Using the Multiphase Optimization Strategy (MOST) to Optimize an Intervention to Increase COVID-19 Testing for Black and Latino/Hispanic Frontline Essential Workers
Phase: NA
Conditions: COVID-19, COVID-19 Testing
Sponsor: New York University

 
 
 STUDY PROTOCOL 
Title: 
Using the multiphase optimization strategy (MOST) to optimize an 
intervention to increase COVID-19 testing for Black and 
Latino/Hispanic frontline essential workers 
Short Title: 
COVID testing project 
Field name:  
New York Community Action Project (NCAP) 
RADx-UP project number: 
#91 
RADx-UP DTA security level 
Limited 
Clinicaltrials.gov CT identifier 
NCT05139927 
Project phone number 
917-382-4782 
Project email address 
NCAP@NYU.edu 
Sponsor: 
National Institute of Minority Health and Health Disparities (NIMHD) 
NIH grant number: 
U01MD017418 
 
UCAIHS Number (IRB): 
 
IRB-FY2022-6023 
NYU SP record 
SP 21-1914 
NMIC unique entity identifier 
(UEI)  
DBL6VJ7GQSW9 
 
 
Protocol Date: 
 
May 2, 2023 
 
Amendment 1 Date: April 25, 2022 
 
Amendment 4 Date: July 1, 2022 
Amendment 2 Date: May 27, 2022 
Amendment 5 Date: July 15, 2022 
Amendment 3 Date: June 24, 2022 
Amendment 6 Date: Jan 24 2023 
Amendment 7 Date: May 2, 2023 
Amendment 8 Date: 
 
Study Principal Investigator 
Marya Gwadz, PhD 
NYU Silver School of Social Work 
MG2890@NYU.EDU 
ERA COMMONS ID: MGWADZ 
Site Principal Investigator (NMIC) 
Maria Lizardo, MSW 
Executive Director 
marializardo@nmic.org 
ERA COMMONS ID: MARIALIZARDO@NMIC.ORG 
Co-Investigator (NMIC) 
Greg Bangser, MPA 
Deputy Executive Director & COO 
gregbangser@nmic.org 
Co-Investigator (NYU SOM) 
Lalitha Parameswaran, MD 
NYU Grossman School of Medicine 
Lalitha.Parameswaran@nyulangone.org 

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ERA COMMONS ID: GREGBANGSER@NMIC.ORG 
ERA COMMONS: PARAML01 
Co-Investigator 
Charles M. Cleland, PhD 
NYU Grossman School of Medicine 
Charles.Cleland@nyulangone.org 
ERA COMMONS: CCLELAND 
Co-Investigator 
Robert L. Hawkins, PhD 
NYU Silver School of Social Work 
rlh6@nyu.edu 
eRA Commons: ROBERTHAWKINS 
 
 
Co-Investigator 
Victoria Stanhope, PhD 
NYU Silver School of Social Work 
victoria.stanhope@nyu.edu 
ERA COMMONS: ves1.nyu 
 
 
 
 
Study personnel 
Jenn Robinson, MA 
NYU Silver School of Social Work 
eRA person ID 78606845 
eRA user name jr6262.2022 
Jenn.robinson@NYU.edu 
 
Fernanda Gonzalez Blanco Serrano 
NYU Silver School of Social Work 
eRA person ID 78734815 
eRA user name FGB218.2022 
fgb218@nyu.edu 
 
Paola Ramirez, LMSW 
NYU Silver School of Social Work 
eRA person ID 78695994 
eRA user name PR2445.2022 
pr2445@nyu.edu  
 
Andrea Negret 
NYU Silver School of Social Work 
eRA person ID 78885988 
eRA user name AN4018.2022 
an4018@nyu.edu 
 
Mehreen Kagzi, MSW 
NYU Silver School of Social Work 
eRA person ID 79154591 
eRA user name MK9476.2023 
Mk9476@nyu.edu  
 
Brianna Amos 
NYU Silver School of Social Work 
eRA person ID 79154791 

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eRA user name BJA9779.2023 
bja9778@nyu.edu  
 
 
Isabella Couto 
NYU Silver School of Social Work 
eRA person ID 79154775 
eRA user name IC2135.2023 
ic2135@nyu.edu  
 
Rauly Chero 
eRA person ID  
eRA user name: raulychero@nmic.org  
 
Hanna Lissinna 
NYU Silver School of Social Work 
eRA person ID 79361449 
eRA user name LISSIH01.2023 
lissih01@nyu.edu 
 
Prema Filippone, PhD 
Era commons user name PLFILIPPONE2 
 
Other personnel TBN 
 
 
 
1. Abbreviations & Definitions of Terms 
 
Abbreviations used in this proposal  
ACASI 
Audio Computer-Assisted Self- Interview format 
BE 
Behavioral economics 
BL 
Baseline (interview) 
BLH 
Black or Latino/Hispanic 
CAB 
Community Advisory Board 
CAPI 
Computer-Assisted Personal Interview format 
CDC 
Centers for Disease Control and Prevention 
CDCC 
Coordination and Data Collection Center 
CDE 
Common Data Elements (required by RADx-UP) 
CFIR 
Consolidated Framework for Implementation Research 
DTA 
Data transfer agreement 
FEW 
Frontline essential workers 
FU 
Follow-up (interview) 
IWG 
Intervention working group 

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MI 
Motivational interviewing  
MOST 
Multiphase optimization strategy 
NMIC 
Northern Manhattan Improvement Corporation 
NYC 
New York City 
NYU 
New York University  
PDI 
Peer-driven intervention  
RADx-UP 
Rapid Acceleration of Diagnostics-Underserved Populations  
RCT 
Randomized controlled trial 
SARS-CoV-2 
Severe acute respiratory syndrome coronavirus 2 
TMQQ 
Test messages, quiz questions  
TTI 
Theory of triadic influence  
 
2.  Abstract 
Background. 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.  
 
Methods. 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.  
 
Aims. 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 documentary evidence; 
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).  
 

5 
 
Sample size and population. Participants will be N=448 BLH-FEW who have not been tested for COVID-
19 in the past six months and who are not vaccinated for COVID-19, 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.  
 
Phases. The study is comprised of three phases: Refinement (5 mos.), Implementation & Evaluation (15 
mos.), and Final (4 mos.).  
 
COVID-19 testing: This study does not conduct testing but provides a randomly subset of participants 
with a rapid antigen self-test kit for COVID-19 as part of Component D: navigation. We will provide test 
kits that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA), 
the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). We will refer to this as the 
“Flowflex test.”  
3. Schedule of Study Procedures 
Table 2. Study schedule 
Weeks 
Activity 
0 
Screen for eligibility 
0 
Brief baseline interview 
0 
Randomization to an intervention condition  
1 
Receipt of intervention components 
6 
First follow-up assessment 
12 
Second follow-up assessment 
12 
In-depth interview 
Study Diagram/study sequence 
 
 

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4. Background Information and Rationale  
4.1. 
Introduction 
 
Racial/ethnic disparities in COVID-19 incidence, morbidity, and mortality rates have been marked since 
the earliest days of the pandemic in the U.S.8. Estimated death rates from COVID-19 for Black 
populations are 178/100k and 154/100k for Latino/Hispanic populations, compared to 124/100k among 
White populations and 95/100k among Asian populations27, attributed to structural racism and social 
determinants of health inequities28-30. Testing for COVID-19 is an essential component of the national 
strategy to control COVID-19, including for those who have delayed or declined vaccination1. Yet, rates 
of testing have dropped dramatically, which will hamper efforts to control COVID-19 spread31.  
The proposed two-year study responds to RFA-OD-21-008 which calls for community-engaged 
interventions to support COVID-19 testing in underserved and vulnerable populations. From the earliest 
days of the pandemic, social inequities between groups of workers, along with disparities in COVID-19 
incidence rates, have been striking32. We focus on a subpopulation of the more than 30 million workers 
in the U.S. who are placed at very high risk for exposure to COVID-19 because they must physically 
report to their jobs and cannot work at home, called frontline essential workers (FEW)33,34. Although 
there is no single definition of FEW, the Department of Homeland Security and the American 
Community Survey provide guidance on the occupational categories most likely to be FEW3. Among 
those at highest risk for exposure to COVID-19 but with the fewest protections is the large population of 
FEW in lower status occupations such as food preparation and serving, retail and sales, building and 
grounds cleaning and maintenance, personal care and service, and home health care3-6. Moreover, 
among FEW in these occupations, Black and Latino/Hispanic (BLH) persons are substantially over-
represented, and the majority of these BLH-FEW reside or work in geographical areas with high rates of 
socioeconomic disadvantage4-8. Although precise data on testing by occupation are limited, rates among 

7 
 
BLH populations are typically lower than among White populations9,10. Further, only an estimated 25-
50% of BLH-FEW are currently vaccinated10,11. The proposed study, therefore, focuses on BLH-FEW in 
these lower status occupations.    
The Centers for Disease Control and Prevention (CDC) recommend viral testing for SARS-CoV-2, the virus 
that causes COVID-19 (antigen and/or nucleic acid amplification [NAATs] tests), in the following 
circumstances. For those who show symptoms of COVID-19 (e.g., fever, chills, cough, shortness of 
breath, fatigue, muscle aches, headache, and loss of taste or smell), immediate diagnostic testing is 
recommended, along with a period of isolation, whether the individual is fully vaccinated or not12. 
Testing is recommended in additional circumstances for those not vaccinated. Diagnostic testing and re-
testing are recommended after exposure to someone with a confirmed or suspected case of COVID-1912 
and those diagnosed should remain in isolation until they meet local criteria for discontinuing 
isolation12. Further, testing asymptomatic persons without recent known or suspected exposure to 
COVID-19, but who are at risk for exposure, is critical for early identification, isolation, and disease 
prevention12. Indeed, persons with asymptomatic or presymptomatic infection are frequent 
contributors to community SARS-CoV-2 transmission. Among those groups the CDC recommends 
prioritizing for this screening testing include racial and ethnic minority groups and other populations 
disproportionately affected by COVID-19 and workers in high-density worksites or worksites with large 
numbers of close contacts to co-workers or customers (e.g., restaurant workers, grocery store workers) 
12. The proposed study, therefore, adheres to CDC guidance on priority populations, scenarios for SARS-
CoV-2 testing and mitigation strategies, and also aligns with local guidelines.  
RFA-OD-21-008 calls for community-engaged research. The proposed study is led by a collaborative 
team at New York University (NYU) and the Northern Manhattan Improvement Corporation (NMIC). 
NYU is a large research university. NMIC is a large and well-established community-based organization 
founded in 1979 that serves the diverse needs of BLH in vulnerable and under-served communities. The 
proposed study builds on NMIC’s experience with BLH-FEW, deep understanding of barriers to COVID-19 
testing among BLH-FEW, and expertise in implementing health promotion interventions in community 
settings. The research team at NYU is highly experienced designing and testing culturally salient 
behavioral interventions with BLH populations that address barriers similar to those that impede COVID-
19 testing35-37.  
4.1.1. 
Factors that promote or impede COVID-19 testing 
The study is informed by critical race theory in that we “center” the experiences of BLH-FEW, focus on 
racism and discrimination (not just race/ethnicity) and contextual barriers, attend to counter-narratives, 
and highlight strengths and resilience22. An emerging literature identifies barriers to COVID-19 testing 
for BLH-FEW populations that operate simultaneously at multiple levels of influence38, similar to other 
racial/ethnic health disparities30. The proposed study, therefore, is guided by the theory of triadic 
influence (TTI), a social-cognitive theory that articulates how individual, social, and structural levels of 
influence promote or impede health behavior23. These multi-level influences are shaped by the larger 
culture, primary among them structural racism, discrimination, and past and present maltreatment of 
BLH populations by institutions and systems39. Individual/attitudinal-level barriers to COVID-19 testing 
include insufficient knowledge about testing guidelines, and health beliefs and emotions such as low 
perceived risk for and low perceived severity of COVID (leading to COVID-19 being experienced as a 
distant threat), fear of consequences of a positive test (unemployment, eviction, deportation), distrust 
of institutional sources of information, and counter-narratives/conspiracy theories about COVID-19 and 
testing13-17. Further, there is growing interest in how cognitive biases and heuristics impede behavioral 
intentions to carry out a health behavior such as COVID-19 testing18. Indeed, individuals typically show 
evidence of biases in judgment and reliance on heuristic ‘‘shortcuts’’ for health decisions,40,41 such as 

8 
 
present-bias (the tendency to meet current desires or needs at the price of future beneficial outcomes) 
and information salience (acting on the information that first comes to mind rather than on all the 
relevant information available)42-44. At the social level of influence, social norms impede regular COVID-
19 testing (e.g., norms that support delaying or declining COVID-19 testing)13,19. At the same time, 
altruism and a sense of collective responsibility can be harnessed to support testing and tap into 
community resilience13,19. Structural-level barriers are systemic issues that impact one's ability to access 
a needed service45-47. Structural barriers impede access to testing. These include insufficient local testing 
sites, language barriers, and lack of paid sick leave20,21.  
 
4.2. 
The multi-phase optimization strategy (MOST) 
RFA-OD-21-008 highlights the need for rigorous research designs including the multiphase optimization 
strategy (MOST)48. The proposed study leverages the MOST framework to advance interventions for the 
challenge of insufficient COVID-19 testing uptake among BLH-FEW. The objective of MOST is to improve 
and strategically balance intervention effectiveness, affordability, scalability, and efficiency (“EASE”) 
using a three phase-model (preparation, optimization, and evaluation), and designs such as factorial 
experiments. The preparation phase entails identifying promising candidate intervention components 
and developing a conceptual model, and the optimization phase comprises the systematic testing of the 
candidate intervention components, the most promising of which, based on pre-specified criteria (called 
the “optimization objective”), can then be combined into a multi-component intervention48. This 
optimized intervention can then be tested in an RCT (i.e., the evaluation phase). MOST is economical 
because multiple intervention components can be tested simultaneously. By testing effects of individual 
components and their interactions, the MOST framework can determine which components contribute 
to effectiveness, how the presence of one component affects the performance of another, and which 
components can be eliminated to avoid including lengthy and costly components with little benefit.  
 
4.3. 
The optimization objective  
In MOST, the optimization objective is the criteria used to guide the decision making to create the new 
optimized intervention from the separate candidate components. The proposed study’s optimization 
objective is to create an efficient multi-component intervention from the candidate components with 
no inactive, poorly performing, or counter-productive elements. For example, depending on findings, 
the optimized intervention may be comprised of 1 or 2 of the most effective components and a core 
session (the standard of care). This new efficient multi-component intervention can then be rapidly 
implemented at NMIC and other community-based organizations for maximum public health benefit, 
and tested in future research. We have completed the preparation phase for the proposed study, as we 
describe in the next section. The proposed study seeks to carry out the optimization phase; namely, an 
efficient factorial experiment to test four candidate intervention components and from the most 
effective of these, optimize a multicomponent intervention. To date, NIH has funded more than 100 
studies using the MOST framework and our research team is highly experienced with MOST37,49. 
 
4.3.1. 
The preparation phase 
The overall goal of the preparation phase in MOST is to create a conceptual model and identify and 
refine promising candidate components to address theoretical mediators in the model (that is, 
candidate components that show acceptability, feasibility, and evidence of effectiveness). Over the past 
year, in collaboration with a CAB comprised of BLH individuals, including BLH-FEW, we explored the 
utility of the MOST framework for the problem of insufficient COVID-19 testing among BLH-FEW. We 

9 
 
used the ADAPT-ITT model50, a well-established framework for adapting evidence-based interventions to 
new populations, to guide the process of developing the conceptual model and identifying candidate 
intervention components for this problem. First, we assessed risk in the new population from the 
perspectives of CAB members and reviewed the literature on barriers to COVID-19 testing and potential 
solutions. We created a comprehensive conceptual model grounded in the TTI and informed by critical 
race theory that described multi-level barriers to COVID-19 testing (Fig. 1). We focused on important but 
modifiable barriers to COVID-19 testing. We grouped individual/attitudinal-level barriers into health 
beliefs and emotions (e.g., low perceived risk, distrust, fear) and cognitive biases and behavioral 
intentions. Insufficient knowledge was another important individual-level barrier. Social-level barriers 
focused on social norms that impede testing and factors that facilitate COVID-19 testing (altruism and 
collective responsibility), and structural-level barriers are those that impede access to testing. Next, we 
focused on how best to address these barriers, selecting clinical approaches and modalities of behavior 
change that align with TTI. With the CAB, we reviewed promising intervention approaches for each type 
of barrier, focusing mainly on our own past effective interventions with BLH populations. We prioritized 
candidate components that were brief or that would require only minimal staff time, to support future 
scale-up of the optimized intervention. All components are culturally salient in that they reflect the 
specific barriers to COVID-19 testing experienced by BLH-FEW. In an iterative process, we selected the 
following candidate components: A) motivational interview (MI) counseling, B) a text message (TM) 
intervention grounded in behavioral economics (BE), C) peer education, and D) access to testing (level 1: 
navigation to testing appointments vs. level 2: provision of a self-test kit; we explain why Component D 
contrasts alternative strategies in Approach). Further, we determined all participants would receive a 
core intervention comprised of the standard of care; namely, health education on COVID-19 testing and 
referrals to testing sites that provide FDA-authorized or approved COVID-19 testing, in compliance with 
CDC and local guidelines12. Third, we worked with the CAB to create the content for components (e.g., 
core messages for peer education in Component C, TMs), refined in an iterative fashion. In step 4 of the 
ADAPT-ITT process, we developed manuals for a core intervention session and the four candidate 
components while maintaining fidelity to the core elements, behavioral theory, and internal logic of the 
original evidence-based interventions. In step 5, the CAB reviewed the first drafts of candidate 
components, and feedback was incorporated (step 6). In a final step, we used qualitative cognitive 
interviewing51 with CAB members to “walk through” candidate components; then the feedback was 
incorporated. The study’s primary outcome is COVID-19 testing and secondary outcomes were identified 
(Fig. 1), including COVID-19 vaccination. Refinement of components will continue in the proposed study. 
Next, we briefly describe the evidence base for candidate components, which are described in the 
Approach.  
 
4.3.2. 
Addressing health beliefs using the MI counseling 
approach  
MI is an evidence-based directive and collaborative approach for behavior change that elicits 
participants’ values, perspectives, and questions, identifies ambivalence and discrepancies, and corrects 
misinformation with permission, to thereby foster durable intrinsic motivation and readiness for 
change52. In reviews and metanalyses, MI interventions, including single-session MI interventions56, have 
been found effective at clinically significant levels for a range of health behaviors53-55. MI has been found 
to be particularly effective with BLH populations compared to White populations58,59. As a non-coercive, 
strengths-based, and autonomy-supportive approach, it may have utility in particular when health 
beliefs and emotions such as distrust/fear impede behavior change60-63. Because MI does not rely on 
persuasion and is non-didactic, it has been recommended by the CDC for the problem of COVID-19 
testing and contact tracing57. We have used MI in numerous studies35,37,61,62, including an RCT for BLH 

10 
 
persons living with HIV who had delayed or declined HIV medication. Indeed, many barriers to HIV 
medication are similar to those that impede COVID-19 access (e.g., distrust, fear)64,65. The HIV 
intervention was feasible and acceptable and the odds of undetectable HIV viral load (the primary 
outcome) were more than five times greater in the intervention condition (OR=5.20)61. Component A 
will be comprised of a single counseling session using evidence-based MI techniques.   
 
4.3.3. 
Circumventing cognitive biases/changing behavioral 
intentions with behavioral economics  
Behavioral economics (BE) is a systematic framework to investigate human actions66. BE is grounded in 
traditional economics in that both perspectives accept the premise that people make decisions based on 
costs and benefits42,67. BE enriches traditional economics with insights from psychology42,66,67. BE 
recognizes that people have limited cognitive capacity and may feel overwhelmed when carrying out a 
complex task42,66,67.  Recent work grounded in BE uses incentive-based strategies, including lottery-type 
prizes, to motivate health behavior, while considering types of biases that impede such behavior (e.g., 
present bias)68. One major advantage to BE interventions is that they can address biases and improve 
behavior with minimal cognitive effort69. Further, BE interventions typically require less staff time than 
traditional counseling interventions70. Grounded in work by Linnemayr42, we have a program of research 
that uses BE approaches to overcome cognitive biases and change behavioral intentions through weekly 
text messages (TMs), quiz questions (QQs), and incentives and prizes to “nudge” participants toward the 
health behavior, HIV medication adherence71. Component B adapts this BE approach for the proposed 
study. 
 
4.3.4. 
Changing social norms 
The study seeks to change social norms that impede testing and harness altruism and collective 
responsibility using peer education. Peer-based interventions have demonstrated high rates of 
acceptability and effectiveness across a range of health outcomes72-74. Our own research uses the peer-
driven intervention (PDI) model created by Broadhead and Heckathorn75,76. In PDI, participants educate 
peers in their social networks on concise culturally specific core messages in support of a specific health 
behavior change. PDI is effective because messages delivered by peers typically have more credibility 
than from professionals76. Further, when individuals educate the peers in their network about the 
benefits of a certain health behavior, their own commitment to the desired behavior is strengthened in 
large part because the act of educating or urging peers is a public affirmation of the desired behavior. 
Through peer education, social norms in a network may be altered77. Moreover, providing participants 
the opportunity to deliver education to peers increases individuals’ self-efficacy and mastery of 
intervention content76. We used the PDI approach in a study addressing low rates of enrollment of BLH 
persons living with HIV in AIDS clinical trials. Barriers to AIDS clinical trials include those that impede 
COVID-19 access (e.g., social norms)78. PDI condition participants were 30 times more likely to be 
screened for trials than controls (49.3% vs. 3.7%; p<.001)62. In addition to the effects of the PDI as a 
whole, the experience of educating peers also increased odds screening for trials (AOR=1.4; p<.05)62. 
Component C adapts this approach and is comprised of training study participants to educate three 
peers who are in their social networks and, if possible, also BLH-FEW on core messages. 
 
 

11 
 
4.3.5. 
Circumventing structural barriers 
Navigation is an individualized efficacious intervention approach first designed to reduce disparities in 
cancer care for low-income women of color79-81. Navigators help identify and resolve barriers that 
individuals encounter to accessing a needed health service such as COVID-19 testing82. We have found 
the navigation approach to have utility in past studies, including because it is flexible and needs-based. 
Component D will address access barriers and have two “levels:” navigation vs. receipt of COVID-19 self-
test kits (Flowflex). We are experienced with biomedical testing components35,83.  
 
4.3.6. 
Significance and conceptual model 
The proposed study fills a need for interventions to encourage COVID-19 testing for BLH-FEW. 1. Clinical 
practice. The optimized intervention has the potential to provide efficient ways of increasing COVID-19 
testing in BLH populations. The study methods and optimized intervention are designed to be 
reproducible; that is, this method should yield comparable results in a range of locations and settings, 
and sustainable; that is, widely accepted in community-based organizations that serve BLH-FEW and 
other BLH populations. The optimized intervention will complement local and national efforts to 
increase COVID-19 testing. 2) Research. MOST has not yet been applied to the problem of insufficient 
COVID-19 testing. The proposed study has potential to increase the uptake of MOST for research on 
COVID-19 and similar disparities, in order to produce more effective, affordable, scalable, and efficient 
behavioral interventions. 3) Public Health. Public health will potentially be improved by providing tools 
that can increase rates of COVID-19 testing in BLH populations, for the current COVID-19 pandemic, 
similar or related disparities, and to better prepare for future pandemics.  
 
Figure 1. Conceptual model that guides the study  
 
 
5. Description of the intervention components 
General description of candidate components. Each component is guided by a manual in English and 
Spanish that includes handouts. Manuals will be comprised of a series of exercises and will be 

12 
 
constructed to be interactive and engaging. All candidate components are culturally salient and take a 
strengths-based and autonomy-supportive approach. Health information will be drawn from the CDC 
and will be reviewed for medical accuracy by a medical expert (Dr. Parameswaran, a study Co-I). 
Components address different theoretical mediators and are designed to be distinct from each other. 
For example, the TMs are informational health messages while the core messages for Component C are 
designed to tap into norms, altruism, and collective responsibility. The behavior change process for each 
component (e.g., MI, BE, peer education, or access) is compatible with the TTI. Each component has two 
levels: assigned/on vs. not assigned/off (Components A-C), or navigation vs. self-test kit (Component D).  
Core session: Standard of care (health education on COVID-19 testing). All participants receive a health 
education session (20-40 minutes) which comprises the standard of care. The goal is to increase 
knowledge regarding COVID-19 testing guidelines, types of tests, prevention and mitigation 
recommendations, and provide referrals to sites that provide FDA-authorized or approved COVID-19 
testing, and (optional), referral to no-cost COVID-19 vaccination site in addition to testing sites 99. 
Because all participants receive the core session, its effects on the primary outcome are not assessed. It 
will be included in the optimized intervention. 
 
Component A. 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. The session uses the Engage, 
Focus, Evoke, and Plan framework and draws on evidence-based MI techniques such as highlighting 
change talk and identifying discrepancy52 and supporting participant autonomy and personal decisions 
about COVID-19 testing. Uncovering and discussing the structural causes of health disparities such as 
structural racism and freely discussing fears and counter-narratives helps build motivation and 
readiness. The primary core elements of this component include evoking views on COVID-19 and testing 
(including its severity, skepticism, counter-narratives, distrust, fears) and why we have medical and 
institutional distrust and counter-narratives (historical factors and structural racism); with permission 
and using the Elicit-Provide-Elicit method, addressing perceived COVID-19 severity and the importance 
of testing by providing information and data on BLH-FEW using graphics and maps; rating readiness for 
COVID-19 testing in various scenarios (when symptomatic, when exposed, serial screening testing) on a 
1-10 scale and discuss; highlighting ambivalence and/or identify discrepancy between values and 
behavior to build motivation (as appropriate); and planning for testing. Theoretical targets: Health 
beliefs (perceived risk and severity, distrust of institutions, counter-narratives), emotions (fear of 
consequences if diagnosed including related to immigration status).  
 
Component A sessions will be audio-recorded for supervision purposes. 
 
VARIABLE: RECEIVED SESSION (YES/NO) 
 
Component B. Text messages (TMs) and quiz questions (QQs; 6 weeks). This component is grounded in 
principles of BE. 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 COVID-19 screening and other forms of 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. Those who provide the correct answer receive a message of congratulations and those who 

13 
 
answer incorrectly receive a TM with the correct answer. Participants earn modest compensation based 
on their points. Participants receive feedback by TM on the number of points received to date and 
reminders that they have the chance to earn compensation.  
 
Compensation: At the 6th week (e.g., at the 6-week follow-up assessment), those with high points (60-
120) receive $25 and the remainder receive $15.  
 
Participants also have a chance to spin a prize wheel win a lottery prize if tested for COVID-19 and 
documentary evidence is provided at the 6-week FU assessment (if tested, 3/10 chance of winning $50 
and 7/10 chance of $25, if not tested or no evidence provided, $15 participation bonus is provided). If 
participants wish to delay spinning the prize wheel until the second survey period, they may do that.  
 
The maximum compensation participants can receive for this component is $75. 
 
As a reminder, this compensation structure described above, with lottery prizes, is for the 
optimization trial phase only, not the refinement phase. In the refinement phase, participants will 
receive 3 weeks of TMQQs and do not have a chance to win a lottery-style prize.  
 
TMs are comprised of information about COVID-19 and testing from the CDC website. Examples of TMs 
include: regular testing for COVID-19 is still an important part of controlling the COVID epidemic; people 
who show signs or symptoms of COVID-19 such as fever, cough, and chills should get tested right away 
even if they have had COVID in the past or have been vaccinated; and people can get COVID-19 testing 
for free. Theoretical targets: cognitive biases, behavioral intentions   
 
VARIABLES:  
 
1) Any participation – at least 1 point 
2) “Dose” – number of points received 
3) Prize has an effect (they know they are getting a prize) 
 
Points are in REDCap 
 
Component C. 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, ideally, BLH-FEW 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. The core messages (Table 3) were developed with our CAB and the 
peer education procedures have been tested in numerous studies62,75,76.  
 
The component manual includes the following activities: a) Participants receive an overview of the 
component and a review and discussion of the core messages. b) Then, we review when and how to 
educate peers; namely: whom to approach (Persons who they know by name or face and have seen in 
the past 30 days who are aged 18 and older, who can conduct activities in English or Spanish, and who 
are not already enrolled in the study, ideally other BLH-FEW), when to approach (at a time that mutually 
convenient and that does not disrupt work), where peer education should take place (in a confidential 
and private location), how to avoid COVID-19 risk during peer education (adhere to public health 
prevention guidelines such as masking and social distancing or conduct peer education virtually), and 

14 
 
how to conduct the education (introduce the core messages using an IRB-approved script, discuss but do 
not coerce testing). c) Participants will receive materials such as the script, a wallet card with the core 
messages (to guide peer education), and three coded coupons that the peer can use to contact the 
study directly to complete the brief interview. d) Participants will be provided with referrals to COVID-19 
testing sites and COVID-19 vaccination in the event peers wish to discuss testing/vaccination. e) 
Participants are encouraged to conduct the peer education in the next 3 weeks; coupon numbers expire 
after that period of time.  
 
Peers contact the study directly, receive a brief assessment including age, race/ethnicity, sex, 
occupation, and true/false questions on the core messages, and are offered referrals to COVID-19 
testing and vaccination. These procedures are intended to motivate a thorough peer education 
experience by the peer and document peer education. Participants receive compensation (maximum 
$25) when the peer contacts the study. The peer also receives compensation for the brief interview 
($25). Peers are not eligible for enrollment into the factorial experiment. Participants can (and should) 
educate peers even if they have not been tested for COVID-19 or made their final decisions about 
testing. Theoretical targets: social norms, altruism & collective responsibility. More details on practical 
and ethical considerations for this component are found below.  
 
Table 3 provides the core messages, the true-false question associated with that message, the answer to 
the true-false statement, and a citation for the statement.  
CORE MESSAGE edited June 
16, 2022 
T/F statement for peer 
Answer 
Citation 
1. Regular COVID testing is 
still an important part of 
fighting the COVID-19 
epidemic in our community. 
COVID testing is no 
longer needed to fight 
the COVID epidemic. 
False 
https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/testing.html 
  
https://www1.nyc.gov/site/doh/covid/covi
d-19-testing.page 
 
2. Weekly COVID testing is 
recommended for people 
who are not fully vaccinated 
yet. 
The only time I need to 
get testing for COVID is 
when I'm exhibiting 
serious health 
symptoms. 
False 
https://www1.nyc.gov/site/doh/covid/covi
d-19-testing.page 
3. COVID testing is quick, 
easy, and available for free 
at hundreds of locations 
without an appointment. 
COVID testing is quick, 
easy, and available for 
free at hundreds of 
locations without an 
appointment. 
True 
https://www1.nyc.gov/site/doh/covid/covi
d-19-testing.page 
4. Many people don’t know 
they have COVID-19. 
Getting tested regularly is 
one important tool to 
protect yourself and your 
community. 
Getting tested for 
COVID regularly is an 
important tool to 
protect yourself and 
your community. 
True 
https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/testing.html 
5.  Regular testing matters 
more for groups affected 
the most by COVID-19, such 
as frontline and essential 
workers. 
Regular COVID testing is 
especially important for 
people  at highest risk 
for exposure to COVID 
True 
https://www1.nyc.gov/site/doh/covid/covi
d-19-prevention-and-care.page 

15 
 
such as frontline and 
essential workers. 
6. Many New Yorkers aren’t 
fully vaccinated for COVID 
yet, so getting tested 
regularly for COVID is critical 
for stopping the spread of 
COVID in our city. 
Experts recommend 
people who are not 
fully vaccinated for 
COVID get tested 
regularly to help stop 
the spread. 
True 
https://www1.nyc.gov/site/doh/covid/covi
d-19-testing.page 
7. There are different ways 
to get tested for COVID, 
including self-tests that can 
be used at home, and 
testing at a health care 
facility. 
There is only one way 
to get tested for COVID 
and that is by going to a 
hospital. 
False 
https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/testing.html 
8. Millions of Black and 
Latino essential and 
frontline workers are doing 
their part and getting tested 
for COVID-19. 
Millions of African 
American and Black and 
Latino essential and 
frontline workers have 
been tested for COVID. 
True 
https://www1.nyc.gov/site/doh/covid/covi
d-19-data.page 
9. If you think you’ve been 
exposed to the COVID virus, 
you can do your part by 
getting a COVID test as soon 
as you can. 
I DO NOT need to be 
tested for COVID if I 
think I have come into 
contact with someone 
who has COVID. 
False 
https://www1.nyc.gov/site/doh/covid/covi
d-19-prevention-and-care.page 
10. If you test positive for 
COVID, inform your health 
care provider or call 311 to 
find out what to do to keep 
yourself and your 
community safe. 
If I test positive for 
COVID, I should NOT tell 
my health care 
provider. 
False 
https://www.cdc.gov/coronavirus/2019-
ncov/if-you-are-sick/index.html 
https://tinyurl.com/3fsbmzt6 
 
 
VARIABLES 
 
1) educated at least 1 peer (range 0-3 peers) 
2) number of peers educated 
 
DATA ISSUES: Please note there are duplicate records for some peers (the same coupon number shows 
up more than once), and sometimes two different people use the same coupon number.  FERNANDA 
will clean that up. 
 
1. remove duplicates (if it is the same peer) 
2. if they educated 3 or fewer and used the same coupon number more than once (and it’s two different 
people) – keep the records – change the second ID number 
3. delete records if more than 3 (3 is the mx) 
 
WE CAN DESCRIBE: peers, who they are, % of T/F correct 
 
 
 

16 
 
Component D. Access (Level 1: Navigation to FDA-authorized or approved COVID testing, Level 2: 
Flowflex test kits). Level 1 (navigation meeting): In as single meeting (approximately 20 minutes), 
navigation includes guidance to assist participants in accessing, and completing COVID-19 testing in a 
timely fashion and resolving barriers such as transportation or the possible need to take off work if 
diagnosed with COVID-19. We will make an appointment for participants if they do desire. We will 
provide written resources for accessing COVID-19 testing a low cost or no cost 
 
Level 2 (self-test kits): We will provide them with Flowflex test kits (2 kits per participant) which can be 
given to them, picked up later, or mailed to them. We will review how to conduct the test, interpret 
results, its limitations, and the need to continue prevention guidelines where possible, and provide 
patient fact sheets as part of the test’s emergency use authorization, in accordance with CDC 
guidelines100.  
 
Component D contrasts alternative strategies for addressing structural barriers to testing, since these 
strategies would be likely to have an antagonistic interaction (each less effective when the other is 
present) if they were delivered as separate on/off components. Also, we believe some form of enhanced 
access needs to be part of any multicomponent intervention.  
 
VARIABLES 
 
TWO LEVELS: NAV vs. KITS 
 
1) attended NAV or KIT meeting (YES/NO) 
6. Eligibility criteria for peers as part of Component C 
(optimization trial) 
 
▪ 
Has a coded coupon  
▪ 
Age 18 years and older 
▪ 
Can carry out activities in English or Spanish 
▪ 
Resides in NYC 
▪ 
Not already enrolled in the NCAP study as a peer or participant 
 
We will assess whether peers are African American/Black or Latino/Hispanic race/ethnicity and  
FEW but these are not eligibility criteria. 
7. Practical and ethical considerations for Component C: Peer 
education 
It is essential that participants conducting peer education with their peers provide accurate and up-to-
date information, are not coercive, and that peers understand the nature of the interaction and what is 
expected of them. We are highly experienced in interventions that entail peer-to-peer education. Peer 
education will be carried out by participants using a set of core messages. Participants will be trained by 
research study staff on when, where, and how to educate peers. Participants will be provided with a 
handout that guide the interaction with peers.   

17 
 
 
Participants will be walked through a discussion of how to carry out peer education in a way that 
minimizes risk of exposure to COVID including conducting education virtually, outdoors, and the use of 
safety precautions such as masks.  
 
Participants will be trained to understand that peers should not be pressured or coerced into receiving 
peer education or contacting the research study. In the training, participants will be instructed on: 
 
1. WHO to approach: Persons who you know by name or face and have seen in the past 30 days. These 
peers should be aged 18 and older, and should not already be enrolled in the NCAP study. To maximize 
the benefits of this study, we recommend you educate frontline essential workers from African 
American or Black or Latino racial/ethnic backgrounds. 
 
2. WHEN to approach: at a time that mutually convenient and that does not disrupt work or other 
activities 
 
3. Where peer education should take place: in a confidential and private location 
 
4. How to avoid COVID-19 risk during peer education: adhere to public health prevention guidelines 
such as masking and social distancing or conduct peer education virtually  
 
5. What the participant should do, step-by-step: 
 
● Ask- Ask for some time with the peer.  
 
● Find – Find a private location (or carry out the encounter virtually) 
 
● Explain – Explain the main parts of what you want to say:  
o I am part of a research project called the NCAP Project 
o The goal of the NCAP Project is to bring information about COVID-19 testing to the 
community.  
o Today I will share some information I have been learning about COVID testing and 
treatment and ask you if you are willing to contact the NCAP study to do a brief 
interview. 
o You can tell me if you do not wish to have a discussion today and you can decline to call 
the NCAP study to do the interview.  
 
● Educate – Educate Peer On the Core Messages (found in Table 3 and on the handout) 
 
● Give – Give peer the Core Messages wallet card.  (This card will have the core messages and the 
study phone number) 
 
● GIVE – referrals to COVID-19 testing sites if needed (handout) 
 
● Explain next steps – Explain the following:  

18 
 
o NCAP is a research project to learn more about what people think about COVID-19 
testing and the best ways to support COVID-19 testing in the community 
o If you call NCAP, you would do a short interview on the phone or in-person. The 
interview includes some true/false questions on these Core Messages.  
o Peers would get $25 for the interview.  
o OPTIONAL – I will also get some compensation if you do the interview.  
o Provide peer with the coupon.  
 
 
Participants will be trained in talking tips:  
● Pick a good time. Make sure the person is not busy. Ask if you could take up 5-10 minutes of 
their time to discuss something. 
● Pick a good place. A place that is confidential and comfortable.  
● Stay neutral. Keep your voice calm and pleasant. Remember, that you are only offering to 
provide them with information. They have a right to not be interested or not want to listen.  
● Watch your body language. The messages you send with your body are as important as what 
you are saying to them. This is especially true if the peer you are educating is not very receptive.  
● Reflect and validate what they say…even if you disagree. Validating their opinions and what 
they say even if you disagree with them helps to diffuse any tension. Using words such as “I hear 
you” or “I think I understand what you are saying (e.g., that you don’t believe that COVID-19 
testing is right for you, etc.).  
 
8. The importance of medical accuracy of materials 
All materials and all information provided to the participants on COVID-19, COVID-19 testing, and 
vaccination will be reviewed regularly by our team medical expert to ensure that they are accurate and 
up-to-date (e.g., reviewing CDC and NYC Health information regularly and updating the information as 
needed). This includes the core messages for Component C (peer education). 
9. Description of the factorial design and figure 
A factorial experiment testing four intervention components, each with two levels, is comprised of 16 
conditions (24, see Fig. 2). Importantly, the design is not a 16-arm RCT. Factorial experiments separate 
component effects, enabling estimation of the main effect contribution of each component. Factorial 
experiments can be economical compared to alternative designs, because they require substantially 
fewer participants to achieve the same goals48. For example, conducting four individual experiments 
using the RCT design, one for each component, would require N=1792 (448 participants per trial). Thus, 
the purpose and logical underpinnings of the factorial experiment are different from those of an RCT. 
The purpose of an RCT is a direct comparison of the efficacy of two or more versions of an intervention. 
By contrast, a factorial design never calls for a direct comparison of experimental conditions to see 
which one is best. Instead, the purpose is to identify which components show effectiveness. Efficiency 
comes from basing all estimated main effects on all 16 conditions in the factorial experiment. For 
example, the main effect of Component C will be estimated by comparing the mean outcome across 
Conditions 1-8 vs. across Conditions 9-16. All participants are included in the estimate of each main 
effect. Factorial experiments can have a small per-condition N (N=28) and still achieve study aims if the 
total N (N=448) is sufficient. All participants receive the core intervention, two conditions (15 & 16) 

19 
 
receive 1 component (access, either navigation or a self-test kit), 2 conditions (1 & 2) receive all 
components, and the remaining 12 conditions receive 2-3 components (Fig. 2). 
 
 
10. Compliance Statement 
This study will be conducted in full accordance all applicable Policies and Procedures of the UCAIHS at 
NYU and all applicable Federal and state laws and regulations including 45 CFR 46. All episodes of 
noncompliance will be documented. 
 
The investigators will perform the study in accordance with this protocol, will obtain consent and assent, 
and will report unanticipated problems involving risks to subjects or others in accordance with UCAIHS 
and all federal requirements. Collection, recording, and reporting of data will be accurate and will 
ensure the privacy, health, and welfare of research subjects during and after the study. 
11. Study Objectives 
11.1. 
Primary aims 
 
11.1.1. 
Aim 1 
Aim 1. Identify which of four components contribute meaningfully to improvement in the primary 
outcome, COVID-19 testing with documentary evidence, and from these results, optimize an efficient 
multicomponent intervention. Participants will be English and Spanish-speaking BLH-FEW (ages 18-70 
years; N=448) in New York City who have not been tested for COVID-19 in the past six months and who 
are not vaccinated for COVID-19. Participants will be randomly assigned to an intervention condition, 
engage in the assigned components, and assessed at 6- and 12-weeks post-baseline.  
 
11.1.2. 
Aim 2 
Aim 2. Identify mediators (e.g., distrust, altruism, access) and moderators (e.g., sociodemographic 
characteristics) of the effects of each component to better understand the intervention components’ 
mechanisms of action and conditions under which they are most effective to advance future research 
and inform implementation of the optimized intervention. 

20 
 
 
11.1.3. 
Aim 3 
Aim 3. Explore the relationships among barriers to, facilitators of, and uptake of COVID-19 testing and 
COVID-19 vaccination. In qualitative research we will explore participants’ experiences with and 
perspectives on the intervention components and on COVID-19 testing and vaccination (N=50) and 
integrate qualitative and quantitative results using the joint display method to inform intervention 
implementation and future research. 
12. Investigational Plan 
12.1. 
General schema of study design 
The study design is presented in Figure 1 above. 
 
12.2. 
Refinement phase/pilot study 
We will carry out additional refinements of the components in this first phase of the study. We 
anticipate these to be minor (e.g., wording and length of exercises). To do so, we will form an 
intervention working group (IWG) led by Dr. Gwadz and comprised of the project coordinator at NMIC, 
the CAB, and Drs. Cleland, Hawkins, Parameswaran and senior project staff members. We will also form 
a community advisory board. We will carry out an initial review of materials and then carry out a pilot 
study with members of the target population. Participants will engage in the pilot test virtually or in-
person. Participants may engage in more than one 2.5 hour meeting depending on their interest and 
availability. 
Procedures for the pilot study in the refinement phase are as follows: 
▪ 
Potential participants will be recruited using the hybrid method described in this protocol (see 
below) 
▪ 
Verbal consent will be obtained for screening 
▪ 
They will be screened for eligibility using a structured instrument 
▪ 
Consent will be obtained for enrollment in the pilot study (signed consent if in-person or 
verbally if virtual contact) 
▪ 
Locator form completed 
▪ 
Intervention session comprised of a subset of intervention components and a cognitive 
interview lasting approximately 2.5 hours in-person, over Zoom, or in the phone 
o All participants will receive the core session 
o Participants will be asked to engage in two of the following: 1) one counseling session 
(lasting about 30-45 minutes) with a study counselor to discuss your health decisions, 
and discuss what you think about COVID testing; 2) receiving text messages over 3 
weeks (2 messages a week) with information about COVID and COVID-19 testing, along 
with quiz questions for which you earn 10 points for a correct answer and 5 points for 
an incorrect answer and compensation based on total points (max. points is 60); 3) 
training on peer education (15-20 minutes), where you will be trained to educate peers 
on core messages about the importance of COVID-19 testing, and you will be given the 
opportunity to educate three Black and Latino/Hispanic peers on these core messages, 
and  

21 
 
o Also, participants will be randomly assigned (by a coin flip) to receive navigation 
guidance to assist them in accessing COVID-19 testing OR FlowFlex rapid COVID test 
kits, along with instructions on conducting the test and interpreting results.  
▪ 
Some participants will have the opportunity to educate up to 3 peers. Peers will contact the 
study directly and receive a brief assessment.  
▪ 
Some participants will receive the TMQQs for 3 weeks after the initial meeting 
▪ 
A subset will receive an open-ended follow-up interview lasting < 60 minutes to review 
experiences with components and solicit perspectives on improving components. This will not 
be audio-recorded but notes will be taken. 
Sample size for refinement phase/pilot study: We will test the components with approximately N=30 
participants (6 participants for each component and the core session minimum) and up to 50 
participants as needed, since some components may need more pilot testing and refinement than 
others.  
Structure of the pilot study: The pilot study will be structured as a single meeting with participants 
lasting approximately 2.5 hours. In this meeting, participants will receive the core session, 2 components 
from among Components A, B, and C, and Component D (with level of component D decided by a coin 
toss) . Participants will receive the component and be asked to reflect on the clarity, acceptability, and 
utility of each major section of the component (the cognitive interview).  
Eligibility for the refinement phase: Eligibility criteria will be similar to the larger trial.  
1. age 18-70 years 
2. can engage in study activities in English  
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 the occupations listed in this protocol 
6. has a phone that can be used for study participation and can receive text messages 
7. is not “fully vaccinated” for COVID-19  
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. willing to be assigned to one or more intervention components 
Recruitment procedures for the refinement phase: These will be the same as recruitment procedures 
described for the larger trial.  
Each pilot test session includes an in-depth qualitative cognitive interview51 and an assessment of 
acceptability. Cognitive interviewing is a psychologically oriented method for empirically studying the 
ways in which individuals process and respond to survey questionnaires and intervention content51 (e.g., 
critique of each core message or TMQQ). The feedback and acceptability ratings, along with feasibility 
ratings, will be brought to the IWG for discussion and recommendations for refinement. If the 
intervention is not adequately refined at this point it will undergo another round of pilot testing.  
Peers in Component C: In addition, as part of Component C, 18 peers will be educated by study 
participants, will contact the study themselves, and will be assessed to evaluate Component C. This 
assessment will include brief semi-structured questions to explore the peer education process.  
Follow-up interview: In some cases, participants will be contacted for an unstructured, qualitative 
follow-up interview, including dates and types of COVID-19 testing and/or vaccination (showing test 
results or certificates where appropriate). The interview will take place within one month of the first 

22 
 
component test meeting. They will be asked to reflect back on the component and ways it was helpful 
and ways it could be improved.  
Goals of the refinement phase: At the conclusion of this phase, the intervention component protocols 
and study procedures will be complete, and assessments will be programmed in REDCap. Materials will 
be translated into Spanish. The activities in this phase are feasible: We will modify an existing REDCap 
database for a MOST study, and have already drafted and tested intervention component manuals.  
 
12.3. 
Study duration, enrollment and number of sites 
This is a 2-year study. There is one performance site (NYU). Study activities will be carried out by NYU 
study staff. 
 
12.3.1. 
Study location 
The study will be located in NYC. 
 
12.4. 
Total number of study sites/total number of subjects projected 
There is one study performance site (NYU). NYU manages field site spaces. The address of the NYU field 
site is NYU, 285 Mercer, 3rd floor, New York, NY 10003.  
 
A total of 48 participants (estimated minimum) will be enrolled in the refinement phase.  
 
A total of 448 participants will be enrolled in the optimization trial.   
 
Peers will be assessed as part of Component C (N=672) in the optimization trial.  
 
12.4.1. 
Duration of study participation 
Participants will be enrolled in the study for 12 weeks. 
 
12.5. 
Study population 
Adult Black and Latino/Hispanic frontline essential workers (FEW) in lower status occupations 
 
The occupations of interest are:  
▪ 
food preparation and serving (e.g., deli, bodega, restaurants, fast food) 
▪ 
retail and sales (e.g., grocery, drug, and convenience stores and other kinds of stores) 
▪ 
building and grounds cleaning and maintenance (e.g., janitorial services, security, reception, 
landscaping) 
▪ 
building and home construction (including carpentry) 
▪ 
personal care and service (e.g., in-home childcare workers, barbers, nail technicians, 
cosmetologists)  
▪ 
in-home health care services (e.g., home health aides) 
 
 Retail work is any type of employment that involves customer interaction and sales. Includes: 
▪ 
Sales associates are responsible for assisting customers as they look for products, keeping the 
store clean, ensuring the shelves are well-stocked and occasionally helping customers check out. 

23 
 
▪ 
Cashiers are responsible for checking customers out at the point of sale, helping customers 
return or exchange items and answering telephone calls at the sales desk area. 
▪ 
Inventory associates are responsible for managing inventory, recording the details of shipments 
and sales and stocking particular items in the warehouse or front of the house. 
▪ 
Customer service representatives manage online or phone-based customer comments, 
questions and concerns, resolve issues with customers and document customer interactions. 
▪ 
Warehouse clerks receive and manage goods and products, package and send orders to 
customers, maintain stock organization and track all products in the warehouse. 
▪ 
Assistant store managers maintain the employee work schedule, handle day-to-day store 
oversight, manage customer concerns and assist the store manager as needed. 
▪ 
And other job titles 
 
 
12.5.1. 
Eligibility criteria for the optimization trial and definitions 
where needed (REVISED MAY 2, 2023) 
 
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 frontline 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 text messages 
7) has not received any dose of a vaccine for COVID-19 (including booster doses) in the past 12 months 
(FORMERLY: is not “fully vaccinated” for COVID-19; see below for definition)   
8) has not been tested for COVID-19 in the past three months (FORMELRY: 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 
12) not a member of the study’s Community Advisory Board  
13) was not enrolled in the study’s refinement phase (the pilot study) 
Activities will be carried out in English and Spanish. 
Consistent with the NYC DOHMH, we define “fully vaccinated” as: People who have received either both 
doses of the Pfizer or Moderna primary vaccine series or the one dose of the Johnson & 
Johnson/Janssen primary vaccine series (https://www1.nyc.gov/site/doh/covid/covid-19-data-
glossary.page). 
Participants who do not meet all of the eligibility criteria will not be enrolled. Any violations of these 
criteria will be reported in accordance with UCAIHS Policies and Procedures.  

24 
 
13. Study Procedures for the optimization trial  
13.1. 
Participant identification number 
The participant identification number used on all forms will be comprised of 
 
▪ 
First two letters of first name 
▪ 
First two letters of last name 
▪ 
Birth date (MM/DD/YY) 
 
13.2. 
First screening interview (a three-step process carried out in a 
single interview) 
● Participants contact the study themselves by phone (text, phone, or email contact) or are 
approached by an NYU study staff member in an indoor or outdoor venue. Participants may 
contact the study themselves using an online contact form linked to a QR code in ads and flyers. 
 
● Consent: Potential participants will provide verbal informed consent for the screening interview 
following an IRB-approved script  
 
● Screening interview: After consent is obtained, they will participate in a brief (< 15 minute) 
structured screening interview using the Computer-Assisted Personal Interview (CAPI) format in 
REDCap to determine eligibility.  
 
● Part 1 will comprise basic demographic information including whether the participant resides in 
New York City. If participants meet the eligibility criteria in Part 1, they will continue to Part 2.  
 
● Part 1 will ask:  
o how participant heard about the study 
o how interview will be conducted (virtually or in person) 
o date of birth 
o age  
o can engage in study activities in English or Spanish 
o resides in NYC (by self-report and confirmed by eliciting a New York City mailing 
address.) 
 
● Part 2 will ask the remaining eligibility criteria, except for vaccination.  
 
● Part 3 will ask about vaccination and check documentary evidence of vaccination.  
 
● Part 3 includes eliciting documentary evidence of vaccination: There are three ways to 
document COVID vaccination status: 1) by accessing or allowing us to access the “My Vaccine 
Record” through NYC Health (as described in more detail below), 2) the participants may 
provide documentary evidence of COVID-19 vaccination such as the CDC vaccine card or 
MyChart record. They can provide a photograph of their vaccine card to the study; or 3) self-
report. This information will be entered into REDCap (dates and type of vaccine for each dose of 
vaccine).   
 

25 
 
● Those who do not meet all eligibility criteria in Parts 1 and 2 will not be asked to complete My 
Vaccine Record, since that is time consuming. But, they will be asked to provide their 
vaccination card or vaccination information by self-report.  
 
● Locator: Those found eligible and who did not complete the contact form will provide some 
locator information, to facilitate future contact and scheduling. Those who completed the 
contact form may not need to provide additional locator information at this stage. 
 
● Screening can take place in recruitment venues, the NYU study field site, or virtually. 
 
● During the informed consent process (for screening and enrollment), participants will be 
informed that their participation is voluntary and that their declining to enroll in the study will 
not affect any services or resources they might otherwise receive. They will be given 
opportunities to ask questions about the study. They can delay providing informed consent until 
another time and date.  
 
● Note that we will not compensate participants for screening.  
 
● Regarding COVID-19 precautions, NYU staff and other investigators and participants will follow 
NYU guidelines including completing the daily screener app, wearing face coverings, and social 
distancing, as appropriate. NYU staff and other investigators will be vaccinated for COVID-19 
and their COVID-19 vaccination card will be uploaded to the NYU health portal and approved.  
 
13.3. 
Procedures to access “My Vaccine Record” 
1. We will ask for the participant to access their vaccine records on “My Vaccine Record” through 
NYC Health.  
 
2. Send the participant the link/url to the “My Vaccine Record” website via text or email: 
https://myvaccinerecord.cityofnewyork.us/myrecord/ 
 
3. The participant will submit a certification statement that certifies that they are the individual to 
whom the vaccine record relates. 
 
4. The following information will be needed to search for the participant’s vaccine record:  
● Name 
● Date of birth 
● Sex assigned at birth 
● Mother’s first name and maiden name 
● Mother’s date of birth 
● Address at time of vaccination 
● Phone number at time of vaccination 
 
5. The participant will authenticate their identity by submitting their IDNYC number or by having a 
code sent to their mobile phone or email. The code will be entered to access the record.  

26 
 
 
6. Participants will be asked to save and send the vaccine record to the NCAP team. They can also 
print the file and bring it to their in-person interview.  
13.4. 
Enrollment, intervention, and follow-up phase 
13.4.1. 
Visit 1 (Enrollment) 
● Enrollment will take place at the NYU field site or virtually.  
 
● Participants will provide electronic signed informed consent in REDCap for enrollment, complete 
a more detailed locator form to facilitate longitudinal FU, and participate in a structured BL 
interview programmed in REDCap.  
 
● Consent: Those who participate virtually will provide verbal consent and a copy of the consent 
form will be mailed or emailed to them. Those who participate in-person can provide signed 
informed consent using the eConsent feature. A copy of the consent form will be provided to 
them. 
 
● Locator: Then, more detailed locator information will be obtained to facilitate future contact. 
 
 
● Baseline: They will then complete the baseline interview using CAPI and ACASI in REDCap. The 
baseline survey will last < 60 minutes.  
 
● Randomization: They will be randomly assigned to an intervention condition using a 
randomization table in REDCap.  
 
● Core session: Then, they have the opportunity to engage in the core session, or to schedule it 
for the next 1-2 weeks. Typically, the baseline and core session will be carried out on the same 
day.  
 
● Compensation and funds for local round-trip transportation provided  
 
● A thank you card will be sent to the participant by mail and electronically after enrollment (text 
will be IRB-approved) 
 
● The project will send birthday cards to participants by mail and electronically (text will be IRB-
approved) 
● The project will send regular holiday cards to participants by mail and electronically (text will be 
IRB-approved) 
 

27 
 
13.4.2. 
Intervention components 
 
● Intervention components will generally be administered after the baseline interview, and within 
the 1-2 weeks after enrollment. Components are brief or carried out mainly independently, thus 
Components A-D can be implemented in a single session.  
 
● Intervention components can be carried out in person at the NYU field site or virtually over the 
phone or Voice over Internet Protocol such as Zoom.  
 
● During the core session, participants will be reminded to collect and retain documentary 
evidence of any COVID testing for the follow-up assessments. 
 
13.4.3. 
Time 2 and Time 3 assessment (6-weeks and 12-weeks 
post BL) 
● Takes place in-person in a private office at the NYU field site or virtually 
 
● Within 2-4 weeks prior to the assessment, the participant will be contacted and reminded to 
provide documentary evidence of COVID-19 testing, if any, and to attend the follow-up 
interview even if not tested for COVID-19. Participants can provide evidence of as many tests as 
they like.  
 
● Participants will also be asked to provide documentary evidence of COVID-19 vaccination if they 
have it (e.g., the CDC vaccination card).  
 
● Follow-up (FU) assessments will be carried out 6- and 12-weeks post-BL in ACASI or CAPI in the 
REDCap platform. 
 
● The FU interviews will last approximately 35-45 minutes. The 6- and 12-week FUs will assess the 
period since the last interview. 
 
● The locator form may be confirmed or updated at each phone or in-person contact with 
participants 
 
● In-between FUs, participants may contact the study to update contact information. 
 
 
13.4.4. 
Qualitative in-depth interview (subset of participants; 
N~50) 
● Participants will be purposively sampled for the qualitative in-depth interviews for maximum 
variability on the following criteria: age, sex, language (English or Spanish), race/ethnicity, type 
of occupation, whether engaged in assigned components or not, and whether was tested for 
COVID-19 or not (N=50).  

28 
 
● We will explore participants’ experiences with and perspectives on the intervention components 
(including acceptability) and on barriers to and facilitators of COVID-19 testing, as well as 
barriers to and facilitators of vaccination, and on the relationship between COVID-19 testing and 
vaccination.  
● The qualitative interview will follow a semi-structured guide that has main questions linked to 
the conceptual model and probes. We will also attend to emergent topics.  
● Interviews will be audio-recorded and transcribed.  
● Qualitative and quantitative results will be integrated, as described below.  
● The qualitative sample size was determined following procedures outlined by Malterud119 called 
information power. Greater sample heterogeneity and a cross-case analysis strategy as we 
propose here call for larger samples; N=50 is a larger sample size. 
● Takes place in-person at the field site or virtually (phone or Voice over Internet Protocol such as 
Zoom) 
● 60-90 minutes 
● Compensation and funds for local round-trip transportation provided  
 
13.5. 
Acuity 
We will use the Acuity program for participant scheduling. In Acuity, participants can be sent a link with 
available slots and can schedule an appointment. They can enter their name and contact information 
and Acuity will send reminder texts or emails. 
 
The Acuity program maintains participant confidentiality. It is a password protected program (on a 
password protected computer) and participants see only available slots, not the names of other 
participants. 
 
Participants can schedule their own visits and we can use Acuity to schedule appointments for them.  
 
13.6. 
Preventing repeat enrollments 
Staff members will check and flag data as possibly fraudulent (i.e., the same person[s] attempting to 
complete the screening interview and/or enroll in the study multiple times) using an algorithm based on 
a combination of geolocation data, survey data, and personal information (Ballard et al., 2019). Data 
that will be reviewed by staff for potential fraud include geolocation outside the study area based on IP 
or mailing addresses, multiple entries from the same IP or mailing address address, phone numbers that 
are invalid or belong to a business or organization, phone numbers that match previous entries, unusual 
email addresses (e.g., containing alternating letters and numbers), email address that matches 
previous entries, date of birth/name that match previous entries, duration of the survey was less than 5 
minutes. Staff members will contact participants suspected of fraud to inform them that their entry was 
flagged and to request they contact staff members to verify their entry to receive compensation. 
Participants who cannot be verified will be determined fraudulent and not included in the final dataset. 
 
The informed consent forms state that participants should not take the survey more than once, and if 
this occurs, incentives will not be received more than once.  
 

29 
 
Ballard AM, Cardwell T, Young AM. 2019. Fraud Detection Protocol for Web-Based Research Among 
Men Who Have Sex With Men: Development and Descriptive Evaluation. JMIR Public Health 
Surveillance;5(1):e12344. 
 
13.7. 
Implementation manual  
The COVID-19 pandemic requires a rapid public health response but the rapid scale-up of effective 
interventions in community settings lags substantially116. The proposed study will draw on 
implementation science principles to support timely implementation of the optimized intervention if  
found effective. We will develop an implementation strategy manual, detailing requirements and 
recommendations for implementation in NMIC and similar community-based settings. To create the 
manual, we will conduct CAB meetings with stakeholders at NMIC including staff and clients who are 
BLH-FEW. Guided by the Consolidated Framework for Implementation Research (CFIR)117, the meetings 
will explore potential barriers and facilitators to implementation of the optimized intervention in 
community-based settings. The CFIR is one of the most widely utilized frameworks in implementation 
science117. It is a meta-theoretical framework that provides a standardized list of constructs found to be 
implementation determinants across five major domains117. We will probe for barriers and facilitators 
organized by CFIR domains: outer setting factors (i.e., funding, policies), inner setting (i.e., leadership, 
organizational readiness), the intervention (i.e., complexity), the people involved (i.e., self-efficacy) and 
the implementation process (i.e., planning). After each CAB meeting, we will map group suggestions 
onto existing implementation strategies118. Dr. Stanhope, a study Senior Advisor and expert on 
implementation science, will play a leadership role in this effort along with our partners at NMIC. 
Further, integrated qualitative and quantitative results from the factorial experiment will be presented 
to the CAB and included in the evaluation of implementation factors. Ultimately, the findings will form 
the basis of a manual providing tailored guidance related to the organizational context to support rapid 
adoption of the optimized intervention after the study is concluded. 
 
13.8. 
Subject completion/withdrawal 
Participants may withdraw from the study at any time without prejudice to their care. They may also be 
discontinued from the study at the discretion of the Investigator if they violate the study plan, due to 
adverse events, or to protect the subject or staff for reasons of safety or for administrative reasons.  
14. Study Evaluations and Measurements  
14.1. 
Screening assessment domains 
We will assess the following by self-report: 
1. Age  
2. Able to conduct activities in English or Spanish 
3. African American or Black and/or Latino or Hispanic race/ethnicity 
4. Residence in the NYC  
5. In the past month, was employed as a frontline worker in an essential occupation listed in this 
protocol 
6. Has a phone that can be used for study participation and can receive TMs (in the event the 
participant is assigned to Component B) 
7. Has not been fully vaccinated for COVID-19 (we will ask to see vaccine certificates if available 
but this is not required and those who have not received any dose of a vaccine will not have a 
certificate) 

30 
 
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 plasma 
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 
12. Not a Community Advisory Board member 
13. Willing to follow NYU’s COVID-19 guidelines (e.g., complete daily screener, facial coverings, 
social distancing) 
14. Willing to provide locator information 
 
14.1.1. 
Domains in the assessment battery (BL and FU), Table 4 
We will use the Common Data Elements developed by the RADx-UP group for the majority of domains 
described in Table 4. 

31 
 
 
Table 4. Description of the measures in the assessment battery (RADx-UP Common Data Elements will be used) 
 
Moderating influences 
Screening CDE 
Identity, Age, race/ethnicity, sex assigned at birth, preferred language (CDE), ZIP code of 
residence, essential worker (Are you considered an essential worker? An essential worker is 
someone who was required to go to work even when stay at home orders were in place.) 
Socio-demographics, background factors 
sexual orientation, gender identity, immigration status,  
 
racism and discrimination experiences, 103   
 
Health status - CDE 
 
Highest level of education – CDE 
 
Housing Employment and Insurance - CDEs 
 
Effects of COVID - CDEs 
 
Family income – CDE  
 
Past COVID-19 testing - CDE 
 
Medical History - CDE 
 
Other CDEs 
Alcohol and tobacco 
Alcohol and tobacco 
 
Work PPE and Distancing 
 
Individual/attitudinal influences 
Knowledge  
8-item true-false questionnaire on aspects of COVID-19104   
Perceived susceptibility to, severity of COVID-19  Wong perceived susceptibility to (three items), and perceived severity of COVID-19 infection 
(three items) scales105  
Perceived benefits of COVID-19 testing 
Guidry 4-item Perceived Benefits of COVID testing106; α = 0.82 
Distrust and fear of COVID-19 testing 
10-items assessed on a 5-point Likert-type scale drawn from existing reliable scales106-108 
Counter-narratives (conspiracy theories) 
6-items assessed on a 5-point Likert-type scale drawn from existing reliable scales (e.g., I could 
be a guinea pig for a test with unknown consequences). 109,110 
Cognitive biases 
Measurement of BE biases42  
Behavioral Intentions 
Various testing scenarios assessed with 3 items (e.g., I intend to get a COVID-19 test regularly) 
on a 6-item Likert scale106 
Motivation/readiness 
Importance of COVID testing and confidence in ability to get serial screening and tested as 
needed on a 1-100 scale.111  
 
Social influences 
Perceived social norms 
Adapting Latkin we will assess social norms using four items: injunctive (e.g., My co-workers 
encourage me to get a COVID test); descriptive (e.g., What percent of your co-workers do you 
think have gotten a COVID test)112. α = 0.77. 
Altruism & collective responsibility 
Three items on testing as an altruistic act (e.g., My getting tested helps my community reduce the 
spread of COVID)108  
 
Structural influences 
Structural barriers to COVID-19 testing 
Perceived barriers including poor access related to insufficient local sites, lack of paid sick leave, 
lack of childcare,  language barriers 113 
 
PRIMARY OUTCOME 
COVID-19 testing 
COVID testing behavior (see protocol for definition) 
 
SECONDARY OUTCOMES 
COVID-19 testing 
Confirmatory and/or re-testing, contact tracing (by participant), self-isolation, health care, 
unintended consequences of testing 
 
Testing behavior - CDE 
Vaccination 
Vaccine Acceptance - CDE 
 
Attitudes toward COVID-19 vaccination106-108, receipt of vaccination doses 
 
Intervention process domains  
Intervention acceptability 
Client Satisfaction Questionnaire (YCSQ) –17 items; reliable and valid measure 114 
Intervention social harms 
Assessment of project-related social harms experienced in social and occupational domains.  
 
Feasibility/Intervention dose 
Intervention dose 
Number of assigned components attended, if assigned: number of peers educated, navigation 
contacts completed and their characteristics/content 
 
 
 
 
 

32 
 
14.1.2. 
Assessment of peers as part of Component C 
Peers will call the study or carry out the assessment independently in REDCap. The peer coupon includes 
a QR code that brings peers to the peer assessment as well as the study phone number.  
 
If the peer is interviewed by a staff member, peers will provide verbal informed consent following an IRB 
approved form and receive a brief interview that includes their coupon number, age, race/ethnicity, sex, 
occupation, relationship to the participant, true/false questions on the core messages, COVID-19 testing 
experiences, and COVID-19 vaccination experiences. They will be given referrals to COVID-19 testing and 
vaccination locations as needed. 
 
If the peer follows the QR code, peers will read the informed consent form in REDCap and indicate their 
informed consent, then carry out the brief interview. 
 
We will collect some identifying information on the peer (name, email address, mailing address) in order 
to compensate the peer for the interview and inform the participant educator that the peer contacted 
the study.  
  
14.1.3. 
Qualitative interviews 
Qualitative interviews will follow a semi-structured interview guide with questions and prompts focused 
on barriers to and facilitators of COVID-19 testing and vaccination, and regarding acceptability of the 
intervention components.  
14.1.4. 
COVID-19 self-test kit (with FDA EUA) 
 
The present study does not test participants for COVID-19 but as part of Component D: navigation, half 
the sample will be provided with rapid antigen self-test kits for COVID-19 that has received U.S. Food 
and Drug Administration (FDA) emergency use authorization (EUA) or full FDA approval.  
 
We will provide the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). We will refer 
to this as the FlowFlex test.  
 
This test is provided in a white box. (FlowFlex tests in a dark blue box do not have FDA EUA.) 
 
An independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has 
indicated that the Flowflex™ COVID-19 Antigen Home Test does detect the Omicron variant in live 
clinical samples (https://www.aconlabs.com/flowflex-documents-new/). 
 
14.1.5. 
Update to Flowflex EUA – serial testing for asymptomatic 
or symptomatic individuals  is required 
 
On June 21, 2022, the FDA updated the Flowflex EUA letter 
(https://www.fda.gov/media/152700/download ) to require serial testing for asymptomatic 
individuals. As it is worded in the EUA, "the test is authorized for individuals with or without 
symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three 
days with at least 24 hours (and no more than 48 hours) between tests."  
 

33 
 
All RADx-UP projects using Flowflex must modify their testing strategy to ensure participants 
are informed that “testing” means they are tested twice over three days with at least 24 hours 
(and no more than 48 hours) between tests. 
 
The present study adherence to FDA guidelines. Study intervention materials and assessment 
instruments were revised to reflect these changes.  
 
14.2. 
Primary outcome  
The study’s primary outcome is COVID-19 testing confirmed with documentary evidence (e.g., a 
doctor’s note or patient portal electronic health record note [e.g., from MyChart] that includes the type 
of test, date of testing, and the result, or a photograph of a self-test result).  
As of March 16, 2022, the NYC Department of Health and Mental Hygiene recommends the following: 
“People who have frequent in-person contact with others and are not fully vaccinated should consider 
getting tested weekly. This is especially true for people in close contact with others who are not wearing 
masks indoors” (https://www1.nyc.gov/site/doh/covid/covid-19-testing.page). 
This is consistent with CDC guidelines: “The CDC recommends conducting screening testing of 
unvaccinated, asymptomatic workers without known or suspected exposures at least weekly ( 
https://www.cdc.gov/coronavirus/2019-ncov/community/organizations/testing-non-healthcare-
workplaces.html#anchor_1615914276994). 
14.3. 
Primary outcome definition and evaluation 
The study’s primary outcome is at least one instance of diagnostic COVID-19 testing in the past six 
weeks (that is, not antibody testing), confirmed with documentary evidence of the result (e.g., a 
doctor’s note or patient portal electronic health record note [e.g., from MyChart] that includes the type 
of test, date of testing, and the result, or a photograph of a self-test result or self-test results). 
The present study does not test participants for COVID-19. Instead, the present study tests a number of 
intervention components intended to increase regular COVID-19 testing in this population. Participants 
can receive testing at any community site or carry out home testing.   
The present study does provide half of the participants with FlowFlex test kits as part of Component D: 
navigation. Thus, we expect that many participants will use the FlowFlex test. (We provide two test kits 
in the self-test level of Component D. Starting in January of 2023, we inform participants in the self-test 
level of Component D that three tests are recommended in certain circumstances. We provide 
information on how to obtain tests.) 
Many self-tests require serial testing within a proscribed window of time in certain circumstances (e.g., 
BinaxNOW, Nano-Check, INDICAID, InteliSwab, Flowflex), while other tests require a single test. Tests 
with current EUAs are listed here: https://www.fda.gov/medical-devices/coronavirus-disease-2019-
covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-
tests-sars-cov-2 
The number of rapid tests required for a complete test for several of the serial rapid test kits has 
changed during the pandemic, including the test we use in the project (Flowflex). This makes assessing 
rapid test completion complicated. Thus, we will define an “instance” of COVID testing as any single 
time a COVID test was administered, whether a rapid, PCR, or other type of test. 
We will also assess test COMPLETION as a secondary outcome. Test completion is defined below. 
Thus, we will assess “instances” of testing for COVID-19 at follow-up and for each instance will assess:  

34 
 
▪ 
Main reason for testing (e.g., screening testing/asymptomatic, exposure, upcoming travel, 
return from travel, preparing for upcoming event, work requirement, symptomatic, other) over 
the prior 6 weeks.  
▪ 
Mechanism of test: Self-test (rapid) or self-test collection vs. facility-based testing 
▪ 
Type of COVID-19 test (rapid/antigen, PCR/molecular) 
▪ 
If self-test, brand name of self-test (e.g., FlowFlex, Inteliswab, BinaxNOW, etc). Participants can 
send a photograph of the test kit box to aid in determining which test was conducted.  
▪ 
Number of self-tests required in this instance  
▪ 
Number of self-tests carried out in this instance 
▪ 
If serial testing was carried out, number of hours between the first and second test 
▪ 
If facility-based testing was carried out, location of testing (laboratory, a standalone testing site, 
a doctor’s office or health clinic, hospital, other) 
▪ 
Dates of test(s) 
▪ 
Result of test(s) – positive, negative, inconclusive, unknown 
We will code these data regarding COVID testing behavior in the following manner:  
▪ 
For non-serial test kits: testing was PERFORMED COMPLETELY if one self-test was completed 
▪ 
For serial test kits that require two tests within a certain window of time (e.g., Flowflex until 
December of 2022, BinaxNOW), testing was PERFORMED COMPLETELY if two tests were carried 
out in compliance with the package instructions. If one test was completed, and no PCR test was 
completed, we will code the test as PERFORMED INCOMPLETELY 
▪ 
For serial test kits that require three tests within a certain window of time (e.g., Flowflex after 
December of 2022), testing was PERFORMED COMPLETELY if three tests were carried out in 
compliance with the package instructions. If one or two tests were completed, and no PCR test 
was completed, we will code the test as PERFORMED INCOMPLETELY 
▪ 
For serial test kits, if participants receive one self-test followed by a PCR test, testing will be 
coded as PERFORMED COMPLETELY  
▪ 
When participants receive a PCR test, testing will be coded as PERFORMED COMPLETELY  
We will request documentary evidence for the result of each test. Documentary evidence will be coded 
as present or absent for each test.  
14.4. 
Secondary outcome evaluation 
Secondary outcomes include:   
● Result of each COVID test 
● If diagnosed with or has a positive COVID test result 
o confirmatory testing, as needed (PCR testing is recommended for symptomatic negative 
and asymptomatic positive persons who carry out a rapid test) 
o contact tracing 
o self-isolation 
o health care receipt 
o unintended consequences 
For all participants: 
● attitudes toward COVID-19 vaccination  
● receipt of COVID-19 vaccination (the CDC vaccination card will be shown if possible)  
These primary and secondary outcomes will be examined in mixed methods and integrated analyses. 

35 
 
15. Statistical Considerations 
15.1. 
Sample size, precision, and statistical power 
For the primary outcome, COVID-19 testing by the final follow-up, we used PASS 2021139 to estimate the 
sample size needed for individual main effects of intervention components corresponding to odds ratios 
of 2.0 in logistic regression, given α=.05. Assuming participants not receiving or receiving the lowest 
intensity of each component have a 20% chance of testing by the final follow-up, a sample size of n=352 
(n=22 in each of 16 conditions) provides 80% power to detect an odds ratio of 2.0 (i.e., 20% vs. 33% 
tested). To account for attrition of up to 20% of enrolled participants, we propose a total sample size of 
448 participants (n=28 in each of 16 conditions), ensuring complete data for at least n=22 per condition. 
Given the proposed sample size, when the main effect of an intervention component on a continuous 
measure of a secondary outcome or mediator is estimated in a linear model or independent-samples t-
test, the sample size provides 80% power to detect a small standardized mean difference (d = .30). 
Moderator effects corresponding to an odds ratio of OR=1 in one subgroup and OR=4 in another can be 
detected with 83% power if subgroups sizes are roughly equal. To estimate the size of a mediated effect 
that can be detected given the proposed sample size, we use the approach described by Vittinghoff and 
colleagues140 as implemented in PASS 2021. Given a substantial correlation between an intervention 
component and a hypothesized mediator (r=.50), an odds ratio of 1.50 can be detected with >80% 
power for the effect of a one-SD increase in a continuous mediator on the COVID-19 testing outcome, 
controlling for treatment assigned. 
15.1.1. 
Missing data 
Missing data in longitudinal studies are inevitable despite best efforts at retention. Several procedures 
based on differing assumptions about the randomness of the missing data will be implemented157. 
Missing values may be handled by full information maximum likelihood (FIML)158,159. Inverse probability 
weighting160,161 and multiple imputation162 will be considered as well. These approaches to handling 
missing data assume data are missing at random (MAR). In addition, methods for non-ignorable missing 
data (missing not at random; MNAR) such as Heckman’s selection model158,163 and pattern-mixture 
models162,164,165 will be used. Sensitivity analyses will assess the degree to which results depend on 
untestable assumptions. 
15.2. 
Primary endpoint/outcome 
The primary outcome is at least one instance of COVID-19 testing in the past 6 weeks, with documentary 
evidence of the testing. 
15.3. 
Secondary endpoints/outcomes 
Secondary outcomes include:   
● Result of each COVID test 
● If diagnosed with or has a positive COVID test result 
o confirmatory and re-testing (as needed) 
o contact tracing 
o self-isolation 
o health care receipt 
o unintended consequences 
● attitudes toward COVID-19 vaccination 
● receipt of COVID-19 vaccination 
 
These primary and secondary outcomes will be examined in mixed methods and integrated analyses. 
 

36 
 
15.4. 
Data Transfer Agreement (DTA) Security Level 
 
As per our Notice of Award, data will be transmitted to the RADx-UP Coordination and Data Collection 
Center (CDCC) weekly.  
 
Our data security level is LIMITED. 
 
We will not provide: Names, street address (city, county, state, and zip code are allowed), Telephone / 
Fax numbers , email, Medical record numbers, Health plan beneficiary numbers. 
 
This corresponds to the following Common Data Elements (CDEs): first_name, last_name, 
current_street, current_street2, mobile_phone, home_phone, other_phone, personal_email, 
other_email, mrn 
 
All other data including the Tier 1 CDEs will be transmitted to the CDCC on the schedule determined by 
the CDCC (e.g., quarterly).  
 
 
15.5. 
Statistical methods 
15.5.1. 
Quantitative data analysis 
Intent-to-treat analysis will be our primary analytic approach and exploratory analyses will examine 
complier average effects of intervention components124,125. Approaches to missing data will include full 
information maximum likelihood estimation126 and multiple imputation127. In sensitivity analysis, missing 
data will be treated as failure to achieve the desired outcome. If data are missing not at random 
(MNAR), we will employ sensitivity analysis, using selection128 or pattern mixture129,130 models. 
Aim 1: Identify which of four components or interactions between components contribute 
meaningfully to improvement in the primary outcome, COVID-19 testing with documentary evidence, 
and from these results, optimize a multicomponent intervention. 
The primary outcome for Aim 1 is COVID-19 testing with documentary evidence by the final follow-up 
point (12-weeks post-baseline). Logistic regression will be used to estimate effects of components on 
the odds of COVID-19 testing. Intervention components will be effect-coded to estimate main effects, 
two-way, three-way, and four-way interactions of all four components (see Equation 1). The coefficient 
for an effect-coded main effect term (e.g., b1), multiplied by two and exponentiated, will estimate the 
effect of the component (e.g., Component A) on the odds of testing. Similarly, the coefficient for an 
effect-coded interaction term, multiplied by two and exponentiated, will estimate interaction effects 
between or among components on the odds of testing. Similar logistic regression analyses will estimate 
effects of components on secondary outcomes. 
Intervention optimization. Based on main and interactive effects estimated in Aim 1, we will use a 
decision-making process to select the most effective combination of component levels, eliminating 
ineffective or poorly performing components. The decision-making process will be led by Drs. Gwadz, 
Cleland, Lizardo, Bangser, and Parameswaran and using procedures outlined in Collins48. To identify 
Equation 1 
   
 

37 
 
important component main effects, we consider both statistical significance at p <.05 as well as the 
probability the more effective component level multiplies the odds of testing by at least OR=1.2. This 
effect size threshold is based on the idea that several components with an effect as large or larger would 
comprise a potent multicomponent intervention. We will use a Bayesian generalized linear model with 
non-informative priors to calculate the probability of OR ≥ 1.2 from the posterior distribution. 
Component main effects that are statistically significant (p < .05) and have a probability > .5 of OR ≥ 1.2 
will be considered important and placed into a screened-in set. Membership in the screened-in set will 
be reconsidered in light of any important interactions. Interactions that are statistically significant (p < 
.05) and have a probability > .5 of OR ≥ 1.2 will be considered important. For example, a component 
level that does not meet criteria for an important main effect could be included if it enhances the 
effectiveness of another component. Component levels that make up the optimized intervention are 
comprised of the higher levels from the screened-in set and the lower levels from the screened-out set.  
Aim 2: Identify mediators and moderators of the efficacy of each intervention component. To examine 
potential mediating mechanisms, analysis for Aim 2 will use the potential outcomes framework132-134. 
This framework highlights assumptions needed to identify direct and indirect effects of interest: no 
unmeasured cofounders of the exposure (an intervention component) and outcome (COVID-19 testing) 
relation; no unmeasured confounders of the mediator and outcome relation; no unmeasured 
confounders of the exposure and mediator relation; and no measured or unmeasured confounders of 
the mediator and outcome relation affected by exposure. Since intervention components are randomly 
assigned, the key issue for the proposed study is addressing confounding of the relation between 
mediators and outcomes. Mediators measured at baseline will be included as confounders of the 
relation between follow-up mediators and COVID-19 testing by the final follow-up. Because unmeasured 
confounding of relations between mediators and outcomes may remain despite attempts to measure 
and include known confounders in the models, sensitivity analysis will be undertaken to determine how 
the size of the correlation between error for the mediator model and error for the outcome model 
impacts inferences for direct and indirect effects. The total natural indirect effect (TNIE) and pure 
natural direct effect (PNDE) of each component will be estimated using the mediation R package135. The 
TNIE compares the outcome when subjects are exposed (e.g., receive a component), and the mediator 
varies as it would naturally under exposure, versus the outcome when subjects are exposed but the 
mediator varies as it would naturally in the absence of exposure (i.e., component not received). In other 
words, the difference estimated by the TNIE compares the expected outcome when the intervention has 
its natural impact on the mediator versus the expected outcome when the action of the mediator is 
blocked. The PDNE compares participants at different levels of a component (e.g., On vs. Off) when a 
mediator is blocked. 
Potential moderator effects will be examined by adding interaction terms to the model described for 
Aim 1. We will include sociodemographics (e.g., age) and occupation as covariates and explore the 
interactions of these variables with intervention components. When interaction effects are detected, we 
will estimate the simple main effects of the intervention component across levels of the moderator 
variable (e.g., MI counseling effects on testing for younger vs. older participants). Identified moderators 
will inform future adaptive interventions138. 
15.5.2. 
Qualitative analyses 
Aim 3. Explore the relationships among barriers to, facilitators of, and uptake of COVID-19 testing and 
COVID-19 vaccination. Coding and analytic methods of qualitative data from in-depth interviews will 
employ a directed content analysis approach141. Analyses will be carried out in the Dedoose platform 
and will begin with pre-determined codes based on the conceptual model (i.e., a “start list”), which will 
be expanded based on emergent findings. This start list fosters data integration across qualitative and 
quantitative data sets, because the same core constructs are assessed in each method. The primary 

38 
 
qualitative data analyst will lead the process of organizing codes into themes, in collaboration with an 
“interpretive community”142 made up of research team members at NYU (including study Co-
Investigators and the Senior Advisors, Drs. Hawkins and Stanhope) and NMIC. We will attend to 
trustworthiness and rigor in analysis using an audit trail and with member checking with the CAB and 
study participants. Integration of qualitative/quantitative results will use the joint display method26. A 
joint display is a state-of-the-art visual tool (i.e., a side-by-side visual presentation of results) to integrate 
data sources. Dr. Gwadz will lead the effort to integrate data with the interpretive community. This will 
be an iterative process in which each joint display table reveals insights about the merged findings that 
shape subsequent iterations. Thus, joint displays are both a method and a cognitive framework for data 
integration and facilitate the production of new inferences26. We are experienced with mixed methods 
data integration and joint display methods36,92-93,96,143.  
 
15.5.3. 
Data integration  
Integration of qualitative and quantitative results will follow procedures outlined by Fetters and 
colleagues (2013) and use the joint display method182. A joint display is a state-of-the-art visual tool (i.e., 
a side-by-side visual presentation of results) to integrate data sources. The process brings about new 
insights beyond the information gained from the separate quantitative and qualitative results. Drs. 
Gwadz will lead the effort to integrate data with the interpretive community (including CAB). This will be 
an iterative process in which each joint display table reveals insights about the merged findings that 
shape subsequent iterations. Thus, joint displays are both a method and a cognitive framework for data 
integration and facilitate the production of new inferences182. We are experienced with data integration 
and joint display methods183-185. 
 
All data provided to the CAB will be de-identified.  
16. Safety Management & Study Administration 
16.1. 
Data collection and management 
16.1.1. 
REDCap 
REDCap (Research Electronic Data Capture) will be used through all study phases. REDCap is a secure 
web-based application for building and managing online surveys and databases. Data can be entered 
from anywhere in the world over a secure web connection with authentication and data logging. It 
allows for multi-site access; that is, REDCap databases/surveys can be used by researchers from multiple 
sites and institutions. It includes features such as a built-in project calendar, a scheduling module, and 
reporting tools. REDCap can be installed in a variety of environments for compliance with such 
standards as HIPAA, 21 CFR Part 11, FISMA (low, moderate, high), and international standards. Only 
trained study staff will have access to the REDCap database. We have developed a comprehensive 
REDCap database for two ongoing studies and can adapt this database architecture for the proposed 
study. Thus private, identifiable information will be collected, but will be kept confidential. 
16.1.2. 
Protection of confidentiality in REDCap 
Participants will be identified by their Participant Identification Number in the REDCap database. A 
separate form linking participants’ names with the Participant Identification Number will also be 
included in REDCap. All consent forms will be signed in REDCap (the eConsent feature) and all 
assessments will be conducted in REDCap. Documentary evidence of COVID tests results will also be 
entered into REDCap. REDCap was designed specifically to protect patient and research participant 

39 
 
privacy and confidentiality while assisting investigators in conducting clinical research. The REDCap 
database can be shared among NYU authorized staff.  
 
We will use computer-assisted personal interviewing (CAPI) and audio computer-assisted self-
interviewing (ACASI) for sensitive sections of the assessments. In ACASI the respondent listens to 
digitally recorded questions and response categories through headphones, and enters her/his answers 
by using the computer keyboard or touching the computer screen. We have used ACASI with 
participants in past studies and found that participants were comfortable with using computers and 
appreciated the privacy it afforded. At each assessment period, the participant can opt out of the entire 
assessment or any part of the assessment. 
 
Audio-recordings and transcripts will be stored on NYU’s cloud-based and password-protected 
application, NYU Box. Recordings will be professionally transcribed within six months of collection and 
audio-recordings will be deleted within six months of transcription. Transcriptions will not include 
identifying information and are labeled with the participant’s identification number. 
 
Participant safety will be monitored by query regarding adverse events at all contacts and social harms 
in domains such as occupation, health care, and housing will be assessed at FU assessments.  
16.1.3. 
Locator form 
We are leaders in the development of successful tracking and retention strategies. Minimal contact 
information will be collected during the screening process. At the time of enrollment, after providing 
signed informed consent, the participant will complete a detailed locator form, which is stored in the 
REDCap database. The project staff member will solicit the names and contact information of at least 
three individuals who will know how to reach the participant in the future. Participants may provide the 
names of case managers and other professionals, as well as personal contacts. A locator form is a crucial 
component of the retention strategy. We will obtain email addresses, cell phone numbers, Facebook 
IDs, and other social media IDs, if participants are comfortable being contacted at these virtual 
locations. The project will maintain an open Facebook page to facilitate communication. The locator 
form is updated with participants at regular intervals. Participants are instructed to get in touch with the 
study if contact information changes. Staff will reach out to update locator information in between 
follow-up periods. 
16.1.4. 
Retention plan  
We will use a detailed locator form that is updated regularly, maintain regular contact with participants, 
ensure adequate, prompt, fair, and timely compensation with Clincard190 (funds are available to 
participants almost immediately), implement specific technical tracking strategies, and train all staff on 
retention strategies191. For the participant, contact info will include cell phone number, email address, 
physical address, and social media handles, as well as contact information for at least three individuals 
who will know how to reach the participant. Attrition is highest in the early phases of studies, and 
regular contact during this period fosters retention192. Thus, participants will be contacted within one 
month to update locator information. Participants will receive compensation if they contact the study to 
update contact information. (Compensation amounts are provided below.) We will send birthday and 
holiday cards to build rapport, and returned mail will help identify participants at risk of attritting. 
Tracking includes direct contact tracking and network-based tracking. This begins with text and social 
media messages, phone calls, and letters to the participant and individuals on the locator form; 
repeated attempts will be made as necessary. If place-based tracking methods are unsuccessful, we will 
initiate systems-level tracking (e.g., searching web-based directories). We will create a positive project 

40 
 
ethos to increase engagement (communicating respect, no judgement, confidentiality, autonomy/
choices) and tap into altruism191. We estimate > 80% of assessments will be completed.  
16.1.5. 
Data sources for optimization trial 
● Consent forms – screening, enrollment 
● Locator form 
● Structured assessment batteries: screening, BL, FU 
● Brief assessment of peers as part of Component C 
● COVID testing form (date, location/type of test, test result, type of confirmation, etc) 
● COVID vaccination form (date or dates of vaccination doses, type of vaccine) 
● Intervention component manuals 
● Qualitative interview guide  
16.2. 
Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies on subject privacy. The Investigator and other site personnel will not use such data 
and records for any purpose other than conducting the study.  
 
The safeguards to maintain subject confidentiality are described in the section on Data Collection and 
Management. 
 
Eligible participants are told about the longitudinal component of the study as part of the enrollment 
informed consent procedure, and the consent form states that we will try to contact them in the future 
and how we will do so. We inform participants that we will not disclose anything about them as part of 
the tracking process other than that they are a participant in a “community health project.” We will use 
a generic name for the study that does not disclose anything about the participant.  
16.3. 
Data sharing with RADx-Up 
The study will obtain permission from participants to collect and share de-identified data with the NIH 
RADx -UP Coordination and Data Collection Center (CDCC) and RADx Data Hub using specific language in 
the Informed Consent Forms (ICF).  
16.4. 
Regulatory and ethical considerations - Data and safety 
monitoring plan (DSMP) 
16.4.1. 
Data safeguards 
The project will maintain study offices in a field site maintained by the NYU Silver School of Social Work 
located in lower Manhattan. Access to NYU offices is restricted to research staff. The NYU Silver field site 
building is secure and monitored by security staff.  
The secure and password-protected REDCap database is used for study activities. Consent forms will be 
signed (as appropriate) and structured assessments will be conducted in REDCap. REDCap was designed 
specifically to protect patient and research participant privacy and confidentiality while assisting 
investigators in conducting clinical research. System-level and application-level security features include 
SSL encryption of internet traffic (e.g., https pages), hosting in a secure data center with nightly backup, 
fine-grained control over user privileges, detailed audit trails, record-locking, and de-identification 
functions for data export. Participants will be identified by their Participant Identification Number (PIN) 
in REDCap forms and assessments. Only research study staff have access to the REDCap database.  

41 
 
All computerized data that are not in REDCap (transcripts of qualitative interviews, audio-recordings) are 
kept on computers that are double password-protected and are only labeled with PINs. Audio files are 
transferred to a secure cloud-based storage system daily (NYU Box), which is also double password 
protected and available only to project staff. Audio-recordings are deleted within six months of their 
creation date.  
16.4.2. 
Confidentiality safeguards 
All participants receive a participant identification number (PIN). This number will be used for all 
materials, audio-recordings, transcripts, study visit notes, and assessments. No other information that 
would disclose the participant's identity will be found on any assessments, notes, audio files, or in the 
transcripts of qualitative interviews.  
 
Study staff do not collect paper forms; all materials are located in the secure REDCap database. 
Participants provide signed consent electronically and the signature is recoded in REDCap. Staff receives 
training about confidentiality. Participants will be provided a paper copy of the consent form that 
includes contact information for the research team PI and the IRB as appropriate. Participants can use 
this contact information to report adverse events or unanticipated problems. 
 
Names and other identifying information will be redacted from transcripts. 
16.4.3. 
Ethics training 
All research personnel will have completed Collaborative Institutional Training Initiative (CITI) training or 
an equivalent training before the research begins. 
 
16.4.4. 
Certificate of Confidentiality 
Participants will be informed that the study will obtain a Certificate of Confidentiality from the awarding 
institute at the NIH to support protection of their data. All data will be used strictly for research 
purposes.  
 
16.5. 
Collection and reporting of “Reportable Events” 
Several mechanisms will be put in place to monitor potentially adverse events that participants may 
experience while enrolled in the study, whether they are related to project participation or not. These 
events are classified as either Reportable, Adverse, or Not Harmful/Expectable, as described below, and 
will be reported to the IRB and Program Official at the study’s awarding institute (i.e., the Sponsor) 
accordingly, as described below.  
In accordance with federal regulations governing Institutional Review Boards (45 CPR 46 and 21 CPR 50 
and 56) and Guidance on Reportable Events from the Office of Human Research Protection, the Food 
and Drug Administration, and NYU, the IRB will review only unanticipated problems involving risks to 
participants or others. An unanticipated problem means that the incident, experience, or outcome is not 
expected (in terms of nature, severity, or frequency) given the research procedures that are described in 
the protocol-related documents, such as the IRB-approved research protocol and informed consent 
documents; and the characteristics of the subject population being studied.  
 
While there are many terms used by behavioral/social, clinical, and biomedical scientists to define a 
given type of reportable event (e.g., serious adverse event [SAE], adverse event [AE], adverse 

42 
 
experience, etc.), the IRB uses the following single definition for an immediate, single-incident IRB-
reportable event: A Reportable Event is an unanticipated problem involving risks to participants or 
others  (“Unanticipated Problem”) and any event or information that (1) was unforeseen and (2) 
indicates that the research procedures  caused harm to participants or others or indicates that 
participants or others are at increased risk of harm. (Other types of adverse events will be reported in 
aggregate or summary form to the IRB and Sponsor, as we describe below.) 
The following definitions are used by IRB at NYU: 
Unanticipated - An event is unanticipated when its specificity or severity is not consistent with, and not 
included in, the current investigator brochure, protocol, consent form, package insert or label; or 
unanticipated in its frequency, severity, or specificity.  
Related - An event is related to research procedures if in the opinion of the Principal Investigator, it was 
more likely than not to be caused by the research procedures or if it is more likely that not that the 
event affects the rights and welfare of current participants. 
Harmful - An event is harmful if it has caused harm to participants or others, or placed them at 
increased risk of harm. The harm does not have to be a direct harm to be reportable. The harm, as 
assessed by the Principal Investigator, may have created increased risk (e.g., losing a laptop with 
participant data such as an audio-recording). Additionally, the harm does not have to be harm to 
participants; it could involve risk to others (researchers, technicians, bystanders, the public, etc.). 
Note:  Non-medical events (e.g., breach of confidentiality, emotional breakdown, loss of insurance due 
to study participation, etc.), if unanticipated, would also be reportable to the IRB. 
Thus, some examples of Reportable Events for the present study might be the following: 
● Emotional breakdown requiring psychiatric intervention as a result of study 
participation 
● Suicidal threat or behavior as a result of study participation; namely, the serious threat 
or attempt to inflict serious bodily harm to oneself that may result in death 
● Serious violent threats or behaviors as a result of study participation including any 
threats, ideations or attempts to seriously injure or kill another person 
● Experiences of domestic violence as a result of study participation 
● Loss of employment or income as a result of study participation (participant was turned 
down for a new job, lost a job, or experienced other problems at work) 
● Loss of education as a result of study participation (participant was turned down by an 
educational program, told to leave an educational program, or experienced other 
problems at school) 
● Refused medical or dental care as a result of study participation  
● Problems with health insurance as a result of study participation (participant lost health 
insurance, had a problem getting new health insurance, or experienced other problems 
related to health insurance) 
● Problems with housing as a result of study participation (participant had trouble getting 
or keeping housing, or had other problems related to housing) 
● Incarceration of an enrolled participant through the study period because the study is 
not approved to include prisoners. (The present study will not be approved to conduct 
research activities with participants while they are incarcerated, and any subjects 
incarcerated during the course of the study and unable to attend study visits will be 
withdrawn.) 

43 
 
● An unresolved participant complaint that indicates a potential increase or unexpected 
risk  
● New information that presents a change to the risks or potential benefits 
● A deviation or violation from the IRB approved protocol 
● Unintentional direct or indirect violation of participant confidentiality by study staff. 
Table 5: Summary of Events Classification and Actions Taken 
Level of event 
Examples 
Action Taken 
Reportable 
(unanticipated, 
related to study 
participation, 
harmful) 
Hospitalizations at least overnight for any 
medical and/or psychiatric reason associated 
with study participation; suicidal or homicidal 
ideation related to study participation; 
incarceration of an enrolled participant through 
the study period; an unresolved participant 
complaint that indicates a potential increase in 
risk or unexpected risk; new information that 
presents a change to the risks or potential 
benefits; a deviation or violation from the IRB-
approved protocol; unintentional direct or 
indirect violation of participant confidentiality by 
study staff. 
 
(1) Report event to the IRB 
within 24 hours, (2) Report 
event to Sponsor’s Program 
Official within 24 hours, (3) 
Report additional details of 
event and actions taken to the 
NYU IRB and NIH Program 
Official within 72 hours, (4) 
Respond to requests for 
additional information by 
and/or recommendations 
from the IRB and NIH. 
Adverse but not 
“Reportable” 
(anticipated in the 
consent form or 
unanticipated, may 
or may not be 
associated with 
study participation, 
harmful) 
Hospitalizations at least overnight for any medical 
and/or psychiatric reason not associated with 
study participation; suicidal or homicidal ideation 
not related to study participation; drug overdose, 
namely, an emergency room visit and/or 
hospitalization due to a reaction to non-
prescribed medications not associated with study 
participation; life threatening or 
disabling/incapacitating events affecting health 
and well-being such as serious accidents or 
physical attacks that result in injury not related to 
study participation; death not related to study 
participation; serious distress as a result of study 
procedures. 
1) Document event on internal 
Events Log Form including 
whether it appears to be 
related to study participation, 
(2) Report events in aggregate 
or summary form to IRB 
annually, (3) Report events in 
aggregate or summary form to 
Program Official at NIH at the 
time of the Progress Report, 
(4) Provide clinical referral as 
appropriate at the time of 
event. 
Not 
Harmful/Expectabl
e (largely 
anticipated, not 
harmful) 
Mild to moderate distress or anxiety as a result of 
study procedures 
Not reported to IRB or NIH but 
provide clinical referral as 
appropriate at the time of 
event. 
 
16.5.1. 
Reporting of adverse events that are not “reportable 
events” 
Adverse Events do not meet the criteria to be considered a Reportable Event, may be unanticipated or 
anticipated (that is, described in the protocol or consent form), may or may not be associated with 
study participation, and are harmful or potentially harmful to the health and well-being of participants 
and others.  

44 
 
Thus, events uncovered during the course of the study will be classified as Reportable, Adverse, or Not 
Harmful/Expectable.  A description of these three types of events and the actions to be taken for each 
are presented in Table 5. 
 
16.6. 
Assessing events  
As means of assessing events, some of which may be Not Harmful/Expectable, Adverse, or Reportable, 
we will administer a Social Impact Form that prompts for events that could occur as a result of 
participation in a study. Social impact will be assessed using a structured interview at each FU 
assessment. This assessment will probe for social, psychological, physical, housing, and other problems 
that have occurred as a result of study participation.  
Furthermore, participants will be reminded to report problems, whether related or potentially related to 
study participation or not, to study personnel between scheduled assessments. They will be instructed 
on how to contact study personnel should problems occur between visits. Event impact will be formally 
and informally monitored, formally documented, and steps will be taken to prevent future similar 
events from occurring.  
When an event is reported, it will be documented on an internal Events Log Form. The Events Log Form 
will assess the details, seriousness, and outcome of the event. As noted in Table 5, events are 
categorized as Not Harmful/Expectable, Adverse, or Reportable. Dr. Gwadz will determine whether an 
event is Not Harmful/ Expectable, Adverse, or Reportable. 
 
16.7. 
Reporting of reportable events to the IRB  
The NYU IRB requires that researchers decide whether the event is RELATED, UNANTICIPATED AND 
HARMFUL before submitting a Reportable Event to the IRB. 
In the event that a RELATED, UNANTICIPATED AND HARMFUL event is reported to the Principal 
Investigator, Dr. Gwadz will use the NYU IRB’s report form to report the event to the IRB within 24 
hours of learning of it.  
The following events will also be treated as Reportable Events as noted in Table 5, and as required by 
the IRB: Incarceration over the study period of an enrolled participant when the study was not 
approved to include prisoners; an unresolved participant complaint that indicates a potential increase 
in risk or unexpected risk; new information that presents a change to the risks or potential benefits; a 
deviation or violation from the IRB-approved protocol. 
 
16.8. 
Reporting of adverse events 
Adverse events discovered during the study that are not Reportable according to the above criteria 
because they are not related to the research (but are harmful and unanticipated/anticipated), will be 
communicated to the IRB at the time of continuing review in summary or aggregate form, and to the 
Program Officer at NIH in aggregate/summary form in the annual Progress Report. Non-
harmful/expectable events are not recorded or reported to the IRB, as noted in Table 5.  
 

45 
 
16.8.1. 
Reporting of reportable events to NIH  
First, Dr. Gwadz will report the Reportable Event to the study’s Program Official at the NIH by phone or 
email within 24 hours and follow-up with a written report (by fax or email) within 72 hours, detailing any 
additional information and whether or not the event is related to participation in the study or may affect 
future participation in the study.  
 
16.8.2. 
Suspension of data collection, further IRB review, or 
modification of the protocol 
If the Principal Investigator determines that there is sufficient evidence of the need to suspend data 
collection, further IRB review, modification of the protocol, or other changes, the Principal Investigator 
shall make this recommendation to the Chairperson of the IRB. The IRB will reach a determination 
whether to suspend data collection or to stop the study from proceeding. Resumption shall be based on 
the concurrence of the Principal Investigator and the Chairperson of the IRB. The Program Official at NIH 
will be informed of this determination and will receive a report by email within 24 hours of any such 
suspension and/or resumption of data collection.  
16.8.3. 
Clinical care and referrals when adverse and reportable 
events are uncovered 
A plan has been developed for referral to clinical care in the event that Adverse and Reportable Events 
occur among the research participants. Individualized referrals to medical care, case management, or 
counseling for treatment or support will be made for participants experiencing Adverse and Reportable 
Events. In rare cases, referrals may be made for Non-harmful/Expectable events. Dr. Gwadz and the 
Project Director will determine the nature of the event, whether a referral is warranted, and the type of 
referral needed. Dr. Gwadz will ask whether the individual wishes to receive services in his/her 
community or outside it. A referral and follow-up with the participant within 24 hours will be completed 
to determine whether s/he made or attended an appointment.  
 
16.9. 
If no adverse or reportable events are identified 
The Principal Investigator will provide an annual summary report of all Adverse and Reportable Events 
to the IRB as part of the annual review. She will also report all Adverse and Reportable Events to the NIH 
as part of the annual Progress Report. If no Adverse or Reportable Events have occurred, the report will 
state, "No Adverse or Reportable Events affecting human subjects have occurred during this project 
year."  
 
16.10. 
Report of changes or amendments to the protocol 
Prior to implementation of the study protocol, the protocol, informed consent forms, recruitment 
materials, and other requested documents will be approved by the IRB. The responsible IRB will review 
the protocol at least annually. The Principal Investigator will provide progress reports to the IRB at least 
annually and within three months of study termination or completion. These reports will include the 
total number of participants enrolled in the study and the number of participants who completed the 
study. 
Substantive changes to the protocol that have the potential to affect study aims will be approved by the 
study’s Program Official at the NIH prior to submission to the IRB for approval. 

46 
 
Changes to the protocol will be submitted to the IRB for approval and will not be implemented prior to 
approval. 
The Program Official at NIH will be informed of any other (that is, any minor) changes to the study’s 
protocol on an annual basis as one component of the Progress Report. 
 
16.11. 
Risk assessment 
The study is minimal risk. 
16.12. 
Potential benefits of study participation 
The proposed study has high potential significance and high innovation. Testing for COVID-19 is an 
essential component of the multipronged national strategy to control the COVID-19 pandemic and 
reduce racial/ethnic disparities in COVID-19. 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 FEW in 
lower status occupations such as food preparation and serving, retail and sales, building and grounds 
cleaning and maintenance, personal care and service, and home health care. Among FEW in these 
occupations, Black and Latino/Hispanic (BLH) persons are substantially over-represented. Moreover, 
although precise data are limited, testing rates among BLH populations are lower than among White 
populations  and only an estimated 25-50% of BLH-FEW are currently vaccinated. Yet, testing for COVID-
19 is recommended in a number of scenarios for symptomatic and asymptomatic individuals in order to 
identify asymptomatic cases, break transmission chains, and reduce community transmission. Yet, BLH-
FEW have serious multi-level barriers to COVID-19 testing. The proposed study focuses on BLH-FEW in 
these lower status occupations and seeks to optimize an efficient and effective behavioral intervention 
to increase COVID-19 testing rates for this population. Participants may find the study activities useful.  
 
16.13. 
Importance of the knowledge to be gained 
BLH-FEW are at high risk for exposure to COVID-19, but have serious barriers to COVID-19 testing. The 
proposed study fills a need for interventions to encourage COVID-19 testing for BLH-FEW. The optimized 
intervention has the potential to provide efficient ways of increasing COVID-19 testing in BLH 
populations. The study methods and intervention components, and, therefore the optimized 
intervention, are designed to be reproducible; that is, this method should yield comparable results in a 
range of locations and settings, and sustainable; that is, widely accepted in community-based 
organizations that serve BLH-FEW and other BLH populations. Second, MOST has not yet been applied to 
the problem of insufficient COVID-19 testing. The proposed study has potential to increase the uptake of 
MOST for research on COVID-19 and similar disparities, in order to produce more effective, affordable, 
scalable, and efficient behavioral interventions. Last, public health will potentially be improved by 
providing tools that can increase rates of COVID-19 testing in BLH populations, for the current COVID-19 
pandemic, similar or related disparities, and to better prepare for future pandemics. The optimized 
intervention created in the proposed study will complement existing local and national efforts to 
increase COVID-19 testing. 
 

47 
 
16.14. 
Risk-benefit assessment 
16.14.1. 
Risks: Loss of confidentiality 
One risk to participants is loss of confidentiality. The research team will make every effort to protect 
participants' privacy and confidentiality. Nonetheless, it is possible that confidentiality may be breached 
as a result of participation in the study. It is also possible that negative social impact will result from 
such a breach. However, we are highly experienced with research with populations in from low-income 
backgrounds and in high-risk settings and with longitudinal tracking methods with populations at risk. 
16.14.2. 
Risks during assessment and intervention activities 
The risk of gathering information from participants in assessments and interviews and conducting 
intervention sessions with participants by properly trained and supervised professional staff is minimal. 
However, it is possible that participants may experience negative affect or distress from answering 
questions about COVID-19, and health in general. The project staff, including intervention facilitators, 
will closely monitor participants for potential distress. If assessments or interventions are unduly 
distressing, the participant will be debriefed and linked to mental health care or support services.   
16.14.3. 
Risks during interviews 
The risk of gathering information from participants in assessments and interviews by properly trained 
and supervised professional staff is minimal. However, it is possible that participants may experience 
negative affect or distress from answering questions about COVID-19, , and health in general. The 
project staff will closely monitor participants for potential distress. If assessments or intervention 
activities are unduly distressing, the participant will be debriefed and linked to mental health care or 
support services. 
16.15. 
Level of risk 
Overall, the level of risk to participants in the proposed study is low. 
 
16.16. 
Recruitment strategy 
We will use a hybrid recruitment plan with both active outreach and passive strategies to reach BLH-
FEW efficiently.  
The recruitment approach includes:  
● Flyers describing the study in English and Spanish. Study staff will use these flyers to directly 
recruit potential participants using ethnographic street recruitment methods (e.g., recruitment 
in parks and on the street)102 and in settings where BLH-FEW are located, but without disrupting 
work activities. These recruitment efforts will focus mainly on the ZIP codes with the lowest 
rates of vaccination (< 50% fully vaccinated)97.  
● Ads placed in the medical research section of free newspapers (e.g., amMetro, Latino Impact), 
and  
● Ads disseminated on social media (Twitter, Snapchat, Tik Tok, Facebook), Reddit, and Craig’s 
List.  
The recruitment plan does not include peer referral methods to reduce the probability of contamination 
across intervention conditions. 
16.16.1. 
Sampling for qualitative interviews 
Participants will be purposively sampled for the qualitative in-depth interviews for maximum variability 
on the following criteria: age, sex, language (English or Spanish), race/ethnicity, type of occupation, 
whether engaged in assigned components or not, and whether was tested for COVID-19 or not (N=50). 

48 
 
 
16.17. 
Informed consent/assent and HIPAA authorization 
NYU at Washington Square is not a HIPAA-covered entity. 
 
Consent will be obtained by NYU research staff. Participants will give verbal or signed informed consent 
prior to participation in all study activities. Informed consent will be obtained from highly trained and 
experienced research staff members. Participants will provide signed consent to have the qualitative 
interviews audio-recorded. Participants may decline to have their qualitative interviews recorded and 
still continue with the interviews. The voluntary nature of all study activities is emphasized in the 
consent forms.  
 
Consent will be obtained in a private and confidential location such as a private office. Ample time will 
be provided for participants to make their decision about whether to enroll. We will remind participants 
that their participation is voluntary to avoid coercion. Once enrolled, participants can decline to engage 
in any activity and remain in the study.  
 
As part of the enrollment consent, we will review each assessment and intervention activity and the 
potential risks and benefits of each. We will review the compensation amounts for each activity.  
 
We will emphasize that participation is voluntary, that participants are free to stop participation at any 
time and are free to refuse to answer specific questions in any assessment and can decline participation 
in any activity. Participants will be informed that their decision to participate or decline to enroll in the 
study or any aspect of the study will not affect any other services they receive elsewhere. 
 
16.17.1. 
Compensation: CAB members  
CAB members will be compensated $100 per meeting (~1.5 hour meeting) by Clincard, cash, or 
electronic gift certificate. 
 
CAB members are not Human Subjects.  
 
16.18. 
Compensation in Phase 1: Refinement phase pilot study 
Compensation will be provided as follows:  
▪ 
$125 for participating in the 2.5 hour meeting  
▪ 
$25 for the follow-up interview 
▪ 
If asked to engage in the peer education experience, $25 for each peer who contacts the study 
(up to 3 peers; participant receives $15 when the peer contacts the study and a $10 bonus if the 
peer receives a score of >50% on the true/false knowledge quiz. This is intended to motivate the 
participant to carry out the peer education.) 
▪ 
If receives text message component, $25 if earns at least 45/60 points from responding to quiz 
questions over 3 weeks (2 text messages and quiz questions a week) 
▪ 
Compensation for round-trip public transportation for these activities if they take place in-
person.  
▪ 
18 peers interviewed will receive $25 each  

49 
 
 
16.19. 
Compensation to participants: Phase 2 (optimization trial) 
 
Participants will be compensated for study activities in Phase 2 (the trial) as follows: 
● $30 for baseline interview and $5 bonus if documentary evidence of vaccination was shown at 
screening, either the CDC card or similar record or the My Vaccine Record website (max. $35) 
● $40 for each FU interview (max. $80) 
● $5 for showing documentary evidence of COVID-19 vaccination at FU, either the CDC card or 
similar record or the My Vaccine Record website (max. $10) 
● $35 for in-depth qualitative interviews 
● Core session: $30 
● Component A: $30 
● Component B: up to $75 for Component B depending on engagement in TMQQ  
● Component C: up to $75 (up to $25 per peer who contacts the study; participant receives $15 
when the peer contacts the study and a $10 bonus if the peer receives a score of >50% on the 
true/false knowledge quiz; 5 or more questions correctly answered receives the bonus) 
● Component D: $20 
● Peers assessed as part of Component C (N=672) receive $25.  (Peers will be compensated in cash 
or through an electronic gift card provided through the Tango platform or Amazon e-gift card) 
 
● Funds for local round-trip public transportation for in-person encounters  
16.19.1. 
Timing of compensation 
For all activities, compensation will be provided immediately after the activity is completed or as soon as 
possible after the activity is completed.  
 
16.19.2. 
ClinCard research participant compensation system 
Compensation will be managed with Greenphire’s ClinCard Program. ClinCard provides a cost-effective 
and HIPAA-safe payment solution utilizing anonymous, reloadable prepaid debit cards that allows 
organizations in the behavioral and medical sciences to streamline their payment operations and 
improve recruitment and retention. ClinCard is more efficient and less labor intensive than cash or check 
compensation systems. Participants are compensated upon completion of each visit. ClinCard payments 
are entered by the staff member into an online program, and funds are available on the participant’s 
card usually within one hour. We have found the ClinCard system to be acceptable to participants in 
past studies, and it is used widely at NYU and other academic and research institutions.  
 
 

50 
 
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