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

NCT ID: NCT06128928

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-08

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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COVID-19 Vaccine

Keywords

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COVID-19 vaccine uptake Latino vaccine hesitancy Network referrals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

REDES

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Rutgers University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen R Page, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Cui Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen R Page, MD

Role: CONTACT

Phone: (410) 321-0909

Email: [email protected]

Adrianna Moore, MSW

Role: CONTACT

Phone: 410-321-0909

Email: [email protected]

Facility Contacts

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Kathleen Page, MD

Role: primary

Adrianna Moore, MSW

Role: backup

Other Identifiers

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R01MD017364

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00345930

Identifier Type: -

Identifier Source: org_study_id