search
Back to results

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

Primary Purpose

COVID-19, COVID-19 Testing

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing (MI) counseling
Text messages (TMs) and quiz questions (QQs)
Peer education
Access to COVID testing
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring multiphase optimization strategy (MOST), COVID-19 testing, Black and Latino, frontline essential workers

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
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; 8) has not been tested for COVID-19 in the past six 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.

Sites / Locations

  • New York University Silver School of Social WorkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Condition 1

Condition 2

Condition 3

Condition 4

Condition 5

Condition 6

Condition 7

Condition 8

Condition 9

Condition 10

Condition 11

Condition 12

Condition 13

Condition 14

Condition 15

Condition 16

Arm Description

Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation

Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit

Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation

Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit

Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation

Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit

Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation

Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation

Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit

Outcomes

Primary Outcome Measures

COVID-19 testing
COVID-19 testing

Secondary Outcome Measures

Confirmatory COVID-19 testing (as needed)
Confirmatory COVID-19 testing (as needed)
Contact tracing (as needed)
Contact tracing (as needed)
Self isolation (as needed)
Self isolation if diagnosed with COVID (as needed)
Receipt of health care (as needed)
Receipt of health care if diagnosed with COVID(as needed)
Attitudes toward COVID-19 vaccination
Attitudes toward COVID-19 vaccination
Receipt of COVID-19 vaccination
Receipt of COVID-19 vaccination

Full Information

First Posted
November 29, 2021
Last Updated
May 12, 2023
Sponsor
New York University
search

1. Study Identification

Unique Protocol Identification Number
NCT05139927
Brief Title
Using MOST to Optimize an Intervention to Increase COVID-19 Testing for Frontline Essential Workers
Official Title
Using the Multiphase Optimization Strategy (MOST) to Optimize an Intervention to Increase COVID-19 Testing for Black and Latino/Hispanic Frontline Essential Workers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, COVID-19 Testing
Keywords
multiphase optimization strategy (MOST), COVID-19 testing, Black and Latino, frontline essential workers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Model Description
Full factorial experiment testing 4 behavioral intervention components. There are 16 conditions needed to test the effects of the 4 components. Each condition comprises a combination of components. In the sections that follow, we describe the 16 conditions.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
448 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Condition 1
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation
Arm Title
Condition 2
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit
Arm Title
Condition 3
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation
Arm Title
Condition 4
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit
Arm Title
Condition 5
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation
Arm Title
Condition 6
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit
Arm Title
Condition 7
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation
Arm Title
Condition 8
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit
Arm Title
Condition 9
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation
Arm Title
Condition 10
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit
Arm Title
Condition 11
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation
Arm Title
Condition 12
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit
Arm Title
Condition 13
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation
Arm Title
Condition 14
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit
Arm Title
Condition 15
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation
Arm Title
Condition 16
Arm Type
Experimental
Arm Description
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing (MI) counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text messages (TMs) and quiz questions (QQs)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Access to COVID testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
COVID-19 testing
Description
COVID-19 testing
Time Frame
12-week FU
Secondary Outcome Measure Information:
Title
Confirmatory COVID-19 testing (as needed)
Description
Confirmatory COVID-19 testing (as needed)
Time Frame
12-week FU
Title
Contact tracing (as needed)
Description
Contact tracing (as needed)
Time Frame
12-week FU
Title
Self isolation (as needed)
Description
Self isolation if diagnosed with COVID (as needed)
Time Frame
12-week FU
Title
Receipt of health care (as needed)
Description
Receipt of health care if diagnosed with COVID(as needed)
Time Frame
12-week FU
Title
Attitudes toward COVID-19 vaccination
Description
Attitudes toward COVID-19 vaccination
Time Frame
12-week FU
Title
Receipt of COVID-19 vaccination
Description
Receipt of COVID-19 vaccination
Time Frame
12-week FU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marya Gwadz, PhD
Phone
212-998-5968
Email
mg2890@nyu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marya Gwadz, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Silver School of Social Work
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marya Gwadz, PhD
Phone
212-998-5965
Email
marya.gwadz@nyu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35729622
Citation
Gwadz M, Cleland CM, Lizardo M, Hawkins RL, Bangser G, Parameswaran L, Stanhope V, Robinson JA, Karim S, Hollaway T, Ramirez PG, Filippone PL, Ritchie AS, Banfield A, Silverman E. Using the multiphase optimization strategy (MOST) framework to optimize an intervention to increase COVID-19 testing for Black and Latino/Hispanic frontline essential workers: A study protocol. BMC Public Health. 2022 Jun 21;22(1):1235. doi: 10.1186/s12889-022-13576-0.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs