CRISOL: Building Community Resilience and Integrating Efforts to Understand and Address Syndemic Health Conditions Afflicting Young LatinoImmigrants
Phase: NA
Conditions: Covid19, Mental Health Issue, Violence
Sponsor: Drexel University

CRISOL Contigo: a Multi-level Intervention to Reduce the Disproportionate Toll of COVID-
19 Among Latino Communities in Philadelphia. (CRISOL Contigo) 
 
 
 
 
 
 
 
Ana Martinez Donate,  
Professor of Community Health and Prevention, Drexel University 
 
 
 
ClinicalTrials.gov Identifier: 
NCT04646616      
 
Other Study ID Numbers: 
3R21MD012352-02S1 ( U.S. NIH Grant/Contract ) 
 
Date: 03.25.2020 
 
 

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
 
 
Proposal: 
1) 
Protocol Title: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
2) 
IRB Review History: 
Considering that our initial exit interview was design to ask about a 1-year intervention 
focus on a different topic, we are submitting a more complete instrument that focuses on 
COVID-19. Finally, we are requesting to add a new member to our study.  
 
Past modifications have been made to reflect COVID-19 recommendations. We requested a 
modification to our protocol to hold our biweekly intervention sessions via Zoom and to 
extend data collection efforts to on online or phone format in order to minimize spread of 
the virus. To reflect these changes we also requested changes to our dispersal of incentives, 
to allow for alternative modalities that do not require meeting face to face with participants. 
In June, we submitted a modification to expand the outreach in the community for 3 more 
months (until end of September 2020). We requested a modification to extend our project 
for a second year and submitted all necessary materials. 
3) 
Objectives: 
The purpose of this study is to implement an additional module related to COVID-19 to our pilot 
peer-driven intervention that seeks to address a cluster of health issues that have been shown to 
impact Latino immigrant communities. These health problems include Substance Abuse, 
Violence exposure, HIV/AIDS, and Mental Health (SAVAME). These conditions represent a 
syndemic because they act synergistically, and stem from multiple, common social and 
environmental determinants. The Cultivating Resilient and Strong Opinion Leaders (CRiSOL) 
intervention aims to reduce the impact of the SAVAME syndemic and COVID-19 among Latino 
immigrants in Philadelphia by integrating a community resilience and opinion leader framework.  
The specific aims of the pilot study are: 
1. To adapt and integrate two interventions previously implemented by our 
community partners in order to develop a new intervention to reduce the impact 
of the SAVAME syndemic among Latino immigrants in Philadelphia, with 
emphasis on changing social norms, promoting utilization of SAVAME-related 
health, behavioral, and social services, and promotion of individual and 
community resilience. 
2. To recruit and train a small sample of peer leaders and implement the Creating 
Resilient and Strong Opinion Leaders (CRiSOL) pilot intervention in Philadelphia 
communities where Latino communities concentrate. 
3. To test the pilot intervention using a comprehensive evaluation framework to 
generate feasibility, acceptability, and pilot efficacy data that will inform a future 
R01 application proposing an effectiveness trial of this intervention.  
4. Include an additional 16-hour module related to COVID-19 to our previous 
implemented pilot. 
 

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
4) 
Background: 
Project CRiSOL will incorporate resilience training with an established peer-driven intervention 
framework in an effort to address the health disparities that exist among Latino immigrants. 
CRiSOL focuses on a set of four inter-related syndemic conditions among Latinos: substance 
abuse, HIV, domestic violence and mental health. During the second year, we will focus on 
COVID-19. 
This project focuses on Latinos, the nation’s largest racial/ethnic minority group in the U.S.2 due 
to the mitigating social factors that they experience: 1 in 3 adults has not completed high school, 
1 in 4 lives in poverty,15 1 in 4 is uninsured,16 and half experience discrimination and prejudice.17 
These social disadvantages result in health disparities, including a disproportionate impact of 
HIV, substance abuse, mental health problems, violence; and most recently, COVID-19. 
Latinos represent 17% of the U.S. population but they make 21% of new HIV infections and 
have a diagnosis rate 3 times that of non-Hispanic Whites (NHW).18 Latinos are also diagnosed 
later19 and have lower rates of viral suppression than their NHW counterparts.20 The disparities 
extend to other STIs. For example, rates of chlamydia, gonorrhea, and syphilis are 1.8-2.2 times 
higher for Latinos compared to NHW.21  
Alcohol and substance abuse levels among Latinos are comparable to or greater than in other 
groups, but there are notable disparities in access, quality of care, and adherence to substance 
treatment among Latinos, calling for evidence- based and culturally responsive strategies to 
minimize these disparities.22  
About 28% of Latino men and 30% of Latinas will develop a psychiatric disorder over their 
lifetime.
11 Latinos have the second highest rate of severe depression, the highest rate of moderate 
depression,23 and more signs of anxiety than other groups.24,25 Yet, this group is less likely to 
seek mental health care and shows lower rates of anti-depressants or anxiety- reducing 
medication utilization compared to NHW.26  
Latinos also experience a greater burden of violent victimization compared to NHW.27 Although 
levels of intimate partner violence (IPV) do not differ much between Latinos and other groups, 
socio-economic conditions, cultural beliefs, and immigration-related factors perpetuate and 
exacerbate the impact of IPV among Latinas.28  
This study focuses specifically on immigrants because migration is a social determinant of 
health.1 About 48.7% of Latino adults in the U.S. were born in another country,2 representing a 
particularly vulnerable population who faces additional disparaging barriers to health and health 
care, including poorer working conditions, acculturative stress, and discrimination.3,5,29 For 9 
million Latino immigrants,6 undocumented status further limits access to services, education and 
work opportunities.  
HIV, substance use, violence, and mental health have an even greater impact on Latino 
immigrants. Immigrants account for 43% of new HIV diagnoses in Latinos,30 are at increased 
risk of delayed HIV diagnosis and late presentation to care, and have shorter survival compared 

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
to non-immigrant Latinos.10 Studies, including some by our own team, have shown high rates of 
STIs, sexual risk behavior, and substance abuse, among Latino immigrant samples31–33 and 
indicated a negative impact of migration to the U.S. on these behaviors. Cumulative exposure to 
U.S. society and higher acculturation increase the risk for substance use34 and psychiatric 
disorders.11 Immigrant women experience higher rates of IPV35–38 and are less likely to seek 
services than native populations.9  
Changes in immigration policies and enforcement practices, possible undoing of Obamacare, as 
well as growing anti-immigration sentiments will likely exacerbate health disparities experienced 
by Latino immigrants over the next four years. President’s Trump threat to defund Sanctuary 
Cities, like Philadelphia, can have profound effects on vulnerable communities and, especially, 
immigrant populations. The evolving socio-political climate is expected to translate into an 
increase in prevalence and less access to services,39 especially for stigmatizing conditions and 
behaviors such as HIV/STIs, substance use, mental health, and violence victimization. Research 
to identify effective strategies for their prevention and treatment and to promote resilience 
among immigrant populations is timely and more relevant than ever.  
Project CRiSOL focuses on a syndemic of health  factors, instead of just one factor since the 
syndemics conceptual framework is gaining ground in public health and health care delivery.40 
Syndemics theory compels us to try to understand how different health problems “interact 
synergistically” within a community, identify risk and protective factors that connect them, and 
develop integrated interventions to simultaneously address these concomitant health problems 
and their shared social determinants.41As stated in the Lancet’s Syndemic Series, a syndemics 
approach is a notable conceptual instrument in population health science42 and can be used to 
tackle health inequities in a comprehensive and effective way.40  
A syndemic model of substance use, HIV/AIDS, violence, and mental health (SAVAME) has 
been established among Latinos. 14,43–45 The adverse interaction of the SAVAME factors is well 
documented. Limited access to HIV treatment augments the physical and mental health impact 
and perpetuates transmission of HIV. Substance abuse increases the risk for HIV/AIDS,46 poor 
mental health,47 and violence victimization.48–50 Mental health conditions can lead to drug 
addiction,51 violence,52 and HIV risk behavior.53 IPV is a risk factor for HIV infection and a 
cause of stress and trauma.54 However, despite evidence of these synergistic interactions, these 
problems continue to be tackled separately.  
Evidence on effective strategies to curb the SAVAME syndemic afflicting Latino immigrants is 
sorely needed. Peer- driven interventions have been found to increase access to health care and 
contribute to reduce health disparities among hard-to-reach, marginalized communities.55–57 A 
particularly successful peer-driven approach is the Popular Opinion Leader (POL) model. Based 
on the Diffusion of Innovation theory,58 POL programs recruit and train influential community 
members to serve as early adopters of new behavioral norms (e.g. risk reduction practices, 
utilization of prevention and treatment services, etc.), helping disseminate these new norms 
among community members in their social networks.59,60 POL approaches have been applied 
with success to address HIV risk,60 but without enough attention to the syndemic relation with 
substance use, poor mental health, and violence victimization.61,62  

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
A community resilience framework offers an innovative approach to address the SAVAME 
syndemic among Latinos. Resilience theory is a strengths-based approach to enable individuals 
and communities to successfully overcome adversity and trauma.63–65 Community resilience can 
be fostered by engaging and empowering members of disadvantaged and underrepresented 
communities in health promotive activities and establishing formal and informal ties between 
these individuals and the available assets and resources in the community.64,66,67 Identifying, 
engaging, and empowering influential Latino community members to serve as agents of change 
within their own social networks could increase the capacity of this community to respond to the 
SAVAME syndemic in more effective and sustainable ways.  
The Philadelphia AIDS Consortium (TPAC) has experience using a POL model for HIV 
prevention and has begun to offer Resilience Training to providers and community members in 
Philadelphia. In this pilot study, we have adapted TPAC’s existing POL program68 to target the 
four SAVAME syndemic factors, not just HIV risk, in the Latino immigrant community. 
Elements of other evidence-based Latino interventions have been incorporated to address the 
mental health, domestic violence and substance use components. In addition to this new 
syndemic approach, the POL program will be enhanced with elements from TPAC’s Resilience 
Training program. This enhancement recognizes that peers often face the same challenging 
circumstances as the individuals they are trying to help and these challenges reduce their ability 
to serve as influential change agents.69,70 The Resilience Training will empower POLs to more 
aptly overcome adversity, so they can also better serve their communities. Resilience training 
will bolster the impact and sustainability of the POL program. To our knowledge, no intervention 
has incorporated syndemics, POL, and resilience theory to address the SAVAME syndemic in 
Latinos.  
This study has two components that will help fill needed research gaps. The first component will 
be the adapted POL training program, where Latino immigrant leaders (hereafter referred to as 
POLs) will be trained and equipped with various skills and knowledge to help peers in their 
communities. Throughout this research proposal, this component of the research study will be 
designated as: “POL program” or “POL Training Program”.  
Once POLs are trained, they will be surveying their peers in the community (hereafter referred to 
as “community contacts”) about their experience with the POL (e.g. satisfaction, intentions to 
follow-through with referrals). Community contacts are individuals within the POLs social 
network who are potentially at risk for or affected by the SAVAME factors.  POLs will also offer 
community contacts the opportunity to take a survey about their experiences with the SAVAME 
syndemic. This survey hopes to gather preliminary data about the extent to which SAVAME 
conditions impact Latino immigrants in Philadelphia. Any section of this IRB proposal 
discussing the community contacts survey component of the research study will be designated 
“Community Contacts”. These layers of participation are standard in peer-driven research 
projects, where peers have often been trained to serve as intervention delivery agents and to 
collect data from community members71-73. Peer researchers have an important role community-
based participatory approaches to researcher. 
5) 
Inclusion and Exclusion Criteria:  
Popular Opinion Leaders (POLs)  

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
This is a community-academic collaborative study. Our community partners will select 
POLs through their own contacts in the community, aided by intervention advertisement 
flyers. Applying the POL model, community partners will identify men and women who 
are most popular, well-liked, and trusted by others in the Latino immigrant community.  
Specific inclusion criteria are listed below: 
• Over 18 years of age 
• Bilingual in English and Spanish 
• Member of Latino immigrant community (self-identified) 
• Experience or connection with the SAVAME factors (e.g. they or someone close to them 
have been affected at some point by one or more of the syndemic factors). 
• Self-describes as "people's person" and comfortable talking to others 
• A significant social network in Philadelphia (self-report) 
• Perceived as trustworthy and influential (by self and by community partners) 
• Highly motivated to serve as agents of change in their community (self-report) 
• Have time for training and project-related activities (self-report) 
• Plans to stay in Philly for the foreseeable future (self-report) 
Our team will strive to recruit a diverse group of POLs, in terms of gender, country of origin, 
sexual orientation, and area of residence, so their networks can reach a large and diverse share of 
the Latino immigrant population in Philadelphia. 
 
Eligibility to be a POL will be determined through interviews with co-investigators and 
community partners. Final selection of POLs will be at the discretion of co-investigators and 
community partners after the interview process.  
 
For the second year, POLs that participated during the first year will be invited to participate. 
Additionally, we will recruit new leaders using flyers. 
Community contacts: 
As interventionists and data collectors, POLs will interact (i.e. face to face, social media, by 
phone) with community contacts within their own social networks during POL outreach. They 
will document the reach of the intervention using iPads provided by our project and equipped 
with the Qualtrics survey software offline application or using a link on their phones. 
 
Every time they interact with a community contact as part of the CRiSOL intervention, they will 
fill out a brief questionnaire (i.e. “POL Activity Log Survey”). Post interaction with POL, POLs 
will go through a brief verbal consent process and ask community members to complete a brief 
anonymous 2-minute “Satisfaction Survey.”, followed by basic demographic characteristics to 
understand the population they are reaching. For a clearer description of the process, see the 
study timeline in the next section. If the contact was not made face to face, the POL will ask the 
community member to complete the survey through an online anonymous survey.  
 
Inclusion criteria for the community interaction is as follows: 
 
• 18 or older 

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
• Bilingual in English or Spanish 
• The POL had a conversation with them or provided services to them as part of the 
CRISOL intervention. 
 
We will use a shortened version of the consent form considering the information to be 
collected is not sensitive and consisting only of satisfaction items and demographics. Also, 
please, note that the surveys will not contain any contact information.  
 
After completion of this survey, the POL will invite the community member to participate in 
a more in-depth 20-minute survey that will be managed by our staff. If the participant 
accepts, the POL will collect a phone/email so our staff can send the link for the survey. 
Additionally, participants will be invited to complete a follow-up survey 3 months after the 
first survey. 
6) 
Study Timelines  
We anticipate that it will take approximately one month to enroll POLs for the CRiSOL training. 
During the enrollment period, POLs will complete baseline interviews that will take 
approximately 45 minutes. The CRiSOL training will consist of 40 hours, delivered in 4-hour 
training sessions at times that are convenient for the group of POLs and the research team. The 
initial training will be followed by 16 biweekly 3-hour reinforcement/booster sessions.  
 
