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

Using the Multiphase Optimization Strategy (MOST) to Optimize an Intervention to Increase COVID-19 Testing for Black and Latino/Hispanic Frontline Essential Workers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05139927
Acronym
NCAP1
Enrollment
438
Registered
2021-12-01
Start date
2022-06-01
Completion date
2024-03-01
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, COVID-19 Testing

Keywords

multiphase optimization strategy (MOST), COVID-19 testing, Black and Latino, frontline essential workers

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.

Interventions

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.

BEHAVIORALText 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.

BEHAVIORALPeer 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.

BEHAVIORALAccess 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.

Sponsors

New York University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
COVID-19 Testing at Follow-up Assessmentby the 12-week FUCOVID-19 testing at the 6- and/or 12-week follow-up assessment (at least one instance)

Countries

United States

Participant flow

Recruitment details

The optimization randomized controlled trial described here was conducted in New York City between July 2022 and February 2024. The trial was a collaboration between New York University and the Northern Manhattan Improvement Corporation. Study activities were conducted at a research field site in lower Manhattan. Persons could participate there in-person or engage in the study virtually. Recruitment took place in the community,

Participants by arm

ArmCount
Condition 1
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation
24
Condition 2
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit
28
Condition 3
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Navigation
28
Condition 4
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - ON Component D: Self-test kit
27
Condition 5
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation
26
Condition 6
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit
28
Condition 7
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Navigation
28
Condition 8
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - ON Component D: Self-test kit
28
Condition 9
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation
27
Condition 10
Component A: motivational interviewing counseling - ON Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit
28
Condition 11
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Navigation
28
Condition 12
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - ON Component C: Peer education - OFF Component D: Self test kit
28
Condition 13
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation
27
Condition 14
Component A: motivational interviewing counseling - ON Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit
28
Condition 15
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Navigation
28
Condition 16
Component A: motivational interviewing counseling - OFF Component B: Text message intervention - OFF Component C: Peer education - OFF Component D: Self test kit
27
Total438

Baseline characteristics

CharacteristicCondition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Total
Age, Continuous37.46 years
STANDARD_DEVIATION 10.56
36.07 years
STANDARD_DEVIATION 8.73
33.54 years
STANDARD_DEVIATION 10.12
39.44 years
STANDARD_DEVIATION 12.07
35.19 years
STANDARD_DEVIATION 11.18
35.29 years
STANDARD_DEVIATION 9.56
33.82 years
STANDARD_DEVIATION 9
31.82 years
STANDARD_DEVIATION 8.46
35.37 years
STANDARD_DEVIATION 7.75
36.04 years
STANDARD_DEVIATION 11.44
35.64 years
STANDARD_DEVIATION 9.19
35.54 years
STANDARD_DEVIATION 10.07
32.59 years
STANDARD_DEVIATION 8.66
33.89 years
STANDARD_DEVIATION 9.32
34.75 years
STANDARD_DEVIATION 9.16
32.41 years
STANDARD_DEVIATION 9.11
34.93 years
STANDARD_DEVIATION 9.65
Race/Ethnicity, Customized
African American/Black or bi- or multi-racial
11 Participants11 Participants15 Participants13 Participants15 Participants12 Participants15 Participants18 Participants10 Participants16 Participants12 Participants12 Participants13 Participants11 Participants17 Participants13 Participants214 Participants
Race/Ethnicity, Customized
Latino/Hispanic (yes)
13 Participants17 Participants13 Participants14 Participants11 Participants16 Participants13 Participants10 Participants17 Participants12 Participants16 Participants16 Participants14 Participants17 Participants11 Participants14 Participants224 Participants
Race/Ethnicity, Customized
Other race
13 Participants17 Participants13 Participants14 Participants11 Participants16 Participants13 Participants10 Participants17 Participants12 Participants16 Participants16 Participants14 Participants17 Participants11 Participants14 Participants224 Participants
Sex/Gender, Customized
Female/woman or gender minority
16 Participants16 Participants8 Participants12 Participants11 Participants12 Participants16 Participants12 Participants15 Participants14 Participants14 Participants9 Participants14 Participants12 Participants15 Participants13 Participants209 Participants
Sex/Gender, Customized
Man/male gender
8 Participants12 Participants20 Participants15 Participants15 Participants16 Participants12 Participants16 Participants12 Participants14 Participants14 Participants19 Participants13 Participants16 Participants13 Participants14 Participants229 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
EG013
affected / at risk
EG014
affected / at risk
EG015
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 280 / 280 / 270 / 260 / 280 / 280 / 280 / 270 / 280 / 280 / 280 / 270 / 280 / 280 / 27
other
Total, other adverse events
0 / 240 / 280 / 280 / 270 / 260 / 280 / 280 / 280 / 270 / 280 / 280 / 280 / 270 / 280 / 280 / 27
serious
Total, serious adverse events
0 / 240 / 280 / 280 / 270 / 260 / 280 / 280 / 280 / 270 / 280 / 280 / 280 / 270 / 280 / 280 / 27

Outcome results

Primary

COVID-19 Testing at Follow-up Assessment

COVID-19 testing at the 6- and/or 12-week follow-up assessment (at least one instance)

Time frame: by the 12-week FU

Population: participants

ArmMeasureValue (MEAN)Dispersion
Condition 1COVID-19 Testing at Follow-up Assessment0.85 proportion of those tested at least onceStandard Deviation 0.37
Condition 2COVID-19 Testing at Follow-up Assessment0.61 proportion of those tested at least onceStandard Deviation 0.5
Condition 3COVID-19 Testing at Follow-up Assessment0.63 proportion of those tested at least onceStandard Deviation 0.49
Condition 4COVID-19 Testing at Follow-up Assessment0.81 proportion of those tested at least onceStandard Deviation 0.4
Condition 5COVID-19 Testing at Follow-up Assessment0.68 proportion of those tested at least onceStandard Deviation 0.48
Condition 6COVID-19 Testing at Follow-up Assessment0.59 proportion of those tested at least onceStandard Deviation 0.5
Condition 7COVID-19 Testing at Follow-up Assessment0.54 proportion of those tested at least onceStandard Deviation 0.51
Condition 8COVID-19 Testing at Follow-up Assessment0.64 proportion of those tested at least onceStandard Deviation 0.49
Condition 9COVID-19 Testing at Follow-up Assessment0.64 proportion of those tested at least onceStandard Deviation 0.49
Condition 10COVID-19 Testing at Follow-up Assessment0.79 proportion of those tested at least onceStandard Deviation 0.41
Condition 11COVID-19 Testing at Follow-up Assessment0.69 proportion of those tested at least onceStandard Deviation 0.47
Condition 12COVID-19 Testing at Follow-up Assessment0.68 proportion of those tested at least onceStandard Deviation 0.48
Condition 13COVID-19 Testing at Follow-up Assessment0.54 proportion of those tested at least onceStandard Deviation 0.51
Condition 14COVID-19 Testing at Follow-up Assessment0.81 proportion of those tested at least onceStandard Deviation 0.4
Condition 15COVID-19 Testing at Follow-up Assessment0.56 proportion of those tested at least onceStandard Deviation 0.51
Condition 16COVID-19 Testing at Follow-up Assessment0.71 proportion of those tested at least onceStandard Deviation 0.46

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026