Trial Outcomes & Findings for LinkUP: COVID-19 Intervention for Underserved Populations (NCT NCT05181657)
NCT ID: NCT05181657
Last Updated: 2024-02-21
Results Overview
Number of participants who agreed to and received onsite a COVID test right after receiving the intervention (i.e., same day as the intervention)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Day of the Intervention; The outcome for the last participant was ascertained on June 6th, 2022.
Results posted on
2024-02-21
Participant Flow
PWID, ≥18 years old, San Diego County residents who had not recently undergone voluntary COVID-19 testing were referred to mobile SSP sites. We randomized the 12 weeks of study implementation to involve either intervention or didactic-control condition administration (i.e., the study team administered the condition allocated to each particular week, regardless of SSP site). Counselors offered on-site rapid COVID-19 antigen testing. The LinkUP pilot RCT was conducted from March-June, 2022.
Unit of analysis: weeks
Participant milestones
| Measure |
LinkUP Active Intervention
The counselor will present basic evidence-based COVID-19 information on SARS-CoV-2 biology and epidemiology, testing and the safety and efficacy of available COVID-19 vaccines. The counselor will also address COVID-19 misinformation (e.g., that COVID is no worse than the flu), and COVID-19 disinformation (e.g., that COVID vaccines include a tracking device).
The LinkUP active intervention combines education, motivational interviewing (MI), problem-solving, and ongoing support from peer counselors. Through an open discussion with one of OnPoint's peer counselors who are trained in MI, the counselor will present evidence-based COVID-19 information. Next, the counselor will attempt to identify the participant's concerns about COVID-19 and vaccination in an attempt to tip their decisional balance.
COVID-19 education: This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.
|
LinkUP Control Condition (Didactic Intervention)
As described above, the control condition is a one-way sharing of COVID-19 information presented by an OnPoint counselor. The counselor will be instructed to answer any questions the participant may have but will not engage in motivational interviewing counseling. The same educational materials used in the LinkUP intervention module will be used for this session and it will be completed within 45 minutes.
COVID-19 education: This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.
|
|---|---|---|
|
Overall Study
STARTED
|
75 5
|
75 7
|
|
Overall Study
Enrollment at the End of Week 1
|
0 0
|
7 1
|
|
Overall Study
Enrollment at the End of Week 2
|
4 1
|
7 1
|
|
Overall Study
Enrollment at the End of Week 3
|
4 1
|
11 2
|
|
Overall Study
Enrollment at the End of Week 4
|
22 2
|
11 2
|
|
Overall Study
Enrollment at the End of Week 5
|
22 2
|
23 3
|
|
Overall Study
Enrollment at the End of Week 6
|
39 3
|
23 3
|
|
Overall Study
Enrollment at the End of Week 7
|
39 3
|
39 4
|
|
Overall Study
Enrollment at the End of Week 8
|
50 4
|
39 4
|
|
Overall Study
Enrollment at the End of Week 9
|
50 4
|
60 5
|
|
Overall Study
Enrollment at the End of Week 10
|
75 5
|
60 5
|
|
Overall Study
Enrollment at the End of Week 11
|
75 5
|
72 6
|
|
Overall Study
Enrollment at the End of Week 12
|
75 5
|
75 7
|
|
Overall Study
COMPLETED
|
75 5
|
75 7
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LinkUP: COVID-19 Intervention for Underserved Populations
Baseline characteristics by cohort
| Measure |
LinkUP Active Intervention
n=75 Participants
The counselor will present basic evidence-based COVID-19 information on SARS-CoV-2 biology and epidemiology, testing and the safety and efficacy of available COVID-19 vaccines. The counselor will also address COVID-19 misinformation (e.g., that COVID is no worse than the flu), and COVID-19 disinformation (e.g., that COVID vaccines include a tracking device).
The LinkUP active intervention combines education, motivational interviewing (MI), problem-solving, and ongoing support from peer counselors. Through an open discussion with one of OnPoint's peer counselors who are trained in MI, the counselor will present evidence-based COVID-19 information. Next, the counselor will attempt to identify the participant's concerns about COVID-19 and vaccination in an attempt to tip their decisional balance.
COVID-19 education: This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.
|
LinkUP Control Condition (Didactic Intervention)
n=75 Participants
As described above, the control condition is a one-way sharing of COVID-19 information presented by an OnPoint counselor. The counselor will be instructed to answer any questions the participant may have but will not engage in motivational interviewing counseling. The same educational materials used in the LinkUP intervention module will be used for this session and it will be completed within 45 minutes.
COVID-19 education: This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.0 Years
n=5 Participants
|
45.0 Years
n=7 Participants
|
40.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
75 participants
n=7 Participants
|
150 participants
n=5 Participants
|
|
COVID-19 self-reported testing at baseline
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
On a scale of 1 to 10, how worried are you about getting COVID-19 (or getting it again)?
|
5.0 units on a scale
n=5 Participants
|
3.0 units on a scale
n=7 Participants
|
4.0 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of the Intervention; The outcome for the last participant was ascertained on June 6th, 2022.Number of participants who agreed to and received onsite a COVID test right after receiving the intervention (i.e., same day as the intervention)
Outcome measures
| Measure |
LinkUP Active Intervention
n=75 Participants
The counselor will present basic evidence-based COVID-19 information on SARS-CoV-2 biology and epidemiology, testing and the safety and efficacy of available COVID-19 vaccines. The counselor will also address COVID-19 misinformation (e.g., that COVID is no worse than the flu), and COVID-19 disinformation (e.g., that COVID vaccines include a tracking device).
The LinkUP active intervention combines education, motivational interviewing (MI), problem-solving, and ongoing support from peer counselors. Through an open discussion with one of OnPoint's peer counselors who are trained in MI, the counselor will present evidence-based COVID-19 information. Next, the counselor will attempt to identify the participant's concerns about COVID-19 and vaccination in an attempt to tip their decisional balance.
COVID-19 education: This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.
|
LinkUP Control Condition (Didactic Intervention)
n=75 Participants
As described above, the control condition is a one-way sharing of COVID-19 information presented by an OnPoint counselor. The counselor will be instructed to answer any questions the participant may have but will not engage in motivational interviewing counseling. The same educational materials used in the LinkUP intervention module will be used for this session and it will be completed within 45 minutes.
COVID-19 education: This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.
|
|---|---|---|
|
COVID-19 Testing
|
69 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: PWID in San Diego County who Participated in the Link-UP Intervention
Received ≥ one COVID shot within 6 months of intervention COVID-19 vaccination: Before trial started, SSP determined that limited staffing capacity to offer vaccination and addressing potential adverse events prevented this secondary outcome to be measured. Study participants were provided with referrals to community vaccine clinics throughout the County.
Outcome measures
| Measure |
LinkUP Active Intervention
n=65 Participants
The counselor will present basic evidence-based COVID-19 information on SARS-CoV-2 biology and epidemiology, testing and the safety and efficacy of available COVID-19 vaccines. The counselor will also address COVID-19 misinformation (e.g., that COVID is no worse than the flu), and COVID-19 disinformation (e.g., that COVID vaccines include a tracking device).
The LinkUP active intervention combines education, motivational interviewing (MI), problem-solving, and ongoing support from peer counselors. Through an open discussion with one of OnPoint's peer counselors who are trained in MI, the counselor will present evidence-based COVID-19 information. Next, the counselor will attempt to identify the participant's concerns about COVID-19 and vaccination in an attempt to tip their decisional balance.
COVID-19 education: This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.
|
LinkUP Control Condition (Didactic Intervention)
n=70 Participants
As described above, the control condition is a one-way sharing of COVID-19 information presented by an OnPoint counselor. The counselor will be instructed to answer any questions the participant may have but will not engage in motivational interviewing counseling. The same educational materials used in the LinkUP intervention module will be used for this session and it will be completed within 45 minutes.
COVID-19 education: This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.
|
|---|---|---|
|
COVID-19 Vaccination
|
15 Participants
|
12 Participants
|
Adverse Events
LinkUP Active Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LinkUP Control Condition (Didactic Intervention)
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
Dr. Steffanie Strathdee
University of California, San Diego
Phone: 858-822-1952
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place