Identifying and Addressing Critical Social, Ethical, and Behavioral Factors Associated With COVID-19 Testing and Vaccination Among Spanish Speakers
Phase: NA
Conditions: COVID-19, Vaccinations
Sponsor: Wake Forest University Health Sciences

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Study Title: Identifying and addressing critical social, ethical, and behavioral factors associated with 
COVID-19 testing and vaccination among Spanish speakers 
 
Principal Investigators: Scott D. Rhodes, PhD, MPH; Amanda E. Tanner, PhD, MPH 
 
Co-investigators: Alain Bertoni, MD, MPH; Mark Hall, JD; Thomas P. McCoy, PhD 
 
Sponsor or funding source: NIH 
 
Background, Rationale and Context 
 
Significance 
 
Latinx communities in the US are disproportionately affected by COVID-19.5-7,33 Latinx (a gender-
inclusive term34,35 that we use to refer to Hispanic/Latino populations in the US) persons comprise 18.5% 
of the US population and as of June 19, 2021, comprised 28.8% of US COVID-19 cases.36 Latinx persons 
are 2 times more likely to contract COVID-19 than their non-Latinx White counterparts, 2.8 times more 
likely to be hospitalized from COVID-19, and 2.3 times more likely to die from COVID-19.1 These 
disparities are even more profound among Spanish speakers and Spanish-speaking immigrants.1-7  
 
Ongoing testing and vaccination are critical to effective control of the pandemic; however, complex 
issues contribute to low rates of COVID-19 testing and vaccination within Spanish-speaking Latinx 
communities.5-8,37 Factors that pose challenges to testing and vaccination include poverty, limited 
resources, and institutional and structural barriers (e.g., discrimination and limited transportation). Latinx 
persons may: lack access to culturally congruent information about COVID-19 testing and vaccination, 
including eligibility and how to access these services; believe they are not at risk for COVID-19; worry 
about missing work due to a positive test result or vaccine side-effects; and assume that they have to pay 
for a test or vaccine. Other challenges include fear of engaging with government systems (including 
public health) and of the long-term health implications of testing and vaccination. These barriers are even 
greater among those who do not speak English, are undocumented, and/or live in mixed-immigration 
status households.2,5-7,37 Our community-based participatory research (CBPR) partnership’s preliminary 
research identified additional barriers, including: misinformation about testing and vaccination 
communicated through Spanish-language TV and social media and within social networks by word-of-
mouth, and distrust in the test or vaccine (e.g., not believing that they will get the real vaccine as has 
happened in Latin America38,39; published2,40 and unpublished data).  
 
A profound need remains to understand the social, ethical, and behavioral implications (SEBI) of 
COVID-19 testing and vaccination interventions within Spanish-speaking Latinx 
communities.2,5,7,33,41-43 COVID-19 testing and vaccination are strongly influenced by social, ethical, and 
behavioral factors at the individual, interpersonal, institutional, community, and policy levels.44 While 
some of these multilevel factors are beginning to be explored, there is a great need for further empirical 
studies that focus on Spanish-speaking Latinx communities. The heterogeneity of the Latinx population is 
well established,34,35,45,46 and Spanish speakers experience markedly different barriers from other Latinx 
persons due to a range of factors such as more pronounced economic challenges, lower levels of 
acculturation, and heightened fear and mistrust of government systems (including public health). 
Furthermore, Spanish-speaking Latinx persons in the US may be undocumented and/or live in mixed 
immigration-status households35,47,48 and thus face unique challenges to testing and vaccination.  
 
Peer navigation has potential to increase COVID-19 testing and vaccination within Latinx 
communities. Natural helping (e.g., peer navigation and lay health advising) is potentially effective in 
addressing health issues in underserved and vulnerable communities.11,15,16,24,27,28,49-62 Peer navigation 

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harnesses relationships and networks to help individuals engage with prevention or care services. Peer 
navigators have advantages over other strategies because they can reach those who are considered “hard-
to-reach” with carefully personalized messaging and support. As trusted community members, peer 
navigators can be the first people turned to for assistance. Effective peer navigators are part of the 
networks in which they work, in terms of self-identity, socioeconomic status, and lived experience; 
understand community needs and strengths and what is meaningful to members and communities; 
communicate in the language of members; and incorporate culture to promote positive 
behaviors.12,15,16,21,24,28,51,53,59,60,62,63 As our partnership has learned, peer navigation strategies can be 
sustainable, as peer navigators often continue their work after a study and funding end.23,64  
 
mHealth can also be a powerful tool to reach Spanish speakers. Spanish speakers have high rates of 
social media use, including Facebook, Instagram, and texting, for acquiring health information,46,65-72 and 
this use extends to COVID-related information.2,42,73,74 These rates are related to increased proliferation of 
mobile devices, including among Spanish-speaking Latinx persons.75-77 Mobile devices support apps, 
including Facebook, which is the most commonly used social media platform.78 Because of its ubiquity 
and frequency of use, Facebook holds promise as a platform for health promotion.9,79-83 Facebook also has 
a direct messaging feature that allows users to communicate one-on-one and to a group. Instagram has 
also grown its user base and features. In addition to supporting photo and video sharing, Instagram offers 
a direct messaging feature, and Spanish speakers in our research recommend that we use this app in 
intervention implementation.12,70 At the same time, texting (including through messaging apps such as 
WhatsApp) continues to increase dramatically in all age groups and can be a powerful health promotion 
tool because it is widely available, inexpensive, and instantaneous, and can be effective at promoting 
behavior change.10,84-89 
 
Because the health-related views of Latinx persons are strongly influenced by trusted social network 
members42,73,90 and because Spanish speakers are active users of social media, combining peer navigation 
with mHealth holds particular promise for increasing COVID-19 testing and vaccination within Spanish-
speaking Latinx communities. Moreover, studies suggest that Latinx persons report increased willingness 
to be tested and vaccinated,91,92 indicating that focused support that addresses barriers and builds on 
facilitators could be highly effective. For example, in a recent national survey, eagerness to receive 
vaccination was more pronounced for Spanish-speaking Latinx persons than English-speaking Latinx 
persons (27% vs. 11%), but Spanish speakers reported greater information gaps and uncertainty about 
how orwhere to seek vaccination.92 
 
This research is significant because Spanish-speaking Latinx communities carry disproportionate burdens 
of COVID-19 and have lower rates of testing and vaccination. However, there is limited understanding of 
the SEBI of testing and vaccination, and thus, a dearth of effective interventions to increase testing and 
vaccination within this population. Our study will fill these gaps through a better understanding of the 
individual, interpersonal, institutional, community, and policy factors influencing testing and vaccination 
and the testing of a Spanish-language intervention, known as NuestraSaludSegura (Our Safe Health), that 
integrates peer navigation and mHealth to increase testing and vaccination. 
 
Innovation 
 
This study is innovative in several ways:  
1) We focus on a distinctly underserved and vulnerable population – the Spanish-speaking Latinx 
population – who encounter multilevel barriers to COVID-19 testing and vaccination in the US.  
2) This study is proposed by a well-established partnership that has been exploring multilevel factors 
influencing health and developing and testing interventions designed to promote health equity within 
Spanish-speaking Latinx communities using authentic CBPR for two decades.15,16,18,19,21,24,26,62,93-104  
3) Our community partners and collaborators cover the entirety of NC, allowing us to capture a wide 
range of experiences and settings (e.g., urban, rural, and suburban) and increasing generalizability.  

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4) This study collects formative research designed to increase our understanding of the SEBI of COVID-
19 testing and vaccination and immediately translates this understanding to NuestraSaludSegura, a novel 
intervention designed to increase testing and vaccination within Spanish-speaking Latinx communities.  
5) The NuestraSaludSegura intervention harnesses the complementary strengths of peer navigation and 
mHealth to increase COVID-19 testing and vaccination. The underlying evidence for these strategies is 
emerging, and to our knowledge, they have not been applied in combination within general Spanish-
speaking communities.  
6) The intervention leverages social media via existing platforms that Spanish-speaking Latinx persons 
already use (e.g., Facebook, Instagram, and texting). Thus, the behavior change focuses on testing and 
vaccination behaviors, not the antecedent behavior of downloading, learning, and using a new “app”, 
which some mHealth strategies rely on for implementation.  
7) We also include a novel strategy to dissemination that our partnership has developed. Designed to be 
low burden for attendees, our theory-based community forum brings together community members, 
partners, and other stakeholders to review study findings and develop next steps for practice and 
research.95,100,105  
 
Approach 
 
CBPR. CBPR has been identified as a critical approach to increase health equity and reduce disparities 
among underserved and vulnerable populations.16,26,94,103,104,106-118 Blending the lived experiences of 
community members, the expertise of service providers and public health practitioners, and sound science 
can develop deeper and more informed understandings of health and yield interventions that are more 
relevant, more culturally congruent, and more likely to be effective and sustained, if 
warranted.10,15,16,26,93,94,118-126 Furthermore, recruitment and retention rates may be higher, measurement 
may be more precise, data collection may be more acceptable, data analysis and interpretation of findings 
may be more accurate, and dissemination may be more likely than when using approaches that do not 
blend these multiple perspectives.94,111,117-119,126-129  
 
The partners proposing this study have worked together for >18 years and have had many successes that, 
in part, we attribute to CBPR.26,96,103 We have engaged in intensive decision-making about all aspects of 
this study, including the qualitative methods (i.e., in-depth interviews and focus groups), the intervention 
strategies (i.e., peer navigation and mHealth) and evaluation methods (i.e., the longitudinal group-
randomized trial design), and dissemination plans. We will continue to use CBPR throughout this study. 
Our partnership is not study-specific; members join and leave, and be more or less involved, but the 
partnership remains.10,11,26,96,100  
 
The proposed study. We have created a conceptually integrated CBPR study that includes systematic 
data collection on the multilevel factors that influence COVID-19 testing and vaccination; refinement of 
an efficacious intervention that uses complementary theory-based strategies (i.e., peer navigation and 
mHealth); intervention implementation and evaluation using a longitudinal group-randomized trial 
design; and dissemination of findings. This is an ambitious study, and we have allocated sufficient effort 
and delineated clear roles and responsibilities among study team members and community partners to 
ensure we accomplish the Aims. As a community member noted, “We can’t wait. COVID is hurting our 
community right now! We must do things that change these trends now!”  
 
Catchment area. We will conduct this study across NC. NC has more than 1 million Latinx persons, 
many of whom are immigrants,139 and the COVID-19 experiences of its Latinx population reflect 
experiences nationally, increasing study generalizability.140,141 In NC, compared to other racial/ethnic 
groups, the rate of COVID-19 infections has been higher within the Latinx community and fewer Latinx 
persons have been vaccinated.142  

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Study-specific steering committee. This study will be guided by a study-specific steering committee. 
This committee will be comprised of representatives from the Latinx community, community-based 
organizations, and academic research institutions. We expect to have ~15 committee members. Our team 
has much expertise with facilitating study-specific steering committees.26,103,143 The committee will meet 
monthly to provide guidance on measurement; recruitment and retention; intervention refinement; and 
interpretation of findings. We will continue to use the “70%-consensus rule” to encourage consensus 
decision-making by asking if each committee member can support a decision by at least 70%.101,128  
 
Objectives 
 
Aim 1: Collect, analyze, and interpret exploratory qualitative data to expand our understanding of 
the SEBI of COVID-19 testing and vaccination within Spanish-speaking Latinx communities. We 
will conduct 50 individual in-depth interviews with health providers (including administrators, clinicians, 
community health workers, and safety-net clinic staff) and with representatives from Latinx-serving 
community-based organizations; and conduct 6 focus groups with Spanish-speaking Latinx community 
members (total number of focus group participants=60).  
 
Aim 2: Refine and test NuestraSaludSegura to determine its impact on COVID-19 testing and 
vaccination among Spanish-speaking Latinx persons using a group-randomized trial design. 
Integrating our successes with peer navigation and mHealth strategies with other relevant COVID-19 
studies and Aim 1 findings, we will refine and test the NuestraSaludSegura intervention. We will enroll 
20 peer navigators, known as Navegantes, who represent 20 unique social networks, and 8 unique 
members from each social network for a total of n=160 social network members. After baseline data 
collection, we will randomize Navegantes, coupled with their social networks, into intervention and 
delayed-intervention groups (10 Navegantes; 80 social network members per group). We will train and 
support intervention-group Navegantes to increase COVID-19 testing and vaccination services within 
their social networks. We will evaluate the intervention by comparing changes in testing and vaccination 
from baseline to post-intervention follow-up between groups. We hypothesize that intervention group will 
demonstrate increased COVID-19 testing and vaccination.  
 
Aim 3: Develop and disseminate practice, research, intervention, and policy priorities and 
recommendations to increase COVID-19 testing and vaccination among Spanish-speaking Latinx 
communities in the US. We will conduct an empowerment theory-based forum with Latinx community 
members and other community members and representatives from community-based organizations and 
universities to develop and disseminate priorities and recommendations based on study findings. 
 
Methods and Measures 
 
Design 
 
Aim 1: 
 
We will conduct individual in-depth interviews with two categories of participants from across 
NC: (1) Health providers (including administrators, clinicians, community health workers, and 
safety-net clinic staff), who have planned, managed, and/or conducted COVID-19 testing and/or 
vaccination activities for Spanish-speaking communities; and (2) Representatives from Latinx-
serving community-based organizations. We also will conduct focus groups with Spanish-
speaking Latinx community participants. 
 
Aim 2:  
 

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We will refine and test the NuestraSaludSegura intervention, integrating our previous successes 
with peer navigation and mHealth strategies with other relevant COVID-19 studies and Aim 1 
findings. We will then recruit, enroll, and collect baseline data from 20 Navegantes (peer 
navigators) and their social network members (n=8 unique social network members per 
Navegante) from across NC. Navegantes (coupled with their social networks) will be randomly 
assigned to: intervention or delayed-intervention groups (10 Navegantes; 80 social network 
members per group). Intervention-group Navegantes will be trained and supported for 6 months 
of implementation in Years 1-2; delayed-intervention group Navegantes will be trained in Year 2. 
CBPR partners emphasized that a delayed-intervention comparison design is the most equitable, 
acceptable, and ethical. 
 
Assessment of intervention efficacy. We will use a longitudinal group-randomized trial design 
with 2 arms (intervention and delayed-intervention) to evaluate the impact of the intervention. 
Quantitative outcome data will be collected from each Navegante and their 8 enrolled social 
network members at 2 time points: (1) baseline (prior to randomization and Navegante training) 
and (2) immediate post-intervention (6 months after the Navegantes in the intervention group are 
trained). 
 
In-depth interviews. After post-intervention follow-up, we will conduct in-depth interviews with 
each Navegante in the intervention group (N=10) to explore and better understand their 
implementation of the intervention, their natural helping behaviors, and other lessons learned. 
 
Aim 3: 
 
The translation of findings into action is a CBPR hallmark,16,26,30,93-95,97,99,100,105,111,129,137,143,190-193 
and we have developed an empowerment theory-based100,169,194,195 and highly collaborative 
process to do just that.95,100,166  We will organize and conduct a bilingual community forum 
to translate findings into practice, research, intervention, and policy priorities and 
recommendations.  
 
Setting 
 
The study will take place in community settings (e.g., community organizations) across NC. 
 
Subjects selection criteria 
 
• 
Inclusion Criteria 
 
Aim 1: 
 
To be eligible to participate in the in-depth interviews as a health provider, a participant must 
(a) be employed at a clinic, health center, or other organization that has planned, managed, 
and/or conducted COVID-19 testing and/or vaccination activities for Spanish-speaking 
communities; (b) be ≥18 years of age; and (c) be willing to participate. To be eligible to 
participate in the interviews as a Latinx-serving community-based organization 
representative, a participant must (a) be affiliated with a Latinx-serving community-based 
organization, (b) be ≥ 18 years of age, and (c) be willing to participate. 
 
To be eligible to participate in the focus groups, a participant must (a) self-identify as 
Hispanic/Latinx, (b) be Spanish speaking, (c) be ≥18 years of age, and (d) provide informed 
consent. 

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Aim 2: 
 
To be eligible to participate in the NuestraSaludSegura intervention as a Navegante, a 
participant must (a) self-identify as Hispanic/Latinx, (b) be Spanish speaking, (c) be ≥18 
years of age, (d) provide informed consent, and (e) report having been vaccinated against 
COVID-19 (because Navegantes serve as role models). Access to a smartphone will not be an 
inclusion criterion. We have some flexibility to provide smartphones and data plans for 
Navegantes without them, though given smartphone proliferation (and our past research 
experiences), this will likely be unnecessary.  
 
To be eligible to participate in the intervention as a social network member, a participant 
must (a) self-identify as Hispanic/Latinx, (b) be Spanish speaking, (c) be ≥18 years of age, 
and (d) provide informed consent. 
 
• 
Sample Size 
 
Aim 1: 
 
We will conduct 50 individual in-depth interviews for a total number of 50 interview 
participants and 6 focus groups with 8-12 participants each for a total number of 60 focus 
group participants. We will screen participants to ensure we obtain representation by: gender, 
documentation status, and those with and without experiences of COVID-19 testing and 
vaccination. As it is difficult to predict saturation144-150 a priori, we have flexibility to expand 
the number of interviews and/or focus groups if warranted. Project members working with 
the qualitative data will meet regularly to discuss emerging themes and determine if 
saturation has been reached. 
 
Aim 2: 
 
Sample size calculations are based on a follow-up adjusted baseline (or ANCOVA) model. 
We estimated the sample size needed (20 Navegantes and 160 social network members) by 
performing calculations in nQuery v8.7. 
 
Interventions and Interactions 
 
Aim 1: 
 
Interviews will be digitally recorded. While interviews and focus groups can be conducted remotely via 
telephone and videoconferencing platforms (e.g., Zoom and WebEx), we will conduct them in-person if 
possible based on the current CDC recommendations. Safety precautions (e.g., personal protective 
equipment) will be followed as indicated. Dr. Rhodes and an infectious disease epidemiologist published 
guidelines for safely conducting community-based and community-engaged in-person research during 
COVID,151 which have been adopted by multiple Clinical and Translational Science Award hubs 
throughout the US and by CDC research teams. 
 
The in-depth interview and focus groups guides. These guides will be structured to gather descriptive 
“deep”152 qualitative data. An initial low-literacy assessment will collect demographic data. Guides will be 
developed iteratively with the steering committee and in consultation with the RADx-UP Coordination 
and Data Collection Center (CDCC) and consortium through ongoing literature review; brainstorming of 
domains and constructs; and drafting, review, and revision of potential questions. Because this Aim is 

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exploratory and designed to be inductive, the framework is subject to revision. This Aim’s outcome will 
be a better understanding of the SEBI of COVID- 19 testing and vaccination among Spanish- speaking 
Latinx persons. Interview guides will adhere to best practices (e.g., creating non-leading/open-ended 
questions, ordering from general to specific, maintaining neutral tone, and depersonalizing behaviors by 
third-person-ing questions) to elicit knowledge, descriptions of experiences, opinions, and 
values.98,146,150,153-156 
 
Aim 2: 
 
The original intervention and its refinement. The bilingual weCare intervention serves as a foundation 
for NuestraSaludSegura. weCare is based on the social cognitive and empowerment theories and social 
support9,10,28,168-170 and harnesses peer navigation and mHealth.9-14 The objectives of weCare (i.e., to 
increase care engagement and improve health outcomes among vulnerable persons with HIV) align with 
the objectives of NuestraSaludSegura (i.e., to increase testing and vaccination among vulnerable persons 
disproportionately impacted by COVID-19). Thus, the refinement process will be efficient and include 
revising the Navegante training and mHealth messages. The study team and the steering committee will 
conduct the refinement in parallel to Aim 1, integrating findings from other relevant studies(e.g., 69,171,172) 
and from Aim 1 as they emerge. Specifically, we will review the theoretical underpinnings of the 
intervention and anticipated outcomes of NuestraSaludSegura and refine the training, including the 
mHealth messages, to build Navegante capacity to increase COVID-19 testing and vaccination within 
their social networks. This process is designed to expedite the translation of Aim 1 findings into 
intervention, which is a hallmark of CBPR94,113 and a priority of our partnership given the burden of 
COVID-19 within Spanish-speaking Latinx communities.  
 
Each Navegante will serve as a health advisor, opinion leader, and community advocate and use in-person 
and/or virtual (through Facetime or Zoom) individual and group activities and mHealth (using Facebook 
messenger, Instagram direct messaging, and text messaging) to communicate and provide social support 
within their social networks during the 6-month intervention. The Navegantes’ approach is personalized 
to each social network member’s needs and priorities. Table 1 provides an abbreviated summary of 
Navegante activities and examples of activities operationalized. 
  
Based on our partnership’s history training peer navigators,15-28 we currently have a Navegante Training 
Manual, which will guide the 4-session interactive training of the Navegantes, including sections on 
effective facilitation, how to prepare for training, session checklists, and all training activities and 
materials. This manual will require refinements related to COVID-19. We also will develop a Navegante 
Resource Guide that will provide details about COVID-19 testing and vaccination across NC (e.g., local 
providers and services and eligibility information) that Navegantes can refer to as they work with their 
social networks after training.  
 
We will refine our weCare library of theory-based sample messages10 that Navegantes can tailor and use 
to meet the specific needs of each social network member. We have much experience with mHealth 
message development to improve health outcomes.9,10,12,14,29,99,135,173 A critical component of 
NuestraSaludSegura is the “connection” between the Navegantes and social network members. Growing 
evidence suggests that in-real-time, personalized, and bidirectional social support and problem solving 
provided by a peer using mHealth may be more successful in changing behaviors among populations 
facing many multilevel barriers to change than other technology-based approaches, such as software 
applications providing automated messages.12,14,29,174-176 In our research to better understand the 
mechanisms underlying weCare, we discovered the importance of participants “knowing the person 
behind the messaging” and perceiving that this person cares about them.12 
 
Table 1. Activities of Navegantes in the NuestraSaludSegura intervention  

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Activities  
Examples  
Raise awareness of the ongoing need for COVID-19 testing and 
vaccination  
Navegantes increase consciousness among their social 
networks about the need for testing and vaccination to slow the 
spread of COVID-19, state and local rates of testing and 
vaccination and among Latinx populations, and the importance 
of taking action.  
Provide information and referrals  
Navegantes provide information about local providers of 
COVID-19 testing and vaccination services (e.g., testing and 
vaccination sites near a social network member’s home or 
workplace, days and hours of operation, and whether an 
appointment is needed and how to make one).  
De-mystify the process of seeking COVID-19 testing and 
vaccination  
Navegantes explain what to expect when accessing COVID-19 
testing and vaccination, including where to go, how to get there 
by public transportation (or where to park if in a car), the 
presence of security, sign-in processes, what information will be 
requested (e.g., if staff will ask for identification or insurance 
information), availability of interpreters or Spanish-speaking 
staff, what steps are involved in the testing or vaccination 
process, and how long the process will take (e.g., turnaround 
time for receiving test results and required observation period 
after receiving the vaccine).  
Reframe and bolster norms and expectations  
Navegantes highlight how the benefits of COVID-19 testing and 
vaccination are linked to social network members’ priorities 
(e.g., protecting the health of their families and communities 
and facilitating the ability to gather with others safely).  
Share announcements and reminders  
Navegantes share announcements with social network 
members about upcoming testing and vaccination events.  
Troubleshoot and problem solve SEBI of COVID-19 testing and 
vaccination  
Navegantes help overcome stigma related to COVID-19 and 
build trust around testing and vaccination (e.g., addressing 
concerns about immigration status and confidentiality). 
Navegantes brainstorm options for overcoming barriers related 
to transportation (e.g., if a COVID-19 testing or vaccination site 
is not on a bus line and a social network member does not have 
a car or a driver’s license), schedules (e.g., conflicts between 
work schedules and testing or vaccination site hours), and other 
challenges (e.g., concerns about the potential impact of a 
positive COVID-19 test result or vaccine side effects on the 
ability to work).  
Support communication with  
providers and staff  
Navegantes talk through ways to effectively communicate and 
share concerns with providers and staff at testing and 
vaccination sites. Navegantes may remind social network 
members to bring a list of questions, symptoms, or information 
about potential COVID-19 exposures when going to get tested 
or vaccinated.  
Support other prevention behaviors  
Navegantes provide guidance on recommendations for other 
prevention behaviors (aligning with current CDC guidelines), 
including mask use, social distancing, and potential need for 
booster vaccination.  
Provide feedback to providers and staff  
Navegantes meet with providers and staff at COVID-19 testing 
and vaccination sites to provide feedback for multilevel changes 
to improve accessibility for Spanish-speaking Latinx 
communities.  
 
Baseline and immediate post-intervention assessment. We will develop a Spanish-language assessment 
to collect data at baseline and immediate post-intervention (6 months post-baseline), based on Aim 1 
findings, other relevant studies describing factors influencing COVID-19 testing and vaccination, our 
previous successes with peer navigation and mHealth strategies, and the theories underlying the 
intervention. Table 2 outlines draft measurement priorities identified by our partnership while preparing 
this application. To ensure data harmonization, we will use the RADx-UP Common Data Elements and 
PhenX toolkit (https://www.phenxtoolkit.org/). The assessment, including final selection of measures, 

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will be created using an iterative process by partners, including consultation with the RADx-UP CDCC 
and consortium 
 
Table 2. Measurement priorities  
Outcome variables  
Primary: COVID-19 testing and vaccination including ever being tested, ever being vaccinated, 
being up to date on recommended doses, and number of doses received 
Demographic variables  
Age and date of birth; birthplace; ethnicity/race; language use; current living situation; zip code; 
marital/partner status; family structure (e.g., children); educational attainment; current 
employment; financial status; immigration status; pregnancy status; insurance status  
Symptoms  
COVID-19 symptoms and exposure to assess need for testing  
Potentially mediating 
variables  
Awareness and knowledge about risk, testing, and prevention of COVID-19; intentions and 
readiness for COVID-19 testing and vaccination; perceived COVID-19 testing and vaccine access; 
knowledge of how to access testing and vaccination services; service use self-efficacy; perceived 
barriers to services; usual source of care; skills and self-efficacy to communicate effectively with 
providers; provider trust; history seeking and using prevention and care services; self-efficacy to 
overcome barriers; perceived provider discrimination; stigma related to COVID-19; social support; 
community attachment; perceived impact of positive test on job security; access to transportation  
Other variables  
Intervention acceptability; satisfaction with participation in intervention; interactions with 
Navegante and social network members regarding COVID-19 testing and vaccination (to assess 
contamination)  
 
Navegante training and support. The Navegante training will be designed to increase knowledge and 
build skills as health advisors, opinion leaders, and community advocates in person and/or virtually and 
through mHealth. Navegantes will be trained to use a version of the “ask-advise-assist” model to provide 
guidance and help others and will be given a wallet-sized reminder card that outlines the steps, as we have 
done within peer navigation interventions in the past.19,70 Trained Navegantes will then carry out helping 
activities to increase COVID-19 testing and vaccination within their social networks for 6 months. During 
this time, Navegantes will be supported and meet with study staff as a group (monthly) and individually 
(as needed) for social support, intervention planning, experience sharing, and problem solving in person, 
virtually, by phone, and/or by social media. As part of the process evaluation, they will submit monthly 
Activity Logs (described below) to document their work with members of their social networks.(e.g., 20,50)  
 
How will the trained Navegantes increase COVID-19 testing and vaccination within social 
networks? Through informal individual interactions and more formal activities, Navegantes will fulfill 
multiple roles. First, as health advisors, Navegantes will raise social network members’ awareness of the 
ongoing need for COVID-19 testing and vaccination and help them think through pros and cons and how 
to overcome commonly experienced barriers to accessing services. For example, a social network 
member may hesitate to seek testing because they fear disclosing their immigration status or do not trust 
providers. Thus, the Navegante will describe what is required for testing and how providers are required 
to maintain confidentiality. As opinion leaders, Navegantes will reframe and bolster norms and 
expectations about COVID-19, testing, and vaccination. Navegantes are taught the concept of reciprocal 
determinism from social cognitive theory168 to illustrate how attitudes and behaviors are influenced by and 
influence one’s environment. For example, some Spanish speakers may have fatalistic views about 
COVID-19; thus, a Navegante may reframe attitudes regarding COVID-19 to encourage testing and 
vaccination as taking control of one’s health. Third, as community advocates, Navegantes will bring the 
voices of Spanish speakers to providers. Navegantes will participate in tours of local testing and 
vaccination site within their region, which will provide Navegantes direct experiences with accessing 
services that will help them support their social network members in using services, build relationships 
between Navegantes and providers, and provide opportunities for Navegantes to share feedback for 
process improvement (based on their own experiences, the experiences of their social network members, 
as well as Aim 1 findings) with providers over time.  
 
Each Navegante will also conduct group activities in-person and/or virtually with their social network 
members including an initial meeting to “inaugurate” their role as a community resource. Study staff will 

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provide guidance to the Navegantes and assist them in conducting group activities. These activities will 
be documented on the Activity Logs (described below) that will provide important details for intervention 
evaluation, especially because not every social network member will attend each session.  
 
In addition to in-person and/or virtual individual and group activities, Navegantes will use the mHealth 
platform(s) preferred by each social network member (i.e., Facebook, Instagram, and/or texting) to 
communicate directly with them during the intervention to plan activities and support use of COVID-19 
testing and vaccination services. For example, Navegantes will use social media to remind social network 
members about group activities and problem solve attendance challenges. A Navegante and social 
network member may also communicate “in-real-time” via social media about the process of receiving 
COVID-19 testing and vaccination; for example, the Navegante may help the social network member 
navigate a clinic. The Navegantes’ ability to provide immediate, efficient, and bidirectional 
communication is critical to overcome barriers to taking action and initiating service use.  
 
Each Navegante will also use personalized Facebook and Instagram accounts for indirect communication 
(e.g., posting information about COVID-19 testing and vaccination events). In our weCare intervention, 
we learned that study-specific Facebook pages are less effective than accounts that function like a 
personal Facebook profile.10 In addition to being low literacy, Facebook and Instagram posts will be 
engaging and informative. For example, graphics that illustrate the rates of COVID-19 testing and 
vaccination in different population subgroups can raise awareness of the importance of taking action. We 
will provide Navegantes with links to reliable sources, including CDC and state COVID-19 informational 
websites. Navegantes will also post informal and welcoming pictures and videos (recorded using 
smartphones) of local COVID-19 testing and vaccination services staff and facilities to demystify what it 
is like to access services and to increase self-efficacy to use services. While it is possible that not all 
participants use all social media platforms, given the current use of Facebook and Instagram, and their 
potential as low burden communication methods, these posts will be worthwhile. Furthermore, they may 
reach others who are not enrolled in this study. All posted information will be correct, consistent, and 
linked to the intervention’s theoretical underpinnings; study staff will be available to help Navegantes 
think through their messaging.  
 
Activity Logs. Navegantes will complete and submit monthly Activity Logs. Activity Logs aid in our 
process evaluation and serve as triggers for Navegantes to initiate activities.20,50 They document whom the 
Navegante worked with for each activity (e.g., codes for those within and outside of the enrolled social 
network members); the type of helping activity; whether it was an individual or group activity (and the 
number of people involved); and whether, which, and how mHealth platforms were used. Importantly, 
the Activity Log will allow us to assess the Navegantes’ work beyond their enrolled social network 
members. An innovation of this study is that we will be able to precisely describe what the Navegantes 
did and who was reached. 
 
In-depth interviews with Navegantes. In-depth interview guide development and data collection with 
Navegantes will mirror the processes described above in Aim 1. 
 
Aim 3: 
 
We will invite partnership members, organization representatives (e.g., providers and clinic and 
community organization staff), community members, and academic researchers, to review and discuss 
study findings. As a group, they will respond to 4 empowerment theory-based trigger questions that move 
from concrete (“What do you see in these findings?” “In what ways do these findings make/not make 
sense to you?”) to action (“What can be done?” “What can we do?”). Based on the triggers, attendees will 
brainstorm specific strategies. Next, using a nominal group process,21,95,100,105,196 attendees will define 
practice, research, intervention, and policy priorities for next steps based on 2 criteria (importance and 

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feasibility) 95,100,197-199 to ensure priorities have potential to decrease COVID-19 disparities. Examples of 
priorities that may emerge include social marketing/social media campaigns; clinical staff training to 
reduce perceived discrimination, better assess risk, and/or problem solve particular testing and 
vaccination access challenges experienced by Spanish-speaking Latinx persons; development of culturally 
congruent COVID-19 educational materials; and additional interventions (e.g., to reduce stigma) to 
increase adherence to recommendations.  
 
Attendees will then divide into small groups based on the identified priorities, develop recommendations 
for carrying out those priorities, and present plans to the larger group of attendees. Action plans may 
include a timeline for next steps or a list of other individuals and organizations to engage. The forum also 
may identify priorities for future research and intervention development.  
 
Outcome Measure(s) 
 
Primary outcome measures are COVID-19 testing and vaccination, including ever being tested, ever 
being vaccinated, being up to date on recommended doses, and number of doses received. 
 
Analytical Plan 
 
Aim 1: 
 
In-depth interview and focus group data analysis. We will analyze the qualitative data using constant 
comparison, a systematic approach to developing grounded theory144,157 that is well-suited to uncovering 
participants’ meanings and experiences. 144,157,158 It combines inductive coding with simultaneous 
comparison; initial observations are continually refined throughout data collection and analysis.149,157,159 
The goal is to identify themes, not to quantify participant experiences.12,62,160,161 Analytical steps include:  
• 
Interviewers will document post-interview and focus group impressions (e.g., content, 
process, and themes).  
• 
Interviews and focus groups will be professionally transcribed and translated (if needed). 
Translation allows for simultaneous, collaborative analysis and iterative discussion of themes 
to yield more accurate findings.162  
• 
Interviewers will verify transcripts by reviewing and correcting discrepancies while listening 
to the recording.  
• 
Transcripts will be managed using the NVivo (Chicago, IL) and examined to identify and 
code domains for theme development.145,163 This will begin with analysts reading the same 3 
transcripts and writing memos (written records of the analysis process linked to the specific 
transcript). These represent conceptual, theoretical, and operational notes to help compare 
domains within and across interviews and focus groups and inform the initial analytical 
coding scheme.144  
• 
The analysts will meet to develop a common coding system and data dictionary.  
• 
All transcripts will be coded by at least 2 analysts (allowing for the addition of emerging 
codes).  
• 
For data triangulation, analysts will develop, compare, then revise matrices that identify 
similarities and differences and explore emic and etic perspectives within and across 
participant categories (e.g., health providers v. Latinx-serving community-based organization 
representatives; health provider/organization representative interview v. Spanish-speaking 
Latinx community member focus group).160  
• 
The CBPR partnership will review themes for validity (e.g., rigor, credibility, and 
trustworthiness).97,164-167  
 

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Aim 1 draws from a rich and thorough set of state-wide experiences that reflect millions of testing and 
vaccination encounters and the diverse perspectives of Spanish speakers and those who directly serve 
them across a wide range of settings. Thus, it will accomplish the most comprehensive qualitative 
assessment to date of SEBI of COVID-19 testing and vaccination among Spanish-speakers. Our results, 
in addition to informing Aim 2, will be important in their own right to inform other researchers and 
practitioners. Accordingly, results from Aim 1 will be shared as soon as available with RADx-UP CDCC 
and consortium. 
 
Aim 2: 
 
Hypotheses. We anticipate that participants in the intervention group, relative to their counterparts in the 
delayed-intervention group, will demonstrate increased COVID-19 testing and vaccination.  
 
Quantitative data analysis plan. Data analysis will include study group description and intervention 
impact evaluation. Study group description. Frequencies and percentages for categorical variables and 
means, medians, standard deviations, and ranges for continuous variables will be tabulated to describe the 
sample. Reliability for measures will be estimated via internal consistency using coefficients alpha and 
omega.178 Baseline intervention and delayed-intervention group comparisons will be performed. 
Correlation analyses will evaluate the associations between pairs of variables. Nonparametric statistics 
will be used when appropriate to evaluate significance of associations.  
 
Evaluation of intervention impact. Data will be analyzed with an intent-to-treat approach.179 
Randomization at the social network level will likely balance cluster-level baseline characteristics; 
however, as randomization may not precisely balance these, and there may be differences in social 
network member characteristics after network randomization, inverse probability weighting using 
propensity scores will be explored to balance baseline characteristics (both network and individual) 
between arms180 using best practices.181 Balance on propensity scores between intervention groups will be 
assessed using standardized differences.182 Propensity scores have been used in cluster RCTs.183 We will 
evaluate the intervention impact by comparing rates of past 6-month COVID-19 testing and vaccination 
completion (defined as complete dosage of approved vaccination: e.g., 2 Pfizer or Moderna doses or 1 
Johnson & Johnson dose) between intervention and delayed-intervention group social network members 
at immediate post intervention (6 months after the intervention group Navegantes are trained), adjusting 
for baseline rates. This ANCOVA approach has the advantage of being unaffected by baseline 
differences; if baseline rates, by chance, were different, the intervention effect would be overestimated by 
looking at change scores and underestimated by a follow-up score analysis. The ANCOVA approach 
gives the same answer regardless of baseline imbalance. Additionally, the approach generally has greater 
statistical power to detect an intervention effect than the other methods.184 Statistical analysis will be 
performed using generalized linear mixed modeling185 for binary outcomes (sometimes termed random-
effects logistic regression). These models can assume a logit link for binary data (i.e., tested or vaccinated 
in past 6 months: yes/no) and allow for accounting for the within-group association of outcomes. If 
participants have repeated COVID-19 testing performed then an additional random effect for multiple 
testing will be considered, where appropriate. The generalized linear mixed model is an extension of 
general linear models that allows for non-independence of observations (e.g., within social networks).  
 
