COVID-19, Vaccinations
Conditions
Keywords
COVID-19, Vaccinations, Spanish-speaking, Latinx, Hispanic/Latino populations
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.
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.
Interventions
BEHAVIORALNuestraSaludSegura
It blends peer navigation and mHealth
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
To be eligible to participate in the in the NuestraSaludSegura intervention as a Navegante: * 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 Inclusion Criteria: To be eligible to participate in the interviews as a Social Network Member: * participant must self-identify as Hispanic/Latinx * participant must be Spanish speaking * participant must be ≥ 18 years of age * participant must provide informed consent
Exclusion criteria
* less than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Ever Tested | Baseline | Number of Subjects Ever Tested |
| Number of Subjects Ever Vaccinated | Baseline | Number of Subjects Ever Vaccinated |
| Number of Subjects Up to Date on Recommended Doses | Baseline | Number of Subjects Up to Date on Recommended Doses |
| Number of Doses Received | Baseline | Number of Doses Received |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 62 |
| 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. | 24 |
| Aim 2: NuestraSaludSegura Intervention Aim 2: NuestraSaludSegura Intervention. This group participated in the study developed Nuestra Salud Segura intervention arm. | 90 |
| 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). | 90 |
| Total | 266 |
Baseline characteristics
| Characteristic | Aim 1: Focus Group Only | Aim 1: Interviews | Aim 2: NuestraSaludSegura Intervention | Aim 2: Delayed NuestraSaludSegura Intervention | Total |
|---|---|---|---|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 13.6 | 49.0 years STANDARD_DEVIATION 11.6 | 41.0 years STANDARD_DEVIATION 14 | 42.4 years STANDARD_DEVIATION 11.6 | 41.7 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 62 Participants | 19 Participants | 90 Participants | 90 Participants | 261 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 10 Participants | 21 Participants | 33 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 59 Participants | 11 Participants | 64 Participants | 55 Participants | 189 Participants |
| Race (NIH/OMB) White | 2 Participants | 11 Participants | 16 Participants | 12 Participants | 41 Participants |
| Sex: Female, Male Female | 40 Participants | 19 Participants | 71 Participants | 67 Participants | 197 Participants |
| Sex: Female, Male Male | 22 Participants | 4 Participants | 19 Participants | 23 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 64 | 0 / 90 | 0 / 90 |
| other Total, other adverse events | 0 / 30 | 0 / 64 | 0 / 90 | 0 / 90 |
| serious Total, serious adverse events | 0 / 30 | 0 / 64 | 0 / 90 | 0 / 90 |
Outcome results
Primary
Number of Doses Received
Number of Doses Received
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NuestraSaludSegura Intervention | Number of Doses Received | 2.6 Number of Doses | Standard Deviation 1.1 |
| Delayed NuestraSaludSegura Intervention | Number of Doses Received | 2.6 Number of Doses | Standard Deviation 0.8 |
Primary
Number of Doses Received
Number of Doses Received
Time frame: Month 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NuestraSaludSegura Intervention | Number of Doses Received | 3.0 Number of Doses | Standard Deviation 1.3 |
| Delayed NuestraSaludSegura Intervention | Number of Doses Received | 2.7 Number of Doses | Standard Deviation 1 |
Primary
Number of Subjects Ever Tested
Number of Subjects Ever Tested
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NuestraSaludSegura Intervention | Number of Subjects Ever Tested | 70 Participants |
| Delayed NuestraSaludSegura Intervention | Number of Subjects Ever Tested | 58 Participants |
Primary
Number of Subjects Ever Tested
Number of Subjects Ever Tested
Time frame: Month 6
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NuestraSaludSegura Intervention | Number of Subjects Ever Tested | 70 Participants |
| Delayed NuestraSaludSegura Intervention | Number of Subjects Ever Tested | 64 Participants |
Primary
Number of Subjects Ever Vaccinated
Number of Subjects Ever Vaccinated
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NuestraSaludSegura Intervention | Number of Subjects Ever Vaccinated | 66 Participants |
| Delayed NuestraSaludSegura Intervention | Number of Subjects Ever Vaccinated | 64 Participants |
Primary
Number of Subjects Ever Vaccinated
Number of Subjects Ever Vaccinated
Time frame: Month 6
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NuestraSaludSegura Intervention | Number of Subjects Ever Vaccinated | 69 Participants |
| Delayed NuestraSaludSegura Intervention | Number of Subjects Ever Vaccinated | 67 Participants |
Primary
Number of Subjects Up to Date on Recommended Doses
Number of Subjects Up to Date on Recommended Doses
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NuestraSaludSegura Intervention | Number of Subjects Up to Date on Recommended Doses | 22 Participants |
| Delayed NuestraSaludSegura Intervention | Number of Subjects Up to Date on Recommended Doses | 13 Participants |
Primary
Number of Subjects Up to Date on Recommended Doses
Number of Subjects Up to Date on Recommended Doses
Time frame: Month 6
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NuestraSaludSegura Intervention | Number of Subjects Up to Date on Recommended Doses | 37 Participants |
| Delayed NuestraSaludSegura Intervention | Number of Subjects Up to Date on Recommended Doses | 30 Participants |