LinkUP: COVID-19 Intervention for Underserved Populations Participating in Parent Study Proyecto La Frontera
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- COVID-19 Testing
Study Overview
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 :
- 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
Neither study participants or principal investigator will know which group participants have been assigned to.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: COVID-19 education (Behavioral)
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.
Intervention: COVID-19 education (Behavioral)
Outcomes
Primary Outcomes
COVID-19 Testing
Time Frame: 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)
Secondary Outcomes
- COVID-19 Vaccination(6 months)
Investigators
Steffanie Strathdee
Distinguished Professor and Harold Simon Chair, Associate Dean of Global Health Sciences, Division of Infectious Disease and Global Public Health, UCSD Department of Medicine
University of California, San Diego