LinkUP: COVID-19 Intervention for Underserved Populations

NCT05181657 | Completed Results DMC

• 2 other identifiers: LinkUPR01DA049644
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Motivational Interviewing

Keywords

Behavior change

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• COVID-19 Vaccination

  6 months

Study Arms (2)

LinkUP Active intervention

EXPERIMENTAL

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

LinkUP Control Condition (didactic intervention)

PLACEBO COMPARATOR

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

Interventions

COVID-19 education BEHAVIORAL

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

LinkUP Active intervention; LinkUP Control Condition (didactic intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

La Frontera Project

San Diego, California, 92103, United States

Location

Related Publications (2)

• Strathdee SA, Abramovitz D, Harvey-Vera AY, Stamos-Buesig T, Vera CF, Artamonova I, Logan J, Patterson TL, Servin AE, Bazzi AR. A Brief Peer-Led Intervention to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs in San Diego County: Results From a Pilot Randomized Controlled Trial. Open Forum Infect Dis. 2023 Jul 21;10(8):ofad392. doi: 10.1093/ofid/ofad392. eCollection 2023 Aug.

  PMID: 37547856 DERIVED

• 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.

  PMID: 36064745 DERIVED

Limitations and Caveats

1. Generalizability limited to study participants. 2. Recall, self-report of sensitive/socially stigmatized behaviors, COVID-19 measures not validated. 3. On-site COVID-19 vaccination not collected. Vaccination referrals provided instead. Additional research to: a) confirm intervention efficacy and further explore the mechanisms of potential mediators and moderators of intervention effects and b) determine if LinkUP can effectively support COVID-19 vaccination uptake (our secondary outcome).

Results Point of Contact

• Title: Dr. Steffanie Strathdee
• Organization: University of California, San Diego

sstrathdee@health.ucsd.edu

858-822-1952

Study Officials

• Steffanie Strathdee, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither study participants or principal investigator will know which group participants have been assigned to.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor and Harold Simon Chair, Associate Dean of Global Health Sciences, Division of Infectious Disease and Global Public Health, UCSD Department of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 6, 2022
• Study Start: March 15, 2022
• Primary Completion: June 6, 2022
• Study Completion: January 31, 2024
• Last Updated: February 21, 2024
• Results First Posted: March 30, 2023

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)