Implementing Innovative and Strategic Approaches to Prevent and Mitigate the Deleterious Effects of HPV Across the Lifespan of Hispanics of Mexican Origin: Community Intervention
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice, Vaccine-Preventable Diseases, Intention, Adherence, Patient
Sponsor: University of Texas, El Paso

Human Papillomavirus Mitigation and Cancer 
Prevention across the 
Lifespan in a Mexican-Origin Population 
 
Protocol Number: 1441487 
National Clinical Trial (NCT) Identified Number:  NCT06098690 
Principal Investigator: Eva M Moya, PhD, LMSW 
Sponsor: The University of Texas at El Paso, Border Biomedical Research 
Center 
Grant Title: Implementing Innovative and Strategic Approaches to Prevent 
and Mitigate the Deleterious Effects of HPV Across the Lifespan of Hispanics 
of Mexican Origin: Community Intervention 
Grant Number: 2U54MD007592-26 
Funded by: National Institutes on Minority Health and Health Disparities 
(NIMHD), a component of the National Institutes of Health (NIH) 
Version Number:  1441487-21 
2024-05-02 
 

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1 
Will this project be conducted anonymously?  
(In person studies and/or collection of IP addresses are not anonymous) 
Yes 
No 
If YES, how will anonymity be preserved throughout the duration of the study? 
2 
Does the study protocol include children as research subjects? 
Yes 
No
3 
Does the study protocol include a protected group(s)? (UTEP employees, UTEP students) 
Yes 
No 
4 
Does the study protocol include prisoners, fetuses, pregnant women, human in vitro 
fertilization, or persons with impaired decision making? 
Yes 
No 
5 
Does the study specifically select economically/educationally disadvantaged individuals? 
Yes 
No 
6 
Does the protocol involve more than minimal risk? 
Yes 
No 
7 
Does the protocol involve deception? 
Yes 
No 
If YES, will the participant be informed at the time of initial consent that they will be unaware 
and/or mislead regarding the true nature and/or purpose of this study? 
Yes 
No 
Clarify how the deception is not likely to be embarrassing or offensive to participants. Why it is not likely to 
result in adverse or long-lasting effects (provide literature, as needed):    
8 
For research conducted outside of the UTEP campus, is the Principal Investigator (PI) and/or 
member(s) of the research team affiliated with the external site, institution, or organization? 
Yes 
No 
If YES, explain: Dr. Kristin Gosselink, C-PI is instrumental in overseeing Project Aim2 and she is affilitaed with UTEP. Former 
faculty with UTEP. 
Briefly state the purpose of the study (research questions and/or study objectives). 
PHASE III - AIM 3.C 
Community Randomized Control Trial (RCT) 
Community RCT Culturally Tailored HPV Psychoeducational Multimedia Intervention. During years four (2022-2023) 
and five (2023-2024), a sample of vaccine naïve (unvaccinated or under-vaccinated) adult community members ages 18 
– 45 years old from the El Paso Region will be recruited to participate in a human papillomavirus (HPV) multi-media
intervention. 
Hypothesis. Young and middle-aged adults who view culturally tailored multimedia stories encouraging HPV vaccination 
will report stronger vaccine intentions and, subsequently, significantly higher vaccination completion rates when 
compared to young and middle-aged adults exposed to a standard HPV vaccination fact sheet and generic HPV vaccine 
videos.  
Goal. The overall goal of the study is to increase in HPV, HPV vaccine, and HPV-associated cancer knowledge, attitudes, 
and practices (KAP). 

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Briefly describe why the study is important to individual subjects or society at large in laymen’s terms (non-scientific and 
non-technical language understood by someone with no scientific background). Do not describe experimental procedures in 
this section. Description should be limited to no more than two to three paragraphs. Avoid technical jargon. 
Please see protocol package# 1441487-14 
List 10, or less, references that are pertinent to the study. 
Please see protocol package# 1441487-14 

Research Protocol V.11  (1/2024) 
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Brief overview of research methodology (e.g., experimental, correlational, qualitative) and specific study design and proposed 
analysis of the research data. 
This project has three consecutive phases: 
Phases completed: 
Phase I includes Aim 1 (n=600) and sections A-B of Aim 3 (n=75) 
Phase II includes section A of Aim 2 (n=100) 
Current Phase: 
Phase III includes section B of Aim 2 (n=150) and C of Aim 3 (n = 100); totaling N = 1025 participants 
over the project lifetime.   
PHASE III - AIM 3.C 
Community Randomized Control Trial (RCT) 
Methods 
Trial Design. A randomized control behavioral trial using a parallel group design will be used to examine the effectiveness 
of the culturally tailored HPV psycho-educational multimedia intervention from baseline to immediately post-
intervention (day 0) and at 1 month post-intervention. Community members who are HPV vaccine naïve or under-
vaccinated (given vaccine recommendations) will be randomly assigned to one of two conditions: 1) experimental 
condition in which they receive the tailored multimedia intervention, and 2) active control condition, in which they 
receive standard materials (standard CDC fact sheet videos). 
1.) Experimental Intervention. Culturally tailored HPV psycho-educational multimedia intervention materials 
will be deployed using Research Electronic Data Capture (REDCap) web tool repository. Materials will use 
the same health messages for adults (e.g., increase HPV vaccine acceptability, uptake, screenings, access to 
care, and increasing health literacy); however, will vary in delivery format (i.e., multimedia scripts depending 
on gender preference) in a bilingual fashion (English and Spanish) among adults 18-45 years-old. 
2.) Active Control Intervention. Standard CDC fact sheet videos will be deployed using Research Electronic Data 
Capture (REDCap) web tool repository. Materials selected will use similar topics discussed in the 
experimental group; however, will be provided in multimedia formats (e.g., digitized into a video and read-
out-loud by artificial intelligence) in a bilingual fashion (English and Spanish) among adults 18-45 years-old. 
Expected Outcomes. 
x
Increase in knowledge scores about HPV, the HPV vaccine, and HPV-associated cancers on the knowledge
attitudes and practices (KAP) survey. Measured at baseline (pre-test/assessment), immediately post-
intervention (0 months), and at 1-month post-intervention.
x
Increased intention to self-vaccinate and complete the vaccine series among unvaccinated adults (ages 18 - 45
years old) on the KAP survey. Measured at baseline (pre-test/assessment), immediately post-intervention (0
months), and at 1-month post-intervention.