We anticipate that the CRiSOL intervention implementation will take place over a 8-month 
period. POLs will commit to complete and document interactions with at least 5 community 
contacts over each 2-week period. Each community contact will be asked to complete a brief 
two-minute anonymous “Satisfaction Survey” based on the interaction with the POL.  
We anticipate that it will take approximately four months to compile, clean, complete primary 
data analysis and prepare a manuscript and/or final report. 
 
For the second year, we will invite the same POLs to participate. The COVID-19 training will 
consist of 16 hours, delivered in 4-hour training sessions at times that are convenient for the 
group of POLs and the research team. The training will be followed by 18 bi-monthly 2-hour 
booster sessions. 
 
Please refer to the following study timeline: 
 
FIRST Year timeline: 

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
 
 
SECOND Year – Extension 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Timeline 
 
Month 
 
1 2 3 4 5 6 7 8 9 10 11 12 
IRB approval, intervention review and surveys programming  
 
 
 
 
 
 
 
 
 
 
 
 
POL re-training 
 
 
 
 
 
 
 
 
 
 
 
 
CRiSOL-COVID-19 intervention implementation 
 
 
 
 
 
 
 
 
 
 
 
 
POL monthly booster training sessions 
 
 
 
 
 
 
 
 
 
 
 
 
Baseline community contacts survey 
 
 
 
 
 
 
 
 
 
 
 
 
Follow up community contacts surveys 
 
 
 
 
 
 
 
 
 
 
 
 
POL exit interviews 
 
 
 
 
 
 
 
 
 
  
 
Follow up community contacts surveys 
 
 
 
 
 
 
 
 
 
 
 
 
CRISOL-COVID-19 intervention data cleaning, analysis and 
manuscript prep 
 
 
 
 
 
 
 
 
 
 
 
 
Community Resource/Service Assessment survey prep/IRB 
 
 
 
 
 
 
 
 
 
 
 
 
Community Resource/Service Assessment survey 
 
 
 
 
 
 
 
 
 
 
 
 
Community Resource/Service Assessment survey analyses, 
manuscript 
 
 
 
 
 
 
 
 
 
 
 
 
Data sharing, data dissemination  
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
7) 
Study Endpoints  
 
The primary endpoint of this study is to be able to assess the feasibility, acceptability, and 
efficacy of a peer-driven intervention to address the factors that contribute to this 
syndemic, increase access to SAVAME and COVID-19 prevention and treatment services, 
and reduce the prevalence and impact of the syndemic conditions and COVID-19 on the 
Latino immigrant community in Philadelphia.  
  
 
8) 
Procedures or Methods Involved  
 
POLs:  
Individuals must provide informed written consent to participate in the POL training. The 
training will cover contextual, etiologic and practical knowledge related to SAVAME syndemic 
and COVID-19 and its impact on the community; knowledge of and navigation through available 
SAVAME services; effective communication and messaging skills; and culturally appropriate 
screening, counseling, and referral/navigation techniques. Training will also cover resilience 
competencies (e.g. self-awareness, self-regulation, optimism, mental agility, strengths of 
character, and connection). POLs will be formally connected with service organizations via 
informative panel sessions with local service providers to facilitate referrals to these services. 
Finally, CRiSOL peers will be trained in rigorous and ethical data collection and documentation 
of activities; and professionalism and leadership skills. The training will use instruction, 
modeling, and extensive role play exercises to promote skills and confidence. In order to 
encourage attendance to the training program, POL's will receive transportation tokens for ten in-
person training sessions at TPAC (112 N Broad St, Philadelphia, PA 19102). We foresee a 
scenario in which some POLs might have to miss a training session, and we would like to have 
video recordings of the training sessions available to them to stay on track with the training to 
avoid any potential risk of loss of confidentiality, these videos will be edited by our team to 
remove any information that the participants might share, or any discussions unrelated to the 
training content. 
 
At the beginning and end of each training session, subjects will complete a questionnaire to 
assess pre/post short term changes in SAVAME-related knowledge, attitudes, counseling skills, 
self-efficacy and behavioral intentions to influence and support others, as well as their individual 
resilience. These questionnaires will cover knowledge, attitudes, self-efficacy, resilience, and 
behavioral intentions to practice the skills covered during each session, while in the initial 
training phase (first 10 sessions). All of the questionnaires will be completed using iPads 
provided by the project. For the second year, the pre/post questionnaire will be about COVID-19 
related knowledge, skills, and self-efficacy. 
 
After 1 month of the implementation period (Community experience phase), the research team 
will conduct a semi-structured interview to gather opinions and overall satisfaction with the 
training, suggestions for amendments to the training in the future and their experience during the 
first month of community outreach. At the end of the 8-month implementation period 
(community experience phase), the research team will conduct semi-structured qualitative 
interviews with POLs, regardless of their continuation or level of activity. These interviews will 

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
be conducted by trained project staff at TPAC offices. Questions for the exit interview will focus 
on the self-reported impact the training and application of CRISOL program had on POLs, 
including their assessment of the level, relevance, and quality of knowledge and skills acquired; 
impact on self-confidence, resilience, social capital, their role in the community, and future 
professional and personal plans. Interview guides will also cover challenges to serving as a POL, 
barriers and facilitators for their role, suggestions for ongoing support system, and ideas to 
maximize the impact of CRISOL on the community. This information will guide future 
improvements of the intervention.  
 
POLs will document their activity in the community on the “POL Activity Log Survey” using 
iPads furnished with an offline Qualtrics® survey. POLs will log every interaction with 
community contacts and indicate the date, time, and place of the contact. POLs will also 
document their response to the issues discussed with the community contact which may include 
modeling of positive social norms, delivery of risk/harm reduction counseling, communication of 
health messages, linkage to resources, and navigation services to reduce SAVAME risk and 
impact. Collectively, we expect POLs will reach and register approximately 720 community 
contacts.  
 
Project staff will also hold 16 bi-weekly recurring meetings (i.e. in person or via Zoom) with 
POLs after the training during the community contacts portion of the research study. Project staff 
will assess any additional support they can provide to POLs and track progress on the 
community contacts research. For the purposes of the intervention and to recruit individuals 
interested in being POLs and to increase awareness among community members about the 
CRISOL project, the project team will be creating a CRiSOL Facebook, and Instagram accounts. 
This strategy has become a standard in today’s community-based projects and an effective way 
to reach minority populations. For example, Omar Martinez from Temple University, a member 
of our research team, works with Latino populations on MSM issues using social media 
platforms (Twitter, Facebook, and Instagram) without any reported adverse events thus far. 
Creation of CRISOL social media accounts would also increase the perception of cohesiveness 
between the Latino-serving work that both Drexel and Temple Universities are engaging with. 
Recruitment flyers and photo updates of the POL intervention (uploaded after receiving consent 
from individuals in the photos) will be posted on social media accounts.  
 
For the second year, after completion of first year intervention, POLs will be invited to 
participate in a second-year intervention. Those that accept to continue will undergo a COVID-
19 16-hour training. Additionally, we will recruit new leaders to the project using a flyer. After 
which, they will continue with the community outreach phase for 9 months. POLs will document 
their activity in the community of this new phase on the “COVID Activity Log Survey”. It is 
expected that each POL will connect with a minimum of 10 contacts each month. During the 
community outreach phase project staff will also hold 18 bi-weekly meeting (in person or via 
zoom) with the POLs. 
 
Community contacts:  
 
Post interaction with POLs, community members will complete a brief anonymous “Satisfaction 
Survey” based on their interaction with the POL, in addition to basic sociodemographic 

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
characteristics. Community members will be provided with the informed consent script and must 
agree to participate before beginning the survey. The CRiSOL survey would be self-administered 
when the POLs and community contacts meet face-to-face, or administered by the POLs when 
interactions are made via phone or other media. The latter situation will be the case when social 
distancing measures are in place due to the coronavirus. The survey relies on Qualtrics®.  
 
Note that by closing the survey, the answers of the individual cannot be accessed anymore except 
by the research team and no names or identifying information is included in the survey. A small 
incentive (i.e. a tote bag with the logo of the project) will be given to participants for their time 
when interactions are done face to face. This will not be possible when interactions are not face 
to face, such as during the coronavirus crisis. 
 
For this second year, the study will be similar. Community members will complete an 
anonymous brief “satisfaction survey” after giving verbal consent (use of short consent version). 
Additionally, for this second year we are adding a new survey. POLs will invite community 
members to participate and collect phone numbers of the ones that agree. The research team will 
contact the community members that expressed interest, provide with a copy of the verbal 
consent and provide a link for them to take the survey. This survey will not collect any personal 
data. 300 community contacts will be invited to complete a follow-up survey 3 months after the 
completion of the first survey. The personal information needed to contact participants (i.e. 
phone number and first name) will be stored in a password-protected document. 
 
Program Facilitators: 
 
After the training the research team will conduct a semi-structured interview with the facilitators 
to gather opinions and overall satisfaction with the training and suggestions for amendments to 
the training in future iterations. Due to COVID-19, interviews will be conducted over phone or 
via Zoom. 
 
 
9) 
Data Banking  
 
All data will be retained for at least three years after the completion of the research. Only 
individuals who are members of the research team and have been approved by the IRB will be 
allowed to access the data.  
 
10) Data Management  
 
Only individuals who have been approved by the IRB will be allowed to access this data. All 
data files will be encrypted, and password protected with passwords known only to the principle 
investigator, co-investigators, and other authorized members of the research team. Additionally, 
the CRiSOL team has obtained a Certificate of Confidentiality from the NIH to protect program 
participants in this study. All digitized records will only be accessible from password-protected 
computers. Information containing participant information will be stored in password-protected 
documents, and participant identifiers will be used in place of names. All data recorded on paper 
will be kept in a locked drawer in a project office. The researcher who collected the paper 

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
records will be responsible for transporting the data in a closed backpack or sealed folder from 
the intervention site to the project office. No paper records will include full participant name, 
sensitive information, or survey data. All other data will be retained for at least three years after 
the completion of the study except for contact information for community contacts.  
 
POL:  
 
 
Three different types of data will be collected from individuals participating in the POL training 
program.  
 
Program records, training attendance logs, and observation checklists will be used to record the 
number and basic sociodemographic profile of POLs recruited, attendance to training sessions, 
and fidelity of each training session delivered relative to the training curriculum. These records 
will be primarily kept on paper and scanned or input into a password protected computer 
database and the team’s password protected and encrypted Drexel One-Drive cloud account as 
needed.  
 
Pre- and post-training questionnaires and weekly practice logs. POLs will complete 
questionnaires before and after each training session to assess pre/post short-term changes in 
SAVAME-related knowledge, attitudes, counseling skills, self-efficacy and behavioral 
intentions to influence and support others, as well as their individual resilience. These 
questionnaires will cover knowledge, attitudes, self-efficacy, resilience, and behavioral 
intentions to practice the skills covered during each session. These questionnaires will be 
completed using the Qualtrics Offline App on project’s iPads. While in the initial training phase 
(first 10 sessions), POLs will also be required to complete weekly paper-and- pencil practice logs 
detailing their practice of the skills covered during previous training sessions. 
 
For quantitative data, data collected through program logs, observation checklists, pre/post 
training questionnaires, activity logs and surveys will be entered into datasets (or downloaded 
from iPads/Qualtrics platform in the case of Qualtrics-based questionnaires or surveys). Process 
(reach, adoption, implementation) data will be analyzed using descriptive statistics (e.g. means, 
standard deviations, percents, frequencies, etc.). Given the small sample size (N=10), changes in 
POL outcomes (e.g. knowledge, behavioral intentions, etc.) will be determined using non-
parametric tests for paired data: McNemar’s test for binary outcomes and Wilcoxon’s Signed 
Ranks Test for ordinal or interval variables. Analysis will be performed using IBM® SPSS® 
22.0 and Stata 14. 
 
The training and experience in the field as a POL is potentially transformative for POLs. At the 
end of the first month after the completion we will conduct semi-structured qualitative interviews 
with POLs. After the end of the first-year intervention leaders will be invited to participate in a 
second-year intervention, an exit interview will be conducted for those that do not wish to 
continue. For those that accept, the interview will be conducted at the end of the second-year 
intervention. These interviews will be conducted by trained project staff at TPAC offices. 
Questions will focus on the self-reported impact the training and application of CRISOL 
program had on POLs, including their assessment of the level, relevance, and quality of 
knowledge and skills acquired; impact on self-confidence, resilience, social capital, their role in 

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
the community, and future professional and personal plans. Interview guides will also cover 
overall satisfaction with the training, challenges to serving as a POL, barriers and facilitators for 
their role, suggestions for amendments to the training and ongoing support system, and ideas to 
maximize the impact of CRISOL on the community. This information will guide future 
improvements of the intervention. 
 
Qualitative interviews with POLs will be audio recorded and transcribed by project staff or by a 
HIPAA-compliant transcription service (e.g. Transcribeme, Inc.). When outsourcing the 
transcription work, our team will make sure the audio files are anonymized before sharing them 
with the transcription services. Transcriptions of the audio files will be coded and analyzed by 
researchers using thematic analysis and grounded theory, using NVIVO software. Audio files 
will be destroyed once the information is transcribed. A codebook with a priori codes and 
emergent themes will be developed after reading a subsample of transcripts. Codes will be 
subsequently revised and refined. Coding discrepancies and errors will be reconciled by 
consensus. Emerging themes and the coding/analysis process will be described in a final report. 
 
NVIVO is a password-protected online software, and no POL identifiers will be used when 
uploading this information for analysis. 
 
For this second year, data collection will be similar as first year. We are updating the pre/post 
questionnaire to reflect the COVID-19 training. At the end, of the second-year intervention a 
qualitative interview will be conducted with those that finish the intervention. 
 
Community contacts: 
As described above, after graduation, POLs will document their activity in the community using 
iPads furnished with an offline Qualtrics® survey. POLs will log every community contact they 
complete and indicate the date, time, and place of the contact (“POL Activity Log Survey”). For 
each community contact, POLs will document their community contacts’ responses to the issues 
identified, which may include modeling of positive social norms, delivery of risk/harm reduction 
counseling, communication of health messages, linkage to resources, and navigation services to 
reduce SAVAME risk and impact. POLs will offer the community contact to take a satisfaction 
survey. The first survey (“Satisfaction Survey”) can be self-administered by the community 
member and is designed to collect data on basic sociodemographic characteristics (e.g. age, 
gender, sexual orientation, race/ethnicity, etc.) and their satisfaction with the services received 
from the POL.  
 
Collectively, we expect POLs will reach and register approximately 720 community contacts. 
These data will serve to establish the level of reach, implementation (feasibility), and 
maintenance of the intervention in the community and provide important community-level 
baseline data to describe the population reached by the POLs. 
 
These quantitative data will be analyzed as follows: Parametric (one-way repeated measures 
ANOVA) or non-parametric tests (Friedman’s test, general estimated equations), depending on 

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the level of measurement and observed distribution of the information. Analysis will be 
performed using IBM® SPSS® 22.0 and Stata 14. 
 
All surveys offered as part of data collection on the community contact section of this protocol 
will be collected with and stored in Qualtrics®.  
 
For the second year, we expect to follow same procedures as prior year. Additionally, we will be 
inviting community members to participate in an additional survey that measures risk behaviors 
and protective factors for SAVAME and COVID-19, as well as sociodemographic 
characteristics. After 3 months, those that expressed interest and gave consent will be contacted 
to complete a follow-up survey. These surveys will be collected and stored using Qualtrics ®. 
 
Program Facilitators: 
 
At the end of the training period we will conduct a semi-structured interview with the facilitators 
to gather opinions and overall satisfaction with the training deliver, barriers perceived and 
suggestions for amendments to the training. These interviews will be conducted by trained 
project staff in a location agreed by facilitators. Due to COVID-19, the interviews will be 
conducted over phone or via Zoom. 
 
Qualitative interviews with facilitators will be audio recorded and transcribed by project staff or 
a HIPAA-compliant transcription service. Transcriptions of the audio files will be coded and 
analyzed by researchers using thematic analysis and grounded theory, using NVIVO software. 
Audio files will be destroyed once the information is transcribed. A codebook with a priori codes 
and emergent themes will be developed after reading a subsample of transcripts. Codes will be 
subsequently revised and refined. Coding discrepancies and errors will be reconciled by 
consensus. Emerging themes and the coding/analysis process will be described in a final report. 
 
 
11) Provisions to Monitor the Data to Ensure the Safety of Subjects  
 
As participation in either branch of this study (POL training or community contacts) involves 
minimal risk to the subjects, this section is not applicable. (N/A) 
 
12) Withdrawal of Subjects  
 
During the consent processes, potential participants will be informed that the alternative to study 
participation is not to participate. If participants choose to withdraw, all data collection will stop 
immediately.  
 
13) Risks to Subjects  
 
A small reasonable risk to participants is their loss of confidentiality. All qualitative interviews 
for both POLs and community contacts will be conducted in a private space, inside of a large 
office building in Center City, Philadelphia (TPAC). Risks to privacy will be minimized through 
staff ethics training, layered data security and by restricting access of sensitive information to 

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staff members who have a specific need for the information. Risks will also be minimized 
through requesting an NIH Certificate of Confidentiality.  
 
Though the semi-structured interview guide used to interview POLs after their experience with 
the program will focus on their experience with the training and with the work in the community, 
it is possible that POLs may discuss their own personal experiences or those of others. With this 
possibility, comes the risk that some information may cause an emotional reaction. However, 
participants will be made aware that they can refuse participation at any time or reschedule the 
interview. Refusing to participate or rescheduling will not be held against participants. They will 
also be told to not use names or specific identifying information during the interview, as the 
interview will be audio recorded. 
 
As part of the CRiSOL training, all POLs will be trained in the ethical treatment of study 
subjects and subject data with special emphasis in maintaining confidentiality. POLs will offer 
community contacts the opportunity to answer a sets of questions about their experiences and 
satisfaction with their encounter with the POL and basic demographic characteristics. 
 
For community contacts, there is no potential risk since the information ask would not be 
sensitive. But we will minimize the potential for psychological discomfort by informing the 
participants that they are not required to participate in the study, that they should only share 
information they feel comfortable sharing, they can refuse to answer any questions or withdraw 
from the study completely, and that there is no penalty for not participating. Participants will also 
be informed that their personal information will be de-identified. The POLs who have had the 
contact with the community contact will not have access to the survey results and will not be 
involved in data analysis.  
 
The risk of loss of confidentiality for community contacts is very low given the procedures we 
are using, such as collecting and storing respondent contact information in a different location 
from survey data and using unique identifiers. All data will be stored in password-encrypted 
files, and access will only be given to trained, authorized personnel.  
 
14) Potential Benefits to Subjects  
 
POLs 
 
POLs will have the opportunity to learn about the health issues that impact their community and 
gain multiple skills. The CRiSOL training program expands opportunities to learn valuable 
information from CRiSOL trainers and services providers in Philadelphia. This training also 
provides the opportunity to gain leadership skills, including training in motivational 
interviewing, communication skills and making and scheduling appointments. Additionally, 
training provides POLs the opportunity to play an active role in addressing the SAVAME 
syndemic and COVID-19 among Latino immigrants in Philadelphia, which may lead to personal 
satisfaction and a better sense of connection to their community. This study hopes to provide 
information to help characterize and address the SAVAME syndemic among Latino immigrants. 
Since POLs will be drawn from the Latino community in Philadelphia, this knowledge may 
benefit POLs as well.  

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The CRiSOL team will be applying to the National Association of Social Workers to qualify the 
training for an official certificate. This certificate would be able to be used as continuing 
education credits for POLs if they are Licensed Master Social Workers (LMSWs). This 
nationally recognized training certificate could be used on POL resumes to improve their job 
prospects. 
 
To incentivize their participation, POLs will also be offered a $50 gift card for every two-week 
period that they remain active in the program after graduating from the POL training program. 
Remaining active means attending meetings every two weeks, being available for a phone check-
in during the week that no group meetings are scheduled. Due to COVID-19, incentives will be 
dispersed online or through mail, based on feasibility and convenience for the leaders. 
For the second year extension, POLs will be offered $300 gift card for completion of the 
training phase, and a $100 gift card every two-week period that they remain active in the 
program. Additionally, each month participants will receive a $50 card to cover travel 
expenses related to their participation in the program. At the of the second year, POLs 
will receive a $25 gift card for the completion of the exit interview. 
Community contacts: 
The satisfaction community survey will be offered to all community members who the 
POLs interact with. Community contacts will also benefit from the informal support and 
resource referrals that POLs offer. 
To incentivize their participation, community contacts will be offered a small token of 
appreciation for their participation in the satisfaction survey. This token will be an item 
branded with the CRiSOL and/or Drexel logos, such as a tote bag.  
The community contacts that agree to participate in the additional surveys (i.e. base and 
follow up) will receive a $25 e-gift card. 
 
15) Vulnerable Populations  
 
Participation in both the POL training program and the community survey will be 18 years or 
older and identify as Hispanic or Latino. No prisoners or children will participate in this study.  
 
Community contacts who are potentially at risk for or affected by the SAVAME factors, 
especially violence or HIV/AIDS may be considering vulnerable due to the stigma and sensitive 
nature associated with this community in the United States. POLs will be trained extensively to 
understand and address factors leading to vulnerability in specific situations, including situations 
that arise when working with marginalized groups. When working with particularly vulnerable 

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groups, it is important to take all ethical considerations into account, to further protect these 
individuals.  
 
Though this research will not inquire about the immigration status of any individual, there is a 
chance that POLs may divulge their immigration status in qualitative interviews. To protect these 
individuals, we will request a certificate of confidentiality.  
 
For the community contact survey, no information about immigration status or contact 
information will be requested. 
 
The researchers have determined that the project contributes to further knowledge expansion and 
literature for the target population and all required precautions will be done to confirm ethical 
execution of the project. 
 
16) Multi-Site Research  
 
This is not a multi-site research study, and as such, this section is not applicable. (N/A) 
 
17) Community-Based Participatory Research  
 
Our community-academic partnership includes members from Drexel University, TPAC, and 
Temple University. It also includes a licensed clinical psychologist who is a trusted member of 
the Latino immigrant community in Philadelphia and has a history of collaboration with the PI of 
this project and with TPAC. TPAC is a non-profit organization that provides the following 
services: 
 
• direct health and social services  
• referrals to racial/ethnic minority and low-income communities 
• leadership and certification training 
• capacity building 
• technical assistance.  
TPAC has two locations: one in Center City, catering mostly to South Philadelphia residents; and 
one in North East Philadelphia, serving residents of North Philadelphia neighborhoods. Our 
community-academic team is multidisciplinary and has extensive experience in survey methods 
(Martinez-Donate); syndemics (Martinez); mixed methods and intervention design (Martinez-
Donate, Martinez); network diffusion measures (Hassrick), and POL and resilience programming 
(Yoshiaki, Perez). The overall project will be guided by the community participatory research 
(CBPR) principles of co-learning, capacity building, benefits to all partners, and long-term 
commitment to improve the health and well-being of the community.  
 
 
18) Sharing of Results with Subjects 
 
Results of this study will be shared with the POLs as well as members of Latino-serving 
organizations during community meetings (date and time TBD) held at either TPAC, WOAR, or 

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Nesbitt Hall (Drexel Dornsife School of Public Health building). Efforts will be made to 
prioritize any interested subjects’ setting preferences, including date and time of day. While the 
meetings will be open to anyone from the community, we do not anticipate to be able to share 
the results with the survey respondents, as contact information will not be collected. 
 
19) Setting  
 
Recruitment, interviews, and training sessions with POLs will take place at TPAC, located at 112 
N Broad Street, Philadelphia, PA 19102.   
 
Interactions between POLs and community contacts have no pre-determined setting, and will 
take place in settings that are most convenient for both the community contact and POL, and will 
be mutually decided by the community contact and POL. Due to COVID-19, these contacts 
might be held over the phone or online to minimize spread of disease. Efforts will be made to 
prioritize the community contact’s setting preferences, including date and day of time. 
Recruitment with community contacts will take place at TPAC or a location that the respondent 
feels most comfortable and allows for privacy. The satisfaction survey will be delivered in this 
setting. POL’s will be given training to ensure that locations chosen protect respondent’s 
confidentiality and maximize respondent’s comfort. Examples of locations are private meeting 
rooms at TPAC, private meeting rooms at Drexel University, etc.  
 
 
20) Resources Available   
 
We recruited 9 POLs and plan to recruit 720 community contacts. These numbers are based on 
several factors: a) Resources (funds and personnel) and time available to the project; 2) 
Previous experience conducting research with Latino populations by the study team; 3) 
Size of the Latino population in Philadelphia; and 4) Discussions with our community 
partners. 
 
We expect that at least 8 POLs will continue during the second year. Additionally we plan to 
recruit 720 community contacts, from which 300 will filled the additional surveys. 
 
Our team has the following people-based resources available to us to conduct the study: 
 
• Ana Martinez-Donate, PhD (myself): I am an associate professor in the Department of 
Community Health and Prevention at the Drexel University Dornsife School of Public 
Health. My academic training, cultural background, and research experience have 
prepared me well to direct this study. I have a PhD in health psychology and my 
postdoctoral work focused on HIV prevention and tobacco control research with Latino 
populations. I am a fully bilingual Latina. During the last 11 years, I have been serving 
as PI for NIH-funded research aimed at estimating the risk for HIV infection, identifying 
risk determinants, and examining health care access among Mexican migrants and 
immigrants. In recognition of the novelty and potential of this work, I received a 
Presidential Early Career Award for Scientists and Engineers in 2009. I have served as 
principal investigator and co-investigator for a number of research studies examining 

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determinants of health behaviors and effective strategies for disease prevention and 
health promotion at the population level. I have extensive experience in the development 
and implementation of population-based phone, household, and intercept surveys on HIV 
risk and other health topics among Mexican migrants and immigrants in the U.S. and 
Mexico. I have conducted longitudinal research with Mexican adolescents in Tijuana, 
Mexico, and recent Latina immigrants in the U.S. I am also proficient in the use of 
qualitative methods. I have demonstrated my ability to partner with various academic 
and community-based agencies and conduct population health research in both domestic 
and international settings. I have been conducting research in Philadelphia for 3.5 years, 
and have close contacts at TPAC, Temple University, and other organizations in the area 
that work with Latino populations. I will be dedicating 15% of my time to the CRiSOL 
program.  
• Omar Martinez: Omar is currently an Assistant Professor (Tenure Track) at Temple 
University’s School of Social Work and College of Public Health. Omar has research 
expertise in the correlates, prevalence, and prevention of substance use/disorders, mental 
illness, and HIV risk behaviors among underserved and vulnerable populations, 
including Latino men who have sex with men (MSM). Omar’s work explores the impact 
of syndemic factors, including individual-level factors (e.g. substance use and mental 
health problems) and the larger social context (e.g. immigration status, immigration 
policies, laws, acculturation issues, language barriers, experiences of discrimination, and 
neighborhood residence) that affect overall health outcomes among Latino LGBT 
populations. Omar’s experience includes developing and implementing programs and 
interventions to address health disparities affecting Latinos and other underserved 
populations; including HoMBReS, a best-evidence community-level HIV prevention 
intervention for self-identified heterosexual Latinos; and Connect ‘n Unite, a couple-
based behavioral HIV prevention intervention for substance using Black MSM; both 
interventions were funded through NIH. Omar is also the PI of a 4-year CDC funded 
randomized clinical trial study, Conectando Latinos en Pareja, a couple-based bio-
behavioral HIV prevention intervention for Latino MSM. In addition, I have been 
involved in several grant foundation research projects including a recent study titled 
“STD Testing: Behavior & Barriers among Sexual & Gender Minority Youth” with 
Public Health Solutions, Inc. in New York City. For this proposed study, Omar will 
contribute with my expertise in HIV and Syndemic research among Latino populations, 
contributing to the design of the recruitment strategies and development of screening 
tools for the detection of SAVAME factors and theoretical determinants to be used by 
the peer leaders in the intervention. Omar will work with Dr. Martinez-Donate and the 
research team in the intervention design, facilitation of intervention health education 
trainings sessions, interpretation and application of the pilot study results for the design 
of a future effectiveness trial.  
• Elizabeth McGhee Hassrick: Elizabeth is a sociologist with extensive expertise in 
studying social networks and their impact on organizational and individual outcomes. 
She has the theoretical and methodological training and the practical experience 
necessary to successfully serve as co-investigator for the proposed work. Elizabeth has 
served as (1) principal investigator for an NAEd/Spencer postdoctoral fellowship with 
the Duke University Network Analysis Center, investigating autism interventions in 
school and clinic contexts; and (2) co-investigator on an NIH R21, mapping the social 

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networks of ASD treatment providers across school, home and clinical settings. Both 
foundation grants supported data collection in school settings, investigating how school 
configuration shapes unequal outcomes for low income, minority students. Prior to her 
academic career, I taught for 10 years in high poverty urban and rural K-12 public 
schools, where I worked closely with district and school leadership to increase parent 
engagement among immigrant, African America, Hispanic and Native American 
families. Elizabeth has extensive research training and data collection experience in 
dynamic social network analysis and longitudinal social network analysis training. 
Elizabeth’s deep expertise in organization-level assessment and social network analysis 
is more than qualifies her for this project. In particular, her previous training and current 
work have prepared her well to apply social network and diffusion of innovations theory 
to this study. Elizabeth will contribute to the development of ethnographic procedures to 
identify influential community leaders and the design of measures and procedures to 
assess the reach of the intervention in the Latino community.  
• Yoshiaki (Yoshi) Yamasaki: Yoshi is a Mexican immigrant of Japanese descent with 
over 25 years of experience in the field of HIV/AIDS and human sexuality. His expertise 
has included developing and delivering training on HIV/AIDS prevention, testing, 
counseling, cultural sensitivity, and working with ethnic/racial and sexual minorities. He 
has developed and implemented HIV/AIDS programming for diverse populations in 
Philadelphia and for over 10 years he has served as a senior partner of the World Health 
Care Infrastructure d.b.a/TPAC, where he collaborated in global outreach initiatives for 
HIV prevention. Yoshi has experience and great interest in conditions that interact with 
HIV risk and infection among Latinos and have worked in collaboration with local 
CBOs, Mexican communities in the U.S. and in Mexico, and international organizations 
in Mexico for the eradication of sexual violence and HIV/AIDS. In addition, his 
educational background in social psychology has given me the foundations to approach 
the problem of HIV/AIDS from a socio, political, and cultural framework, therefore 
enabling him to take a holistic approach to program development and service delivery. In 
that regard, as Executive Director of TPAC, he is committed to developing and 
providing services that address the inter-related issues that contribute to, or result from, 
HIV infection and that prevent proper treatment and care for those affected. Finally, as a 
member of the board of directors for several Latino-serving CBOs in Philadelphia, he 
works with an extensive network of organizations and institutions that focus on a range 
of issues in the community, including sexual violence, substance use, reproductive care, 
and advocacy for immigrants. For the proposed pilot study, Yoshi will serve as the 
primary community partner and offer my expertise in HIV/AIDS and the interrelated or 
syndemic conditions present in the Latino immigrant community. As the community 
partner for this pilot study, Yoshi is ready to provide support with the intervention design 
and implementation, which will be adapted from our previous POL intervention and 
resilience training. He will also provide support with recruitment of community leaders, 
results interpretation, manuscript writing, and dissemination of study findings TPAC will 
also assist in developing a community resources list to be used by CRISOL peer leaders 
in their community work to connect peers to formal health and social community 
resources in Philadelphia.  
• Cristina Perez: For over 25 years, Cristina has been working with Mexican and other 
Latin American immigrants in the U.S. Cristina’s experience with the Latino community 

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includes development and provision of educational trainings on parenting skills, 
domestic violence, sexual assault, sexual harassment in the workplace, and individual 
and community resilience. These trainings are developed and tailored for a diverse 
population of community members as well as professionals. In addition, Cristina has 
extensive training and expertise in counseling and therapeutic services for victims of 
domestic violence, sexual assault, and trauma survivors. Cristina is currently the Director 
of Community Outreach for WOAR (Women Organized Against Rape) and has been 
there for 18 years. In this position, Cristina has developed and implemented numerous 
prevention programs, including a sexual harassment prevention program with Latino 
men who work in the restaurant industry in Philadelphia, using a peer-to-peer model. In 
2015, Cristina was the award winner of a Robert Wood Johnson Foundation grant for the 
implementation of the Promoting Resilience Communities program at La Casa de Los 
Soles. This program provides training in the theory and application of Resilience to 1) 
education and mental health professionals and 2) all community members who want to 
acquire the skills and knowledge to be agents of change in their community. This 
training combines WOAR’s well-established sexual assault preventive-education 
program with Resilience principles and methods, to promote physical, mental, and 
emotional health. The Individual Resilience and Community Resilience Training has the 
Latino immigrant community as its target and thus incorporates the different challenges 
immigrants confront during the different immigration phases to frame the challenges 
faced by this community and the tools to overcome them. Cristina’s extensive experience 
working with the Latino community is well-suited for the proposed study, in which she 
will provide consulting services around intervention development, particularly for the 
incorporation of violence exposure, mental health, and the interconnections between 
these health areas and HIV/STDs, theory and concepts of individual and community 
resilience; co-facilitation of intervention training session and boosters; as well as 
assistance with the interpretation of findings and implications for scaling up the proposed 
pilot intervention in the future. 
• 
Jonas Ventimiglia is a Data Analyst at the A.J. Drexel Autism Institute at Drexel University in the 
Life Course Outcomes Program. He has a BS in Psychology and is completing his MA in 
Quantitative Methods at the University of Maryland. His research background includes 
statistical and methodological work as well as a focus in child development. He will be applying 
his social network analysis skills as a data analyst under the supervision of Dr. Hassrick. 
 
For this study, we also have the following student support: 
 
• Kristin Giordano: Kristin is a Masters of Public Health candidate at the Drexel 
Univeresity Dornsife School of Public Health. She received her undergraduate degree in 
Hispanic Studies and Linguistics from the College of William & Mary, and has worked 
with communities in Nicaragua, Argentina and Chile. She previously worked for two 
years in the Colorado Springs Fire Department’s Community Health & Prevention 
Division. She will be dedicating 15 hours per week to this project.  
• Jamile Tellez Lieberman, MPH DrPH(c): Jamile is a doctoral candidate at the Drexel 
University Dornsife School of Public Health in the Department of Community Health & 
Prevention. She received her MPH degree at Drexel University and has significant 

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experience with working with the Latino and Latino immigrant communities in 
Philadelphia and other cities. Jamile is bilingual in English and Spanish. Jamile 
specializes in mixed-methods, community-based research with vulnerable or hidden 
populations. Her dissertation will focus on the health and well-being of children from 
Latino immigrant families who have been separated by deportation. Dr. Martinez-Donate 
is her doctoral advisor. Jamile will be dedicating 8-10 hours a week to the study.  
• Nishita Dsouza, MPH: Nishi is a doctoral student the Drexel University Dornsife 
School of Public Health. She received her MPH degree at Washington University in St. 
Louis and has significant experience with community health and minority communities. 
She will be dedicating 20 hours a week to the study. 
• Maho Okumura: Maho is a Master of Public Health candidate at the Drexel University 
Dornsife School of Public Health, majoring in Community Health and Prevention. Her 
research background prior to Drexel focuses on molecular biology, immunology, and 
microbiology, but she has worked with Dr. Martinez-Donate for a year on developing the 
CRiSOL project.  
• Emily Nolasco-Barrientos: Emily is a Master of Public Health candidate at the Drexel 
University Dornsife School of Public Health. She is concentrating in Community Health 
and Prevention. She has experience working within community health as it pertains to 
minority populations. She received her B.S. in Biological Sciences with a minor in 
Women’s Studies from the University of California, Irvine.  
• Nayrobi Mosquera: Nayrobi is a Master of Public Health candidate with a 
concentration in Community Health and Prevention at Drexel University’s, Dornsife 
School of Public Health. She received her BA degree in economics and a minor in public 
health from Wheaton College, MA. Her public health interests include Latino and 
immigrant health and has extensive research experience with racial and ethnic minority 
populations.   
• Claudia Zumaeta Castillo, MPH: Claudia is a doctoral student at the the Drexel 
University Dornsife School of Public Health. She received her MPH degree at Drexel 
University and has experience with working with the Latino immigrant community in 
Philadelphia. Claudia is bilingual in English and Spanish. 
• Leah Bakely: Leah is a Master of Public Health student at Drexel University. She is 
concentrating in Community Health and Prevention. Leah is bilingual in English and 
Spanish. 
• Sierra Cuellar: Sierra is a Master of Public Health student at Drexel University with a 
concentration in Community Health and Prevention. Her Public Health interests include 
social determinants of health in vulnerable populations.  
• Gabrielle Connor: Gabrielle is a Master of Public Health candidate at the Drexel 
University School of Public Health, majoring in Health Management and Policy. Her 
research interests include health policy, economics of health care, mental health and 
behavioral economics. 
 
We have the following facilities available at our disposal:  
 
• Drexel University Dornsife School of Public Health – Nesbitt Hall: The Dornsife 
School of Public Health is located at the heart of Drexel’s main campus in the University 
City section of West Philadelphia in a newly renovated 78,000 square foot, seven-floor 

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dedicated building with easy access to a broad range of Drexel university resources, 
Philadelphia’s Center City, and the 30th Street Station transportation hub. This location 
eases cross-disciplinary collaboration among University programs, allows Drexel 
students from other academic programs to more easily engage with the school’s 
programming, and further enables the School to closely collaborate with communities in 
the surrounding neighborhoods. Nesbitt Hall was completely renovated and redesigned 
to meet the specific needs of a school of public health. The remodeled building includes: 
innovative research space, cutting edge classrooms, conference rooms with state-of-the-
art communication capabilities, numerous open and flexible collaboration spaces, a 
student lounges, and other amenities. There are two large lecture halls on the first floor, 
available for School of Public Health use and the entire Drexel community. Several areas 
are designed to foster collaborative student work. Conference rooms in the School’s 
space are used for administrative purposes, research meetings, committee meetings, 
doctoral defenses, and instructional classroom purposes. For the purposes of this study, 
meetings can be scheduled in Nesbitt Hall, and space will be used to store incentives. 
 
POLs and participants will also use space at TPAC, public libraries, and other spaces deemed fit 
by both POLs and participants for meeting purposes.  
  
Drexel University has medical and/or psychological resources available if necessary through the 
Drexel University School of Medicine and the Office of Counseling and Health Services. 
Mr. Yamasaki (TPAC) and Mrs. Perez have also identified themselves as available as 
psychological resources and have strong connections to any medical or psychological 
resources that participants might need to utilize.  
 
All individuals that will be assisting with the study will be informed of study processes and 
resources through meetings. POLs will be made aware of resources through the CRiSOL 
training.  
 
 
21) Prior Approvals  
 
Research team will request a Certificates of Confidentiality (CoC) to protect research data from 
forced disclosure in any civil, criminal, administrative, legislative, or other proceeding, whether 
at the federal, state, or local level. Due to the sensitivity of data collected the CoC will assure the 
confidentiality of subjects’ private information.   
 
22) Recruitment Methods 
 
POLs will be recruited by our community partners from the community. Participants will receive 
informed consent information prior to the baseline survey. Participants of the POL training may 
withdraw from the study at any time with no adverse consequences. 

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23) Number of Subjects  
 
This study aims to recruit and train 10 POLs and 720 community contacts. And for the second 
year, aims to retain 8 POLs and recruit a total 720 community contacts. 
 
24) Confidentiality  
 
Risks to privacy will be minimized through staff ethics training, layered data security and by 
restricting access of sensitive information to staff members who have a specific need for the 
information. 
 
• Training: All study staff are trained in the ethical treatment of study subjects and subject 
data with special emphasis in maintaining confidentiality. 
• Data Security: All data files will be encrypted, and password protected with passwords 
known only to the principle investigator, co-investigators, and graduate students.  
 
Community contacts:  
The data collected from community contacts will be anonymous if participants agree to take the 
“Satisfaction Survey”.  Throughout the study, the privacy interest of community contacts will be 
protected, no contact information would be collected for participants. The database will be 
accessible by selected team members on an “need-to-know” basis and will remain in a password-
protected and encrypted folder. 
 
25) Provisions to Protect the Privacy Interests of Subjects  
 
During the consent process, participants will be given the option to not participate in the study 
and the option to withdraw at any point without having to be penalized.  
 
The nature of the project is voluntary. Throughout the study, we will minimize any potential for 
discomfort by informing participants that they are not required to participate in the study, that 
they should only share information that they feel comfortable sharing, and that they can refuse to 
answer any questions or withdraw from the study at any point. In addition, all surveys will be 
administered through Qualtrics which is password protected, and will only be accessible from the 
primary account of the researcher who accesses it. Any data that is downloaded from Qualtrics 
will be stored on password protected computers and the Drexel OneDrive cloud.  

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26) Compensation for Research-Related Injury  
 
Not Applicable 
 
27) Economic Burden to Subjects  
 
There is no economic burden unique to the study for the subjects. While CRiSOL is 
actively working to minimize the economic burden to participants, there may be some 
economic burden incurred through travel costs to the location of the trainings. CRiSOL is 
minimizing this cost to participants by hosting trainings at central locations and may 
consider looking into hosting some trainings in North and South Philadelphia, closer to 
participants. Economic costs associated with POL work with community contacts is 
minimal, since POLs will be interacting with the same people who they interact with in the 
course of their daily lives. The $50 incentives provided for every two-week period that 
POLs remain active will help offset this burden.  
 
28) Consent Process  
 
POLs:  
The research team is responsible for obtaining informed written consent from the participants of 
the POL training. Written information describing the research will be provided to the subject 
explaining that the study is voluntary, the purpose of the study, why they were chosen to 
participate, and what their participation entails. Participants will be provided with investigator 
contact information should they have any further questions. If the prospective subject agrees to 
participate, he or she will be asked to sign the consent form. 
 
Community contacts:  
The verbal consent script will be provided to community contacts by POLs before the CRiSOL 
satisfaction survey. POLs will explain the study to the potential subject, providing all pertinent 
information and appropriate additional elements of consent disclosure. The research presents no 
more than minimal risk of harm to the subjects. Written information describing the research will 
be provided to the subject explaining that the study is voluntary, the purpose of the study, why 
they were chosen to participate, and what their participation entails. The consent process will 
take place the day of the interview. Participants will be provided with investigator contact 
information and will have ample time to ask questions. Participants will provide verbal consent 
before proceeding with the study.  
 
Prospective participants may speak Spanish. For Spanish-speaking participants, POLs will go 
over the consent process with the participant and the consent form will be provided in Spanish. 
The consent process outlined will apply to Spanish-speaking participants as well.  
 
Facilitators: 
Research team is responsible for obtaining verbal consent prior to the interview. Written 
information describing the research will be provided to the subject explaining that the study is 

PROTOCOL TITLE: Cultivating Resilient and Strong Opinion Leaders (CRiSOL) Program 
Protocol Version Date: 03.25.2020 
voluntary, the purpose of the study, why they were chosen to participate, and what their 
participation entails. Participants will be provided with investigator contact information should 
they have any further questions. If the prospective subject agrees to participate, he or she will 
provide verbal consent before the interview. 
 
29) Process to Document Consent in Writing  
 
POLs: 
The informed consent process will be explained by either Dr. Ana Martinez-Donate, Jamile 
Tellez Lieberman, or Claudia Zumaeta Castillo in either English or Spanish. Written consent will 
be documented during the initial interview, prior to the POL training.   
 
Community contacts:  
This study is requesting a waiver of written documentation consent, as the evaluation presents no 
more than minimal risk of harm to participants. The written script of the consent form provides 
all written information describing the study and will be provided to all participants. All study 
participants will provide verbal consent.     
 
Facilitator: 
This study is requesting a waiver of written documentation consent, as the interview presents no 
more than minimal risk of harm to participants. The written script of the consent form provides 
all written information describing the study and will be provided to all participants. All study 
participants will provide verbal consent prior to the interview.     
 
 
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