LinkUP: COVID-19 Intervention for Underserved Populations

University of California, San Diego150 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Motivational Interviewing

Interventions

COVID-19 educationBEHAVIORAL

This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

La Frontera Project

San Diego, California, United States

Outcomes

Primary Outcomes

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)

Time frame: Day of the Intervention; The outcome for the last participant was ascertained on June 6th, 2022.

Secondary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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