach, open-ended questions, affirmations, reflections, and summaries.
|
Training on motivational interviewing (MI) led by community health workers on how to use MI to address vaccine hesitancy using a guiding approach, open-ended questions, affirmations, reflections, and summaries.
|
|
Active Comparator: Control: COVID-19 vaccine information
Participants in the control condition will receive a brief community health worker-led training about the safety and efficacy of the vaccine.
Participants will have the opportunity to ask clarifying questions from the community health workers during the training.
|
Brief CHW-led training about the safety and efficacy of the COVID-19 vaccine.
Participants will have the opportunity to ask clarifying questions from the CHWs during the training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
COVID-19 vaccine status among networks
Time Frame: Up to 18 months
|
Number of network participants who receive the COVID-19 vaccine
|
Up to 18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cui Yang, PhD, Rutgers University
- Principal Investigator: Kathleen R Page, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Treatment Refusal
- Vaccination Refusal
- COVID-19
- Vaccination Hesitancy
Other Study ID Numbers
- IRB00345930
- R01MD017364 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
PfizerActive, not recruitingCOVID-19 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | COVID-19 Vaccines | SARS-CoV-2 Infection, COVID19 | COVID-19 Vaccination | SARS-CoV-2 Infection, COVID-19 | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionUnited States
-
Shanghai Public Health Clinical CenterNot yet recruiting
-
Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
Eggensberger OHGBavarian Health and Food Safety Authority (LGL)RecruitingPost COVID-19 Condition | Post COVID-19 | Post COVID-19 Syndrome | Long COVID-19 Syndrome | Post COVID-19 Condition (PCC)Germany
-
PfizerRecruitingRespiratory Tract Diseases | COVID-19 | Pneumonia | Lung Diseases | Coronavirus Disease 2019 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | Upper Respiratory Tract Infections | Respiratory Tract Infection | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionBelgium
-
ModeX Therapeutics, An OPKO Health CompanyRecruitingCOVID -19 | COVID-19 (Prevention)United States
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRecruitingFatigue | Post-COVID-19 Syndrome | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19 | Long-COVID | Post-COVID ConditionCanada
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia