Tertulias: Addressing Social Isolation to Reduce Depression Among Women of Mexican Origin
Phase: NA
Conditions: Social Isolation, Depression
Sponsor: University of New Mexico

PROTOCOL TITLE: TERTULIAS 
 
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PROTOCOL TITLE: 
TERTULIAS: Addressing Social Isolation to Reduce Depression Among Female Mexican 
Immigrants  
 
PRINCIPAL INVESTIGATOR: 
Janet Page-Reeves 
Family & Community Medicine 
505-306-3041 
 
VERSION NUMBER: 
4-3-23 
 
VERSION DATE: 
4-3-23 
Table of Contents 
1.0 
Objectives ................................................................................................................ 3 
2.0 
Background .............................................................................................................. 3 
3.0 
Inclusion and Exclusion Criteria ............................................................................ 10 
4.0 
Study-Wide Number of Subjects ........................................................................... 11 
5.0 
Study-Wide Recruitment Methods ........................................................................ 11 
6.0 
Multi-Site Research ............................................................................................... 14 
7.0 
Study Timelines ..................................................................................................... 14 
8.0 
Study Endpoints ..................................................................................................... 14 
9.0 
Procedures Involved*............................................................................................. 14 
10.0 Data and Specimen Banking .................................................................................. 26 
11.0 Data and Specimen Management........................................................................... 27 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 32 
13.0 Withdrawal of Subjects .......................................................................................... 33 
14.0 Risks to Subjects .................................................................................................... 33 
15.0 Potential Benefits to Subjects ................................................................................ 36 
16.0 Vulnerable Populations .......................................................................................... 37 
17.0 Community-Based Participatory Research ............................................................ 37 
18.0 Sharing of Results with Subjects ........................................................................... 37 
19.0 Setting .................................................................................................................... 38 
20.0 Resources Available............................................................................................... 39 
21.0 Recruitment Methods ............................................................................................. 43 
22.0 Number of Subjects................................................................................................ 47 
23.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 47 
24.0 Compensation for Research-Related Injury ........................................................... 49 
25.0 Economic Burden to Subjects ................................................................................ 49 
26.0 Consent Process ..................................................................................................... 49 
27.0 Data Transfer/Sharing ............................................................................................ 49 

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28.0 Specimen Transfer/Sharing .................................................................................... 55 
29.0 Principal Investigator’s Assurance ........................................................................ 55 

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1.0   
Objectives 
The purpose of this project is to test TERTULIAS (Spanish for “conversational gatherings”), an 
innovative peer support group model for reducing social isolation and depression among female 
Mexican immigrants (FMIs).  
 
TERTULIAS is a peer support group model with bi-directional knowledge exchange with a 
trained facilitator and culturally appropriate food sharing and storytelling. 
 
Goal: We will conduct a randomized controlled trial with 240 female FMIs. Intervention 
participants will attend a weekly peer group session over 12 months. Control group participants 
will receive a bimonthly check-in call. All will be surveyed using validated instruments and give 
hair samples gathered at baseline and 12 months. A subset will be interviewed, and group 
sessions will be documented. We will triangulate data gathered using different methods with a 
QUAL➔QUAN simultaneous data collection and analysis approach to integrate, converge, and 
elaborate findings in a way that would not be feasible using only one method. Our prior work and 
demonstrated capacity to work with a hard-to-reach population will make this project a success.  
 
     Aim 1. To measure whether a culturally situated peer group intervention will reduce 
depression and stress associated with the experience of immigration.  
Question: Does an intervention design that reproduces culturally important interactions, 
activities, and constructs that are lost through immigration result in decreased participant 
depression and stress?  
Hypothesis: Incorporating peer-to-peer social interaction, food sharing, and storytelling 
into the design of a peer support group intervention will leverage positive aspects of participant 
culture and create an experiential context that will (a) decrease participant depression scores by at 
least 6.5 points more on the Center for Epidemiologic Studies Depression Scale (CES-D) as 
compared to controls (effect size Cohen’s d = 0.43), and (b) lower stress scores in participants 
more than in controls with d ≥ 0.5 as measured by the Perceived Stress Scale (PSS). We will also 
assess stress using a cutting-edge biological assessment of hair cortisol as a biomarker for chronic 
stress. 
 
     Aim 2. To test whether an intervention using a “women’s funds of knowledge” approach 
results in improved resilience, knowledge and empowerment.  
Question: Does an intervention design that encourages participants to share knowledge 
they developed through life experience and that values this knowledge as a form of expertise 
nurture protective factors (resilience and knowledge/empowerment) to help FMIs adapt to the 
immigration context and disrupt the mechanisms that produce health disparities?  
Hypothesis: Incorporating, valuing and validating women’s knowledge and experience in 
the design of a peer support group intervention will improve participant capacity to adapt to 
the immigrant context and provide participants with empowering knowledge to deal with new 
situations. Intervention participants will have higher scores at 12 months and have a larger 
increase over time as compared to controls (d = 0.5) on the Connor-Davidson Resilience Scale-25 
(CD-RISC 25). We will assess knowledge and empowerment at 12 months and expect to find 
high scores with the Trauma-Informed Practice (TIP) Scale (which is designed for post-use). 
 
     Aim 3. To investigate whether a culturally situated peer group intervention using a 
women’s funds of knowledge approach can give participants’ a sense and experience of 
social and physical connection (“emplacement”) that is lost in the process of immigration.  
Question: Can the proposed peer support group intervention recreate social and 
physical connections lost through immigration and strengthen participant social networks?  

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Hypothesis: The peer group will create a culturally appropriate context for establishing 
interpersonal connections between group members and will give participants a sense of belonging 
within a social and contextual milieu. At study end, (a) intervention participants will have a 
marked increase in social support scores v.s. the control group using the Medical Outcomes Study 
Social Support Survey (MOS SSS)  (d ≥ 0.5), and (b) stronger, more dense social connections as 
described by a social network analysis. 
 
     Project Outcomes. This intervention with FMIs will test an innovative intervention to reduce 
social isolation as a mechanism for reducing depression by leveraging positive cultural dynamics 
and women’s funds of knowledge to nurture social connectedness, knowledge, and resiliency 
factors in the lives of participants in a transformative way. Generalizability. This trial of 
TERTULIAS will create a replicable, scalable model for culturally appropriate health promotion 
with FMIs that has implications for health promotion work with other women from recent and 
first generation immigrant populations. 
 
2.0     Background 
Social Isolation: A Critical, Complex Health Problem.  
Social Isolation is a critical health risk factor affecting millions of people in the U.S. and, 
disturbingly, has been shown to have an even larger social impact.1,2 While most people would 
not think of social isolation as a “health” issue per se, as a chronic stressor, it is a well-established 
health risk factor3 associated with the experience of depression, loneliness, and other mental 
health problems,4–8 increased risk for the development of chronic disease,9–12 and even 
mortality.13–18  
 
Under-Assessed & Under-Addressed: No Clinic-Based Solution.  
Despite evidence that social isolation is both a major health risk factor and that it is increasing, it 
continues to be under-assessed and under-addressed.19 There is a lack of consensus on how to 
screen for risk of social isolation,20 and few studies have attempted to document prevalence 
beyond narrow populations (such as older adults21 or individuals with a chronic health 
condition22,23). Most reviews of social isolation as a health risk suggest that actual prevalence in 
the U.S. is much higher than has been documented.24 Because social isolation is caused by a 
complex concatenation of individual, family, social, and structural factors, any solution must go 
beyond individual treatment. Therefore, it is difficult to design an intervention that is functionally 
viable or economically sustainable in a clinic setting. The need, then, is determining what type of 
intervention can be developed given that few successful or sustainable examples have been 
documented.17 
 
Social Isolation, Depression, & Health Disparities Among Immigrants.  
Cacioppo & colleagues describe how a lack of social relationships can become “toxic,”25 with 
severe, negative, cascading impacts on individual health and family wellbeing.17,19 However, the 
challenge of dealing with “toxic” social isolation is disproportionately greater for immigrants and 
contributes to mental and physical health disparities.26–28 Immigrants leave behind meaningful 
social, emotional, and cultural connections in their home country. In the new setting, it is often 
difficult to create social relationships, feel socially, emotionally, and culturally connected to other 
people, or have knowledge regarding access to essential resources. Language barriers, social 
stigma, discrimination, and poverty29—the structural circumstances24 of immigrants’ lives—
exacerbate this dynamic. Increasingly, the migration experience itself is understood as a risk 
factor for clinically significant mental health problems.30 For Mexican immigrants, despite a 
protective effect of immigration on health discussed as the “Latino paradox”31 in which many 
first generation immigrants demonstrate better health than their U.S.-born counterparts, further 

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cross-border research32 that controls for demographic variables has revealed that Mexican 
immigrants have twice the risk (odds ratio of 1.8) for first onset of any depressive disorder than 
those in Mexico who do not immigrate. As such, recognizing social isolation and related 
depression as health disparities requires that we consider both the complex, multifactorial nature 
of how social isolation operates in the lives of immigrants through multiple “social determinant” 
pathways, as well as the multilevel impact on individuals, families, and the immigrant 
community. Merrill Singer33 conceptualized how multiple streams of influence can come together 
to form a “syndemic” in which the synergistic interaction of social, environmental, economic, and 
political factors produce disease—often disproportionately affecting a particular group. The 
syndemic framework was explored in a recent special edition of The Lancet34,35 as a 
comprehensive approach for addressing health disparities. A syndemic framework is useful for 
thinking about how social isolation creates toxic health problems in immigrant communities and 
highlights the need for holistic solutions. 
 
The Specter of Social Isolation and Depression for Women Immigrants.  
Women immigrants, in particular, are at high risk for social isolation.26,27,36–41 For many first 
generation female Mexican immigrants (FMIs) from low-income households (per NIH definition 
in the RFP, first gen = born in Mexico), the elements that have been identified as key protective 
factors42–44 (culture and family) are eviscerated by social isolation. For FMIs, social isolation 
from the loss of extended family networks is often experienced as a form of cultural 
bereavement26 that is emotionally traumatic,27,45 leading to disproportionately high rates of 
depression. As a group, Latinas (Hispanic women) have higher rates of depression (14%) 
compared with non-Hispanic white women (7%).44 Yet troublingly, Latinas are less likely to 
receive mental health treatment (56% vs 72%).46 However, research has shown that for FMIs, 
while many recent immigrants report less depressive symptomology the closer they are to arrival 
in the U.S., the longer a FMI lives here, her risk for depression increases.44 Moreover, the rate of 
depressive disorders among FMIs is twice that for male Mexican immigrants.41,47 While it is 
challenging to find statistical data to describe an immigrant subgroup such as FMIs, a number of 
studies that disaggregate data or that have focused specifically on FMIs reveal alarming insights. 
A study with Latinas in South Florida, 95% of whom were immigrants including many FMIs, 
found that 38% of participants screened positive for depressive symptoms.48 In a study of a 
nursing intervention with FMIs and their children, 36% of participants reported depression at or 
above cut-off for referral—higher than the national average of 10% for all Americans.49 And in a 
study of Mexican immigrant patients at a health center in San Antonio, FMIs were three times 
more likely (32%) than non-Hispanic white women (10%) to present with depression.50 Building 
on Singer’s33,35 conceptualization of syndemic health, Mendenhall51 developed a groundbreaking 
model of “syndemic suffering” that opens our eyes to the fundamental synergistic nature of 
disease and social determinants in the lives of FMIs as she demonstrates interconnections 
between social isolation, depression, and diabetes risk within an experiential framework of 
pervasive violence (physical, emotional, and structural). As such, health disparities related to 
social isolation are not merely concerns of individual immigrant women, but instead, reflect even 
deeper complex social and cultural dynamics that affect the health of entire families. In 
Albuquerque, New Mexico (NM), social isolation among FMIs has been identified as a 
compelling health concern by health providers, organizations, and members of the community. In 
a study we conducted with a FMI social isolation support group,52 participants shared stories 
related to their own experiences of social isolation and the dangers and challenges associated with 
immigrating. We documented reports of depression, stress, loneliness, chronic disease, rape, 
domestic violence, and poverty. We found that it is common for women to have a great deal of 
fear when seeking social assistance or interacting with people they do not know or who do not 
speak Spanish,53 and often they do not have a way to make friends or build relationships.52 

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Our Preliminary Research On Women’s Social Networks. 
 In two of our prior community-engaged, NIH-funded research projects, we revealed the key 
nature of group interaction in the lives of Latina women, including FMIs. One of our projects36,37 
focused on women’s social networks and food insecurity in a historic Latino community, and our 
intervention involved project events (“fiestas”) where women learned to lead meetings and 
interacted with each other in a way that resulted in increased participant ability to adapt to new 
circumstances (resilience), increased recognition of personal assets (empowerment) and more 
social connectivity. Social interaction helped participants to see their own reality reflected in the 
lives of other women. Information presented and discussed at project events improved critical 
understanding of the things that influence people’s lives and increased women’s desire to become 
involved in the community. In our other study,52 we worked with the FMI social isolation support 
group discussed above. For immigrant women, the realities of the immigration experience mean 
that the process of building relationships and creating or finding a social network of support is 
often extremely challenging.54 We found that 100% of the FMI participants reported that their 
experience in the support group had been helpful or even transformational in their lives in relation 
to forming social relationships and friendships, and increasing their sense of social connectedness 
by making them feel as if they are not alone. Listening to others, and sharing experiences, 
feelings, ideas, and information helped them understand their own problems and the problems of 
others with a new lens. Participants reported: 
 
   “I don’t have anyone here. No sister, or sisters-in-law, not anyone. But since I have 
been coming here [to the group], the others listen to me and I feel good. It is 
important to get everything that is inside us to come out—that’s how we feel good. 
We need people to listen to us. Here we come to learn and I have learned many 
things about what has happened to each one. So I have listened to the others and then 
I compare my own situation with theirs and I see that mine is not as bad as some of 
the others. So if they can move on and move ahead, then I can do it also. This is what 
listening is about. I feel supported by the group by the way they listen to me.”52 
   “I have adored getting to know these women. … I am so glad to be with this group. 
It has been very healthy for me to get to know them. I think I will stay in the group 
until my blood stops running! I plan to stay because it is such a good experience. For 
me, this group is very important. There is no other place for people to listen to the 
problems I have. You know, sometimes you feel ashamed or shy, you don’t want 
people to know what is really happening in your life. But then you hear the braver 
ones talk about what they did and the others give advice on how to resolve the 
problem and it helps you. This is important because if the same thing happens to a 
few of us, you hear different situations but you say this is what is happening to me 
and this is what I have to do. Here with the group, I found two different ideas about 
how to deal with a problem I was having ... I had been trying to deal with this 
problem since I was small and wow, I found the solution. The women here helped me 
figure it out. This group, for me, has so much value.”52 
 
Participation in the group also reduced depression and relieved stress and anxiety. For example: 
 
   “When you come here, you start to see changes in yourself…in your character and 
in your personality. It is because you are getting out of the house. You come here, 
you de-stress a bit. Then when you go back home and you continue with your kids, 

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you are a bit more relaxed. You see things in a different manner. This is an outlet for 
a release of tension. I think this is really a good thing.”52 
   “There are people who God sends to our life and for me it is this group. Sometimes 
coming here is like wiping the slate clean and starting new. You are able to let go of 
what has been going on and when you leave you are like new. You have a new 
outlook on things. … It gives you energy and desire to do things….Or maybe you 
have been feeling depressed and you haven’t been wanting to eat and you come here 
and then you feel like trying the food. Coming here you just get motivated in a lot of 
ways.”52 
 
And, participants reported that participation in the group was empowering to them as women. 
They said: 
   “I feel as if in my life I have lacked a sense of myself as a woman and haven’t had a 
voice. But here I learned. It was through this group that I learned about myself and 
about how to be with my kids. It has been so helpful to me. And I feel really good 
about it.”52 
   “I think the group has been important in keeping me healthy. The discussions we 
have help me feel good about my body, about myself… And here in the group, I 
learned that we don’t have to try to be perfect. Not everyone is happy with what they 
have been given, but you have to feel good about yourself. The group helps lift us up 
and feel good about ourselves—to give us self-esteem and to try so that everyone in 
the group feels good.”52 
For FMIs then, social interaction plays a critical role in assisting them to rebuild their lives, 
redefine or reclaim their identity(s), and maintain health through shared knowledge and access to 
resources.55–57 The group experience in our project was key in creating a mechanism for positive 
social engagement. 
 
INNOVATIONS 
     The Proposed TERTULIAS Intervention Research is Innovative in Three Notable Ways. The 
proposed project challenges and seeks to shift current research and practice:  Innovation #1.) We 
utilize a novel integrated theoretical framework that accounts for the interplay of multiple factors 
that together become a mechanism producing health disparities in the lives of FMIs; Innovation 
#2.) We implement an intervention using an 
innovative design that incorporates cultural 
dimensions of women’s lives and creates a 
context for co-learning; and, Innovation 
#3.) We use a cutting-edge biological 
measure for research on chronic stress. 
 
     #1) INNOVATIVE THEORETICAL 
ARTICECTURE. To account for the 
syndemic complexity associated with 
understanding the interconnectedness of the 
domains of inquiry for this study, our 
hypothesis and research design are based 
on a fusion of three conceptual frameworks:  
             ◼)  Cultural and contextual situatedness. Trickett’s conceptualization of cultural and 
contextual situatedness58–60 proposes integrating components of an intervention “into the local 
expression of culture as reflected in the multiple levels of the ecological context.”60 Rather than 

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merely “tailoring” an intervention to target a specific context or population (e.g., by offering 
curriculum materials in Spanish or using images of individuals who “look” Latino), Trickett 
emphasizes the need for an intervention to be “situated” to fit synergistically within broader 
community dynamics (culture and context). An intervention should find a cultural and contextual 
“fit,” but it should also be strategically designed to leverage dimensions of culture and context to 
enhance intended outcomes. Thus, culture becomes a vehicle for promoting positive outcomes.  
           ◼)  Funds of knowledge. Moll, Gonzalez, & colleagues’ notion of funds of knowledge61–
63 from the literature on learning and culture has implications for health intervention 
programming for FMIs. They postulate that women have “historically accumulated and culturally 
developed bodies of knowledge and skills.”61 We propose that women bring these funds to their 
participation in health interventions and that the success of a health intervention is mediated by 
the extent to which program design positively leverages cultural values and accommodates the 
socio-economic circumstances of a population in a way that incorporates and values participants’ 
knowledge and experience (funds of knowledge), and creates synergy with the specific social 
dynamics that define participants’ everyday lives (situated in participants’ culture and context). 
This synergy creates a learning environment that promotes transformative personal and social 
change, and nurtures empowering individual psychosocial dynamics that increase resilience and 
improve health outcomes. 
           ◼)  Gendered emplacement theory. Gendered emplacement theory64–67 informs our use 
of a structured dialogue peer support group as the foundational design of the intervention. A large 
body of literature has explored the significant ways place is connected to health and wellness68 
through multi-level environmental influences in which an individual is embedded—many of 
which are defined as the social determinants of health. However, social science researchers have 
identified that the ways that a person experiences and perceives a connection to a place is also 
key. This sense of “emplacement,” both spatial and social, plays an important role in personal 
wellbeing. Social connectedness is an essential component of this dynamic. Feminist scholars 
have expanded this concept through investigation of the gendered dimensions of “emplacement” 
in which women are displaced from historically male dominant spaces and therefore compelled to 
create alternative, protected spaces for feeling connected and engaged.64–67 For obvious reasons, 
immigrants experience this sense of displacement in an inherently heightened way, which for 
women immigrants is doubly disorienting.  
 
     #2) INNOVATIVE INTERVENTION DESIGN: Structured Dialogue.  
We will test the integration of our 3 theoretical frameworks in TERTULIAS, an 
innovative peer support group intervention. Peer support groups have been shown to be 
efficacious for a variety of contexts, populations, and health conditions.69–73 For women 
immigrants, culturally based interaction with peers in protected spaces that promote personal 
empowerment is important for rebuilding lives, redefining or reclaiming identity(s), and knitting a 
strong social fabric to make women and their families healthy and resilient.36,37,54,74,75 Yet just 
bringing women together would not likely result in systematic change to improve health 
outcomes and reduce health disparities. As per our theoretical architecture, cultural and 
contextual dimensions of women’s lives need to be considered (situated), women’s own 
knowledge and experience (funds of knowledge) must be valued and validated, and women need 
to develop a feeling of personal connection with others and have a way to conceptually 
understand their lives within a larger social context (emplacement). In our preliminary research, 
we worked with women from the Latino community, including FMIs, to develop a novel 
“structured dialogue” approach for engaging small groups of participants in a way that integrates 
these three theoretical frameworks.36,37,52 The structured dialogue approach upon which the 
TERTULIAS intervention is based involves 3 fundamental components: 

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◼) Peer-to-Peer Interaction. In both of our previous projects, participants shared stories, 
experiences, and ideas with each other. Through the group design of the intervention, participants 
expanded their social networks by making friends, helping each other, and learning about 
resources available in the community. From each other, they learned about, explored, discussed, 
and analyzed issues that they found to be of interest, they listened to ways that others in the group 
(women like themselves) confronted challenges and resolved problems, they developed their 
skills and knowledge for dealing with the situations that they experience, and they increased their 
capacity to deal with adversity with resilience.  
   
◼) Bi-Directional Expert Facilitation. In our prior research, a trained facilitator led bi-
directional “structured dialogue” that allowed discussion to occur in an organic, open-ended 
manner. The facilitator built on themes emerging in the peer-to-peer discussion by presenting 
powerful life stories and analyses from other studies of women’s health, and themes that emerged 
from the interviews with individual participants. The group considered stories and themes that 
were presented and discussed them in relation to their own lives and experience—weaving 
together their own experiences with those of other women, both inside and outside the group. 
Through this process, they developed an understanding of the broader forces that influence and 
structure their choices and practices on an everyday basis. We found that this approach engaged 
women in a way that decreased depression and other negative emotional states, improved their 
capacity to deal with socioeconomic conditions and relationships with intimate partners, and gave 
them a new way of thinking about their own lives and for understanding their community.36,37,52 
Women described these changes as personally empowering and transformative.  
◼) Food-Sharing and Storytelling. Food-sharing and storytelling are central 
components of the innovative structured dialogue group intervention that we have developed. 
Food-sharing is a well-established core cultural value for Latinos and particularly for Mexican 
Americans, especially at gatherings. But food (in its guises as kitchenspace,76 food sourcing and 
food access expertise,77 food preparation, cooking, and meal serving) is also important as a 
symbol and domain of women’s identity.36,36 In our projects, funds allowed for some provision of 
food, but of their own accord, the women in each of the groups developed a potluck-style process 
to bring food to share with others. Although it may seem insignificant, food-sharing created a 
culturally situated context for women to feel engaged and connected, and the food itself 
integrated something from women’s funds of knowledge into the group. Given that many of the 
participants in our projects experience food insecurity in their homes, the fact that they were 
interested in and enthusiastic about bringing food to the meetings must be understood as a 
reflection of the significance the group held in their lives. And, both projects used storytelling, an 
evidence-based strategy from research on empowerment among women that has been found to be 
particularly effective among women of color.78–80 In our projects, the participants shared stories of 
their experiences, or the facilitator presented stories from other women. For women in our 
studies, the act of storytelling was evocative. They shared experiences, expressed feelings, and 
saw the connection between their own stories and stories of others. Women found participation in 
this process to be empowering, giving them information and tools to understand the root causes of 
disparities they recognize in their own lives. The group-centered learning was generative through 
the development of social connections, and the identification of both individual actions and group 
strategies to improve health. Structured dialogue helped women participants create their own 
narratives in a way that was healing and personally transformative (empowering). The peer-to-
peer nature of the proposed structured dialogue group intervention will help participants “locate” 
and “ground” (emplace) themselves within a supportive social network. The critical social 
“literacy” that accrues from the structured dialogue design of our model will help women further 
“locate” and “ground” themselves in relation to shared stories and experiences—stories and 
experiences from others in the group and those presented by the facilitator—that tether 
participants’ lives to policy and structural relations of power through transformative learning, 
building resilience, and becoming empowered. 

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     #3) INNOVATIVE RESEARCH METHODOLOGY: Hair Cortisol Bio-Measure of 
Chronic Stress. Health disparities research has matured through the application of the social 
determinants of health framework. However, the need to move beyond merely understanding 
social determinants to action-oriented intervention research is increasingly recognized. 
Identifying biomarkers to support this work is imperative. Therefore, as part of this project, we 
will gather hair samples to test for cortisol, a biomarker of stress. We know that stressful 
experience influences physical and psychological health,81 and we now understand that stress can 
accumulate or become toxic, ultimately influencing the biology of the human body, including the 
hormones, cortisol and adrenalin, and the immune system. Such chronic toxic stress is an 
emerging construct in health research.82–84 However, measuring stress biochemically in the 
context of research is challenging. Many studies (the proposed study included) use psychosocial 
instruments that rely on self-report or recall. While often revealing valuable information, data 
from these instruments can be limited by respondent subjectivity or reporting bias.85 Hence there 
is a critical need to develop an objective biomarker that can be used for unbaised measurement of 
chronic stress,, such as altered hormone levels that the experience of stress provokes. In the 
context of this study, advances in studying hair cortisol, an emerging validated biomarker for 
chronic stress,86–90 offer exciting opportunities. Cortisol levels are altered in people with chronic 
stress. Cortisol has traditionally been measured in blood, saliva, or urine by a variety of clinical 
testing approaches.91 Because of the diurnal variation in cortisol levels, these measures are 
unreliable. Furthermore, measures of bodily fluids offer only a snapshot of cortisol levels at any 
particular moment that can have valuable clinical uses, but fails to reveal the bigger picture of 
chornicity Unlike bodily fluids, hair provide a long-term read-out of cortisol levels over time. 
Typically hair grows by 1 cm per month. Therefore, cortisol extracted from 3 cm of hair detects 
the average cortisol levels in that person over the preceding 3 months. This innovative, non-
invasive bio-measure of long-term or chronic stress is emerging with applications to a range of 
questions, including stress and diabetes, stress and poverty, and stress and child maltreatment. In 
recent literature, measurement of cortisol levels in hair has proven useful to determine the long-
term effects of stress86,92–99, including in relation to depression.100–102 Previously, there has been 
no good assay to determine this effect. Now, with the ability to measure average cortisol over a 
span of time, more complex relationships will be identified and analyzed.103,104 This line of 
inquiry is a major advance in revealing the often subtle ways that dysregulation of cortisol levels 
is implicated in the risk of disease and negative health outcomes.100 We recently received NIH 
(NCATS) funding to analyze correlations between hair cortisol, depression, and A1c for 100 
Latino participants (many of them Mexican immigrants) sampled at 2 time points. Specimen 
collection concludes in February 2019. This experience with cortisol testing and analysis provides 
us a solid foundation to pursue this innovative approach to measuring chronic stress in the study 
proposed here. 
 
 
3.0     Inclusion and Exclusion Criteria 
     Population. This project focuses on FMIs for 4 reasons: 1.) FMIs experience disparities in the 
prevalence of depression and in lack of access to treatment compared with Mexican immigrant 
men and non-Hispanic white women.44,105 2.) Social isolation and depression among FMIs has 
been identified in our community work and research as compelling health concerns by health 
providers, organizations, and members of the Latino community. 3.) The PI’s previous research 
has expanded our understanding of the negative impact that social isolation has on the lives of 
Latinas (FMIs and nonimmigrants) and their families, and the ways that supportive groups and 
expanded social networks can positively transform health and social outcomes.36,37,52 4.) It is our 
experience that women tend to be more likely to be interested in community-engaged activities 

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and they are uniquely positioned within the household to provide connection to other family 
members and influence health dynamics among extended family networks.  
     Inclusion Criteria. All participants will be female immigrants over the age of 18 (maximum 
age 90) who were born in Mexico, report household income below 250% of the Federal Poverty 
Level (FPL), and speak Spanish fluently (because group sessions will be conducted in Spanish). 
We will not recruit children, individuals unable to provide consent, or individuals that are 
incarcerated or pregnant women.  Pregnant women will be excluded because pregnancy will 
influence cortisol levels, one of the measures being used in this study. 
 
4.0 
Study-Wide Number of Subjects 
     Sample Size. We will recruit 252 participants (N=252). We will randomize participants 
into one of two arms. We will enroll 60 participants each year during Y1 and Y2 (30 Arm 1 and 
30 Arm 2). During Y3 and Y4, we will increase enrollment to 66 each year (33 Arm 1 and 33 
Arm 2) to ensure we account for attrition to be able to power the study. Sample size 
accommodates attrition. 
◼) Arm 1 (n=126): Control participants will be recruited in four 12-month cohorts to 
coincide with the intervention cohorts. At the end of their 12-month participation in the control 
group, they will be offered the option of participating in the Y2, Y3, or Y4 intervention cohort or 
if they prefer, to join the ongoing group at the Hopkins Center outside of the research.  
◼) Arm 2 (n=126): Intervention participants will be recruited in four 12-month cohorts. 
Each cohort will be divided into three groups. With 3 groups in each cohort, over the four cohort 
cycles, we will have a total of 12 groups.  
 
5.0   Study-Wide Recruitment Methods 
Recruitment.  
We will recruit a total of 260 FMI participants. Our two research partner agencies (Centro Sávila 
with its affiliate, The Hopkins Center and One Hope Centro de Vida) that both have a large 
Mexican immigrant clientele will recruit at their sites, but we will also reach out to other agencies 
where we have contacts. Potential participants will be contacted in-person, by email, by phone, by 
text, or by Zoom. For all in-person recruitment, we will follow COVID-19 safety guidance for in-
person meetings, using screening questions, thermometers, facial coverings, social distancing (6-
ft when possible), and sanitization of hands and surfaces. 
 
We will document successful recruitment strategies.  We will track methods used to identify 
potential participants at each site, # approached for interest, # who are interested/not interested, # 
who are screened for eligibility, and # of eligible participants who agree/decline to enter the 
study. We will use Consort standards106,107 to track recruitment and attrition. We will document 
contextual factors or aspects of the intervention that influence participation and retention. We will 
track reasons for interest/no interest and reasons eligible participants decline to participate, and 
we will ask potential participants to indicate the importance of different aspects of the project in 
their decision (e.g., time, location, group design, food sharing, babysitting, etc.). We will track 
attendance at meetings and attrition, and document reasons if participants leave the study.  
                             
Deciding to Participate 
In our current HPRO-approved, PCORI-funded research study with Latinos from low-income 
households, we have recruited 452 participants. Of those, 183 are FMIs. The level of education 
for this subset of PCORI participants is: 47% have less than an 8th grade education and another 
18% have some high school but no diploma. Because we will be recruiting from the same 
immigrant population for this study, we anticipate that potential participants for this study will 

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have a similarly low level of education. In addition, we know that this population may also be 
wary of the idea of participating in a research study. This means that we need to ensure that the 
consent process provides potential participants with sufficient information to allow them to 
provide informed consent but that it does not become so burdensome and complicated that it will 
be counterproductive to the study by discouraging individuals from electing to participate—
which would significantly affect our ability to recruit from a participant population that is already 
known to be challenging to recruit. 
 
Participation in this study would normally present no greater than minimal risk, however because 
of COVID-19, risk is elevated. As a result, we have instituted safety measures to protect staff and 
participants. Potential participants will be contacted in-person, by phone, by email, by text or by 
Zoom. For recruitment, data collection and intervention-related meetings, we will use Zoom 
meetings when possible and follow COVID-19 safety guidance for in-person meetings, using 
screening questions, thermometers, facial coverings, social distancing (6-ft when possible), and 
sanitization of hands and surfaces. 
 
In addition, because the study is complex, the consent form is extremely long (9 pages in 
Spanish). Moreover, randomization is a complicated concept and will need to be explained in a 
way that potential participants can be sure to understand what it means and why we do it. 
Consenting for this study will be conducted in Spanish by FMI members of the research team 
who have extensive experience consenting individuals from this population through our current 
PCORI-funded project that has enrolled and consented 452 low-income Latino diabetes patients 
and social supports, including many Mexican immigrants. Given our experience, we anticipate 
that individual informational/consent sessions will take an hour or more to go over everything in 
a way that will ensure that the participant understands what it will mean to be randomized and the 
nature of their participation in order to decide whether or not to participate. The length of this 
process would create great burden on our project staff and on participants and challenge the 
feasibility of the study. 
 
To address these issues, we obtained approval for an alteration of the consent process that 
includes a meeting, a PowerPoint presentation, and a randomization video (see attached script in 
English—the video itself is in Spanish and will be submitted when complete). Because of 
COVID-19 social distancing restrictions, in Year 1, we will hold this meeting by Zoom in 6 
groups of 10 participants each. In subsequent years, we will determine the appropriate safety 
context for whether or not we meet in-person or not. We have designed a culturally appropriate 
group information meeting that includes detailed information about why we are doing the study 
and what participation will be like for individuals in both the control group and the intervention 
group. The presentation will include all required information that is in the consent form.  
 
The informational meeting will be held by Zoom or at a convenient location in the community 
and will follow COVID-19 safety guidance for in-person meetings, using screening questions, 
thermometers, facial coverings, social distancing (6-ft when possible), and sanitization of hands 
and surfaces. The meetings will be conducted in Spanish by FMI members of the research team. 
The informational meeting will have the following: 
• 
A PowerPoint presentation describing (in Spanish) (English version attached) the 
scientific and social contribution that this study will make and why we are doing it. This 
will be submitted for HRRC approval when it becomes available and before recruitment 
starts. 
• 
A detailed explanation about the research and what participation entails. The presenter 
will clearly explain the research, the risks to participants, and the procedures for 
safeguarding their privacy. Participants will be informed that they will be assigned 

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randomly to a group, that they can refuse to answer any questions and stop the survey, 
interview, or participation in a focus group at any time. The investigators have training 
and will understand the importance of these issues and their responsibility for 
maintaining high ethical standards and they will have current human subjects research 
training certification.  
• 
An explanation of what randomization means and why we do it. To this end, NIH funded 
us to produce a brief video with FMI presenters describing (in Spanish) (English script 
attached) how the randomization works, and why randomization is important, to help 
participants understand why we have structured the project to have two arms. After 
viewing the video, participants interested in participating will continue the informed 
consent process (in English or Spanish, depending on participant preference).  
 
Randomization 
After the presentation is over, those who decide not to participate in the larger research study will 
then be free to leave the meeting (whether by Zoom or in-person). Those who decide to 
participate will be asked to approach a table or if by Zoom, will be told they will be contacted to 
sign the consent form and research team members at the consent table or who do the contact will 
do a brief review of the consent form. If an in-person meeting is not feasible because of COVID-
19 restrictions, oral consent will be obtained prior to conducting the baseline data collection 
survey. 
 
There will be an option for conducting an informational session individually either in-person or 
by Zoom with women who cannot attend the informational meeting or those who choose to do the 
consent process in private, but we will encourage potential participants to attend the meeting 
because we believe that for this population, the meeting process will be more engaging and a 
superior context for learning about the research than going over the lengthy consent form 
individually, and because it will also alleviate feasibility concerns. 
 
Consented participants will randomized to the intervention group or control group. Each woman 
will draw a number from a bowl. The numbers will have been randomized to one of the groups 
prior to the meeting. Randomization will be done using a block randomization design to allocate 
50% of participants to the control group and 50% to the intervention. Randomization will be done 
using a block randomization design to allocate 50% of participants to the control group and 50% 
to the intervention. Random block sizes of 2, 4, and 5 will be implemented to ensure balance 
between arms. Intervention group participants will be offered three group meeting options to 
accommodate participants’ schedules related to day/time and location considerations, but the 
three options will all be conducted using the same structure and format. 
 
1) COVID-related change: Because of COVID-19 restrictions, we previously obtained 
approval to hold weekly peer support group meetings for the intervention arm by Zoom. 
In doing so, we have identified a need to make two modifications. Participants in the 
intervention arm will be notified of these changes, but control participants would not be 
notified. 
 
a.) Now that the meetings are being held by Zoom, the participants are generally 
participating from their homes. To ensure sufficient privacy for the meetings that will 
ensure privacy for all participants, we are adding that we will supply participants with 
inexpensive ear bud-style earphones. 
 

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b.) The intervention arm participants are joining a weekly 2-hour Zoom meeting. 
We have identified that many participants do not have sufficient internet connection or 
data use plans to allow this to continue and that it is an expense to them. We are adding in 
a payment of $30/month per intervention arm participant to help cover the cost of 
allowing them to have sufficient bandwidth/plans to be able to participate. This is 
fundable because we had money for babysitting that we are not using because we are 
holding the meetings remotely. This is not an incentive, it is covering the costs they are 
incurring and making participation feasible. 
 
6.0     Multi-Site Research 
N/A 
7.0     Study Timelines 
Each participant will be in the study for 12 months. . 
 
This is a 5-year project. If funded, the project would tentatively start in late summer or 
fall of 2019. 
 
We expect to end the intervention in month 6 of Y5.   
We will complete analysis by month 12 of Y5. 
 
 
8.0     Study Endpoints 
The research endpoint for each participant is after the 12-month data collection 
appointment. 
 
The study research endpoint will be in month 6 of Y5 when the last cohort of participants 
completes 12-month follow-up data collection appointments. 
 
There are no safety endpoints identified for this study. 
 
9.0     Procedures Involved* 
QUANTITATIVE DATA COLLECTION: 
 ◼) Surveys. We will administer a multi-dimensional pre/post survey to all participants at 
baseline prior to the first group session and at 12-months. The survey will combine demographic 
questions with questions from validated instruments to measure domains of interest 
(Depression109,110, Stress111, Resilience and Adaptability112, and Social Support113,114) plus 
questions to document the participant’s social network to measure social connectedness113,114 to 
inform the social network analysis (see Table and attachments). At baseline, all participants will 
also be asked demographic questions. At baseline and 12 months, all participants will be asked 
the pre/post survey questions. At 12 months, Arm 1 (control) participants will be asked to 
answer questions about interest in participating in an intervention group, and Arm 2 (intervention) 
participants will also be asked a series of questions designed to evaluate their participation in and 
perspective on the TERTULIAS intervention, including the Trauma-Informed Practice Scale to 
measure Empowerment and Knowledge115,116. At each time point, data collection appointments 
will be in-person because of the need to gather hair samples and will follow COVID-19 
guidelines as appropriate related to screening questions, temperature screening, face masks, social 
distancing as much as possible, and use of sanitizing products. The survey will be administered 

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orally in Spanish or English (depending on the preference of the participant) by trained FMI data 
collectors using IPads and entering data into REDCap, the secure data capture system operated by 
the UNM CTSC. Participants will receive a $50 merchandise card. We have developed a protocol 
and have professional team members to assist any participant (control or intervention) identified 
as needing immediate medical or counseling services.  
 
 
 
 
 
 
 
 
 
 
We will alter the data collection process for our Social Network Analysis (SNA) beginning with 
data collection for baseline Y3 and 12-month follow-up for Y2 that will occur in summer 2022, 
and then we will continue using the new process for the remainder of the project. The reason for 
this alteration is that the SNA questions were very repetitive and extremely tedious for both the 
data collectors and the participants. When Dr. Thomas joined the team (replacing previous SNA 
analyst, Molly Bleecker), he brought enhanced SNA expertise. He made the suggestion that we 
could improve data collection and enhance the scientific quality of our data by moving to 
Network Canvas software, an NIH-funded SNA App. Dr. Thomas will program the Network 
Canvas software to ask the specific Tertulias questions. 
 
Network Canvas (https://networkcanvas.com/about.html) 
Funded by NIH # R01 DA042711 (or 5R01DA042711-02?) 
"netCanvas: Development, Hardening, and Dissemination of a Software Suite for the 
Collection of Complex Network and Contextual Data in HIV and Drug Research" 
PI Michelle Birkett, Northwestern University 
other PI Gregory Phillips II 
https://reporter.nih.gov/project-details/9306043 
 
The Network Canvas software suite is an Open-Sourced package of applications developed by 
researchers at Northwestern University and Oxford University with NIH funding, for the purpose 
of collecting survey data on the personal social networks of subjects in the field with one-on-one 
help from interviewers. Per NIH requirements, the Network Canvas software technology is 
appropriate for use in research studies and was designed for ease of use. The Network Canvas 
interface is interactive and uses graphic images that the participant can name, click, drag, and 
drop rather than merely answering a series of repetitive questions. The software significantly 
eases the cognitive burden of this process on both subjects and interviewers, compared to earlier 
social network survey techniques, which reduces the time the survey takes and improves the 
quality of the data collected. The software also eases the management of the data collection 
process across multiple interviewers in multiple locations. Network Canvas consists of three 
component applications: Architect, for designing surveys, Interviewer, for conducting the survey 
in the field, and the optional Server component, for transmitting data securely from the devices in 
the field to a computer managed by the project team (at UNM in this case). 
 
Impact on Construct or 
Domain 
Measure or Instrument 
*All instruments have validated Spanish versions available 
Decrease Depression 
Center for Epidemiologic Studies Depression Scale (CES-D), 20 
items, total score range from 0 to 100. (α= .85-.90) 
Decrease Stress 
Perceived Stress Scale (PSS-14), 14 items, total score range from 0 
to 56 (α=0.84-0.86) 
Lab analysis of hair cortisol  
Increase Resilience  
& Adaptability 
Connor-Davidson Resilience Scale (CD-RISC), 25 items, total score 
range 0 to 100 (α= .81) 
Increase Social Support 
Medical Outcomes Study Social Support Survey (MOS SSS), 19 
items, total scaled score ranges from 0 to 100.  (α= .97) 
Increase Social Connectedness 
Social Network Analysis Questions 
Increase  
Knowledge & Empowerment  
Trauma-Informed Practice (TIP) Scale (α= .85-.98) 

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For the new process, instead of merely asking a series of questions and putting the answers into 
REDCap, the SNA question portion of the data collection will be gathered by the Data Collectors 
on the same tablet device (i.e., an iPad) that they use for the REDCap log-in and survey data 
collection. The IPads will run the Network Canvas Interviewer application. The data is stored 
locally on the device (which is kept in the Data Collector’s possession) until it is either manually 
copied from the device by the Tertulias team, or transmitted to the Network Canvas Server at 
UNM, which is administered by the Tertulias team. Transmission of data from the tablet devices 
to the Network Canvas Server uses end-to-end encryption, employing a symmetric Advanced 
Encryption Standard (AES) algorithm to encyrpt the data pre-transmission, and then using a 
Transport Layer Security (TLS) for the transmission. Any third-party interception of the 
transmission between the iPad and the Network Canvas Server would only yield heavily 
encrypted data. Data from the Network Canvas apps for this project will never be transmitted to 
any other server or entity except for the server at UNM.  
 
Network Canvas data from the iPads will be transmitted to the Network Canvas Server in one of 
two ways: 1) by connecting the iPad to the UNM network via a Virtual Private Network (VPN), 
and then connecting to the campus-located computer running the Network Canvas Server and 
uploading the data, or 2) by physically bringing the iPads to campus to connect to the server on 
the secure UNM local area network (LAN), or 3) by transferring the data directly from the iPad to 
a Tertulias team laptop by a physical cable. 
 
The Network Canvas technology will allow us to add a series of questions to measure additional 
characteristics of the people in the respondents' networks (their "alters"), to estimate how and 
whether the Tertulias interventions change the diversity and composition of their networks. These 
include age, gender, ethnicity, education and occupation. We will also add questions to measure 
additional information about the participants’ relationships with each alter (the people they 
know). These include frequency of interaction, when and how they first met the person (if not 
family). 
 
To measure alters' gender, the interface will show the respondents a visualization of the people 
they have identified in the survey, and prompt them to "select the people you know who are 
Males". 
 
The interface will then show them an assortment of circles labeled with different ethnic/racial 
categories, and ask the respondents "Please place each person in the circle that best matches their 
ethic or race". These will include "Hispanic/Latino", "Anglo", "Black", "Asian", "Native 
American", and "Other/Multiracial" (which initiates a text prompt). 
 
To measure education, the interface will show them a scale ranging from "No Formal Education" 
to "High School or Equivalent" to "College Degree" and "Advanced Post-College Degree". It will 
prompt the respondents to "Please place each person on the scale to match their level of 
education".  
 
To collect data on age and occupation, the survey will show the respondent a list of questions for 
each alter (one alter at a time), asking them to type in their age and occupation in text boxes. 
 
To measure frequency of interaction, the interface will show the respondents a scale of frequency 
(e.g. "Daily" "Every few days" "Once a week" "Once a month" "Less than once a month") and 
ask them to drag and drop each alter into a place on the scale ("How often do you talk to each of 
these people you know?"). 
 

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To measure how they first met each alter who isn't a blood-relationship, the survey will show 
them a list of ways people first meet each other, and ask them to choose all that apply (separately 
for each alter, one at a time). Options will include "Through Friends" "Through Family" "At a 
party" "At Work" "In my Neighborhood" etc. 
 
To measure how long have they known each alter, the interface will ask participants to select 
their (the participant’s) age when they first met the alter. 
 
The Network Canvas software allows us to measure the closeness that people feel to others in a 
more nuanced way that the previous survey. The original survey instrument simply asked if the 
respondent felt close to the other person, yes or no. The new Network Canvas version of the 
survey will ask respondents to place each of the people they tell us about in a 2-dimensional 
space, by dragging their icons with their finger or stylus. This screen has three concentric circles 
in the background representing differing levels of closeness, with the central circle representing 
feeling most close to the person, and the larger circles representing more peripheral feelings of 
closeness, and outside of the circles entirely representing feeling not close. The interviewers will 
explain this interface to the subjects, though we expect this exercise to be quite visually intuitive 
to most respondents. The resulting data file includes the coordinates of each icon placement, 
allowing for detailed metrics of closeness. 
 
Respondents are currently asked about their relationships to various other people in their lives, 
but they are not asked about the relationships between those people. For instance, in the current 
survey instrument the respondents tell the Tertulias team about the people they know who they do 
fun activities with, but we do not measure whether those people participate in entertainment 
activities with each other, or even know each other at all. We will add a question asking the 
participants to indicate which of the people in their life that they have told us about know which 
other people in their life, using the same measures of "knowing" that we use for subject-alter 
relationships. The new Network Canvas software makes this relatively simple for us to 
implement, and a quick task for the subjects to complete. 
 
◼) Additional Survey Questions. At the end of Y2, we conducted a preliminary analysis 
of the data. Qualitative data were extremely powerful regarding participant self-report about the 
importance of the intervention and the deep significance it has had on them as individuals and in 
their lives. These findings are clear in the data from meeting notes, interviews, evaluation 
discussions, and Ripple Effects Mapping sessions, and are supported by perceptions of team 
members who facilitate the peer support groups. However, when we analyzed the pre/post survey 
data using quantitative methods, there was little or no difference between the arms. It didn’t seem 
possible that being in such an intensive intervention with reports from the participants of such 
deep impact could be the same as receiving nothing. So the results were not only surprising to us, 
they don’t make sense. After much discussion with team members, our Advisory Board, 
individuals from the population of study, and experts in research methods, and reviewing the 
literature, we hypothesize that the discrepancy and lack of alignment between our qualitative and 
quantitative data may reflect the following: 1.) There may be some impact from the pandemic 
which was universally affecting participants from both arms of the study, 2.) Although the survey 
is conducted by 2 female Mexican immigrant data collectors, the participants do not know the 
data collectors—they are strangers—and this makes disclosing truthful answers to questions 
about mental and behavioral health (the focus of this study) challenging. There is much published 
data regarding the fact that in Mexican culture, people tend not to want to disclose information 
about mental and behavioral health (the focus of this study), and that this is particularly true for 
Mexican women. 3.) There is a lot of shame associated with mental and behavioral health issues 
in Mexican culture. 4.) Many people from the population of study do not really understand what 

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depression and social isolation are, and therefore when asked questions about these issues, they 
do not associate them with their own lives and experience. 5.) There may be a “response-shift 
bias” occurring in our data collection process. Tugwell & Knottnerus (2014) define this as “a 
change in the meaning of one's self-evaluation of a target construct as a result of 1) a change in 
the respondent's internal standards of measurement (ie, scale recalibration); 2) a change in the 
respondent's values (ie, the importance of component domains constituting the target construct; 
ie, reprioritization), or 3) a redefinition of the target construct (ie, reconceptualization).” In this 
study, that would mean that at baseline, participants in both arms are answering the questions 
from the perspective that they don’t know the data collectors, that there is shame in admitting 
mental and behavior health problems, and that they don’t see these things as relevant to their 
lives. So, everyone at baseline kind of answers the same – “I’m fine”—which may or may not 
reflect how they really feel. At follow-up, the control participants have not had any experience to 
shift the way they answer the questions, so they still just answer “I’m fine.” For the intervention 
arm participants, they have had a transformative experience in the group and they are now much 
more trusting of the data collectors and they have a much deeper understanding of what 
depression and social isolation are and they have a lot of experience disclosing and talking about 
these types of mental health issues. So at follow-up, they answer the questions and they say “I’m 
fine,” but it now means something completely different that is not captured by the quantitative 
survey instrument. So, while the two arms score similarly on the survey instrument, the responses 
no longer align between pre and post, and they do not align with the qualitative data.  
 
Retrospective pre-test design 
We want to validate the qualitative data analysis because it seems to align with the 
experience people report and that we observed, while the preliminary results of the survey data 
analysis do not align with what we have observed or what people report. To deal with this mis-
alignment, we consulted with a methodologist who suggested we use a “retrospective pre-test 
design” and administer some new questions. With this method, we will use the qualitative results 
as the constructs for the new questions. Each question will get asked at the 12-month follow-up in 
2 ways using this format on a scale of 1-5: 
 
1. Before you started Tertulias, how would you rate your knowledge of resources in the community? 
2. When you finished Tertulias, how would you rate your knowledge of resources in the community? 
 
3. Before you started Tertulias, how would you rate your confidence using technology such as Zoom? 
4. When you finished Tertulias, how would you rate your confidence using technology such as Zoom? 
 
5. Before you started Tertulias, how lonely or socially isolated did you feel? 
6. When you finished Tertulias, how lonely or socially isolated did you feel?? 
 
7. Before you started Tertulias, how much of a sense of belonging did you feel? 
8. When you finished Tertulias, how much of a sense of belonging did you feel? 
 
 
The literature suggests that this format of question asked at follow-up tends to elicit more truthful 
responses from participants. We will compare these responses with answers to the validated 
instrument questions and to the qualitative data. 
 
We will add these questions to the 12-month follow-up survey and administer them to all of the 
Y3 and Y4 participants as part of the 12-month data collection. We will be gathering follow-up 
data from Y3 participants in July/August of this year and from Y4 participants in July/August 
2024. 

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For Y1 and Y2 participants who have already completed the intervention and completed follow-
up data collection, we will reach out to them by phone, text, Zoom, or email and ask them if they 
would be willing to answer a few more questions. We will use the attached recruitment script. If 
they are willing, one of the team members will set up the meeting, administer the new questions 
orally, and record the responses in REDCap using a tablet or laptop. The additional data 
collection for Y1 and Y2 participants should only take 15-20 minutes. Participants will receive a 
$25 merchandise card for answering the additional questions. Because for Y3 and Y4 
participants, the questions will be incorporated into the follow-up data collection, we will not 
offer additional incentive. 
 
We are requesting approval to obtain oral consent for Y1 and Y2 participants to answer these 
additional questions. They have already signed the consent form for the project. We will 
document the fact that they consented in REDCap. 
 
Lit Review 
We conducted literature reviews Mexican immigrant women and reporting mental and 
behavioral health issues, Response-Shift Bias, and Retrospective Pre-Test Design. 
 
Mental Health Disclosure and Culture 
Vargas-Willis, G., & Cervantes, R. C. (1987). Consideration of psychosocial stress in the 
treatment of the Latina immigrant. Hispanic Journal of Behavioral Sciences, 9(3), 315-329. 
 
Martinez-Hollingsworth, A., Hamilton, N., Choi, K., & Heilemann, M. (2021). The Secret-Self 
Management Loop: A grounded theory of provider mistrust among older Latinas with type 2 
diabetes and mental health symptoms. Diabetes Research and Clinical Practice, 175, 108787. 
 
Unger, J. B., Cabassa, L. J., Molina, G. B., Contreras, S., & Baron, M. (2013). Evaluation of a 
fotonovela to increase depression knowledge and reduce stigma among Hispanic adults. Journal 
of Immigrant and Minority Health, 15, 398-406. 
 
Giacco, D., Matanov, A., & Priebe, S. (2014). Providing mental healthcare to immigrants: current 
challenges and new strategies. Current opinion in psychiatry, 27(4), 282-288. 
 
Pratt, C. C., McGuigan, W. M., & Katzev, A. R. (2000). Measuring program outcomes: Using 
retrospective pretest methodology. American Journal of Evaluation, 21(3), 341-349. 
 
Eghaneyan, B. H., & Murphy, E. R. (2020). Measuring mental illness stigma among Hispanics: A 
systematic review. Stigma and Health, 5(3), 351. 
 
Añez, L. M., Paris Jr, M., Bedregal, L. E., Davidson, L., & Grilo, C. M. (2005). Application of 
cultural constructs in the care of first generation Latino clients in a community mental health 
setting. Journal of Psychiatric Practice®, 11(4), 221-230. 
 
Kouyoumdjian, H., Zamboanga, B. L., & Hansen, D. J. (2003). Barriers to community mental 
health services for Latinos: treatment considerations. Clinical Psychology: Science and Practice, 
10(4), 394. 
 
Vega, W. A., Karno, M., Alegria, M., Alvidrez, J., Bernal, G., Escamilla, M., ... & Loue, S. 
(2007). Research issues for improving treatment of US Hispanics with persistent mental 
disorders. Psychiatric Services, 58(3), 385-394. 

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Vega, W. A., Kolody, B., & Valle, J. R. (1987). Migration and mental health: An empirical test of 
depression risk factors among immigrant Mexican women. International Migration Review, 
21(3), 512-530. 
 
Escobar, J. I., Nervi, C. H., & Gara, M. A. (2000). Immigration and mental health: Mexican 
Americans in the United States. Harvard review of psychiatry, 8(2), 64-72. 
 
Vega, W. A., & Rumbaut, R. G. (1991). Ethnic minorities and mental health. Annual review of 
Sociology, 17(1), 351-383. 
 
Cervantes, R. C., & Castro, F. G. (1985). Stress, coping, and Mexican American mental health: A 
systematic review. Hispanic Journal of Behavioral Sciences, 7(1), 1-73. 
 
Vega, W. A., Kolody, B., Aguilar-Gaxiola, S., & Catalano, R. (1999). Gaps in service utilization 
by Mexican Americans with mental health problems. American Journal of Psychiatry, 156(6), 
928-934. 
 
Lucero, N. B., Beckstrand, R. L., Callister, L. C., & Sanchez Birkhead, A. C. (2012). Prevalence 
of postpartum depression among Hispanic immigrant women. Journal of the American Academy 
of Nurse Practitioners, 24(12), 726-734. 
 
Tobin, C. L., Di Napoli, P., & Beck, C. T. (2018). Refugee and immigrant women’s experience of 
postpartum depression: a meta-synthesis. Journal of transcultural nursing, 29(1), 84-100. 
Schmied, V., Black, E., Naidoo, N., Dahlen, H. G., & Liamputtong, P. (2017). Migrant women’s 
experiences, meanings and ways of dealing with postnatal depression: A meta-ethnographic 
study. PloS one, 12(3), e0172385. 
 
Nadeem, E., Lange, J. M., Edge, D., Fongwa, M., Belin, T., & Miranda, J. (2007). Does stigma 
keep poor young immigrant and US-born Black and Latina women from seeking mental health 
care?. Psychiatric Services, 58(12), 1547-1554. 
 
Kirmayer, L. J., Narasiah, L., Munoz, M., Rashid, M., Ryder, A. G., Guzder, J., ... & Pottie, K. 
(2011). Common mental health problems in immigrants and refugees: general approach in 
primary care. Cmaj, 183(12), E959-E967. 
 
Haque, S., & Malebranche, M. (2020). Impact of culture on refugee women’s conceptualization 
and experience of postpartum depression in high-income countries of resettlement: A scoping 
review. PLoS One, 15(9), e0238109. 
 
Shattell, M. M., Hamilton, D., Starr, S. S., Jenkins, C. J., & Hinderliter, N. A. (2008). Mental 
health service needs of a Latino population: A community-based participatory research project. 
Issues in mental health nursing, 29(4), 351-370. 
 
Callister, L. C., Beckstrand, R. L., & Corbett, C. (2011). Postpartum depression and help‐seeking 
behaviors in immigrant Hispanic women. Journal of Obstetric, Gynecologic & Neonatal Nursing, 
40(4), 440-449. 
 
Caplan, S., & Whittemore, R. (2013). Barriers to treatment engagement for depression among 
Latinas. Issues in mental health nursing, 34(6), 412-424. 
 

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Kaltman, Stacey, Alejandra Hurtado de Mendoza, Felisa A. Gonzales, and Adriana Serrano. 
"Preferences for trauma-related mental health services among Latina immigrants from Central 
America, South America, and Mexico." Psychological Trauma: Theory, Research, Practice, and 
Policy 6, no. 1 (2014): 83. 
 
Caplan, S., & Buyske, S. (2015). Depression, help-seeking and self-recognition of depression 
among Dominican, Ecuadorian and Colombian immigrant primary care patients in the 
Northeastern United States. International journal of environmental research and public health, 
12(9), 10450-10474. 
 
Vega, W. A., Rodriguez, M. A., & Ang, A. (2010). Addressing stigma of depression in Latino 
primary care patients. General hospital psychiatry, 32(2), 182-191. 
 
Recto, P., & Champion, J. D. (2018). “We Don't Want to be Judged”: Perceptions about 
Professional Help and Attitudes Towards Help-Seeking among Pregnant and Postpartum 
Mexican-American Adolescents. Journal of pediatric nursing, 42, 111-117. 
 
Response-shift bias 
Tugwell, P., & Knottnerus, J. A. (2014). Does response shift bias invalidate asking patients if 
they are better or worse?. Journal of Clinical Epidemiology, 67(5), 485-486. 
 
Pratt, C. C., McGuigan, W. M., & Katzev, A. R. (2000). Measuring program outcomes: Using 
retrospective pretest methodology. American Journal of Evaluation, 21(3), 341-349. 
 
Oort, F. J., Visser, M. R., & Sprangers, M. A. (2009). Formal definitions of measurement bias 
and explanation bias clarify measurement and conceptual perspectives on response shift. Journal 
of clinical epidemiology, 62(11), 1126-1137 
 
Schwartz, C. E., & Sprangers, M. A. G. (2000). Methodological approaches for assessing 
response shift in longitudinal health-related quality-of-life research. In C. E. Schwartz & M. A. G. 
Sprangers (Eds.), Adaptation to changing health: Response shift in quality-of-life research (pp. 
81–107). American Psychological Association. https://doi.org/10.1037/10382-006 
 
Nolte, S., Elsworth, G. R., Sinclair, A. J., & Osborne, R. H. (2012). The inclusion of ‘then-
test’questions in post-test questionnaires alters post-test responses: a randomized study of bias in 
health program evaluation. Quality of Life Research, 21, 487-494. 
 
Rosenman, R., Tennekoon, V., & Hill, L. G. (2011). Measuring bias in self-reported data. 
International Journal of Behavioural and Healthcare Research, 2(4), 320-332. 
 
Blome, C., & Augustin, M. (2016). Measuring change in subjective wellbeing: Methods to 
quantify recall bias and recalibration response shift (No. 2016/12). HCHE Research Paper. 
 
Blome, C., & Augustin, M. (2015). Measuring change in quality of life: bias in prospective and 
retrospective evaluation. Value in Health, 18(1), 110-115. 
 
Kaushal, K. (2016). Response shift bias in pre-and post-test studies. Indian J Dermatol, 61(1), 91. 
 
Howard, G. S., & Dailey, P. R. (1979). Response-shift bias: A source of contamination of self-
report measures. Journal of Applied Psychology, 64(2), 144. 
 

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Howard, G. S. (1980). Response-shift bias: A problem in evaluating interventions with pre/post 
self-reports. Evaluation review, 4(1), 93-106. 
 
Bray, J. H., Maxwell, S. E., & Howard, G. S. (1984). Methods of analysis with response-shift 
bias. Educational and Psychological measurement, 44(4), 781-804. 
 
Sibthorp, J., Paisley, K., Gookin, J., & Ward, P. (2007). Addressing response-shift bias: 
Retrospective pretests in recreation research and evaluation. Journal of leisure research, 39(2), 
295-315. 
 
Howard, G. S., & Dailey, P. R. (1979). Response-shift bias: A source of contamination of self-
report measures. Journal of Applied Psychology, 64(2), 144. 
 
Howard, G. S., Dailey, P. R., & Gulanick, N. A. (1979). The feasibility of informed pretests in 
attenuating response-shift bias. Applied Psychological Measurement, 3(4), 481-494. 
 
Sprangers, M. (1989). Response-shift bias in program evaluation. Impact Assessment, 7(2-3), 
153-166. 
 
Retrospective pre-test design (Drennan 2012) 
Drennan, J. (2012). Masters in nursing degrees: an evaluation of management and leadership 
outcomes using a retrospective pre‐test design. Journal of Nursing Management, 20(1), 102-112. 
 
Drennan, J., & Hyde, A. (2008). Controlling response shift bias: the use of the retrospective pre‐
test design in the evaluation of a master's programme. Assessment & Evaluation in Higher 
Education, 33(6), 699-709. 
 
Thomas, E. V., Wells, R., Baumann, S. D., Graybill, E., Roach, A., Truscott, S. D., ... & 
Crimmins, D. (2019). Comparing traditional versus retrospective pre-/post-assessment in an 
interdisciplinary leadership training program. Maternal and child health journal, 23, 191-200. 
 
Kruger, J. S., Tona, J., Kruger, D. J., Jackson, J., & Ohtake, P. J. (2023). Validation of the 
Interprofessional Collaborative Competency Attainment Survey (ICCAS) retrospective pre-test 
measures. Journal of Interprofessional Care, 1-6. 
 
Lyons, O., Kingsley-Smith, H., Kotze, K., Nandra, K., Galante, J. R., Fahy, N., & Canter, R. 
(2022). Changing estimates of leadership ability before a programme: retrospective self-
assessments and response-shift bias. BMJ Leader. 
 
◼) Hair Samples. We will gather hair samples from all participants at baseline and 12 
months to measure average levels of circulating cortisol as a biological marker for chronic stress. 
As indicated above, our team has experience gathering hair samples with this population. The 
data collectors will use scissors to obtain a pencil-width (at least 3 cm long) of hair from the 
crown of the participant’s head. Hair will be stored in pre-prepared foil packets placed inside 
plastic bags to maintain the orientation of the head-end of the hair sample. Participants will 
receive a $50 merchandise card. In our pilot and ongoing studies, we have had 78% of Latino 
subjects agree to have their hair tested (or are able to—some participants are bald or have 
extremely short hair and are unable). We have established collection procedures and our research 
assistants have been trained and >90% of samples yield measurable amounts of cortisol. Each 
assay is performed in duplicate. Inconsistent measurements between duplicates are discarded or 

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re-tested. We control for hair dye, although hair products are not known to affect cortisol 
measurements.  
 
QUALITATIVE DATA COLLECTION: 
What’s App. We will enroll women from each Tertulias group into separate What’s App chat 
groups. Participants will be informed of the potential risks to privacy that exist when participating 
in an online chat group—both within the group as all members of the group see the posts, and 
external from threats to internet security. In Y1, we will reconsent the participants orally mid-year 
and document oral consent in REDCap. In subsequent years Y2-Y4, this information will already 
be included in the consent form from the beginning of when participants enroll in the study. 
Given that we are still operating remotely under COVID-19 safety restrictions, we will use our 
existing HRPO approval for the mid-year oral consent right now in Y1. Because we conduct 
baseline data collection appointments in-person, subsequent consent will most likely be 
conducted in-person, except in cases where that is not permissible for COVID-19 safety concerns. 
 
The What’s App chat groups serve two purposes: 
• 
The first purpose is logistical/practical, given the COVID-19 restrictions and the new, 
sudden need for electronic solutions. Women in the group are primarily attending the 
Zoom meetings using their phones. Few of them have access to a computer and few of 
them have an email address—and of those with an email address, few check it with any 
regularity.  What’s App is a platform that is widely used by Mexican immigrants and 
their families both in the US and in Mexico. The vast majority of participants already use 
What’s App, they are familiar with how it functions, and they have the app on their 
phone. We will use the What’s App chat to communicate things about trouble shooting 
access to zoom or reminders for the meetings.  
 
• 
The second purpose is social, created by the new need for an electronic solution in the 
context of COVID-19 restrictions. Because we had to transition to a Zoom-based meeting 
for the intervention, the opportunity for social interaction/making friends/sharing 
information that would normally happen before or after the meetings or during the food 
sharing that would have been a feature of the meetings is lost. This interaction is key to 
the success of the intervention. Therefore, it is important for us to try to find a way for the 
participants to be able to communicate and interact outside of the very restrictive type of 
interaction that occurs through Zoom. What’s App is the perfect solution. It is used 
extensively in the Mexican immigrant population. It is free and people are able to 
maintain an everyday connection with friends and family in Mexico or here in 
Albuquerque. Almost all of our participants already have the What’s App app on their 
phone. So when we create a What’s App chat group, they will already be familiar with 
how it functions. 
 
We will review the chat streams as qualitative data.  
• 
Analytic purpose 
o We will analyze the What’s App chat streams because interaction between the 
participants in the context of the weekly Zoom meetings is very structured. With 
the What’s App chat group, they have an opportunity to interact in an 
unstructured way. The use of the chat so far in the project has been constant for 
all three groups. The participants are extremely engaged, giving each other tips, 
sending each other information about resources, praising each other, offering 
support, comforting each other, etc. Therefore the What’s App chat groups have 
become an unanticipated rich source of research data that can help us understand 

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more about the impact of the social support between participants that is 
happening as a result of and in the context of the intervention. Given that this is a 
project focusing on social isolation, the chat group narratives are important data. 
o Also important is the manner from a research perspective is the actual language 
and content of the chat communication (e.g., use of emojis, pictures, emphatic 
text fonts, etc.) because this will help us to understand something about the 
content of the social interaction between participants and how it unfolds during 
the intervention. We have seen that participation in the chat groups has made the 
group participants more comfortable with each other in a way that would not 
have been likely to occur if they only had the opportunity to talk with each other 
or interact with each other in the structured Zoom meetings. This will also shed 
light on unanticipated dimensions of the remote social context required by 
COVID-19. 
o In our meeting notes, we have documented that participants have mentioned the 
interaction in the What’s App chat groups and specifically how important the 
chat groups, the Tertulias groups, and the women in them have already become 
in their lives, and that they derive strength and support from participating 
together in both the chat and the weekly group meetings. Therefore, this is an 
important domain for us to understand more fully. It will allow us to understand 
how the chat group contributes to the success of the intervention in the context of 
COVID 19 restrictions which prohibit in-person meeings.  
• 
Benefit to participants 
o It became clear immediately after the groups started that the What’s App chat 
groups were important to the participants. All of the participants joined the study 
because they really WANT and were desperate for social support from other 
women. Of 64 women who attended project interest meetings for recruiting 
participants, 56 joined the study and we only had to recruit 4 participants 
individually. This is an amazing statistic given that the intervention is intensive 
(weekly for 2 hours by Zoom) and that the population of study is considered 
extremely hard to reach and retain. So we knew from the outset that the 
intervention was one that was of interest to women in the community. 
o This is a community-engaged study and we are working with community partner 
agencies and members of the community to implement the research. We have not 
specified a particular way that we will communicate the results of this study back 
to the participants, but we will be working with our partners as the data analysis 
for this study is completed in order to determine the best method for informing 
participants and other members of the community about the study results.  We 
believe that they will be very interested to learn what happens since they are 
contributing to the research. Our meeting notes documented that participants are 
very committed to contributing and want their participation to be meaningful. 
 
In Y1, we will re-consent the participants in order to obtain their permission to use the What’s 
App chat groups in the context of this project. We will do in July 2021 prior to the end of the Y1 
groups on July 28. We will not begin analyzing the What’s App data until re-consenting has been 
completed. Because of continuing COVID-19 restrictions on meetings all of the project activities 
except baseline and 12-month data collection (which require obtaining hair samples) are being 
conducted remotely. We already obtained permission from HRPO to consent individuals orally if 
necessary because of COVID restrictions, so in this instance, a team member will contact each 
participant individually by phone or by Zoom. The participants already understand what 
participating in the What’s App groups entails so the team member will explain the risks involved 

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using an approved script and obtain their consent orally regarding continuing to participate in the 
What’s App group. We will document oral consent in REDCap. 
 
In Y2-Y4, we will use the revised consent form (see attached revised consent 3-5-21) to inform 
participants about the What’s App when they join the study. 
 
             ◼) Participant Observation and Meeting Logs. We will conduct participant 
observation of TERTULIAS group sessions. PI Page-Reeves, an experienced anthropologist, will 
attend TERTULIAS group meetings on a rotating basis and keep an observational log on a laptop 
computer. Facilitators will maintain weekly group meeting logs to document group dynamics of 
interest. Observation notes and logs will serve as an objective measure of dimensions of women’s 
participation and aspects of the group dynamic of interest in this study. 
◼) Policy Log. We will document multilevel impacts. In our previous work, we 
documented that TERTULIAS has multilevel impact on individual women, on women’s family 
relationships and families, and on the group. In addition, we recognize that some of the factors 
influencing women’s lives in relation to social isolation may be larger structural, systems, or 
policy issues that are outside the control of individual women, their families, or the group that 
could be addressed or targeted for change in a future project. Facilitators and the participant 
observer will keep a policy component as part of their logs to document these types of issues 
identified from group discussions.  
◼) Interviews. We will conduct interviews with a subset of participants (n = 24). For in-
person interviews, we will follow COVID-19 safety guidance for at the time of the activity, using 
screening questions, thermometers, facial coverings, social distancing (6-ft when possible), and 
sanitization of hands and surfaces. In keeping with standards for systematic theoretical sampling 
in qualitative research,126–129 interviewees will be identified by the facilitators as individuals likely 
to have something to contribute to our understanding of the group dynamic. Interviews will be 
conducted by the PI in Spanish or English, depending on the preference of the participant, and 
will last approximately one to two hours. We will use an ethnographically inspired approach to 
allow participants to drive the flow of the interview. Questions will be posed in a semi-structured 
format with some open-ended questions. The interviewer will use interviewee responses to 
formulate prompts and follow-up questions. When appropriate in the context of the interview and 
depending on the content of the interviewee’s narrative, concepts from preceding interviews and 
group session will be incorporated into prompts and follow-up questions to engage the 
interviewee in a discussion of ideas or issues emerging within the context of the research. 
Interviews will be audio-recorded and transcribed/ translated. Interviewees will receive a $50 
merchandise card.  
◼) Group Discussion. In the later part of each year, we will ask participants to contribute 
a 1-2- page creative work (e.g., story, poem, drawing, photo, etc) that says something about 
themselves or about their experience in the group, and we will make copies of all the 
contributions and create 3-ring binders to give to each of them. We will audio record their 
explanation what the art work represents when they present the work to the group. Audio 
recordings will be transcribed and translated. We will use the final group session at the end of 12 
months of each of the 12 groups to ask participants to discuss the intervention (n=12), its impact 
on their lives, and the domains of interest related to health outcomes. Depending on the social 
distancing requirement, we will hold the meeting by Zoom or in-person. We will follow COVID-
19 safety guidance at the time regarding in-person meetings, using screening questions, 
thermometers, facial coverings, social distancing (6-ft when possible), and sanitization of hands 
and surfaces as appropriate. The session will be facilitated by PI Page-Reeves, together with Co-
Is/Lead Group Facilitators J.Perez and Regino, and will be audio-recorded, transcribed, and 
translated. Participants will receive a $50 merchandise card.   

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There is a new method for facilitating a group meeting called Ripple Effects Mapping 
(REM). We will add this technique into a couple of the group meetings near the end of the study. 
Participants will be informed about the process that will be used. REM is an innovative 
participatory evaluation technique that provides a way to document the “radiant” impacts of a 
program in a way that captures the dynamics of context. REM reveals interconnections between 
program elements, activities and impacts in a way that helps to understand what actually 
happened. REM uses software to create visual “maps” that can tell the story of change and 
impacts. REM captures and documents complex processes – the “ripples” that happen in the 
program or in the community. REM elicits stakeholders to give input on how something (like an 
intervention) has had an impact--to capture impacts that generally aren't easily quantifiable--like 
X thing helped all of us feel more involved and because we felt we are more involved, we have 
made new friendships, and because we have new friendships, we are less depressed--etc. And 
during the Tertulias meeting a "scribe" from the team will take notes into this new software that 
allows you create visual "maps" of how the data are connected--kind of like a tree.  Then we will 
display the results back to the group and get them to see what they are saying the impacts or 
"ripples" are and get commentary on that.  Invisible changes such as building social connections 
(which are the precursors of change), changes in policy, shifts in narrative, and cultural 
transformation can be documented and mapped visually. I was able to bring in a trainer to train 
folks here at UNM in this method. We will use this facilitation technique into two meetings of 
each of the Tertulias group meetings at the very end of each cohort year. We will audiorecord 
each REM session and take notes from the recording and then destroy the recording. 
 
10.0 Data and Specimen Banking 
Data generated through this study will be administered in accordance with both University 
and NIH policies.  Data will be accessible only to the study staff to ensure confidentiality.   
 
In the consent form, we ask for the participant to allow us to keep their contact information in the 
form of a “contact list” for follow-up in future studies by the PI only.  
 
After lab analysis of hair samples, remaining hair will be destroyed. 
After transcription, audio recordings of interviews, REM sessions, and presentations of artwork 
will be destroyed. Each participant will indicate on the consent form whether or not they want 
their name associated with the art work or the explanation of the work that they contribute 
 
 
After data analysis is completed, study materials will be kept in the PI’s locked office and 
destroyed after five years.  
 
After final analysis of data is concluded, de-identified, quantitative data from the survey and hair 
cortisol testing will be available to interested researchers only under a data-sharing agreement 
that provides for: (1) a commitment to using the data only for research purposes and not to 
identify or attempt to identify any individual participant; (2) a commitment to securing the data 
using appropriate computer technology; and (3) a commitment to destroying the data after 
analyses are completed.  
 
Qualitative data will contain large amounts of personal identifiers. Deidentification will not be 
feasible. Therefore, qualitative data will not be available to share.  
 
The products/resources that are a result of this study will be disseminated via publications, 
presentations at national conferences, presentations and reports to study stakeholders.  

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11.0 Data and Specimen Management 
 
Data & Safety Monitoring Plan 
Participants will be asked to provide the following data: 
• 
Name 
• 
Contact information 
• 
Signed consent forms or oral consent 
• 
Baseline and 12-month survey responses related to the following domains: 
o Demographic information 
o Depression 
o Stress 
o Resilience 
o Empowerment 
o Social support 
o Social connectedness (social networks—informational and personal) 
o Evaluation the experience of participating in the intervention 
• 
Baseline and 12-month hair samples that will be analyzed for hair cortisol 
• 
A subset of participants will be interviewed and interviews will be audio-recorded and 
transcribed. 
• 
Observational notes and group meeting logs will be kept by study team members 
• 
A piece of creative work (a story, poem, drawing, recipe, etc.) will be gathered and 
copied and all participants will receive a notebook with creative works from all the 
participants in their cohort year. 
• 
We will create an audio recording of the explanation of what the project means/represents 
for each participant when they present the work at a group session. Audio-recordings will 
be transcribed and translated.  
• 
We will conduct REM sessions that will be audio-recorded and then notes will be taken 
from the recordings. 
• 
The final group session of the year of participation will be a research meeting and the 
group discussion will be audio-recorded and transcribed. 
 
Overall Framework for Data and Safety Monitoring Commensurate with Risk 
Participation in this study would normally present no greater than minimal risk, however because 
of COVID-19, risk is elevated. As a result, we have instituted safety measures to protect staff and 
participants. Potential participants will be contacted in-person, by email, by phone, by text or by 
Zoom. For all recruitment, data collection and intervention-related meetings, we will use Zoom 
meetings when possible and follow COVID-19 safety guidance for in-person meetings, using 
screening questions, thermometers, facial coverings, social distancing (6-ft when possible), and 
sanitization of hands and surfaces as appropriate. 
 
We will assign a study ID to all participants and no participant identifiers will be associated with 
the data or stored together with the data. The link will be kept separately. All data will be labeled 
with the study. Survey data and hair cortisol results will be stored in REDCap. Contact 
information will be stored in REDCap in a separate project that will only be accessible to project 
staff who need to have access, but it will not be associated with the data.  Qualitative data 
(interview and group session transcripts, observational notes and meeting logs will be stored on 
password protected computers and hardcopy documents will be stored in a locked drawer. The 

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consent forms will be stored in a binder in a separate locked drawer in the office of the PI. A list 
of the names of individuals who have been consented orally will be stored together with the 
signed consent forms. 
 
We will alter the data collection process for our Social Network Analysis (SNA) beginning with 
data collection for baseline Y3 and 12-month follow-up for Y2 that will occur in summer 2022, 
and then we will continue using the new process for the remainder of the project. The reason for 
this alteration is that the SNA questions were very repetitive and extremely tedious for both the 
data collectors and the participants. When Dr. Thomas joined the team (replacing previous SNA 
analyst, Molly Bleecker), he brought enhanced SNA expertise. He made the suggestion that we 
could improve data collection and enhance the scientific quality of our data by moving to 
Network Canvas software, an NIH-funded SNA App. Dr. Thomas will program the Network 
Canvas software to ask the specific Tertulias questions. 
 
Network Canvas (https://networkcanvas.com/about.html) 
Funded by NIH # R01 DA042711 (or 5R01DA042711-02?) 
"netCanvas: Development, Hardening, and Dissemination of a Software Suite for the 
Collection of Complex Network and Contextual Data in HIV and Drug Research" 
PI Michelle Birkett, Northwestern University 
other PI Gregory Phillips II 
https://reporter.nih.gov/project-details/9306043 
 
The Network Canvas software suite is an Open-Sourced package of applications developed by 
researchers at Northwestern University and Oxford University with NIH funding, for the purpose 
of collecting survey data on the personal social networks of subjects in the field with one-on-one 
help from interviewers. Per NIH requirements, the Network Canvas software technology is 
appropriate for use in research studies and was designed for ease of use. The Network Canvas 
interface is interactive and uses graphic images that the participant can name, click, drag, and 
drop rather than merely answering a series of repetitive questions. The software significantly 
eases the cognitive burden of this process on both subjects and interviewers, compared to earlier 
social network survey techniques, which reduces the time the survey takes and improves the 
quality of the data collected. The software also eases the management of the data collection 
process across multiple interviewers in multiple locations. Network Canvas consists of three 
component applications: Architect, for designing surveys, Interviewer, for conducting the survey 
in the field, and the optional Server component, for transmitting data securely from the devices in 
the field to a computer managed by the project team (at UNM in this case). 
 
For the new process, instead of merely asking a series of questions and putting the answers into 
REDCap, the SNA question portion of the data collection will be gathered by the Data Collectors 
on the same tablet device (i.e., an iPad) that they use for the REDCap log-in and survey data 
collection. The IPads will run the Network Canvas Interviewer application. The data is stored 
locally on the device (which is kept in the Data Collector’s possession) until it is either manually 
copied from the device by the Tertulias team, or transmitted to the Network Canvas Server at 
UNM, which is administered by the Tertulias team. Transmission of data from the tablet devices 
to the Network Canvas Server uses end-to-end encryption, employing a symmetric Advanced 
Encryption Standard (AES) algorithm to encyrpt the data pre-transmission, and then using a 
Transport Layer Security (TLS) for the transmission. Any third-party interception of the 
transmission between the iPad and the Network Canvas Server would only yield heavily 
encrypted data. Data from the Network Canvas apps for this project will never be transmitted to 
any other server or entity except for the server at UNM.  
 

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Network Canvas data from the iPads will be transmitted to the Network Canvas Server in one of 
two ways: 1) by connecting the iPad to the UNM network via a Virtual Private Network (VPN), 
and then connecting to the campus-located computer running the Network Canvas Server and 
uploading the data, or 2) by physically bringing the iPads to campus to connect to the server on 
the secure UNM local area network (LAN), or 3) by transferring the data directly from the iPad to 
a Tertulias team laptop by a physical cable. 
 
 
 
 
Responsible Party for Monitoring 
The PI will be the ultimate individual responsible for monitoring risk, but facilitators and data 
collectors who interface with participants will have training and protocols in place in the event 
that they encounter a data or safety issue. 
 
Procedures for reporting Adverse Events/Unanticipated 
Adverse events or unanticipated issues related data or safety will be reported to the UNM Human 
Research Protections Office (HRPO).  
 
Confidentiality  
The primary risk is loss of privacy/confidentiality from participants sharing their personal data 
with the study team. Participants in both arms have the normal risk of loss of 
privacy/confidentiality that comes with participation in a research study associated with signing a 
consent form and providing personal information on surveys, through biological samples, and in 
interviews. We make all efforts to protect participant data. All project staff are trained and 
certified in HIPAA and CITI. We keep consent forms or lists of individuals consented orally in a 
locked cabinet in the office of the PI. We have protocols for dealing with hair sample data and we 
keep tight control over access and conduct quality control checks. Once we turn samples over to 
the UNM Clinical and Translational Science (CTSC) Lab, there is another protocol for logging 
delivery/receipt. We use the CTSC’s REDCap secure data capture for survey data entry and 
storage, and all of our staff who deal with data through REDCap will have the required UNM 
account access passwords. IPads used by the Data Collectors to collect survey data are UNM 
password-protected. We conduct quality checks to ensure that our REDCap database is properly 
structured and functioning. We have a UNM-approved FTP site for safe electronic transfer of 
audio recording to our professional transcriptionists/translators and receipt of transcripts. Only the 
PI has access to this site. Qualitative data is stored on the UNM password-protected computer of 
the PI. We do recognize that immigrant populations often have heightened sense of the need for 
personal privacy/confidentiality. Therefore the Certificate of Confidentiality that we will obtain 
from NIH will be a part of our privacy protocol. 
 
STATISTICAL ANALYSIS OF SURVEY RESPONSES  
All statistical analyses for the project will be led by Co-I biostatistician Murray-Krezan. 
Descriptive statistics (e.g., means, standard deviations, medians, frequencies, and percentages) 
will be calculated to summarize characteristics of the study arms and to identify any variables that 
may differ between them thus implying need for inclusion in modeling. In general, should any 
outcome measures have substantial departure from normality, remedial measures such as 
appropriate transformations or robust methods will be used for analyses. For the primary and 
secondary outcome measures of each Aim described below, unadjusted mean changes over time 
will be calculated and compared between the study arms. Linear mixed models will be fitted to 
the measures with the primary independent variable of interest Study Arm. Covariates will 

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include age, marital status, number of children, other family or close friend living in same 
location as participant, speaks English, employed, health status, and number of group sessions 
attended. Least squares mean estimates and their 95% confidence intervals (CIs) for the changes 
over time and for the difference between arms will be calculated for the primary and secondary 
outcome measures. The extent of missing data will be examined, and the patterns of missing data 
will be assessed for randomness. This will be accomplished in part by comparing participant 
characteristics of those who complete the 12-month survey and related instruments to those who 
do not, using the non-missing data from all participants. In addition to these checks for patterns of 
missingness, we will evaluate whether multiple imputation methods might be appropriate. We 
will analyze the data using both case deletion and multiple imputation approaches and compare 
the results from the two methods. Should the two approaches differ markedly, we will conclude 
that the data missingness did not occur completely at random and will perform additional 
sensitivity analyses prior to reporting the results that are the least sensitive to the observed pattern 
of missing data. Analyses will be performed in SAS 9.4 and R 3.5 or higher. 
     Aim 1. To measure whether a culturally situated peer group intervention will reduce 
depression and stress associated with the experience of immigration. Primary Hypothesis: 
Intervention participants will decrease their depression scores by at least 8 points, as measured by 
the CES-D, from baseline to 12 months with at least a 6.5-point greater decrease than control 
participants (between arms effect size Cohen’s d = 0.43 with SD=15), as shown to be feasible in 
prior work.117,118 Power and Sample Size: With 100 participants completing in each arm, the 
minimum hypothesized changes in these measures will be detected with >80% power, assuming 
type I error = 0.017 for three primary outcome measures (one in each Aim). Secondary 
Hypothesis: Perceived stress (PSS-14) will decrease more over this time period in the intervention 
arm versus in the control arm (Cohen’s d = 0.50).118,119 As a tertiary outcome measure, changes of 
hair cortisol levels over time will be compared between arms using similar methods. The 
correlation between hair cortisol levels and the other outcome measures will be assessed.  
◼) Lab Analysis of Hair Cortisol.  Lab analysis of hair cortisol will be led by Co-I 
Bearer. Hair will be pulverized in a Retsch Mixer Mill Type MM 400 100-240V 50/60HZ and 
extracted in methanol overnight, dried and re-suspended in buffer. Cortisol concentration will be 
measured by a Salimetrics immunoassay. Cortisol levels will be compared to the established 
averages and determined to be within normal limits or not. Summary measures (means or 
medians and corresponding 95% CIs, as appropriate) will be computed for hair cortisol measures 
at each time point and the mean changes and 95% CIs over time in each arm will be compared 
between arms. Correlational analysis will be performed to understand how hair cortisol levels, as 
a marker for stress, is related to our primary and secondary outcome measures. Following lab 
analysis, any remaining hair samples will be destroyed. 
 
     Aim 2. To test whether an intervention using a “women’s funds of knowledge” approach 
results in improved resilience, knowledge and empowerment. Primary Hypothesis: Intervention 
participants will have higher scores at study completion and have a larger increase over time as 
compared to controls on the Connor-Davidson Resilience Scale-25 (CD-RISC 25). Based on 
previous literature, we expect to find a moderate effect size (d = 0.5) of the change scores 
between arms, favoring the intervention arm. Power and Sample Size: Based on standard 
deviations of CD-RISC scores reported in the literature for changes over time reported when 
comparing two arms (SD = 1.0-9.2)119–121, with 100 participants per arm completing both time 
points, we can detect a Cohen's d effect size ≥ 0.33 with 80% power and type I error = 0.017. The 
range of effect sizes for differences between arms previously reported range from 0.32 to 7.4.119–
121 Secondary Descriptive Measure: To assess knowledge and empowerment in the intervention 
arm only, we will calculate summary statistics for the six subscales of the Trauma-Informed 
Practice (TIP) Scale administered post intervention at 12 months, and an overall total score. 
Means and 95% CIs for the total and subscales will be reported.  

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     Aim 3. To investigate whether a culturally situated peer group intervention using a women’s 
funds of knowledge approach can give participants’ a sense and experience of social and physical 
connection (“emplacement”) that is lost in the process of immigration. Primary Hypothesis: The 
experimental participants will have a marked increase in social support scores than the control 
group using the MOS SSS (expect d ≥ 0.5). A limited number of previous studies122–124 assessed 
changes over time between arms and reported that interventions have variable effects on social 
isolation, with effect sizes ranging from small (d = 0.2) to very large (d = 1.5). Power and 
Sample Size: Given our previous work where we qualitatively observed extremely positive 
changes in perceived social isolation52, our sample size (100 participants per arm) will provide 
>86% power to detect differences between arms in change scores from baseline to 12 months on 
the MOS SSS with effect sizes as small as d = 0.5 (type I error = 0.017). Secondary Measure: 
Social connectedness will be measured using Social network analysis (SNA). Led by Co-I 
Reuben Thomas, our SNA will involve three types of analyses: 1.) Using answers to questions 
modeled after the General Social Survey113, an individual social network will be constructed for 
each participant. Baseline and post-survey individual networks will be compared and changes in 
network density and characteristics (e.g., family, friends, locality, distance) will be assessed. 2.) 
The level of inclusion of other study participants in individual social networks pre- and post-
intervention will be assessed. Combining the individual networks of participants in each 
intervention group will constitute what is referred to as a “complete network.”114 Complete 
networks can be analyzed using network-level measures--centrality, betweenness, and degree--to 
identify internal social dynamics of the intervention groups. 3.) Using questions about local 
resources (e.g., the health insurance exchange, health navigation programs, local subsidized food 
coop programs, public food and benefit programs such as SNAP or WIC, free legal assistance 
programs, low-cost ESL and GED programs, domestic violence programs, local food charities, 
local clothing charities, transportation and utilities assistance programs, etc.), we will assess 
changes in each study participant’s awareness of, knowledge about, and likelihood of accessing 
resources.  
ANALYSIS OF QUALITATIVE DATA 
◼) Qualitative Data Analysis will be led by PI Page-Reeves using accepted qualitative 
analysis techniques to analyze observational, group, and policy logs, participant observer notes, 
transcripts from interviews and the final group session, and the stories, poetry, and art created by 
the participants as part of the group process. We will review these data using a rigorous, 
disciplined approach to create an empirical analysis according to Hammersley’s130 criteria for 
qualitative research based on plausibility, credibility, and relevance. We will follow Gläser and 
Laudel’s131 framework for theory-driven qualitative content analysis. We will review the 
transcripts and identified conceptual categories and patterns related to the domains of inquiry, 
extract data, and develop conceptual summaries. Following review and summary, we will code 
extracted data internally for systematic subthemes and their domains. We will use “constant 
comparison”132 to explore interconnections between theme/sub-theme categories and make 
connections with concepts we identify in the literature by developing a holistic interpretation of 
the data. Input for the interpretation will also be provided by the Advisory Board. Based on this 
analysis we will further refine conceptual categories and patterns, and we will develop conceptual 
summaries of issues of interest. Using this refined analysis, we will conduct a secondary review 
of the literature to identify further ideas, concepts, and approaches to help us understand what we 
were seeing in the data, and we will identify ways that data from this study and our emerging 
analysis could address gaps in the literature and/or contribute to theory in relation to immigrant 
health disparities. 
◼) Policy Analysis. Policy analysis will be led by Co-I Wagner. We will document issues 
that we uncover that may have policy implications from the observational and meeting logs and 

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from interviews using the Center for Disease Control’s (CDCs) Policy Analytic Framework133 to 
inform our future implementation of this model of peer support in the context of a larger multi-
level intervention. We will identify problems faced by participants, appropriate policy 
solutions/options, and outline strategies for policy change 
 
ANALYTIC INTEGRATION & TRIANGULATION.  
Through triangulation, we will integrate quantitative and qualitative data134,135 with a 
QUAL➔QUAN simultaneous data collection and analysis approach.136 PI Page-Reeves is 
experienced in using this approach. To enhance the quality and credibility of results from 
different methods/data sources,137 determine areas where more complex understanding of issues 
may be needed, and provide a strong basis for conclusions, we will undertake side-by-side 
comparisons of data derived from 1.) Different qualitative methods/data sources (e.g., 
observational, group, and policy logs, participant observer notes, transcripts from interviews and 
the final group session, and the stories, poetry, and art created by the participants as part of the 
group process), 2.) Survey responses, 3.) Hair cortisol testing, and 4.) Social network analysis. 
We will create a series of user-friendly matrices intended to identify and illustrate issues of 
convergence, complementarity, and expansion. For example, do results from one method/data 
source corroborate, complement, and validate results from another method/data source, or yield a 
more holistic understanding of the issues under investigation. Matrices outlining different 
methods/ data sources will make it possible to determine the degree to which results are 
consistent or provide the same answer to the same research questions, i.e., does interview data 
concur with survey data on the degree to which participants experience a change in depression? 
The matrices may also reveal areas of divergence, prompting us to delve into the reasons for 
discrepancies. These comparisons can yield insight into points of expansion. 
 
Dissemination 
As part of the dissemination of the results of this project, we will create an art exhibit 
using the stories, poetry, and art created by the participants as part of the group process to 
show others how impactful the Tertulias project has been. We will include text of 
participant explanations of their work. Participants will can decide whether they want 
their name associated with their project, or whether they would like to have it be 
anonymous. They will indicate this decision on the consent form. All participants will be 
invited to come and see all the work. 
 
 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
Safety/Wellbeing  
Risk #1: Because this research does focus on mental and behavioral health issues there is a risk 
that we could identify a participant who needs support or assistance beyond the regular 
components of participation in the study. All of our facilitators are trained in Mental Health First 
Aid, two of our team members are licensed mental health professionals—any of whom can be 
available if we identify a woman who needs individual additional mental health support related to 
participation in this study. 
 
Risk #2: We recognize that it is essential that we do not just go into the community and create 
something and then leave the participants in a lurch when the research is done. Our work in with 
participants in this community-engaged study creates a responsibility on our part. Therefore, we 

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have created an infrastructure to ensure that the participants have the possibility of continued 
social support. Centro Sávila has a continuous supply of interns (social work and counseling 
students) who spend at least 1 year working with clients about mental and behavioral health 
issues. When TERTULIAS groups end, we will invite participants to continue meeting with 
facilitation by a pair of Centro Sávila interns. This infrastructure creates a feasible way to create 
continuity and sustainability. 
 
Risk #3: There is now a risk of COVID-19 contagion associated with any in-person meeting. 
Therefore, participants will be at elevated risk during data collections appointments (cannot be 
done by Zoom or by phone because we have to gather hair samples) and group meetings—if we 
are able to start holding them in-person at a later point after the start of the group. We believe that 
the risk is offset by the potential for benefit for the participant related to both social isolation and 
depression. We have people in the community telling us how much they need this intervention 
now, more than ever. To reduce risk, we will follow COVID-19 safety guidance at the time of the 
activity regarding in-person meetings, using screening questions, thermometers, facial coverings, 
social distancing (6-ft when possible), and sanitization of hands and surfaces as appropriate.  
 
 
13.0 Withdrawal of Subjects 
 
We do not anticipate that any participants will need to be removed from the study without 
their consent. However, given that this is a group project, if a participant becomes 
disruptive in group sessions or has a conflict with another participant outside of the group 
settings that is manifesting during group sessions, we will tell the participant that they 
can no longer participate in the study. If any individual wishes to withdraw, they can do 
so at any time by notifying one of the facilitators who they interact with. If an individual 
is withdrawing for personal reasons or because they no longer wish to participate, they 
can either have the data they have provided continue to be used in the study and or they 
can inform us that they wish to have their data removed by letter to the PI as indicated in 
the consent form. If the latter, we will exclude their data from the analysis. The research 
team will not be required to destroy or retrieve any information that has already been 
used or shared before the date that the request for withdrawal is received. 
 
14.0 Risks to Subjects 
 
This project does not pose more than minimal risk to participants.  
Before gaining informed consent of individuals, investigators will clearly explain the research, 
the risks to participants, and the procedures for safeguarding their privacy. Participants will be 
informed that they can refuse to answer any questions and stop the survey, interview, or 
participation in a focus group at any time. The investigators will have training and will 
understand the importance of these issues and their responsibility for maintaining high ethical 
standards and they will have current human subjects research training certification.  
Confidentiality  
Risk #1:  The primary risk in this study is loss of privacy/confidentiality. Participants in both 
arms have the normal risk of loss of privacy/confidentiality that comes with participation in a 
research study associated with signing a consent form and providing personal information on 
surveys, through biological samples, and in interviews. We make every effort to protect 

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participant data. All project staff are trained and certified in HIPAA and CITI. We keep consent 
forms and a list of the names of those who have provided oral consent in a locked cabinet in the 
office of the PI. We have protocols for dealing with hair sample data and we keep tight control 
over access and conduct quality control checks. Once we turn samples over to the UNM Clinical 
and Translational Science (CTSC) Lab, there is another protocol for logging delivery/receipt. We 
use the CTSC’s REDCap secure data capture for survey data entry and storage, and all of our 
staff who deal with data through REDCap will have the required UNM account access passwords. 
IPads used by the Data Collectors to collect survey data are UNM password-protected. We 
conduct quality checks to ensure that our REDCap database is properly structured and 
functioning. We have a UNM-approved FTP site for safe electronic transfer of audio files to our 
professional transcriptionists/translators and receipt of transcripts. Only the PI has access to this 
site. Qualitative data is stored on the UNM password-protected computer of the PI. We do 
recognize that immigrant populations often have heightened sense of the need for personal 
privacy/confidentiality. Therefore the Certificate of Confidentiality that we will obtain from NIH 
will be a part of our privacy protocol.  
 
