Trial Outcomes & Findings for COVID-19 Testing and Vaccination Among Spanish Speakers (NCT NCT05302908)
NCT ID: NCT05302908
Last Updated: 2026-01-15
Results Overview
Number of Subjects Up to Date on Recommended Doses
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
274 participants
Primary outcome timeframe
Month 6
Results posted on
2026-01-15
Participant Flow
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.
Participant milestones
| Measure |
Aim 1: Interviews
In-depth interviews with 30 representatives from health and service organizations.
|
Aim 1: Focus Group Only
7 focus groups with 64 diverse adult Spanish-speaking Latine persons.
|
Aim 2: NuestraSaludSegura Intervention
Aim 2: NuestraSaludSegura Intervention. This group participated in the study developed Nuestra Salud Segura intervention arm.
|
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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
64
|
90
|
90
|
|
Overall Study
COMPLETED
|
30
|
64
|
88
|
89
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Aim 1: Focus Group Only
n=62 Participants
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.
|
Aim 1: Interviews
n=24 Participants
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.
|
Aim 2: NuestraSaludSegura Intervention
n=90 Participants
Aim 2: NuestraSaludSegura Intervention. This group participated in the study developed Nuestra Salud Segura intervention arm.
|
Aim 2: Delayed NuestraSaludSegura Intervention
n=90 Participants
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).
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 13.6 • n=62 Participants • 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.
|
49.0 years
STANDARD_DEVIATION 11.6 • n=24 Participants • 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.
|
41.0 years
STANDARD_DEVIATION 14.0 • n=90 Participants • 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.
|
42.4 years
STANDARD_DEVIATION 11.6 • n=90 Participants • 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.
|
41.7 years
STANDARD_DEVIATION 12.9 • n=266 Participants • 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.
|
|
Sex: Female, Male
Female
|
40 Participants
n=62 Participants • 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.
|
19 Participants
n=23 Participants • 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.
|
71 Participants
n=90 Participants • 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.
|
67 Participants
n=90 Participants • 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.
|
197 Participants
n=265 Participants • 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.
|
|
Sex: Female, Male
Male
|
22 Participants
n=62 Participants • 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.
|
4 Participants
n=23 Participants • 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.
|
19 Participants
n=90 Participants • 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.
|
23 Participants
n=90 Participants • 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.
|
68 Participants
n=265 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
62 Participants
n=62 Participants • 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.
|
19 Participants
n=24 Participants • 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.
|
90 Participants
n=90 Participants • 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.
|
90 Participants
n=90 Participants • 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.
|
261 Participants
n=266 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=62 Participants • 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.
|
4 Participants
n=24 Participants • 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.
|
0 Participants
n=90 Participants • 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.
|
0 Participants
n=90 Participants • 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.
|
4 Participants
n=266 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=62 Participants • 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.
|
1 Participants
n=24 Participants • 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.
|
0 Participants
n=90 Participants • 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.
|
0 Participants
n=90 Participants • 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.
|
1 Participants
n=266 Participants • 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.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=62 Participants • 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.
|
0 Participants
n=24 Participants • 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.
|
0 Participants
n=90 Participants • 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.
|
0 Participants
n=90 Participants • 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.
|
0 Participants
n=266 Participants • 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.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=62 Participants • 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.
|
0 Participants
n=24 Participants • 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.
|
0 Participants
n=90 Participants • 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.
|
0 Participants
n=90 Participants • 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.
|
0 Participants
n=266 Participants • 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.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=62 Participants • 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.
|
0 Participants
n=24 Participants • 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.
|
0 Participants
n=90 Participants • 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.
|
0 Participants
n=90 Participants • 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.
|
0 Participants
n=266 Participants • 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.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=62 Participants • 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.
|
1 Participants
n=24 Participants • 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.
|
0 Participants
n=90 Participants • 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.
|
2 Participants
n=90 Participants • 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.
|
3 Participants
n=266 Participants • 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.
|
|
Race (NIH/OMB)
White
|
2 Participants
n=62 Participants • 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.
|
11 Participants
n=24 Participants • 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.
|
16 Participants
n=90 Participants • 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.
|
12 Participants
n=90 Participants • 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.
|
41 Participants
n=266 Participants • 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.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=62 Participants • 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.
|
1 Participants
n=24 Participants • 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.
|
10 Participants
n=90 Participants • 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.
|
21 Participants
n=90 Participants • 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.
|
33 Participants
n=266 Participants • 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.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
59 Participants
n=62 Participants • 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.
|
11 Participants
n=24 Participants • 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.
|
64 Participants
n=90 Participants • 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.
|
55 Participants
n=90 Participants • 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.
|
189 Participants
n=266 Participants • 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.
