Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach
Phase: NA
Conditions: Recruitment
Sponsor: NYU Langone Health

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Study Title: 
  
Advancing People of Color in Clinical Trials Now Using a Patient 
Centered Website: A Community-Engaged Approach (ACTNOW) 
 
 
Funding 
Sponsor: 
Merck Pharmaceuticals 
2000 Galloping Hill Road 
Kenilworth, NJ 07033 
USA 
(908)-740-4000 
 
Institution Name 
New York University School of Medicine- Department of Population 
Health 
 
Investigator 
Contact 
Information: 
 
Dr. Girardin Jean-Louis 
227 East 30th Street, 6th Floor 
New York, NY 10016 
(646) 501-2623 
(212) 263-4201 (fax) 
girardin.jean-louis@nyumc.org 
NCT: 
NCT03243071 
Study Number: 
17-00170 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL Title: Advancing People of Color in Clinical Trials Now 
Using a Patient Centered Website: A Community-Engaged Approach 
(ACTNow) (S17-00170) 
 
 
1. BACKGROUND AND SIGNIFICANCE 
 
Compelling evidence demonstrates racial/ethnic disparities in health and healthcare in 
the United States.1-4 These disparities arise from various factors including unequal access 
to adequate medical care, perceived racial discrimination, and poor health literacy.1-4 The 
Center for Healthful Behavior Change (CHBC) has been involved in numerous initiatives 
to eradicate health disparities and have implemented NIH-funded interventions to address 
inequities in health. While our initiatives to reduce disparities have been successful, 
interventions targeting patient-centered outcomes have been suboptimal because of 
inadequate infrastructure to support equitable contributions from stakeholders (patients, 
providers, and community leaders) in all aspects of the research process. This is crucial 
to promote sustainable effects regarding minority patients’ ability to make informed 
decisions about participating in existing clinical trials. This study will address this gap, 
bringing together academic investigators and important stakeholders to develop a website 
providing access to culturally tailored videos to enhance awareness of clinical trial, health 
literacy, thus promoting participation in existing clinical trials.  
 
Supporting Evidence and Purpose of the Study  
 
Minorities are under-represented in clinical trials, therefore limiting the evidence base for 
what works and does not work for racial/ethnic minority and health disparity populations. 
A systematic review of the factors influencing minorities participation in clinical trials 
revealed that though medical mistrust is often cited as a barrier to participation, other 
barriers such as poor understanding of clinical trials, low health literacy, pre-existing 
disease co-morbidities resulting in study exclusion, structural barriers related to access, 
and social barriers such as lack of social support have also been cited as barriers for 
racial/ethnic minorities.5-6 Health literacy levels are lower among members of racial/ethnic 
minority groups and individuals with lower levels of educational attainment, traits are also 
linked with very low clinical trial participation.7-8 The proposed pilot study will address 
associations of poor health literacy with low participation among racial/ethnic minorities 
in clinical trials and will ascertain effects of a culturally-tailored clinical trial literacy website 
on increased likelihood of participation in existing clinical trials.   
 

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Objective 1: To evaluate the comparative effectiveness of patient-centered messages to 
enhance clinical trial participation, through a culturally tailored website, accessed using 
iPads, versus NYU’s standard clinical trial participation website.  
Hypothesis 1: Participants exposed to tailored messages about clinical trial literacy will 
exhibit greater likelihood in participating in clinical trials than those exposed to NYU’s 
standard website. 
Objective 2: To determine whether psychosocial factors (awareness of clinical trial, 
intrinsic motivation, health literacy, and self-efficacy) and medical factors (risk behavior, 
history of preventive behavior, and clinical diagnoses) mediate greater likelihood of 
participating in clinical trials among individuals exposed to the intervention.  
Hypothesis 2: Greater likelihood of participating in clinical trials will be mediated by 
greater health literacy and self-efficacy independent of other individual-level factors 
(medical, knowledge, attitude/beliefs, and intrinsic motivation) and contextual-level 
factors (social support and socio-economic position). 
Study Design 
 
Objective 1: To evaluate the comparative effectiveness of a culturally and linguistically 
tailored clinical trial literacy website in increasing likelihood of participating in clinical 
trials. To achieve this objective, we will use a randomized group design, assessing the 
following patient-centered outcomes: willingness to enroll in clinical trials and behavioral 
intent as well as likelihood of referring others to enroll in such trials) before and after 
exposure to a culturally-tailored clinical trial literacy website. Health literacy will be 
measured both before and post exposure to tailored messages. 
 
Participants will be randomized into two groups. The intervention group (n=50) will have 
access to culturally tailored website. Participants in the control group (n=50) will have 
access to NYU ‘s standard trial participation website.    
 
 
 
 
 
 

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Study Flowchart 
 
*Flow chart for participants in the 
ACTNOW trial; focus group data will be 
derived from previous RCTs. 
ACTNOW Project Timeline 
Year 1 
Year 2 
Tasks 
1-3 4-12 1-6 7-12 
Train Staff & Formalize 
Procedures 
 
 
 
 
Engage the CAB 
 
 
 
 
Heuristic Testing and 
Endorsement 
 
 
 
 
Recruitment/Data collection 
 
 
 
 
Intervention/Follow-Up 
Assessment 
 
 
 
Information Diffusion 
 
 
 
Data Entry/Analysis 
 
 
 
 
Report Writing/Dissemination 
 
 
 
 
The ACTNOW conceptual framework was developed according to best practices and 
recommendations from the NIH Behavior Change Consortium (BCC) and was informed 
by CONSORT statements. Adherence to these recommendations ensures program 
implementation fidelity, thus enhancing the internal validity and generalizability of its 
findings. During the formative period, we will refine our strategies to ensure that all 
components are feasible and acceptable to potential participants and stakeholders 
(patients, leaders, and providers) comprising the Community Advisory Board. We will 
assemble and meet with a Community Advisory Board to seek endorsement of our 
implementation plan. We will also meet with leaders in representative communities to 
discuss plans for participant selection and enrollment to achieve our study objectives.  
 
Study Duration 
We estimate 4 months to assemble the Community Advisory Board, building consensus 
for project aims and materials, contracting all enrollment sites, and recruit participants. 
We estimate 3 months for initial meetings with stakeholders to discuss and endorse the 
implementation plan (Phase 1); 6 months for development and heuristic testing of the 
tailored website (Phase 2); 9 months for data collection and analysis in Phase 3, and 6 
months for debriefing at the end of Year 2 and optimizing the website before 
dissemination (Phase 4). 

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II. SUBJECT IDENTIFICATION, RECRUITMENT AND CONSENT/ASSENT 
 
1. Recruitment 
We will use several recruitment strategies. First, we will utilize a recruitment funnel that 
we have developed from several studies (MetSo: IRB#S13-00897, Grant# 
NCT01946659; Multi-Site: IRB# v i13-00182, Grant# R01 HL095799-01A2; PEERS-ED: 
IRB# i14-01028, Grant# 5R01MD007716-02). 
 
During the consent phase, all participants in these IRB approved studies are asked if 
they would like to be contacted for future studies. We have a recruitment pool of 
approximately 400 participants (who have completed studies) from which to draw upon 
who meet the eligibility criteria and who indicated that they would like to be contacted 
for future studies. 
 
In addition, we will also obtain participants from research match, an online tool used to 
bridge individuals who are seeking out research studies and researchers who are 
looking for participants. Participants will be contacted via phone to ascertain their level 
of interest and eligibility. If participants express interest, they will be invited to come to 
our project office. Then, a member of the research team will provide detailed information 
about the study protocol, and read the consent form. Participants will have time to 
answer questions. No study procedures are conducted without written consent. 
 
Second, in addition to this existing pool of potential participants, others will be recruited 
who meet the study criteria through community steering committee members, health 
fairs, and community events. At this time, recruitment will be conducted on site at the 
requisite health fair or community event. Study fliers will be available for participants 
who are interested in the study. Participants will have the opportunity to ask the study 
personnel questions about the study.  Those who express interest will be scheduled for 
an enrollment session to join the study at the Center for Healthful Behavior Change to 
begin the enrollment process.   
 
For the eligible participants contacted via telephone, the trained research assistant 
placing these calls will 1) provide detailed information about the study protocol 2) 
discuss requirements and expectations of participants, and 3) ascertain interest in 
moving forward with the study. Participants who are interested will be scheduled into an 
enrollment session. Participants will have time over the phone with the trained research 
assistant, and also during their assigned enrollment session, to answer questions of the 
investigative team. 
 
