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

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

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

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 participant

Network tested is measured at the participant level by the number of network members that are tested through the SNS.

Outcome measures

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 participant

Number vaccinated is measured at the participant level by the number of study participants that are vaccinated through the SNS.

Outcome measures

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

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

Dr. John Schneider

The University of Chicago

Phone: (773) 702-2453

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place