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Recruiting NCT06128928

Connecting Friends and Health Workers to Boost COVID-19 Vaccination in Latino Communities

No phase Interventional COVID-19 Vaccine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REDES, Control.
Who it may be relevant to
Registry conditions: COVID-19, Vaccine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

REDES: a Peer Network and mHealth Community Health Worker (CHW) Model to Improve COVID-19 Vaccination Among Latinos

Overview

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: 1. 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? 2. What are the things that make it easier or harder for Latinos and networks to get the COVID-19 vaccine? 3. 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.

Detailed description

This study will test the efficacy of an intervention REDES ("Networks") - a social network intervention - to address COVID-19 vaccine hesitancy and uptake among a cohort of Latinos and networks. 300 index participants who have taken the COVID-19 vaccine will be recruited. Half of the index participants (n=150) will be randomized to the experimental group and will receive training on motivational interviewing to promote vaccine acceptance and uptake with networks. Index participants in the control group (n=150) will receive updated information about the COVID-19 vaccine. In addition, unvaccinated primary and secondary network members of indexes will be recruited for study participation and COVID-19 vaccination. All participants will be followed prospectively at 6, 12, and 18 months after baseline intake. The specific aims are: 1) Evaluate the efficacy of the REDES intervention to promote COVID-19 vaccine uptake among Latinos; 2) Examine ongoing barriers and facilitators of vaccine uptake among Latinos and networks to tailor the intervention and address new challenges, and 3) Evaluate the implementation determinants and outcomes of REDES to inform future broad-scale implementation.

Interventions

  • Behavioral REDES
    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.
  • Behavioral Control
    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.

Primary outcome measures

  • COVID-19 vaccine status among networks [Time frame: Up to 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Johns Hopkins University — Baltimore

Identifiers

NCT: NCT06128928 · IRB00345930 · R01MD017364

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