 
Study Intervention 
Participants randomized to the intervention arm will have free access to a password 
protected interactive culturally and linguistically tailored website via a tablet device. No 
private identifiable data about you will be collected. Participants will receive a brief 10-

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minute tutorial by a trained research assistant on login procedures and use of the 
website. 
 
Control Condition 
Participants randomized to the control condition will have free access to the NYU 
standard clinical trials website. Currently, there is no specific comparative effectiveness 
data evidencing superiority of any website or other format for increasing clinical trials 
literacy. Furthermore, there has been previous research to suggest the overall difficulty 
that patients have in using generic, versus tailored clinical trial materials. This, our study 
will ascertain effectiveness of a tailored website compared to the standard website. 
Participants in the control condition will have access to the tailored website at the date 
of study completion (no later than 6 months’ post-date of enrollment). 
 
2. Process of Consent 
We will explain to participants that the purpose of the study is to understand barriers 
pertaining to why blacks do not participate in clinical trials, assess their willingness to 
enroll in clinical trials, and ascertain whether or not they will refer others to participate in 
such trials. We will obtain participants consent to audio-record the debriefing session. 
The screening team will comprise ethnically concordant investigator: Dr. Jean-Louis.  All 
participants will be reminded that their responses are confidential and that they may 
refuse to participate in the project or withdraw at any time without explanation, and 
further, that such action will in no way affect their future interactions with their health 
care provider, or with New York University Medical Center. To ensure confidentiality, 
data will be associated with an individual participant only by an assigned identification 
number, the code for which will be kept in a locked drawer that only the study 
investigators will have access to. 
 
3. Number of subjects.  
The proposed study expects to recruit a total of 100 participants from all recruitment 
strategies over a period of 9 months.  
 
4. Gender of Subjects.  
The study will include black men and women 
 
5. Age of Subjects.  
The sample frame will include black men and women 18 years old and older. 
 
6. Racial and Ethnic Origin.  
Our emphasis on blacks is justified by the low participation in clinical trials in this group.  
 
7. Inclusion Criteria.  
Self-reported race/ethnicity as African American, African, Caribbean American or black 
men and women; ages ≥18 years; accessible by telephone; no plans to move away 
from the region within the year following enrollment; consent to participate. 
 
8. Exclusion Criteria.  

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Progressive medical illness in which disability or death is expected within one year; 
impaired cognitive or functional ability, which would preclude meaningful participation in 
the study; stated intention to move within the same year of enrollment. 
 
9. Vulnerable Subjects.  
This study does not involve vulnerable subjects  
 
10. Subject/Representative Comprehension. 
Participants will be asked to repeat back to the research assistant the salient points of 
the consent form to make sure that they understand the study they are agreeing to 
participate in. Children and/or decisionally impaired adults will not be subjects in this 
study. 
 
11. Debriefing Procedures. 
Information will not be purposely withheld from the subject. Participants will be asked to 
sign the audio-consent form. An audio-recording will be obtained for an accurate 
summary of the debriefing process. At the three-month follow-up visit, participants will 
be asked to provide overall feedback and experience about the study to encapture 
content that may not otherwise be received through the survey measures. The audio-
recording will be held in perpetuity to evaluate after the study is closed. Participants will 
be given the opportunity to ask questions, and provide comments on the study 
importance.  
 
12. Consent Forms. 
We will use consent forms approved by the IRB. All participants will be reminded that 
their responses are confidential and that they may refuse to participate in the project or 
withdraw at any time without explanation, and further, that such action will in no way 
affect their future interactions with their health care provider, or with New York 
University Medical Center. To ensure confidentiality, data will be associated with an 
individual participant only by an assigned identification number, the code for which will 
be kept in a locked drawer. 
 
13. Costs to the Subject. 
There will be no costs to study subjects. 
 
14. Payment for Participation. 
Participants in Phase I Heuristic Testing will receive $50 for providing baseline data. 
Participants in Phase II (Intervention/Control) will receive $25 at baseline, $50 at the 1 
month follow up period and $25 at 3 months. 
 
III.STUDY DESIGN/METHODS 
Using data from previous RCTs (R25H116378, R01MD004113, and R01MD007716, we 
will use previously gathered data on barriers and facilitators to clinical trial participation 

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among minorities in partnering communities.  Barriers and facilitators have been elicited 
through focus groups using standard OBSSR-recommended approaches.  These data 
will be used to develop a culturally-tailored website, to assess participants knowledge of 
clinical trials and to promote increased clinical trial health literacy, leading to enhanced 
in rates of participation.  Our team has considerable experience translating qualitative 
data into relevant interventions.  Previously, we developed and tested the TASHE 
website (Tailored sleep health education: a community-engaged approach-
R25H116378).  The objective was to develop a web-based sleep education program for 
blacks with metabolic syndrome and who were at risk for sleep-related CVD.  We will 
utilize a similar approach to develop and test the proposed ACTNOW website 
www.nyulmc.org/sleephealtheducationwww.nyulmc.org/sleephealtheducation 
The proposed ACTNOW website will use an existing health education and social 
networking website initially developed by the Harlem Health Promotion Center (HHPC), 
one of 37 Prevention Research Centers in the Centers for Disease Control and 
Prevention (CDC) network (U48DP000030). This will be a world-class clinical trial 
literacy program describing in lay terms the rationale for clinical trials, importance of 
participation, and knowledge to be gained by participating. The parent website 
(GetHealthyHarlem.org) was built by Woven Web Digital Design in collaboration with 
community stakeholders, serving minority communities in New York. Currently, it 
provides health advice regarding physical activity, nutrition, the built and social 
environment, psychosocial concerns, and other topics of interest to the health and well-
being of New Yorkers. Online formats include interviews with community health experts, 
health testimonials based on interviews with community members and short informative 
articles on various health topics. Additionally, it provides a forum for community 
members to connect, engage, and network. On a monthly basis, more than 6,000 users 
access the website. 
The platform will be incorporated in the getHealthyHarlem.org portal.  Initially, this portal 
was created using Drupal, a popular, highly flexible, sophisticated, and scalable content 
management system.  It allows easy creation of different types of content including 
video vignettes, animations, and RSS feeds.  Drupal has fine-grained user permissions, 
allows for “plug and play” added functionality, provides mechanisms for easy 
customization, and has active development support from the technical community. This 
allows community stakeholders and visitors to rate various website elements, use 
communication and collaboration tools such as the discussion boards. Web tools allow 
sharing of research and educational materials among researchers.  The platform will be 
designed so that project staff can easily configure it in accordance with community 
preferences and needs as gleaned from the final debriefing sessions in year 2.  
Specific content of the site will assist users in understanding the basics of clinical trial 
using previously developed educational materials, customized at the 5-6th grade 

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reading level.  The site will be password-protected, accessible only by participants in the 
exposure arm.  By providing a specific password to each participant, we will be able to 
track their activity on the site (e.g., frequency and time spent on the site) using Google 
Analytics log file data and relate it to other participant characteristics.  The site will be 
designed for use by individuals with low literacy and computer experience, in 
consultation with an experienced linguist. 
Data acquisition for objective 1: We will use a randomized group design, assessing 
patient-centered outcomes (health literacy, willingness to participate in a clinical trial, 
willingness to refer others), contrasting participants who were exposed to health 
messages via NYU’s standard clinical trial website (http://www.med.nyu.edu/oct/home) 
[control arm] and those exposed to the newly created culturally and linguistically tailored 
website [intervention arm].  They will all complete measures at baseline assessing 
demographics, general health status (Medical Outcomes Study Short Form), baseline 
health literacy measures (National Assessment of Adult Literacy), and willingness to 
participate in a clinical trial (“On a scale from 1 to 5, with 1 being ‘not at all willing’ and 5 
being ‘very willing’, how willing would you be to participate in a clinical trial in the 
future?” Response anchors will be; not at all willing, somewhat unwilling, neutral, 
somewhat willing, and very willing).   
At the 1-month debriefing, we will reassess participants’ willingness to participate in a 
clinical trial, and ask whether or not they opted to register with ResearchMatch; an 
online volunteer clinical research registry. These data will help establish a model for 
future translational and dissemination research. At the end of the 2-year project, we 
expect to have developed a culturally-tailored clinical trial literacy website that could be 
widely accessed. There are over 31,000 racial/ethnic minority barbershops, beauty 
salons, and faith-based organizations across the United States that could use this non-
traditional model promoting participation in clinical trials. The long-term goal is to use 
this infrastructure for dissemination of evidence-based clinical trial health literacy and 
participation at the community level. 
 
