COVID-19 PandemicNCT05534061
Motivation, Syringe Exchange, and COVID-19
A study testing Connect2Test in people with COVID-19 Pandemic, run by University of Oregon at 1 site in United States.
Trial summary
People who inject drugs (PWIDs) are highly vulnerable to SARS-CoV-2 infection and to the disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), however, rates of SARS-CoV-2 testing and vaccination uptake -vital to mitigating the spread of COVID-19 and achieving herd immunity - are lower among PWIDs… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Connect2Test
- Type of treatment
- Vaccines, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to 30 Jun 2023
- 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
- 18 and older, understand English
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motivational Enhancement to Augment Contingency Management for SARS-CoV-2 Testing and Vaccination Utilization Among Syringe Exchange Clients
People who inject drugs (PWIDs) are highly vulnerable to SARS-CoV-2 infection and to the disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), however, rates of SARS-CoV-2 testing and vaccination uptake -vital to mitigating the spread of COVID-19 and achieving herd immunity - are lower among PWIDs compared to the general population. Building on our Phase I Rapid Acceleration of Diagnostics project, which found that contingency management (CM) increased testing utilization among PWIDs, the proposed project evaluates the comparative effectiveness of CM versus CM plus a brief motivational enhancement intervention on SARS-CoV-2 testing and vaccination uptake among PWIDs. This project has the potential to reduce COVID-19 health disparities among PWIDs and to decrease population level COVID-19 morbidity and mortality.
Read the detailed description
This study uses contingency management, specifically $10 financial incentives for participation in SARS-CoV-2 testing and $10 for participating in COVID-19 vaccination. It also uses a motivational enhancement intervention which is a brief conversation with clients to improve intrinsic motivation for testing and vaccination. Thus, the clinical trials portion of this study is a randomized control trial (N = 349) in which 177 participants will be assigned to contingency management plus the Connect2Test intervention and 172 will be assigned to the contingency management alone (i.e. services as usual). There will be a per site quota to ensure there are relatively equivalent numbers of participants per site to avoid site-specific biases. The data collection software (e.g., Qualtrics, PowerBI) will randomly assign individuals to condition in real time, after a participant consents to participate in the study.
- Conditions
- COVID-19 Pandemic
- Being tested
- Connect2Test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connect2TestBehavioural
Also called Motivational Enhancement
Brief motivational enhancement intervention to improve the likelihood of testing and vaccination among syringe exchange clients
| Study group | Role | What they receive |
|---|---|---|
| Connect2Test Intervention + Contingency Management | Experimental | $10 financial incentive for vaccination and $10 financial incentive for testing plus a brief feedback-based motivational enhancement intervention. Receives: Behavioral: Connect2Test |
| Contingency Management Alone | Active comparator | $10 financial incentive for vaccination and $10 financial incentive for testing. Receives: Behavioral: Connect2Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 Testing
Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from medical record
Measured: Immediate post intervention (i.e., same day)
SARS-CoV-2 Testing
Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from medical record
Measured: Up to 9-months after intervention
Secondary outcomes (2)
COVID-19 Vaccination
Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was vaccinated for COVID-19 at syringe exchange visit, data collected from vaccine records
Measured: Immediate post intervention (i.e., same day)
COVID-19 Vaccination
Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was vaccinated for COVID-19 at syringe exchange visit, data collected from vaccine records
Measured: Up to 9-months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start8 Aug 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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.
- Other trials for COVID-19 PandemicStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534061
- Sponsor's protocol ID
- 11162020.013b
- Other IDs
- 1U01DA055982-01
- Status last verified
- Jan 2024
- First submitted
- 7 Sep 2022
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In line with funding requirements, we will share data with our data coordination center and the national institutes of health
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Enhancement to Augment Contingency Management for SARS-CoV-2 Testing and Vaccination Utilization Among Syringe Exchange Clients
- ClinicalTrials.gov ID
- NCT05534061
- Acronym / sponsor ID
- 11162020.013b
- Conditions
- COVID-19 Pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Sep 2022 (actual)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People who inject drugs (PWIDs) are highly vulnerable to SARS-CoV-2 infection and to the disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), however, rates of SARS-CoV-2 testing and vaccination uptake -vital to mitigating the spread of COVID-19 and achieving herd immunity - are lower among PWIDs compared to the general population. Building on our Phase I Rapid Acceleration of Diagnostics project, which found that contingency management (CM) increased testing utilization among PWIDs, the proposed project evaluates the comparative effectiveness of CM versus CM plus a brief motivational enhancement intervention on SARS-CoV-2 testing and vaccination uptake among PWIDs. This project has the potential to reduce COVID-19 health disparities among PWIDs and to decrease population level COVID-19 morbidity and mortality.
Detailed description
This study uses contingency management, specifically $10 financial incentives for participation in SARS-CoV-2 testing and $10 for participating in COVID-19 vaccination. It also uses a motivational enhancement intervention which is a brief conversation with clients to improve intrinsic motivation for testing and vaccination. Thus, the clinical trials portion of this study is a randomized control trial (N = 349) in which 177 participants will be assigned to contingency management plus the Connect2Test intervention and 172 will be assigned to the contingency management alone (i.e. services as usual). There will be a per site quota to ensure there are relatively equivalent numbers of participants per site to avoid site-specific biases. The data collection software (e.g., Qualtrics, PowerBI) will randomly assign individuals to condition in real time, after a participant consents to participate in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connect2Test Intervention + Contingency Management | Experimental | Behavioral: Connect2Test$10 financial incentive for vaccination and $10 financial incentive for testing plus a brief feedback-based motivational enhancement intervention. |
| Contingency Management Alone | Active comparator | Behavioral: Connect2Test$10 financial incentive for vaccination and $10 financial incentive for testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 and older, understand English
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Connect2TestAlso: Motivational EnhancementBrief motivational enhancement intervention to improve the likelihood of testing and vaccination among syringe exchange clients | Behavioural | Connect2Test Intervention + Contingency Management, Contingency Management Alone |
Primary outcome
SARS-CoV-2 Testing
Time frame: Immediate post intervention (i.e., same day)
Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from medical record
SARS-CoV-2 Testing
Time frame: Up to 9-months after intervention
Yes/no indicator (coded 1 = yes, 0 = no) of whether or not person was tested for SARS-CoV-2 testing at syringe exchange visit, data collected from medical record
2 secondary outcomes
COVID-19 Vaccination
Time frame: Immediate post intervention (i.e., same day)
COVID-19 Vaccination
Time frame: Up to 9-months after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. In line with funding requirements, we will share data with our data coordination center and the national institutes of health
Related trials for COVID-19 Pandemic
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Enrolling by invitationObservational study
Prescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic
Dementia
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
Active, not recruiting
Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use
Liver Diseases, Alcohol Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connect2Test in people with COVID-19 Pandemic, run by University of Oregon 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 1 inclusion and 1 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 28 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. 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 28 Feb 2024). 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?
SARS-CoV-2 Testing (time frame: Immediate post intervention (i.e., same day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.