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x
Increased vaccine uptake and completion of the vaccine series among unvaccinated adults (ages 18 - 45 years
old) on the KAP survey. Measured at baseline (pre-test/assessment), immediately post-intervention (0 months),
and at 1-month post-intervention.
Expected Outcomes and Interpretation. Upon completion of the intervention, it is expected that community members 
who are HPV vaccine naïve (or under vaccinated) and allocated to the Experimental Group (i.e., culturally tailored HPV 
psycho-educational multimedia intervention) will report increased levels of vaccine intentions and subsequent vaccine 
uptake and dose series completion compared to those allocated to the Control Group. 
Randomization 
Sequence Generation. After determining eligibility, randomization of participants to treatment groups (experimental 
group vs. control group) will take place, while controlling for the potential bias introduced by factors of sex and age. To 
achieve this goal, we will utilize a randomization software (e.g., table within REDCap) to create balanced treatment 
groups based on these factors and reduce the effect of selection bias. 
Analytical Methods. Approximately 100 adults (ages 18 – 45 years old) will be randomly assigned to one of two 
conditions: 
Group 1 – the experimental condition, in which they receive the tailored multimedia intervention.  
Group 2 – the active control condition, in which they receive standard materials (standard CDC fact sheet 
videos).  
Power. 
Group I: The proposed sample size of 50 (n=50) participants provides 80% statistical power to detect a small to 
moderate size difference in vaccine intentions between the intervention and control group (assuming a 
standardized mean difference of 0.40 in the population, a two-tailed significance test, and alpha equal to 0.05). 
Group II: The proposed sample size of 50 (n=50) participants provides 80% statistical power to detect a small to 
moderate size difference in vaccine intentions between the intervention and control group participants 
(assuming a standardized mean difference of 0.40 in the population, a two-tailed significance test, and alpha 
equal to 0.05).  
Analysis Plan. All statistical analyses will be conducted using R (V. 4.0.3) and will use two-tail alpha to reject null 
hypotheses at 0.05. Prior to conducting analyses, data will be screened to ensure that statistical assumptions are met 
and any transformations or adjustments to the model will be employed. We may employ multiple imputation 
procedures in order to handle missing data for nominal variables. Descriptive statistics will be reported for demographic 
variables including age in years, sex, and gender.  
Primary Outcome. Chi-square analyses will be used to assess associations between variables reported on the pre-test 
(baseline), and post-test knowledge, attitudes, and practices (KAP) scales/surveys. T-test analysis will be used to examine 
differences between experimental group and control group; dependent on statistical assumptions, further t-tests may 
be conducted to examine differences between two age groups (18 - 26 years old and 27 - 45 years old), and sex for both 
groups. Multilevel modeling may be used to assess changes in proportions from baseline per participant overtime (time-
points [0 and 1-month post-intervention]) reported on the post-test KAP survey questionnaires.   

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Intervention Effect. Multilevel modeling may be used to assess differences between group proportions reported from 
baseline overtime (time-points [0 and 1-month post-intervention]) on the knowledge, attitudes, and practices 
scales/surveys.  
Intervention Impact. Finally, multilevel modeling may be used to assess differences between group proportions reported 
at 0 and 1-month post-test.    cc 
CONSORT Flow Diagram: Progress through the phases of this planned randomized trial (i.e., enrolment, intervention 
allocation, follow-up, and data analysis) will be visually represented using the Consolidated Standards of Reporting Trials 
(CONSORT) flow diagram shown below. 
Identify the sources of potential participants, derived materials, or data. 
Define the study sample (number of subjects to be enrolled, characteristics of subjects, inclusion, and exclusion 
criteria).  
PHASE III - AIM 3.C 
Community Randomized Control Trial (RCT) 
Participants 
Sample Size. A sample size of N=100 was a conservative estimate considering the Central Limit Theorem, 
planned approach to analysis, and anticipated attrition for this parallel (two) group design. Group I 
(experimental group) sample size will be n=50 (mixed gender participants between the ages of 18-45 years-old). 
Group II (active control) sample size will be n=50 (mixed gender participants between the ages of 18-45 years-
old). 
Power. 
Group I (experimental group): The proposed sample size of 50 (n =50) participants provides 80% 
statistical power to detect a small to moderate size difference in vaccine intentions between the 
intervention and control group (assuming a standardized mean difference of 0.40 in the population, a 
two-tailed significance test, and alpha equal to 0.05) (40).  
Group II (active control): The proposed sample size of 50 (n =50) participants provides 80% statistical 
power to detect a small to moderate size difference in vaccine intentions between the intervention and 
control group participants (assuming a standardized mean difference of 0.40 in the population, a two-
tailed significance test, and alpha equal to 0.05) (40). 
Recruitment & Retention. Recruitment is expected to take take place over 4 months (i.e., February 2024 – June 
4 from IRB approval for participant recruitment). Participants will be active in the project for approximately 3 
months – from time of recruitment to deployment of the pre-test, post-test, and at 1-month follow-up time-
points. 
Sampling Plan. Researchers will use a purposive sampling to recruit participants primarily in-person at dedicated 
venues and events, and via multimedia outlets (e.g., print, email, and video content on social platforms). 
Specifically, participants will be stratified given sex/gender (e.g., male, female, other) and age groups (e.g., ages 
18-45 years) to ensure representation in both experimental and control group.  The study sample will consist of 

