Guardians Receiving Information Through Navigators
Phase: NA
Conditions: Oral Health, Child, Adolescent, High-risk, Community Health Workers
Sponsor: KDH Research & Communication

  
Research protocol for GRIN outcome evaluation 
 
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GUARDIANS RECEIVING INFORMATION THROUGH NAVIGATORS (GRIN) 
STUDY PROTOCOL 
5R44MD016352-03 
AUGUST 8, 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
Research protocol for GRIN outcome evaluation 
 
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KDH RESEARCH & COMMUNICATION 
RESEARCH PROTOCOL FOR GRIN OUTCOME EVALUATION 
 
 
BACKGROUND 
  
Purpose of Research 
KDH Research & Communication (KDHRC) received funding from the National Institutes of 
Health (NIH) National Institute on Minority Health and Health Disparities (NIMHD) to develop 
and evaluate Guardians Receiving Information through Navigators (GRIN). GRIN is an online 
professional development course (course) that aims to prepare community health workers 
(CHWs1), trusted community lay health workers familiar with their communities’ needs and 
resources, to provide oral health outreach to low-income Black guardians of children and 
adolescents (henceforth, Black guardians). 
 
In Phase II, KDHRC finalized the GRIN course with eight full course lessons with text, video 
vignettes, and artificial intelligence (AI) avatar simulations. KDHRC proposes to conduct a 
randomized controlled trial (RCT) to evaluate the extent to which the GRIN course increases 
CHWs’ knowledge, attitudes and beliefs, perceived self-efficacy, and intentions to conduct oral 
health care outreach to low-income Black guardians. KDHRC will conduct the study with CHWs 
nationwide.  
 
The study will consist of pretest, posttest, and 3-month follow-up surveys. CHWs will be 
assigned to the treatment condition (up to eight lessons) or the control condition (pages from the 
American Dental Association (ADA) website). Participants may complete the study completely 
virtually (e.g., receive all links and reminders via email and phone/text communication) or 
during an in-person event (e.g., receive all links via flyers and verbal reminders during the 
event).  
 
This protocol describes the procedures for the study. 
 
Responsible Parties 
Dexter Cooper, MPH, is the Principal Investigator of the GRIN project. Nicole Wanty, 
KDHRC’s senior research scientist, is the Project Director. Elizabeth Phelps, a KDHRC 
researcher, will manage the study. 
 
Specifically, KDHRC will:  
• Contract with a recruitment contractor to share study materials with referral partners, 
share the study with the KDHRC CHW Panel2, and conduct evaluation sessions at CHW 
conferences to recruit participants.  
• Program and manage the online eligibility and consent forms, pretest survey, posttest 
 
1 CHWs include community health workers (CHWs), community health representatives (CHRs), lay health 
workers, and other titles. 
2 The KDHRC CHW Panel is a list of CHWs who have opted-in to receive communications about program 
development and study opportunities. 

  
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survey, and 3-month follow-up survey. 
• Send follow-up communications to consented participants. 
• Manage, clean, and analyze data. 
• Manage incentive distribution. 
• Report on study findings. 
 
KDHRC will use a multi-pronged recruitment strategy to recruit up to 320 CHWs to participate 
in the study, including: 
1. Hiring a contractor to manage recruitment of CHWs  
a. The contractor will briefly explain the research study and provide an overview of 
the study requirements, time commitment, and consent process to participating 
sites (e.g., community-based organization (CBO) and other CHW organizations). 
2. Sharing the opportunity with the KDHRC CHW panel. The CHW panel includes CHWs 
who have voluntarily signed up to be notified about future research opportunities.  
3. Attending the National Association of Community Health Workers (NACHW) Annual 
Conference, the Southeast Community Health Worker Network Summit, and other CHW 
conferences 
4. Recruiting participants via social media or through another recruitment panel provider 
 
For approach #1, KDHRC will begin work with the contractor by scheduling a kick-off call, 
during which KDHRC will briefly explain the study and provide an overview of the study 
requirements, time commitment, and consent process. The Contractor will then share the 
KDHRC-developed and IRB approved referral materials (e.g., flyer, email template) with 
participating sites.  
 
RESEARCH DESIGN 
 
Goal 
The goal of the GRIN study is to examine the impact of the GRIN online professional development 
course. Specifically, the study aims to explore the following research question: “To what extent does 
the GRIN course increase CHWs’ knowledge, attitudes and beliefs, perceived self-efficacy, and 
intentions to conduct oral health care outreach to low-income Black guardians of children and 
adolescents?”  
 
Approach 
The study will use a treatment/control, pretest/posttest/follow-up design. KDHRC will program the 
eligibility and consent forms, and the pretest /posttest/follow-up surveys in Alchemer, a secure 
online survey platform.  
 
