- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05139927
Using MOST to Optimize an Intervention to Increase COVID-19 Testing for Frontline Essential Workers
May 12, 2023 updated by: New York University
Using the Multiphase Optimization Strategy (MOST) to Optimize an Intervention to Increase COVID-19 Testing for Black and Latino/Hispanic Frontline Essential Workers
COVID-19 testing is essential to controlling the COVID-19 pandemic to break transmission chains and reduce community transmission.
However, Black and Latino/Hispanic populations in lower status frontline essential occupations such as food preparation, retail, building maintenance, personal services, and in-home health care have serious barriers to COVID-19 testing and, therefore, insufficient testing rates.
The proposed study will use the multiphase optimization strategy framework to address the problem of low COVID-19 testing rates for this population: We will test the effects of four distinct candidate intervention components and then create an efficient multicomponent made up of the most effective combination of the components that can be rapidly scaled up in community settings to boost COVID-19 testing rates.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The proposed study responds to RFA-OD-21-008 which calls for community-engaged interventions to support COVID-19 testing in underserved and vulnerable populations.
Among those at highest risk for exposure to COVID-19 is the large population of frontline essential workers (FEW) in lower status occupations (e.g., retail, in-home health care), among whom Black and Latino/Hispanic (BLH) persons are over-represented.
The CDC recommends testing for all those experiencing symptoms of COVID-19.
For those not vaccinated, testing is recommended after exposure to individuals with a COVID-19 diagnosis, and regular COVID-19 screening testing is recommended even when asymptomatic for those with frequent close contact with others in indoor settings such as FEW.
However, BLH-FEW experience serious impediments to COVID-19 testing at individual/attitudinal- (e.g., lack of knowledge of guidelines, distrust), social- (e.g., social norms), and structural-levels of influence (e.g., poor access to testing).
Indeed, testing rates are lower among BLH than White populations and only 25-50% of BLH-FEW are currently vaccinated.
The proposed community-engaged study is led by a collaborative team at New York University and the Northern Manhattan Improvement Corporation (NMIC).
Its main goal is to optimize a behavioral intervention to boost COVID-19 testing rates for BLH-FEW.
Consistent with RFA-OD-21-008, the proposed study uses the multiphase optimization strategy (MOST) framework to test four candidate intervention components grounded in our past research.
The candidate components are informed by critical race theory and guided by the theory of triadic influence, are brief or do not require substantial staff time, and will be tested in a highly efficient factorial experimental design.
They are A) motivational interview counseling, B) a text message component grounded in behavioral economics, C) peer education, and D) access to testing (via navigation to a test appointment vs. a self-test kit).
All participants receive the standard of care, namely, health education on COVID-19 testing, and referrals.
The specific aims of the study are to: identify which of four candidate components contribute meaningfully to improvement in the primary outcome, COVID-19 testing with medical confirmation; the most effective combination of components will comprise the "optimized" intervention (Aim 1), identify mediators (e.g., distrust, access) and moderators (e.g., sociodemographic characteristics) of the effects of each component (Aim 2), and use a mixed-methods approach to explore relationships among barriers to, facilitators of, and uptake of COVID-19 testing and COVID-19 vaccination (Aim 3).
Participants will be N=448 BLH-FEW who have not been tested for COVID-19 in the past three months and have not been vaccinated for COVID-19 in the past 12 months, randomly assigned to an intervention condition, and assessed at 6- and 12-weeks post-baseline; N=50 participants will engage in qualitative in-depth interviews.
We will also uncover, describe, and plan for implementation issues so the optimized intervention can be rapidly scaled up by NMIC and other community-based organizations.
Study Type
Interventional
Enrollment (Anticipated)
448
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marya Gwadz, PhD
- Phone Number: 212-998-5968
- Email: mg2890@nyu.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Recruiting
- New York University Silver School of Social Work
-
Contact:
- Marya Gwadz, PhD
- Phone Number: 212-998-5965
- Email: marya.gwadz@nyu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
INCLUSION CRITERIA: 1) age 18-70 years; 2) can engage in study activities in English or Spanish; 3) Black or African American (including Caribbean, African, or multi-ethnic Black) and/or Latino or Hispanic race/ethnicity; 4) resides in NYC; 5) in the past month, was employed as a frontline worker in a lower status essential occupation in one or more of the domains listed above; 6) has a phone that can be used for study participation and can receive TMs; 7) has not received any doses of a COVID-19 vaccination in the past 12 months; 8) has not been tested for COVID-19 in the past three months; 9) if previously diagnosed with COVID-19, has not been symptomatic in the past two weeks or 90 days has passed since treatment with monoclonal antibodies or convalescent plasma98; 10) has not been educated/interviewed as a peer for Component C; 11) willing to engage in a core session and be randomly assigned to receive 1-4 components.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Condition 1
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation
|
Those assigned to receive Component A will engage in a MI single session lasting approximately 30-45 minutes.
The overall goal of the session is to increase participants' motivation and readiness to test for COVID-19 in various circumstances.
This intervention lasts 6 weeks.
This component is grounded in principles of behavioral economics.
Its main goal is to add interest and excitement to the goal of COVID-19 testing, serve as a reminder that COVID-19 testing is recommended in a number of scenarios, and "nudge" participants toward testing and creating a habit of serial screening and COVID-19 testing as needed.
Participants first receive a brief orientation to the component (15 min.),
and the participant will put the study phone number into his/her phone and a test TM and QQ will be sent.
TMs and QQs are programmed into the Telerivet program and sent automatically.
Twice a week participants will receive a TM with information about COVID and COVID-19 testing followed by a true/false question about that TM two days later, for which they earn 10 points for a correct answer, and 5 points for an incorrect answer.
Participants earn modest prizes based on their points.
This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min.
training).
Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages.
These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 2
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit
|
Those assigned to receive Component A will engage in a MI single session lasting approximately 30-45 minutes.
The overall goal of the session is to increase participants' motivation and readiness to test for COVID-19 in various circumstances.
This intervention lasts 6 weeks.
This component is grounded in principles of behavioral economics.
Its main goal is to add interest and excitement to the goal of COVID-19 testing, serve as a reminder that COVID-19 testing is recommended in a number of scenarios, and "nudge" participants toward testing and creating a habit of serial screening and COVID-19 testing as needed.
Participants first receive a brief orientation to the component (15 min.),
and the participant will put the study phone number into his/her phone and a test TM and QQ will be sent.
TMs and QQs are programmed into the Telerivet program and sent automatically.
Twice a week participants will receive a TM with information about COVID and COVID-19 testing followed by a true/false question about that TM two days later, for which they earn 10 points for a correct answer, and 5 points for an incorrect answer.
Participants earn modest prizes based on their points.
This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min.
training).
Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages.
These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 3
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation
|
This intervention lasts 6 weeks.
This component is grounded in principles of behavioral economics.
Its main goal is to add interest and excitement to the goal of COVID-19 testing, serve as a reminder that COVID-19 testing is recommended in a number of scenarios, and "nudge" participants toward testing and creating a habit of serial screening and COVID-19 testing as needed.
Participants first receive a brief orientation to the component (15 min.),
and the participant will put the study phone number into his/her phone and a test TM and QQ will be sent.
TMs and QQs are programmed into the Telerivet program and sent automatically.
Twice a week participants will receive a TM with information about COVID and COVID-19 testing followed by a true/false question about that TM two days later, for which they earn 10 points for a correct answer, and 5 points for an incorrect answer.
Participants earn modest prizes based on their points.
This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min.
training).
Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages.
These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 4
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit
|
This intervention lasts 6 weeks.
This component is grounded in principles of behavioral economics.
Its main goal is to add interest and excitement to the goal of COVID-19 testing, serve as a reminder that COVID-19 testing is recommended in a number of scenarios, and "nudge" participants toward testing and creating a habit of serial screening and COVID-19 testing as needed.
Participants first receive a brief orientation to the component (15 min.),
and the participant will put the study phone number into his/her phone and a test TM and QQ will be sent.