The hypothesis that intervention and delayed-intervention groups differ in their prevalence, p, of COVID-
19 testing or vaccination will be tested with the mixed-effects logistic model: Logit (pij1) = β0 + β1 Yijo + 
β2 INTVN + υi, where pij1 is the probability of testing or vaccination at immediate post-intervention for 
participant i in social network j, Yij0 is 1 if participant i in social network j reports testing or vaccination at 
baseline and 0 otherwise, and, INTVN =1 for the intervention group and 0 for the delayed-intervention 
group. The random effect υj is the random effect for participants in social network j. The variance 
component for this random effect addresses the within-social network correlation. Under this model, β2 

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corresponds to the difference in prevalence of testing or vaccination at immediate post-intervention 
between the intervention and delayed-intervention groups on the logit scale. This random-effects logistic 
regression model will be fit using adaptive Gaussian quadrature in SAS PROC GLIMMIX.186  
 
This regression approach will allow us to produce estimates of prevalence and prevalence change 
additionally adjusting for individual and cluster-level covariates, which will be compared to unadjusted 
estimates. Individual-level covariates may include age, country of origin, employment status, and 
education level. Because there are only a small number of clusters (social networks), the literature advises 
that the number of cluster-level covariates should be limited to one or two key variables.187,188 To assess 
the importance of covariates, we will use a backwards elimination model building approach, with primary 
consideration on assessment of confounding on the intervention-group difference. If confounding is 
present (defined to be greater than a 10% change in the regression estimate of the intervention-group 
effect), the confounder will be retained in the multivariable model. If many confounders are retained, 
alternative/sensitivity analyses will be conducted using propensity score weighting. All analyses will be 
2-sided.189 Note: While a better understanding of the relationships between members of social networks 
can be interesting, social network analysis is beyond the scope of this proposal based on our hypotheses 
and analysis plans. 
 
Quantitative data collection/management. Assessment data will be collected by the study team in a safe 
and private location using audio-computer-assisted self-interview (ACASI) technology. We most recently 
used ACASI in our weCare intervention for English and Spanish data collection9-14 and have worked out 
logistical details (e.g., data saving and backup) and ways to maintain participant interest. ACASI data 
collection overcomes challenges of literacy and will be conducted in Spanish. Saved ACASI files will be 
transferred using the Warehouse Manager to SAS data files for analysis and stored on a password 
protected secure server. 
 
In-depth interview data analysis. Analysis of the data from in-depth interviews with Navegantes will 
mirror the qualitative data analysis processes described above in Aim 1. 
 
Aim 3: 
 
We will develop a final report of findings and practice, research, intervention, and policy priorities and 
recommendations to distribute to attendees, the RADx-UP CDCC and consortium, and others for whom 
the findings will be relevant (e.g., local and state-level health department leaders). We successfully used 
this approach previously to translate findings into action in a study of HIV disparities among sexual 
minority men. Subsequent actions led by forum attendees were (1) redirection of NC state prevention 
funds to develop safe spaces for facilitated group dialogue around intimacy and HIV risk; (2) a statewide 
conference to develop advocacy skills among community leaders; and (3) a new research partnership to 
explore the impact of immigration policy on healthcare use within Latinx communities.26,100 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
 
Aim 1:  
 
In-depth interview and focus group participants for Aim 1 will be recruited through our partnership’s 
broad networks of collaborators and community partners and by word-of-mouth. 
 
Aim 2:  
 

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Intervention participants for Aim 2 can be recruited as a Navegante or social network member of a 
Navegante. Potential Navegantes will be recruited by being invited to an individual interview in which we 
will explore eligibility and personal, performance, and situational characteristics relevant to serving as a 
Navegante. We will then select Navegantes. After enrolling, each Navegante will be provided a script and 
recruitment materials to present to their social network members, explaining the study and asking them to 
contact staff using the study’s toll-free number to enroll. 
 
Informed Consent 
 
Verbal informed consent will be obtained from each focus group participant, and signed informed consent 
will be obtained from each Navegante and each social network member participant. The investigators or 
other study staff will obtain informed consent in community-based settings before collecting data from 
participants. 
 
Interview participants will be provided with a brief description of the study to review before deciding to 
participate. 
 
Confidentiality and Privacy 
 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner.  To help ensure subject privacy 
and confidentiality, only a unique study identifier will appear on the data collection form.  Any 
collected patient identifying information corresponding to the unique study identifier will be 
maintained on a linkage file, store separately from the data.  The linkage file will be kept secure, with 
access limited to designated study personnel.  Following data collection subject identifying 
information will be destroyed six years after closure of the study, consistent with data validation and 
study design, producing an anonymous analytical data set.  Data access will be limited to study staff.  
Data and records will be kept locked and secured, with any computer data password protected.  No 
reference to any individual participant will appear in reports, presentations, or publications that may 
arise from the study. A limited dataset will be sent to the CDCC via a secure web portal. Data will be 
stored by the CDCC on protected, secure computer systems. Anyone with permission to see these 
data will have to use a password and multi-factor authentication. 
 
Data and Safety Monitoring 
 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants.  The principal investigator will be assisted by other members of the study staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to 
the IRB and sponsor or appropriate government agency if appropriate. 
 
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