The study will include up to 320 CHWs nationwide (160 treatment groups, 160 control groups). 
After referral to the study, CHWs will access an online link for eligibility screening and 
informed consent form. Across all approaches named above, information about the study will be 
shared with potential participants through KDHRC-developed and IRB-approved referral 
materials (e.g., email template, flyer, social media posts). The referral materials will contain the 
link to the eligibility form, information on the time commitment, and instructions for contacting 
KDHRC with questions. KDHRC will also share the study opportunity with the KDHRC CHW 

  
Research protocol for GRIN outcome evaluation 
 
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panel and at CHW conferences, like the National Association of CHWs Annual Conference and 
the Southeast Community Health Worker Network Summit. 
 
Eligibility criteria for CHWs include: 
• Must be at least 18 years old. 
• Must have six months of field experience. KDHRC defines “field experience” as 
conducting outreach activities in their community, for example, working with clients in a 
clinic, conducting home visits, or educating clients at health fairs or community events. 
• Must be an active CHW/health educator/individual who conducts health outreach. 
KDHRC defines “active” as conducting outreach activities, such as working with clients 
in a clinic, conducting home visits, or educating clients at health fairs or community 
events, in the last six months. 
• Must have Internet access either at home or at work (or at in-person session). 
 
These criteria will be assessed through the eligibility screener, after which each eligible 
participant will see a consent form. KDHRC will confirm consent for each participant and after 
confirming consent, KDHRC will randomize each participant with completed consent into the 
treatment or control group. KDHRC will alternate assigning each participant with completed 
consent to the treatment or the control groups. Then, KDHRC will provide each participant with 
the link to the online pretest survey. After completing the pretest survey, each treatment group 
participant will receive access to the GRIN course (up to eight lessons). The control group will 
be directed to ADA webpages. 
 
Virtual-only 
Virtual-only participants will complete the above eligibility, consent, and pretest steps 
independently via computer, tablet, or phone. After completing the pretest, KDHRC will email 
the participant access to the appropriate treatment or control links. Treatment and control 
participants will have up to three weeks to review their assigned materials. KDHRC will send at 
least one reminder (email or phone) per week to participants to promote continued engagement 
with the study (e.g., remind treatment participants to complete the GRIN lessons; remind control 
participants of the date when they will receive their posttest survey). After reviewing the 
assigned materials, participants will receive the link to the online posttest survey. Then, three 
months after the posttest survey, KDHRC will send the link to the online follow-up survey 
(treatment group only).  
 
In-person 
KDHRC may host in-person sessions at CHW conferences and meetings. For in-person sessions, 
KDHRC will divide the treatment and control participants into separate rooms to prevent 
potential crosstalk. Participants who complete the study in-person will receive food and 
refreshments during the session, which will last approximately 2.5 hours. In-person session 
participants will receive links to complete all eligibility, consent, and surveys during the session. 
 
KDHRC will distribute a flyer with the link and QR code to access GRIN lessons (treatment) or 
control materials (ADA webpages). After reviewing the assigned materials, KDHRC will 
provide participants with a flyer with the link to the posttest survey. Then, three months after the 

  
Research protocol for GRIN outcome evaluation 
 
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posttest survey, KDHRC will send the link to the online follow-up survey (treatment group 
only).  
 
Incentives 
Each participant in both the treatment groups and the control groups will receive a $25 Amazon 
gift card incentive for completing the pretest survey, and a $50 Amazon gift card incentive for 
completing the posttest survey for a total of up to $50 in card incentives. Treatment participants 
will receive an additional $50 Amazon gift card incentive for reviewing the full GRIN course 
and a $25 Amazon gift card for completing the follow-up survey.  
 
Participants who complete the study virtually will receive an e-gift card incentive. In-person 
session participants will receive their physical gift card upon completion of the posttest survey 
and prior to exiting the session. Participants who complete the session in-person will also receive 
food and refreshments during the session.  
 
The links to the pretest, posttest, and follow-up surveys will be used to collect participant data 
and access to the secure survey platform responses is restricted to KDHRC research staff. 
Therefore, only KDHRC research staff will have access to raw data. Each survey will take no 
more than 30 minutes to complete.  
 
Analysis 
KDHRC will program the eligibility and consent forms, pretest/posttest/follow-up surveys, in 
Alchemer, a secure online survey platform. After completion of the study, KDHRC will 
download the raw data from Alchemer into encrypted Excel spreadsheets.  
 
KDHRC will import the data into STATA, a quantitative statistical software, to analyze and 
assess the extent to which the GRIN course increases CHWs’ knowledge, attitudes and beliefs, 
perceived self-efficacy, and intentions to conduct oral health care outreach to low-income Black 
guardians. 
 
Timeline 
The study will begin immediately upon obtaining IRB approval. All data collection will conclude 
by March 31, 2026.  
 
DATA COLLECTION 
KDHRC will collect quantitative data from up to 320 CHWs (160 CHWs per treatment groups, 
160 per control groups) through online surveys. If KDHRC encounters low referral numbers 
and/or high attrition rates, then KDHRC will utilize additional referral methods (e.g., social 
media, recruitment vendor/panel) to reach additional participants. This will not impact on the 
rights of or risk to study participants.  
 
Identifying Information 
The recruitment contractor and sites will not have access to enrolled participants’ survey 
responses. Although the recruitment contract and sites may have access to potential participant 
information (e.g., name, email address) from their listservs, they will not have knowledge of who 
truly participates as study participants and will not have access to enrolled participants’ data.  

  
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KDHRC will not share consented participants’ names or contact information. KDHRC will 
collect participants’ names, email addresses, and phone numbers to share study information and 
send reminders. KDHRC will not link names or other identifying information to the responses. 
Each participant will create an ID number based on survey questions at the start of each survey 
(last two letters of his or her last name, his or her three letter initials, and his or her year of birth). 
KDHRC will collect this information solely to match participant data. Although each 
participant’s ID number will be collected at the start of each survey, participants will not enter 
full names or provide other identifying information to researchers through the surveys.  
 
KDHRC will save all raw data on KDHRC’s secure server in project specific, password 
protected files. KDHRC will not share personal information (participant name, phone number, 
email address) regarding participants with any third party without the participant’s written 
permission unless it is required by law to protect their rights or to comply with judicial 
proceedings, a court order, or other legal processes. Data will remain stored on a password-
protected computer or in a locked cabinet accessible only by KDHRC, as outlined in Table 1.  
 
KDHRC will submit de-identified data from this study to a public access repository, such as 
OpenICPSR (Inter-university Consortium for Political and Social Research). It is a requirement 
of the study’s federal funding to share the data to a repository to make data accessible and useful 
for the American public, businesses, and researchers. The goal of data sharing is to improve the 
use of data for decision-making and accountability for the Federal Government, thereby 
increasing transparency and reproducibility. For more information, please see the National 
Institutes of Health Data Management and Sharing Policy 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html).     
 
To protect research participants, before data sharing in the repository KDHRC will:  
• Remove any personal information from the shared data that could identify a specific 
person (like name, birthdate, age, gender, address including zip code, etc.).  
• Assign each participant’s data a code number to distinguish one study participant from 
another.  
 
De-identified data from this study will be made publicly available (e.g., on the OpenICPSR 
website). Anyone can use information from a public access repository for any purpose in the 
future. There are no more than minimal risks to participants in the study as a result of this data 
sharing requirement. 
 
Table 1. Data Retention 
 
DATA  
TYPE 
DELETION  
TIMELINE 
STORAGE  
LOCATION 
DELETION  
METHOD 
Screener contact 
information listing 
all potential 
participants that have 
screened into the 
feasibility study. 
 
One month after the end of 
data collection to allow time 
for incentive delivery. 
Stored on a password-
protected computer or a 
locked cabinet accessible 
only by KDHRC. 
Destroyed by 
permanently deleting 
from the computer 
and shredding 
documents. 

  
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Quantitative 
screener data 
3 years after data analysis 
ends. 
Stored on a password-
protected computer or a 
locked cabinet accessible 
only by KDHRC. 
Destroyed by 
permanently deleting 
from the computer 
and shredding 
documents. 
Participant consent 
forms 
3 years after data collection 
ends. 
Stored on a password-
protected computer or a 
locked cabinet accessible 
only by KDHRC. 
Destroyed by 
permanently deleting 
from the computer 
and shredding 
documents. 
Participant survey 
responses 
3 years after data analysis 
ends. 
Stored on a password-
protected computer or a 
locked cabinet accessible 
only by KDHRC. 
Destroyed by 
permanently deleting 
from the computer 
and shredding 
documents. 
De-identified survey 
responses 
Will not be deleted, shared to 
public access repository after 
data analysis ends. 
Maintained by repository 
(e.g., on the OpenICPSR 
website). 
N/A 
 
Assurance of Confidentiality 
Confidentiality is crucial to the protection of human subjects. Therefore, KDHRC will strictly 
follow its established procedures on the protection of confidential information. Moreover, all 
KDHRC staff who have access to these data will sign confidentiality pledges. Online surveys 
will be used to collect participant data, therefore only KDHRC staff will have access to raw data. 
KDHRC will keep information that participants provide private and confidential. KDHRC will 
inform participants prior to their participation that their responses are confidential. KDHRC will 
also advise participants of the nature of the activity, the length of time it will require, and that 
participation is purely voluntary and that they can stop at any time. KDHRC will assure 
participants that no penalties will occur if they wish not to respond, either to the information 
collected as a whole or to specific questions.  
 
As a further confidentiality guarantee, KDHRC will present data in reports in aggregate form 
only and will not preserve links to individuals. KDHRC will track consent electronically and 
collect data through Alchemer, the online platform that is only accessible with the KDHRC 
username and password. Further, KDHRC will store participant responses in password-protected 
files on the KDHRC cloud-based server. As noted above, KDHRC will submit de-identified data 
from this study to a public access repository, such as OpenICPSR (Inter-university Consortium 
for Political and Social Research). 
 
Mitigation of Potential Risks  
KDHRC acknowledges that the referral approach introduces the potential for coercion into the 
study. KDHRC has carefully crafted several safeguards against coercion given this potential 
which is outlined below:  
• The recruitment contract will work with sites (e.g., CBOs and other CHW organizations) 
who are promotional and referral partners and will not directly refer participants. 
Although sites will promote participation to potential participants and may have access to 
potential participant information (e.g., name, email address) from listservs at their 
respective organizations, no site will have knowledge of who ultimately participates in 

  
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the study and will never have access to enrolled participants’ data. KDHRC will not share 
participant names with sites.  
• The recruitment contractor and sites must adhere to the following rules to avoid coercion: 
o Send general announcements with the promotional materials to his/her full 
network of contacts. Not approaching CHWs individually about participating in 
the study. This includes sending individual emails to CHWs about the study, 
talking one-on-one with CHWs about the study, and/or calling CHWs 
individually about the study. All promotional activities must be done on a group-
wide basis.  
o Never ask CHWs if they enrolled in and/or completed the study.  
o Never communicate or imply that CHWs “must” or “should” participate in the 
study. Participation must be presented as optional and discretionary.  
• KDHRC will remind participants that participation in the study is completely voluntary, 
that the sites that shared promotional materials with the participant will not have 
knowledge of who serves as study participants, and that his or her participation is no way 
tied to his or her position at and/or relationship with the site that shared promotional 
materials with him or her. These tenets are clearly stated in the study consent form.  
 
Assessment and Reporting of Protocol Deviations and Adverse Events 
KDHRC’s IRB is listed on the consent form if participants have questions about their rights as 
research subjects. 
 
The PI and project director will ensure that there are appropriate oversight systems in place to 
monitor all research activities and identify any adverse events or deviations from the study 
protocol. Upon discovery of an adverse event, the PI is responsible for reporting protocol 
deviations to the IRB using a standard reporting form. Any protocol deviations will be reviewed 
by the PI to assess whether participant safety or study integrity has been affected by the deviation 
and to what extent the deviation has affected the project. If the deviation meets the threshold for 
a protocol violation, appropriate measures will be taken to address the occurrence, which may 
include the development of a corrective action plan. Any protocol violations and corrective 
action plans will be reported to KDHRC IRB. In addition, corrective actions that lead to a change 
in the protocol shall be submitted to and approved by KDHRC IRB as an amendment to the 
protocol prior to implementation. 
 
Subject privacy and data confidentiality breaches are serious risks and will be reported within 
one hour of discovery to NIH and the KDHRC IRB (etwombly@7research.org).  
 
The following will be communicated in an initial notification to the NIH and KDHRC IRB 
(etwombly@7research.org) as soon as possible (generally within 24 hours) with a full report 
submitted within 10 days.  
• Serious Adverse Event: An adverse health event that is life-threatening or results in 
death, initial or prolonged hospitalization, disability or permanent damage, congenital 
anomaly, or birth defect, or requires medical or surgical intervention to prevent one of the 
other outcomes.  
• Unexpected Adverse Event: An adverse health event that was not identified in nature, 
severity, or frequency in the research protocol/informed permission documents.  

  
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• Unanticipated Problem: Any incident, experience, or outcome that meets all the 
following criteria:  
1. Unexpected (in terms of nature, severity, or frequency) given a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed permission document; and b) the 
characteristics of the subject population being studied;  
2. Related or possibly related to the subject’s participation in the research; and  
3. Suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) related to the 
research than was previously known or recognized.  
• Protocol Violation: Any change, divergence, or departure from the study design or 
procedures of a research protocol that affects the subject's rights, safety, or wellbeing 
and/or the completeness, accuracy, and reliability of the study data.  
 
The following will be communicated on a routine non-urgent basis but no less than annually:  
• Expected Adverse Events: Those health effects and other risks that are listed in the 
protocol and informed consent forms as being likely to occur or as a result of 
participation in the study.  
• Minor Protocol Deviation: Any change, divergence, or departure from the study design 
or procedures of a research protocol that has not been approved by the IRB and that 
DOES NOT have a major impact on the subject's rights, safety, or well-being, or the 
completeness, accuracy, and reliability of the study data.