TMs and QQs are programmed into the Telerivet program and sent automatically.
Twice a week participants will receive a TM with information about COVID and COVID-19 testing followed by a true/false question about that TM two days later, for which they earn 10 points for a correct answer, and 5 points for an incorrect answer.
Participants earn modest prizes based on their points.
This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min.
training).
Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages.
These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 5
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation
|
Those assigned to receive Component A will engage in a MI single session lasting approximately 30-45 minutes.
The overall goal of the session is to increase participants' motivation and readiness to test for COVID-19 in various circumstances.
This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min.
training).
Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages.
These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 6
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit
|
Those assigned to receive Component A will engage in a MI single session lasting approximately 30-45 minutes.
The overall goal of the session is to increase participants' motivation and readiness to test for COVID-19 in various circumstances.
This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min.
training).
Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages.
These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 7
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation
|
This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min.
training).
Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages.
These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 8
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit
|
This component has two aspects: Participants are trained to educate their peers on core messages about the importance of COVID-19 testing that address social norms about COVID-19 testing and highlight COVID-19 testing as an altruistic act (15-20 min.
training).
Then, participants are given the opportunity to educate three peers who are Black and Latino/Hispanic frontline essential workers on the core messages.
These peers contact the study directly and receive a brief assessment and referrals to testing, but are not enrolled in the study.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 9
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation
|
Those assigned to receive Component A will engage in a MI single session lasting approximately 30-45 minutes.
The overall goal of the session is to increase participants' motivation and readiness to test for COVID-19 in various circumstances.
This intervention lasts 6 weeks.
This component is grounded in principles of behavioral economics.
Its main goal is to add interest and excitement to the goal of COVID-19 testing, serve as a reminder that COVID-19 testing is recommended in a number of scenarios, and "nudge" participants toward testing and creating a habit of serial screening and COVID-19 testing as needed.
Participants first receive a brief orientation to the component (15 min.),
and the participant will put the study phone number into his/her phone and a test TM and QQ will be sent.
TMs and QQs are programmed into the Telerivet program and sent automatically.
Twice a week participants will receive a TM with information about COVID and COVID-19 testing followed by a true/false question about that TM two days later, for which they earn 10 points for a correct answer, and 5 points for an incorrect answer.
Participants earn modest prizes based on their points.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 10
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit
|
Those assigned to receive Component A will engage in a MI single session lasting approximately 30-45 minutes.
The overall goal of the session is to increase participants' motivation and readiness to test for COVID-19 in various circumstances.
This intervention lasts 6 weeks.
This component is grounded in principles of behavioral economics.
Its main goal is to add interest and excitement to the goal of COVID-19 testing, serve as a reminder that COVID-19 testing is recommended in a number of scenarios, and "nudge" participants toward testing and creating a habit of serial screening and COVID-19 testing as needed.
Participants first receive a brief orientation to the component (15 min.),
and the participant will put the study phone number into his/her phone and a test TM and QQ will be sent.
TMs and QQs are programmed into the Telerivet program and sent automatically.
Twice a week participants will receive a TM with information about COVID and COVID-19 testing followed by a true/false question about that TM two days later, for which they earn 10 points for a correct answer, and 5 points for an incorrect answer.
Participants earn modest prizes based on their points.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 11
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation
|
This intervention lasts 6 weeks.
This component is grounded in principles of behavioral economics.
Its main goal is to add interest and excitement to the goal of COVID-19 testing, serve as a reminder that COVID-19 testing is recommended in a number of scenarios, and "nudge" participants toward testing and creating a habit of serial screening and COVID-19 testing as needed.
Participants first receive a brief orientation to the component (15 min.),
and the participant will put the study phone number into his/her phone and a test TM and QQ will be sent.
TMs and QQs are programmed into the Telerivet program and sent automatically.
Twice a week participants will receive a TM with information about COVID and COVID-19 testing followed by a true/false question about that TM two days later, for which they earn 10 points for a correct answer, and 5 points for an incorrect answer.
