Trial Outcomes & Findings for Community Network-driven COVID-19 Testing and Vaccination of Vulnerable Populations in the Central US (NCT NCT04743908)
NCT ID: NCT04743908
Last Updated: 2024-10-10
Results Overview
Network tested is measured at the participant level by the number of network members that are tested through the SNS.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1328 participants
Primary outcome timeframe
21 days from initial study visit for each participant
Results posted on
2024-10-10
Participant Flow
Participant milestones
| Measure |
Social Network Strategy (SNS Condition)
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walkthrough and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared.
|
Social Network Strategy + Messaging
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walk through and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared. Finally, community developed COVID-19 public health messages will be shared in the participant's preferred language.
Social Network Strategy + COVID-19 messaging: Contextually adapted and theory-driven messages - misinformation correction and self-affirmation - to increase awareness, self-efficacy and community engagement in our adapted Social Network testing Strategy (SNS). SNS is an evidence-based testing intervention that has been widely used in multiple settings with marginalized individuals (ie substance-users) who facilitate the recruitment of their social contacts into testing services.
|
|---|---|---|
|
Overall Study
STARTED
|
661
|
667
|
|
Overall Study
COMPLETED
|
478
|
485
|
|
Overall Study
NOT COMPLETED
|
183
|
182
|
Reasons for withdrawal
| Measure |
Social Network Strategy (SNS Condition)
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walkthrough and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared.
|
Social Network Strategy + Messaging
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walk through and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared. Finally, community developed COVID-19 public health messages will be shared in the participant's preferred language.
Social Network Strategy + COVID-19 messaging: Contextually adapted and theory-driven messages - misinformation correction and self-affirmation - to increase awareness, self-efficacy and community engagement in our adapted Social Network testing Strategy (SNS). SNS is an evidence-based testing intervention that has been widely used in multiple settings with marginalized individuals (ie substance-users) who facilitate the recruitment of their social contacts into testing services.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
181
|
180
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Community Network-driven COVID-19 Testing and Vaccination of Vulnerable Populations in the Central US
Baseline characteristics by cohort
| Measure |
Social Network Strategy (SNS Condition)
n=661 Participants
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walkthrough and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared.
|
Social Network Strategy + Messaging
n=667 Participants
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walk through and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared. Finally, community developed COVID-19 public health messages will be shared in the participant's preferred language.
Social Network Strategy + COVID-19 messaging: Contextually adapted and theory-driven messages - misinformation correction and self-affirmation - to increase awareness, self-efficacy and community engagement in our adapted Social Network testing Strategy (SNS). SNS is an evidence-based testing intervention that has been widely used in multiple settings with marginalized individuals (ie substance-users) who facilitate the recruitment of their social contacts into testing services.
|
Total
n=1328 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 14.8 • n=99 Participants
|
39.7 years
STANDARD_DEVIATION 14.4 • n=107 Participants
|
39.6 years
STANDARD_DEVIATION 14.6 • n=206 Participants
|
|
Sex/Gender, Customized
Assigned Sex at Birth · Female
|
353 Participants
n=99 Participants
|
328 Participants
n=107 Participants
|
681 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Assigned Sex at Birth · Male
|
296 Participants
n=99 Participants
|
329 Participants
n=107 Participants
|
625 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Assigned Sex at Birth · Intersex
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Assigned Sex at Birth · Unknown, Refused, or Missing
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
213 Participants
n=99 Participants
|
217 Participants
n=107 Participants
|
430 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
427 Participants
n=99 Participants
|
429 Participants
n=107 Participants
|
856 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
256 Participants
n=99 Participants
|
273 Participants
n=107 Participants
|
529 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
220 Participants
n=99 Participants
|
237 Participants
n=107 Participants
|
457 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
31 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
130 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
244 Participants
n=206 Participants
|
|
Self-Reported COVID-19 Tests at Baseline
Yes, participant had been tested for COVID-19 prior to baseline.
|
530 Participants
n=99 Participants
|
519 Participants
n=107 Participants
|
1049 Participants
n=206 Participants
|
|
Self-Reported COVID-19 Tests at Baseline
No, participant had not been tested for COVID-19 prior to baseline.
|
118 Participants
n=99 Participants
|
135 Participants
n=107 Participants
|
253 Participants
n=206 Participants
|
|
Self-Reported COVID-19 Tests at Baseline
Don't know, participant did not know if they been tested for COVID-19 prior to baseline.
