Reducing Drug-Related Mortality Using Predictive Analytics: A Randomized, Statewide, Community Intervention Trial
Phase: NA
Conditions: Opioid Overdose, Drug Overdose
Sponsor: Brown University

 
 
The Preventing Overdose Using Information and 
Data From the Environment (PROVIDENT) Study  
STUDY PROTOCOL 
NCT05096429 
 
Document Date: ​  ​
     ​
June 25, 2024 
 
Upload Date: ​
​
​
October 17, 2025 
 
Official Study Title:  
Reducing Drug-Related Mortality Using Predictive Analytics: A Randomized, 
Statewide, Community Intervention Trial 
 
U.S. NIH Grant/Contract Award Number: 
R01DA046620 
 
Principal Investigators: 
Brandon DL Marshall (Brown University) 
Magdalena Cerdá (New York University Langone Health) 
 
Scope: 
This document covers (a) Phase 1 PROVIDENT model development, (b) the Phase 2 
randomized cluster trial (39 Rhode Island municipalities randomized 1:1 to PROVIDENT vs 
comparator), (c) a parallel Phase 2 implementation study (surveys/focus groups; staff 
enrollment; no randomization of individuals), and (d) the COVID-19 supplement study. The 
ClinicalTrials.gov record (NCT05096429) reports only the Phase 2 randomized cluster trial. The 
implementation study, Phase 1 model development, and COVID supplement are not 
included. 

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Brown University
Human Subjects Research Application
Instructions on how to complete this application can be found in our guidance tool.
Study Title:  PROVIDENT (Preventing Overdose using Information and Data from the Environment) R01 
DA046620  
Principal Investigator: Brandon DL Marshall, PhD 
If PI is a graduate/medical student, please upload Appendix I: Human Subjects Research Advisor. 
1. Provide the scientific background of the study. 
Phase 1 – PROVIDENT Model Development (original parent application; approved November 
2019): In light of the accelerating and rapidly evolving overdose epidemic, new strategies are needed 
to identify communities most at risk, and to utilize resources more effectively to curb overdose 
deaths. To address these public health priorities, we will develop a forecasting tool to predict 
overdose deaths before they occur, and then conduct a randomized, statewide, community-level 
intervention to evaluate resource targeting based on these predictions. This tool, called PROVIDENT 
(Preventing Overdose using Information and Data from the Environment), will be used to identify 
neighborhoods at high risk of future overdose outbreaks.
Phase 2 – Cluster Randomized Trial (Amendment 4; approved September 2021): We will 
conduct a randomized policy experiment to evaluate whether targeting overdose prevention 
interventions to neighborhoods at the highest risk reduces overdose morbidity and mortality. The 
state's department of health will receive PROVIDENT model prediction maps for half of the 39 
cities/towns in Rhode Island and work with community-based organizations to prioritize and allocate 
resources according to model predictions. Community-based organizations will access model 
prediction maps through the secure Web Tool, and maps will be updated every six months. 
Phase 2 – Implementation Study (Amendment 4; approved September 2021): Machine learning 
methods offer significant potential as an innovative intervention to curb the ongoing and escalating 
overdose crisis. These methods help to predict, or forecast, persistent and emerging hotspots in 
neighborhoods at risk for increased overdose activity. Machine learning predictions can enable 
community organizations and state health departments to better assess, plan, and intervene in a 
neighborhood in ways that traditional surveillance does not allow. That is because traditional 
surveillance datasets (i.e., overdose deaths, emergency department visits, and ambulance runs) are 
limited to past events and subject to greater regional variation over time. Machine learning methods 
can enhance existing overdose surveillance efforts by leveraging additional structural datasets (such 
as census data) to identify persistent hotspots.  
However, using machine learning methods to drive service delivery and intervention warrants 
caution, particularly regarding the support needed for optimal uptake and fidelity of an innovative 
intervention. Furthermore, the extent to which the intervention is used effectively within 
organizations and across the state is yet to be determined. To address these concerns, we are 
conducting an implementation study using an ecological framework, where we will assess factors 
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across such a framework.  
COVID Supplement (Amendment 2; Approved November 2020): The proposed research 
addresses significant limitations to previous studies of the impacts of ‘big events’ on drug-related 
harms. Most research conducted in the aftermath of ‘big events’, such as natural disasters, are cross-
sectional and focusing on the immediate impacts of the ‘big event’ among convenience samples. This 
supplemental research uses several population-based datasets to create a representative picture of the 
variegated impacts of the COVID-19 pandemic and the associated response among PWUD. Further, 
the use of an interrupted time series design allows for the assessment of both abrupt changes in the 
short-term and gradual changes in the long-term following the ‘big event’. These findings have the 
strong potential  to  inform  the  mitigation  of  both  the  immediate  and  long-
last  impacts  of  future  public health  crises towards the building of more resilient harm reduction 
and substance use treatment systems.  
2. Identify the research question(s) of the study and how the study will contribute to generalizable 
knowledge. 
Research Question: How are current responses to the opioid overdose epidemic limited by the 
available surveillance data?
Most overdose mortality surveillance systems suffer from substantial delays due to the complex 
nature of overdose death investigations. Thus, many data-driven responses to the epidemic are often 
based on outdated information, potentially limiting intervention effectiveness. Furthermore, despite 
myriad federal and statewide initiatives, few interventions are targeted to the most heavily affected 
communities, thus reducing their potential impact. 
To overcome this limitation, we propose a new paradigm in overdose prevention. Rather than target 
interventions based solely on past overdose burden, we will use predictive analytics methods and 
timely surveillance data to identify neighborhoods at highest risk of future overdose deaths. 
Specifically, we will leverage spatial machine learning methods to develop a predictive analytics 
model. This model, called PROVIDENT (Preventing Overdose using Information and Data from the 
Environment), will be used to create neighborhood-level overdose risk indices, representing the 
likelihood of future overdose deaths.
1. PHASE 1: As described in the parent IRB application, we will develop a predictive analytics 
model to forecast future overdose mortality at the neighborhood level, defined as census block 
groups. There are 809 populated census block groups in Rhode Island, grouped in 39 cities/towns. 
We will use a spatiotemporal machine learning approach, in which the outputs of multiple 
classification and spatial-temporal machine learning prediction models are combined based on 
minimizing cross-validated risk. An overdose risk index will be generated for each census block 
group, which represents the forecasted probability of an overdose death in the subsequent 12-month 
period.
2. PHASE 2: As described in Amendment 4, we will launch the Phase 2 randomized cluster 
intervention trial and the Phase 2 implementation study. The primary outcome of the PROVIDENT 
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trial will be annual city/town-level overdose rates, measured from six months after the interventions 
have been implemented. Data collection methods will include a continuation of secondary data 
transfers with RIDOH and analyses established in Phase 1. We  will  evaluate,  at  the  city/town  
level,  whether targeted  intervention  deployment to neighborhoods at high risk of future overdose 
reduces population-level overdose morbidity and mortality. Fatal overdoses will be defined as 
accidental drug-related deaths deemed by a medical examiner to be attributed to a prescription or 
illicit drug. Non-fatal overdoses will be defined as ED visit for a suspected overdose reported through 
the state’s 48-Hour Overdose Reporting System. 
The implementation study is a parallel study designed to better understand how contextual factors and 
implementation strategies impact the overall uptake, reach, and fidelity of the PROVIDENT 
prediction tool. Data collection methods include surveys, focus groups, key informant interviews, and 
a Brown-CIS build Web Tool database. The Ecological Framework (Durlack & Dupre, 2008) 
highlights five key areas for analyzing both the characteristics of the intervention and the setting in 
which the intervention is implemented, and seeing how those factors affect the overall success of the 
larger intervention. Using this framework, we will analyze Community-Level Factors, Provider 
Characteristics, Characteristics of the Innovation, Organizational Capacity, and the Prevention 
Support System (Statewide systems) (See Table 1.)  Specifically, we want to understand how the 
roles of individual-level data literacy (defined broadly as knowledge of data quality, data reliability, 
and understanding data-driven maps) and organizational-level data maturity (defined broadly as an 
organization's data capabilities across several dimensions) affect the implementation of an innovative 
intervention at the community and state levels. We also want to understand whether planned technical 
assistance efforts are enough to increase the fidelity and reach of the PROVIDENT intervention. We 
hypothesize that by providing timely and responsive technical assistance sessions for these factors 
both prior to, during, and following the launch of the innovative intervention, we will be able to 
increase the overall fidelity and reach of the intervention (see Figure 1).  Other qualitative themes to 
assess include organizational structures and activities such as support and oversight for administrative 
work (administrative supervision); training and support around emotional labor, trauma exposure and 
outreach skills; themes of stress and burnout among peer workers; and assessing organization's 
comfort with harm reduction interventions (versus abstinence-focused services or medication for 
treatment).  We believe that the Ecological Framework's themes related to organizational capacity 
will also play an important role in the implementation and may offer additional insights for adapting 
or further co-creating elements of the innovation and available harm reduction services to meet the 
needs of the community.
The primary aim of this study is to understand factors of implementation (individual data literacy, 
organizational capacity and culture, organizational data maturity) that may influence the utilization of an 
online mapping tool ( The PROVIDENT Web Tool, which is the interface for the PROVIDENT Model results) 
(See Figure 1). The secondary aim is to assess web tool utilization, including statewide reach of the web tool 
and harm reduction dosage at the neighborhood level. We will map out how these factors may contribute to the 
outcomes of the larger intervention trial (reduction in overdose deaths) (See Table 1 in Question 7, Study 
Procedures)
Theory/Framework/Type of study Prospective Implementation study: 
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Qualitative mixed methods Ecological Framework, a multilevel framework for understanding effective 
implementation (Durlak, Dupre 2008). 
Figure 1. PROVIDENT Implementation Study Overview
COVID Supplement 
Research Question: How do policies enacted as part of the response to the COVID-19 pandemic 
impact the use of harm reduction and substance use treatment services and rates of non-fatal and fatal 
overdoses? What is the relationship between acute changes in SARs-CoV-2 diagnoses and COVID-
19 hospitalizations and deaths at the community level on rates of non-fatal and fatal drug overdose?
The proposed research aims to identify and assess the magnitude of adverse effects of the COVID-19 
pandemic and the associated policy responses on the ongoing drug overdose epidemic. This work will 
help build an urgently needed evidence base to determine how best to effectively manage these 
impacts and to support the building of more resilient harm reduction and substance use treatment 
systems in the face of future unanticipated public health crises (e.g., emerging outbreaks, natural 
disasters, civil unrest, and war). This work  is  also  well-aligned  with  the objectives of the NIDA 
notice of special interest (NOT-DA-20-  47), including research to understand and mitigate the impact 
of COVID-19 on methadone treatment programs, syringe exchange services, and other interventions. 
In sum, this work will help build an urgently needed evidence base to determine how best to 
effectively manage the adverse effects of COVID-19 on the overdose epidemic, and to support 
addiction-related health and social service systems during unanticipated public health crises in the 
future.  
3. Describe each participant population for the study and list all eligibility criteria. 
Phase 1, PROVIDENT Model: The study will involve a retrospective review of existing overdose 
surveillance data in Rhode Island to build the PROVIDENT forecasting model. Secondary overdose 
surveillance data will help inform the creation of the PROVIDENT forecasting tool. This same 
overdose surveillance system will be used to capture the primary endpoints. In a review of 2014-2016 
data, accidental overdose events among children under 18 years of age were rare. However, we do 
wish to capture qualifying events for children aged 12 and older, as these may represent emerging 
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patterns, including an increasing risk of overdose among adolescents. As such, fatal and nonfatal 
overdoses occurring among individuals under 12 years of age will be included in all analyses. The 
gender and racial/ethnic breakdown of the participants representing these qualifying events will most 
likely be similar to that of the available underlying epidemiology of the overdose epidemic in Rhode 
Island from 2014-2016 data, approximately 72% male, and 80% white, as shown in more detail 
below:
Overdose Deaths in Rhode Island (2014-2016): 
Race: American Indian/Alaska Native 2% (n=10) 
Asian 1.5% (n=8) 
Native Hawaiian/Other Pacific Islander 1% (n=5) 
Black or African American 20% (n=100) 
White 60% (n=302) 
Mixed race 15% (n=75) 
Ethnicity: 
Hispanic/Latino Ethnicity 15% (n=75)
Gender: 
Female 33% (n=165) 
Fatal and nonfatal overdoses in Rhode Island (2014-2016): 
Age: 12-17 1% (n=36) 
18+ 99% (n=3,745)
In sum, there are no exclusion criteria related to age, sex/gender, or race/ethnicity in this study. 