 
Schedule of Events 
The primary aim of this study is to compare the tailored materials to control information 
only materials that are not tailored to the population being studied. However, before the 
Intervention/Control study, all messages and online resources will be assessed using 
cognitive heuristic testing to ensure the website is user friendly and culturally and 
linguistically tailored to the population. Heuristic testing to ensure cultural and linguistic 
appropriateness of the resource will be conducted, followed by the Intervention/Control 
study. 
 

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Our collaborator from SUNY Downstate, Dr. Senathirajah, will conduct heuristic 
evaluation and cognitive walkthroughs of all web materials, and then perform standard 
formative usability testing onsite with 10 representative participants to ensure the site is 
well-suited to the needs of the intended community. These participants will be recruited 
from the existing pool of participants from previous RCT’s mentioned above.. 
Participants will be contacted, and recruited for this portion of the study via telephone. 
Participants will be scheduled into time slots of approximately 40 minutes in duration. 
Participants will come to CHBC at their assigned timeslot, read and sign the consent 
form, and then begin the heuristic testing. She will ascertain whether health materials 
are acceptable and whether they capture daily experiences of potential patients whose 
lives vignettes intend to portray. She will recommend necessary changes based on log-
file analysis that captures computer activity while the participant uses the website. In 
addition, Dr. Senathirajah will ask participants several debriefing questions, such as 
their experience with the Internet, their willingness to use the resource in the future, and 
their overall user experience. This will ensure that messages are credible and 
understandable to the partner community. 
Materials will also be presented to stakeholders in our Community Advisory Board for 
final approval. Once approved, materials will be available for use in the 
Intervention/Control Study. 
 
Intervention/Control Study 
Participants in the Intervention/Control study will be asked to come to the Center for 
Healthful Behavior Change for three discrete visits, including baseline, 1-month follow 
up, and 3-month follow up.  
 
Baseline: 
I. 
Participants will be contacted from our prior IRB approved studies. Potential 
participants recruited through community locations and events like health fairs 
will also be contacted. All potential participants will be scheduled into an 
enrollment slot at which time they arrive at the CHBC (227 East 30th Street, 6th 
Floor, New York, NY) to fill out baseline surveys and receive study instructions. 
II. 
When participants arrive, they will be invited to go to either the intervention or 
control enrolment sessions. These groups will remain separate so as not to 
cross-contaminate instructions or materials. 
III. 
Participants will receive the consent forms, and will be asked to read the 
documents carefully. Participants will be provided time to call any family or 
friends, and given the time they need to make an informed decision about 
participation. The consent forms will be approved by the IRB, and include a 
request for participant cell phone number and email address. Cell phone is 
collected so that participants may be sent study reminders, and email is 

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requested so that the study personnel might share the intervention resource with 
participants in the control condition at the end of the study. Participants will also 
be asked if the study team can record the debriefing session. If so, consent will 
be obtained. 
IV. 
Participants will take baseline surveys; this will take approximately 25 minute. 
Next, participants will receive their experimental materials, which include a Wi-Fi 
enabled tablet that has been pre-loaded with either intervention or control 
materials on the browser. Participants will receive verbal and paper-based 
instructions from the research assistant on how to log into the online, tailored 
website (intervention condition) or how to access the generic informational 
website (control condition). Participants will be debriefed, thanked for their time, 
and scheduled for a slot for their 1-month follow up visit. Participants will receive 
    
$25 for their participation. 
 
One-month follow up: 
• Participants will return to the Center for healthful Behavior Change at their 1- 
month follow up appointment. At this time, participants will be instructed to bring 
their tablets with them to return the device, and take a follow up survey. The 
survey will take approximately 25 minutes. 
• Participants will be thanked for their time, and scheduled for a slot for their for 
their 3-month follow up visit. Participants will receive $50 for their participation. 
 
Three-month follow up: 
• Participants will arrive at the CHBC for their 3-month follow up to simply take on 
last, follow up survey. Participants in the intervention condition will receive $25 
for their participation, debriefed, and released from the study. 
• Participants in the control condition will also receive $25 for their participation, 
debriefed, and instructed that they will receive access to the intervention 
resources via email after no later than 3 months. 
 
