Trial Outcomes & Findings for Examining How a Facilitated Self-Sampling Intervention and Testing Navigation Intervention Influences COVID-19 Testing (NCT NCT05606016)
NCT ID: NCT05606016
Last Updated: 2026-08-26
Results Overview
Percent of participants from each study arm who complete testing (antigen or PCR)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1232 participants
Primary outcome timeframe
between baseline and 2 months after the intervention
Results posted on
2026-08-26
Participant Flow
Unit of analysis: priority block groups
Participant milestones
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Overall Study
STARTED
|
320 16
|
333 16
|
579 32
|
|
Overall Study
COMPLETED
|
204 16
|
249 16
|
397 31
|
|
Overall Study
NOT COMPLETED
|
116 0
|
84 0
|
182 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
Baseline characteristics by cohort
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=320 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=333 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=579 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
Total
n=1232 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=282 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
10 Participants
n=326 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
10 Participants
n=526 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
21 Participants
n=1134 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
|
Age, Categorical
Between 18 and 65 years
|
228 Participants
n=282 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
249 Participants
n=326 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
402 Participants
n=526 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
879 Participants
n=1134 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
|
Age, Categorical
>=65 years
|
53 Participants
n=282 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
67 Participants
n=326 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
114 Participants
n=526 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
234 Participants
n=1134 Participants • Data were not collected for 38 participants in the Facilitated Self-Sampling Intervention (FSSI) arm. Data were not collected for 7 participants in the Testing Navigation Intervention (TNI) arm. Data were not collected for 53 participants in the Control arm.
|
|
Sex: Female, Male
Female
|
204 Participants
n=320 Participants
|
233 Participants
n=333 Participants
|
337 Participants
n=579 Participants
|
774 Participants
n=1232 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=320 Participants
|
100 Participants
n=333 Participants
|
242 Participants
n=579 Participants
|
458 Participants
n=1232 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
180 Participants
n=320 Participants
|
187 Participants
n=333 Participants
|
333 Participants
n=579 Participants
|
700 Participants
n=1232 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
140 Participants
n=320 Participants
|
139 Participants
n=333 Participants
|
244 Participants
n=579 Participants
|
523 Participants
n=1232 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=320 Participants
|
7 Participants
n=333 Participants
|
2 Participants
n=579 Participants
|
9 Participants
n=1232 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=320 Participants
|
3 Participants
n=333 Participants
|
3 Participants
n=579 Participants
|
6 Participants
n=1232 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=320 Participants
|
0 Participants
n=333 Participants
|
4 Participants
n=579 Participants
|
5 Participants
n=1232 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=320 Participants
|
1 Participants
n=333 Participants
|
0 Participants
n=579 Participants
|
1 Participants
n=1232 Participants
|
|
Race (NIH/OMB)
Black or African American
|
79 Participants
n=320 Participants
|
77 Participants
n=333 Participants
|
97 Participants
n=579 Participants
|
253 Participants
n=1232 Participants
|
|
Race (NIH/OMB)
White
|
197 Participants
n=320 Participants
|
212 Participants
n=333 Participants
|
423 Participants
n=579 Participants
|
832 Participants
n=1232 Participants
|
|
Race (NIH/OMB)
More than one race
|
32 Participants
n=320 Participants
|
33 Participants
n=333 Participants
|
36 Participants
n=579 Participants
|
101 Participants
n=1232 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=320 Participants
|
7 Participants
n=333 Participants
|
16 Participants
n=579 Participants
|
34 Participants
n=1232 Participants
|
|
Region of Enrollment
United States
|
320 participants
n=320 Participants
|
333 participants
n=333 Participants
|
579 participants
n=579 Participants
|
1232 participants
n=1232 Participants
|
PRIMARY outcome
Timeframe: between baseline and 2 months after the interventionPercent of participants from each study arm who complete testing (antigen or PCR)
Outcome measures
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=204 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=249 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=397 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Number of Participants Who Complete Testing (Antigen or PCR)
|
38 Participants
|
41 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: baselineAppropriate use of antigen test is defined as taking the test when a test should have been taken (that is, symptoms present, known exposure to COVID).
Outcome measures
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=320 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=333 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=579 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Number of Participants Who Appropriately Used Antigen Test as Assessed by Survey
|
15 Participants
|
15 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 2 months after the interventionAppropriate use of antigen test is defined as taking the test when a test should have been taken (that is, symptoms present, known exposure to COVID).
Outcome measures
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=38 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=41 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=46 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Number of Participants Who Appropriately Used Antigen Test as Assessed by Survey
|
30 Participants
|
24 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: baselinePopulation: Data were not collected for this outcome measure because the relevant questions were inadvertently omitted from the questionnaire. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure. Alternative data collected are reported in the Outcome Measure titled "Number of Participants Who Has Ever Tested Positive for COVID-19"
Mitigation measures include mask wearing, isolating and notifying close contacts.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 months after the interventionPopulation: Data were not collected for this outcome measure because the relevant questions were inadvertently omitted from the questionnaire. Data collection and analysis for this outcome measure will not be conducted in the future. Therefore, no participants were measured or analyzed for this outcome measure.