Secondary analyses of overdose surveillance data will help inform the creation of the PROVIDENT 
forecasting tool. This same overdose surveillance system will be used to capture the primary 
endpoints described above. Based on 2016 data, we expect to observe approximately 1,800 events of 
fatal or non-fatal overdoses per year, which will be analyzed to evaluate the effects of the targeted 
community-level intervention.   
 
Phase 2 Implementation Study
GROUP 1
Inclusion Criteria: 
●
Participants must be at least 18 years old. 
●
Participants must be currently employed or volunteer with a harm-reduction or peer recovery 
organization in Rhode Island; the organization must be a Tier 1 organization. 
●
Participants must be willing to provide informed consent. 
●
Participants must attend at least one Technical Assistance workshop to be eligible for a pre and 
post survey (not a requirement for the focus groups or key informant interviews).  
●
Participants must not work at law enforcement.
Exclusion Criteria
●
Participants must not be currently employed or volunteer with a Tier 2 organization.
●
Participants must not work at law enforcement.
There is no upper limit to participant age. Across the community-based non-profit organizations in 
Rhode Island, the currently employed staff who engage with the RIDOH Task Force and Outreach 
Worker Meetings are all aged 18 and older. We anticipate that the study sample will reflect this age 
distribution with a minimum age of 18 years.  
There are no exclusion criteria related to age, sex/gender, or race/ethnicity in this study. Every effort 
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will be made to ensure that women and minority individuals are included in the study sample. The 
study will enroll individuals aged 18 and older who are current staff or volunteer at a community-
based non-profit organization in Rhode Island and the organization where they are employed is 
recruited through the Rhode Island Department of Health Task Force and Outreach Worker Meetings.  
We will recruit a purposive sample of professionals in the community through existing relationships. 
This means we plan to recruit from organizations with existing harm reduction service contracts with 
RIDOH. Specifically, RIDOH will refer existing organizational staff from each of their contracted 
harm reduction and outreach organizations by creating an introductory email. Brown will send 
follow-up emails to the organizational staff with information on how to participate if interested. Many 
staff at the organizations are peer-outreach workers and have prior lived experience with substance 
use. The organizations strive to have their staff reflect the demographics of the populations they 
serve. Therefore, we feel the sub-study will have overall demographics similar to those in the primary 
PROVIDENT study, including significant representation from women and minority individuals.  
In sum, there are no exclusion criteria related to age, sex/gender, or race/ethnicity in this study. 
GROUP 2
Inclusion Criteria: 
●
Participants must be at least 18 years old. 
●
Participants must be currently employed or volunteer with a community-based harm-reduction, 
peer recovery, or health equity organization in Rhode Island; the organization must be a Tier 2 
organization. 
●
Participants must be willing to provide informed consent. 
●
Participants must attend at least one Technical Assistance workshop to be eligible for a pre and 
post survey (not a requirement for the focus groups or key informant interviews).
Exclusion Criteria
●
Participants must not be currently employed or volunteer with a Tier 1 organization.
●
Participants must not work at law enforcement.
There is no upper limit to participant age. Across the community-based non-profit organizations in 
Rhode Island, the currently employed staff who engage with the RIDOH Task Force and Outreach 
Worker Meetings are all aged 18 and older. We anticipate that the study sample will reflect this age 
distribution with a minimum age of 18 years.  
There are no exclusion criteria related to age, sex/gender, or race/ethnicity in this study. Every effort 
will be made to ensure that women and minority individuals are included in the study sample. The 
study will enroll individuals aged 18 and older who are current staff or volunteer at a community-
based non-profit organization in Rhode Island and the organization where they are employed is 
recruited through the Rhode Island Department of Health Task Force and Outreach Worker Meetings.  
We will recruit a purposive sample of professionals in the community through existing relationships. 
This means we plan to recruit from organizations with existing service contracts with RIDOH within 
the harm reduction, overdose, and health equity communities (Tier 2 organizations). Many staff at the 
organizations are peer-outreach workers and have prior lived experience with substance use. The 
organizations strive to have their staff reflect the demographics of the populations they serve. 
Therefore, we feel the sub-study will have overall demographics similar to those in the primary 
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PROVIDENT study, including significant representation from women and minority individuals.  
In sum, there are no exclusion criteria related to age, sex/gender, or race/ethnicity in this study. 
Anticipated enrollment includes individuals from Groups 1 and 2
Anticipated total enrollment over the course of the two year study n = 180 (overlap between 
focus groups, key informant interviews, and surveys is expected). 
Anticipated enrollment in surveys over the course of the two year study n = 100 (split between 
Group 1 and Group 2 organizations). 
Anticipated enrollment in focus groups and key informant interviews over the course of the two 
year study n = 80 (split between Group 1 and Group 2 organizations).
The anticipated enrollment will not change by enrolling individuals from Tier 2 organizations to 
participate in the study through the Tier 2 expansion. Therefore, we are not requesting changes to n.
Phase 2 Cluster Randomized Trial  
Inclusion Criteria: Cities and towns in Rhode Island 
Exclusion Criteria: There are no exclusion criteria 
Target population distribution (e.g., women, minorities, etc.) 
The target population will be secondary data events from overdose surveillance records in the State of 
Rhode Island, randomized at the level of the city/town. Therefore, the target population for this 
project will be all persons residing in the State of Rhode Island. We anticipate the actual enrollment 
distribution for qualifying data events will be similar to the underlying epidemiological trends for 
overdose observed in the state. Currently, fatal and nonfatal overdose events affect all cities and 
towns across Rhode Island (see Table S2 in the DSMP). We expect the demographic breakdown of 
the participants representing the overdose-related events will be similar to that of the available 
underlying epidemiology of the overdose epidemic in Rhode Island from 2014-2016 data, 
approximately 72% male, and 80% white.
COVID-19 Supplement  
The study involves a retrospective review of the same existing overdose surveillance data in Rhode 
Island that is used for the Phase 1 PROVIDENT Model, therefore we expect the population 
distribution to be the same. Eligibility criteria include residents of Rhode Island. 
    
3.1 Select all vulnerable populations you intend to target for recruitment.
☐Brown 
Faculty, Staff, 
or Students
☐Children (30 
days – 17 years)
☒Justice-Involved☐Decisionally- 
Impaired
☒
At Risk for / 
Experiencing 
Substance Use 
Disorder 
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☐Students
☐Known 
Interpersonal 
Relationships
☐At Risk of / 
Experiencing 
Homelessness
☐Unauthorized 
Immigrants
☐
Refugees
☐LGBTQ+
☐Pregnant People ☐Fetuses / 
Neonates
☐ American 
Indian / 
Alaskan Native
☐ Disabled People 
/ People with 
Disabilities
Phase 1 PROVIDENT Model Development: 
Vulnerable populations selected: Justice-Involved, At Risk for / Experiencing Substance Use 
Disorder 
This research is a retrospective review of surveillance records, and there will be no more than 
minimal risk to the participants whose records may be included. This study involves no procedures 
for which written consent is normally required outside of the research context. As stated in 
attachment Marshall 2566, Subpart C Certification, 07-14-2021.pdf, the Office of Human Research 
Protections placed the research under category "CFR 46.306(a)(2)(i), "Study of the possible causes, 
effects, and processes of incarceration, and of criminal behavior, provided that the study presents no 
more than minimal risk and no more than inconvenience to the subjects,” and authorized the study to 
include prisoners in human subjects research. 
Phase 2 Randomized Cluster Trial:
Vulnerable populations selected: At Risk for / Experiencing Substance Use Disorder 
We are not targeting individuals at risk for experiencing substance use disorder for recruitment. We 
are using secondary data only. We will be enrolling cities and towns in the trial.
Phase 2 Implementation Study:
Vulnerable populations selected: At Risk for / Experiencing Substance Use Disorder 
We are enrolling individuals who may be at risk for experiencing substance use disorder for 
recruitment in Groups 1 and 2. Importantly, the revision request (Amendment 6/Modification 2) 
submitted to add Group 2 and Tier 2 organizations to the implementation study will not change the 
vulnerable populations selected for the Phase 2 Implementation Study because this population is 
approved for the Group 1 participant population, which is currently approved (Amendment 4). 
COVID-19 Supplement:
Vulnerable populations selected: Justice-Involved, At Risk for / Experiencing Substance Use 
Disorder 
The study involves a retrospective review of the same existing overdose surveillance data in Rhode 
Island that is used for the Phase 1 PROVIDENT Model. Similarly, there will be no more than 
minimal risk to the participants whose records may be included. This study involves no procedures 
for which written consent is normally required outside of the research context. As stated in 
attachment Marshall 2566, Subpart C Certification, 07-14-2021.pdf, the Office of Human Research 
Protections placed the research under category "CFR 46.306(a)(2)(i), "Study of the possible causes, 
effects, and processes of incarceration, and of criminal behavior, provided that the study presents no 
more than minimal risk and no more than inconvenience to the subjects,” and authorized the study to 
include prisoners in human subjects research. 
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4. Describe the recruitment methods.   ☐ N/A 
Phase 1 PROVIDENT Model Development: N/A Secondary Data Analysis
Phase 2 Randomized Cluster Trial: N/A Secondary Data Analysis
Phase 2 Implementation Study: 
We will recruit individuals into two groups: Group 1 and Group 2. We will begin recruitment of 
Group 1 prior to the baseline Technical Assistance series, which will start prior to the launch of the 
trial, and continue recruitment for the duration of the study. We will begin recruitment of Group 2 
one year after the launch of the study and continue recruitment for the remainder of the study.
GROUP 1 (approved in Amendment 4 in September 2021).
Purposive sampling through the Rhode Island Department of Health (RIDOH). Recruitment from 
three outreach organizations (Tier 1 organizations) with existing service contracts with RIDOH; Tier 
1 organizations will receive more intensive training and implementation strategies.
We will recruit a purposive sample of professionals in the community through existing relationships. 
This means we plan to recruit from organizations with existing harm reduction service contracts with 
RIDOH. Specifically, RIDOH will refer existing organizational staff from each of their contracted 
harm reduction and outreach organizations by creating an introductory email. Brown will send 
follow-up emails to the organizational staff at Tier 1 organizations with information on how to 
participate if interested and a description of the more intensive study activities for Group 1. 
GROUP 2
Purposive sampling through the Rhode Island Department of Health (RIDOH) - Recruitment from 
organizations that are not one of the three Tier 1 organizations; we will call these organizations Tier 2 
organizations. Tier 2 organizations will receive less intensive training and implementation strategies. 
We will recruit a purposive sample of professionals in the community through existing relationships. 
This means we plan to recruit from organizations with existing harm reduction contracts with RIDOH 
that are not one of the three Tier 1 organizations. Specifically, RIDOH will refer existing 
organizational staff from each of their contracted harm reduction and outreach or related 
organizations by creating an introductory email. Brown will send follow-up emails to the 
organizational staff at Tier 2 organizations with information on how to participate if interested and a 
description of the less intensive study activities for Group 2. 
COVID-19 Supplement: N/A Secondary Data Analysis
5. Explain the informed consent process.   ☐ N/A 
Phase 1 PROVIDENT Model: N/A
Waiver of consent: Because Phase 1 is a retrospective review of multiple secondary data sources that 
are already being collected administratively for other purposes, we requested a waiver of consent. The 
risk to participants is no greater than minimal risk and is limited to loss of privacy. Our measures to 
protect against those risks are outlined in the PROVIDENT DSMP. Our research environment in 
Stronghold is designed to provide the utmost security for these sensitive datasets and all datasets will 
be transferred under Data Use Agreements with the participating state agencies (BHDDH, RIDOH, 
RIDOC); all DUAs have been negotiated.  
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Phase 2 Randomized Cluster Trial: N/A 
Waiver of consent: Because the Phase 2 Randomized Cluster Trial involves a retrospective review of 
existing overdose surveillance secondary data in Rhode Island that is used to build the PROVIDENT 
forecasting model (approved in Phase 1, November 2019), we requested a waiver of consent. This 
same overdose surveillance system will be used to capture the primary endpoints of the trial (fatal and 
nonfatal overdoses).  The risk to participants is no greater than minimal risk and is limited to loss of 
privacy. Our measures to protect against those risks are outlined in the PROVIDENT DSMP. Our 
research environment in Stronghold is designed to provide the utmost security for these sensitive 
datasets and all datasets will be transferred under Data Use Agreements with the participating state 
agencies (BHDDH, RIDOH, RIDOC); all DUAs have been negotiated.  
Phase 2 Implementation Study: 
We will follow separate consent processes to consent eligible individuals who work or volunteer at 
Tier 1 organizations (Group 1) and consent eligible individuals who work or volunteer at Tier 2 
organizations (Group 2). This includes different informed consent forms: one to participate in surveys 
and one to participate in focus groups and/or key informant interviews.
GROUP 1: Consent Process for Individuals at Tier 1 Organizations
Baseline informed consent for Group 1 to participate in surveys will be separate from baseline 
informed consent to participate in focus groups and/or key informant interviews; the consent form for 
focus groups and key informant interviews will be combined. This includes two, separate informed 
consent forms.
PRE/POST SURVEYS
Baseline informed consent to participate in the surveys will occur via Brown Qualtrics prior to 
the start of the Technical Assistance series with electronic signature confirmation. Eligible 
individuals at Tier 1 community organizations will be emailed a link to the informed consent 
document in Brown Qualtrics. 
FOCUS GROUPS AND KEY INFORMANT INTERVIEWS
Baseline informed consent to participate in focus groups and/or key informant interviews will 
occur via Brown Qualtrics as each new individual is enrolled, with electronic signature 
confirmation. Eligible individuals at Tier 1 community organizations will be emailed a link to 
the informed consent document in Brown Qualtrics. 
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GROUP 2: Consent Process for Individuals at Tier 2 Organizations
Baseline Informed Consent for individuals from Tier 2 organizations will combine the consent 
process to participate in surveys, focus groups, and/or key informant interviews. This includes a 
single, combined, bulleted consent form.
PRE/POST SURVEYS,FOCUS GROUPS, AND KEY INFORMANT INTERVIEWS
Baseline Informed Consent for individuals who work or volunteer at Tier 2 organizations to 
participate in pre/post surveys, focus groups, and/or key informant interviews will occur via 
Brown Qualtrics, with electronic signature confirmation. Eligible individuals at Tier 2 
organizations will be emailed a link to a bulleted, combined consent document in Brown 
Qualtrics.
In sum, informed consent will occur via Brown Qualtrics with electronic signature confirmation only.
COVID-19 Supplement: N/A  
Waiver of consent: Because the COVID-19 supplement is a retrospective review of multiple data 
sources that are already being collected administratively for other purposes, we requested a waiver of 
consent. The risk to participants is no greater than minimal risk and is limited to loss of privacy. Our 
measures to protect against those risks are outlined in the PROVIDENT DSMP. Our research 
environment in Stronghold is designed to provide the utmost security for these sensitive datasets and 
all datasets will be transferred under Data Use Agreements with participating state agencies, which 
have all been negotiated.
5.1 To request a waiver or alteration of consent, at least one box must be checked   ☒ N/A 
(Phase 2 Implementation study)
☐ The research involves public benefit and service programs, is conducted by or subject to the 
approval of state or local officials, and could not practicably be carried out without the waiver 
or alteration;
☒ The research meets all requirements for a general waiver or alteration of consent (Phase 1 
PROVIDENT Model, Phase 2 Random Cluster Trial, COVID-19 Supplement; see Q5 above for 
explanation)
☐ For the purpose of screening, recruiting, or determining eligibility of prospective participants, 
the investigator will obtain information or biospecimens either through oral or written 
communication with participants, or by accessing records or stored identifiable biospecimens.
5.2 To request a waiver of documentation of consent, at least one box must be checked   ☒ N/A
☐ The only record linking the subject and the research would be the informed consent form and 
the principal risk would be potential harm resulting from a breach of confidentiality.
☐ The research presents no more than minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context.
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☐ Participants or legally authorized representatives are members of a distinct cultural group or 
community in which signing forms is not the norm, the research presents no more than 
minimal risk of harm and there is an appropriate alternative mechanism for documenting that 
informed consent was obtained.
6. Describe if the study design involves deception or incomplete disclosure.   ☒ N/A 
Click or tap here to enter text.
7. Describe the study procedures.   
If study procedures involve asking participants about depression, suicide, or the risk of harm to self 
or others; may result in participants experiencing emotional distress; include populations at high risk 
for self-injury; administer study medications with a side effect of suicidal ideation, or involve other 
research components that could increase suicidal risks, please upload Appendix F: Mental Health 
Safety Plan.
Phase 1 Development of the PROVIDENT model 
The methods and procedures outlined here will lead to the development and validation of 
PROVIDENT, a forecasting model to predict future overdose death.   
To develop the PROVIDENT model, we will analyze detailed geospatial data from all overdose 
fatalities that have occurred in Rhode Island since 2014. Data from publicly available sources (i.e., 
census records) and the state’s multicomponent surveillance system (including hospital visits, opioid 
prescribing records, emergency medical services calls, and addiction treatment admissions data) will 
serve as model predictors.   
We will forecast future fatal overdose burden using an ensemble machine learning approach, in which 
multiple classification and spatiotemporal machine learning prediction algorithms are combined 
based on minimizing cross-validated risk. The PROVIDENT model will generate an overdose risk 
index that estimates the likelihood of future overdose death in every neighborhood (defined as a 
census block group) across Rhode Island.   
As a conceptual framework for selecting inputs for the PROVIDENT model, we will adopt a 
theoretical schema for the contextual determinants of drug use-related risks. In this conceptual model, 
overdose and related risk behaviors are influenced by four domains. First, social capital (the extent 
and depth of social trust, norms, and networks) and family fragmentation (e.g., divorced, separated, or 
single-parent families) are positively correlated with overdose mortality rates at the county level. 
Second, measures of neighborhood disadvantage (including urban deprivation, income inequality, and 
poverty) have shown strong relationships with neighborhood overdose rates. Third, health and social 
resources include availability of OAT and opioid treatment programs, which may serve as proxies for 
underlying opioid use in a population. Finally, the physical environment influences overdose risk, 
which includes measures of environmental disorder and deterioration of the built environment (e.g., 
number of houses in dilapidated condition).   
Additionally, overdoses tend to cluster in space and time at multiple geographic and temporal 
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resolutions. Thus, we expect that previous counts of overdoses and other surveillance indicators in the 
given neighborhood, nearby, and similar neighborhoods may be predictive. These data complement 
the conceptual model by accounting for unobserved social determinants of risk. We will employ this 
framework to identify publicly available sources of information that contain relevant geospatial data 
for predicting overdose. We note that the proposed approach does not seek to estimate causal 
relationships linking predictors of interest with neighborhood-level overdose rates. Rather, we will 
include a broad set of potentially relevant variables in the forecasting model so as to achieve optimal 
predictive ability. The appeal of the machine learning approach is in its ability to find complex 
relationships between variables and fit flexible functional forms without simply overfitting the 
observed data, enabling the model to achieve high accuracy when forecasting future data. As the 
model focuses on forecasting neighborhood-level overdose disease burden, individual-level variables 
(e.g., cognitive functioning, biological susceptibility to overdose) will not be considered. In this 
manner, the proposed project complements other research, including the development of clinical 
prediction algorithms, which seek to estimate individual-level overdose risk.  
Phase 2 Cluster randomized trial  
Data Collection  
The study will involve a retrospective review of existing overdose surveillance data in Rhode Island 
to build the PROVIDENT forecasting model (approved in Phase 1, November 2019). This same 
overdose surveillance system will be used to capture the primary endpoints. To ensure adequate 
power, we will consider as the primary endpoint both fatal and non-fatal overdoses.   
Analysis  
We will employ standard methods for community intervention and cluster trials. The intervention 
effect will be quantified as an overdose incidence rate ratio. We will have at least five years of data 
(from 2014 to 2018) to serve as the pre-intervention period. We will use Poisson regression to 
estimate incidence rate ratios comparing treatment vs. control overdose rates. Although we will use 
stratified randomization to reduce pre-intervention differences in the treatment and control groups, 
potential biases from the imbalance can be corrected by including other covariates in the model. We 
will allow for a six-month washout period to allow for lagged intervention implementation.   
Next, we will construct time-lagged regression models to consider the delayed impact of the 
interventions by staggering outcomes 0 to 6 months. Finally, we will employ a counterfactual 
framework for direct, indirect, and spillover effects in group randomized trials to accommodate issues 
of spillover across treatment and control clusters.   
Given our study timeline, we anticipate two years of post-intervention follow-up time. We can 
therefore elaborate the model to incorporate stochastic variation in the underlying overdose rate (e.g., 
seasonality and natural temporal variation) and to estimate the effect of the intervention as a function 
of time. With this approach we can ascertain the rate at which the intervention begins to show 
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differences. Repeated measures regression can be used for this purpose, with models fit using 
generalized estimating equations.    
Phase 2 Implementation Study
We will conduct an Implementation Study in parallel with the PROVIDENT Cluster Randomized 
Trial, to assess how contextual factors may affect implementation, and ultimately, the outcomes of 
the trial. The Ecological Framework (Durlack & Dupre, 2008) highlights five key areas for analyzing 
both the characteristics of the intervention and the setting in which the PROVIDENT Cluster 
Randomized Trial is implemented, and seeing how those factors affect the overall success of the 
larger intervention. Using this framework, we will analyze Community-Level Factors, Provider 
Characteristics, Characteristics of the Innovation, Organizational Capacity, and the Prevention 
Support System (Statewide systems).  
We will assess both individual and organizational level factors related to the uptake of the Web Tool 
intervention for harm reduction outreach workers and the organizations they work in (See Figure 2). 
Figure 2. PROVIDENT Phase 2 Data Collection and Outcomes
(last updated 2024.03.27) https://docs.google.com/presentation/d/1bs2KUUrTE3i71ohVhO-
WN7LRmnL7bw8p086QUEKn94A/edit#slide=id.g2c70cb95e37_0_0
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Table 1. Data Collection Points for Ecological Framework
Proposed data 
sources
Components studied
Components 
assessed
Frequency
Pre Survey 
(self- report)
data literacy/numeracy, Data Academy 
learning objectives (understanding the goals of 
the Trial) (Study ID only)
Fidelity
once (or at each TA 
session) 
(descriptive trends)
Post Survey 
(self-report)
data literacy/numeracy, Data Academy learning 
objectives (understanding the goals of the 
Trial). (Study ID only)
Fidelity
once
(descriptive trends)
Focus Groups 
(self report)
organizational culture towards data, data 
entry, data quality, using data to drive change, 
organizational definition of harm reduction, 
organizational capacity. (Study ID only)
Reach
Baseline, every 6 
months (qualitative 
coding)
Key Informant 
Interviews 
(self report)
Organizational culture towards data, using data 
to drive change, , organizational capacity, 
functionality of the web tool, how it impacted 
individuals' work, how it can be improved in 
the future
Reach
once
(descriptive trends)
Web Tool Logs 
(Observation)
Frequency of logins by users, aggregated to 
organization level; total neighborhoods with 
rapid assessments, total neighborhoods with 
brief plans associated w them
Dosage, 
Reach
Monthly database 
reporting logs 
(descriptive trends)
Web Tool 
Rapid 
Neighborhood 
Assessment
Rapid services assessment by census tract 
(neighborhood data only)
Baseline 
Dosage, 
Reach
Baseline, every 6 
months
Web Tool 6 
month 
Progress Plans
(database 
forms)
Organization-led 6 month progress plans, 
approach, changes, goals. (web tool user data 
aggregated to organization level, 
neighborhood data)
Dosage, 
Reach
every 6 months, 
look at planning 
progress.
Technical 
Assistance 
Support
Per "Series". Each series includes 1-4 sessions 
on requested topics. Initial 4 sessions (8hrs) for 
all organizations, with follow-up TA (1-4 
sessions) offered every 6 months or as 
requested by organizations. (not measured as 
study data)
Training only
technical 
assistance 
workshop content 
to address 
organizational 
needs
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As part of the Phase 2 implementation study, we will assess both individual and organizational level 
factors related to the uptake of the Web Tool intervention for harm reduction outreach workers and 
the organizations they work in. We will work with three community-based harm reduction 
organizations, which we will call “Tier 1 organizations”, by engaging in on-site outreach, hosting 
data academies, providing training tools, and sharing video tutorials. The implementation study will 
enroll individuals from these three Tier 1 community-based harm reduction organizations into Group 
1. Recruitment of individuals from Tier 1 organizations into Group 1 will begin prior to the baseline 
Technical Assistance series, which will start prior to the launch of the two-year implementation study 
and continue for the duration of the study. Study activities for Group 1 will include more intensive 
training, engagement, and implementation strategies.
While recruitment and retention of participants from Tier 1 organizations is proceeding without 
delays or problems, there has been increased interest in the study from organizations outside of these 
three Tier 1 organizations, including various community-based organizations and groups within the 
Rhode Island overdose prevention, harm reduction, and health equity communities. Therefore, in 
addition to engaging the three Tier 1 organizations, we will also engage these other organizations in 
the study, which we will call “Tier 2 organizations”. And we will enroll individuals from these Tier 2 
organizations into Group 2. Recruitment of individuals from Tier 2 organizations into Group 2 will 
begin one year from the launch of the implementation study and continue for the remainder of the 
study (one year in total). Study activities for Group 2 will include less intensive training, engagement, 
and implementation strategies. Less intensive training and implementation strategies will include 
supplementing the Technical Assistance workshop series offered to Group 1 with virtual technical 
assistance workshops and other online training resources. 
While the entire study procedure used for Group 1 is different than that used for Group 2, Group 1 
and Group 2 will both be invited to participate in the pre/post surveys,focus groups, and key 
informant interviews (i.e., we will administer the same surveys and use the same focus group and 
interview guides for both Group 1 and Group 2).
STUDY PROCEDURE FOR GROUP 1 PARTICIPANTS AND INDIVIDUALS WHO WORK AT 
TIER 1 ORGANIZATIONS
PRE/POST-SURVEY 
Brief anonymous pre-survey questionnaire (per individual) before each Technical Assistance (TA) 
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series (anywhere from 1-4 workshops in a series, based on need). Approximately 15 minutes in length 
for the survey, including a bulleted consent form (Up to 2 pre-tests per year, for 2 years). 
●
Baseline Informed Consent will occur via Brown Qualtrics prior to the start of the TA series, 
with electronic signature confirmation. Participants will still be encouraged to come to 121 South 
Main Street or 66 Pavilion Avenue to take the survey in person, to ensure confidentiality and 
ease of compensation. Participants who take the survey in person will still complete the Baseline 
Informed Consent via Brown Qualtrics, with electronic signature confirmation.
●
Surveys will be emailed with a secure Qualtrics link to each eligible individual. 
●
Surveys will be linked by Study ID 
●
The surveys will be given at 121 South Main Street or 66 Pavilion Avenue in our study offices. 
Participants will be asked to wear a mask the entire time. Technical assistance workshops will 
take place in larger conference rooms so that people attending the workshops will be able to 
distance themselves from others. Though these surveys and workshops will take place in person, 
participants will also be able to participate in surveys remotely and attend workshops via Zoom. 
Should cases of COVID-19 rise and Brown University policies change, the surveys and 
workshops may be held entirely on Zoom. 
Brief anonymous post-survey questionnaire (per individual) after each Technical Assistance series. 
Approximately 15 minutes in length for the survey (Up to 2 post-tests per year, for 2 years). 
●
Surveys will be emailed with a secure Qualtrics link to each eligible individual. 
●
Surveys will be linked by Study ID 
SAMPLE TECHNICAL ASSISTANCE MENU 
The baseline TA series will start prior to the launch of the trial. 
●
Four 2-hour sessions over a 1 month period (i.e., the Data Academy) that cover data to action 
concepts and key themes for the Web Tool application and Trial. 
●
The TA sessions are meant to be responsive to the needs of the community. The TA menu will 
broadly consist of Data Storytelling, Neighborhood level risks, Maps, Resource Planning, Web 
Tool coaching, Administrative Supervision, Data Maturity for organizations, Preventing 
Burnout, DIY Mapping: Google Maps & Google Forms. Other topics may emerge from Focus 
Group discussions. 
●
Follow-up TA Sessions will include a similar TA Guidance Menu with pre/post survey at 6 
month intervals following the launch of the trial, for 2 years.  
FOCUS GROUPS
We will conduct semi-structured, organization-specific (all members from the same employer) focus 
groups at baseline and every 6 months thereafter for the duration of the clinical trial. 
●
These focus groups will occur at 121 South Main Street or 66 Pavilion Avenue. Participants will 
be asked to wear a mask the entire time. Focus groups will take place in a larger conference 
room so that people attending will be able to distance themselves from others. Though these 
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focus groups will take place in person, participants will also be able to attend by Zoom. Should 
cases of COVID-19 rise and Brown University policies change, the focus groups may be held 
entirely on Zoom. 
●
Baseline informed consent will occur via Brown Qualtrics as each new individual is enrolled, 
with electronic signature confirmation prior to participation.  
●
A brief, voluntary, anonymous survey will be administered to participants who enrolled in focus 
groups to collect information about demographics. Data collection and security procedures used 
for the focus group survey are the same as those used for the “pre-test” survey.
●
The focus group survey will be linked by Study ID
One focus group per harm reduction organization
●
People recruited for the focus groups will include all individuals recruited for the surveys. The 
focus groups will be open to other staff from the harm reduction organizations, including 
individuals who have not participated in the surveys. 
●
These will be used to assess organizational culture toward data, approach to harm reduction, 
planning and capacity for delivering harm reduction services, and overall use of the web tool 
application (up to 2024). 
Focus groups will be assigned a study ID at both the organizational and individual levels during 
transcription and analysis. All identifiers will be removed from transcripts prior to analysis. Each 
focus group will last no more than 90 minutes, and occur every 6 months.  
KEY INFORMANT INTERVIEWS
We will conduct semi-structured key informant interviews with individuals after they have been 
exposed to either the Data Academies or the Web Tool.
●
These interviews will occur at 121 South Main Street, 66 Pavilion Avenue, or an individual's 
workplace. Interviews will take place in private settings. Though these interviews will take place 
in person, participants will also be able to attend by Zoom. Should cases of COVID-19 rise and 
Brown University policies change, the interviews may be held entirely on Zoom. 
●
Informed consent will occur via Brown Qualtrics as each new individual is enrolled, with 
electronic signature confirmation prior to participation.  
●
A brief, voluntary, anonymous survey will be administered to participants who enrolled in 
interviews to collect information about demographics. We will use the same survey used to 
collect basic demographic information from focus group participants so that individuals will only 
take the survey once. Data collection and security procedures used for the interview survey are 
the same as those used for the “pre-test” survey.
●
The interview survey will be linked by Study ID.
One key informant interview per person enrolled
●
People recruited for key informant interviews will include individuals who have attended any of 
the Data Academies or have registered in  the PROVIDENT Web Tool. The interviews will be 
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open to other staff from the harm reduction organizations, including individuals who have not 
participated in the surveys and/or focus groups. 
●
These will be used to assess how the Web Tool functioned for organizations and how it can be 
improved to be more useful for harm reduction and direct service organizations. Interviews will 
also be used to understand how the Web Tool was used or not used toward data-centered 
approaches to harm reduction, planning and capacity for delivering harm reduction services, and 
overall use of the Web Tool applications. 
Interviews will be assigned a study ID at both the organizational and individual levels during 
transcription and analysis. All identifiers will be removed from transcripts prior to analysis. Each 
interview will last no more than 30 minutes. 
STUDY PROCEDURE FOR GROUP 2 PARTICIPANTS AND INDIVIDUALS WHO WORK AT TIER 2 
ORGANIZATIONS
PRE/POST-SURVEY
Brief anonymous pre-survey questionnaire (per individual) before each Technical Assistance (TA) series 
(anywhere from 1-4 workshops in a series, based on need). Approximately 15 minutes in length for the survey, 
including a combined, bulleted consent form (Up to 2 pre-tests per year, for 1 year). 
●
Baseline Informed Consent will occur via Brown Qualtrics prior to the start of the TA series, with 
electronic signature confirmation. This baseline informed consent document will combine consent to 
participate in the pre-survey, post-survey, focus groups, and key informant interviews. The informed 
consent form will include information that they may participate in one or more of these activities. . 
Participants will still be invited to come to our study offices at 121 South Main Street or 66 Pavilion 
Avenue to take the survey in person, to ensure confidentiality and ease of compensation. Participants who 
take the survey in person will still complete the Baseline Informed Consent via Brown Qualtrics, with 
electronic signature confirmation.
●
Consented individuals will be assigned a Study ID code. Contact information, consent, pre/post surveys, 
and focus group surveys will be linked by Study ID.
●
Surveys will be administered via Brown Qualtrics.
●
Surveys will be emailed with a secure Qualtrics link to each eligible individual. 
●
Surveys will be linked by Study ID 
●
Participants will be able to participate in surveys remotely and attend workshops via Zoom.
Brief anonymous post-survey questionnaire (per individual) after each Technical Assistance series. 
Approximately 15 minutes in length for the survey (Up to 2 post-tests per year, for 1 year). 
●
Surveys will be emailed with a secure Qualtrics link to each eligible individual. 
●
Surveys will be linked by Study ID 
SAMPLE TECHNICAL ASSISTANCE MENU 
The baseline TA series will start one year after the launch of the trial. 
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●
The TA sessions will cover data to action concepts and key themes for the Web Tool application and 
Trial. 
●
The TA sessions are meant to be responsive to the needs of the community. The TA menu will broadly 
consist of Data Storytelling, Neighborhood level risks, Maps, Resource Planning, Web Tool coaching, 
Administrative Supervision, Data Maturity for organizations, Preventing Burnout, DIY Mapping: Google 
Maps & Google Forms. Other topics may emerge from Focus Group discussions. 
●
Follow-up TA Sessions will include a similar TA Guidance Menu with pre/post survey at 6-month 
intervals for the remainder of the study.  
●
Online training and technical assistance videos and resources will be available on the Web Tool and users 
may access these resources at a time that is convenient for them.
FOCUS GROUPS 
We will conduct semi-structured focus groups at baseline and every 6 months thereafter for the 
remainder of the clinical trial. 
●
These focus groups will occur at 121 South Main Street or 66 Pavilion Avenue. Though these 
focus groups will take place in person, participants will also be able to attend by Zoom.
●
Baseline Informed Consent will occur via Brown Qualtrics as each new individual is enrolled, 
with electronic signature confirmation prior to participation. This baseline informed consent 
document will combine consent to participate in the pre-survey, post-survey, and focus groups. 
The informed consent form will include information that they may participate in the surveys, 
focus groups, both, or neither surveys nor focus groups.
●
Consented individuals will be assigned a Study ID code. Contact information, consent, pre/post 
surveys, and focus group surveys will be linked by Study ID.
●
A brief, voluntary, anonymous survey will be administered to participants who enrolled in focus 
groups to collect information about demographics. Data collection and security procedures used 
for the focus group survey are the same as those used for the “pre-test” survey.
●
The focus group survey will be linked by Study ID.
One focus group per harm reduction organization 
●
People recruited for the focus groups will include all individuals recruited for the surveys. The 
focus groups will be open to other staff from the harm reduction organizations, including 
individuals who have not participated in the surveys. 
●
These will be used to assess organizational culture toward data, approach to harm reduction, 
planning and capacity for delivering harm reduction services, and overall use of the web tool 
application (up to 2024). 
Focus groups will be assigned a Study ID at both the organizational and individual levels during 
transcription and analysis. All identifiers will be removed from transcripts prior to analysis. Each 
focus group will last no more than 90 minutes, and occur every 6 months.  
KEY INFORMANT INTERVIEWS
We will conduct semi-structured key informant interviews with individuals after they have been 
exposed to either the Data Academies or the Web Tool.
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●
These interviews will occur at 121 South Main Street, 66 Pavilion Avenue, or an individual's 
workplace. Participants will be asked to wear a mask the entire time. Interviews will take place 
in private settings. Though these interviews will take place in person, participants will also be 
able to attend by Zoom. Should cases of COVID-19 rise and Brown University policies change, 
the interviews may be held entirely on Zoom. 
●
Baseline informed consent will occur via Brown Qualtrics as each new individual is enrolled, 
with electronic signature confirmation prior to participation.  
●
A brief, voluntary, anonymous survey will be administered to participants who enrolled in 
interviews to collect information about demographics. We will use the same survey used to 
collect basic demographic information from focus group participants so that individuals will only 
take the survey once. Data collection and security procedures used for the interview survey are 
the same as those used for the “pre-test” survey.
●
The interview survey will be linked by Study ID
One key informant interview per person enrolled
●
People recruited for key informant interviews will include individuals who have attended any of 
the Data Academies or have registered in the PROVIDENT web tool. The interviews will be 
open to other staff from the harm reduction organizations, including individuals who have not 
participated in the surveys. 
●
These will be used to assess how the Web Tool functioned for organizations and how it can be 
improved to be more useful toward direct services organizations. Interviews will also be used to 
understand how the Web Tool was used or not used toward data-centered approaches to harm 
reduction, planning and capacity for delivering harm reduction services, and overall use of the 
Web Tool applications. 
Interviews will be assigned a study ID at both the organizational and individual levels during 
transcription and analysis. All identifiers will be removed from transcripts prior to analysis. Each 
interview will last no more than 30 minutes. 
ANALYSIS 
Qualitative analyses of focus group and key informant interview themes. Also assess organizational 
capacity, flexibility, approach to supervision, etc. 
Baseline & Follow-Up Analyses: 
We will conduct a baseline series of focus groups to better understand overall themes at the start of 
the trial, including organizational capacity, overall organizational data maturity, and organizational 
approach to harm reduction. We will conduct 6 month follow up focus groups to examine those 
themes plus additional themes related to ongoing implementation and uptake of the intervention and 
the response to maps and technical assistance trainings.  We will conduct key informant interviews at 
the end of the trial to better understand overall themes at the end of the trial, including organizational 
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capacity, overall organizational data maturity, and organizational approach to harm reduction. We 
will examine themes related to the uptake of the intervention within each organization.
Aim: To understand contextual factors related to overall uptake of the web tool intervention 
Hypothesis: We hypothesize that the stronger the themes around capacity and data maturity of an 
organization, the greater the uptake of the intervention web tool. 
Analytic method: Qualitative coding using Dedoose, Transcription using Daily Transcription 
Pre/Post Analysis of Technical Assistance Supports 
Use Pre/Post surveys to assess whether learning objectives of TA were achieved, whether individuals 
feel comfortable with the PROVIDENT model, and using data-driven products such as maps. 
Web Tool utilization: 
We will use Web Tool forms to assess back-end administrative data to understand at both the 
organizational and regional levels: 
- Fidelity (minimum of 5 logins every 6 months, ideally ~75% for intervention towns) 
- Reach (at least 60% of prioritized towns have a neighborhood assessment in any 6 month period) 
- Dosage (Of those towns with a neighborhood assessment, at least 75% will show an increase in 
overall dosage of harm reduction services from baseline)
COVID-19 Supplement 
In Specific Aim 1 of this administrative supplement, we will determine how policies enacted as part of the 
state of Rhode Island’s COVID-19 pandemic response have influenced both access to overdose prevention 
and treatment resources, as well as rates of fatal and non-fatal overdoses in the community. Using an 
interrupted time series design, we will estimate the impact of Rhode Island’s ‘stay at home’ order on 
naloxone distribution, initiation, and use of medications for opioid use disorder (OUD), emergency 
department (ED) visits, and emergency medical services (EMS) runs for non-fatal drug overdose, deaths due 
to drug overdose, and other harm reduction services.  
In Specific Aim 2 of this administrative supplement, we will examine the relationship between acute changes 
in COVID-19 diagnoses, hospitalizations, and deaths at the community level on rates of non-fatal and fatal 
drug overdose. We will also determine whether these relationships are particularly strong in economically 
distressed and racial/ethnic minority communities. Using a combined fixed-effects and time-series design, we 
will estimate the relationship between COVID-19 disease burden and spikes of ED visits and EMS runs for 
non-fatal drug overdose and deaths due to drug overdose at the city/town level. Therefore, the study will be 
randomized at the level of the city/town, rather than at the level of the individual.  
8. Describe the compensation.   ☐ N/A
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Phase 1: N/A 
Phase 2 Cluster Randomized Trial: N/A  
COVID-19 Supplement: N/A
Phase 2 Implementation Study:  
COMPENSATION FOR GROUP 1 PARTICIPANTS
PRE/POST-SURVEY COMPENSATION 
Participants will be compensated $25 per survey questionnaire completed (pre and post), for up to 
$50 each TA workshop series (potential of up to $200 over the course of the 2 year study if someone 
takes all available survey questionnaires). Participants will be compensated cash or via electronic gift 
card.
●
Further criteria: Participants must attend at least one TA workshop to be eligible for a pre and 
post survey. Participants who attend the TA workshops can opt out of the surveys if they do not 
wish to participate. 
●
Research team staff will pay participants directly in cash or with electronic gift cards, whichever 
they prefer. 
●
Research team staff will discuss compensation options with participants at enrollment. The first 
option is that they may be compensated at 121 South Main Street or 66 Pavilion Avenue offices 
and participate on-site via zoom, the second option is for research team staff to visit the 
participants at/near their workplace directly, and the third option is for participants to be 
compensated via electronic gift card, whatever the participants prefer. If the participant chooses 
to be compensated with an electronic gift card, research team staff will collect the participant’s 
name and phone number or email for disbursement. This contact information will be collected 
and stored in Brown Qualtrics and linked to the participant by a study identification number for 
disbursement and scheduling purposes only. The collection of the participant’s name, phone 
number and/or email is described in the consent form.
FOCUS GROUP COMPENSATION
Compensation for the Focus Groups will be $50 per focus group, up to two times per year, for two 
years (potential of up to $200 over the course of the 2 year study if someone attends all focus groups). 
Participants will be compensated in cash or via digital gift card.
●
Research team staff will pay participants directly in cash, with an electronic gift card. 
Participants may be compensated in cash at 121 South Main Street or 66 Pavilion Avenue 
offices, or research team staff may arrange to visit the participants at their workplace 
organizations directly, whatever the participants prefer. If the participant chooses to be 
compensated with an electronic gift card, research team staff will collect the participant’s name 
and phone number or email for disbursement. This contact information will be collected and 
stored in Brown Qualtrics and linked to the participant by a study identification number for 
disbursement and scheduling purposes only. Compensation procedures will be covered during 
the Informed Consent process. 
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KEY INFORMANT INTERVIEW COMPENSATION
Compensation for the interviews will be $25 per interview
●
Research team staff will pay participants directly in cash or with an electronic gift card. 
Participants may be compensated in cash at 121 South Main Street or 66 Pavilion Avenue 
offices, or research team staff may arrange to visit the participants at their workplace 
organizations directly, whatever the participants prefer. If the participant chooses to be 
compensated with an electronic gift card, research team staff will collect the participant’s name 
and phone number or email for disbursement. This contact information will be collected and 
stored in Brown Qualtrics and linked to the participant by a study identification number for 
disbursement and scheduling purposes only. Compensation procedures will be covered during 
the Informed Consent process. 
COMPENSATION FOR GROUP 2 PARTICIPANTS
PRE/POST-SURVEY COMPENSATION 
Participants will be compensated $25 per survey questionnaire completed (pre and post), for up to 
$50 each TA workshop series (potential of up to $100 over the course of the study if someone takes 
all available survey questionnaires). Participants will be compensated in cash or via digital gift card. 
●
Further criteria: Participants must attend at least one TA workshop to be eligible for a pre and 
post survey. Participants who attend the TA workshops can opt out of the surveys if they do not 
wish to participate. 
●
Research team staff will pay participants with cash or electronic gift cards, whichever they 
prefer. 
●
Compensation procedures will be covered at enrollment. The first option is that they may be 
compensated at 121 South Main Street or 66 Pavilion Avenue offices and participate on-site via 
zoom, the second option is for research team staff to visit the participants at/near their workplace 
directly, and the third option is for participants to be compensated via electronic gift card, 
whatever the participants prefer. If the participant chooses to be compensated by electronic gift 
card, research team staff will collect the participant’s name and phone number or email for 
disbursement. This contact information will be collected and stored in Brown Qualtrics and 
linked to the participant by a study identification number for disbursement and scheduling 
purposes only. The collection of the participant’s name, phone number and/or email is described 
in the informed consent form.
FOCUS GROUP COMPENSATION
Compensation for the Focus Groups will be $50 per focus group, up to two times per year, for one 
year (potential of up to $100 over the course of the study if someone attends all focus groups). 
Participants will be compensated in cash or via digital gift card.
●
Research team staff will pay participants directly in cash or with an electronic gift card. 
Participants may be compensated in cash at 121 South Main Street or 66 Pavilion Avenue 
offices, or research team staff may arrange to visit the participants at their workplace 
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organizations directly, whatever the participants prefer. If the participant chooses to be 
compensated by electronic gift card, research team staff will collect the participant’s name and 
phone number or email for disbursement. This contact information will be collected and stored in 
Brown Qualtrics and linked to the participant by a study identification number for disbursement 
purposes only. Compensation procedures will be covered during the Informed Consent process. 
The collection of the participant’s name, phone number and/or email is described in the informed 
consent form.
KEY INFORMANT INTERVIEW COMPENSATION
Compensation for the Focus Groups will be $25 per interview
●
Research team staff will pay participants directly in cash or with an electronic gift card. 
Participants may be compensated in cash at 121 South Main Street or 66 Pavilion Avenue 
offices, or research team staff may arrange to visit the participants at their workplace 
organizations directly, whatever the participants prefer. If the participant chooses to be 
compensated by electronic gift card, research team staff will collect the participant’s name and 
phone number or email for disbursement. This contact information will be collected and stored in 
Brown Qualtrics and linked to the participant by a study identification number for disbursement 
and scheduling purposes only. Compensation procedures will be covered during the Informed 
Consent process. 
9. Is the study a clinical trial?   ☒ Yes   ☐ No 
10. Describe the possible research risks to participants. 
Phase 1 PROVIDENT Model Development 
This project uses secondary data exclusively; therefore, confidentiality of human subjects data is of 
utmost importance. Our research requires the use of existing, identifiable records related to overdose, 
medical events, and prescribing data. Access to such records for legitimate research purposes has 
been approved by our data sharing partners through support letters and a forthcoming Data Use 
Agreement, and our team will work carefully to ensure the protection of these data, as we have in the 
past.  
We recognize that a loss of confidentiality may also result in psychological harm to individuals or in 
social harm. As such, we will be using Brown’s state of the art secure computing environment for 
the transfer, analysis, and protection of all research data. Data sharing partners (e.g., RIDOH, 
BHDDH) will share only the required datasets and variables needed for analysis. Additionally, only 
select members of the analytic team will have access to any identifiable datasets. All data transfer 
procedures, analytic plans, and datasets will be approved by the Brown IRB, any additional 
institutional IRBs.  
Research Database Infrastructure: This project will benefit from and expand upon data security 
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resources provided by the Brown University “Stronghold Research Environment for Data 
Compliance” secure computing system. Stronghold is a secure computing and storage environment 
that enables Brown researchers to analyze sensitive data, while complying with regulatory or 
contractual requirements. Stronghold is currently certified to meet the security requirements and 
controls for HIPAA (Health Insurance Portability and Accountability Act) and is undergoing the 
certification process for FISMA (Federal Information Security Management Act) and CJIS 
(Criminal Justice Information Security). We will use the Stronghold secure computing environment 
to store, maintain, and transfer dataset between Brown University and data stakeholders, including 
the Rhode Island Department of Health (RIDOH) and other state agencies (e.g., Office of the State 
Medical Examiners).  
This service is customized to the needs of individual users and their data use agreements. Each 
investigator is given a dedicated environment for their project to support their co-investigators, 
graduate students, research assistants, interviewers, and other collaborators. Access to the Internet is 
restricted except for required locations for data imports or necessary software downloads. Import and 
export controls are in place to limit who can perform data migration, where sensitive data can come 
from and where desensitized or anonymized data can be moved to. Sensitive data is subject to file 
system auditing, and real-time alerting is available at the request of the PI.  
Additional Security Policies for Project Investigators and Staff: Dr. Marshall has additional 
requirements regarding credentials, connections methods, or clients based on the nature of the data. 
Specifically, all systems (workstations, laptops, etc.) used to connect to Stronghold must have the 
following security precautions in place: A password-protected lock out screen that appears after 
inactivity of 5 minutes or less. Up-to-date antivirus and malware installed. An up-to-date operating 
system with all currently available updates installed. Physical security (either card access or keyed 
locks) in all working environments, such that unauthorized users are prevented from physically 
accessing the system while it is connected to Stronghold. All study reports, results, and published 
manuscripts will suppress all identifiable information, and include only aggregated results.  
Phase 2 Cluster Randomized Trial and Implementation Study 
Potential Risks for Participants: Loss of Confidentiality 
Phase 1 of the study, and the analyses for the cluster randomized trial use secondary data that 
includes identifiers previously approved during Phase 1. Phase 2 uses primary data that includes 
several identifiers (i.e. name, email address) for enrollment purposes, but will ultimately rely on a 
Study ID and de-identification of records prior to analysis.  
Nevertheless, confidentiality of study data will continue to be of the utmost importance. Access to 
records will be explicitly used for legitimate research purposes and access to these records will not 
only be monitored, but access will also be restricted through a user login. Furthermore, we have 
worked with Brown University Center for Computation and Visualization to design the Web Tool 
with careful attention to security, protecting an individual’s identity, and minimizing risk of loss of 
confidentiality.  
We will continue to receive updated secondary data every six months from our IRB approved data 
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sharing partners, as described in the original approved Brown University IRB protocol # 
1910002566. The updated secondary data will be used to update the model throughout the course of 
the study through July, 2024 and conduct analyses for the cluster randomized trial. The secondary 
data used during phase I to develop the model will continue to be transferred to, stored and analyzed 
in Brown University’s Stronghold secure research environment. All project analyses will be done 
within the Stronghold environment and no data will leave this environment unless it has been 
aggregated and de-identified. Data used by the PROVIDENT model will solely reside in Stronghold 
and only de-identified data will leave this environment (by design). The PROVIDENT model data 
used in the Web Tool will be de-identified data aggregated to the census block group prior to leaving 
Stronghold. In sum, use of secondary data for the PROVIDENT model for visualization in the Web 
Tool should not increase the risks or benefits.   
For the survey data, all data will be securely captured in Qualtrics and transferred directly to a 
departmental server (at the School of Public Health) for analyses.   
For the Focus Groups, audio records will be recorded on a Brown University device (laptop, 
desktop, or audio recorder), then uploaded to a password-protected folder on Brown School of 
Public Health departmental servers, only accessible to designated study staff. Audio files will be 
transcribed using the secure service Daily Transcription. Once transferred and backed up, audio files 
will be deleted from the Brown University device, in compliance with university protocol. De-
identified transcripts will be analyzed using qualitative software Dedoose.  
Potential Risks for Participants: Focus Groups 
There is minimal risk to participating in focus groups. We are asking focus group participants about 
their work culture, how their organization approaches data collection and reporting, and how their 
workplace delivers overdose prevention services. Participants may experience some discomfort in 
discussing these topics. Although individuals will be asked about their work, all transcripts will be 
de-identified prior to analysis. Individuals will have the right to skip any question they do not want 
to answer or stop participation at any time.  
Potential Risks for Participants: Key Informant Interviews
There is minimal risk to participating in key informant interviews. We are asking key informant 
interview participants about how they used the Web Tool, how we can improve it, and what benefits 
and/or challenges the webtool presented. Participants may experience some discomfort in discussing 
these topics. Although individuals will be asked about their work, all transcripts will be de-identified 
prior to analysis. Individuals will have the right to skip any question they do not want to answer or 
stop participation at any time.   
Potential Risks for Participants: Survey Instruments 
There is minimal risk to participating in this study. We are asking individuals working in community 
organizations about the nature of their work and the surveys are confidential. Although individuals 
will be asked about their work, we will ensure that questions are not specific as to give away a 
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person’s identity. Data will be captured using Brown Qualtrics. Individuals will have the right to 
skip any question they do not want to answer or stop participation at any time.  
COVID-19 Supplement: 
There are no direct individual risks, as only secondary data are being analyzed. The risk is no greater 
than minimal risk and is limited to loss of privacy. Our measures to protect against those risks are 
outlined in the PROVIDENT DSMP. Our research environment in Stronghold is designed to provide 
the utmost security for these sensitive datasets. In brief, although most data required to achieve the 
aims of this project will be de-identified and aggregated to the municipal level prior to transfer into 
Stronghold, any sensitive data or datasets containing PHI (specifically, dates and addresses) will be 
transferred, stored, and analyzed within our team’s Stronghold computing environment. PHI 
accessed in the research under this supplement are limited to dates and addresses only, consistent 
with Appendix G in the parent study. 
Stronghold administrators (Brandon Marshall, Claire Pratty, and Maxwell Krieger) maintain 
protocols and security groups for regulating access to project data. All data is stored separately from 
other projects which utilize Stronghold and are assigned a separate security group. Stronghold is 
actively monitored and logged, including monthly reports detailing active users as well as alerts sent 
within 15-minute of incoming or outgoing data transfers. Only authorized administrators have access 
to exporting data outside of Stronghold. All external personnel, which includes those who transfer 
data into Stronghold, are onboarded by registering a sponsored ID through Brown University which 
must be reactivated each year.
Data and Safety Monitoring:
A single Data and Safety Monitoring Board (DSMB) is appointed to oversee this project. The 
DSMB will consist of members outside of the research group conducting this study, but may include 
individuals who are affiliated with one or more of the data sharing partners, but are not directly 
related to the project. The DSMB will include, at minimum, one individual with expertise in 
statistics or biostatistics. Any potential conflicts of interest must be disclosed during the application 
process. The Brown University IRB will ultimately approve the membership, meeting frequency, 
and Safety Monitoring Plan for the DSMB. 
As outlined in the Data and Safety Monitoring Plan (DSMP), this  independent  Data and 
Safety  Monitoring  Board will assess the progress of a clinical study,  the safety  data, and critical 
efficacy endpoints (if appropriate) and provide  recommendations  to  the  sponsor. The 
members  of  the DSMB serve  in an individual 
capacity  and  provide  their  expertise,  including  recommendations  regarding  the  continuation, 
modification, or termination of any or all arms of the study.  The DSMB will review cumulative 
study data to evaluate safety, study conduct, scientific validity, and data integrity of the study.  
11. Describe the anticipated benefits to participants. 
Phase 1 PROVIDENT Model
There are no direct individual benefits to the participants of this study, as only secondary data is 
being analyzed.
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Phase 2 Cluster Randomized Trial
There are no direct individual benefits to the participants of this study, as only secondary data is 
being analyzed.
Phase 2 Implementation Study
There are minimal benefits to participating in the study. There is a chance individuals will learn 
more about data tools and mapping through their participation. There is a chance that information 
collected during the focus groups or key informant interviews will improve the PROVIDENT 
Web Tool, and be used to improve Technical Assistance trainings. 
COVID-19 Supplement
There are no direct individual benefits to the participants of this study, as only secondary data is 
being analyzed.
12. Does the study involve the use of secondary data (identifiable information or identifiable 
biospecimens)?   ☒ Yes (complete Questions 12.1-12.3)   ☐ No (skip to Question 16)
12.1 Provide the source of the data.
Phase 1 PROVIDENT Model Development
Table S1 represents the intended data sources for the PROVIDENT forecasting tool. The datasets that contain protected health information 
or sensitive identifiable information are limited to data from the State Agencies RIDOH, BHDDH, RIDOC, and EOHHS. The other data sources 
listed provide aggregated or publicly available data by request.
Table 1: Summary of overdose surveillance and neighborhood-level data sources for PROVIDENT model
Domain
Description
Data Source 
(Agency)
Overdose Deaths
All unintentional drug-related deaths that occur in Rhode Island 
(model outcome)
SUDORS (RIDOH)
EMS runs for suspected 
opioid overdose
EMS runs for suspected opioid overdoses (based CDC case 
definition using ICD-10 codes) [46]
CEMS 
Database 
(RIDOH)
Opioid analgesic prescribing rate**
PDMP (RIDOH)
Rate of patients receiving >90 MME**
PDMP (RIDOH)
Rate of multiple provider episodes for opioids (≥5 physicians 
or ≥5 pharmacies over 6 months)
PDMP (RIDOH)
Prescribing
Number of patients prescribed an opioid and a benzodiazepine 
within 30-day period
PDMP (RIDOH)
Buprenorphine prescribing rate**
PDMP (RIDOH)
Buprenorphine initiating rate**
PDMP (RIDOH)
Treatment
Buprenorphine retention rate**
PDMP (RIDOH)
Rescue
Rate of naloxone distribution by pharmacies**
PDMP (RIDOH)
Social Capital & Family 
Fragmentation
Social capital (density of civic and charitable organizations, 
religious organizations, foundations, census response rate)
DBR
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Rate of incarceration and release from settings of incarceration RIDOC
Family fragmentation (household composition, proportion of 
children living in single parent households)
ACS
Neighborhood Advantage/
Disadvantage
Unemployment rate, household income, percent below the 
poverty line, Gini coefficient, proportion with public assistance
ACS
Rate of licensed addiction treatment programs**
BHDDH
Health & Social Resources
Health insurance coverage
ACS
Average age of structures, heating fuel type, monthly owner 
costs as a percentage of household income, gross rent
ACS
Physical Environment
Occupancy status of residential properties
ACS
* Data collected at the address level but will be aggregated to the census block group (CBG) for analysis; ** All rates expressed as number 
per 1,000 residents;
American Community Survey (ACS); BHDDH = Department of Behavioral Health, Developmental Disabilities, and Hospitals; BHOLD = 
Behavioral Health Online Database; Census Block Group = Census Block Group; CEMS = Centers for Emergency Medical Services; CHDAPHI 
= Center for Health Analysis and Public Health Informatics; DATA = Drug Addiction Treatment Act; MME = morphine milligram equivalents; 
PONI = Preventing Overdose and Naloxone Intervention; OSME = Office of the State Medical Examiner; RIDOH = Rhode Island Department 
of Health; RIDOC = Rhode Island Department of Corrections; DBR = Department of Business Regulation
Phase 2 Cluster Randomized Trial
We will evaluate, at the city/town level, whether prioritized intervention deployment to neighborhoods at high 
risk of future overdose reduces population-level overdose morbidity and mortality. The primary outcome of 
the trial will be fatal and non-fatal overdose rates, measured at the city/town level. Fatal overdoses will be 
defined as accidental drug-related deaths deemed by a medical examiner to be attributed to a prescription 
or illicit drug. Non-fatal overdoses will be defined as ED visits for a suspected overdose reported through the 
state’s 48-Hour Overdose Reporting System. These data are captured in the Rhode Island Office of the State 
Medical Examiner’s drug overdose death records database, and the state’s 48-Hour Overdose Reporting 
System, which requires that all emergency departments report suspected overdoses to the RIDOH within 48 
hours. 
Phase 2 Implementation Study: N/A
COVID-19 Supplement
We are including a summary of data sources for the supplement in Table 2.
List of data sources and responsible agency (Table S2)
Table 2: Summary of overdose surveillance and neighborhood-level data sources for PROVIDENT COVID-19 
administrative supplement
Domain
Outcome
Data Source
Data 
Source 
Agency
Smallest 
Geographic Unit
Access**
Number of naloxone kits 
distributed by pharmacies
PDMP
RIDOH
Census Block 
Group (CBG)*
PROVIDENT
Naloxone Distribution Number of naloxone kits 
distributed by community 
organizations
WuFoo
RIDOH
Zip Code
PROVIDENT
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Number of individuals actively 
receiving buprenorphine
PDMP
RIDOH
CBG*
PROVIDENT
Medications for 
Treatment of Opioid 
Use Disorder
Number of individuals actively 
receiving methadone
RI-BHOLD
BHDDH
Zip Code
PROVIDENT
Emergency 
Department Visits
Number of emergency 
department visits for 
suspected drug overdose
48-Hour Reporting 
System
RIDOH
CBG*
Other
Emergency Medical 
Services
Number of emergency 
medical services runs for 
suspected drug overdose
Time from dispatch to arrival 
on scene for suspected drug 
overdose
NEMSIS/EMS
RIDOH
CBG*
PROVIDENT
All unintentional or 
undetermined drug overdose 
deaths
SUDORS
RIDOH
CBG*
PROVIDENT
Drug Overdose 
Deaths
All accidental drug-related 
deaths that occur in Rhode 
Island
OSME
RIDOH
CBG*
PROVIDENT
Number of STI cases
Rapid HCV and/or 
Syphilis Test 
Reporting Form
RIDOH
Zip Code
Other
Number of HCV cases
Rapid HCV and/or 
Syphilis Test 
Reporting Form
RIDOH
Zip Code
Other
STI/HCV/HIV
Number of HIV cases (with 
viral load counts included)
eHARS
Rapid HIV Test 
Reporting Form
RIDOH
CBG*
Other
Number of COVID-19 
hospitalizations
State COVID-19 
Case Databases
RIDOH
CBG*
Other
Number of COVID-19 cases/ 
diagnoses
State COVID-19 
Case Databases
RIDOH
CBG*
Other
COVID-19
Number of COVID-
19     deaths
State COVID-19 
Case Databases
RIDOH
CBG*
Other
BHDDH = Department of Behavioral Health, Developmental Disabilities, and Hospitals; RI-BHOLD = Rhode Island Behavioral Health Online 
Database; Census Block Group = Census Block Group; EOHHS = Rhode Island Executive Office of Health and Human Services; OSME = 
Office of the State Medical Examiner; RIDOH = Rhode Island Department of Health; APCD = All Payers Claims Database; WuFoo = Non-
pharmacy naloxone distribution data; RIDMAT/MRC = Rhode Island Disaster Medical Assistance Team’s Medical Reserve Corps; NEMSIS 
= National Emergency Medical Services Information System; SUDORS = State Unintentional Death Reporting System; STI = sexually 
transmitted infection; HCV = Hepatitis C virus; RHCSTRF = Rapid Hepatitis C and/or Syphilis Test Reporting Form; eHARS = Enhanced 
human immunodeficiency virus, acquired immunodeficiency syndrome (HIV/AIDS) Reporting System; RHTRF = Rapid HIV Test Reporting 
Form; COVID-19 = coronavirus disease 2019
* Data collected at the address level but will be aggregated to the census block group (CBG) for analysis
**Access: PROVIDENT = access to data source available through parent study; Other = access to data source is a secondary data source 
that is already being or has already been collected administratively for other purposes. 
12.2 Describe the type(s) of data / biospecimens and date range(s) of the data you will use and 
the characteristics of the study research population (e.g., age range, sex, and any other 
pertinent demographic information. 
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Phase 1 PROVIDENT Model
Please see table S1 (above) for a description of the types of datasets. The date range will be for 2016-2019. We will ask for demographic 
identifiers if they are available for the datasets, as well as geographic identifiers (as listed in S2).
Phase 2 Cluster Randomized Trial
Change in accidental fatal and non-fatal drug overdoses [ Time Frame: Baseline up to 2.5 years following intervention, with assessment of 
primary outcome at 2.5 years ]
The primary outcome is the municipal-level rate of fatal and non-fatal drug overdoses. Fatal overdoses will be defined as drug-related 
deaths deemed accidental by a state medical examiner. The location of these overdose events will be aggregated to the city/town level. 
Non-fatal overdoses will be defined as an Emergency Department (ED) visit for a suspected overdose reported through the state's 48-Hour 
Overdose Reporting System. Since patient outcomes are recorded, patients who did not survive or who were dead upon arrival will be 
excluded to avoid double-counting. There are no exclusion criteria.
COVID-19 Supplement
Please see table S2 (above) for a description of the types of datasets. The date range for the supplemental research is 2016-2021. We will 
ask for demographic identifiers if they are available for the datasets, as well as geographic identifiers (as listed in S2).
12.3 Describe how will you use, study, or analyze the data / biospecimens.
Analyses are included in Question 7 Study Procedures.
13. Does the study involve the use of PHI from a HIPAA-covered entity?   
☒ Yes (complete Question 13.1-13.2)     ☐ No (proceed to Question 14)
If “yes,” please upload Appendix G: Use of Protected Health Information (PHI) in Research. If 
applicable, upload a HIPAA Authorization form.
13.1 Describe how authorization to access the data will be obtained. 
With support from the Office of Research Integrity, Data Use Agreements have been negotiated with 
each State Agency.
13.2 Is the data considered a limited data set?      ☐ Yes      ☒ No 
14. Does the study involve the use of Family Educational Rights and Privacy Act (FERPA) or 
Protection of Pupil Rights Amendment (PPRA) data? 
☐ Yes (complete 14.1-14.2)   ☒ No (proceed to Question 15)
14.1  What type of FERPA or PPRA data will be accessed for this research?
☐ Directory information
☐ Education records
☐ Instructional material
☐ Personally identifiable information (PII)
☐ Data involving a PPRA-protected category
☐ Other, please describe: Click or tap here to enter text.
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14.2  Describe how authorization to access the data will be obtained. 
Click or tap here to enter text.
15. Is a Data Use Agreement (DUA), Material Transfer Agreement (MTA), or other agreement 
required by the source to obtain, use, study, or analyze the data / biospecimens?
☒ Yes      ☐ No
If “yes,” please upload a copy of the Agreement(s) (draft or executed).
16. What type of data will be collected? 
☐ Identifiable biospecimens
☒ Personally identifiable Information (PII)
☐ Coded data and the study team has access to the linking file / key
☐ Coded data and the study team does not have access to the linking file / key 
☒ Anonymous data
☒ Publicly available data
☐ Other, please describe: Click or tap here to enter text.
17. Briefly describe your plan for managing the integrity of the data and monitoring the safety of 
participants.    ☐ N/A
Phase 1 PROVIDET model development, Phase 2 Cluster Randomized Trial, and the COVID-19 
Supplement are each a retrospective review of multiple secondary data sources and are already being 
collected administratively for other purposes. The risk to participants is no greater than minimal risk, and 
is limited to loss of privacy. Our measures to protect against those risks are outlined in the PROVIDENT 
DSMP. Our research environment in Stronghold is designed to provide the utmost security for these 
sensitive datasets, and all datasets will be transferred under Data Use Agreements with the participating 
state agencies.
A single Data and Safety Monitoring Board (DSMB) is appointed to oversee this project. The DSMB will 
consist of members outside of the research group conducting this study, but may include individuals who 
are affiliated with one or more of the data sharing partners, but are not directly related to the project. The 
DSMB will include, at minimum, one individual with expertise in statistics or biostatistics. Any potential 
conflicts of interest must be disclosed during the application process. The Brown University IRB will 
ultimately approve the membership, meeting frequency, and Safety Monitoring Plan for the DSMB.
As outlined in the Data and Safety Monitoring Plan (DSMP), this  independent  Data and Safety  
Monitoring  Board will assess the progress of a clinical study,  the safety  data, and critical efficacy 
endpoints (if appropriate) and provide  recommendations  to  the  sponsor.   The members of  the DSMB 
serve  in an individual capacity  and  provide  their  expertise,  including  recommendations  regarding  the  
continuation, modification, or termination of any or all arms of the study.  The DSMB will review 
cumulative study data to evaluate safety, study conduct, scientific validity, and data integrity of the study. 
Additional details about data and safety monitoring can be found in the PROVIDENT DSMP, including 
who will be performing the monitoring, what data will be collected, study stopping rules, and notification 
procedures.
18. How will you protect the privacy of participants? 
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Phase 1 PROVIDENT Model Development, Phase 2 Cluster Randomized Trial, COVID 
Supplement
The model, trial, and supplement use secondary data exclusively; therefore, privacy of study data is of 
utmost importance. Our research requires the use of existing surveillance records related to overdose, 
medical events, and prescribing events. Access to such records for legitimate research purposes has been 
approved by our data sharing partners (including the Rhode Island Department of Health and the Rhode 
Island Department of Corrections), and our team has worked carefully to ensure the protection of these 
data.
We recognize that a loss of privacy may also result in psychological harm to individuals or in social 
harm. As such, the Project Investigator will be using Brown’s state of the art Stronghold computing 
environment for the transfer, analysis, and protection of all research data. Data sharing partners will share 
only the required datasets and variables. Additionally, only select members of the analytic team will have 
access to any identifiable datasets. All data transfer procedures, analytic plans, and datasets will be 
approved by the Brown IRB, any additional institutional IRBs, and the DSMB.
Research Database Infrastructure: This project will benefit from and expand upon data security 
resources provided by the Brown University “Stronghold” computing system. Stronghold is a secure 
computing and storage environment that enables Brown researchers to analyze sensitive data, while 
complying with regulatory or contractual requirements. Stronghold is currently self-certified to meet the 
security requirements and controls for HIPAA (Health Insurance Portability and Accountability Act) and 
is undergoing the certification process for FISMA (Federal Information Security Management Act) and 
CJIS (Criminal Justice Information Security). We will use the Stronghold secure computing environment 
to store, maintain, and transfer data between Brown University and data stakeholders, including RIDOH 
and other state agencies (e.g., Office of the State Medical Examiners, the Rhode Island Department of 
Corrections).