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
Number of Subjects Ever Tested
Outcome measures
| Measure |
NuestraSaludSegura Intervention
n=78 Participants
Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2
NuestraSaludSegura: It blends peer navigation and mHealth
|
Delayed NuestraSaludSegura Intervention
n=79 Participants
delayed-intervention group Navegantes will be trained in Year 2
NuestraSaludSegura: It blends peer navigation and mHealth
|
|---|---|---|
|
Number of Subjects Ever Tested
|
70 Participants
|
58 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
Number of Subjects Ever Vaccinated
Outcome measures
| Measure |
NuestraSaludSegura Intervention
n=78 Participants
Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2
NuestraSaludSegura: It blends peer navigation and mHealth
|
Delayed NuestraSaludSegura Intervention
n=79 Participants
delayed-intervention group Navegantes will be trained in Year 2
NuestraSaludSegura: It blends peer navigation and mHealth
|
|---|---|---|
|
Number of Subjects Ever Vaccinated
|
66 Participants
|
64 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
Number of Subjects Up to Date on Recommended Doses
Outcome measures
| Measure |
NuestraSaludSegura Intervention
n=78 Participants
Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2
NuestraSaludSegura: It blends peer navigation and mHealth
|
Delayed NuestraSaludSegura Intervention
n=79 Participants
delayed-intervention group Navegantes will be trained in Year 2
NuestraSaludSegura: It blends peer navigation and mHealth
|
|---|---|---|
|
Number of Subjects Up to Date on Recommended Doses
|
22 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
Number of Doses Received
Outcome measures
| Measure |
NuestraSaludSegura Intervention
n=78 Participants
Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2
NuestraSaludSegura: It blends peer navigation and mHealth
|
Delayed NuestraSaludSegura Intervention
n=79 Participants
delayed-intervention group Navegantes will be trained in Year 2
NuestraSaludSegura: It blends peer navigation and mHealth
|
|---|---|---|
|
Number of Doses Received
|
2.6 Number of Doses
Standard Deviation 1.1
|
2.6 Number of Doses
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: Month 6Population: 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.
Number of Subjects Ever Tested
Outcome measures
| Measure |
NuestraSaludSegura Intervention
n=78 Participants
Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2
NuestraSaludSegura: It blends peer navigation and mHealth
|
Delayed NuestraSaludSegura Intervention
n=79 Participants
delayed-intervention group Navegantes will be trained in Year 2
NuestraSaludSegura: It blends peer navigation and mHealth
|
|---|---|---|
|
Number of Subjects Ever Tested
|
70 Participants
|
64 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: 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.
Number of Subjects Ever Vaccinated
Outcome measures
| Measure |
NuestraSaludSegura Intervention
n=78 Participants
Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2
NuestraSaludSegura: It blends peer navigation and mHealth
|
Delayed NuestraSaludSegura Intervention
n=79 Participants
delayed-intervention group Navegantes will be trained in Year 2
NuestraSaludSegura: It blends peer navigation and mHealth
|
|---|---|---|
|
Number of Subjects Ever Vaccinated
|
69 Participants
|
67 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: 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.
Number of Subjects Up to Date on Recommended Doses
Outcome measures
| Measure |
NuestraSaludSegura Intervention
n=78 Participants
Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2
NuestraSaludSegura: It blends peer navigation and mHealth
|
Delayed NuestraSaludSegura Intervention
n=79 Participants
delayed-intervention group Navegantes will be trained in Year 2
NuestraSaludSegura: It blends peer navigation and mHealth
|
|---|---|---|
|
Number of Subjects Up to Date on Recommended Doses
|
37 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: 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.
Number of Doses Received
Outcome measures
| Measure |
NuestraSaludSegura Intervention
n=78 Participants
Intervention-group Navegantes will be trained and supported for 6 months of implementation in Years 1-2
NuestraSaludSegura: It blends peer navigation and mHealth
|
Delayed NuestraSaludSegura Intervention
n=79 Participants
delayed-intervention group Navegantes will be trained in Year 2
NuestraSaludSegura: It blends peer navigation and mHealth
|
|---|---|---|
|
Number of Doses Received
|
3.0 Number of Doses
Standard Deviation 1.3
|
2.7 Number of Doses
Standard Deviation 1.0
|
Adverse Events
Aim 1: Interviews
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 1: Focus Group Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 2: NuestraSaludSegura Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 2: Delayed NuestraSaludSegura Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place