Motivational InterviewingNCT05181657
LinkUP: COVID-19 Intervention for Underserved Populations
A study testing COVID-19 education in people with Motivational Interviewing, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motivational Interviewing
- What is being tested?
- COVID-19 education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LinkUP: COVID-19 Intervention for Underserved Populations Participating in Parent Study Proyecto La Frontera
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.
Read the 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).
- Conditions
- Motivational Interviewing
- Being tested
- COVID-19 education
- Keywords
- Behavior change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 educationBehavioural
This session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: COVID-19 education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day of the Intervention; The outcome for the last participant was ascertained on June 6th, 2022.
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start15 Mar 2022
- Primary completion6 Jun 2022
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Motivational InterviewingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Steffanie Strathdee, University of California, San Diego
- Investigators
- Steffanie Strathdee, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181657
- Sponsor's protocol ID
- LinkUP
- Other IDs
- R01DA049644
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2022
- Last updated
- 21 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37547856Bazzi 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.
PubMed 36064745
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LinkUP: COVID-19 Intervention for Underserved Populations Participating in Parent Study Proyecto La Frontera
- ClinicalTrials.gov ID
- NCT05181657
- Acronym / sponsor ID
- LinkUP
- Conditions
- Motivational Interviewing
- Keywords
- Behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Posted 30 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| LinkUP Active intervention | Experimental | Behavioral: COVID-19 educationThe 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. |
| LinkUP Control Condition (didactic intervention) | Placebo comparator | Behavioral: COVID-19 educationAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 educationThis session will be completed within 45 minutes. The LinkUP intervention will be available in English and Spanish. | Behavioural | LinkUP Active intervention, LinkUP Control Condition (didactic intervention) |
Primary outcome
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)
1 secondary outcome
COVID-19 Vaccination
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37547856Strathdee 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.
- Derived from this study: PubMed 36064745Bazzi 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.
- Individual participant dataSharing planned: No
Related trials for Motivational Interviewing
Not yet recruitingPhase 1/2
Reducing Firearm Suicide Among Veterans: Evaluating the Effectiveness of Peer-Delivered Lethal Means Counseling
Suicide, Secure Firearm Storage
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
Chronic Low Back Pain (CLBP)
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Active, not recruiting
IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention
HIV-1-infection, Unhealthy Alcohol Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffanie Strathdee, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 education in people with Motivational Interviewing, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 Testing (time frame: Day of the Intervention; The outcome for the last participant was ascertained on June 6th, 2022.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05181657, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.