All outcome measures are located in Table 1. 
 
Table 1 Outcome Measures 
Baseline 
1 months 
3 months 
Demographic and Clinical 
Variables 
X 
 
 
Medical Outcomes Study 
Short Form 36 
X 
 
 
 
 
 
 
Internet Self-efficacy Scale 
X 
X 
X 
Clinical Trials Literacy 
X 
X 
X 

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Message Effectiveness 
Scale 
 
X 
X 
Clinical Vignette 
 
 
X 
 
 
 
 
 
 
IV.DATA ANALYSIS AND DATA MONITORING 
Throughout the study, Dr. Jean-Louis will oversee data entry and verification, ensure 
adherence to coding, clean and edit protocols.  Data will be maintained on a password-
protected PC with backup copies kept on external disks in a secured location.  
Participant-identifying information will be kept in a locked file cabinet with only numerical 
identifiers in computer files.   
Hypothesis 1: Participants exposed to tailored messages about clinical trial literacy will 
exhibit greater likelihood in participating in clinical trials than those exposed to NYU’s 
standard website.  Secondarily, we expect them to show greater likelihood to refer 
others to clinical trials as well. 
Analysis:  While the primary goal of the study is to develop and test effectiveness of 
tailored messages to overcome identified to participating in clinical trials, the secondary 
goal is to examine factors likely to facilitate adoption of such messages.  All participants 
in the intervention arm will have been exposed to all tailored web-based messages.  To 
compare participants who exhibited improvement in health literacy and those who did 
not 2-months post-enrollment, t-tests and chi-squared tests will be used.  Baseline 
subjective factors will be entered in a logistic regression model in order to determine 
which factors are associated with higher likelihood of (a) registering to participate in 
clinical trials, contrasting individuals in the two study arms and (b) referring others to 
participate as well.  Multivariate analysis of covariance will be used to assess effects of 
messages on the secondary outcome: health literacy scores; effects of 
sociodemographic confounders will be adjusted. 
Hypothesis 2: Greater likelihood of participating in clinical trials will be mediated by 
greater health literacy and/or self-efficacy independent of other individual-level factors 
(medical, knowledge, attitude/beliefs, and intrinsic motivation) and contextual-level 
factors (social support and socio-economic position). 
Analysis:  We will examine the path toward greater participation in clinical trials using 
Structural Equation Modeling (SEM). SEM will determine influences of 
mediating/moderating factors on the role of tailored messages in improving participation 
rates in existing clinical trials. Specifically, we will use moderated path analysis from 
Baron and Kenny’s model.  We chose these factors based on research showing 
acceptable effect size in predicting likelihood of increased participation.  Alternatively, 
we will employ probabilistic modeling methods (e.g., Bayesian Belief Network) to 
investigate interactions (omni-directionality) among predictors and different pathways to 
the desired study outcomes, determining which factors best differentiate cases and 
controls. Thus, we will ascertain patient characteristics most likely to show improvement 
in rates of participation. 

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V. STATISTICAL PLAN 
Power Calculations: Primary Objective: Assuming a medium effect size (d = 0.32), as 
derived from Cohen, and a sample size of 100, the study will be adequately powered (> 
80%) to detect significant differences between participants likely to show improvement 
in health literacy scores and those who are not using Fisher’s Exact tests (critical X2 = 
6.58).  This will also permit detection of a significant increase in the number of 
participants in the intervention arm opting to register for clinical trials.  In a previous pilot 
study, we found that 45% of minority patients in the community adopted 
recommendations for medical treatments after exposure to tailored health messages, 
which compares to 25% who did without such exposure. Assuming a 20% increase in 
the likelihood of adopting health messages and a sample size of 100, the proposed 
study will have adequate power for a preliminary test of the hypothesis that exposure to 
health messages will foster greater update of tailored health messages and 
improvement in clinical trial health literacy level.  Achieving the goal of a 20% increase 
would have an important public health impact regarding adoption of messages about 
clinical trials. A two-tailed test, with 80% power and α= 0.05 comparing 25% to 45% 
requires 50 participants per arm.  The study is powered to assess differences in 
participation rates between the two arms as well as the mediating effect of individual 
and contextual factors between tailored clinical trial messages and participation rates, 
considering a 23% attrition rate. 
 
VI. DATA HANDLING 
 
Confidentiality 
Steps will be thoughtfully taken throughout the execution of this study to maintain 
confidentiality of participant data. First, consent forms will be retained in locked cabinet. 
Only the PI and lead administrative assistant to the CHBC will have access to the key. 
In addition, all participant data will be made anonymous.  
 
All personal identifiers will be removed and replaced with a pseudonym. In addition, any 
comments that could potentially identify a participant will be removed and discarded. All 
participant data collected in Phase III Intervention/Control activities will be assigned a 
user ID, only the consent form will link a participant with their responses, and consent 
forms will be retained in locked cabinet described above. 
 
Furthermore, all spreadsheets with participant information will be retained in password 
protected computer, with Firewall and security software in compliance with the latest 
guidelines of the Medical Center Information Technology (MCIT) department. 

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VII. Data Safety and Monitoring  
In compliance with Merck Pharmaceuticals requirements, we will establish a Data 
Safety Monitoring Plan (DSMP). The purpose of the DSMP is to ensure the safety of 
participants and the validity and integrity of the data. The DSMP will be tasked to 
develop its data sharing plan in consultation with representative(s) from the research 
office at NYU Langone Medical Center. Data will be made available from the medical 
center’s website once the main findings of the project will have been published. The 
plan will incorporate language to ensure that the rights and privacy of people who 
participate in Merck Pharmaceuticals-sponsored research are protected at all times. 
Thus, data will be free of identifiers that would permit linkages to individual research 
participants and variables that could lead to deductive disclosure of individual 
participants. All requests for data will be reviewed by the DSMP internal committee 
before access to the data is granted. 
 
Personnel involved in the monitoring activities will include: 
• The Principal Investigator, Dr. Girardin Jean-Louis 
• The Co-Investigators: Drs. Alicia Chung, Rebecca Robbins, Azizi Seixas 
 
• Study Coordinator: Shannique Richards 
 
The data and safety monitoring plan will comprise the following elements: Reporting of 
adverse events to the NYU Langone Medical Center’s IRB, as well as the study 
sponsor, Merck Pharmaceuticals. Summaries of adverse events reports will be made to 
Merck Pharmaceuticals in the yearly progress report or, at the end of year 2, in the final 
report, unless the nature of a particular event is such that it bears reporting to Merck 
Pharmaceuticals immediately. 
 
 
 
VIII. RISK/BENEFIT ASSESSMENT 
 
Risks/Discomfort : 
1). Psychological Discomfort answering questions 
The physical and psychological risks of the study are minimal, as no invasive procedures 
are proposed. No PHI will be collected by accessing the website; access to such sites will 
be restricted.  As part of the process involved in obtaining written consent, all participants 
will be reminded that their responses are confidential and that they may refuse to 
participate in the project or withdraw at any time without explanation.  
2). Potential loss of confidentiality 

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To protect confidentiality, consent forms will be stored in locked files, with data coded so 
that identification of an individual’s data can only be made with a master list. This list will 
also be kept in a locked file and will be available only to the PI or the research assistant. 
While we do not anticipate any adverse events, we will comply with reporting 
requirements as required by the Institutional Review Board. 
Potential Benefits to the Subjects 
The dissemination procedures are designed to be practical so that, if efficacy is 
demonstrated, they can be widely adopted. By evaluating the intervention in the context 
of a community-based setting, we can evidence to other organizations how tailored 
health messages can promote uptake of healthful messages. There are other 
populations in the country, with similar settings that might adapt this type of health 
information diffusion in their communities. It will also evidence that partnership between 
academic investigators and community providers and stakeholders is a proven 
approach to establish a strong infrastructure to enable translational and dissemination 
research. 
 
IX. INVESTIGATOR’S QUALIFICATIONS AND EXPERIENCE 
See attached CVs.  
 
X. Publication Plan 
We anticipate developing 2 manuscripts in each year of the proposed study. We plan to 
submit these manuscripts to journals such as American Journal of Public Health and 
Trials. We will plan to submit the first manuscript by December 1, 2017. These 
manuscripts will emanate from abstracts that will be developed for scientific meetings, 
including American Public Health Association, Society for Behavioral Medicine, and 
Society of Clinical Research Associates (SOCRA). 
 
 
 
 
 
 
 
 

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