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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01MD017431 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NuestraSaludSegura intervention | Experimental | Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2 |
|
| delayed NuestraSaludSegura intervention | Experimental | delayed-intervention group Navegantes will be trained in Year 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuestraSaludSegura | Behavioral | It blends peer navigation and mHealth |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria: To be eligible to participate in the in the NuestraSaludSegura intervention as a Navegante:
Inclusion Criteria: To be eligible to participate in the interviews as a Social Network Member:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott D Rhodes, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36385019 | Derived | 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. |
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Of the 274 that enrolled, 266 completed baseline data collection. This is because our Aim 1 Qualitative focused phase of interviews and focus group participants did not all fill out REDCap-based surveys with structured demographic questions. Specifically, 62 of 64 (97%) focus group participants and 24 of 30 (80%) interview participants provided demographic data and are reported below.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aim 1: Interviews | In-depth interviews with 30 representatives from health and service organizations. |
| FG001 | Aim 1: Focus Group Only | 7 focus groups with 64 diverse adult Spanish-speaking Latine persons. |
| FG002 | Aim 2: NuestraSaludSegura Intervention | Aim 2: NuestraSaludSegura Intervention. This group participated in the study developed Nuestra Salud Segura intervention arm. |
| FG003 | Aim 2: Delayed NuestraSaludSegura Intervention | Aim 2: Delayed NuestraSaludSegura Intervention. Participants in this arm comprised a comparison group until intervention was over, at which the intervention was given (i.e., delayed intervention arm). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aim 1: Focus Group Only | Aim 1: Focus group only. In-depth interviews with 30 representatives from health and service organizations and 7 focus groups with 64 diverse adult Spanish-speaking Latine persons. Demographic data was provided from 62 of 64 (97%) focus group participants and 24 of 30 (80%) of interview participants. This group gives the demographic data available from the 62 available focus group participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | We report baseline survey data from Aim 2 participants in the Intervention and Delayed Intervention arms and separately from. Aim 1 participants that were unique from Aim 2 paritcipants and had baseline survey data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Ever Tested | Number of Subjects Ever Tested | 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. | Posted | Count of Participants | Participants | Baseline |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aim 1: Interviews | In-depth interviews with 30 representatives from health and service organizations. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Rhodes, Ph.D | Wake Forest School of Medicine | 336-713-5080 | srhodes@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2025 | May 28, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2024 | Feb 26, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| BG001 | Aim 1: Interviews | Aim 1: Interviews only. In-depth interviews with 30 representatives from health and service organizations and 7 focus groups with 64 diverse adult Spanish-speaking Latine persons. Demographic data was provided from 62 of 64 (97%) focus group participants and 24 of 30 (80%) of interview participants. This group gives the demographic data available from the 24 available interviews' participants. |
| BG002 | Aim 2: NuestraSaludSegura Intervention | Aim 2: NuestraSaludSegura Intervention. This group participated in the study developed Nuestra Salud Segura intervention arm. |
| BG003 | Aim 2: Delayed NuestraSaludSegura Intervention | Aim 2: Delayed NuestraSaludSegura Intervention. Participants in this arm comprised a comparison group until intervention was over, at which the intervention was given (i.e., delayed intervention arm). |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | We report baseline survey data from Aim 2 participants in the Intervention and Delayed Intervention arms and separately from Aim 1 participants that were unique from Aim 2 paritcipants and had baseline survey data. Please note that for sex for the 24 interview participants 1 had missing sex. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | We report baseline survey data from Aim 2 participants in the Intervention and Delayed Intervention arms and separately from. Aim 1 participants that were unique from Aim 2 paritcipants and had baseline survey data. | Count of Participants | Participants |
|
| Race (NIH/OMB) | We report baseline survey data from Aim 2 participants in the Intervention and Delayed Intervention arms and separately from. Aim 1 participants that were unique from Aim 2 paritcipants and had baseline survey data. | Count of Participants | Participants |
|
|
|
| Primary | Number of Subjects Ever Vaccinated | Number of Subjects Ever Vaccinated | 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Number of Subjects Up to Date on Recommended Doses | Number of Subjects Up to Date on Recommended Doses | 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Number of Doses Received | Number of Doses Received | 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. | Posted | Mean | Standard Deviation | Number of Doses | Baseline |
|
|
|
| Primary | Number of Subjects Ever Tested | Number of Subjects Ever Tested | 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. | Posted | Count of Participants | Participants | Month 6 |
|
|
|
| Primary | Number of Subjects Ever Vaccinated | Number of Subjects Ever Vaccinated | 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. | Posted | Count of Participants | Participants | Month 6 |
|
|
|
| Primary | Number of Subjects Up to Date on Recommended Doses | Number of Subjects Up to Date on Recommended Doses | 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. | Posted | Count of Participants | Participants | Month 6 |
|
|
|
| Primary | Number of Doses Received | Number of Doses Received | 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. | Posted | Mean | Standard Deviation | Number of Doses | Month 6 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Aim 1: Focus Group Only | 7 focus groups with 64 diverse adult Spanish-speaking Latine persons. | 0 | 64 | 0 | 64 | 0 | 64 |
| EG002 | Aim 2: NuestraSaludSegura Intervention | Aim 2: NuestraSaludSegura Intervention. This group participated in the study developed Nuestra Salud Segura intervention arm. | 0 | 90 | 0 | 90 | 0 | 90 |
| EG003 | Aim 2: Delayed NuestraSaludSegura Intervention | Aim 2: Delayed NuestraSaludSegura Intervention. Participants in this arm comprised a comparison group until intervention was over, at which the intervention was given (i.e., delayed intervention arm). | 0 | 90 | 0 | 90 | 0 | 90 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|