Mitigation measures include mask wearing, isolating and notifying close contacts.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baselineTesting is needed for those with symptoms or known exposure to COVID.
Outcome measures
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=320 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=333 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=579 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Number of Participants Who Share Antigen Tests With Close Contacts Who Need to Test as Assessed by Survey
|
35 Participants
|
30 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 2 months after the interventionTesting is needed for those with symptoms or known exposure to COVID.
Outcome measures
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=204 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=249 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=397 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Number of Participants Who Share Antigen Tests With Close Contacts Who Need to Test as Assessed by Survey
|
32 Participants
|
26 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=204 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=249 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=397 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Number of Participants Who Tested Positive for COVID-19 in the Past 30 Days
|
91 Participants
|
129 Participants
|
212 Participants
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=204 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=249 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=397 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Number of Participants Vaccinated Against COVID-19
|
148 Participants
|
168 Participants
|
292 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data was only collected from participants who provided a response.
The percentage of individuals within each participant's self-identified community network who have tested positive for COVID-19. Participants provide a list of individuals they regularly communicate with (community network). The percentage is calculated for each participant as: (Number of community members reported positive for COVID-19 ÷ Total number of community members listed) × 100. Higher percentages indicate greater COVID-19 exposure within the participant's community network.
Outcome measures
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=119 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=137 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=313 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Percentage of Community Members Reported to Have Tested Positive for COVID-19
|
36.3 percentage of community members
Standard Deviation 47
|
39.9 percentage of community members
Standard Deviation 47
|
28.1 percentage of community members
Standard Deviation 44.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data was only collected from participants who provided a response.
The percentage of individuals within each participant's self-identified community network who are reported to be vaccinated against COVID-19. Participants provide a list of individuals they regularly communicate with (community network). The percentage is calculated for each participant as: (Number of community members reported to be vaccinated against COVID-19 ÷ Total number of community members listed) × 100. Higher percentages indicate greater COVID-19 vaccination coverage within the participant's community network.
Outcome measures
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=119 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=137 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=313 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Percentage of Community Members Reported to Be Vaccinated Against COVID-19
|
36.3 percentage of community members
Standard Deviation 47
|
39.9 percentage of community members
Standard Deviation 47.1
|
28.1 percentage of community members
Standard Deviation 44.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data was only collected from participants who answered the question.
Trust in national government COVID-19 information was assessed using the survey question: "What level of trust do you have in the information about COVID-19 from your national government?. Responses were reported on a 5 point likert scale ranging from 1 (none at all) to 5(a great deal), a higher score indicating greater trust.
Outcome measures
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=204 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=232 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=358 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Number of Participants Reporting Trust in National Government Regarding COVID-19 Information
|
2.94 score on a scale
Standard Deviation 1.38
|
3.13 score on a scale
Standard Deviation 1.26
|
3.94 score on a scale
Standard Deviation 1.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
| Measure |
Facilitated Self-Sampling Intervention (FSSI)
n=320 Participants
Participants in the FSSI arm will receive education on COVID-19 testing and be provided with rapid antigen tests. Participants will also receive pre and post surveys.
Facilitated Self-Sampling Intervention (FSSI): CHWs will consent and enroll participants to the FSSI from the randomized PBGs. FSSI will consist of Community Health Worker (CHW) delivered education intervention about COVID-19 testing at a home visit. In addition, the participant will receive a batch of 4 rapid antigen tests which can be shared with people in the household or other close contacts if needed. The CHWs will provide low-literacy instructions for administering the tests, including print and video. The CHWs will also provide guidance if they tested positive (e.g. quarantine, notify contacts, wearing a mask). The CHWs will also be available by phone to the participants for any follow-up questions. CHW will follow-up via text and phone with the participants during the two months post intervention. In addition to the intervention, the participants will be asked to complete the pre and post test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Testing Navigation Intervention (TNI).
n=333 Participants
Participants in the TNI arm will receive COVID-19 testing education and be navigated to PCR testing sites. Participants will also receive pre and post surveys.
Testing Navigation Intervention (TNI).: CHWs will consent and enroll participants to the TNI from the randomized PBGs. The TNI will consist of CHW-led intervention at a home visit where they will provide low health literacy materials about how and when to conduct a COVID 19 test (including antigen and PCR) using a decision tree model and provide navigation to nearby PCR testing sites, locations to purchase antigen tests and support in accessing federal government antigen tests if not already obtained by the participant. In addition to the intervention, the participants will be asked to complete the pre and post-test surveys. Post surveys will be administered online or over the phone two months after the initial intervention.
|
Control
n=579 Participants
Participants in the Control Group arm will receive a CDC-designed COVID-19 testing brochures, and pre and post surveys only.
Control: Participants in the Control arm will receive CDC-designed COVID-19 testing brochures, and pre and post surveys only.
|
|---|---|---|---|
|
Number of Participants Who Has Ever Tested Positive for COVID-19
|
144 Participants
|
165 Participants
|
275 Participants
|
Adverse Events
Facilitated Self-Sampling Intervention (FSSI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Testing Navigation Intervention (TNI).
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Maria E Fernandez, PhD
The University of Texas Health Science Center at Houston
Phone: 713-500-9626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place