Research Protocol V.11  (1/2024) 
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100 (n = 100) young to middle-aged adults from 18-45 years-old. The research team will complete such 
recruitment with flyer distribution and outreach initiatives.  Recruitment will be initiated by the research team 
members in key locations in El Paso County and surrounding areas/colonias of San Elizario, Socorro, Montana 
Vista, Anthony (TX). Flyers will be mainly distributed around partnered health clinics͕ higher educational 
institutions͕supermarkets, parks, and local community-based, private, and non-governmental organizations , 
and will include and not limited to electronic/social media outreach ( i.e., Facebook, Instagram, Messenger, 
WhatsApp). The partner agencies identified have a trajectory in working with the population of interest and 
have agreed to collaborate in the proposed project by facilitating the identification of potential participants as 
well as the inclusion of established letters of support (see attached letters of support [LoS] NIH Research 
Project Protocol – LoS). 
Inclusion criteria: Adults between the ages 18 and 45 years old, who have not completed the HPV vaccine series 
(unvaccinated or under vaccinated), and currently living or working in El Paso, TX.   
Exclusion criteria: Previously having participated in Phases I or II of the larger research project [cross-sectional 
phases], ages less than 18 years old or greater than the age of 45 years old, does not plan to be living or working 
in the El Paso region within the next 6-months following or is unable to participate in the full intervention and 
follow-up time-points, or unable to complete participation and activities in the English or Spanish language.  
Incentives: Participants will be compensated for their time with an online (e-gift card) or physical gift card (if 
applicable) of $30.00 value after completion of the initial intervention and surveys (pre-test, intervention, and 
post-test survey questionnaire). Participants will receive an additional gift card of $10.00 value for participation 
in three follow-up survey sessions (post-test survey questionnaire). The total amount of compensation 
participants may receive is $40.00 if they participate in and complete all components of the research study. 
Specifically define the procedures that will be used to recruit, screen, and follow study participants. 
Potential participants will be invited to join the study by completing an electronic screening questionnaire provided 
through the REDCap platform. Participants will be deemed eligible and invited to join the study if they are adults 
between the ages of 18 and 45 years old, who have not completed the HPV vaccine series (unvaccinated or under 
vaccinated), and currently living or working in El Paso County, TX. Once consented, participants who agree to take part 
in the study, will be asked to: complete a 5 minute demographic questionnaire, a 15 minute survey (pre-test), followed 
by an 15 minute video activity (intervention), and concluding with a 15-minute survey (post-test). See further below 
for full description of each phase of the study (pre-test, intervention, post-test, and follow-up). The research team will 
follow-up with participants to complete a similar 15-minute post-assessment survey that will be emailed/electronically 
sent to them 1-month after their participation in the intervention. 
The survey questionnaire will be provided through a secure REDCap link, set up with anonymity assurance enabled, 
which does not allow for the collection of IP addresses or participant location. The survey will be completed 
electronically using their own personally owned computer, tablet, or cell phone if study equipment/materials are not 
available or appropriate. They will be allowed to complete the surveys and the training component on their own time. 
Once an activity for any single day is initiated, it must be completed within a limited and defined amount of time on that 
day (i.e., 24 hours upon initiation). Once participants complete the first activity on the on the initial study day, and a 
follow-up survey will be given a month after the intervention session via a REDCap link. To assist with follow-up and 
survey completion, we will be integrating Mosio, a two-way text messaging platform that directly linkgs to REDCap that 

Research Protocol V.11  (1/2024) 
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the leading text messaging software for clinical research. Mosio improves subject enagement and adherence in research 
studies with automated text messages. Mosio is a secure platform that is hosted on HIPAA-compliant servers and follow 
HIPAA technical and administrative guidelines to ensure confidentiality in research.  
Is there a possibility of coercion or undue influence? 
Yes 
No 
If YES, describe whether some, or all, the participants are likely to be vulnerable to coercion or undue influence, 
and if so, what additional safeguards are included to protect their rights and welfare. 
N/A 
What is your rationale for using participants whose ability to give voluntary informed consent may be in question. 
Participants include students in one’s class, people currently undergoing treatment for an illness or problem that is the topic of the research 
study, people who are cognitively impaired, and vulnerable populations. 
N/A 
The following sections outline types of research activities. Please check the box(es) ONLY if ALL activities 
involving human subjects fall into one or more the applicable categories.  
Research conducted in established or commonly accepted educational settings, involving normal 
educational practices. (EX1)  
This category may include research on effectiveness as well as comparisons about educational strategies, techniques, 
curricula, or classroom management. Educational tests, such as cognitive, diagnostic, aptitude, achievement tests 
Notes: The research must not adversely impact students’ opportunity to learn required educational content. 
The research must not adversely impact the assessment of educators who provide instruction. 
A study information sheet or abbreviated consent document should be used.  
Research that ONLY includes surveys, interviews, focus groups, or observation of public behavior with 
adults who can consent for themselves and covering benign topics. (EX2) (LIM) 
Notes: The term “benign” describes activities that are brief, not expected to cause physical or emotional harm, 
persistent discomfort, be experienced by the subject as embarrassing, or be offensive, and not likely to have a lasting 
adverse impact. 
Interventions are not allowed.  
A study information sheet or abbreviated consent document should be used. 
Research involving benign behavioral interventions in conjunction with the collection of information from 
an adult subject through verbal or written responses (including data entry) or audiovisual recording if the 
subject prospectively agrees to the intervention and information collection. Benign research on perception, 
cognition, motivation, communication, social behavior, behavioral games, or minimal risk performance 
tasks. (EX3) (LIM)  
Notes: A study information sheet or abbreviated consent document should be used. 
Secondary research not requiring consent. Secondary research use of identifiable private information or 
identifiable biospecimen originally collected for other purposes. (EX4)  
Notes: When the identifiable private information or biospecimens are publicly available. 
The information is recorded by the investigator in such a way that the identity of subjects cannot readily be 
ascertained, and the investigator does not contact the subjects or try to re-identify subjects. 
Taste/Food quality evaluation and consumer acceptance. (EX6) 

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General Notes: The above research may involve randomization between groups if disclosed to participants. The above research 
may be audiotaped, if the subject agrees, if identities are not shared, and the confidentiality of the information is properly 
protected. 
Exempt category 5 is not listed as it applies to projects conducted or supported by, or subject to, the approval of Federal department and agency heads. Please 
contact the IRB office if you feel your project meets these criteria.  
UTEP will not implement exemption categories 7 & 8 at this time. 
Prospective collection by non-invasive procedures such as ultrasound, MRI without contrast, Doppler, MEG, 
EEGs, ECGs, eye tracking 
Moderate exercise, muscular strength testing, body composition assessment in healthy adults (XP4) 
Non-invasive collection of biospecimens (XP3) 
Non-invasive tests (body composition, BP, pulse) (XP4) 
Technology Type 
If Yes, Answer the Required Questions 
Examples 
Yes   
No 
Mobile technology 
Who does mobile technology belong to?  
܆ Sponsor provided device, not owned by 
UTEP. 
; Study participant owned device. 
; UTEP provided device. 
Identify: Study will rely on participant owned 
devices (i.e., cell phone, computer, tablet, etc.), 
if participant does not own a personal device, 
participatn will be allowed to complete on 
study team electronic devices 
iPhone, Android devices, iPods, 
tablets, or other wireless 
devices. 
Yes   
No 
Social Media 
Provide Link(s):  
www.facebook.com 
www.instagram.com 
www.whatsapp.com 
www.mobile.twitters.com 
Purpose: recruitment, promotion 
(advertisement)  
Facebook, Twitter, or 
Instagram. Provide links to 
pages/profiles that will be 
utilized for research. 
Yes   
No 
Website survey, or 
similar tool 
Name of website survey, or similar tool you 
are using:  
QR Code Generator 
REDCap (Research Electronic Data Capture) 
Software 
MOSIO or Twillio 
QuestionPro, Qualtrics, surveys 
on external websites 
Yes   
No 
Cloud based storage 
A cloud computing model in 
which data is stored on remote 
servers accessed from the 
internet, or “cloud.”
Identify:  
Microsoft One drive: www.office.com 
Google Drive, iCloud, Microsoft 
OneDrive, etc.  
See institutional policy for use of 
DropBox in research.  
Yes   
No 
Wearable Technology 
Name of the device: 
Examples of wearable 
biosensors include 
accelerometers, activity 
trackers, wireless heart rate 

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monitors, pulse oximetry 
sensors, and glucose sensors. 
Yes   
No 
Phone, Video or Web 
Conferencing  
Name of the conferencing system: Blackboard 
Collaborate 
Webex  
Zoom  
Skype for Business  
Microsoft Teams 
Apple FaceTime 
WhatsApp Video Conference  
Jamboard (google for education) 
The recording captures. 
; Images    ; Audio    ; Video 
Microsoft Teams, Zoom, Adobe 
Connect, Skype for Business, 
FaceTime, etc.  
Yes   
No 
Text/secure messaging 
What type of messaging will be used:  
; Text     ; Email     ; Other 
Purpose: Messaging through reminder 
application, for purposes of study reminders 
and access to insentives 
Outlook, text, etc. 
Yes   
No 
Mobile Applications 
Name of the application: Reminder App or 
similar application that can be used to send 
messages to participants to remind them of 
vaccination schedule or provide general 
vaccine information (e.g., REDCap, 
MOSIO/Twillio).  
Apps created by the PI, Apple 
health, Garmin connect, Fitbit, 
etc. 
The formal consent of each subject must be obtained before that subject is subjected to any study procedure. 
Describe how participants will be fully informed of this research prior to their participation and how their voluntary consent 
will be documented. 
Procedures for obtaining consent.  
Once the participant is deemed eligible and agrees to participate, the SIS will be provided before participation. No 
personal identifiers will be included; participant IDs will be randomly generated and assigned with information 
securely stored separately from gathered data. Data will also be securely stored and analyzed via REDcap and with the 
support of the UTEP Statistical Consulting Laboratory. Respondents will be randomly assigned to control and 
treatment groups prior to completing pre/post assessments and intervention activities. Participants will also be made 
aware that participation in voluntary and that they can opt out at any time. Recruitment and participation of subjects 
will be completed in accordance with UTEP’s Institutional Review Board (IRB) Guidelines for human subject research 
(please see study information sheet [SIS] for Aim 3.C).  
If you anticipate enrolling subjects whose primary language is not English, how will you obtain informed consent in the 
language of those participants.
For participants who are not fluent in English, we have prepared Spanish documents/files that mirror all English 
documents, to ensure that not only the intervention is bilingual, but also culturally tailored to our local 
community’s needs. 

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Identify who will be involved in the consent process and where this will occur. 
Recruitment and participation of subjects will be completed in accordance with UTEP’s Institutional Review Board 
(IRB) Guidelines for human subject research and completed completely online by the participant via the REDCap 
platform (please see Appendix E study information sheet [SIS] for Aim 3.C). 
If applying for a waiver of documented consent, specifically state this and provide justification. 
PHASE III - AIM 3.C 
Community Randomized Control Trial (RCT) 
Waiver of documented consent. Participants will be provided an information sheet (SIS), a wavier/alteration of ICF for 
Aim 3.C activities as this study: 
x
The proposed research involves no more than minimal risk to the participants, as stated in the SIS and protocol
x
The wavier/alteration will not adversely affect the rights and welfare of the participants as they will be provided all
information of participating in the study minus complete detail of the intervention materials to be tested
x
The Community Culturally Tailored HPV Psychoeducational Multimedia Intervention is solely educational in
nature. This phase of the research (RCT) could not be carried out practicably without using participant information
in an identifiable form to be randomly assigned (masked/unaware of group assignment) to an intervention or
control group to test the effectiveness/differences of outcomes between the groups.
x
Participants will be provided contact/study website information to obtain additional pertinent
information/findings following their participation in the study
If the study involves deception, describe the procedures for re-consenting and debriefing the participants. 
N/A 
Outline step-by-step what will happen to the human subjects in this study. 
What will you ask your participants to do? 
During the years 4 (2022-2023) & 5 (2023-2024) of the project, instruments for Phase III will be developed for the 
randomized control trial portions of the project. See below for specific details. 
PHASE III - AIM 3.C 
Community Randomized Control Trial (RCT) 
Intervention Materials. Participants will be randomly assigned to one of two conditions: 
1)
Experimental condition in which they receive the Tailored Psycho-Educational Multimedia Intervention, and
2)
Control condition in which they receive the General Educational Intervention.
An online platform will be developed to deploy the interventions (both the experimental and control conditions). The 
platform will include access to videos (using visual and audio) accessible by smartphone/tablet or computer/laptop. It 

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is expected that participants will take approximately 10 minutes to view all video content assigned depending on group 
allocation and gender preference.  
Experimental group materials. The experimental [treatment] group will receive the Tailored Psycho-Educational 
Multimedia Intervention, to include three of four tailored videos depending on gender preference. Health messaging 
themes will include:  
1)
A plain language information on HPV and its relation to cancer
2)
The HPV vaccine and eligibility; and
3)
Ways to access and obtain the HPV vaccine in the El Paso County.
Control Group materials. The control group [active comparator] will receive the General Educational Intervention, 
which consists of general standardized untailored health messages via digitized Centers for Disease Control and 
Prevention (CDC) HPV for adults fact sheets.  
Intervention Measures.  All the survey questionnaire measures/instruments will be available both electronically and in 
hard copy to both control and experimental group in the participants language of preference (English & Spanish). See 
attached survey questionnaires for more details (screening, informed consent, pre-test, and post-test instruments).  
Screening questionnaire. Questions will ask if they meet eligibility criteria: between the ages 18 and 45 years 
old, have not completed the HPV vaccine series (unvaccinated or under vaccinated), are currently living or 
working in El Paso County, plan to stay in the region for the next 6 months, and language preference (English or 
Spanish language).  
Demographics. A demographic instrument will be used to obtain information such as age in years, biological sex, 
race/ethnicity, medical health insurance status, socioeconomic status, employment status, engagement in 
health services, and other related information.  
Pre-test. Prior to delivery of the intervention materials participants will be asked to complete complete a 15-
minute pre-assessment survey. A modified version of the Vaccine Attitudes, and Knowledge Scale (VAKS) will be 
developed, tested, and deployed to assess HPV knowledge, and HPV vaccine behaviors. All measures will be 
administered via technology mediums to community participants.  
Post-test. Following delivery of the intervention and at 1-month post intervention, participants will be asked to 
complete a 15-minute post-assessment survey. A modified version of the pre-assessment will be administered 
to assess 1) knowledge scores about HPV and HPV vaccines, 2) intention to self-vaccinate and complete the 
vaccine series, and 3) vaccine uptake and completion of the vaccine series. All measures will be administered 
via technology mediums to community participants.  
AIM 3.C (RCT Culturally Tailored HPV Psychoeducational Multimedia Intervention). If participants agree to enroll in 
the study, they will be asked to complete the following online activities: a survey questionnaire about background 
information and information related to HPV, view informational videos (the intervention) on HPV, and additional survey 
questionnaires about their experience during the research study. If participants choose to get vaccinated, they will be 
referred to one of our partner vaccine providers (i.e., Project Vida or Tiempo de Vacunarte) or provided healthcare 

Research Protocol V.11  (1/2024) 
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navigation. Participant’s involvement will include a total of approximately 60-minutes over one month. All activities will 
be completed electronically using a mobile or electronic device (such as a smart-phone, laptop, desktop computer, or 
other device) and an internet connection. Activities will include:  
First day of study activities (45-minutes):  a demographic questionnaire, two survey questionnaires (pre and post-
test), informational videos (intervention), and a text message or phone call at 2 weeks about experience and reminder 
for follow up at 1 month. To assist with follow-up, Mosio will be used as it is a helpful platform that directly links to 
REDCap to improve subject enagement and adherence clinical research studies thought the use of automated text 
messages. 
x
Follow-up activity after 1-months (of 15-minutes): one post-survey questionnaire.
When and where will they do it? 
Recruitment will be initiated by the research team members in key locations in El Paso County, TX. Flyers will be 
mainly distributed around partnered health clinics, higher educational institutions supermarkets, parks, and local 
community-based, private, and non-governmental organizations͕ and will include and not limited to electronic/social 
media outreach ( i.e., Facebook, Instagram, Messenger, WhatsApp). The partner agencies identified have a trajectory 
in working with the population of interest and have agreed to collaborate in the proposed project by 

Research Protocol V.11  (1/2024) 
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facilitating the identification of potential participants as well as the inclusion of established letters of support (see 
attached letters of support [LoS] NIH Research Project Protocol – LoS). 
Participants will complete the survey online using personally own computers, tablets, or cell phones (if study 
equipment/materials are not available/appropriate).  
How long will it take them to do it? 
Involvement will last about 45-mintues on the first day, with a one 15-minute follow-up session at 1-month after the 
initial study day. Total contact time is ~60-mintues to compete all research activities across a 1-month period (two 
contact points).  
Describe the type of research information that you will be gathering from your subjects, i.e., the data that you will collect. 
Anonymous, self-administered surveys, which will not contain any identifying information, will be collected from all 
participants in order to maintain confidentiality. All survey data reported will be in aggregate form only.  
Identify the measurement/instrumentation. For surveys, focus groups, or interviews – clarify whether question items and 
measures are standardized, published, or designed specifically for this project.
Demographic Survey Questionnaire. Following randomization, participants will be administered a ~5 minute pre-
assessment survey prior to participation in the educational portion of the intervention. The assessment will include 
information about the respondent’s age in years, biological sex, race/ethnicity, medical health insurance status, 
socioeconomic status, employment status, engagement in health services, and other related information.  
Pre-test. Prior to delivery of the intervention materials participants will be asked to complete a ~15-minute pre-
assessment survey. A modified version of the Vaccine Attitudes, and Knowledge Scale (VAKS) will be developed, tested, 
and deployed to assess HPV knowledge, and HPV vaccine behaviors. All measures will be administered via technology 
mediums to community participants.  
Intervention. Participants will be randomly assigned to one of two conditions: 1) experimental condition in which they 
receive the Tailored Psycho-Educational Multimedia Intervention, and 2) control condition in which they receive the 
General Educational Intervention. An online platform was developed to stream video or digitized materials for both the 
experimental and controlled conditions. It is expected that participants will take approximately 10 minutes to view all 
video content assigned depending on group allocation and gender preference.   
Post-test. Following delivery of the intervention and at 1-month post intervention, participants will be asked to complete 
a ~15-minute post-assessment survey. A modified version of the pre-assessment will be administered to assess 1) 
knowledge scores about HPV and HPV vaccines, 2) intention to self-vaccinate and complete the vaccine series, and 3) 
vaccine uptake and completion of the vaccine series. All measures will be administered via technology mediums to 
community participants.  
Will you be audio or video recording during any portion of this project? 
Yes   
No 
If yes, this information must be described in all pertinent sections and the ICF(s). 
Will subjects be compensated (payment, incentives, extra credit, etc.)? 
Yes   
No 
If yes, details should be included here. 
Incentives will be offered in the form of gift cards from local vendors at each stage: 

Research Protocol V.11  (1/2024) 
 Page 19 of 24 
1)
Upon completion of the initial contact point (day that demographic survey, pre-test, intervention, and post-
test is delivered), participants will receive a $30 gift cardll be provided.
2)
At completion of second contact point, after completion of the follow-up assessment, the participant will be
provided with a $10 gift card (to total $40 for completion of the entire study).
Describe how the project team will protect the privacy and confidentiality of study participants. 
Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, 
behaviorally, or intellectually) with others. Confidentiality pertains to the treatment of information or data that an individual 
has disclosed in a relationship of trust with the expectation that it will not be divulged to others in ways that are inconsistent 
with the understanding of the original disclosure. Ensuring privacy of participants is different from confidentiality of data. 
Individuals participating in the study will be informed verbally by the person obtaining consent and/or in print/electronic 
writing through the consent form, that personal identifying information will not be documented in any materials that 
will be used to collect data (i.e. questionnaires). They will also be informed that consent forms containing initials and/or 
signature, will never be attached to the questionnaire; only those including de-identifiable information (e.g., participant 
number, electronic/verbal acknowledgement). Every effort will be made to keep participant information confidential 
and may only be disclosed if required by law. Organizations that may inspect and/or copy research records for quality 
assurance and data analysis include, but are not necessarily limited to: 
•National Institutes of Health/National Institute of Minority Health and Health Disparities
•UTEP Institutional Review Board
•Burrell College of Osteopathic Medicine Institutional Review Board
•QuestionPro® survey software
•REDCap database and survey software
• DocuSign
• Microsoft Office 365
• Zoom
• Electronic Devices (personally owned or study equipment)
Because of the need to release information to these parties, absolute confidentiality cannot be guaranteed. 
Describe how the project team will collect, manage, and analyze data. 
All data will be de-identified. No identifying data will be obtained. Hard copies of study records (informed consents and 
project surveys/questionnaires) will be kept in a secured and locked filing cabinet in the locked office of Dr. Eva Moya 
(College of Health Sciences School of Nursing office# 437) for up to 5-years after completion of the study. Only the 
research team will have access to the data. Electronic data will be password protected and stored on external drives or 
cloud-based storage (i.e., Microsoft OneDrive and Drobox) that only the research team will have access to.  Project staff 
will be extensively trained in maintaining confidentiality of research data. Surveys will contain no identifying data.  The 
signed and/or initialed consent forms will be stored separately from the moment of signing and/or initialing. UTEP will 
provide centralized and secure office space for research staff, and safe/secure storage of equipment, research supplies, 
and data. Electronic data will be kept on password-protected/encrypted desktop/laptop computers and external storage 
drives. All research team members who have access to the surveys for data entry or analysis will have participated in 

Research Protocol V.11  (1/2024) 
 Page 20 of 24 
UTEP and CITI responsible conduct of research/research ethics with human participants training, and will undergo 
rigorous additional training as part of their work. All data and consent forms will be archived in UTEP storage until they 
are destroyed based upon University guidelines.  
Describe the type of research information that you will be gathering from your subjects, i.e., the data that you will collect. 
Anonymous, self-administered surveys, which will not contain any identifying information, will be collected from all 
participants in order to maintain confidentiality. All survey data reported will be in aggregate form only.  
Describe provisions that will be made to maintain confidentiality of the data. Will it contain subject names or images? (e.g., 
surveys, video, audio tapes, database).  
Only the research team will have access to the data for analysis. The results of this research study may be presented at 
meetings or in publications; however, findings will be reported in aggregate form (i.e., no identifying information will be 
reported).  
Describe the security plan for data, including where data will be stored, and for how long, noting that you may not keep 
identifiable data indefinitely (i.e., password protection, encrypted, locked filing cabinet, etc.) 
All data will be de-identified. No identifying data will be obtained. Hard copies of study records (informed consents 
and project surveys/questionnaires) will be kept in a secured and locked filing cabinet in the locked office of Dr. Eva 
Moya (Colleges of Health Sciences and Nursing #429) for up to 5-years after completion of the study. Only the 
research team will have access to the data. Electronic data will be password protected and stored on external drives or 
cloud-based storage (i.e., Microsoft OneDrive and Drobox) that only the research team will have access to.  Project 
staff will be extensively trained in maintaining confidentiality of research data. Surveys will contain no identifying data. 
The signed and/or initialed consent forms will be stored separately from the moment of signing and/or initialing. UTEP 
will provide centralized and secure office space for research staff, and safe/secure storage of equipment, research 
supplies, and data. Electronic data will be kept on password-protected/encrypted desktop/laptop computers and 
external storage drives. All research team members who have access to the surveys for data entry or analysis will have 
participated in UTEP and CITI responsible conduct of research/research ethics with human participants training, and 
will undergo rigorous additional training as part of their work. All data and consent forms will be archived in UTEP 
storage until they are destroyed based upon University guidelines.  
Identify the measurement/instrumentation. For surveys, focus groups, or interviews – clarify whether question items and 
measures are standardized, published, or designed specifically for this project.
Demographic Survey Questionnaire. Following randomization, participants will be administered a ~5 minute pre-
assessment survey prior to participation in the educational portion of the intervention. The assessment will include 
information about the respondent’s age in years, biological sex, race/ethnicity, medical health insurance status, 
socioeconomic status, employment status, engagement in health services, and other related information. The 
questionnaire has been designed for this project. 
Pre-test. Prior to delivery of the intervention materials participants will be asked to complete a ~15-minute pre-
assessment survey. A modified version of the Vaccine Attitudes, and Knowledge Scale (VAKS) will be developed, tested, 
and deployed to assess HPV knowledge, and HPV vaccine behaviors. All measures will be administered via technology 
mediums to community participants. The questionnaire has been designed for this project. 
Intervention. Participants will be randomly assigned to one of two conditions: 1) experimental condition in which they 
receive the Tailored Psycho-Educational Multimedia Intervention, and 2) control condition in which they receive the 
General Educational Intervention. An online platform was developed to stream video or digitized materials for both the 

Research Protocol V.11  (1/2024) 
 Page 21 of 24 
experimental and controlled conditions. It is expected that participants will take approximately 10 minutes to view all 
video content assigned depending on group allocation and gender preference. The interventions have been designed 
for this project. 
Post-test. Following delivery of the intervention and at 1-month post intervention, participants will be asked to complete 
a ~15-minute post-assessment survey. A modified version of the pre-assessment will be administered to assess 1) 
knowledge scores about HPV and HPV vaccines, 2) intention to self-vaccinate and complete the vaccine series, and 3) 
vaccine uptake and completion of the vaccine series. All measures will be administered via technology mediums to 
community participants. The questionnaire has been designed for this project.  
Will you be audio or video recording during any portion of this project? 
Yes   
No 
If yes, this information must be described in all pertinent sections and the ICF(s). 
Will subjects be compensated (payment, incentives, extra credit, etc.)? 
Yes   
No 
If yes, provide details here. 
Incentives will be offered in the form of gift cards from local vendors at each stage: 
3)
Upon completion of the initial contact point (day that demographic survey, pre-test, intervention, and post-
test is delivered), participants will receive a $30 gift card will  be provided.
4)
At completion of second contact point, after completion of the follow-up assessment, the participant will be
provided with a $10 gift card (to total $40 for completion of the entire study).
Will you maintain a subject list that has direct identifiers linked to a unique study ID/code? 
Yes   
No 
If yes, how will you secure this linked subject list? 
Click or tap here to enter text. 
Will UTEP study personnel electronically transmit identifiable data or identifiable samples to a non-UTEP recipient? 
If yes, provide the type of data and plans to secure them. 
Yes   
No 
Click or tap here to enter text. 
What will happen to the identifiable data at the end of the study? 
Identifiers permanently removed and destroyed. 
Recordings transcribed without identifiers and destroyed. 
Identifiable or coded (that can be linked) data are retained. 
Most studies pose some degree of risk, even if the risk is minimal. A common risk is the loss of the confidentiality of 
participants’ responses.   
Describe any potential risks (physical, psychological, social, legal, or other) and assess their likelihood and seriousness 
There are no known risks directly associated with participation in this study.  This research study is considered “minimal 
risk”, which is “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and 
of themselves than those ordinarily encountered in daily life or during the performance of routine physical or 
psychological examinations or tests.” (45 CFR 46.303(i)).   
Describe the procedures for protecting against (or minimizing) any potential risks and include an assessment of their 
effectiveness. 
Anonymous information, which will not contain any identifying information, will be collected from all participants in 
order to maintain confidentiality. All survey data reported will be in aggregate form only. The informed consent 
document will include a description of the purpose of the study, the anonymous nature of data collected, the reporting 

Research Protocol V.11  (1/2024) 
 Page 22 of 24 
of data only in aggregate form, and researcher contact information in the event they have additional questions about 
the study. Participants will be reminded that they have the right to end their participation in the study at any time by 
not completing the survey.  
If the study involves a procedure that introduces a physical risk, specify arrangements for providing medical treatment if it 
should be needed.  
N/A 
If the study involves a procedure that introduces a psychological risk, such as the recall of a traumatic event, specify 
arrangements for providing psychological treatment if it should be needed.  
N/A 
Were there alternate and potentially less risky methods that were considered as possible methods; why were they not used? 
The risks involved with participating in this study are no greater than people experience when voluntarily discussing 
potentially sensitive topics. Overall, we evaluate the risk to benefit ratio for this study to be very favorable. There are 
no known risks directly associated with participation in this study. 
If the research methods impose risks on the subjects, include evidence that may justify their use (such as previous experience 
with the procedures).   
N/A 
Could the information obtained or recorded about subjects place them at risk of criminal or civil liability or 
be damaging to the participants’ financial standing, employability, insurability, or reputation?  
Yes   
No 
Describe and assess the potential benefits to be gained by participants (if any) and the benefits that may accrue to society in 
general because of the planned work.  Discuss the risks in relation to the anticipated benefits to the participants and to 
society.  
Potential benefits to participants include the opportunity to provide input that will help researchers develop HPV risk 
reduction programs tailored to the priority population. Results from this research will inform and enhance future 
interventions and enhance HPV prevention services and treatment within the El Paso community. There are no known 
risks associated with this research. However, sometimes when people talk about personal information such as HPV, they 
may feel uncomfortable or upset. This research study is considered “minimal risk”, which is “the probability and 
magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily 
encountered in daily life or during the performance of routine physical or psychological examinations or tests.” (45 CFR 
46.303(i)). Importance of knowledge to be gained. Knowledge generated by the study will help inform educational 
platforms, training for future health professionals, research among underserved populations, non-profit program curricula, 
and potential policy changes. Anticipated gains in knowledge resulting from this research study or as an extension of 
results from the proposed research will be described. In addition, the investigator will discuss why the anticipated risks 
associated with the proposed research are reasonable in light of the increase in knowledge that stands to be gained 
from or result from the proposed studies. 
Note: Monetary compensation and extra credit are not a benefit. 
Please describe your research resources. 
Discuss the staff, space, equipment, and time necessary to conduct research and how these needs are met. 
Office space. The PI and Co-Investigators have ample personal office space (approximately 125 sq. ft. each) 
including both office-type workspace and secure data storage space ranging from 200-400 additional sq. ft each. 

Research Protocol V.11  (1/2024) 
 Page 23 of 24 
Hardware and Software. All faculty and professional staff have access to standard laptop or desktop computer and 
through both wireless and hard-wired connections with access to Microsoft Windows 8, Microsoft Office, 
Banner/Goldmine, Adobe Acrobat Reader, BIS/Define, Avira Antivirus Professional and more. Office computers are 
connected to laser printers and scanners. A wide variety of software for research support (word processing, relational 
database, data analysis, power analysis) is available. Multiple university computer laboratories provide hardware and 
software support, and access to laptops, scanners, projectors, and other resources. Investigators and the Stat Lab also 
have, a variety of software the software available for use in the Statistical Consulting Laboratory include SAS v9.2, 
Splus v7.0 (Windows/Unix), Mathematica v5.0 (Windows), Minitab v14.0 and MatLab v7 (Windows/Unix). SPSS and 
EpiInfo are also available on an internal network free of charge to university personnel and students. 
The PI and the Co-investigators have percent effort covered by the UTEP and/or grant funding that allows them to 
work on research projects because they are seen as a benefit to the UTEP. 
Please include a description of the proximity of any resources such as emergency facilities, emergency care or 
medical/psychological care, and any support services.   
N/A 
If the study necessitates Environmental Health & Safety (EHS) or Institutional Biosafety Committee (IBC) oversight and 
approval, please describe here. 
N/A 
All UTEP researchers (faculty, staff, and students) and outside collaborators who will be conducting human subjects’ research 
(intervention and/or interaction) must complete human subject research ethics training to conduct research with human 
participants.
Do you or any person responsible for the design, conduct, or reporting of this project have an economic 
interest in, or act as an officer or director of any outside entity whose financial interests may reasonably 
appear to be affected by this project? 
Yes   
No 
If yes, explain any potential conflict of interest. 
Click or tap here to enter text. 
Do you or any person responsible for this project have existing financial holdings or relationships with the 
sponsor of this study? 
Yes   
No 
If yes, explain any potential conflict of interest. 
N/A 
With this submission I certify that: 
I agree to fully comply with the ethical principles and regulation regarding the protection of human subjects in research. 
I agree that the information provided in this form and all other supporting documents are accurate and complete. 
I accept responsibility for making sure all study personnel involved in the project have been appropriately trained. PI 
affirms responsibility for keeping training records on file for all study personnel. 
I understand that any changes in procedure with affect to participants must be submitted to the IRB for written approval 
prior to their implementation. Furthermore, I understand that any adverse events and significant changes in risk for 
participants must be immediately reported in writing to the UTEP IRB. 

Research Protocol V.11  (1/2024) 
 Page 24 of 24 
Copies of all required documentation of consent (if applicable) and any related to this research are securely 
stored as outlined above in the Health Sciences and School of Nursing (HSSN)

University of Texas at El Paso (UTEP) Institutional Review Board
Study Information Sheet
Protocol Title: HPV (Human Papillomavirus) Mitigation and Cancer Prevention across the 
Lifespan in a Mexican-Origin Population
Principal Investigators: Drs. Eva M. Moya, Kristin L. Gosselink, Margie M. Padilla, and Gabriel A. 
Frietze
UTEP Border Biomedical Research Center
Sponsor: National Institutes of Health/National Institute of Minority Health and Health 
Disparities (NIH/NIMHD) Grant #2U54MD007592
Introduction
You are being asked to voluntarily take part in the Cuídate El Paso research project described 
below. Please take your time making a decision. Before agreeing to take part in this research 
study, it is important that you read and understand the description of the study and what to 
expect if you do agree to participate. If you do agree to be part of the study, you will be asked 
to sign this form electronically at the end, and you will receive a copy for personal use. If you 
need to speak with a study team member, contact us directly at cuidateep@utep.edu or by 
phone at (915) 747-6313 (or using the contact information listed under “Who do I call if I have 
questions or problems?” at the end of this form) to answer any questions you may have about 
the study.
Why is this study being done? 
You have been asked to take part in a behavioral research study in El Paso, TX about the human 
papillomavirus (HPV) and the HPV vaccine. The purpose of this study is to increase HPV 
vaccination access and vaccine completion among eligible adults in El Paso and the surrounding 
areas.
Approximately 100 vaccine-eligible adults will be recruited in El Paso using either a recruitment 
flyer, by email, direct outreach by project research team members, or by word of mouth. 
You are being asked to participate in this study because you are between the ages of 18 and 45 
years old, are currently living or working in El Paso, and you have not completed the HPV 
vaccine series. 
What is involved in the study? 
If you agree to take part in this study, you will be asked to complete online activities that 
include: a survey questionnaire about your background information and information related to 
HPV, informational videos on HPV, and additional survey questionnaires about your experience 
during the research survey. If you choose to get vaccinated, we will refer you to one of our 
Approved on: May 2, 2024
Expires on: January 29, 2025
Study Number: [1441487-21]

