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

New York University (NYU) logo

New York University (NYU)

Status and phase

Completed
Phase 2

Conditions

COVID-19
COVID-19 Testing

Treatments

Behavioral: Access to COVID testing
Behavioral: Peer education
Behavioral: Motivational interviewing (MI) counseling
Behavioral: Text messages (TMs) and quiz questions (QQs)

Study type

Interventional

Funder types

Other

Identifiers

NCT05139927
IRB-FY2022-6023

Details and patient eligibility

About

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.

Full 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.

Enrollment

438 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

438 participants in 16 patient groups

Condition 1
Experimental group
Description:
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation
Treatment:
Behavioral: Text messages (TMs) and quiz questions (QQs)
Behavioral: Motivational interviewing (MI) counseling
Behavioral: Peer education
Behavioral: Access to COVID testing
Condition 2
Experimental group
Description:
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit
Treatment:
Behavioral: Text messages (TMs) and quiz questions (QQs)
Behavioral: Motivational interviewing (MI) counseling
Behavioral: Peer education
Behavioral: Access to COVID testing
Condition 3
Experimental group
Description:
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation
Treatment:
Behavioral: Text messages (TMs) and quiz questions (QQs)
Behavioral: Peer education
Behavioral: Access to COVID testing
Condition 4
Experimental group
Description:
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit
Treatment:
Behavioral: Text messages (TMs) and quiz questions (QQs)
Behavioral: Peer education
Behavioral: Access to COVID testing
Condition 5
Experimental group
Description:
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation
Treatment:
Behavioral: Motivational interviewing (MI) counseling
Behavioral: Peer education
Behavioral: Access to COVID testing
Condition 6
Experimental group
Description:
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit
Treatment:
Behavioral: Motivational interviewing (MI) counseling
Behavioral: Peer education
Behavioral: Access to COVID testing
Condition 7
Experimental group
Description:
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation
Treatment:
Behavioral: Peer education
Behavioral: Access to COVID testing
Condition 8
Experimental group
Description:
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit
Treatment:
Behavioral: Peer education
Behavioral: Access to COVID testing
Condition 9
Experimental group
Description:
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation
Treatment:
Behavioral: Text messages (TMs) and quiz questions (QQs)
Behavioral: Motivational interviewing (MI) counseling
Behavioral: Access to COVID testing
Condition 10
Experimental group
Description:
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit
Treatment:
Behavioral: Text messages (TMs) and quiz questions (QQs)
Behavioral: Motivational interviewing (MI) counseling
Behavioral: Access to COVID testing
Condition 11
Experimental group
Description:
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation
Treatment:
Behavioral: Text messages (TMs) and quiz questions (QQs)
Behavioral: Access to COVID testing
Condition 12
Experimental group
Description:
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit
Treatment:
Behavioral: Text messages (TMs) and quiz questions (QQs)
Behavioral: Access to COVID testing
Condition 13
Experimental group
Description:
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation
Treatment:
Behavioral: Motivational interviewing (MI) counseling
Behavioral: Access to COVID testing
Condition 14
Experimental group
Description:
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit
Treatment:
Behavioral: Motivational interviewing (MI) counseling
Behavioral: Access to COVID testing
Condition 15
Experimental group
Description:
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation
Treatment:
Behavioral: Access to COVID testing
Condition 16
Experimental group
Description:
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit
Treatment:
Behavioral: Access to COVID testing

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Marya Gwadz, PhD

Data sourced from clinicaltrials.gov

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