LinkUP: COVID-19 Intervention for Underserved Populations

Motivational Interviewing Clinical Trial

Official title:

LinkUP: COVID-19 Intervention for Underserved Populations Participating in Parent Study Proyecto La Frontera

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181657
• Other study ID #: LinkUP
• Secondary ID: R01DA049644
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the present study is to evaluate a pilot intervention (LinkUP) to improve the uptake of COVID-19 testing and vaccination among PWID in San Diego County. Results will be shared with RADxUP consortium members, policymakers and program planners in California and across the US and used to estimate effect sizes for a future efficacy trial. Our study will inform efforts to leverage any of the 185 SSPs around the US as 'touchpoints' to reach marginalized communities, strengthening the nation's pandemic preparedness infrastructure to reduce COVID-19 health disparities.

Description:

Together with our community partner, the Harm Reduction Coalition of San Diego's (HRCSD) OnPoint, a mobile safe syringe program (SSP), we will evaluate develop and evaluate an intervention to improve uptake of COVID-19 testing and vaccination. HRCSD's OnPoint will rely on UCSD's IRB review and approval for all aspects related to oversight of study and intervention implementation. Completion of primary endpoint data analyses was achieved on April 13, 2023. Study final completion date is January 31, 2024. Our Study Aims are :

1. To adapt an existing behavioral intervention incorporating motivational interviewing (MI) to improve uptake of HIV pre-exposure prophylaxis among people who inject drugs (PWID), by replacing the educational content with information intended to improve uptake of COVID19 testing and COVID19 vaccination.

2. To pilot test the intervention in Aim 1 (called LinkUP) at OnPoint's 4 mobile SSP locations across San Diego County. We expect that the LinkUP intervention will be acceptable to PWID and considered feasible and sustainable by OnPoint staff and the project's Community Scientific Advisory Board (CSAB).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 31, 2024
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Enrolled in La Frontera,

AND

2. Report NOT having been voluntarily tested for COVID-19 outside of La Frontera or report having had a mandatory COVID-19 test more than 2 months ago

AND

3. a) Never vaccinated OR b) Received 1 shot of the Moderna vaccine (>=1 month ago) OR c) received 1 shot of the Pfizer vaccine (>=3 weeks ago) OR d) received 1 shot of the Jenssen vaccine (>=2 months ago) OR e) received 2 shots of the Moderna OR Pfizer vaccine (last shot >=5 months ago) OR f) received 1 shot of another vaccine (>=1 month ago) OR g) received 2 shots of another vaccine (last shot >=5 months ago). NOTE: participants who indicate that they were vaccinated but don't remember what vaccine they received would fall under the f category if they only received one shot and under the g category if they received 2 shots.

OR

4. Enrolled in La Frontera AND report TWO or more of the following symptoms: a) new loss of smell or taste, b) cough, c) sore throat/congestion/runny nose, d) skin rash within the last week without having tested positive for COVID within the last month.

OR

5. Enrolled in La Frontera AND report having EITHER fever/chills OR shortness of breath within the last week without having tested positive for COVID within the last month.

Exclusion Criteria

1. Not enrolled in La Frontera,

AND

2. Report having been voluntarily tested for COVID-19 outside of La Frontera or report having had a mandatory COVID-19 test less than 2 months ago

AND

3. a) Be vaccinated OR b) Received 1 shot of the Moderna vaccine (<1 month ago) OR c) received 1 shot of the Pfizer vaccine (<3 weeks ago) OR d) received 1 shot of the Jenssen vaccine (<2 months ago) OR e) received 2 shots of the Moderna OR Pfizer vaccine (last shot <5 months ago) OR f) received 1 shot of another vaccine (<1 month ago) OR g) received 2 shots of another vaccine (last shot <5 months ago). NOTE: participants who indicate that they were vaccinated but don't remember what vaccine they received would fall under the f category if they only received one shot and under the g category if they received 2 shots.

OR

4. Not enrolled in La Frontera AND do NOT report TWO or more of the following symptoms:

a) new loss of smell or taste, b) cough, c) sore throat/congestion/runny nose, d) skin rash within the last week without having tested positive for COVID within the last month.

OR

5. Not enrolled in La Frontera AND do NOT report having EITHER fever/chills OR shortness of breath within the last week without having tested positive for COVID within the last month.

Related Conditions & MeSH terms

• Motivational Interviewing

Intervention

Behavioral:
• COVID-19 education
This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.

Locations

Country	Name	City	State
United States	La Frontera Project	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 Testing	Number of participants who agreed to and received onsite a COVID test right after receiving the intervention (i.e., same day as the intervention)	Day of the Intervention; The outcome for the last participant was ascertained on June 6th, 2022.
Secondary	COVID-19 Vaccination	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.	6 months