Trial Outcomes & Findings for Social Network Diffusion of COVID-19 Prevention for Diverse Criminal Legal Involved Communities (NCT NCT05500274)
NCT ID: NCT05500274
Last Updated: 2025-05-18
Results Overview
Number of participants with at least one test within 3 months of baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
778 participants
Primary outcome timeframe
3 months
Results posted on
2025-05-18
Participant Flow
A total of 1235 participants were screened, 936 were eligible, and 778 consented. Baseline surveys could be completed remotely, but intervention sessions required in-person attendance. Randomization occurred only when participants were physically present. Some participants did not attend due to scheduling conflicts and were not randomized.
Participant milestones
| Measure |
Education Arm
The Education condition will include COVID-19 prevention messaging and an interactive activity reinforcing the messages. Testimonial videos will be played including those that describe the testing experience and motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors.
Education: Testimonial videos will be played including those that describe the testing experience and their motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors. The self-affirmation activity will always precede the presentation of the testimonial videos as leading with misinformation correction can be construed by some as a threat to one's self-adequacy.
|
Motivational Arm
Study participants randomized to the Motivational Intervention will receive the intervention using a social network diffusion approach. This is a Type I network intervention that includes specific training on mobilization of network members. The Motivational intervention will be based upon a previous workshop divided into four learning and practice modules.
Motivational: This is a Type I network intervention that includes specific training on mobilization of network members. Training occurs in a group-based setting of 8-10 enrolled participants facilitated by a community facilitator and Motivational Interviewing trained interventionist. At 30 days, a 15-20-minute phone booster communication session reinforces the intervention content
|
|---|---|---|
|
Overall Study
STARTED
|
378
|
400
|
|
Overall Study
COMPLETED
|
295
|
334
|
|
Overall Study
NOT COMPLETED
|
83
|
66
|
Reasons for withdrawal
| Measure |
Education Arm
The Education condition will include COVID-19 prevention messaging and an interactive activity reinforcing the messages. Testimonial videos will be played including those that describe the testing experience and motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors.
Education: Testimonial videos will be played including those that describe the testing experience and their motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors. The self-affirmation activity will always precede the presentation of the testimonial videos as leading with misinformation correction can be construed by some as a threat to one's self-adequacy.
|
Motivational Arm
Study participants randomized to the Motivational Intervention will receive the intervention using a social network diffusion approach. This is a Type I network intervention that includes specific training on mobilization of network members. The Motivational intervention will be based upon a previous workshop divided into four learning and practice modules.
Motivational: This is a Type I network intervention that includes specific training on mobilization of network members. Training occurs in a group-based setting of 8-10 enrolled participants facilitated by a community facilitator and Motivational Interviewing trained interventionist. At 30 days, a 15-20-minute phone booster communication session reinforces the intervention content
|
|---|---|---|
|
Overall Study
Not able to complete the session and follow-up visits.
|
7
|
15
|
|
Overall Study
Lost to Follow-up
|
76
|
51
|
Baseline Characteristics
Social Network Diffusion of COVID-19 Prevention for Diverse Criminal Legal Involved Communities
Baseline characteristics by cohort
| Measure |
Education Arm
n=378 Participants
The Education condition will include COVID-19 prevention messaging and an interactive activity reinforcing the messages. Testimonial videos will be played including those that describe the testing experience and motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors.
Education: Testimonial videos will be played including those that describe the testing experience and their motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors. The self-affirmation activity will always precede the presentation of the testimonial videos as leading with misinformation correction can be construed by some as a threat to one's self-adequacy.
|
Motivational Arm
n=400 Participants
Study participants randomized to the Motivational Intervention will receive the intervention using a social network diffusion approach. This is a Type I network intervention that includes specific training on mobilization of network members. The Motivational intervention will be based upon a previous workshop divided into four learning and practice modules.
Motivational: This is a Type I network intervention that includes specific training on mobilization of network members. Training occurs in a group-based setting of 8-10 enrolled participants facilitated by a community facilitator and Motivational Interviewing trained interventionist. At 30 days, a 15-20-minute phone booster communication session reinforces the intervention content
|
Total
n=778 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 14.7 • n=93 Participants
|
42.5 years
STANDARD_DEVIATION 14.5 • n=4 Participants
|
42.9 years
STANDARD_DEVIATION 14.6 • n=27 Participants
|
|
Sex/Gender, Customized
Male
|
156 Participants
n=93 Participants
|
193 Participants
n=4 Participants
|
349 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Female
|
180 Participants
n=93 Participants
|
181 Participants
n=4 Participants
|
361 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Intersex
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Unknown, Refused, or Missing
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
61 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
128 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
317 Participants
n=93 Participants
|
333 Participants
n=4 Participants
|
650 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
48 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
109 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
316 Participants
n=93 Participants
|
334 Participants
n=4 Participants
|
650 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
COVID-19 Testing
|
378 Participants
n=93 Participants
|
400 Participants
n=4 Participants
|
778 Participants
n=27 Participants
|
|
COVID-19 Vaccination
|
378 Participants
n=93 Participants
|
400 Participants
n=4 Participants
|
778 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 monthsNumber of participants with at least one test within 3 months of baseline.
Outcome measures
| Measure |
Education Arm
n=378 Participants
The Education condition will include COVID-19 prevention messaging and an interactive activity reinforcing the messages. Testimonial videos will be played including those that describe the testing experience and motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors.
Education: Testimonial videos will be played including those that describe the testing experience and their motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors. The self-affirmation activity will always precede the presentation of the testimonial videos as leading with misinformation correction can be construed by some as a threat to one's self-adequacy.
|
Motivational Arm
n=400 Participants
Study participants randomized to the Motivational Intervention will receive the intervention using a social network diffusion approach. This is a Type I network intervention that includes specific training on mobilization of network members. The Motivational intervention will be based upon a previous workshop divided into four learning and practice modules.
Motivational: This is a Type I network intervention that includes specific training on mobilization of network members. Training occurs in a group-based setting of 8-10 enrolled participants facilitated by a community facilitator and Motivational Interviewing trained interventionist. At 30 days, a 15-20-minute phone booster communication session reinforces the intervention content
|
|---|---|---|
|
COVID-19 Testing
|
378 Participants
|
400 Participants
|
PRIMARY outcome
Timeframe: 3 monthsNumber of participants receiving at least one vaccination within 3 months of baseline.
Outcome measures
| Measure |
Education Arm
n=378 Participants
The Education condition will include COVID-19 prevention messaging and an interactive activity reinforcing the messages. Testimonial videos will be played including those that describe the testing experience and motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors.
Education: Testimonial videos will be played including those that describe the testing experience and their motivations for testing. This approach combines self-affirmation with misinformation correction to take advantage of the ability to promote adaptive COVID-19 prevention behaviors. The self-affirmation activity will always precede the presentation of the testimonial videos as leading with misinformation correction can be construed by some as a threat to one's self-adequacy.
|
Motivational Arm
n=400 Participants
Study participants randomized to the Motivational Intervention will receive the intervention using a social network diffusion approach. This is a Type I network intervention that includes specific training on mobilization of network members. The Motivational intervention will be based upon a previous workshop divided into four learning and practice modules.
Motivational: This is a Type I network intervention that includes specific training on mobilization of network members. Training occurs in a group-based setting of 8-10 enrolled participants facilitated by a community facilitator and Motivational Interviewing trained interventionist. At 30 days, a 15-20-minute phone booster communication session reinforces the intervention content
|
|---|---|---|
|
COVID-19 Vaccination
|
378 Participants
|
400 Participants
|
Adverse Events
Education Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Motivational Arm
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