Trial Outcomes & Findings for Creating a Sustainable Infrastructure for SARS-CoV-2 Testing (COVID-19) at Syringe Exchange Programs (NCT NCT04852848)
NCT ID: NCT04852848
Last Updated: 2023-06-06
Results Overview
Binary outcome, yes/no participated in COVID-19 tested, reported by CLIA laboratory
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
205 participants
Primary outcome timeframe
Immediately post-intervention assessment of whether clients participated in COVID-19 testing following either the brief intervention or services as usual
Results posted on
2023-06-06
Participant Flow
Participant milestones
| Measure |
Connect2Test Intervention
A brief MI intervention to motivate individuals to participate in COVID-19 testing after receiving syringe exchange services
Connect2Test Intervention: Brief assessment based feedback and motivational interviewing intervention
|
Control
Services as usual
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
100
|
|
Overall Study
COMPLETED
|
105
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Creating a Sustainable Infrastructure for SARS-CoV-2 Testing (COVID-19) at Syringe Exchange Programs
Baseline characteristics by cohort
| Measure |
Connect2Test Intervention
n=105 Participants
A brief MI intervention to motivate individuals to participate in COVID-19 testing after receiving syringe exchange services
Connect2Test Intervention: Brief assessment based feedback and motivational interviewing intervention
|
Control
n=100 Participants
Services as usual
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 13.6 • n=93 Participants
|
42.9 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
43.1 years
STANDARD_DEVIATION 18.6 • n=27 Participants
|
|
Sex/Gender, Customized
Man
|
65 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
125 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Woman
|
29 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Sex/Gender, Customized
Other or Unknown
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
123 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=93 Participants
|
100 participants
n=4 Participants
|
205 participants
n=27 Participants
|
|
Participants Tested Previously for SARS-CoV-2
|
78 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
144 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Immediately post-intervention assessment of whether clients participated in COVID-19 testing following either the brief intervention or services as usualBinary outcome, yes/no participated in COVID-19 tested, reported by CLIA laboratory
Outcome measures
| Measure |
Connect2Test Intervention
n=105 Participants
A brief MI intervention to motivate individuals to participate in COVID-19 testing after receiving syringe exchange services
Connect2Test Intervention: Brief assessment based feedback and motivational interviewing intervention
|
Control
n=100 Participants
Services as usual
|
|---|---|---|
|
Individual Participation in COVID-19 Testing
|
25 Participants
|
21 Participants
|
Adverse Events
Connect2Test Intervention
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
Anne Marie Mauricio, Research Associate Professor
University of Oregon
Phone: 602-920-7459
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place