Participants earn modest prizes based on their points.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 12
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit
|
This intervention lasts 6 weeks.
This component is grounded in principles of behavioral economics.
Its main goal is to add interest and excitement to the goal of COVID-19 testing, serve as a reminder that COVID-19 testing is recommended in a number of scenarios, and "nudge" participants toward testing and creating a habit of serial screening and COVID-19 testing as needed.
Participants first receive a brief orientation to the component (15 min.),
and the participant will put the study phone number into his/her phone and a test TM and QQ will be sent.
TMs and QQs are programmed into the Telerivet program and sent automatically.
Twice a week participants will receive a TM with information about COVID and COVID-19 testing followed by a true/false question about that TM two days later, for which they earn 10 points for a correct answer, and 5 points for an incorrect answer.
Participants earn modest prizes based on their points.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 13
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation
|
Those assigned to receive Component A will engage in a MI single session lasting approximately 30-45 minutes.
The overall goal of the session is to increase participants' motivation and readiness to test for COVID-19 in various circumstances.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 14
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit
|
Those assigned to receive Component A will engage in a MI single session lasting approximately 30-45 minutes.
The overall goal of the session is to increase participants' motivation and readiness to test for COVID-19 in various circumstances.
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 15
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation
|
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
Experimental: Condition 16
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit
|
Component D is an adaptive intervention component that avoids unnecessary costs; it is only provided if needed.
Level 1: Over a 2-3 week period, navigation includes a brief needs assessment and guidance to assist participants in prioritizing, accessing, and completing COVID-19 testing sequences in a timely fashion and resolving barriers such as transportation or the possible need to take off work if diagnosed with COVID-19.
Level 2: 1 month after enrollment, participants will be contacted by phone.
If they have not been tested, we will provide them with a BinaxNOW test kit which can be picked up or mailed to them.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 testing
Time Frame: 12-week FU
|
COVID-19 testing
|
12-week FU
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmatory COVID-19 testing (as needed)
Time Frame: 12-week FU
|
Confirmatory COVID-19 testing (as needed)
|
12-week FU
|
Contact tracing (as needed)
Time Frame: 12-week FU
|
Contact tracing (as needed)
|
12-week FU
|
Self isolation (as needed)
Time Frame: 12-week FU
|
Self isolation if diagnosed with COVID (as needed)
|
12-week FU
|
Receipt of health care (as needed)
Time Frame: 12-week FU
|
Receipt of health care if diagnosed with COVID(as needed)
|
12-week FU
|
Attitudes toward COVID-19 vaccination
Time Frame: 12-week FU
|
Attitudes toward COVID-19 vaccination
|
12-week FU
|
Receipt of COVID-19 vaccination
Time Frame: 12-week FU
|
Receipt of COVID-19 vaccination
|
12-week FU
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marya Gwadz, PhD, New York University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Anticipated)
January 1, 2024
Study Completion (Anticipated)
March 1, 2024
Study Registration Dates
First Submitted
November 29, 2021
First Submitted That Met QC Criteria
November 29, 2021
First Posted (Actual)
December 1, 2021
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 12, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY2022-6023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
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University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
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Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
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Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
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Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
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Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
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Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
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University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
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Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
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University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on Motivational interviewing (MI) counseling
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University of IowaCompletedSelf-efficacyUnited States
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Vanderbilt University Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedEnd Stage Renal Disease on DialysisUnited States
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Vanderbilt University Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingEnd Stage Renal Disease on DialysisUnited States
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Qazvin University Of Medical SciencesCompletedCoronary Artery Bypass Grafting (CABG) SurgeryIran, Islamic Republic of
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Chinese University of Hong KongThe University of Hong KongCompleted
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Qazvin University Of Medical SciencesCompleted
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University of Illinois at Urbana-ChampaignUniversity of WashingtonNot yet recruiting
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Northeastern UniversityCompleted
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Brigham and Women's HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedOsteoarthritis | Degenerative Joint DiseaseUnited States
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Western University, CanadaNot yet recruitingHead and Neck Cancer | Survivorship