COVID-19NCT05302908

COVID-19 Testing and Vaccination Among Spanish Speakers

A study testing NuestraSaludSegura in people with COVID-19 and Vaccinations, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19, Vaccinations
What is being tested?: NuestraSaludSegura
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 274 participants
Where: 1 siteUnited States
Study dates: 9 Feb 2023to 30 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

less than 18 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Identifying and Addressing Critical Social, Ethical, and Behavioral Factors Associated With COVID-19 Testing and Vaccination Among Spanish Speakers

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.

Read the detailed description

A profound need remains to understand the social, ethical, and behavioral implications (SEBI) of COVID-19 testing and vaccination interventions within Spanish-speaking Latinx communities. The proposal is a conceptually integrated community-based participatory research (CBPR) study that includes systematic data collection on the multilevel factors that influence COVID-19 testing and vaccination; refinement of an efficacious intervention that uses complementary theory-based strategies (i.e., peer navigation and mHealth); intervention implementation and evaluation using a longitudinal group-randomized trial design; and dissemination of findings.

Conditions: COVID-19, Vaccinations
Being tested: NuestraSaludSegura
Keywords: COVID-19, Vaccinations, Spanish-speaking, Latinx, Hispanic/Latino populations
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NuestraSaludSeguraBehavioural
It blends peer navigation and mHealth

Study groups in NCT05302908
Study group	Role	What they receive
NuestraSaludSegura intervention	Experimental	Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2 Receives: Behavioral: NuestraSaludSegura
delayed NuestraSaludSegura intervention	Experimental	delayed-intervention group Navegantes will be trained in Year 2 Receives: Behavioral: NuestraSaludSegura

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Ever Tested
Number of Subjects Ever Tested
Measured: Baseline
Number of Subjects Ever Vaccinated
Number of Subjects Ever Vaccinated
Measured: Baseline
Number of Subjects Up to Date on Recommended Doses
Number of Subjects Up to Date on Recommended Doses
Measured: Baseline
Number of Doses Received
Number of Doses Received
Measured: Baseline
Number of Subjects Ever Tested
Number of Subjects Ever Tested
Measured: Month 6
Number of Subjects Ever Vaccinated
Number of Subjects Ever Vaccinated
Measured: Month 6
Number of Subjects Up to Date on Recommended Doses
Number of Subjects Up to Date on Recommended Doses
Measured: Month 6
Number of Doses Received
Number of Doses Received
Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Feb 202330 Nov 2024

First posted31 Mar 2022
Study start9 Feb 2023
Primary completion30 Nov 2024
Study completion30 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05302908
Sponsor's protocol ID: IRB00079510
Other IDs: 5U01MD017431
Status last verified: Dec 2025
First submitted: 29 Mar 2022
Last updated: 15 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 36385019

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Identifying and Addressing Critical Social, Ethical, and Behavioral Factors Associated With COVID-19 Testing and Vaccination Among Spanish Speakers
ClinicalTrials.gov ID: NCT05302908
Acronym / sponsor ID: IRB00079510
Conditions: COVID-19, Vaccinations
Keywords: COVID-19, Vaccinations, Spanish-speaking, Latinx, Hispanic/Latino populations
Study type: Interventional
Recruitment status: Completed
Enrolment: 274 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 9 Feb 2023 (actual)
Primary completion: 30 Nov 2024 (actual)
Study completion: 30 Nov 2024 (actual)
First posted: 31 Mar 2022 (actual)
Results: Posted 1 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
NuestraSaludSegura intervention	Experimental	Behavioral: NuestraSaludSeguraIntervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2
delayed NuestraSaludSegura intervention	Experimental	Behavioral: NuestraSaludSeguradelayed-intervention group Navegantes will be trained in Year 2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (1 listed)

less than 18 years of age

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NuestraSaludSeguraIt blends peer navigation and mHealth	Behavioural	NuestraSaludSegura intervention, delayed NuestraSaludSegura intervention

Primary outcome

Number of Subjects Ever Tested
Time frame: Baseline
Number of Subjects Ever Tested
Number of Subjects Ever Vaccinated
Time frame: Baseline
Number of Subjects Ever Vaccinated
Number of Subjects Up to Date on Recommended Doses
Time frame: Baseline
Number of Subjects Up to Date on Recommended Doses
Number of Doses Received
Time frame: Baseline
Number of Doses Received
Number of Subjects Ever Tested
Time frame: Month 6
Number of Subjects Ever Tested
Number of Subjects Ever Vaccinated
Time frame: Month 6
Number of Subjects Ever Vaccinated
Number of Subjects Up to Date on Recommended Doses
Time frame: Month 6
Number of Subjects Up to Date on Recommended Doses
Number of Doses Received
Time frame: Month 6
Number of Doses Received

Results and safety

Results posted to the registry on 1 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aim 1: Interviews	30	30
Aim 1: Focus Group Only	64	64
Aim 2: NuestraSaludSegura Intervention	90	88
Aim 2: Delayed NuestraSaludSegura Intervention	90	89

Primary outcome: Number of Subjects Ever Tested

Time frame: Baseline. Count of participants. Unit: Participants

Measure	NuestraSaludSegura Intervention n = 78	Delayed NuestraSaludSegura Intervention n = 79
Value	70	58

Population analysed: Aim 2 had 180 enrolled - 20 Navegantes/Peer Interventionist and 160 participants with 80 per arm. Of the 80 per arm, n=78 completed follow-up for Intervention and n=79 completed follow-up for Delayed Intervention arm.

Primary outcome: Number of Subjects Ever Vaccinated

Time frame: Baseline. Count of participants. Unit: Participants

Measure	NuestraSaludSegura Intervention n = 78	Delayed NuestraSaludSegura Intervention n = 79
Value	66	64

Primary outcome: Number of Subjects Up to Date on Recommended Doses

Time frame: Baseline. Count of participants. Unit: Participants

Measure	NuestraSaludSegura Intervention n = 78	Delayed NuestraSaludSegura Intervention n = 79
Value	22	13

Primary outcome: Number of Doses Received

Time frame: Baseline. Mean (Standard Deviation). Unit: Number of Doses

Measure	NuestraSaludSegura Intervention n = 78	Delayed NuestraSaludSegura Intervention n = 79
Value	2.6 (1.1)	2.6 (0.8)

Adverse events

Time frame: For Aim 1 with both interviews and focus groups, the time frame of collection was from study beginning until study interview/focus group completion, including those who provided REDCap survey data additionally. These data were cross-sectional and not followed/collected over multiple time-points. For Aim 2 RCT with intervention and delayed intervention groups, the time frame of collection was from study beginning (baseline) until immediate post-intervention at 6-months follow-up later.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aim 1: Interviews	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Aim 1: Focus Group Only	0 of 64 (0%)	0 of 64 (0%)	0 of 64
Aim 2: NuestraSaludSegura Intervention	0 of 90 (0%)	0 of 90 (0%)	0 of 90
Aim 2: Delayed NuestraSaludSegura Intervention	0 of 90 (0%)	0 of 90 (0%)	0 of 90

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36385019Rhodes 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott D Rhodes, PhD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NuestraSaludSegura in people with COVID-19 and Vaccinations, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Ever Tested (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05302908, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.