Clinical trial NCT06128928: Connecting Friends and Health Workers to Boost COVID-19 Vaccination in Latino Communities
Official title: REDES: a Peer Network and mHealth Community Health Worker (CHW) Model to Improve COVID-19 Vaccination Among Latinos
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Vaccine
Keywords: COVID-19 vaccine uptake
Latino
vaccine hesitancy
Network referrals
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Rutgers University
First posted: 2023-11-13
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: COVID-19 vaccine status among networks
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kathleen R Page, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Cui Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: