A Nurse-Community Health Worker-Family Partnership Model to Increase COVID19 Testing in Urban Underserved and Vulnerable Communities
Phase: NA
Conditions: COVID-19
Sponsor: New York University

 
 
 
 
 
 
 
 
1 
 
Evaluating the efficacy of a nurse-community health worker-family partnership 
intervention in promoting COVID-19 testing uptake in an underserved community:  
a study protocol for a randomized control trial 
 
NCT #: NCT04832919 
Document Date: 07/12/22 
Names of protocol contributors 
Dr. Vincent Guilamo-Ramos 1-3;contact information: vincent.ramos@duke.edu 
Dr. Holly Hagan4; contact information: hh50@nyu.edu  
Dr. Melody Goodman4; contact information: melody.goodman@nyu.edu 
Adam Benzekri1; contact information: adam.benzekri@duke.edu 
Marco Thimm-Kaiser1; contact information: marco.thimmkaiser@duke.edu 
Hanaan Osman1; contact information: ho2295@tc.columbia.edu  
Desiree Williams4; contact information: dw2483@nyu.edu  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
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Abstract 
Background: The impact of COVID-19 has been unequal across the nation in regards to number 
of cases, hospitalizations and deaths. Notably, primary strategies employed for COVID-19 mitigation at 
the national, state, and local levels (i.e. COVID-19 testing, vaccination rollouts, etc) often have 
inadequate reach in communities that experience COVID-19 disparities. Therefore, new approaches for 
COVID-19 mitigation are needed to more effectively reduce disparities. The current trial tests a novel 
approach by evaluating the efficacy of the Nurse-Community-Family Partnership (NCFP) intervention to 
improve primary (COVID-19 testing uptake) and secondary (COVID-19 vaccine uptake, adoption of 
COVID-19 infection control measures, household mutual aid capacity, and seasonal influenza vaccine 
uptake) outcomes in a community experiencing disproportionate COVID-19 morbidity, mortality, and 
barriers to mitigation.  
 
Methods: In this two-arm parallel randomized control trial, we will evaluate the efficacy of the 
NCFP intervention in improving the primary and secondary outcomes. We will recruit 150 households 
from the Bronx in New York City. These households will be randomized in a 2:1 ratio, 
intervention:control, using a computer-generated algorithm. The NCFP intervention will take place over 5 
months. The core components of the intervention include regular home visits by nurses and community 
health workers, development of a household-specific infection control plan, offer of at-home COVID-19 
tests, and navigation to COVID-19 vaccination and other ancillary services. NCFP intervention 
components and intensity is informed by a household risk algorithm (low, medium, high). All households 
will complete a baseline assessment, monthly follow-up surveys during months 1-6 post baseline, and a 
delayed 9-month follow-up survey. We will use intent-to-treat analysis to evaluate the efficacy of the 
intervention in improving the primary and secondary outcomes compared to the standard of services. 
Subgroup analyses based on select household characteristics will be conducted.   
Discussion: The NCFP intervention may have utility for mitigating COVID-19 at the household 
level—a novel and promising approach. If the trial achieves this, this care delivery model relying on a 
partnership between nurses, community health workers, and families will expand the available cadre of 
effective strategies for COVID-19 mitigation in underserved communities.  
 
Trial registration: ClinicalTrials.gov NCT04832919. Registered on April 6th, 2021.  
 
 
 
Keywords 
 
COVID-19, nurse-driven models of care, household intervention, testing, randomized control trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
3 
 
Administrative Information 
 
Title {1}  
Evaluating the efficacy of a nurse-community-family-partnership intervention in promoting COVID-19 testing uptake in an 
underserved community: a study protocol for a randomized control trial 
Public Title 
A nurse-community-family partnership program to increase COVID-19 testing in urban, underserved and vulnerable communities 
Scientific Title 
A nurse-community health worker-family partnership model: addressing uptake of COVID-19 testing and control measures 
Trial registration {2a and 2b}.  
ClinicalTrials.gov (NCT04832919) 
Date of First Posting: 04/06/2021  
Protocol version {3}  
Last updated: July 12, 2022 
Funding {4}  
Research reported in this publication was supported by the National Institute on Drug Abuse of the National Institutes of Health under 
award number 3P30DA011041-23S1. 
Author details {5a}   
1Center for Latino Adolescent and Family Health, Duke University, Durham, North Carolina, United States  
2 Duke University School of Nursing, Durham, North Carolina, United States  
3 Presidential Advisory Council on HIV AIDS, U.S. Department of Health and Human Services, Washington, DC, United States 
4 School of Global Public Health, New York University, New York, New York, United States 
Name and contact information for the trial sponsor {5b}  
National Institute on Drug Abuse of the National Institutes of Health, Bethesda, MD, 301-443-1124  
Role of sponsor {5c}  
The funding bodies will not influence the content or opinions expressed in future manuscripts, such as the study design, collection, 
management, analysis and interpretation of data; or writing of the protocol. 
Role of coordinating center {5d} 
The RADx-UP Coordination and Data Collection Center (CDCC), comprised of the Duke Clinical Research Institute (DCRI) and the 
UNC Center for Health Equity Research (CHER), is the coordinating center that oversees the RADx-UP program. The RADx-UP 
CDCC provides funding awards to more than 125 research teams across the United States and its territories as well as Tribal Nations. 
The RADx-UP CDCC is made up of four cores that provide central leadership and serve as the support team assisting the NIH and 
our project as we serve our community. The four cores include: the COVID-19 Testing Core, the Community Engagement Core, the 
Data Science and Biostatistics Core, and the Administrative Core. For more information visit this link.  
Contact for Public Queries 
Vincent Guilamo-Ramos; Vincent.ramos@duke.edu, 919-684-9444 
Contact for Scientific Queries 
Principal Investigator: Vincent Guilamo-Ramos, Vincent.ramos@duke.edu, 919-684-9444 
Principal Investigator: Holly Hagan, hh50@nyu.edu, 212.998.5221 
Data Sharing Statement:  
The project team will share all individual participant data that underlie the results reported in any future published manuscript, after 
deidentification (text, tables, figures, and appendices). The project team will make the data available beginning 3 months and ending 
5 years following article publication for investigators whose proposed use of the data has been approved by an independent review 
committee to conduct analyses to achieve the aims in their proposal. Proposals should be directed to Dr. Holly Hagan 
(hh50@nyu.edu). To gain access, data requesters will need to sign a data access agreement. 
 

 
 
 
 
 
 
 
 
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Introduction 
Background and rationale {6a} 
Despite concerted efforts at the global, national, and local levels to mitigate the impact of 
COVID-19, the pandemic continues to inflict far-reaching health, socioeconomic, and political 
repercussions globally. In the US alone, the COVID-19 pandemic produced devastating health 
consequences with more than 80 million cases and 990,000 confirmed or probable deaths due to COVID-
19 [1]. However, the impact of COVID-19 in the US has been unequal, with some communities 
experiencing substantially higher rates of COVID-19 cases, hospitalizations, and deaths. The disparities 
found in morbidity and mortality are driven by differences in exposure and susceptibility to COVID-19 
across communities, with the greatest observed COVID-19 disparities occurring in communities where 
both elevated exposure and susceptibility exist [2]. Numerous community-level factors are associated 
with greater risk of exposure to COVID-19. For example, communities with large proportions of front-
line workers who are in frequent face-to-face contact, heavily rely on public transportation, and live in 
crowded households located in densely populated areas are at a higher risk of exposure to COVID-19 [3]. 
Similarly, community-level factors can increase susceptibility to severe COVID-19 among those who are 
exposed. For example, communities that face poor access to timely health care, poor quality of care, and 
pre-existing health conditions are more biologically susceptible to COVID-19 morbidity and mortality [4-
10]. In the US, residents in structurally underserved communities with elevated exposure and 
susceptibility to COVID-19 are disproportionately people of color and families with household incomes 
below the national average. As a result, there are pronounced disparities in COVID-19 cases, 
hospitalizations, and deaths along the lines of race/ethnicity and socioeconomic status are reflected in 
national data [4-10].  
COVID-19 testing is one of the most important measures the global community has adopted to 
help mitigate the spread of the virus. Previous research demonstrates that testing was vital to slow the rate 
of transmission when undetected cases were widespread. Testing is also crucial in mitigating local spikes 

 
 
 
 
 
 
 
 
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and newly emerging waves of COVID-19. For example, a recent study showed college campuses across 
the US reduced the number of infection cases by 96% after imposing routine diagnostic tests of 
asymptomatic students [11]. Furthermore, early detection allows individuals to seek treatment before the 
illness progresses in severity and optimize their chances of survival. The importance of availability and 
uptake of testing for early detection of COVID-19 is particularly salient in the context of innovative 
antiviral medications (Sotrovimab, Nirmatrelvir-Ritonavir, Remdesivir, and Molnupiravir) that are 
currently available, and for which effectiveness appears higher early in the disease cycle [12]. According 
to Phase 2/3 results of the EPIC-HR study, the Nirmatrelvir-Ritonavir pill significantly decreased the risk 
of hospitalization or death by 89% for those who took the pill within the first few days of experiencing 
symptoms [12].  
While the significance of COVID-19 testing is well-documented, existing barriers prevent 
communities who need it the most from receiving it. For instance, long wait-times, sparse testing 
locations, fear of contracting the virus at testing sites, and language barriers were among a few of the 
concerns voiced by these underserved communities [13]. Additionally, undocumented and/or uninsured 
individuals face more challenges when testing sites impose restrictions to receive free COVID-19 tests. 
This highlights the growing need for new approaches to expand testing availability for all, particularly in 
communities with elevated risk of exposure and susceptibility to COVID-19. 
Throughout the COVID-19 pandemic, healthcare facilities helped increase testing rates by 
offering walk-in appointments, setting up drive-through sites, and sending out in-home testing kits [14]. 
While these strategies provide numerous options for individuals to get tested, it places the burden of 
seeking them out on the individual. Moreover, these options only accommodate those with their own 
means of transportation or those who can afford the high costs of at-home COVID-19 test kits. As a 
result, COVID-19 testing rates are disproportionately lower in underserved communities. Underserved 
communities that face structural barriers to COVID-19 testing tend to disproportionately make-up people 
of color. For instance, a study found that testing rates decreased as the percentage of ethnic-minority 

 
 
 
 
 
 
 
 
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residents residing in a New York City (NYC) neighborhood increased during the months of March and 
April of 2020 [15]. Existing evidence from health service delivery targeting other conditions suggests, 
nurse-driven approaches have utility for addressing these gaps. For example, an approach used regular in-
home visits by nurses to successfully improve parental care and maternal life course in low-income 
families [16]. This method of by tailoring service delivery to the unique contexts of underserviced 
communities presents an opportunity to improve reach of services and improve outcomes [16]. The 
implications of previous studies that use this strategy suggest similar nurse-driven approaches have the 
potential to address the challenges associated with COVID-19 testing. 
The current randomized control trial (RCT) tests the efficacy of a new intervention that draws 
from previous nurse-driven approaches, the Nurse-Community-Family Partnership (NCFP) program. 
Similar to existing nurse-driven approaches, the program consists of regular in-home visits by nurses and 
community health workers. These nurses will employ a range of infection control measures, such as 
frequent in-home COVID-19 testing. They will also work with families to create and monitor the practice 
of an infection control plan uniquely tailored to the household’s needs. Furthermore, community health 
workers will provide culturally appropriate support to the families, address stigma, medical mistrust, and 
help direct household members to a range of relevant services. This trial will be implemented in a sub-
community in the US that pose at a greater risk to exposure and susceptibility of COVID-19: NYCHA 
households in Mott Haven, a neighborhood located in the Bronx, NYC. This intervention is designed to 
increase COVID-19 screenings and access to results as a way to improve these health outcomes. The 
overarching goal of this project is to inform current and future initiatives related to COVID-19 mitigation 
in similar socioeconomically underserved communities and households of color. 
Objectives {7} 
The objectives of the study are to evaluate the efficacy of the Nurse-Community Health Worker-Family 
Partnership intervention to: 
a. Improve uptake of household COVID-19 testing 

 
 
 
 
 
 
 
 
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b. Increase adoption of COVID-19 control measures as defined by:  
i. Use of personal protective equipment (PPE) 
ii. Frequent use of hand disinfectant and handwashing 
iii. Maintenance of social distance 
c. Increase vaccine uptake 
d. Improve household-level mutual aid capacity as defined by family resiliency to 
secondary sequelae (psychological distress, financial insecurity, housing and food 
insecurity, job instability, substance abuse, and sexual behavior) and family cohesiveness.  
Trial design {8} 
This intervention study is a parallel, assessor-blind, randomized control trial. 150 households from public 
housing developments in the South Bronx, New York City, will be enrolled and randomized in a 2:1 ratio, 
intervention:control. Households will be randomly assigned to either the NCFP intervention group (n = 
100) or the treatment-as-usual control group (n = 150). The unit of random assignment and intervention 
delivery will be the household; however, the primary and secondary outcomes will be measured and 
analyzed at the individual household member-level. The study hypothesis is that the NCFP intervention 
will be superior to the standard level of care in improving the primary (household-level COVID-19 
testing uptake) and secondary (adoption of COVID-19 control measures, household-level mutual aid 
capacity, household-level COVID-19 vaccine uptake and seasonal influenza vaccine uptake) outcomes. 
The study consists of a baseline assessment, a 5-month intervention period, monthly follow-up 
assessments during months 1-6 and a delayed follow-up assessment at 9 months post-baseline. The study 
is registered with ClinicalTrials.gov (NCT04832919). A CONSORT flow diagram of the study is shown 
in Fig. 1. 
 
 
 

 
 
 
 
 
 
 
 
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Figure 1. CONSORT flow diagram 
 
 
 

 
 
 
 
 
 
 
 
9 
 
Methods: Participants, interventions and outcomes 
Study setting {9} 
Since the start of the pandemic, the Bronx has had the highest rate of COVID-19 cases (140 per 1000), 
deaths (4.7 per 1000) and the lowest rate of COVID-19 testing per capita (35 per 1000) compared to other 
boroughs [1]. Many of the health and economic inequities that characterize the Bronx have made it 
difficult to combat these outcomes. Households will be recruited from public housing developments in 
Mott Haven, a neighborhood located in the South Bronx, New York City. Eleven buildings located in this 
neighborhood will be the catchment area for recruitment.  
Eligibility criteria {10} 
Inclusion Criteria: 
• 
Residence in one of the public housing complexes in Mott Haven, South Bronx 
• 
English or Spanish-speaking 
• 
Age 10 years or older 
• 
Willing and able to provide informed consent or assent 
Exclusion Criteria: 
• 
Non-resident of one of the public housing complexes in Mott Haven, South Bronx 
• 
Neither English nor Spanish speaker 
• 
Younger than 10 years old  
• 
Unwilling or unable to provide informed consent or assent 
Who will take informed consent? {26a} 
A study staff member trained in human subjects protection will explain all study components, screen for 
eligibility, and obtain informed consent/assent from the participants. Participants who are 18 years or 
older will provide consent for themselves. Participants who are younger than 18 years will provide assent 
for themselves and their parent or legal guardian will provide consent for their child’s participation as 

 
 
 
 
 
 
 
 
10 
 
well. All eligible participants must provide written consent/assent prior to enrollment and randomization 
to one of the study arms. During the consent process, the study staff member will emphasize the measures 
that will be taken to ensure confidentiality is not breached, including the use of encryption software to 
protect any identifiers.   
Compensation:  
Participants will receive a gift card after the completion of each survey (at baseline as well as monthly 
during months 1-6 and at 9 months post-baseline). This will total to an amount of $270 United States 
Dollar (USD) in gift card value.  
Additional consent provisions for collection and use of participant data and biological specimens 
{26b} 
Participants will be informed that all assessments and COVID-19 test results will be de-identified. 
Participant names will be replaced with a unique identification number, which only research staff have 
access to. Additionally, the consent forms explain how saliva/nasal swab samples may be collected for 
COVID-19 testing use from enrolled participants in the intervention arm. Only identified positive 
COVID-19 test results will be reported by name to the NYC Department of Health as part of the NYC 
COVID-19 test reporting protocol. This research is covered by a Certificate of Confidentiality from the 
National Institutes of Health (NIH); therefore, the research personnel will not disclose or use information 
that may reveal participants’ names to any federal, state or local civil, criminal, administrative, legislative, 
or other action, suit, or proceeding, even if a court subpoena is issued. After the study is terminated, 
participants’ data may be used for future research or stored in a data repository without obtaining 
additional consent.  
Interventions 
Explanation for the choice of comparators {6b} 
This 2-arm randomized control trial will compare the efficacy of standard, publicly available COVID-19 
testing and messaging to a Nurse-Community-Family Partnership intervention.  The investigators 

 
 
 
 
 
 
 
 
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hypothesize that the NCFP intervention will improve household-level COVID-19 testing, COVID-19 
vaccine and seasonal influenza vaccine uptake, adoption of COVID-19 infection control measures, and 
mutual aid capacity for households in the experimental group compared to the standard of care control 
group.  
Intervention description {11a} 
Experimental condition 
The NCFP intervention is delivered by nurses and community health workers (CHWs) as part of a 
collaborative partnership with households over the course of 5 months. On average, there will be three 
nurse-CHW home visits to households randomized to the intervention condition per month. Each visit 
will last for approximately 45 minutes on average.  
The NCFP intervention prioritizes provision of intervention content based on three household risk levels: 
low, medium, and high. This intervention will use an algorithm to determine household-level risk to 
COVID-19. Low risk is defined by experience of no symptoms and no exposures by all household 
members. Medium risk is defined by experience of either symptoms (i.e. new cough, chest pain, fever 
above 100.4, and/or loss of taste or smell) or an exposure to someone with known or suspected COVID-
19 by any household member. High risk is established when a household member has a confirmed 
positive COVID-19 test. The algorithm will be informed by self-report of symptoms and exposures 
through a nurse hotline that is available for households placed in the intervention arm to use. 
Additionally, nurses will conduct weekly phone screenings to continue monitoring household symptoms 
and exposures. For households that are at low risk, the intervention delivery team will provide the 
standard intervention content, which consists of (1) development and follow-up of an infection control 
plan tailored to the unique circumstances of the household, (2) printed NCFP family materials, (3) offer of 
monthly routine Polymerase Chain Reaction (PCR) COVID-19 test (self-administered saliva test), (4) 
provision of PPE (masks, hand sanitizer, gloves) and a thermometer, and (5) navigation to at-home or 
community-based COVID-19 vaccination services, as well as health, social welfare, vocational, 

 
 
 
 
 
 
 
 
12 
 
economic, or other support services as needed. For households that are at medium risk, in addition to the 
standard intervention content, the intervention delivery team will offer a rapid antigen COVID-19 tests to 
household members who are experiencing symptoms or were exposed and conduct enhanced symptom 
monitoring (daily phone screenings of new or worsening symptoms for seven days after report of 
symptoms or exposure). For households that are at high risk, nurses will additionally offer rapid antigen 
tests to all household members, enhanced symptom monitoring with all household members, and provide 
isolation support and guidance. In the event household members display any other acute emergency, 
nurses and CHWs will coordinate with the clinical triage team, where they will conduct triage, medical 
case management, monitoring, referrals to care, and follow-up.  
In this intervention, nurses will supervise CHWs. Nurses will work with households on clinical and 
technical COVID-19 related issues, as well as build knowledge and skills that will help mitigate the 
spread and development of COVID-19 symptoms in households. For instance, nurses will offer routine 
in-home COVID-19 testing to all members of the household and deliver training on household infection 
control skills, including the safe and correct use of PPE, frequent use of hand disinfectant and 
handwashing, and social distancing techniques. The CHWs will serve as a culturally appropriate resource 
for families randomized to the intervention condition to ensure continued engagement and retention in the 
Nurse-Community-Family Partnership. CHWs will work with households to address expectancies, norms, 
and emotions that may represent barriers to COVID-19 testing and other related services. Additionally, 
CHWs will provide navigation to support services as needed.  
Treatment-as-usual condition 
Control participants will be informed of free COVID-19 testing, COVID-19 vaccination, and influenza 
vaccination sites located in the community and provided with the current NYC Department of Health 
standard COVID-19 information. 
Criteria for discontinuing or modifying allocated interventions {11b} 

 
 
 
 
 
 
 
 
13 
 
No plans to discontinue interventions. Intervention messages may be modified in accordance with 
changing scientific evidence on COVID-19, COVID-19 mitigation, and Centers for Disease Control and 
Prevention (CDC) guidance.  
Strategies to improve adherence to interventions {11c} 
There will be flexibility in scheduling NCFP visits (including on weekends), a reminder call to 
households before each scheduled visit to confirm, and reminders materials to highlight the importance of 
calling the nurse hotline in case of symptoms or exposure (e.g., a refrigerator magnet).  
Relevant concomitant care permitted or prohibited during the trial {11d} 
There will be no restrictions imposed.  
Provisions for post-trial care {30}  
At the end of the intervention phase, all households will receive information on available testing and 
vaccination sites in the community.  
Outcomes {12} 
The primary outcome of interest is the following: 
1. Household COVID-19 testing 
Household COVID-19 testing uptake at the 9-month follow-up (9MFU) with be the primary outcome of 
interest. Our project will document testing uptake that is either administered by nurses or self-
administered during home visits in the experimental arm, as well as self-reported information regarding 
COVID-19 testing uptake by study participants in the treatment and control groups. Participants will be 
asked whether they have received COVID-19 testing in the past three months, as well as about variables 
collected via the COVID-19 Symptoms, Diagnoses, and Testing scale. The COVID-19 Symptoms, 
Diagnoses, and Testing scale is adapted from the COVID-19 Cannabis Health Questionnaire. 
Specifically, participants will be asked questions regarding whether they are currently sick with an illness 
that might be related to COVID-19, any symptoms the participant experienced in the past three months, 
and the result of the participant’s last COVID-19 test. 

 
 
 
 
 
 
 
 
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The secondary outcomes of interest are: 
1. Household COVID-19 Testing Uptake  
All medical services delivered by nurses during home-visits (such as COVID-19 test administration) will 
be carefully documented by the investigative team. At the time of the 6-month-follow-up (6MFU) 
assessment, the project team will obtain self-reported information regarding COVID-19 testing uptake by 
study participants in the treatment and control groups. Respondents will be asked whether they have 
received COVID-19 testing in the past six months. Respondents will also be asked questions from the 
COVID-19 Symptoms, Diagnoses, and Testing scale regarding whether they are currently sick with an 
illness that might be related to COVID-19, any symptoms the participant experienced in the past six 
months, and the result of the participant’s last COVID-19 test. 
2. COVID-19 control measure uptake 
COVID-19 control measure uptake will be assessed using the COVID-19 Knowledge, Attitudes, and 
Avoidant Behaviors section of the Understanding America Study. Respondents will be asked questions on 
a 5-point Likert scale (Almost Never to Always), with higher values representing greater uptake of 
COVID-19 prevention behaviors (e.g., "Had close contact (within 6 feet) with people who do not live 
with you. "Gone out to a bar, club, or other place where people gather) and COVID-19 control uptake 
(e.g., "Worn a mask or other face covering." "Washed your hands with soap or used hand sanitizer several 
times per day"). COVID-19 control measure uptake will be assessed at the immediate follow-up (6 
months) and at the delayed follow-up (9 months).  
3. Vaccine Uptake 
The investigators will obtain self-reported information and documentation of influenza and COVID 
vaccine uptake by study participants at the 6-month and 9-month follow-up assessments. Respondents 
will be asked if they received the flu shot [Yes/No] and whether they received the COVID-19 vaccine 
[Yes/No], the type of vaccine, and the number of doses. 

 
 
 
 
 
 
 
 
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4. Household mutual aid capacity 
A set of measures will assess household mutual aid capacity, defined by the overall impact of COVID-19 
on food and housing insecurity, substance use, sexual behavior, psychological distress, and family 
dynamics and relationships.  
Participant timeline {13} 
 
STUDY PERIOD 
 
Enrolment 
Allocation 
Post-allocation 
Close-
out 
TIMEPOINT** 
Month 0 
Month 0 
Baseline 
Month 
1 
Month 
2 
Month 
3 
Month 
4 
Month 
5 
Month 
6 
Month 
9 
ENROLLMENT: 
 
 
 
 
 
 
 
 
 
 
Eligibility screen 
X 
 
 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
Allocation 
 
X 
 
 
 
 
 
 
 
 
INTERVENTIONS: 
 
 
 
 
 
 
 
 
 
 
Nurse-Community 
Health Worker-
Family 
Partnership 
 
 
 
 
 
 
 
 
 
 
Treatment-as-
usual 
 
 
 
 
 
 
 
 
 
 
ASSESSMENTS: 
 
 
 
 
 
 
 
 
 
 
COVID-19 
Symptoms, 
Diagnoses, and 
Testing Scale 
(PhenX Toolkit) 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
COVID-19 
Avoidant 
Behaviors Scale 
(PhenX Toolkit) 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
COVID-19 
Household 
Environment 
Scale 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
Self-Reported 
Vaccine Uptake 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 

 
 
 
 
 
 
 
 
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Sample size {14}  
Power for the proposed study was calculated using Power Analysis and Sample Size software based on 
household level randomization, individual level outcomes using conservative estimates and adjusting for 
15% attrition and allowing for subgroup analyses. A test for the difference in two proportions using a 
mixed model based on a clustered 3-Level Hierarchical Design with level-3 (household) 2:1 intervention: 
control randomization. The total sample size of 300, obtained from 100 level-3 units (households) in the 
intervention group and 50 level-3 units in the control group with an average of 2 level-2 units 
(individuals) per level-3 unit (household) and an average of 3 level-1 units (timepoints) per level-2 unit 
(individual), achieves >80% power to detect a difference between the group proportions of at least 0.15. 
The proportion in group 2 is 0.10. The correlation of level-1 units within a level-2 unit is <0.7. The 
correlation of level-2 units within a level-3 unit is <0.3. A test based on a mixed-effects logistic 
regression is anticipated at a significance level of 0.05. 
Recruitment {15} 
Recruitment from randomly selected households will begin with canvassing, when flyers will be placed in 
the building announcing the study. Study staff will talk to residents in the lobbies and courtyards about 
the opportunity to participate. Once study staff have adequately established their presence, the study 
recruitment team will move forward with door-to-door recruitment of randomly selected households. 
Once potential participants open their front door, the recruitment team will take the opportunity to explain 
the study. For interested households, the recruitment team will administer a screening questionnaire to 
assess their initial eligibility. If households are eligible and interested to enroll into the study, they will 
move forward to the consent process.  
Assignment of interventions: allocation 
Sequence generation {16a} 
The allocation sequence will be generated using a computer algorithm prior to the begin of study 
enrolment.  

 
 
 
 
 
 
 
 
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Concealment mechanism {16b} 
The allocation sequence will be coded into REDCap where it will only be visible to the REDCap data 
management team.  
Implementation {16c} 
Households that are enrolled into the study will be entered into the REDCap database, which 
automatically assigns a study ID. REDCap assigns the household study ID to either the experimental or 
control condition using the pre-generated and coded sequence. After completion of the baseline 
assessment (assessors are blinded), the REDCap data manager notifies the NCFP intervention team of 
new households that have been assigned to the experimental condition. The intervention team then 
contacts the household to begin the NCFP intervention program.  
Assignment of interventions: Blinding 
Who will be blinded {17a} 
The statistician and physicians that comprise the Data Safety Monitoring Board (DSMB) will be blinded 
to the allocation. Additionally, all study staff members who are involved with scheduling, coordinating, 
and implementing data collection will be blinded to the allocation (assessor blinded).   
Procedure for unblinding if needed {17b} 
In this trial, participants will be aware of the study condition they were assigned to. As such, procedures 
for unblinding will not be needed.  
Data collection and management 
 
Plans for assessment and collection of outcomes {18a} 
Data will be collected at eight time-points: baseline, monthly during months 1-6 of the study, and at 9 
months post-baseline. Participants will complete self-reported surveys that assess basic demographics 
such as birthdate, age, gender, race/ethnicity, educational attainment, etc. In addition to collecting basic 
demographics, the study surveys will contain items and scales from the PhenX Toolkit and the NIH 
Disaster Response website. These survey items and scales will assess participants’ household-level 

 
 
 
 
 
 
 
 
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COVID-19 routine testing, household-level COVID-19 indicated testing, COVID-19 vaccine uptake, 
adoption of COVID-19 control measures, household-level mutual aid capacity, and seasonal influenza 
vaccine uptake. All survey items developed by our team will be shared with the Rapid Acceleration of 
Diagnostics Underserved Populations (RADx-UP) Coordination and Data Collection Center and made 
public. Data will be collected via tablets that will be programmed in REDCap. Surveys are available in 
English and Spanish to facilitate, survey data collection. The survey may be self-administered or, in the 
case of low literacy or lack of familiarity with electronic devices, data collection staff will read prompts 
and record survey responses onto the tablets. Mode of administration will be recorded for later analysis of 
potential bias. To reduce social desirability bias, CHWs and nurses who deliver the NCFP intervention 
will not take part in the data collection process. Rather, data collection will be conducted by dedicated 
staff who are trained in survey research methods and human subject protections, including confidentiality. 
Additionally, social desirability tendency will be assessed using designated items in the study surveys. 
Furthermore, we will record participation rates for each household by member. 
Plans to promote participant retention and complete follow-up {18b} 
During the consent process, the study team will obtain extensive tracking information, including phone 
numbers, email addresses, and home addresses. Participants will be asked to provide contact information 
for three people who know how to reach them in most circumstances. These methods were used in 
previous work in the South Bronx with an attrition rate of 8% over 12 months [17]. Prior experience 
indicates that virtually all respondents will have a cell phone or access to a phone. However, as part of the 
consent process, we will obtain permission to revisit the home to make follow-up appointments if phone 
contact is not possible. Additionally, we will allow for flexibility in scheduling by conducting reminder 
calls before scheduled data collection appointments.   
Data management {19} 
In accordance with the NIH requirements, the clinical trial created a data and safety monitoring plan to 
protect participants’ privacy and confidentiality during the study. A DSMB will be established and be in 

 
 
 
 
 
 
 
 
19 
 
direct communication with the relevant program officer at NIH. The DSMB will be comprised of at least 
4 individuals (with a designated committee chair), who represent expertise in bioethics, statistics/ 
methodology, medical testing, vaccinations, and research knowledge in COVID-19 and infection control.  
Data will be collected by trained and supervised staff members on tablets that are programmed in 
REDCap. Access to the project’s offices are restricted to faculty and staff. The building is secure and 
monitored by security staff. File drawers containing participant information are kept locked when not in 
use. Only project staff members have keys to these file cabinets. Only the consent forms, locator forms, 
and computerized tracking database link the participant's name to the identification number. The 
computerized tracking database is kept on a password-protected folder on the NYU server, which requires 
a separate password to be accessed. Staff who are not members of the research team for this study do not 
have access to this folder. All computerized data (survey data, transcripts, and biological specimen 
results) are kept on computers that are double-password protected and files are only labeled with 
participant identification numbers. Files are sent to the NYU share drive for back-up, which is also double 
password protected and available only to project staff. A master database that contains participant 
identifying information and participant identification (PID) numbers is kept on the internal NYU share 
drive. This folder is double password protected and can only be accessed by the study’s staff members.  
Confidentiality {27} 
To protect the integrity of the participants’ data, the following procedures will be followed. First, all 
participants enrolled in the study are assigned a random code number. This code number is used on all 
information collected from participants, including consent forms, surveys, and biological specimen 
results. Participants will never be identified by name on consent forms, surveys, and biological 
specimens. No other information that would disclose the participant’s identity will be found on any 
assessment or notes. We will maintain a list of participants with links between identifying information 
and code numbers. Only the Investigative Team will have access to these lists, which are kept in on a 
password protected computer system. All data will be stored in locked files or on password protected 

 
 
 
 
 
 
 
 
20 
 
computers in the Principal Investigators’ and project statistician’s offices. As part of the informed consent 
process, participants will also be informed that all information they provide in interviews is confidential 
with the following exceptions: (1) If they are in imminent danger of committing suicide or homicide, the 
appropriate local agency will be contacted and (2) if they are physically or sexually abusing someone, the 
appropriate local agency will be contacted.  
All project staff must complete certain levels of training before working on the project. Study 
staff also sign confidentiality statements that specify that if the participants’ confidentiality is breached 
unintentionally, then study staff members will follow the procedures for reporting this breach to the 
Principal Investigators. The confidentiality statement also states that unintentional or deliberate violations 
of participants’ confidentiality may result in demotion or termination depending upon the severity of the 
event. Personnel also participate in training with the Investigative Team regarding data safety, 
confidentiality of participants, limits of confidentiality, and proper administration of the study protocol. 
We estimate that 40 hours of training will be completed by all project staff.  
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or 
molecular analysis in this trial/future use {33} 
Saliva/nasal swab samples from participants in the experimental condition may be collected for COVID-
19 tests. These samples will not be used for analysis or stored for future use. 
Statistical methods 
Statistical methods for primary and secondary outcomes {20a} 
SAS, M Plus, R, and/or Stata statistical software will be used for data analysis; statistical significance will 
be assessed as p<0.05. For the RCT, we will conduct analysis in two stages: cross-sectional analysis at 
each time point and subsequently conducting longitudinal analysis.  
Analyses for primary and secondary outcomes will include a descriptive examination of outcomes for 
participants at baseline, months 1-6, and 9 months post-baseline. These data are dichotomous (i.e. “Have 
you ever been diagnosed or tested positive for COVID-19 by a swab or a saliva test?”), nominal (i.e. 

 
 
 
 
 
 
 
 
21 
 
COVID-19 symptoms), and continuous (i.e. “If you had to guess, how many of your household/family 
members have been tested for COVID-19?”) in nature. Bivariate analyses will be conducted to examine 
associations between testing practices and key predictors (intervention group), confounders (i.e. previous 
infection or vaccination), moderators (i.e. essential worker status, testing fatigue), and demographic 
characteristics (e.g., age, gender, race, ethnicity). These differences will be examined in bivariate analyses 
(unadjusted) and multivariable analysis (adjusted).  
Interim analyses {21b}  
The data analysis team will conduct interim analyses every 6 months during the duration of the trial. The 
data analysis team will review data on recruitment, participant characteristics, protocol compliance, and 
study outcomes (improve household-level COVID-19 routine testing, household-level COVID-19 
indicated testing, COVID-19 vaccine uptake, seasonal influenza vaccine uptake, adoption of COVID-19 
control measures, and household-level mutual aid capacity). This analysis will also assess the differential 
proportion of self-reported COVID-19 infection between the two trial groups (a safety assessment of the 
trial primary outcome). There are no planned adjustments of the significance level due to interim analysis.  
Methods in analysis to handle protocol non-adherence and any statistical methods to handle 
missing data {20c} 
This trial will follow a per-protocol analysis to address non-adherence. We will analyze the results using 
both the intent-to-treat and per protocol analysis approaches. We will use the intent-to-treat approach 
when reporting the results. In addition, we will pursue the per protocol approach for sensitivity analysis. 
 
In some analyses, there is likely to be missing data due to a respondent not answering a question. In 
general, this occurs infrequently, but occasions may arise where missing data must be formally dealt with. 
Data can be missing at random (MAR), missing completely at random (MCAR) or missing in a 
systematic way that precludes application of simple methods of missingness, such as the Expectation-
Maximization (EM) methods. To gain perspective on the nature of the missingness for a given variable, 
we will create a dummy variable coded for each respondent as 1 = has a missing value on the variable in 

 
 
 
 
 
 
 
 
22 
 
question and 0 = does not have a missing value, and then test for associations between these variables and 
other variables in the models. We will also apply Little’s multivariate test for MCAR. Ideally, 
missingness will not be related to other variables. Missing data also can result from study attrition. We 
will differentiate these two sources of missingness and explore the dynamics of each. We will approach 
missing data using either Full Information Maximum Likelihood methods, multiple imputation methods 
or systematically model missing data bias, depending on the nature of the data and the models being 
evaluated. 
Oversight and monitoring 
Composition of the coordinating center and trial steering committee {5d} 
The overall study leadership and staff will implement the study as three separate teams: the data 
collection team, the intervention team, and the data management team. The data collection team will be 
overseen by Dr. Hagan and will implement all aspects of participant recruitment, enrollment/consent, and 
data collectors. The intervention team will be overseen by Dr. Guilamo-Ramos and will implement 
delivery of the NCFP intervention. The data management team will be overseen by Dr. Goodman and is 
responsible for data management in REDCap. These three teams are kept separate from one another to 
reduce the risk of contamination and allow the data collection team to remain blinded.  
Composition of the data monitoring committee, its role and reporting structure {21a} 
Data Safety and Monitoring Board will include a statistician/methodologist and two physicians who are 
highly experienced in study monitoring. The DSMB will review blinded reports of social or clinical 
outcomes and other adverse events.  
Adverse event reporting and harms {22} 
Adverse events will be brought to the attention of the principal investigators of the study. The events will 
immediately be reported to the Institutional Review Board (IRBs) at New York University (NYU) and 
Duke University. The event will also be reported to the Sponsor’s Program Officer and the DSMB 

 
 
 
 
 
 
 
 
23 
 
subsequently. The IRB will determine if it is necessary to halt or terminate the study or if modifications to 
the study protocol are needed.  
Plans for communicating important protocol amendments to relevant parties (e.g. trial  
participants, ethical committees) {25} 
Substantive changes to the protocol that have the potential to affect study aims or methods will be 
approved by the study’s Program Officer at NIH prior to submission to the NYU IRB for 
approval. Changes to the protocol will be submitted to the NYU IRB for approval and will not be 
implemented prior to approval. The Program Officer 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. All 
relevant changes will be reflected in the study’s clinicaltrials.gov registry.  
Dissemination plans {31a} 
The study’s results will be disseminated in peer-reviewed journals, national conferences, and other 
publications. Once the trial has concluded, all data that was collected will be stored in a repository. As we 
complete data analysis, our team will host community forums to disseminate the results to the community 
and develop a set of COVID-19 Best Practices. 
Discussion 
If successful, the NCFP intervention will be the first to form a partnership between nurses, 
community health workers, and families to help mitigate COVID-19 at the household level in 
underserved communities with a disproportionate impact of COVID-19. Previous literature has 
demonstrated that the risk of COVID-19 transmission is greatest inside the home. This particular nurse-
driven approach is novel because it addresses this issue by focusing on COVID-19 mitigation at the 
family/household level.  
National efforts to mitigate COVID-19 at the community level have been prioritized in hopes to 
reduce the rate of transmission through community spread [18]. For instance, current CDC guidelines 
suggests that if an individual was within close contact of someone who has a known or suspected case of 

 
 
 
 
 
 
 
 
24 
 
COVID-19, then the individual should remain at home and isolate from others to break the chain of 
transmission [18]. Additionally, the CDC recommends individuals who have been in close contact with 
someone who has a suspected or known case of COVID-19 to get tested immediately. While this strategy 
has proven to slow the rate of COVID-19 transmission, it does not take into consideration that the risk to 
contracting COVID-19 is much higher within a household. However, little to no guidance exists to help 
address this issue. More specifically, existing guidance are difficult to follow in communities like Mott 
Haven, where conditions such as crowded households, the inability to work from home, and frequent 
reliance on public transportation make it challenging to practice social distancing.  
The NCFP intervention addresses this shortcoming in several ways. First, the focus of the 
intervention is to help mitigate COVID-19 at the household level by developing a sustained partnership 
between nurses, CHWs, and families to increase the uptake of feasible strategies at home. Through 
regular at-home visits by nurses and CHWs, families receive relevant information on how to slow the rate 
of COVID-19 transmission at home and be offered COVID-19 tests free of charge.  The NCFP 
intervention also helps to create an infection control plan that is uniquely tailored to each household’s 
circumstances. Therefore, the mitigation strategies these households practice will make a difference in 
minimizing the COVID-19 impact at home. Through this sustained partnership, the intervention delivery 
team will build a relationship with these households based on mutual trust and cooperation, so households 
will be more inclined to incorporate COVID-19 mitigation behavior in their daily routine.  
There are a few limitations that should be considered in this trial. First, the outcome measures 
relied on self-reports, which may be biased on the basis of social desirability and recall. The random 
assignment of participants will ensure that an equal amount of social desirability will be present in both 
study arms; therefore, social desirability will not bias the results. The study’s outcomes will also be 
assessed on a monthly basis to eliminate any recall bias. Second, we recruited participants in a single 
geographic and clinic setting, so overall generalizability to other settings should be considered. However, 
recruitment from Mott Haven will increase generalizability to underserved communities that have also 

 
 
 
 
 
 
 
 
25 
 
faced a disproportionate impact of COVID-19. Third, there is a possibility that cross-contamination may 
occur between the intervention and control groups. Meaning, there is a chance the control group may 
receive some portion of the intervention material without intending to. The research team has taken 
measures to prevent this from happening. The intervention delivery team (nurses and CHWs) will not be 
in contact with the control group at any point during the study. The research staff that do interact with the 
control group (i.e. through the recruitment process) will not have any knowledge of the intervention 
material; therefore, the language they use when recruiting or consenting the control group will not allude 
to what the intervention group will specifically receive. The intervention study arm will also be instructed 
to not share any intervention material with other families in their community. Furthermore, there is a 
possibility that not all eligible household members may be completely enrolled. For instance, there may 
be cases where a particular eligible age group within a household decides to not participate in the study. 
Nonetheless, this should be true in both study arms due to random assignment, so the chances of results 
being systematically skewed for one study arm and not the other arm would be low.  
The NCFP intervention may offer an opportunity to improve COVID-19 mitigation strategies for 
underserved communities. The study is novel for integrating a care delivery team that is capable in 
assessing and meeting the needs of families who have been disproportionately impacted by COVID-19. 
We predict this program can be effective in improving COVID-19 testing uptake, COVID-19 vaccination 
uptake, COVID-19 infection control measures and seasonal influenza vaccine uptake in these 
communities. If the trial successfully achieves this, we infer this care delivery model has the potential to 
join national efforts in fighting COVID-19 by expanding the cadre of effective mitigation strategies 
designed for households.  
 
 
 
 

 
 
 
 
 
 
 
 
26 
 
Trial Status 
Trials guidance: Authors should report the protocol version number and date, the date recruitment began, 
and the approximate date when recruitment will be completed. 
Protocol Version 1: ____________ 
Recruitment Start Date: July 23rd, 2021 
Current Status: Recruiting 
Anticipated End Date: July 31, 2022 
 
Abbreviations 
Trials guidance: If abbreviations are used in the text they should be defined in the text at first use, and a 
list of abbreviations should be provided. 
COVID-19 
NCFP: Nurse-Community Health Worker-Family Partnership 
PPE: Personal Protective Equipment 
CHW: Community Health Worker 
PCR COVID-19 Test: Polymerase Chain Reaction COVID-19 Test 
CDC: Centers for Disease Control and Prevention 
PASS: Power Analysis and Sample Size 
DSMB: Data Safety Monitoring Board  
RADx-UP: Rapid Acceleration of Diagnostics Underserved Population 
NIH: National Institutes of Health  
MAR: Missing At Random 
MCAR: Missing Completely At Random 
EM: Expectation-Maximization  
IRB: Institutional Review Board 
NYU: New York University 
USD: United States Dollar 
 
 
Acknowledgements 

 
 
 
 
 
 
 
 
27 
 
Funding {4} 
 
Research reported in this publication was supported by the National Institute on Drug Abuse of the National 
Institutes of Health under award number 3P30DA011041-23S1. 
 
Ethics approval and consent to participate {24} 
 
The institutional review boards at New York University and Duke University approved the study 
protocol. The clinicaltrials.gov primary register database approved the protocol on 04/06/2021.  
 
All written consent from participants are obtained prior to enrollment. 
 
Consent for publication {32} 
 
N/A 
 
Competing interests {28} 
 
The principal investigators declare no financial or competing interests.  
 
Author’s Information (optional)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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