NCT05302908

Brief Summary

Latinx communities are disproportionately affected by the COVID-19 pandemic, with Spanish-speaking Latinx communities carrying even heavier burdens of infection, hospitalization, and mortality. Major barriers to COVID-19 testing and vaccination exist, and a profound need remains to understand and address the social, ethical, and behavioral implications (SEBI) of COVID-19 testing and vaccination within Latinx communities. Our community-academic partnership proposes a rigorous mixed-methods, community-based participatory research study to better understand the SEBI of COVID-19 testing and vaccination and to refine and test a novel and culturally congruent intervention that integrates two evidenced-based strategies - peer navigation and mHealth - to increase COVID-19 testing and vaccination within Spanish-speaking Latinx communities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Feb 2023

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

February 9, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 1, 2025

Completed
Last Updated

January 15, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

March 29, 2022

Results QC Date

May 28, 2025

Last Update Submit

December 23, 2025

Conditions

COVID-19Vaccinations

Keywords

COVID-19VaccinationsSpanish-speakingLatinxHispanic/Latino populations

Outcome Measures

Primary Outcomes (8)

  • Number of Subjects Ever Tested

    Number of Subjects Ever Tested

    Baseline

  • Number of Subjects Ever Vaccinated

    Number of Subjects Ever Vaccinated

    Baseline

  • Number of Subjects Up to Date on Recommended Doses

    Number of Subjects Up to Date on Recommended Doses

    Baseline

  • Number of Doses Received

    Number of Doses Received

    Baseline

  • Number of Subjects Ever Tested

    Number of Subjects Ever Tested

    Month 6

  • Number of Subjects Ever Vaccinated

    Number of Subjects Ever Vaccinated

    Month 6

  • Number of Subjects Up to Date on Recommended Doses

    Number of Subjects Up to Date on Recommended Doses

    Month 6

  • Number of Doses Received

    Number of Doses Received

    Month 6

Study Arms (2)

NuestraSaludSegura intervention

EXPERIMENTAL

Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2

Behavioral: NuestraSaludSegura

delayed NuestraSaludSegura intervention

EXPERIMENTAL

delayed-intervention group Navegantes will be trained in Year 2

Behavioral: NuestraSaludSegura

Interventions

NuestraSaludSeguraBEHAVIORAL

It blends peer navigation and mHealth

NuestraSaludSegura interventiondelayed NuestraSaludSegura intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participant must self-identify as Hispanic/Latinx
  • participant must be Spanish speaking
  • participant reports having been vaccinated against COVID-19
  • participant must be ≥18 years of age
  • participant must provide informed consent
  • participant must self-identify as Hispanic/Latinx
  • participant must be Spanish speaking
  • participant must be ≥ 18 years of age
  • participant must provide informed consent

You may not qualify if:

  • less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • Rhodes SD, Tanner AE, Mann-Jackson L, Alonzo J, Hall MA, Bertoni AG, McCoy TP, Aguilar-Palma SK, Garcia M, Miranda D, Turner MJ. Increasing COVID-19 testing and vaccination among Spanish speakers in the USA: protocol for the development and evaluation of the Nuestra Comunidad Saludable intervention using a group-randomised trial design. BMJ Open. 2022 Nov 16;12(11):e066585. doi: 10.1136/bmjopen-2022-066585.

    PMID: 36385019DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Scott Rhodes, Ph.D
Organization
Wake Forest School of Medicine
srhodes@wakehealth.edu
336-713-5080

Study Officials

  • Scott D Rhodes, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

March 31, 2022

Study Start

February 9, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

January 15, 2026

Results First Posted

October 1, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)