LinkUP: COVID-19 Intervention for Underserved Populations

Study Overview
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Brief Summary
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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
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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. Our Study Aims are : 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. 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).

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

Conditions
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Motivational Interviewing

Intervention / Treatment
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* Behavioral: COVID-19 education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Enrolled in La Frontera, AND 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 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 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 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 Not enrolled in La Frontera, AND 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 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 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LinkUP Active intervention<br>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. | Behavioral: COVID-19 education<br>* This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.<br>|
| Placebo Comparator: LinkUP Control Condition (didactic intervention)<br>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. | Behavioral: COVID-19 education<br>* This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior change