Hispanic Men Building Respect Education and Safety (Family Men) - Substudy Under Center for Latino Research Opportunities (CLaRO)
Phase: NA
Conditions: Substance Abuse, Domestic Violence, HIV/AIDS
Sponsor: University of Miami

 
 
 
 
PI: Dr. Victoria Behar-Zusman, PhD. 
Study PI: Dr. Patria Rojas, Ph.D. 
 
 
 
Study Title:  Hispanic Men Building Respect Education and Safety (Family Men) Substudy 
Under Center for Latino Research Opportunities (CLaRO) 
Version Date: 04/12/2020 
NCT Number:  NCT03730987 
 

Study#: 20170769        Effective Date: 4/12/2020 
IRB Study Number: 
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1) Protocol Title: 
Hispanic Men Building Respect Education and Safety/ HoMBRES Manteniendo   
Respeto, Educacion y Seguridad (HoMBRES De Familia) - Substudy under Center for 
Latino  Research Opportunities  (CLaRO) 
2) IRB Review History* 
Previously approved by the UM IRB for NIH JIT purposes. The study is being 
conducted by FIU personnel under CLaRO. FIU has approved for UM to be the IRB of 
record. 
3) Objectives* 
The study described in this protocol is examining the efficacy of a culturally adapted 
group intervention program with fathers and their son dyads from a seasonal farm 
working community in South Florida. The goal of the HoMBRES de Familia project is to 
adapt and test the efficacy of an intervention that will be adopted, implemented, and 
sustained with Latino fathers who live or work in the farm industry, construction, sales, 
services, selfemployed, or any other work industry in the semi-rural areas or urban 
areas of MiamiDade County. The HoMBRES intervention will seek to reduce risk for the 
SAVA (Substance Abuse, Violence, AIDS) syndemic among this group of men and their 
adolescent sons. 
The study aims of HoMBRES De Familia are: 
1. Conduct a community assessment via qualitative data methods (in-depth interviews; 
focus groups) that will inform the adaptation of HoMBRES, an evidence-based 
intervention targeting the SAVA syndemic among adult and adolescent males in the 
Latino seasonal farmworker community; 
2. Adapt, implement, and evaluate the preliminary efficacy of the adapted intervention 
through a randomized trial; and 
3. In combination with the CLaRO Community Engagement and Dissemination Core, 
develop an effective dissemination plan that engages community members, 
partnering organizations, local service providers, and other stakeholders in 
disseminating study findings into a sustainable intervention that effectively reduces 
SAVA related health disparities among males in these communities. 
4) Background* 
Syndemic conditions refer to two or more intertwined endemic or epidemic health 
conditions that interact and impact the health of a population.12 The syndemic framework 
promotes a deeper understanding of the relationships between co-morbid health 
conditions and how these health conditions may interact synergistically to negatively 
impact the health of affected communities. This framework emphasizes the underlying 
factors that link comorbid health and health disparity conditions together. When 
investigating  the substance abuse,  family violence, and HIV/AIDS (SAVA) syndemic 
among Latino men, it is essential to examine both the conditions themselves and the 
underlying individual (e.g., poverty, selfefficacy), interpersonal (e.g., family involvement, 
partner characteristics), cultural (e.g., machismo, gender norms, cultural stressors), and 
socio-environmental factors (policies, access to  health  care, structural  stressors)  that 
may serve as common risk and protective factors for these three conditions. Thus, 

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interventions that address the underlying multi-level factors linking the SAVA syndemic 
to effective programs can potentially and simultaneously reduce substance abuse, 
violence, and HIV risk behaviors among males in the Latino seasonal farmworker 
community. 
An estimated four million farmworkers, mostly Latinos, live and work in rural areas in 
42 of 50 states in the US.13 Seasonal farmworkers are defined as individuals involved 
in field and orchard agriculture, packing and sorting procedures in food processing, 
horticultural specialties (including nursery operations, greenhouse activities, and 
crops grown under cover), and reforestation.  Unlike migrant farmworkers, who leave 
their home to seek employment, seasonal farmworkers usually stay in their 
permanent place of residence and shift jobs depending on the season. Given South 
Florida’s climate, most farmworkers in the area are seasonal and work in several 
areas of the agricultural industry in a given year.14 
The life circumstances of seasonal farmworkers often place them at risk for substance 
abuse, family violence, and HIV/AIDS.15,16,17 A confluence of socio-demographic, 
ecological, and behavioral factors contribute to the disproportionate rates of SAVA 
syndemic in this population. Farmworkers face social and structural barriers, including 
immigration status (fear of deportation), geographical isolation, language barriers, 
separation from extended families, hazardous working conditions, substandard living 
conditions, limited access to health services, poverty/economic stress, and 
ethnic/racial intolerance.13,18   Many seasonal  farmworkers report high  levels of  
depression  and anxiety, which exacerbate health-compromising behaviors.15 Socio-
cultural risk factors [e.g., acculturation and acculturation related stress, traditional 
gender  roles (machismo), poor family functioning, and stigma] have been associated 
to increased risk of SAVA in   this population.19,16,20 Conversely, holding strong Latino 
cultural values such as familismo (i.e., strong family bond), respeto (respect for 
parents and elders), religiosity, and caballerismo (i.e., positive machismo; e.g., dignity, 
honor, man’s role as provider) have been found to be protective against  SAVA risk 
behaviors.21,22 
Peer-advocate based  interventions have been effective in decreasing  health  risk 
behaviors among Latino men.2,3 Researchers attribute the success of these models to 
peeradvocates, who (a) reside in the community, (b) understand the communities’ 
strengths and needs, (c) communicate in the language of the community, and (d) share 
cultural (e.g., identity, values, belief) similarities with the community to promote health 
outcomes within their communities.23 Furthermore, intervention approaches that utilize 
existing community assets (e.g., peer-advocates) have been shown to remain effective 
after a research project or grant funding has ended—underscoring the impact and 
sustainability of these intervention models.5 Given the efficacy of peer-advocate based 
models, such as HoMBReS and HoMBRes-2 among Latino males in rural areas, we 
propose  to adapt  these  proven strategies  within the local context of males. 
Specifically, in the proposed adapted intervention, HoMBRES de Familia, peer-
advocates will target identified risk factors (i.e., stigma, machismo, stressors) and take 
advantage of key protective factors (i.e., familismo, respeto) associated with the SAVA 
syndemic in this population. For instance, peeradvocates will be trained to bolster 
positive, and reframe negative, socio-cultural expectations regarding masculinity, debunk 
SAVA-related myths, and increase knowledge and accessibility of available substance 
abuse, HIV/AIDS and other STI, and family violence services in the community. 

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Etiological  studies  among Latino  adolescents  have indicated  that higher  levels  of 
positive family relationship processes, such as parental involvement, parent-youth 
communication, and family cohesion,24 are associated with lower levels of substance 
use,25,26 sexual risk behavior,25 mental health,27 and violent/aggressive behavior.28 
Intervention studies that enhance positive family relationship processes among Latino 
families simultaneously  report decreases  in  these  negative outcomes29,30  However, 
most family-based prevention programs that target SAVA outcomes among Latino youth 
have a significant limitation: they are not tailored to gender-specific determinants of 
SAVA. Researchers have found that Latino adolescent boys who are socialized to adhere 
to machismo attitudes may be more inclined to engage in sexual risk and aggressive 
behaviors,21,31 and the socialization of machismo may occur more commonly among 
immigrant families and families living in poverty.32,33 
Family-based prevention programs that target SAVA outcomes among Latino 
adolescents and other ethnic minority youth may be more efficacious by increasing the 
father’s involvement and strengthening father-son positive family relationship 
processes.34,35   Social Cognitive Learning Theory36 posits that fathers may serve as a 
more relatable model for adolescent sons. Few family-based prevention programs have 
focused on father-son dyads; however, there is evidence indicating that improving 
family functioning among ethnic minority father-son dyads may improve SAVA 
outcomes.37 Research on father-son interventions have primarily focused on African 
American families;34,37  there is a need  for more studies investigating  the Latino  father-
son context in this  research area. 
To date, no studies have examined the context of father-son relationship and 
communication and its impact on externalizing risk behaviors among youth among 
seasonal farmworkers. The scarce evidence in this area of research suggests (via 
qualitative in-depth interviews) that despite the challenges associated with their working 
conditions, LSFW fathers are motivated and seeking creative ways to express their 
roles as fathers.38  Previous studies  have found that, among Latino men, the cultural 
factors  that protect them against the SAVA conditions—including  higher levels of 
respeto (respect), familismo (familism), and caballerismo (positive aspects of machismo  
connected to chivalry and being family provider) — also make them more likely to be  
more involved with their children.39,35,40   In contrast,  acculturative stress  and  greater 
levels of acculturation have been found to negatively impact family relationships among 
farmworkers.41,42, 43 The proposed HoMBRES de Familia will examine the unique 
intersections between behavioral, structural, and cultural circumstances experienced by 
seasonal  farmworkers as a context of father involvement and  leverage the LSFW  
fathers’ interest in improving communications with their sons to reduce the prevalence 
of the SAVA syndemic among adult Latino males and enhance parenting skills that will 
ultimately lead  to preventing these  conditions in future  generations. 
Taking in consideration the US Department of agriculture’s study from November 2018 
reporting the shortage  of farmers and plant  growers in the US (Zong, Btalova, &  
Burrows, 2019; Krogstad, Passel & Cohn, 2019), the current study will recruit Latino  
males who live in the urban areas of Miami Dade, semi-rural areas of Homestead, 
Naranja and Florida City or work in the farm industry, sales, construction, truck industry, 
landscaping,  self-employment or other  work industry will be included in the  study. 

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5) Inclusion and Exclusion Criteria* 
Latino fathers and father figures with 11-17 adolescent sons who live in or work in the 
farm communities, farm industry, construction, sales, services, self-employed, or any 
other work industry in the urban and semi-rural areas of Miami Dade County. We will be 
recruiting the sample, in part, through community-based agencies serving the Latino 
community in those areas. 
Aim 1 –Participants in the Community Assessment will be recruited from the community 
using word of mouth, fliers, and outreach in the community. Focus groups will be 
facilitated with adult men, adolescents (13-17 years old), and service providers and 
community leaders, from the community.  Criteria for participating in the focus groups 
are: 1) being a farm worker (or adolescent child of a farm worker) or living in a farm 
working community or working with the farm working community or being a leader 
within the community. 2) Speaking and Understanding English or Spanish 
Aim 2 - In order to participate in the randomized clinical trial (RCT) intervention - 
Adult father and son (11-17 years old) dyads, living or working in the farm industry, 
sales, construction, truck industry, landscaping, self -employment or other work 
industry or living in the urban areas or semi-rural areas of Miami-Dade such as 
Homestead, Naranja and Florida City will be eligible to participate in the Research 
Project.  
Prisoners are excluded. Inclusion criteria for RCT participants are shown in Table 1 
  Table 1. Inclusion Criteria 
  
Criteria 
Inclusion 
 
Fathers 
 
Sons 
 
Age 
18 yrs. of age and over 
11 to 17 yrs. of age 
Language 
Ability to speak and understand 
Spanish 
Ability to speak and understand 
English or Spanish 
Community 
residency 
Living in the urban or semi-rural 
areas of Miami Dade such as 
Homestead, Naranja or Florida  
City who will remain in area for 
6 months or working in the work 
industries described below or 
Who will remain in area for 6 
months 
Jobs 
Working in the farm industry, 
nurseries, sales, construction, 
truck industry, landscaping, self-
employed or other work industry. 
Unemployed fathers are also 
eligible.  

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Consent 
Dyad 
Able to understand & provide 
consent 
Be considered a father/father 
figure to participate 1, 2 
Able to understand & provide 
assent and has parental consent 
Preferably the youngest eligible of 
sons 2 
 
1. In cases where men have more than one son that meets the inclusion criteria, 
attempts will be made to recruit the youngest son, which will allow prevention 
measures as early as possible. 
2. In cases where the adult male is not the legal guardian, written consent from the 
child’s legal guardian will be required in addition to assent from the adolescent. 
6) Number of Subjects* 
Aim 1 
The number of participants for in-depth interviews will be no more than 20.  
The number of participants for the focus groups will be 
48. i) 2 focus groups with fathers (n=16) ii) 2 focus groups 
with youth (n=16) iii) 2 focus groups with community 
leaders (n=16) 
Aim 2 
Number of participants will be N=320 
iv) 160 dyads 
v) n=160 fathers vi) 
n=160 sons 
7) Study-Wide Recruitment Methods* 
Aim 1: Seasonal farmworkers, people (adult men, women, and youths) working in the 
farm working community (or adolescent child of a farm worker), nurseries, and leaders 
of the farm working communities will be sampled, in part, through community-based 
agencies serving the Latino seasonal farmworker (LSFWs) families of MDC. In addition 
to referrals from our community partners, we will conduct recruitment efforts in locations 
frequented by male LSFWs and their families, including local farmworker camps, Latino 
festivals, health fairs, soccer fields and other parks, social service agencies, and health 
care facilities. Various methods may be used to recruit participants including study 
flyers, dissemination through social and mass media outlets, and word of mouth. 
Recruitment efforts for the focus groups will be coordinated with CBOs which will 
identify additional stakeholders via partnerships with faith-based organizations, youth 
and recreational organizations, and other service providers in the seasonal farmworker 
community. We will also recruit via presentations and other previously successful 
strategies used by our community outreach team in areas where farmworkers live, 
gather, socialize, and work. 
Aim 2:  Various methods will continue to be used to recruit participants. We will send 
flyers to agencies’ program coordinators and other contacts in urban communities, 
community leaders, and nurseries to recruit participants for the study. Participants 
recruited into the study via word of mouth and radio ads will be asked to refer other 
participants and provide the contact information of men who may meet eligibility criteria 

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using a respondent-driven sampling (RDS) approach, which is an effective strategy to 
recruit participants from hidden populations. 
In RDS, each participant (seed) will be asked to refer up to three other individuals in 
their social network who meet study inclusionary criteria. Seeds will be compensated 
twenty ($20.00 dollars) per each eligible participant who enrolls in the study. This 
procedure will be followed for three legs for each initial participant (seed) at which 
point a new seed will begin in effort to avoid skewing the sample. 
In addition to the recruitment strategies used for Aim 1, we will be recruiting using 
telephone outreach calls to previous community gatekeepers in the urban areas and 
extant participant’s pipeline. The electronic and telephone calls, and voicemails 
outreach approach may be a temporary measure due to the 2019-2020 Coronavirus 
Pandemic.  
Presently, we will be conducting recruitment remotely.  Additionally, we will continue 
recruiting vial local radio stations, social media, online resources and different technology 
venues available to reach the urban and the semi-rural community. These 
recommendations will be followed for the safety of participants, staff and the community.  
8) Study Timelines* 
The timeline shown in Table 2 is the intended timeline. Some of the activities may not 
be completed within the proposed time. 
Aim 1. After the study protocol has been approved by the IRB. Participants will be 
recruited for the focus groups and interviews. Focus groups and interviews will be 
facilitated by trained protocol personnel and transcription will commence immediately 
after data collection as shown in Table 2. 
Aim 2.  After potential participants are identified and screened for eligibility, a meeting will 
be scheduled to complete informed consent procedures and baseline assessments. Father-
son dyads interview time and dates will be scheduled simultaneously and will be 
interviewed separately in order to maintain confidentiality. Once dyadic groups are 
interviewed, they will be entered into the study in waves of 20 dyads to avoid delays 
between recruitment, randomization, and intervention delivery.  Intervention sessions will 
be scheduled based on participants groups availability (6-8 fathers will be invited to 
participate per group session for the control and the intervention).  Control and intervention 
groups will be conducted within the same time frame (participants eligibility includes being 
available for the intervention group and the control group). 
During the temporary social distancing, the assessments for both fathers and sons will be 
completed remotely; fathers will be interviewed by telephone and adolescents will receive a 
well-proven secured link to complete the questionnaire or may be interviewed by 
telephone.  There will be an interviewer available to ensure the completion of the baseline 
assessment and answer any questions the participant may have.   
Table 2. Timeline of HoMBRES de Familia depicted in a quarterly fashion. 
Proposed activities (quarterly basis)  
Year 01 
Year 02 
Year 03 
Year 04 
1
2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
Develop focus group protocol/recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct focus groups 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Qualitative data analyses of focus groups 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop key informant interview protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Conduct key informant interviews  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Qualitative analyses of key informant 
interviews 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Adapt intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruit, hire and train staff 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Training of peer-advocates 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-test adapted intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruit participants 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Baseline assessments (Tx. & control) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Implement intervention  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6 month post-tests 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Fidelity and process evaluations 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analyze intervention efficacy, evaluation 
reports 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dissemination of research findings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9) Study Endpoints* NA 
10) Procedures Involved* 
Aim 1: 
Focus groups and in-depth interviews will provide qualitative data on community 
capacity, feasibility, and acceptability of the HoMBRES de Familia intervention and 
provide information on the adaptations needed to culturally tailor it to the target 
community. We intend to conduct a total of 6 focus groups (n = 48): 2 with men 
(fathers), 2 with adolescents (13-17 years old), and 2 with community service 
providers/ stakeholders (e.g., representatives from community service providers and 
local farmworker organizations, faith-based organizations, community health centers, 
advocacy centers, and other service providers). 
We intend to also conduct up to 20 interviews with community leaders (business 
owners, day care providers, farm working supervisor and others) who did not 
participate in the focus groups. 
Focus groups and interviews will be conducted by bilingual trained protocol 
personnel, audio-recorded, and transcribed verbatim for analysis (in the language 
they were conducted) using N-vivo. For each focus group, participants will determine 
whether the focus groups will be conducted in English or Spanish. We anticipate that 
adolescent groups will prefer English and adults will prefer Spanish. Interviews (40-
60 minutes) will be conducted in English or Spanish according to the participant’s   
preference. A semi-structured in-depth interview guide will be developed based on 
previous   formative research, using questions from the focus groups and focus 
group findings.  
The data from Aim 1 will provide the foundation for adapting and pre-testing the 
HoMBRES de Familia intervention. A subsequent quantitative evaluation of the 
adapted intervention’s efficacy (Aim 2) will be completed via a 2-arm randomized 
control trial (RCT) with a sample of 160 father-son dyads (N=320) 
Aim 2: 
The 2-arm RCT will test the efficacy of the adapted intervention with a sample of 160 
father-son dyads (N=320). After potential participants are identified and screened, a 

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meeting will be scheduled to complete informed consent procedures and baseline 
assessments. Father-son dyads will be entered into the study in waves of 20 dyads to 
avoid delays between recruitment, randomization, and intervention delivery. Father-son 
dyads will be randomized into the intervention or control condition using the computer 
software RANDI2.  Randomization will be done using the dyads ID after pre-test. 
Father-son dyads will be randomized into the intervention (HoMBRES) or control 
condition. Adolescents will only be expected to participate in baseline and 6-month 
follow up assessments, as the intervention program is solely parent-based. 
A locator form completed by each participant father during the baseline assessment will 
guide initial attempts to contact participants. This screening form will contain two or 
three local phone numbers associated with the participant (father), the address where 
the participant lived when interviewed, email address, social media contact information. 
We will also use the following retention strategies as needed: (1) send a letter to 
participants seeking their continuous participation in the study; (2) contact participants 
by email; (3) conduct home visits if we cannot reach participants by phone or email; (4) 
make up to monthly phone calls to ascertain if there are changes in contact information 
or   address; (5) use corroborative contact sources (from locator form); and (6) maintain 
routine contact with participants through project newsletters or cards for birthdays or 
US/Latin American holidays. If participants cannot be reached by the above methods, 
we will use online phone directories, Internet search engines, and social networking 
sites to locate updated contact information. Only adults will be searched/contacted in 
this manner. A combination of postal mail, email, and text reminders and confirmation 
calls will help minimize missed appointments. 
HoMBRES Intervention. Due to the outlined measures above, the intervention 
HoMBRES will consist of four sessions remotely facilitated via a well-tested video 
platform accessible by a link sent to the participants’ telephone, computer, tablet or IPad 
(approximately 1.5 hours each session) during the period of social distancing, and 
perhaps beyond if we find that the remote sessions are working well. Intervention videos 
will be followed up with a telephone call to respond to any questions participants may 
have about the sessions and clarify (if needed) the material covered in the videos via 
telephone or text messages. Staff will schedule the times when participants will watch 
the videotaped sessions in order to be available for their questions.  Topics covered 
across the modules/ sessions are shown below. Participants will also be provided with a 
resource application (app) and online link with a list of community service providers 
related to substance abuse, HIV/AIDS, and violence. 
Hombres Intervention modules: 
Module1: 
• 
Program introduction/ Parental cultural influence on adolescents Module 
2: 
• 
HIV prevention and STIs and sexual behaviors  
• 
The role of parents as educators/ the role of educators in the community 
Module 3: 
• 
Talking to your son about sexual practice and relationships 
• 
Alcohol and drug prevention  
Module 4 
• 
Domestic violence prevention/Father as educator 
• 
Class Review 

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• 
Parents feedback and evaluation 
Health Promotion Control. Fathers randomized to the control group will receive a Health 
Promotion /Diabetes Prevention intervention guided by the CDC recognized Prevent2 
program.64 The diabetes prevention lifestyle program will be provided to the fathers in 
a secured link or website platforms accessible from a phone, computer, tablet or IPad. 
The session will be 1.5 hours approximately.  Session content will focus on the 
importance of   physical activity, healthy eating, and maintaining a healthy weight. 
Fathers will receive information to share with their participant sons and other family. 
The intervention will not include discussion on SAVA-related factors in the   population. 
Figure 1. Research Design [Noonly father participants in the interventions] 
 
Assessments.  Baseline data will be collected for fathers and sons in both the 
intervention  
and control group prior to initiating the intervention followed by a 6month 
follow-up assessment. During the time of social distancing data (for baseline 
or follow-up assessments) will be collected via telephone calls, FaceTime 
application, WhatsApp or other remote alternative venues. When CDC 
recommends that social distancing is no longer necessary, consenting and 
interviewing may be done by phone or face to face as per participant request. 
Survey data will be collected utilizing Apple iPad tablet computers and 
REDCap (Research Electronic Data Capture; survey and data management 
software). Pre- and post-test for the fathers will be collected using an 
interviewer administered assessment. Interviews are culturally congruent with 
our target population—given that some Latinos value personalismo, a cultural 
feature that values cordial interactions and interpersonal engagement.  
Interviewer-administered assessments will help mitigate any issues related to 
poor literacy. The interview with the adolescents will also be remotely 
administered at baseline and 6 months follow up, using a REDCap link sent 
to the participants accessible on their phones, computers, tablets or IPads or 
by telephone. Study staff will be available via telephone to assist adolescents 
in completing the assessment. Survey administration will take approximately 
1 to 2 hours for the fathers and 1 to 1.5 hours for the youth. 
Measures: 
The following table includes a list of the measures that will be utilized during the baseline 
and the 6-month follow up of the study: 
Table 1.  HoMBRES Measures 
CONSTRUCT 
MEASURE 
Tested Dyad 
Member* 
Risk and Protective Factors 
 

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▪ Culture-Related Risk/Protective Factors to be Considered in Cultural 
Tailoring of Interventions 
 
Cultural Values  
Gender Roles 
Culture-Related Stress 
Mexican American Cultural Values Scale  
Machismo and Caballerismo Scale  
Hispanic Stress Inventory 2; Hispanic  
Stress Inventory for Adolescents 
FY  
FY  
FY 
▪ Risk/Protective Factors that are Potentially Malleable Targets for 
Intervention 
 
Health Literacy 
Health Literacy Screening Questionnaire 
F 
HIV Knowledge 
HoMBRES Brief HIV Knowledge 
F 
Self-efficacy 
Questionnaire 
Self-Efficacy for HIV Scale 
F 
Attitudes about Sex 
Measure of Sexual Attitudes and Behavior FY 
Parent-Child Relationship 
Family Connectedness Scale 
FY 
Family Functioning  
Parental Monitoring; 
Parent-Child  
Communication 
Family Environment Scale Parenting 
Practices Scale 
FY  
FY 
Moderator Variables 
 
Demographics 
El Centro Demographics Form 
FY 
Neighborhood 
PhenX Toolkit Neighborhood 
F 
Disadvantage 
Concentrated Disadvantage 
 
Neighborhood Safety & 
PhenX Toolkit Neighborhood Scales: 
FY 
Support 
Collective Efficacy, Safety 
 
Acculturation 
Bidimensional Acculturation Scale for 
Hispanics8 
FY 
 
SAVA Indicators 
 
Substance Use/Abuse 
Timeline Follow-back 
F 
Trauma Exposure 
PhenX Toolkit Exposures to Violence; 
FY 
Psychological Distress 
Immigration Trauma Items 
Patient Health Questionnaire (PHQ9) 
F 
Sexual Risk Behavior 
PhenX Toolkit Sexual Risk Behavior 
F 
*Denotes whether measure will be given to Father (Y) and/or Youth (Y) among 
father-son dyad members 
Telephone contact assessment. There will be a telephone contact at 2-
3 months after the first session of the intervention in which a study team 
member will contact participant fathers. Some of the questions will be 
the following: 
1. How have you been in the last several weeks? 
2. Have you been talking to your son about any issues 
related to the program? 
3. Has there been any changes in your living 
arrangements? In your family? 

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4. Have you been working in the last month? 
5. Are you planning to move soon? 
6. Have you shared any information from [the intervention] 
with anybody among your family or friends? 
11) Data and Specimen Banking* 
Not applicable 
12) Data Management* 
All paper data will be kept in locked file cabinets in locked project offices at  
FIU and will be accessible only to study staff. Staff from the Integrated 
Biostatistics and Data Management Center at FIU will develop and test all data 
collection and quality control processes and create a REDCap database. 
Access to REDCap is secure, and all data will be backed up within a secure 
data center (see Facilities    and Other Resources). 
Quality control will be enhanced through REDCap’s built-in quality checks and 
mechanisms to detect inappropriate values on questionnaire items. The 
project statistician will work closely with study staff to export the REDCap 
data to statistical analysis software loaded on the project’s HIPAA-compliant 
computer. All audio recordings will be transferred to a computer, transcribed 
verbatim, entered into standard word processing files, and verified. De-
identified qualitative data in the form of transcripts will be returned to the 
Project Lead (Dr. Rojas) and Co-Lead (Dr. Sanchez) by the transcriptionist on 
a regular basis and kept in locked file cabinets. Audio files will be deleted 
from the digital recorder immediately after successful download. The files will 
be converted into data files compatible with Atlas.ti. Focus groups and 
interviews will be transcribed and translated by trained bi-lingual study staff or 
through an IRBapproved transcription service. 
Qualitative Data Analysis Bilingual coders will transcribe in-depth interviews (IDIs) and 
focus groups (FGs) in the language in which they were conducted. For the focus groups 
and in-depth interviews, we will use a constant comparison analytic strategy; we will 
develop a preliminary codebook after reviewing the first transcript. Two independent 
coders will code each text segment and compare coding, discussing and resolving any 
areas of discrepancy. Disagreements will be discussed until consensus is reached. 
Although this analytic approach is time consuming, its implementation will help minimize 
coding bias. The primary codes identified across the focus groups and moderator notes 
will serve as the basis for the textual content of the new intervention. 
Quantitative Data Analysis Plan In testing the efficacy the HoMBRES de Familia 
intervention, we will utilize a 2-arm RCT employing intent-to-treat analysis using the 
initial group assignment, without considering the number of sessions that participants 
attend. We will run descriptive analyses at baseline for sociodemographic variables 
including age, country of birth, education, income, and marital status, and assess the 
differences between intervention group and control group at baseline using t-test for 
continuous variables and Chi-square test for categorical variables. We will test the 
efficacy of the intervention on individual outcomes (substance use, family violence, HIV) 
to examine how each component of the SAVA syndemic was independently impacted. 
We will use linear mixed model for continuous outcomes and generalized linear mixed 
model for categorical outcomes at follow-up, while adjusting for baseline measures, 
sociodemographics, and potential cluster effect among groups in intervention group 
and father-son dyads. 

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13) Provisions to Monitor the Data to Ensure the Safety of Subjects* 
All aspects of the Research Project implementation will be governed by Research  
Project Lead (Dr. Rojas) with assistance of Project Co-Lead (Dr. Sanchez) or Project 
Coordinator (Mrs. Canedo) under the monitoring of the Protocol PI (Dr. Behar-
Zusman, formerly known as Dr. Mitrani). Data quality assurance procedures will be 
done by a trained staff member. Researchers will monitor and follow-up and report as 
required suicidality ideation and child as well as elderly   abuse. 
The study will be monitored by the CLaRO Study Monitoring Unit which is 
based at the UM School of Nursing and Health Studies.  The Study Monitoring 
Unit   will (1) verify compliance with regulatory requirements, (2) ensure that the 
Project Leads and staff (including those at community agencies) are fully 
informed of regulatory requirements and properly trained to perform the duties 
assigned, and (3) monitor procedures to prevent errors and minimize protocol 
deviations that can negatively affect quality of the data collected and 
compromise human subjects’ protection. The project will have a quality 
assurance (QA) review: prior to initiation, upon conducting baseline procedures 
with the first wave of study participants; and bi-annually for interim reviews. 
Adverse Events and Serious Adverse Events (AE and SAE): The Project Lead and 
protocol PI will be responsible for monitoring and reporting and comply with the 
reporting requirements of the IR B and NIMHD. The Data and Safety Monitoring plan 
will have required reports will include any adverse events as well as the results of 
analysis conducted.  The PI and Project Lead will ensure that any AE or SAE are timely 
reported to the IRB. 
During the study implementation, we foresee that they may be certain events with the 
families such as: 1) domestic violence; 2) work contract was terminated and participant has 
to move to another city; 3) entire family is moving to another estate; 4) father moved out of 
the home; 4) father was kicked out of home. 
Among the Serious adverse events (SAE) we may encounter: 1) physical abuse  
with partners and adolescents, 2) hospitalization, 3) substance abuse. 
All assessments conducted by the study’s interviewers are opportunities for identifying 
adverse events if reported by the participant and/or a family member. The educators 
will be trained to identify AEs and SAEs at session of the intervention and at each 
interview or assessment points.  Additionally, anytime during the study, a participant or 
his/her family member may report an AE/SAE to their group facilitators/educators. 
These events will be identified, classified as serious or not, and will be handled in the 
same manner as AEs/SAEs during the formal assessments. 
Study personnel (including peer advocates) will be trained to identify adverse events, 
and categorize serious adverse events, based on direct reporting during sessions. 
Upon identification of an adverse event, the team member should notify the study 
coordinator who will assess the event for seriousness to guarantee that appropriate 
care and reporting occur within approximately 24 hours. As soon as an adverse event is 
identified either by querying or direct report, the event will be recorded in the AE log.  In 
addition, the Project Lead (Dr. Rojas) or Co-Project Lead (Dr. Sanchez) or Project 
Coordinator (Mrs. Canedo) will be notified of any and all AEs. In both treatment 
conditions, action   may be taken by the peer advocate to respond to non-serious 
events (e.g., referral to counselor, community program, local agency or hospital).  The 

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Project Lead or CO- Project Lead are responsible for conducting further evaluations 
and completion of the AE log. 
In addition to the SAE’s listed above, SAEs will include all issues that involve imminent 
danger to self or other. In cases of current suicidal, homicidal, and abusive behaviors, 
participants in both conditions will be immediately referred to the Open-Door clinic or to 
the local emergency room in order to ensure that appropriate crisis intervention 
services are provided. The reporting procedures for SAEs experienced by any 
participant in the study will be in accordance with the UM IRB reporting policy. When an 
SAE occurs, the Project Lead and the PI must be notified when possible within 2 hours 
of identification.  The PI, in consultation with the Project Lead will be responsible for 
assessing   relatedness to the intervention and forwarding the report to the UM IRB and 
NIH as required. 
Safety will be assessed using two principal Safety Assessment Strategies: (1) incident 
and adverse event monitoring through a passive system, which will entail reporting 
using a form that details the various reportable event categories, and an (2) active 
system, whereby Dr. Rojas will, on a weekly basis, determine if any reportable events 
occurred. The events reportable through the active and passive adverse event 
monitoring system include: (a) unauthorized disclosures or breaches of confidentiality; 
(b) threats or acts of violence or self-harm; (c) acts of negligence and violence against a 
minor or an elderly person. Interviews with participants will ensure the report of suicidal 
ideation, family violence, or other sentinel events. 
14) Withdrawal of Subjects* 
Subjects may choose to withdraw from the study at any time. We will discontinue data 
collection on the withdrawn subject and will use the partial data collected with 
participant’s permission. Participants will be told that their participation in the study 
may be stopped at any time by the investigator without their permission. Subjects will 
be withdrawn by the PI (in consultation with the Project Lead) if their safety is 
endangered by attending the intervention groups. Reasons for withdrawal may be if 
the participant appears to be extremely distraught by the discussion in the group 
sessions or if the participant threatens to harm himself or others. 
15) Risks to Subjects* 
Overall, data collection and intervention in the HoMBRES study presents minimal risks 
for participants. All of the steps that may be taken to protect the well-being of    
participants or their family members deemed to be in danger will be described fully to 
all participants and we will do everything possible to minimize harm to the youth, family 
or any of its members. The following are possible risks for the participants divided by 
the study’s aims: 
Aim 1: During the focus group sessions, participants might reveal highly sensitive 
information regarding their substance use, sexual behavior, and HIV status; there is a 
potential risk for breach of privacy and confidentiality regarding these sensitive topics. 
There is also a risk that some questions may distress the participants. In order to 
prevent those risks, all participants will be briefed on the issues of   confidentiality. 
Participants will be asked to avoid using their names or naming others and will be 
asked to maintain the confidentiality of other focus group members. Identifying 
information will be redacted from transcriptions. 

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Aim 2: No side serious side effects have been noted in the current literature in 
association with the behavioral questionnaires, interviews, and interventions used in 
this study, although, as with many assessment batteries, some people may experience 
mild fatigue or momentary concern about their ability to do well. Although there are no 
specific questions regarding abuse and neglect of minors or elderlies in the baseline or 
posttest assessments, there is a risk that participants disclose abuse and other 
reportable behavior during the assessments or during the interventions.  Interviewers 
will be trained to identify cases of child and elderly abuse (sexual, physical and 
emotional). 
Training will include providing them with a battery of the appropriate questions to ask 
participants when they report physical punishments, negligence, or sexual abuse. 
Participants will be reassured that their confidentiality is safe and will be informed that 
due to federal regulations and Florida statues we are mandated reporters. 
Interviewers and facilitators are informed also that an incident report needs to be filed 
within 48 hours. 
There is a risk that some of the questions may distress the participants. Adult 
participants will be asked to provide information about highly sensitive topics such as 
substance use, sexual behavior, and HIV status.  The measures with sexual or 
substance use questions completed by the youth are gated so that children to limit 
their exposure to sensitive topics. 
During the intervention participant may feel shy or may not feel comfortable talking about 
certain taboo issues.  Additionally, by participating in this research project, participants 
may become aware of or sensitized to their HIV risks, family violence, risk for a substance 
use disorder or other health risks. In order to decrease feelings of comfort, participants 
will be told to speak in a third   person. 
Providing incentives to participants may inappropriately persuade them to participate in 
research— pressure that may meet criteria for coercive recruitment, especially because 
most of those who will participate in the proposed Research Project are persons of very 
low income. 
There is a potential risk for a breach in data security that may infringe on the 
participant’s privacy and confidentiality regarding these sensitive topics. As an NIH 
sponsored study, the study will automatically be issued a Certificate of Confidentiality. 
Participants will be made aware that there could be a breach of confidentiality by other 
participants who might be aware of their participation in the study, given the sampling 
methodology. However, they will be assured that no data will be linked to their 
personal information. 
Aim 3:   The specific procedures for Aim 3 are to be determined 
16) Potential Benefits to Subjects* 
Aim 1: There are no direct benefits to participant, however participants may 
occasionally experience a sense of relief or satisfaction discussing barriers 
that they face in the community. 
Aim 2: Benefit participants may receive is referral to services as needed. Participants 
randomized to the HoMBRES intervention may increase their skills of communicating 
with their adolescent sons and their knowledge about HIV, substance abuse and 
domestic violence. Participants randomized to the control intervention may increase 
their knowledge about health promotion and diabetes prevention. 

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Aim 3:   We do not anticipate direct benefits to participants; however, the community at 
large may benefit from learning about an intervention for Latino parents that may help 
men and their sons. Participants will be able to share the results of the intervention with 
other members of their community and advocate for similar programs from local 
agencies. 
17) Vulnerable Populations* 
The youth (ages 11-17) who will participate in this study will be required to have 
their parent/legal guardian consent to participate and additionally will meet the 
regulatory requirements described in the HHS regulations, Subpart D. All the 
consent and assent forms will be submitted to the UM IRB for review and 
approval. All the adolescents will sign an IRB approved assent form before 
participation. 
The proposed study aims at increasing education and HIV prevention skills 
among adult men and their adolescent sons, therefore, including youth in the 
assessment portion is critical for testing the effectiveness of the study. 
The intervention HoMBRES was developed for farm working men, a socio- 
economically vulnerable population, and therefore the researchers will take all 
the necessary precautions to ensure confidentiality and avoid coercive 
approaches. The entire research team has conducted various NIH funded 
studies and a couple of interventions for this vulnerable high-risk minority 
population. 
Participants will be explained the consent and assent forms in order to ensure 
that they understand the protocol and will be encouraged to ask questions. 
Aim 2: Participants will be encouraged to ask questions during the interventions 
and will be asked to provide feedback regarding their experience as well as 
evaluating the sessions. Sessions will be randomly supervised for quality control 
during the duration of aim 2. 
18) Multi-Site Research* NA 
19) Community-Based Participatory Research* 
Researchers will be working with various community organizations such as the  
Farm Workers Association and the Coalition of Florida Farmworkers   
Organization (COFFO) to recruit and facilitate interventions. These community 
partners will help us recruit participants for the focus groups which will guide 
the adaptation of the intervention 
Partners from the community will be asked to provide feedback about the 
intervention during the CAB meetings. 
20) Sharing of Results with Subjects* 
Under Aim 3, dissemination of the study findings will be accomplished in close 
collaboration with the Community Engagement and Dissemination Core of CLaRO 
(parent NIH contract for this study). 

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Strategies for providing relevant information to the LSFW community: Under Aim 3 
dissemination strategies will be performed in areas where LSFWs gather, socialize, and 
celebrate. In MDC, this includes local flea markets, recreational parks, Latino festivals, 
health fairs, and places. Dissemination activities will include: (a) Presentations to 
community stakeholders and service providers involved in addressing substance 
abuse, family violence, and HIV/AIDS in the local community, and (b) Distributing 
information to the local community via informational booths at local health fairs and 
ethnic festivals. 
21) Setting 
Procedures for Aims 1 and Aims 2 will be provided in private community settings including 
the COFFO offices as well as the Everglades Community Center and Redland farm camp 
community center or other locations in the urban, semi-rural areas of Homestead, 
Naranja and Florida City or other locations within walking distance or short drive of 
participants homes. During the COVID-19 Pandemic, procedures of Aims 2 will be 
conducted remotely as described above. Once dyads are interviewed, they will be sent 
a private link with the video sessions based on the group randomization. This approach 
will help us avoid delays between recruitment, randomization and intervention delivery. 
Interventions will be facilitated via a secured link. The webinar style video will be solely 
available to participants using a private link (ie. Zoom, youtube, powerpoint and other 
venues available to the participants). These venues can provide privacy and 
confidentiality.  
Incentives for participation will be delivered by money order, electronic cash deposits or 
payments such as Zelle or another electronic platform preferred by participants   
It should be noted that participants in this study are of very limited financial means and 
may not all have access to platforms used at UM (e.g., Zoom), furthermore, we are trying 
to use means of communication that participants are accustomed to. We will have to 
assess their technology and will proceed accordingly, using the UM platforms as first line, 
but may need to use other means of communication and transmission as per participant 
access.  
22) Resources Available 
This project is being conducted as part of the Center for Latino Health Research 
Opportunities (CLaRO), which is funded by the NIMHD under a U54 contract. CLaRO is 
led by Drs. Victoria Behar-Zusman (UM PI) and Mario de La Rosa (FIU PI). CLaRO is a 
cross-institutional partnership rooted in shared commitment of UM and FIU to address 
ethnic/racial and sexual/minority health and health disparities through research and 
community engagement, and commitment to nurture the careers of the next generation 
of health disparity scientists. The PIs have decades of experience as health disparities 
researchers focused on Latino populations and as mentors dedicated to diversity in the 
scientific workforce; they share a common vision for the mission of CLaRO. Dr. Behar- 
Zusman is researcher in family-based behavioral interventions, family process and 
measurement with families of adolescents, women, and seniors, and with extensive 
experience in regulatory, research conduct, and human subjects’ oversight. Dr. De La 
Rosa is a researcher in substance abuse and HIV with recent Latino immigrants, Latina 
mother-daughter dyads, and Latino seasonal migrant workers—including the 
development of HIV prevention interventions targeting the HIV risk behaviors of Latina 
seasonal migrant workers. Dr. Behar-Zusman will serve as the protocol PI. Resources 
of CLaRO that are available to this study include the Administrative, which will provide 

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assistance for monitoring of human subjects’ protection, quality assurance, measures, 
and research administration, and the Community Engagement Core which maintains a 
CommunityScientific Advisory Board, which will be instrumental in Aim 3 of this 
protocol. 
The study team qualifications: 
Dr. Rojas – Project Lead 
Dr. Rojas has several years working in the field of health disparity with the target 
population in the current study. She is knowledgeable about the community and the 
HoMBRES study is a progression of a past study targeting adult women. Dr. Rojas is a 
bilingual and bicultural researcher who has experience in data collection, community - 
based research and interventions with LFWS. Dr. Rojas has supervised intervention 
studies and has worked with adolescent studies in the past. Dr. Rojas research aims to 
understand health behaviors among Latino adults, family health correlates related to 
health behaviors. 
Dr. Sanchez – Co-Project Lead 
Dr. Sanchez has been a contributing to the data collection instruments for Dr. Rojas’ 
studies and also has assisted in the translation and backtranslation of instruments 
and consent forms for several studies in the past. Dr. Sanchez is an avid researcher 
who has been working in health disparity for the last decade. Dr. Sanchez has 
extensive experience in establishing good working relationships with referral 
sources and other community partners. 
Dr. Cano – Co-Investigator 
Dr. Cano’s research focuses on Latino adolescent health behaviors and family function.  
He has published extensively on the role of family attachment and family functioning on 
Hispanic adolescents. He has conducted preliminary studies on recent born in the 
community as well as adult women. His research aims to reduce health disparity among 
Latinos in the areas of mental health and substance   abuse. 
Marisabel Canedo- Project Coordinator 
Mrs. Canedo has experience coordinating longitudinal studies at University of 
California, Los Angeles and University of Miami. She is bilingual and has worked 
in several studies as group facilitator, community recruiter, interviewer with the 
Latino communities in Los Angeles and Miami. Mrs. Canedo will provide support   
to the project lead and co-leads, will oversee the administration of protocol for 
data collection in Aim 1 and Aim 2, will be back up for interviews and will conduct 
daily administrative duties. 
Maria Khalona - Community Researcher 
Ms Knalona has extensive experience conducting studies in the target 
community.  She will be in charge of building rapport with community leaders and 
assisting in the recruitment and retention. We anticipate that recruitment of the 
target sample will be feasible given that accessibility to the sampling frame 
should be more than sufficient. As with most LSFW communities, most seasonal 
farmworkers in MDC are males. In addition, our community partner provides 
many adolescent-centered programs in the LSFW community. Ms. Khalona is 
working closely with three group facilitators and outreach workers. 

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Selection, training, and supervision of research staff: Research staff on the protocol are 
experienced in research with the Latino community and Latino males and will be trained 
in all relevant aspects of the protocol. 
23) Prior Approvals 
FIU has authorized the UM IRB to be the IRB of record for this study 
24) Recruitment Methods 
As described in section 7, participants will be recruited through a variety of methods 
including word of mouth, flyers, radio add, community agency collaborators as well as 
active outreach in the different activities in the community. 
25) Local Number of Subjects 
Aim 1: Sixty-eight (N=68) participants will be sampled in the focus groups (n=48) 
and the interviews (N=20). 
Aim 2: The total number of subjects in the intervention will be 320 (160 father/son 
dyads). 
Aim 3:  To be determined 
26) Confidentiality 
The issues surrounding confidentiality are of supreme importance and sensitivity 
because highly personal clinical information will be obtained from the fathers and 
adolescent sons in Aim 2. Adult participants will provide written consent attesting 
consent to their understanding that the information they provide will be held as 
personal and confidential to the extent permitted by law. Youth will provide written 
approval to the assent form that explains the limits of confidentiality. Consent and 
assent forms will clearly state the right to refuse participation at any time. Further, the 
refusal to participate will not influence any of the services the adolescent or his/her 
family may receive. In addition to the confidentiality assurances, the participants in the 
study are protected by a Certificate of Confidentiality under section 301(d) of the 
Public Health Service Act (42 U.S.C. 241(d), authority delegated to the National 
Institutes of Health (NIH). 
Regarding data and other records confidentiality, researchers will follow the UM 
established set of procedures designed to ensure the protection of confidentiality. All 
project staff will be specifically trained on issues of confidentiality. Due to the use of the 
web-based REDCap system we anticipate that there will not be any hard copies of data 
and all the documents pertinent to the study such as consent forms and contact 
information will be stored in a locked cabinet at the FIU Center for Research on US  
Latino HIV/AIDS and Drug Abuse (CRUSADA) offices overseen by CLaRO PI, De La  
Rosa and protocol lead, Dr. Rojas.  Passwords are used to restrict entry into the    
REDCap database.  There will be very few documents with identifying information 
(consent forms) and all documents with identifying information will be stored at the in 
locked file cabinets within a locked office in the PI office and the project director’s office. 
It should be noted that in our years of clinical research (over 14 years), not a single 
incident of violation of confidentiality has occurred. 
The technology system that will be used in the study will collect usage data that will be 
securely housed on the project servers. Data will be collected without requiring that the 
participant actively send them. Data collected in real-time do not contain names or 
identifying information, only case numbers. In addition, the system will require a 

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password to see messages sent to the participant. Physical access to servers at the 
Data Center are controlled by security systems, intruder alarms, and monitored by the 
Department of Security video surveillance/recording systems. At FIU, the Data Center 
provides appropriate environmental control via HVAC systems, uninterruptible Power 
Supply and emergency generators to maintain power without interruption, The Data 
Center also provides secure backup for all data systems. 
The study will be monitored by the CLaRO Study Monitoring Unit which is based at the 
UM School of Nursing and Health Studies. The Study Monitoring Unit will (1) verify 
compliance with regulatory requirements, (2) ensure that the Project Leads and staff 
(including those at community agencies) are fully informed of regulatory requirements 
and properly trained to perform the duties assigned, and (3) monitor procedures to 
prevent errors and minimize protocol deviations that can negatively affect quality of the 
data collected and compromise human subjects’ protection. The project will have a 
quality assurance (QA) review: prior to initiation, upon conducting baseline procedures 
with the first wave of study participants; and bi-annually for interim reviews. 
27) Provisions to Protect the Privacy Interests of Subjects 
As explained previously, interviews will be done in a private setting chosen by 
the participant. Data will be entered to RedCap in a password protected IPad. 
Data will be only available to researchers approved by the IRB and to the study 
monitoring unit.  Participants will be reminded of their ability to stop the 
interview   or refuse to answer questions that make them uncomfortable. 
During the recruitment and consent/assent process, and prior to any data 
collection, participants will be assured that their information is confidential, and 
will only be accessed by study staff members. As described above, participants 
will sign a statement attesting to their understanding that their information will 
be kept private and confidential to the extent permitted by law. Participants 
know that they will be assigned unique case numbers (and that their names will 
not be used) to protect their identity. For telephone data collection, participant 
will be asked to choose a quiet and private area where he can answer 
questions while keeping confidentiality. Whenever, possible and as per 
participant preference, he will be interviewed via videoconference to increase 
the rapport and ensure privacy.    
28) Compensation for Research-Related Injury 
N/A 
29) Economic Burden to Subjects 
Aim 1: Participants may incur costs associated with transportation to and from 
intervention sessions. However, most participants will live within walking distance to 
the program location. Participants will be compensated to offset their expenses.  
Aim 2: We do not anticipate that the participants will endure any financial cost as the 
recruitment, consenting, and intervention will be provided using digital venues and 
participants will be able to complete the study from their homes. To further prevent 
participants’ financial burden, we will suggest free telephone applications such as 
WhatsApp. When the CDC recommends that social distancing is no longer 
necessary, consenting and interviewing may be done face to face as per participant 
request. Additionally, when social distancing restrictions are no longer active, UBER 
services would be available for participants who report transportation difficulties to 
get to interviews.  

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FIU entered into an agreement with Uber Health to help with transporting research 
participants from their homes or work or preferred location to the research sites and return. 
According to Uber Health, they take healthcare patient and confidentiality seriously and 
already treat research participants in the same manner. To handle Protected Health 
Information (PHI) with appropriate care, they’ve built HIPAA compliance into Uber Health 
from the ground up. According to Robert L. Chaput, CEO Clearwater Compliance, “In June 
2017, we conducted a HIPAA Risk Analysis of the technical, physical, and administrative 
controls related to Uber Health’s new dashboard and technology. Our team concluded that 
Uber Health has an unusually robust security environment involving numerous information 
security safeguards.” Uber Health states that they have a HIPAA-trained Uber Health team 
dedicated to building technology for healthcare and that rider information is encrypted as 
a safeguard for handling PHI when ordering rides for participants. Uber signed a Business 
Associate Agreement (BAA) with FIU and under the BAA, Uber is committed to performing 
steps, which safeguard and protect PHI. When a driver receives an Uber Health trip 
request, it is indistinguishable from any other type of Uber request to protect patient 
privacy. 
The internal infrastructure of the Uber's data storage: 
"Uber Health applies an information security defense-in-depth strategy where layers of 
technical and administrative controls are deployed and then validated by user access 
and activity reviews, alerting, deployment of near-universal two- factor authentication, 
and use of encryption. Ongoing monitoring provides reasonable assurances that only 
authorized users have access to the Uber Health environment. Uber Health and Uber 
Technologies have implemented numerous information security safeguards that are 
considered industry best practices, including but not limited to: authentication, 
password management, expiring certificates, imaging, encryption, internal monitoring 
and reporting, role-based access and disaster recovery. Uber Health’s ePHI is stored 
within a reputable, HIPAA-compliant thirdparty cloud environment to which physical 
access is highly restricted and monitored, and in transit ePHI in the Uber environment is 
subject to encryption and strict administrative and technical controls." In addition, Uber 
has controls in place to make sure only the necessary individuals within FIU can see 
participants’ information. Administrators and billing contacts will only receive a sum total 
of the money spent on rides and a transaction list of each ride leading up to that 
amount.   The coordinators within FIU who are arranging the rides would only be able to 
see the rides they order themselves and not of others. 
30) Consent Process 
Aim 1: All participants will provide their consent (or assent as applicable) prior to 
participating in the interviews and focus groups. Participants will be given a consent 
(or assent) form which will be read to them by a study team member in their preferred 
language (Spanish or English) as some of our participants have a very low literacy 
level. The consent process will either take place in a group or individual format. 
Participants will be encouraged to ask questions regarding any aspect of the study 
and the study personnel will answer these questions.  Participants will keep a copy of 
the consent/ assent forms. 
Aim 2. After potential participants are identified and screened, a meeting will be 
scheduled with the father-son dyads to complete informed consent/assent 
procedures and baseline assessments. Fathers and adolescents will be read the 
consent/assent forms for the reasons explained previously. Participants will be 
encouraged to ask questions regarding any aspect of the study and the study 

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personnel will answer these questions. Once all questions are answered the 
participants will be asked to provide written approval to the consent/assent form. 
Once the minor turns 18 years old, a new consent form will be read and requested to 
provide written approval by such participant. In cases where the adult male (father) 
is not the legal guardian, written consent from the child’s legal guardian will be 
required in addition to assent from the adolescent. 
As result of the social distancing recommendations, eligible participants will be 
contacted via telephone, FaceTime apps, WhatsApp, telephone or video call to read 
the consent form. Consent will be read to eligible participants over the phone with 
two staff members present (one listening on the speakerphone who will sign as a 
witness to the consenting). The participant will also be given the option of having a 
witness on his side of the phone. If a potential participant agrees to participate in the 
study, he will provide verbal consent which will have the signature of the staff 
obtaining the consent and the witness.  Then 2 copies of the consent with signatures 
will be emailed, texted or mailed as per participant choice of delivery. This will be sent 
with a stamped return envelope for the participant to sign and return to the research 
team. The same procedure will be used for the consenting of the legal representative 
and the assenting of the youth. Father-son dyads interviews (time and date) will be 
scheduled simultaneously, and they will be interviewed via phone separately in order 
to maintain confidentiality. A staff will conduct the interview with the father using any 
available venue for the participant (Phone or video conference). Since the 
adolescents are self-administering the questionnaire, they will receive a RedCap link 
to the questionnaire on their telephone, computer, tablet or IPad so they can respond 
to the measures. The adolescents will also be given the option of phone interview. A 
staff member will be available to guide the adolescent as well as answering any 
questions and ensuring completion. When CDC recommends that social distancing 
is no longer necessary, consenting will return to face-to-face process, however the 
interviewing may be done face to face or via phone as per participant’s request. 
Participants already enrolled in the study prior to the social distancing requirement will 
be informed of changes to the protocol with a consent addendum which will be shared 
with them via telephone or web, depending on modality we are using with that 
participant.  
Non-English-Speaking Subjects 
For all aspects of this study, we will defer to language preference of the participants. 
The explanation of all aspects of the study (forms, procedures, measures and 
interventions) will all be available in either Spanish or English. Data analytic 
discussions and all reports will be in English.  Back translations, whenever 
appropriate, will be conducted. Quantitative surveys will be conducted by the bilingual 
research team and staff in the preferred language of the participants (English or 
Spanish). We anticipate that survey protocols will be administered in Spanish for 
parents and English for the adolescents. Trained coders will transcribe interviews and 
focus groups in the language in which they were conducted. Data collected in 
Spanish will be coded using the codebook described below. We will construct the 
instrument in Spanish and will analyze the transcripts from each session in the 
original language to avoid second and third order level analysis. The HoMBRES de 
Familia Research Project will communicate with the male Latino farmworker 
population in a language that speaks to them—from a cultural and social perspective. 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves deception) 
• 
NA 

Study#: 20170769        Effective Date: 4/12/2020 
IRB Study Number: 
Version HoMBRES de Famlia (HoMBRES) #1  
 
 
Page 23 of 23 
Revised: March 23, 2020 
Cognitively Impaired Adults 
• 
NA 
Adults Unable to Consent 
• 
NA 
31) Process to Document Consent in Writing 
We are requesting a waiver of signed consent/assent for Aim 1 as the procedures are 
of negligible risk and signing forms can be anxiety-producing in this population due to 
uncertain immigration legal status. 
Written approval to the consent/assent will be collected for Aim 2, except for the  
modification described above for purpose of COVID-19 social distancing. After the 
study is explained and the participant verbally indicates that he understands, 
participants will provide written approval and date 2 copies of the consent or assent 
(youth) form. The research staff or interviewer will co- sign the forms. The participant 
will be given one copy of the signed consent form for his records, and the second copy 
will be stored in a locked cabinet at FIU offices. 
32) Drugs or Devices 
NA