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Self-Reported COVID-19 Tests at Baseline
Missing
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Self-Reported COVID-19 Vaccination at Baseline
Yes, participant reported that they have been vaccinated for COVID-19
|
479 Participants
n=99 Participants
|
471 Participants
n=107 Participants
|
950 Participants
n=206 Participants
|
|
Self-Reported COVID-19 Vaccination at Baseline
No, participant reported that they have not been vaccinated for COVID-19
|
173 Participants
n=99 Participants
|
182 Participants
n=107 Participants
|
355 Participants
n=206 Participants
|
|
Self-Reported COVID-19 Vaccination at Baseline
Don't know, participant didn't know whether they had been vaccinated for COVID-19
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Self-Reported COVID-19 Vaccination at Baseline
Missing
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 21 days from initial study visit for each participantNetwork tested is measured at the participant level by the number of network members that are tested through the SNS.
Outcome measures
| Measure |
Social Network Strategy (SNS Condition)
n=661 Participants
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walkthrough and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared.
|
Social Network Strategy + Messaging
n=667 Participants
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walk through and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared. Finally, community developed COVID-19 public health messages will be shared in the participant's preferred language.
Social Network Strategy + COVID-19 messaging: Contextually adapted and theory-driven messages - misinformation correction and self-affirmation - to increase awareness, self-efficacy and community engagement in our adapted Social Network testing Strategy (SNS). SNS is an evidence-based testing intervention that has been widely used in multiple settings with marginalized individuals (ie substance-users) who facilitate the recruitment of their social contacts into testing services.
|
|---|---|---|
|
Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested).
Tested
|
444 Participants
|
437 Participants
|
|
Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested).
Not Tested
|
196 Participants
|
206 Participants
|
|
Total Number of Tests Among Network Members Referred for COVID Testing (Network Tested).
Missing Testing Data
|
21 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: 21 days from initial study visit for each participantNumber vaccinated is measured at the participant level by the number of study participants that are vaccinated through the SNS.
Outcome measures
| Measure |
Social Network Strategy (SNS Condition)
n=182 Participants
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walkthrough and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared.
|
Social Network Strategy + Messaging
n=196 Participants
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walk through and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared. Finally, community developed COVID-19 public health messages will be shared in the participant's preferred language.
Social Network Strategy + COVID-19 messaging: Contextually adapted and theory-driven messages - misinformation correction and self-affirmation - to increase awareness, self-efficacy and community engagement in our adapted Social Network testing Strategy (SNS). SNS is an evidence-based testing intervention that has been widely used in multiple settings with marginalized individuals (ie substance-users) who facilitate the recruitment of their social contacts into testing services.
|
|---|---|---|
|
Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated)
Missing, Unknown, or Refused
|
83 Participants
|
75 Participants
|
|
Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated)
Vaccinated
|
18 Participants
|
27 Participants
|
|
Total Number of Vaccinations Among Study Participants Given COVID Vaccine Information (Number Vaccinated)
Not Vaccinated
|
81 Participants
|
94 Participants
|
Adverse Events
Social Network Strategy (SNS Condition)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Social Network Strategy + Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Social Network Strategy (SNS Condition)
n=661 participants at risk
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walkthrough and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared.
|
Social Network Strategy + Messaging
n=667 participants at risk
Study staff will describe the Social Network Strategy, construct a plan for successfully referring network members into the study, and discuss compensation for the recruitment efforts. Study staff will specifically discuss network members of interest: "friend, family, coworker or someone you spend time with on a regular basis". Walk through and scenario play will be strategies to assist with planning regarding: (1) how the conversation will be raised, (2) how potential barriers to testing will be addressed, (3) how the screening by phone or web survey will be conducted, (4) how network members will have the option to bring others into the study visit with them, (5) what information about the study will be shared. Finally, community developed COVID-19 public health messages will be shared in the participant's preferred language.
Social Network Strategy + COVID-19 messaging: Contextually adapted and theory-driven messages - misinformation correction and self-affirmation - to increase awareness, self-efficacy and community engagement in our adapted Social Network testing Strategy (SNS). SNS is an evidence-based testing intervention that has been widely used in multiple settings with marginalized individuals (ie substance-users) who facilitate the recruitment of their social contacts into testing services.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.15%
1/661 • 21 days from initial study visit for each participant
|
0.00%
0/667 • 21 days from initial study visit for each participant
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place