Stronghold is a secure virtual computing environment designed for remotely analyzing sensitive data. It 
uses encrypted SSH (Secure Shell) with two-factor authentication for remote access. Access to each 
virtual network is limited to a single PI and any additional students or staff who the PI authorizes in 
writing to Brown University Computing & Information Services (CIS). The PI enters into a written 
agreement with CIS that authorized users must comply with all necessary training requirements. CIS 
staff who have access to Stronghold have completed CITI course modules for working with human 
subject data as required by Brown’s Office of Research Protection.
Stronghold is accessible only from within the Brown campus network and by Virtual Private Network 
connections (using two-factor authentication) from outside the campus network. All network connections 
to Stronghold pass through at least two firewalls: a dedicated firewall on the Brown campus network and 
a host-based firewall in the Stronghold environment.
The Stronghold system is physically located in a locked rack in a CCTV monitored data center on the 
Brown campus. Only certain authorized CIS staff have access to this locked rack. Entry to the data center 
is limited to authorized Brown IT personnel and their guests, and all entries are logged.
Phase 2 Implementation Study
Participants will be identified by a Participant Study ID in Focus Groups, Key Informant Interviews, and 
Surveys.
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●
Focus groups and key informant interviews will be recorded (zoom), recordings will be stored 
(departmental server), and transcribed (Daily Transcription). Prior to uploading the transcribed 
focus group text into the qualitative analysis software (Dedoose), the research team will remove 
any potential identifiers from the transcripts.
●
Daily Transcription will have access to audio interview files. No data is stored at Daily 
Transcription. Audio files will be uploaded onto their secure website. Their transcriptionist will 
then download the audio files for transcription. Audio files will be kept on Daily Transcription’s 
secure server for 90 days in case revisions are needed. Then all files will be destroyed.
●
Surveys will capture only Participant Study ID and will be in Qualtrics. All extracted data and 
analyses will be stored on the Departmental Server. Some broad demographic information is 
collected in the pre-survey (year of birth, race, gender, sex) but are only connected to a 
Participant Study ID.
●
Identifiable user or group information collected through the Web Tool will not be presented or 
made public. Data elements that may enable data linkages to other datasets will not be shared. 
Web Tool metadata and use statistics will be generalized and aggregated. 
19. Does the study have or will you apply for a Certificate of Confidentiality (CoC)?
☒ Yes    ☐ No
20. How will you maintain the confidentiality of participant data? 
The model, trial, and supplement use secondary data exclusively; therefore, confidentiality of study data 
is of utmost importance. Our research requires the use of existing surveillance records related to overdose, 
medical events, and prescribing events. Access to such records for legitimate research purposes has been 
approved by our data sharing partners (including the Rhode Island Department of Health and the Rhode 
Island Department of Corrections), and our team has worked carefully to ensure the protection of these 
data.
We recognize that a loss of confidentiality may result in psychological harm to individuals or in social 
harm. As such, the Project Investigator will be using Brown’s state of the art Stronghold computing 
environment for the transfer, analysis, and protection of all research data. Data sharing partners will share 
only the required datasets and variables. Additionally, only select members of the analytic team will have 
access to any identifiable datasets. All data transfer procedures, analytic plans, and datasets will be 
approved by the Brown IRB, any additional institutional IRBs, and the DSMB.
Research Database Infrastructure: This project will benefit from and expand upon data security resources 
provided by the Brown University “Stronghold” computing system. Stronghold is a secure computing and 
storage environment that enables Brown researchers to analyze sensitive data, while complying with 
regulatory or contractual requirements. Stronghold is currently self-certified to meet the security 
requirements and controls for HIPAA (Health Insurance Portability and Accountability Act) and is 
undergoing the certification process for FISMA (Federal Information Security Management Act) and CJIS 
(Criminal Justice Information Security). We will use the Stronghold secure computing environment to 
store, maintain, and transfer data between Brown University and data stakeholders, including RIDOH and 
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other state agencies (e.g., Office of the State Medical Examiners, the Rhode Island Department of 
Corrections).
Stronghold is a secure virtual computing environment designed for remotely analyzing sensitive data. It 
uses encrypted SSH (Secure Shell) with two-factor authentication for remote access. Access to each virtual 
network is limited to a single PI and any additional students or staff who the PI authorizes in writing to 
Brown University Computing & Information Services (CIS). The PI enters into a written agreement with 
CIS that authorized users must comply with all necessary training requirements. CIS staff who have access 
to Stronghold have completed CITI course modules for working with human subject data as required by 
Brown’s Office of Research Protection.
Stronghold is accessible only from within the Brown campus network and by Virtual Private Network 
connections (using two-factor authentication) from outside the campus network. All  network connections 
to Stronghold pass through at least two firewalls: a dedicated firewall on the Brown campus network and 
a host-based firewall in the Stronghold environment.
The Stronghold system is physically located in a locked rack in a CCTV monitored data center on the 
Brown campus. Only certain authorized CIS staff have access to this locked rack. Entry to the data center 
is limited to authorized Brown IT personnel and their guests, and all entries are logged.
The intervention will use a web tool and interactive dashboard to visualize the neighborhood-level risk 
predictions from the PROVIDENT model. The PROVIDENT Web Tool has undergone a security review 
with Brown Computing and Information Services (CIS) and the Center for Computation and Visualization 
(CCV). Use of the Web Tool has been approved and our team has worked carefully to ensure the protection 
of the model predictions.
We recognize that a loss of confidentiality through unauthorized access to the PROVIDENT Web Tool 
and model predictions may also result in psychological harm to individuals or in social harm. As such, 
personnel from the Center for Computation and Visualization will be responsible for administration of the 
system. Research staff will have logins to manage data and download data. Individuals accessing the web 
application will have access to only the required information and will share only what is required. 
Additionally, only select members of the analytic team will have access to any identifiable datasets. All 
data transfer procedures, analytic plans, and datasets will be approved by the Brown IRB, any additional 
institutional IRBs, and the DSMB.
PROVIDENT Web Tool Infrastructure: The web application is hosted in Firebase with application data 
stored in Firestore. The application is intended to be used exclusively by personnel of organizations (e.g 
non-profits helping opioid overdose prevention). Once an individual has been approved, they may create 
a username and password. Authentication is managed using Firebase native authentication. 
Logged-in individuals interact with a series of surveys, approved by Brown IRB, that collect information 
about services and programs for opioid overdose prevention available in corresponding neighborhoods. 
Approved organizations will also have access to the PROVIDENT model predictions through use of the 
web application. Approved Brown researchers will use the data collected to examine what and how many 
directed overdose prevention activities are driven in part by the PROVIDENT model to measure fidelity 
and penetration. Finally, using the surveys, we will regularly query organizations approved to use the Web 
Tool about unauthorized use in community settings (e.g., inadvertent sharing of PROVIDENT screenshots 
during a community meeting). 
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Data will be downloaded from Firebase to Brown University data servers through provided, secure APIs 
(including web). Firebase and Firestore encrypt data during transfer and at rest. Firebase is certified under 
major security and privacy standards. Privacy and security information in Firebase can be found here. 
Data protection is managed through security rules, which in this particular case are set to only allow write 
access to users that have passed the simple authentication mechanism.
Personnel from the Center for Computation and Visualization will be responsible for administration of 
the system. Researchers from the People, Place, and Health Collective will have logins to manage data 
and download data.
21. Who will have access to your study data / biospecimens? 
☒ Brown PI and other Brown research team members (including advisor). 
Describe how unauthorized access by others will be prevented.
Stronghold is a secure virtual compute environment designed for remotely analyzing sensitive 
data. It uses encrypted SSH (Secure Shell) with two-factor authentication for remote access. 
Access to each virtual network is limited to a single PI and any additional students or staff who 
the PI authorizes in writing to CIS. The PI enters into a written agreement with CIS that 
authorized users must comply with all necessary training requirements. CIS staff who have 
access to Stronghold have completed CITI course modules for working with human subject data 
as required by Brown’s Office of Research Protection.   
Stronghold is accessible only from within the Brown campus network and by Virtual Private 
Network connections (using two-factor authentication) from outside the campus network. All 
network connections to Stronghold pass through at least two firewalls: a dedicated firewall on 
the Brown campus network and a host-based firewall in the Stronghold environment. The 
Stronghold system is physically located in a locked rack in a CCTV monitored data center on the 
Brown campus. Only certain authorized CIS staff have access to this locked rack. Entry to the 
data center is limited to authorized Brown IT personnel and their guests, and all entries are 
logged. 
  
The Stronghold system is physically located in a locked rack in a CCTV monitored data center 
on the Brown campus. Only certain authorized CIS staff have access to this locked rack. Entry to 
the data center is limited to authorized Brown IT personnel and their guests, and all entries are 
logged.   
All data transfers to and from Stronghold take place through a staging area accessed with the 
SCP (Secure Copy) protocol using two-factor authentication. Once uploaded, data is only 
accessible from virtual machines within the Stronghold system. Data must be explicitly moved 
into the staging area by the PI (or anyone the PI authorizes in writing) before it can be 
downloaded. All transfers are logged and audited, and real-time alerting can be enabled at the 
PI’s request.    All analyses and data will take place and remain on Stronghold. Research 
collaborators external to Brown must be credentialed through Brown University with explicit 
written authorization from the PI. 
 
Only authorized research team members will have access to the Google Firestore, Qualtrics, 
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Zoom, Daily Transcription, and Dedoose accounts. In addition to the AES 256 bit encryption of 
data within Google Firestore, only designated research staff and CIS staff will have access to the 
account. The focus group and key informant interview audio files will be uploaded by Brown 
staff to a password-protected folder on Brown School of Public Health departmental servers, 
only accessible to designated study staff, before uploading the files to Daily Transcription. All 
original transcripts will be stored on the Departmental Server, and de-identified transcripts from 
Daily Transcription will be managed/analyzed in Dedoose.   
☐ Data will be shared with research collaborators external to Brown. 
Describe how you will securely share / transfer the data outside of Brown.
Click or tap here to enter text.
☐Data will be shared with a data repository.
Describe how you will securely share / transfer the data outside of Brown.
Click or tap here to enter text.
PRINCIPAL INVESTIGATOR AGREEMENTS & RESPONSIBILITIES 
 A. Conduct of the Research
1. I accept responsibility for the ethical conduct of this research and protection of participants as set 
forth in the Belmont Report, Federal Regulations for the Protection of Human Subjects (45 CFR 
46) , and Brown University policies.
2. I certify that I will assume responsibility for the proper conduct of this research and compliance 
with all Brown policies and procedures, and federal and state requirements. 
3. I accept responsibility for ensuring that all members of the research team have or will complete 
human subjects CITI training before any work with participants or identifiable information / 
biospecimens begins.
B. Ensuring and Maintaining Compliance
1. I will comply with relevant regulatory and institutional reporting requirements, including Brown 
University’s Reportable Events Policy. 
2. I will notify the Brown HRPP when I have completed all activities involving human subjects or 
identifiable participant information or identifiable biospecimens.
3. I will maintain approval, as applicable, with collaborative parties, including approvals from other 
countries or jurisdictions.
4. I will cooperate with any post-approval monitoring or auditing of study activities and/or study 
records as requested and/or required by the Brown ORI, the Brown IRB, funding entities, 
sponsors, and/or any federal or state regulatory agencies.
C. Study records, Reports and Documentation
1. I will comply by Brown’s Research Data and Research Materials Management, Sharing and 
Retention Policy.
2. I will maintain all research protocol materials and consent materials for the duration of this 
study.
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3. I will maintain research records for at least three years following the end of this research, or for a 
longer length of time if specified in applicable regulations or sponsor requirements. I will take 
measures to prevent accidental or premature destruction of these records.
               
By submitting this document, I certify that I have read and agree to uphold all of 
the Agreements and Responsibilities in this application.
Brown University IRB Approval Jun 25 2024