Risk #2: In addition to the normal individual risk of participating in a study and having 
participants share their data with research team members, in this study, intervention arm 
participants will attend group meetings where individuals will share personal stories and 
information. This creates another level of risk. Although we cannot assure that participants will 
not share information from group sessions with outsiders, we have found that group participants 
appreciate having a group discussion about privacy in the first group session so that everyone is 
clear about the risk, and if all participants are in agreement, they sign a letter of commitment to 
keep the personal information of others private and not to share it with outsiders. Signing the 
letter of commitment helps participants to realize and remember the need for privacy.  
 
Now that the meetings are being held by Zoom, the participants are generally participating from 
their homes. To ensure sufficient privacy for the meetings that will ensure privacy for all 
participants, we are adding that we will supply participants with inexpensive ear bud-style 
earphones. 
 
Safety/Wellbeing  
Risk #1: Because this research focuses on mental and behavioral health issues, there is a risk that 
we could identify a participant who needs support or assistance beyond the regular components of 
participation in the study. All of our facilitators are trained in Mental Health First Aid, two of our 
team members are licensed mental health professionals—any of whom can be available if we 
identify a woman who needs individual additional mental health support related to participation 
in this study. 
 
Risk #2: We recognize that it is essential that we do not just go into the community and create 
something and then leave the participants in a lurch when the research is done. Our work in with 
participants in this community-engaged study creates a responsibility on our part. Therefore, we 
have created an infrastructure to ensure that the participants have the possibility of continued 
social support. Centro Sávila has a continuous supply of interns (social work and counseling 
students) who spend at least 1 year working with clients about mental and behavioral health 
issues. When TERTULIAS groups end, we will invite participants to continue meeting with 
facilitation by a pair of Centro Sávila interns. This infrastructure creates a feasible way to create 
continuity and sustainability. 
 
Risk #3: There is now a risk of COVID-19 contagion associated with any in-person meeting. 
Therefore, participants will be at elevated risk during data collections appointments (cannot be 

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done by Zoom or by phone because we have to gather hair samples) and group meetings—if we 
are able to start holding them in-person at a later point after the start of the group. We believe that 
the risk is offset by the potential for benefit for the participant related to both social isolation and 
depression. We have people in the community telling us how much they need this intervention 
now, more than ever. To reduce risk, we will follow COVID-19 safety guidance at the time of the 
activity regarding in-person meetings, using screening questions, thermometers, facial coverings, 
social distancing (6-ft when possible), and sanitization of hands and surfaces as appropriate.  
 
Risk #4: In Y3 of the study, in the context of one of the groups, two participants in the 
same group recently disclosed that they are living in a situation that could be 
characterized as domestic violence. In neither case has there been any physical violence. 
In both cases, the abuse from the male spouse/partner is emotional/psychological, 
jealously, and controlling behaviors related to how the woman spends her time and who 
she sees or talks with. In one of the cases, the male sometimes takes her phone away from 
her and keeps it for weeks. 
 
Immediately following the meeting where this was disclosed, members of our team who 
are trained in mental health first aid and experienced with domestic violence support 
contacted the participants individually. This was done in a way so that the participants 
were not put in danger.  The conversations took place when the participants felt safe and 
when their male partners were not be aware of or disturbed by the contact. We also 
scheduled a meeting with our Data and Safety Management Board to discuss our 
response to this situation.  
 
There are many issues to consider in relation to this situation. These women trusted in the 
group to open up and disclose this very private and traumatic information. At the same 
time, we realize that there are challenges to the safety of the participants if the spouse 
feels threatened by their participation in the group or to the safety of the group since the 
meetings occur remotely by Zoom from the participants’ homes. We discussed these 
issues with our DSMB. The DSMB emphasized the need to consider safety first, both of 
the participants and for the group. The team feels very strongly that if we were to remove 
these participants from the group because they disclosed domestic violence, this would be 
experienced as punitive and the result would actually be that they would be left 
completely isolated and without support. This feels like it would be unethical.  
 
In order to address the situation, we have taken a number of steps: 
• Our team is keeping regular individual communication with both of the 
participants.  
• One participant lives in Las Lunas, NM and she is already connected to a 
domestic violence organization there. However, she said that she does not feel 
that she is really receiving any meaningful support from that organization. At her 
request, we connected her with Enlace Comunitario.  
• The other participant lives in Albuquerque. At her request, we connected her with 
Enlace Comunitario.  

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• Unfortunately, Enlace Comunitario currently has a long waitlist and while both 
participants are now on the waitlist, neither participant has been able to receive 
individualized services.  
• Therefore, our team is working with each of these participants to create an 
“emergency plan” that would be followed if the participant feels threatened and 
communicates this to us, or if the participant fails to show up at meetings or to 
respond to texts and calls. If these things were to happen, the participants agree 
that we should contact the police. We have advised both participants to create an 
“emergency kit” containing a couple of changes of clothes for themselves and 
children, important documents, some money (if possible), and telephone numbers 
of important contacts, and to store this kit with a trusted friend outside of the 
home.  
• We have made it clear to them that they can reach out to our team if they need 
assistance, resources, or a referral. 
• We provide all participants with earbuds to provide as much privacy as possible 
since they are joining the meeting from their homes. However, we have provided 
these two participants with higher quality earbuds that provide heightened 
privacy.  We are in the process of providing the rest of the participants with the 
same kind of earbuds. 
• Each of the groups created a “safe word” that the participant can use if they feel 
that they are not free to talk. We have done this for every group from the 
beginning of the project, recognizing that participants might have children or 
other people around.  This will prevent the people around them to know what the 
conversation is about.   The groups have chosen safe words like chocolate that 
when uttered out of context, we would know that they are listening but cannot 
contribute to the conversation.  For these two participants we are also in the 
process of agreeing upon a “safety signal” that the participant could use if they are 
on camera but cannot use the safety word and/or are in danger. 
• To protect the privacy and safety of the entire group of participants, we have 
stopped having participants’ full names displayed on the Zoom screen. Instead, 
we now label the zoom screen with first names and last name initial only. 
 
 
15.0 Potential Benefits to Subjects 
 
Based on our previous research and experience, we anticipate that this project will have a positive 
impact in the lives of participants. As indicated in the Aims, we hypothesize improvements in 
social isolation, social connectedness, resource knowledge, depression, stress, and empowerment. 
It is our experience that rather than producing anxiety, it is more likely that participants may find 
it interesting, rewarding, or empowering to participate in the research or to discuss the issues 
involved. Intervention participants will participate in a peer support group which we have 
hypothesized will have beneficial impact on their health and social experience. Furthermore, this 
research will contribute to the science of addressing health disparities for FMIs, which may be 
important to participants interested in an altruistic contribution. 
 
 

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16.0 Vulnerable Populations 
 
We will not recruit children, individuals unable to provide consent, individuals that are 
incarcerated, or pregnant women. 
We will obtain a Certificate of Confidentiality to further protect participant privacy. 
 
 
17.0 Community-Based Participatory Research 
 
This is a community-engaged study. We are partnering with Centro Sávila the Hopkins 
Center for Children and Families, and One Hope Centro de Vida. The proposed study is 
based on previous HRPO-approved/CTSC-funded/community-engaged research 
conducted by the PI with collaborators at the Hopkins Center. 
The PI has extensive experience conducting research using community-engaged 
principles and has developed a reputation for this work both locally and nationally.  
Collaborators at all three sites were involved in conceptualizing and writing the proposed 
project. The research team includes members from all three sites as co-investigators and 
the project budget is equitable in distribution of resources and salaries. Any member of 
the team who contributes to the work will have the potential to work on and be a co-
author on presentations and publications that emerge from this research. 
The Data Collectors for this project will be women who participated in the pilot study 
who are part of the original peer group co-created by Hopkins Center counselors and 
women in the group. Other team members are also members of the community of study 
(see table below in section 20), and ½ of the team are immigrants from Mexico or have 
parents who were immigrants. 
All of the patient-facing members of the team are fluent in Spanish, and the majority of 
them have Spanish as their fist language. 
Community partners and members of the population of study will be involved in all 
aspects of the research (conceptualization, design, recruitment, implementation, data 
collection, data analysis, and dissemination). 
 
 
18.0 Sharing of Results with Subjects 
 
Dissemination Strategies 
     ◼) Dissemination in New Mexico.  
1.)  We will present findings from this study to our research advisory board consisting of 
12 FMIs who participate in the original TERTULIAS group at the Hopkins Center 
and who helped develop the model. We will not present results directly to the 
participants. 
2.)  We will present findings from this study at the New Mexico Public Health 
Association (NMPHA) which is held annually in either Albuquerque or Las Cruces. 

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We have budgeted for us to be able to present our work as a panel involving multiple 
members of the team, including community partners and members of the Advisory 
Board. We believe that this work will be of great interest to the professional 
community in New Mexico as the issues of social isolation and depression among 
FMIs are recognized as key health disparities. Our ability to demonstrate a scientific 
and measurable quantitative impact will be received as extremely exciting. 
3.)  Members of our team from UNM, Centro Sávila and One Hope Centro de Vida will 
be available to advise organizations interested in pursuing this model. 
 
     ◼) Local Continuity and Sustainability.  
We recognize that it is essential that we do not just go into the community and create 
something and then leave the participants in a lurch when the research is done. Therefore, 
we have created an infrastructure to ensure that the participants have the possibility of 
continued social support. Centro Sávila has a continuous supply of interns (social work 
and counseling students) who spend at least 1 year working with clients about mental and 
behavioral health issues. When TERTULIAS groups end, we will invite participants to 
continue meeting with facilitation by a pair of Centro Sávila interns. This infrastructure 
creates a feasible way to create continuity and sustainability. One Hope will seek funding 
to be able to support the facilitators for groups held at their site.  
 
     ◼) Dissemination Nationally.  
1.) We will present findings from this study at national professional conferences such as 
the American Public Health Association, the American Anthropological Association, 
the Health Disparities Conference, the Addressing Health Disparities Conference, the 
Southwest Anthropological Association Conference, or other relevant venues.  
2.) We will publish findings from this study in peer-reviewed journals. The PI has a 
prolific publication record and the capacity to lead the team to produce multiple 
manuscripts from this work. 
 
     ◼) Future Research.  
1.)  We will apply for R01 funds to scale-up150–153 our approach to investigate the 
cascading impacts of the intervention at multiple levels: on the health of children and 
families, on the community at large, on how participation in TERTULIAS affects 
participants’ adaptation to the new context, if participation increases social/economic 
success for participants and their families, and if policy change could improve 
outcomes. 
2.) We will develop future research to use our model for work with women from other 
immigrant groups.  
3.) We will explore the possibility of adapting the design of this model to be appropriate 
to work with men. 
 
19.0 Setting 
Facilities 
Recruitment and data collection will take place at locations in the community, primarily at Centro 
Sávila, the Hopkins Center for Children and Families, and One Hope Centro de Vida Health 
Center.  

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Centro Sávila is a behavioral health services nonprofit in the South Valley that serves a primarily 
low-income Latino population. 
 
The Hopkins Center, which is run by Centro Sávila, is a behavioral health counseling center in 
the La Mesa Presbyterian Church in Albuquerque’s International District.  
 
One Hope is a community clinic operated by East Central Ministries, a faith-based organization 
in Albuquerque’s International District. 
 
All three sites work with a large number of Mexican immigrant clients and are currently 
participating or previously have participated in HRPO-approved research with UNM 
investigators, including with the PI on this project. 
 
Advisory Board 
We will present findings from this study to our research Advisory Board consisting of 12 
FMIs who participate in the original TERTULIAS group at the Hopkins Center and who 
helped develop the model, and who previously participated in the CTSC-funded pilot 
study conducted by the PI and partners at the Hopkins Center. The Advisory Board will 
meet quarterly and provide input for troubleshooting recruitment or data collection 
challenges that are related to participant lifestyle or culture, and for interpreting results of 
qualitative analyses and final results. Advisory Board members will not have access to 
any raw participant data. 
 
20.0 Resources Available 
 
The research team reflects a collaborative partnership between researchers at UNM with the 
Hopkins Center for Children and Families (and its parent, Centro Sávila), and One Hope Centro 
de Vida Health Center. This team provides a powerful, complementary blend of clinical expertise, 
behavioral health science research experience, community-connectedness, academic knowledge, 
and community acumen that will create the synergy necessary to make this project successful. 
The investigators have substantial experience working with the immigrant community on health 
disparities, demonstrated ability to conduct research in Spanish, and the team includes 6 FMIs 
and 1 male Mexican immigrant team member. The PI and other team members bring expertise 
from anthropology that is not commonly employed in health research, and the PI has expertise in 
gender theory and research with women and is experienced with conducting research with the 
Mexican immigrant community using a community-engaged approach. 
 
Research Team. 
Research Team Member 
Team Position 
Title & 
Project Role 
1st Gen 
Mexican 
Immigrant 
Institution 
Janet Page-Reeves, PhD 
Associate Professor 
Department of Family & Community 
Medicine  
& Office for Community Health 
PI 
Principle Investigator 
 
UNM 
Elaine Bearer, MD-PhD, FAAAS 
Professor 
Department of Pathology 
Co-I 
Hair Cortisol Research Lead 
 
UNM 
Molly Bleecker, MA 
Senior Research Scientist 1 
Office for Community Health 
Co-I 
Social Network Analyst 
 
UNM 
Cristina Murray-Krezan,  
Research Assistant Professor 
Co-I 
Biostatistician 
 
UNM 

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All members of the research team will receive training in research on human subjects. Each will 
take the online Human Subjects Research Training Modules from the Collaborative Institutional 
Training Initiative (CITI) to fulfill the requirement for NIH human subjects training. They will 
also take a HIPAA compliance training, obtain HIPAA certification to conduct the proposed 
research, and complete the UNM Conflict of Interest training and certification.  
We will ensure that all team members are properly trained in the specific procedures 
outlined in our protocol. For Data Collectors, they will be trained on the specifics of Data 
Collection and protecting participant privacy, and will have REDCap passwords when 
appropriate.  
All facilitators are trained in Mental Health First Aid and two of our team members are 
licensed counsellors—any of whom can be available if we identify a woman who needs 
individual mental health support related to participation in this study. 
 
Study Timeline 
 
Study Year 
Month 
Activity 
Year 1 
1. 
 
Hire Data Collectors, Train Staff (CITI, COI, HIPAA), Create Protocols 
Create contract with local filmmaker for randomization video (a filmmaker has been 
identified) 
Produce randomization video  
conclude team certifications. 
2. 
 
3. 
 
4. 
 
 
Recruit for COHORT #1 
Consent, Randomize & Baseline 
5. 
 
6. 
 
7. 
 
COHORT #1 
GROUPS 
Conduct Interviews 
 
8. 
 
9. 
 
10.  
11.  
12.  
Year 2 
1. 
 
2. 
 
3. 
 
4. 
 
Recruit for COHORT #2 
Consent, Randomize & Baseline 
5. 
 
6. 
 
Department of Internal Medicine 
Ph.D. Candidate 
Daniel Perez 
Research Assistant 
Office for Community Health 
Co-I 
Research Manager 
  
UNM 
Lidia Regino, BA/BUS 
Health Extension Rural Officer 
Office for Community Health 
Co-I 
Lead Facilitator #2 
  
UNM + One Hope Centro de Vida  
Felisha Rojan-Minjares, MD 
Assistant Professor 
Department of Family & Community 
Medicine 
Co-I 
Project Physician 
2nd Gen 
Mexican 
Immigrant  
UNM 
Bill Wagner, PhD, MSW, LCSW 
Executive Director & Founder 
Centro Sávila 
Co-I 
Policy Analyst 
& Licensed Mental Health 
Professional 
 
Centro Sávila 
Jackie Perez, MSW, LCSW 
Director, The Hopkins Center 
Co-I 
Lead Facilitator #1 
& Licensed Mental Health 
Professional 
  
Hopkins Center for Children & 
Families  
(A Project of Centro Sávila) 
 
Maria Tellez, Lic. 
Research Coordinator 
One Hope Centro de Vida 
Co-I 
Co-Facilitator #1 
  
One Hope  

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7. 
 
COHORT #2 
GROUPS 
COHORT #1 Post Survey 
8. 
 
9. 
 
Conduct Interviews  
Analyze QUAL data from COHORT #1 
10.  
11.  
12.  
Year 3 
1. 
 
2. 
 
3. 
 
4. 
 
Recruit for COHORT #3 
Consent, Randomize & Baseline 
5. 
 
6. 
 
7. 
 
COHORT #3 
GROUPS 
COHORT #2 Post Survey 
8. 
 
9. 
 
Conduct Interviews  
Analyze QUAL data from COHORT #2 
10.  
11.  
12.  
Year 4 
1. 
 
2. 
 
3. 
 
4. 
 
Recruit for COHORT #4 
Consent, Randomize &  
5. 
 
6. 
 
7. 
 
COHORT #4 
GROUPS 
COHORT #3 Post Survey 
8. 
 
9. 
 
Conduct Interviews  
Analyze QUAL data from COHORT #3 
10.  
11.  
12.  
Year 5 
1. 
 
2. 
 
3. 
 
4. 
 
5. 
 
6. 
 
7. 
 
Analyze QUAL data from 
COHORT #4 
COHORT #4 Post Survey 
Analyze Meeting Transcripts, Observation Notes, Logs & 
Participant shared notebooks from COHORT #3 
8. 
 
Analyze QUANT data 
9. 
 
10.  
Create matrices QUAL & QUAN data 
Triangulate  
Final Analysis 
11.  
12.  
 
Facilities 
Recruitment and data collection will take place at locations in the community, primarily at Centro 
Sávila, the Hopkins Center for Children and Families, and One Hope Centro de Vida Health 
Center.  
 
Centro Sávila is a behavioral health services nonprofit in the South Valley that serves a primarily 
low-income Latino population. The PI works with them on a Kellogg-funded program grant. 
 
The Hopkins Center, which is run by Centro Sávila, is a behavioral health counseling center in 
the La Mesa Presbyterian Church in Albuquerque’s International District. The PI has worked with 

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them on a variety of projects for many years, including collaboration on an HRPO-
approved/CTSC-funded pilot study that provided data for this project. 
 
One Hope is a community clinic operated by East Central Ministries, a faith-based organization 
in Albuquerque’s International District. The PI has collaborated with them on a variety of 
projects over many years, including 2 HRPO-approved research projects—one a CTSC-funded 
pilot and a large PCORI-funded study (current). 
 
All three sites work with a large number of Mexican immigrant clients and are currently 
participating or previously have participated in HRPO-approved research with UNM 
investigators, including with the PI on this project. 
 
Hopkins Center for Children and Families (The Hopkins Center) 
The Hopkins Center for Children and Families (The Hopkins Center), a research partner for this 
project, is a behavioral health counseling program that primarily serves Mexican immigrant 
families located at La Mesa Presbyterian Church in Albuquerque’s International District. The 
Hopkins Center is the continuation of the St. Joseph’s Center for Children and Families (SJCCF), 
formerly of the Samaritan Counseling Center. The counseling program was founded in 2004 in 
response to a community needs assessment conducted with residents of the International District. 
Dr. Paul Hopkins, then the Executive Director of Samaritan, was instrumental in starting and 
shaping the mission of the program. In 2017, Centro Sávila (described below) took over 
operations at SJCCF and renamed the program The Hopkins Center. The Hopkins Center 
program focuses on providing quality, affordable bilingual counseling services and support for 
the Spanish-speaking and immigrant community in the International District. Current program 
director, Co-I Jackie Perez and the staff team includes licensed clinical social workers, licensed 
counselors, a Pathways Navigator from UNM who provides essential case management and 
systems navigation, and master’s level interns from local social work programs. In 2009, in 
response to a high incidence of female patients presenting with the combined concerns of social 
isolation and depression, Co-I Perez implemented a social isolation support group that meets 
weekly. Preliminary research for the proposed project was conducted by the PI in collaboration 
with Perez and women from the group.  
 
Centro Sávila 
As indicated above, Centro Sávila is the parent organization for the Hopkins Center and will 
partner with us on this project. Centro Sávila Director, Co-I Bill Wagner will lead the policy 
component of the proposed project. Begun in 2012, Centro Sávila is the only Behavioral & 
Mental Health Clinic in Albuquerque’s South Valley that serves the Spanish-speaking 
community. Because “place matters”, their innovative support services – like Community Health 
Systems Navigation, Promotoras, Community Gardening, and Medicaid/Health Exchange 
Enrollment – are integrated with evidence-based individual, group, and family treatment and 
prevention services to meet clients “where they are.” Their comprehensive model of care works 
to decrease health disparities in Bernalillo County by providing: outpatient mental health 
services, case management, Free Health Insurance Enrollment Assistance for Medicaid and the 
NM Health Insurance Exchange, school-based restorative justice programs, food security support, 
drug and alcohol counseling and recovery support, and supervision, training and research 
opportunities for students and health professionals. Centro Sávila, is a 501 (c) (3) non-profit 
organization governed by a volunteer board of seven Directors. Their treatment approach is based 
on the key principles of public health prevention, collective impact, community building, and 
collaboration. Their current staff of 18 professionals, five graduate level social work student 
interns, and a network of volunteers provide culturally competent care that enhances the natural 
resiliency of our clients. In 2017, they provided services to over 2,000 families within their 

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clinical, outreach & enrollment, case management, and food security programs. Their mission is 
to improve the behavioral health of our community through prevention and by ensuring access to 
linguistically and culturally appropriate, quality behavioral health services in Bernalillo and 
surrounding areas. Their services are offered in English and Spanish and are accessible to 
community members regardless of their ability to pay. In addition, they have a successful pipeline 
program in coordination with Highlands School of Social Work to increase the number of 
culturally and linguistically appropriate trained social workers through internships. Centro Sávila 
provides regular trainings from veteran community health workers to staff and clients about 
systemic barriers to accessing services that meet clients most basic needs in a manner that is 
strengths based, client-centered and trauma informed. In addition, The relationship of trust that 
Centro Sávila has created in the Mexican immigrant community will be important in allowing us 
to recruit from a hard-to-reach population for the proposed research project. 
 
One Hope Centro de Vida Health Center /East Central Ministries 
One Hope Centro de Vida Health Center, a research partner on this project, is a community clinic 
run by East Central Ministries (ECM), a non-profit, grassroots, faith-based, and social justice-
oriented organization in Albuquerque’s International District. ECM is the parent 501c3 
organization for One Hope. Co-I Regino was a the long-time clinic Director at One Hope, Co-I 
Tellez is based at One Hope, and One Hope will be the site for implementation of two 
TERTULIAS groups each year during this project. Co-I’s Regino and Tellez and One Hope have 
been collaborating with PI Page-Reeves for many years developing diabetes research with the 
Mexican immigrant community and they currently collaborate on a large PCORI-funded research 
project (about diabetes) under the direction of the PI. This expertise and experience provides an 
important foundation for the proposed project and will contribute greatly to our success. 
 
ECM operates programs and initiatives to assist community members (primarily Latino 
immigrants) with access to health care through One Hope and a variety of on-site social services, 
including a food pantry with nonperishable goods and fresh produce, an urban farm initiative with 
a community garden, a housing cooperative, after school tutoring, patient navigation, and diabetes 
self-management and prevention services. In the summer of 2005, ECM partnered with over 50 
residents of the La Mesa and Trumbull neighborhoods in Southeast Albuquerque to hold a 
Community Health Fair. The event was a huge success with more than 250 neighborhood 
participants. From that pivotal event a long-term collaborative effort formed—One Hope began 
that year as a partnership with the community to create a community-run clinic. One Hope has 
grown from a small one-room clinic to a health center with three exams rooms, two dental 
stations, follow-up interviews, and case management. One Hope operates three days a week to 
serve approximately 50 patients a week. The clinic is run by Community Health Workers, staffed 
entirely by volunteer providers, and does not accept health insurance. One Hope uses a multi-
dimensional Chronic Care Model (CCM) for care provision. The mission of One Hope is to 
improve the total health of their community by partnering to leverage resources to provide 
affordable healthcare, follow-up, holistic health support, education, and spiritual guidance in a 
friendly and welcoming environment. The relationship of trust that One Hope and ECM have 
created in the Mexican immigrant community will be important in allowing us to recruit from a 
hard-to-reach population for the proposed research project.  
 
21.0 Recruitment Methods 
 
Recruitment.  
We will recruit a total of 252 FMI participants. Our two research partner agencies (Centro Sávila 
with its affiliate, The Hopkins Center and One Hope Centro de Vida) that both have a large 

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Mexican immigrant clientele will recruit at their sites, but we will also reach out to other agencies 
where we have contacts. Potential participants will be contacted in-person, by email, by phone, by 
text, or by Zoom. For all in-person recruitment, we will follow COVID-19 safety guidance, using 
screening questions, thermometers, facial coverings, social distancing (6-ft when possible), and 
sanitization of hands and surfaces as appropriate. 
We will document successful recruitment strategies.  We will track methods used to identify 
potential participants at each site, # approached for interest, # who are interested/not interested, # 
who are screened for eligibility, and # of eligible participants who agree/decline to enter the 
study. We will use Consort standards106,107 to track recruitment and attrition. We will document 
contextual factors or aspects of the intervention that influence participation and retention. We will 
track reasons for interest/no interest and reasons eligible participants decline to participate, and 
we will ask potential participants to indicate the importance of different aspects of the project in 
their decision (e.g., time, location, group design, food sharing, babysitting, etc.). We will track 
attendance at meetings and attrition, and document reasons if participants leave the study.  
                             
For Y1 and Y2 participants who have already completed the intervention and completed 
follow-up data collection, we will reach out to them by phone, text, Zoom, or email and 
ask them if they would be willing to answer a few more questions. We will use the 
attached recruitment script. If they are willing, one of the team members will set up the 
meeting, administer the new questions orally, and record the responses in REDCap using 
a tablet or laptop. The additional data collection for Y1 and Y2 participants should only 
take 15-20 minutes. Participants will receive a $25 merchandise card for answering the 
additional questions. Because for Y3 and Y4 participants, the questions will be 
incorporated into the follow-up data collection, we will not offer additional incentive. 
 
Deciding to Participate 
In our current HPRO-approved, PCORI-funded research study with Latinos from low-income 
households, we have recruited 452 participants. Of those, 183 are FMIs. The level of education 
for this subset of PCORI participants is: 47% have less than an 8th grade education and another 
18% have some high school but no diploma. Because we will be recruiting from the same 
immigrant population for this study, we anticipate that potential participants for this study will 
have a similarly low level of education. In addition, we know that this population may also be 
wary of the idea of participating in a research study. This means that we need to ensure that the 
consent process provides potential participants with sufficient information to allow them to 
provide informed consent but that it does not become so burdensome and complicated that it will 
be counterproductive to the study by discouraging individuals from electing to participate—
which would significantly affect our ability to recruit from a participant population that is already 
known to be challenging to recruit. 
 
Participation in this study would normally present no greater than minimal risk, however because 
of COVID-19, risk is elevated. As a result, we have instituted safety measures to protect staff and 
participants. Potential participants will be contacted in-person, by email, by phone, by text or by 
Zoom. For all recruitment, data collection and intervention-related meetings, we will use Zoom 
meetings when possible, and we will follow COVID-19 safety guidance for in-person meetings, 
using screening questions, thermometers, facial coverings, social distancing (6-ft when possible), 
and sanitization of hands and surfaces as appropriate. 
 
However, because the study is complex, the consent form is extremely long (9 pages in Spanish). 
Moreover, randomization is a complicated concept and will need to be explained in a way that 

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potential participants can be sure to understand what it means and why we do it. Consenting for 
this study will be conducted in Spanish by FMI members of the research team who have 
extensive experience consenting individuals from this population through our current PCORI-
funded project that has enrolled and consented 452 low-income Latino diabetes patients and 
social supports, including many Mexican immigrants. Given our experience, we anticipate that 
individual informational/consent sessions will take an hour or more to go over everything in a 
way that will ensure that the participant understands what it will mean to be randomized and the 
nature of their participation in order to decide whether or not to participate. The length of this 
process would create great burden on our project staff and on participants and challenge the 
feasibility of the study. 
 
To address these issues, we are obtained an alteration of the consent process that includes a 
meeting, a PowerPoint presentation, and a randomization video (see attached script in English—
the video itself is in Spanish and will be submitted when complete). Because of COVID-19 social 
distancing restrictions, in Year 1, we will hold this meeting by Zoom in 6 groups of 10 
participants each. In subsequent years, we will determine the appropriate safety context for 
whether or not we meet in-person or not. We have designed a culturally appropriate group 
information meeting that includes detailed information about why we are doing the study and 
what participation will be like for individuals in both the control group and the intervention 
group. The presentation will include all required information that is in the consent form.  
 
The informational meeting will be held by Zoom or if later it is deemed acceptable, at a 
convenient location in the community. Any in-person meeting will follow COVID-19 safety 
guidance for in-person meetings, using screening questions, thermometers, facial coverings, 
social distancing (6-ft when possible), and sanitization of hands and surfaces as appropriate. The 
meetings will be conducted in Spanish by FMI members of the research team. The informational 
meeting will have the following: 
 
The informational meeting will have the following: 
• 
A PowerPoint presentation describing (in Spanish) the scientific and social contribution 
that this study will make and why we are doing it. This will be submitted for HRRC 
approval when it becomes available and before recruitment starts. 
• 
A detailed explanation about the research and what participation entails. The presenter 
will clearly explain the research, the risks to participants, and the procedures for 
safeguarding their privacy. Participants will be informed that they will be assigned 
randomly to a group, that they can refuse to answer any questions and stop the survey, 
interview, or participation in a focus group at any time. The investigators have training 
and will understand the importance of these issues and their responsibility for 
maintaining high ethical standards and they will have current human subjects research 
training certification.  
• 
An explanation of what randomization means and why we do it. To this end, NIH funded 
us to produce a brief video with FMI presenters describing (in Spanish) how 
randomization works, and why randomization is important to help participants 
understand why we have structured the project to have two arms. After viewing the 
video, participants interested in participating will continue the informed consent process 
(in English or Spanish, depending on participant preference).  
 
Randomization 
After the presentation is over, those who decide not to participate in the larger research study will 
then be free to leave the meeting. Those who decide to participate will be asked to approach a 

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table or be told that they will be contacted to sign the consent form and research team members at 
the consent table or who do the contacting will do a brief review of the consent form. For those 
who are not able to participate in an in-person baseline data collection appointment because of 
COVID-19 restrictions, we will obtain oral consent. 
 
There will be an option for conducting an informational session individually (in-person or by 
Zoom) with women who cannot attend the informational meeting or those who choose to do the 
consent process in private, but we will encourage potential participants to attend the meeting 
because we believe that for this population, the meeting process (whether in-person or by Zoom) 
will be more engaging and a superior context for learning about the research than going over the 
lengthy consent form individually, and because it will also alleviate feasibility concerns. 
 
Consented participants will randomized to the intervention group or control group. Each woman 
will draw a number from a bowl. The numbers will have been randomized to one of the groups 
prior to the meeting. Randomization will be done using a block randomization design to allocate 
50% of participants to the control group and 50% to the intervention. Random block sizes of 2, 4, 
and 5 will be implemented to ensure balance between arms. Intervention group participants will 
be offered three group meeting options to accommodate participants’ schedules related to 
day/time and location considerations, but the three options will all be conducted using the same 
structure and format. 
◼) Arm 1: Control. Using a modified Attention Control Placebo (ACP) design108 to 
reduce attrition over the control participation year, control arm participants will receive a 
bimonthly phone call from our project coordinator to check in with them and to let them know 
that the study is continuing. They will be given priority for entering the intervention cohort the 
following year as a delayed intervention if they are interested.  
◼) Arm 2: Intervention. We will conduct TERTULIAS structured dialogue groups 
using the model we developed and tested through our preliminary research. Each group will have 
10 women and will meet weekly for two hours over a 12-month period. Group meetings will be 
conducted by Zoom or in-person at the community partner facilities. If in-person, they will follow 
COVID-19 safety guidance as appropriate for in-person meetings, using screening questions, 
thermometers, facial coverings, social distancing (6-ft when possible), and sanitization of hands 
and surfaces. Meetings will be conducted in Spanish, led by a team of two FMI facilitators. Co-Is 
J.Perez & Regino, experts in community-engagement with extensive experience with this 
population, will be the lead facilitators. All of our facilitators are trained in Mental Health First 
Aid, two of our team members are licensed mental health professionals—any of whom can be 
available if we identify a woman who needs individual additional mental health support related to 
participation in this study. Facilitation will use our structured dialogue approach.  
 
Participants in both groups will not be compensated per se. But we recognize the time 
commitment they make to provide us with data and we provide an incentive to thank them for 
taking the time to contribute to the research. All women who attend the meeting will receive a 
$50 merchandise card to remunerate them for their time regardless of whether they decide to 
participate or not. For those who decide to participate, after they have been randomized at the 
meeting, each woman will receive a T-shirt with the project name and Logo. There is no 
requirement that they wear the T-shirt but we anticipate that it will help them feel connected to 
and stay involved with the research. 
 
Those who join the study will later receive a $50 merchandise card for each research component 
($50 for baseline survey, $50 for baseline hair sample, $50 for 12-month survey, $50 for 12-
month hair sample, $50 for the final group meeting discussion and $50 for a subset who are 

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invited to have an interview), but not for participating in the support group. All participants who 
receive a merchandise card will be asked to sign a receipt that is required by UNM. The receipt 
will be used solely for project accounting purposes and will not otherwise be associated with the 
research data. Babysitting will be provided during group sessions and a meal will be shared. 
For the additional survey questions, Y1 and Y2 participants will be asked to do the 
survey as an additional data collection appointment. They will receive a $25 merchandise 
card. For Y3 and Y4 participants, the questions will be added into the 12-month follow-
up survey and no additional incentive will be provided. 
 
22.0 Number of Subjects 
 
     Sample Size. We will recruit 252 participants (N=252). We will randomize participants 
into one of two arms. We will enroll 60 participants each year during Y1 and Y2 (30 Arm 1 and 
30 Arm 2). During Y3 and Y4, we will increase enrollment to 66 each year (33 Arm 1 and 33 
Arm 2) to ensure we account for attrition to be able to power the study. Sample size 
accommodates attrition. 
◼) Arm 1 (n=136): Control participants will be recruited in four 12-month cohorts to 
coincide with the intervention cohorts.  
◼) Arm 2 (n=136): Intervention participants will be recruited in four 12-month cohorts. 
Each cohort will be divided into three groups. With 3 groups in each cohort, over the four cohort 
cycles, we will have a total of 12 groups.  
 
 
23.0 Provisions to Protect the Privacy Interests of Subjects 
 
Privacy & Confidentiality 
Guidelines for the protection of participant privacy and confidentiality will be followed in all 
cases. All members of the research team will maintain current Human Subjects training.  They 
will understand the importance of privacy issues and their responsibility to maintain the highest 
research ethical standards in all respects. As indicated above, we are requesting permission to 
make alterations to the consent process using a meeting, a PowerPoint presentation and a video. 
We believe that this will lead to superior understanding by the participants regarding the nature of 
participation and the concept of randomization. It will also make the study more feasible. 
However, women who choose will be able to have the information presented individually in a 
private setting. Also, we are requesting permission to obtain oral consent from those who are 
unable to attend an in-person baseline data collection appointment because of COVID-19 
restrictions. When we are attempting to schedule the appointment, it may not be feasible to have 
the data collectors meet with the participant in-person where the consent form would be signed 
prior to answering baseline survey questions or obtaining the baseline hair sample if the 
participant answers affirmatively to COVID-19 screening questions (e.g., positive COVID-19 
test, contact with a COVID-19 person, recent out-of-state travel, fever or other symptoms of 
illness). We are attempting to conduct in-person data collection appointments because we need a 
baseline hair sample in addition to the survey questions. However, if the participant is unable to 
meet in-person, we do not wish to exclude the participant since the intervention is being 
conducted by Zoom and there is no further risk of contagion apart from the baseline data 
collection appointment. Therefore, we will obtain oral consent by phone or Zoom and document 
the participant’s name, the date of consent and the team member who conducted the consent. All 
of the consenting participants will have attended a 2-hr Zoom meeting where we describe the 

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study and the contents of the consent form in detail and show the randomization video. Following 
oral consent, we will provide the participant with a printed copy of the consent form by mail. We 
will conduct the baseline survey by phone or Zoom and we will attempt to schedule the hair 
sample collection at a later date, if feasible.  If not feasible, the lack of hair sample for that 
participant will be recorded as missing data. 
Now that the meetings are being held by Zoom, the participants are generally participating from 
their homes. To ensure sufficient privacy for the meetings that will ensure privacy for all 
participants, we are adding that we will supply participants with inexpensive ear bud-style 
earphones. 
 
Surveys, gathering of hair samples, and interviews will be conducted at a location to provide 
privacy. The final group session will not be private as it will be a group discussion resembling a 
focus group. 
At the beginning of each 12-month group cohort, the facilitator will instruct participants 
regarding privacy measures for the group context. The group participants will discuss the concept 
of privacy and if there is consensus, they will sign a letter committing not to discuss the content 
of the sessions with outsiders. All participants will be asked to sign a receipt for a merchandise 
card incentive which will be used for project accounting purposes only and will not be linked 
with or associated with research data.  
Consents and participant contact information sheets will be assigned a study ID. The ID and the 
contact sheet will be the only link between the participant and the data. We need to be able to 
maintain a link between the participant and the data to be able to notify participants of meeting 
logistics, to schedule follow-up appointments at 12 months, to schedule interviews, and to be able 
to make bi-monthly check-in calls with control participants. Consent Forms, the list of 
participants who provided oral consent, and contact information will be stored in separate locked 
cabinets in the office of the PI and with access only by the investigators. All other research data 
will be de-identified. The only link between the participant and the data or contact information 
will be through the study ID. Contact information will be destroyed 5 years following the end of 
the study. Consent Forms and the list of those who provided oral consent will be kept for 3 years 
following the end of the project, at which time they will be destroyed. Participant information 
will be considered confidential and will not be shared. De-identified quantitative project data will 
be shared only per our Data Sharing Protocol. Qualitative data cannot be de-identified and 
therefore will not be shared. De-identified project data will be kept for at least 5 years. 
Data Management 
Consents and contact information will be assigned a study ID. The ID will be the only links 
between the participant and the data. These will be stored in separate locked cabinets in the office 
of the PI and with access only by the investigators. Contact information will be destroyed 5 years 
following the end of the study. Consent Forms and the list of those who provided oral consent 
will be kept for 3 years following the end of the project, at which time they will be destroyed. 
Participant information will be considered confidential and will not be shared. De-identified 
quantitative project data will be shared only per our Data Sharing Protocol. Qualitative data 
cannot be de-identified and therefore will not be shared. De-identified project data will be kept 
for at least 5 years. 
Participant demographics, hair sample testing results, and survey data will be entered into 
REDCap. Data from REDCap will be exported to STATA and stored on a secure, managed 
network share maintained by our university’s Health Sciences Library and Informatics Center’s 
IT services. Data from observational notes and meeting logs will be stored on the password-
protected computer of the PI. Data from interviews and group meetings will be captured on an 

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audio-recording device and transcribed. If in Spanish, transcripts will be translated into English 
for analysis. Following transcription/translation, audio-recordings will be destroyed. Transcripts 
of interviews and focus groups will be identified by the project ID. Electronic transcript files will 
be stored on secure UNM computers, accessible only to the researchers via their password-
protected machines. Hard copy data will be stored in binders in the locked offices of the PI. 
 
24.0 Compensation for Research-Related Injury 
This study does not involve more than minimal risk and we do not believe there is a 
likelihood of research-related injury. 
 
25.0 Economic Burden to Subjects 
We do not anticipate that participation in this study will impose significant economic 
burden to participants. Travel to/from data collection appointments and group sessions 
will be necessary, but we do not believe this will be outside of the ordinary for daily life. 
During group sessions, childcare will be provided on-site and the group will share a meal. 
For data collection appointments that occur outside of the group meetings, data collectors 
can meet participants at a location of convenience to them which may reduce any 
potential economic burden.  In addition, we will provide participants with a $50 
merchandise card at each data collection appointment to thank them for their participation 
in the research and we believe that this will defray any costs incurred in participation.  
Now that the meetings are being held by Zoom, the participants are generally participating from 
their homes. To ensure sufficient privacy for the meetings that will ensure privacy for all 
participants, we are adding that we will supply participants with inexpensive ear bud-style 
earphones. In addition,  
 
In addition, the intervention arm participants are joining a weekly 2-hour Zoom meeting. We 
have identified that many participants do not have sufficient internet connection or data use plans 
to allow this to continue and that it is an expense to them. Since we do not want participation to 
be an economic burden, we are adding in a payment of $30/month per intervention arm 
participant to help cover the cost of allowing them to have sufficient bandwidth/plans to be able 
to participate. This is fundable because we had money for babysitting that we are not using 
because we are holding the meetings remotely. This is not an incentive, it is covering the costs 
they are incurring and making participation feasible. 
 
26.0 Consent Process 
Following recruitment and screening for eligibility, for participants indicating interest, a 
member of the research team will schedule a meeting to go over the details of the study. 
Whenever feasible, we will obtain written consent from all participants prior to collecting 
any data. We are requesting a waiver of written consent for gathering the data required to 
determine eligibility and contact information.  
 
This information is necessary up front for us to recruit because as described above, we 
will be conducting a group informational meeting describing the research and the consent 
form, and because this is a randomized study, we need to show them the randomization 
video as described above and below to determine if they really do want to participate. We 
will destroy the contact information from participants who later decline to participate at 
the time of written consent.  

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In our current HPRO-approved, PCORI-funded research study with Latinos from low-income 
households, we have recruited 452 participants. Of those, 183 are FMIs. The level of education 
for this subset of PCORI participants is: 47% have less than an 8th grade education and another 
18% have some high school but no diploma. Because we will be recruiting from the same 
immigrant population for this study, we anticipate that potential participants for this study will 
have a similarly low level of education. In addition, we know that this population may also be 
wary of the idea of participating in a research study. This means that we need to ensure that the 
consent process provides potential participants with sufficient information to allow them to 
provide informed consent but that it does not become so burdensome and complicated that it will 
be counterproductive to the study by discouraging individuals from electing to participate—
which would significantly affect our ability to recruit from a participant population that is already 
known to be challenging to recruit. 
 
Participation in this study would normally present no greater than minimal risk, however because 
of COVID-19, risk is elevated. As a result, we have instituted safety measures to protect staff and 
participants. Potential participants will be contacted in-person, by email, by phone, by text or by 
Zoom. For all recruitment, data collection and intervention-related meetings, we will use Zoom 
meetings when possible and follow COVID-19 safety guidance for in-person meetings, using 
screening questions, thermometers, facial coverings, social distancing (6-ft when possible), and 
sanitization of hands and surfaces as appropriate. 
 
To address these issues, we are obtained approval for an alteration of the consent process that 
includes a meeting, a PowerPoint presentation, and a randomization video. Because of COVID-
19 social distancing restrictions, in Year 1, we will hold this meeting by Zoom in 6 groups of 10 
participants each. In subsequent years, we will determine the appropriate safety context for 
whether we meet in-person or not. We have designed a culturally appropriate group information 
meeting that includes detailed information about why we are doing the study and what 
participation will be like for individuals in both the control group and the intervention group. The 
presentation will include all required information that is in the consent form.  
 
The informational meeting will be held by Zoom or at a convenient location in the community. If 
it is an in-person meeting, we will follow COVID-19 safety guidance for in-person meetings, 
using screening questions, thermometers, facial coverings, social distancing (6-ft when possible), 
and sanitization of hands and surfaces as appropriate. The meetings will be conducted in Spanish 
by FMI members of the research team. The informational meeting will have the following: 
• 
A PowerPoint presentation describing (in Spanish) (English version attached) the 
scientific and social contribution that this study will make and why we are doing it. This 
will be submitted for HRRC approval when it becomes available and before recruitment 
starts. 
• 
A detailed explanation about the research and what participation entails. The presenter 
will clearly explain the research, the risks to participants, and the procedures for 
safeguarding their privacy. Participants will be informed that they will be assigned 
randomly to a group, that they can refuse to answer any questions and stop the survey, 
interview, or participation in a focus group at any time. The investigators have training 
and will understand the importance of these issues and their responsibility for 
maintaining high ethical standards and they will have current human subjects research 
training certification.  
• 
An explanation of what randomization means and why we do it. To this end, NIH funded 
us to produce a brief video with FMI presenters describing (in Spanish) (English script 
attached) how the randomization works, and why randomization is important, to help 

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participants understand why we have structured the project to have two arms. After 
viewing the video, participants interested in participating will continue the informed 
consent process (in English or Spanish, depending on participant preference).  
 
After the presentation is over, those who decide not to participate will then be free to 
leave the meeting. If the meeting is in-person, those who decide to participate will be 
asked to approach a table to sign the consent form and research team members at the 
consent table will do a brief review of the consent. There will not be a waiting period for 
consent as there is no safety or scientific purpose to a delay. If the meeting is by Zoom, 
the participant will be told that a member of the team will contact them to obtain consent. 
 
The research team members at the tables or those who obtain consent later will be Spanish-
speaking and will ensure that participants understand that their participation is voluntary and that 
they can choose not to participate or to withdraw their participation at any point in the study. The 
consent form contains contact information for the PI and for the UNM HRPO in case the 
participant has a question or concern. Both the participant and the research team member will 
sign the consent form.  The participant will be given a copy of the consent to keep for their files.  
 
Also, we are requesting permission to obtain oral consent from those who are unable to attend an 
in-person baseline data collection appointment because of COVID-19 restrictions. When we are 
attempting to schedule the appointment, it may not be feasible to have the data collectors meet 
with the participant in-person where the consent form would be signed prior to answering 
baseline survey questions or obtaining the baseline hair sample if the participant answers 
affirmatively to COVID-19 screening questions (e.g., positive COVID-19 test, contact with a 
COVID-19 person, recent out-of-state travel, fever or other symptoms of illness). We are 
attempting to conduct in-person data collection appointments because we need a baseline hair 
sample in addition to the survey questions. However, if the participant is unable to meet in-
person, we do not wish to exclude the participant since the intervention is being conducted by 
Zoom and there is no further risk of contagion apart from the baseline data collection 
approintment. Therefore, we will obtain oral consent by phone or Zoom and document the 
participant’s name, the date of consent and the team member who conducted the consent. All of 
the consenting participants will have attended a 2-hr Zoom meeting where we describe the study 
and the contents of the consent form in detail and show the randomization video. Following oral 
consent, we will provide the participant with a printed copy of the consent form by mail. We will 
conduct the baseline survey by phone or Zoom and we will attempt to schedule the hair sample 
collection at a later date, if feasible.  If not feasible, the lack of hair sample for that participant 
will be recorded as missing data. 
In addition, participants will be asked to fill out a contact information sheet. The contact 
information will be gathered on a separate sheet that will be kept separately from the 
demographic data. The contact information will be used to schedule follow-up appointments, for 
meeting invitations, and for control arm check-in calls.  
 
The consent form requests permission to be allowed to contact the participant if we have a future 
project that we think might be of interest to them. We will keep their contact information for 5 
years after the study ends and after that it will be destroyed.  
 
There will be an option an individual informational session with women who cannot attend the 
informational meeting or those who choose to do the consent process in private, but we will 
encourage potential participants to attend the meeting because we believe that for this population, 
the meeting process will be more culturally appropriate, more engaging and a superior context for 

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learning about the research than going over the lengthy consent form individually, and because it 
will also alleviate feasibility concerns. 
 
At interviews and 12-month data collection, we will remind the participant about the 
study and the consent they signed and answer questions if they have any. 
 
In Y1, we will reconsent the participants with a new consent form and an approved script that 
reflects the addition of the What’s App chat groups in July 2021 prior to the end of the Y1 groups 
on July 28. We will not begin analyzing the What’s App data until re-consenting has been 
completed. In subsequent years Y2-Y4, this information will already exist in the consent form. 
Given that we are still operating remotely under COVID-19 safety restrictions, we will use our 
existing HRPO approval for oral consent in Y1. Because we conduct baseline data collection 
appointments in-person, subsequent consent will most likely be conducted in-person, except in 
cases where that is not permissible for COVID-19 safety concerns. The consent form will have an 
option for the participant to select whether they would like to be part of the What’s App chat 
group—an opt in/opt out. With those who opt out, they will not be included in the chat group 
and we will communicate with them directly regarding any logistical information about the 
meetings. 
 
In January 2023, we submitted an amendment to the consent form. On the consent form, 
the interview with a subset of participants was listed under the bullets describing group 2 
(the intervention). We have already interviewed 11 intervention participants from Y1 and 
have decided that we would also like to conduct interviews with some of the control 
participants to help us contextualize the survey responses from both groups. We are 
amending the consent form by moving the interview to the bulleted list that describes 
activities that are or are potentially conducted with participants from both arms. When we 
call the control participants and invite them to do an interview, we will indicate that we 
we added in these interviews with control participants because we want to understand 
their experience in the study and so we will be asking them to re-sign the amended 
consent form at the time of the interview to reflect the fact that they understand and agree 
to this change. 
 
 
In addition, we changed the wording in the Spanish version of the consent to re-word the 
places where participants opt in or out of the WhatsApp chat group and having their 
name associated with the creative project. We were instructed by the data collectors who 
invite the participants to sign the consent that this wording was confusing to participants 
and always had to have more explanation. We believe that the re-wording will clarify that 
for when we consent Cohort #4 in summer 2023 (the last cohort). 
 
For the additional survey questions to validate the interim qualitative analysis results: For Y1 
and Y2 participants who have already completed the intervention and completed follow-
up data collection, we will reach out to them by phone, text, Zoom, or email and ask them 
if they would be willing to answer a few more questions. We will use the attached 
recruitment script. If they are willing, one of the team members will set up the meeting, 
administer the new questions orally, and record the responses in REDCap using a tablet 
or laptop. The additional data collection for Y1 and Y2 participants should only take 15-
20 minutes. Participants will receive a $25 merchandise card for answering the additional 
questions. Because for Y3 and Y4 participants, the questions will be incorporated into the 
follow-up data collection, we will not offer additional incentive. 

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We are requesting approval to obtain oral consent for Y1 and Y2 participants to answer 
these additional questions. They have already signed the consent form for the project. We 
will document the fact that they consented in REDCap. 
 
Non-English Speaking Subjects 
Because this is a study with FMIs, we anticipate that they will have Spanish as their first 
language and that many may not speak English well or at all. Fluency in Spanish is a 
criteria for inclusion in the study, as group sessions will be conducted in Spanish.  
 
All of our project materials, including consent and the recruitment video will be available 
in English and Spanish. We anticipate that the vast majority of participants will prefer 
Spanish language materials, but in case they prefer English, both will be available.  
 
All of the data collectors and facilitators who interface with participants in this project 
have Spanish as their fist language. The PI, who will conduct interviews, is fluent in 
Spanish. 
 
27.0 Data Transfer/Sharing 
Complete this section if the research involves transferring/sharing of data with an 
external entity (institution, company, etc.). 
A. Will data be transferred/shared with an external entity (institution, company, 
etc.)?   
 Yes 
 No. The remainder of this section does not apply.  
B. Indicate if the data is incoming and/or outgoing: outgoing   
C. Provide the name of the entity that data will be transferred/shared with:  
University of Pittsburgh 
D. Provide the contact name, email and phone number with whom data is being             
transferred/shared with: Cristina Murray-Krezan, PhD, cmmk@pitt.edu, 412-864-
3023 
E. Who is responsible for transmission of the data? Janet Page-Reeves, PhD           
F. Who is responsible for receiving the data? Cristina Murray-Krezan, PhD 
G. Describe how the data will be transferred/shared. Please note data cannot be 
transferred/shared without assistance from UNM HSC IT. Requesting HSC 
Central IT Transfer is detailed on the Sponsored Projects website: Dr. 
Murray-Krezan will have access to REDCap. Data will be downloaded from 
REDCap and stored on an access-limited, password-protected University of 
Pittsburgh secured server behind the institution’s firewall.           
H. For data being transferred/shared with outside locations or entities, describe the 
following: 
• Where is data storage and how will it be maintained in a secure manner 
(i.e. encryption, password protection, use of Qualtrics or REDCap, etc)?    

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Data downloaded from REDCap will be stored on an access-limited, 
password-protected University of Pittsburgh secured server behind the 
institution’s firewall.    
• What is method in which data will be collected and stored (i.e. electronic, 
hard copy, etc)?  Data will be collected by UNM research personnel and 
entered directly into UNM’s REDCap system.     
• How long will the data be stored? The data will be stored on the 
University of Pittsburgh server for up to 5 years following completion of 
the study. 
• Who will have access to data? Only Cristina Murray-Krezan, PhD will 
have access to the data at the University of Pittsburgh.         
I.  Please list all specific data elements, variables, etc. to be sent out and/or received. 
Indicate if the data contains identifiers and health information. Please note that 
identifiers that MUST be removed to make health information de-identified are as 
follows: Names, All geographic subdivision smaller than a State, All elements of 
year (except year), Telephone, Fax numbers, E-mail addresses, Social Security, 
Medical record number, Health plan beneficiary, Account numbers, 
Certificate/license numbers, Vehicle identifiers and serial numbers, Device 
identifiers and serial numbers, Web URLs, IP address numbers, Biometric 
identifiers, full face photographic images, and Any other unique identifying 
number, characteristic or code.)  Demographic characteristics including DOB,  
health status (pregnant, whether using medications, sleep quality), questions about 
experiences with social isolation, discrimination,  COVID questions (ever tested, 
diagnosed, employment/healthcare/lifestyle disruption/changes due to COVID), 
Center for Epidemiologic Studies Depression Scale (CES-D), Perceived Stress 
Scale (PSS-14), Connor Davidson Resilience Scale (CD-RISC), Medical 
Outcomes Study Social Support Survey, Trauma-Informed Practice Scale (TIP), 
intervention evaluation questions.            
J. If the research requires the access, use, or disclosure of any of the 18 individually 
identifiable protected health information (PHI) identifiers that can be used to 
identify, contact, or locate a person (e.g., name, medical record number, etc.), are 
the subjects going to consent to or authorize the disclosure of their individually 
identifiable health information?  Yes 
a. Or is HIPAA authorization altered or waived? No     
K. What is the classification of the data (de-identified, limited data set, protected 
health information, other). Limited data set 
L. Does the request to transfer/share data include clinical data that belongs to the 
UNM Health Systems? No 
M. Does the data to be transferred/shared include information about patients seen at 
external health system or at a third party medical provider? No      
N. Is the external entity a “covered entity”? yes        
O. Is the data that is going to be transferred/shared owned or partially owned by 
another party or have any type of restrictions including regulatory restrictions (i.e. 
HIPAA, FERPA, etc.)? no      
P. Is the data publically available? If yes, please provide details: no       

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Q. Does the data include information about substance abuse treatment, sexually 
transmitted diseases, genetic testing results, HIV/AIDS testing results, and/or 
mental health?   Yes-depression only      
 
28.0 Specimen Transfer/Sharing 
Complete this section if the research involves transferring/sharing of specimens with an 
external entity (institution, company, etc.).  
A. Will specimens be transferred/shared with an external entity (institution, 
company, etc.)?  
      
 Yes 
 No. The remainder of this section does not apply.  
B. Indicate if the specimens are incoming and/or outgoing:       
C. Provide the name of the entity that specimens will be being transferred/shared 
with:       
D. Provide the contact name, email and phone number with whom specimens are 
being transferred/shared with:       
E. Who is responsible for sending out the specimens? Please note specimens cannot 
be sent out without a fully executed material transfer agreement.       
F. Who is responsible for receipt of the specimens? Please note specimens cannot be 
received without a fully executed material transfer agreement.             
G. For specimens being transferred/shared with outside locations or entities, describe 
the following: 
• Where is specimen storage and how will it be maintained in a secure manner? 
      
• What is method in which specimens will be collected and stored?       
• How long will the specimens be stored?       
• Who will have access to the specimens?         
 
29.0 Principal Investigator’s Assurance 
By submitting this study in the Click IRB system, the principal investigator of this study 
confirms that: 
☐  The information supplied in this form and attachments are complete and correct.   
☐  The PI has read the Investigator’s Manual and will conduct this research in 
accordance with these requirements.  
 ☐  Data will be collected, maintained and archived or destroyed per HSC Data Security 
Best Practices, including: 

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1. Best Practice for data collection is for it to be directly entered onto a data 
collection form that is in a secured access folder on an HS drive behind a firewall, 
or in a secure UNM Data Security approved system such as RedCap. 
2. Data collection of de-identified data, if done in a clinical setting or other setting 
that does not allow direct entry into a secured system, may be done temporarily 
using a personal or university owned electronic storage device or hard copy 
document. The important security safeguard is that no identifiers be include 
if the data is entered or stored using an untrusted device or storage. 
3. Permanent (during data analysis, after study closure) storage must reside on 
HSC central IT managed storage. Processing of data (aggregation, etc.) are to be 
carried out in such a way as to avoid creating/retaining files on untrusted storage 
devices/computers. Trusted devices are HSC managed and provide one or more of 
following safeguards: access logs, encryption keys, backups, business continuity 
and disaster recovery capabilities. 
4. Alternate storage media must be approve by HSC IT Security as meeting or 
exceeding HSC central IT provided security safeguards.