Clinical trial NCT05181657: LinkUP: COVID-19 Intervention for Underserved Populations
Official title: LinkUP: COVID-19 Intervention for Underserved Populations Participating in Parent Study Proyecto La Frontera
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motivational Interviewing
Keywords: Behavior change
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-01-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The four OnPoint syringe exchange locations will be randomized to deliver either the active (intervention) or didactic (control) version of the LinkUP intervention. The randomization scheme will be developed using an algorithm by La Frontera's statistician. Half way into enrollment, there will be a one-week 'washout' period, after which time the two original intervention syringe exchange sites will become control sites and the two original control sites will become intervention sites. This cluster randomization scheme will help ensure that no neighborhood in San Diego County is denied access to the LinkUP intervention. By the end of the study, 75 LinkUP participants will have been randomized to an intervention site and 75 will have been randomized to a control site.
Primary purpose: PREVENTION

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: COVID-19 Testing
timeFrame: Day of the Intervention; The outcome for the last participant was ascertained on June 6th, 2022.
Secondary outcomes:
measure: COVID-19 Vaccination
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: La Frontera Project
state: California
Study officials:
affiliation: University of California, San Diego
name: Steffanie Strathdee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bazzi AR, Harvey-Vera A, Buesig-Stamos T, Abramovitz D, Vera CF, Artamonova I, Patterson TL, Strathdee SA. Study protocol for a pilot randomized controlled trial to increase COVID-19 testing and vaccination among people who inject drugs in San Diego County. Addict Sci Clin Pract. 2022 Sep 5;17(1):48. doi: 10.1186/s13722-022-00328-z.