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LinkUP: COVID-19 Intervention for Underserved Populations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05181657
Recruitment Status : Active, not recruiting
First Posted : January 6, 2022
Last Update Posted : June 8, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steffanie Strathdee, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Motivational Interviewing Behavioral: COVID-19 education Not Applicable

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. 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Participant, Investigator)
Masking Description: Neither study participants or principal investigator will know which group participants have been assigned to.
Primary Purpose: Prevention
Official Title: LinkUP: COVID-19 Intervention for Underserved Populations Participating in Parent Study Proyecto La Frontera
Actual Study Start Date : March 15, 2022
Actual Primary Completion Date : June 2, 2022
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Behavioral: COVID-19 education
This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.

Placebo Comparator: 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.
Behavioral: COVID-19 education
This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.




Primary Outcome Measures :
  1. COVID-19 Testing [ Time Frame: 6 months ]
    had a COVID test within 6 months of the intervention


Secondary Outcome Measures :
  1. COVID-19 Vaccination [ Time Frame: 6 months ]
    had ≥ one COVID shot within 6 months of intervention,



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05181657


Locations
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United States, California
La Frontera Project
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Steffanie Strathdee, PhD University of California, San Diego
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Responsible Party: 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
ClinicalTrials.gov Identifier: NCT05181657    
Other Study ID Numbers: LinkUP
R01DA049644 ( U.S. NIH Grant/Contract )
First Posted: January 6, 2022    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Steffanie Strathdee, University of California, San Diego:
Behavior change