partnered vaccine providers (e.g., Project Vida or Tiempo de Vacunarte) or we can additionally 
provide navigation to help you connect with an unaffiliated vaccine provider that you find most 
appropriate for your situation.

First day of study activities (45 minutes): two survey questionnaires, informational
videos, and a one-month follow-up text message about your experience

First follow-up activity at one month (15 minutes): one survey questionnaire about your
experience
If you agree to join this study, your involvement will include a total of approximately 60 minutes 
over one month. All activities will be completed electronically using a mobile or electronic 
device (such as a smart phone, laptop, desktop computer, or other device) and an internet 
connection. You can also contact a study team member directly at cuidateep@utep.edu or 
(915) 747-6313 for further assistance and to help identify accommodations that will work best 
for you. Please note that if you request an alternate form of the study materials (e.g., hard copy 
or voice/telephonic version), your participation in this study would then involve distanced 
and/or virtual research interactions with our research study team; privacy and confidentiality 
are not guaranteed due to the nature of the research environment in that case. 
Risks and Benefits
There are minimal known negative outcomes (risks) with joining this study. This study does not 
include any greater risks than those involved in daily activities. However, sometimes when 
people talk about personal information relating to topics such as HPV, they may feel 
uncomfortable or upset. If this happens, please use the information listed under “Who do I call 
if I have questions or problems?”, and we will connect you with a study team member trained 
in providing behavioral health and social services, who will then connect you with services that 
best fit your needs. 
Potential positive outcomes (benefits) of joining this study include the opportunity to provide 
input that can help researchers have better understand what is known about HPV in our 
community. Findings and knowledge from this research can also improve HPV education, 
information tools, and related services in the El Paso, TX region.
What other options are there? 
You have the right to not join or participate in this study. There are no drawbacks to declining 
or not wanting to join this study.
If you choose to take part, you have the right to skip any questions or stop at any time. If there 
are any new findings during the study that may affect whether you want to continue to take 
part, you will be told about them.
Approved on: May 2, 2024
Expires on: January 29, 2025
Study Number: [1441487-21]

Will I be paid to participate in this study? What are my costs? 
You will be compensated with an online gift card of $30.00 value after completion of the initial 
session for participating in this study (this includes the two-week follow-up text); you will 
receive an additional gift card of $10.00 value for participation after completion of the follow-
up survey session. The total amount of compensation you may receive is $40.00 if you 
participate in and complete all activities of the research study.
This study only supports vaccine delivery by our partnered vaccine providers: Tiempo de 
Vacunarte and Project Vida. If you qualify and use one of our partnered vaccine providers, there 
will be no direct costs to you to participate in the research study. If you choose a different 
vaccine provider, there might be a cost associated with your participation (e.g., using personal 
insurance, doctor visit, co-pay, etc.) which this research study will not cover. 
What if I want to withdraw, or am asked to withdraw from this study? 
Joining or participating in this research study is voluntary. You have the right to choose not to 
take part in this study. If you do not take part in the study, there will be no penalties or 
drawbacks. If you choose to take part, you have the right to stop at any time. Also, a research 
team member may decide to stop your participation without your permission if they believe 
being in the study may cause you harm or if it is determined that you do not truly qualify for the 
study. If you withdraw or are asked to withdraw from this study, you will not receive the 
remaining compensation.
What about confidentiality and my personal information? 
Your part in this study is confidential (only you and the study staff that recruited you [if 
applicable] will know of your participation). Your responses will be de-identified as your name is 
never included on any of the study documents or materials. All records and information will be 
maintained in a secure location. Electronic information will be password-protected and stored 
under the supervision of the lead research investigators. All members of the research team will 
consider your information confidential to the extent permitted by law. Your records may also 
be reviewed for audit purposes by authorized University or other agents who will be bound by 
the same laws of confidentiality. Because your name is not on any of the study documents, your 
information will remain de-identified. Every effort will be made to keep your information 
confidential; we will only provide personal information if required by law. Organizations that 
may inspect and/or copy your research records for quality assurance and data analysis include, 
but are not necessarily limited to:

National Institutes of Health/National Institute of Minority Health and Health Disparities

UTEP Institutional Review Board

REDCap database and survey software

DocuSign

Microsoft Office 365

Zoom
Approved on: May 2, 2024
Expires on: January 29, 2025
Study Number: [1441487-21]


Electronic devices (personally owned or study equipment)
Because of the need to release information to these parties, absolute confidentiality cannot be 
guaranteed. Also, the results of this research study may be presented at meetings or in 
publications up to five years after the study’s completion; however, your identity will not be 
disclosed in those presentations or publications.
Who do I call if I have questions or problems? 
You may ask any questions you have now. If you have questions later, you may contact Dr. Eva 
Moya (emmoya@utep.edu) or a study team member (cuidateep@utep.edu). 
You may also contact the Human Subjects Protection Office to speak to someone outside of the 
research team if you have questions or concerns about your rights as a research participant. 
The UTEP Institutional Review Board (IRB) can be reached at (915) 747-6590 or 
irb.orsp@utep.edu.
Authorization Statement
I have read each page of this form about the study (or it was read to me). I understand that my 
participation in this study is voluntary, and I choose to be in this study. I am aware that I can 
stop being in this study at any time, without facing drawbacks or negative outcomes. I will get a 
copy of this consent form now and can get information on results of the study later if I wish (if 
completing online, please feel free to print a copy for your records). 
___ Yes, I agree to participate in this research project by completing a survey 
questionnaire about my background information and information related to HPV, 
viewing informational videos on HPV, being referred to an appropriate vaccine provider, 
and completing additional survey questionnaires about my experience during the 
research study.
___ No, I do not agree to participate in this research study.
Approved on: May 2, 2024
Expires on: January 29, 2025
Study Number: [1441487-21]