Using MOST to Optimize an Intervention to Increase COVID-19 Testing for Frontline Essential Workers (NCAP1)

April 30, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
438

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Marya Gwadz, PhD
  • Phone Number: 212-998-5968
  • Email: mg2890@nyu.edu

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York University Silver School of Social Work

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Condition 1
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation
Behavioral: Motivational interviewing (MI) counseling
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.
Behavioral: Text messages (TMs) and quiz questions (QQs)
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.
Behavioral: Peer education
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.
Behavioral: Access to COVID testing
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
Behavioral: Motivational interviewing (MI) counseling
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.
Behavioral: Text messages (TMs) and quiz questions (QQs)
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.
Behavioral: Peer education
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.
Behavioral: Access to COVID testing
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
Behavioral: Text messages (TMs) and quiz questions (QQs)
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.
Behavioral: Peer education
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.
Behavioral: Access to COVID testing
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
Behavioral: Text messages (TMs) and quiz questions (QQs)
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.
Behavioral: Peer education
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.
Behavioral: Access to COVID testing
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
Behavioral: Motivational interviewing (MI) counseling
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.
Behavioral: Peer education
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.
Behavioral: Access to COVID testing
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
Behavioral: Motivational interviewing (MI) counseling
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.
Behavioral: Peer education
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.
Behavioral: Access to COVID testing
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
Behavioral: Peer education
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.
Behavioral: Access to COVID testing
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
Behavioral: Peer education
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.
Behavioral: Access to COVID testing
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
Behavioral: Motivational interviewing (MI) counseling
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.
Behavioral: Text messages (TMs) and quiz questions (QQs)
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.
Behavioral: Access to COVID testing
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
Behavioral: Motivational interviewing (MI) counseling
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.
Behavioral: Text messages (TMs) and quiz questions (QQs)
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.
Behavioral: Access to COVID testing
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
Behavioral: Text messages (TMs) and quiz questions (QQs)
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.
Behavioral: Access to COVID testing
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
Behavioral: Text messages (TMs) and quiz questions (QQs)
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.
Behavioral: Access to COVID testing
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
Behavioral: Motivational interviewing (MI) counseling
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.
Behavioral: Access to COVID testing
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
Behavioral: Motivational interviewing (MI) counseling
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.
Behavioral: Access to COVID testing
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
Behavioral: Access to COVID testing
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
Behavioral: Access to COVID testing
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
COVID-19 Testing at Follow-up Assessment
Time Frame: by the 12-week FU
COVID-19 testing at the 6- and/or 12-week follow-up assessment (at least one instance)
by the 12-week FU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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