Leveraging Social Networks to Increase COVID-19 Testing Uptake: A Comparison of Credible Messenger and Chain Referral Recruitment Approaches
Phase: NA
Conditions: Covid-19, Substance Use, Opioid Use
Sponsor: New York State Psychiatric Institute

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CLINICAL STUDY PROTOCOL 
 
Leveraging Social Networks to Increase 
COVID-19 Testing Uptake 
A Comparison of Credible Messenger and Chain Referral Recruitment 
Approaches 
 
National Clinical Trial (NCT) Identified Number: NCT04873401 
 
Sponsor 
National Institute on Drug Abuse 
National Institute of Health 
 
Grant Title: Leveraging Social Networks to Increase COVID-19 Testing Uptake: A 
Comparison of Credible Messenger and Chain Referral Recruitment Approaches 
Grant Number: UG1DA050071-S1 
Funded by: National Institute on Drug Abuse (NIDA) 
 
Conducted by the New York State Psychiatric Institute with Alliance for Positive Change, Argus 
Community Inc., Columbia University 
 
 
Protocol Version 2.0 
[01/17/2023] 
 
 

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Section 1: Basic Information ............................................................................................................................................. 4 
1.1. Study Title ............................................................................................................................................................. 4 
1.2. Is this study exempt from federal regulations? ...................................................................................................... 4 
1.3. Exemption Number ............................................................................................................................................... 4 
1.4. Clinical Trial Questionnaire .................................................................................................................................... 4 
1.4.a. Does the study involve human participants? ................................................................................................... 4 
1.4.b. Are the participants prospectively assigned to an intervention? ..................................................................... 4 
1.4.c. Is the study designed to evaluate the effect of the intervention on the participants? ...................................... 4 
1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome? ................................ 4 
1.5. Provide the ClinicalTrials.gov Identifier for this trial, if applicable .......................................................................... 4 
Section 2. Study Population Characteristics ...................................................................................................................... 5 
2.1.1. Conditions or Focus of Study .............................................................................................................................. 5 
2.2. Eligibility Criteria ................................................................................................................................................... 6 
2.3. Age Limits .............................................................................................................................................................. 6 
2.4. Inclusion of Women, Minorities and Children ........................................................................................................ 6 
2.5. Recruitment and Retention ................................................................................................................................... 7 
2.6. Recruitment Status ................................................................................................................................................ 8 
2.7. Study Timeline....................................................................................................................................................... 8 
2.8. Enrollment of First Subject .................................................................................................................................... 8 
Table 2. Inclusion Enrollment Table for Staff Participants ......................................................................................... 9 
Section 3. Protection and Monitoring Plans ...................................................................................................................... 9 
3.2 Single IRB plan .......................................................................................................................................................20 
If MPIs deem the event likely to affect participants, it must be reported to the IRB immediately..........................22 
3.5 Overall Structure of the Study Team ......................................................................................................................27 
Section 4. Protocol Synopsis ............................................................................................................................................28 
4.1. Brief Summary......................................................................................................................................................28 
4.2. Brief Summary......................................................................................................................................................28 
4.2.b. Primary Purpose ................................................................................................. Error! Bookmark not defined. 
4.2.c. Interventions ...................................................................................................... Error! Bookmark not defined. 
4.2.d. Study Phase ........................................................................................................ Error! Bookmark not defined. 
4.2.e. Intervention Model ............................................................................................. Error! Bookmark not defined. 
4.2.f. Masking............................................................................................................... Error! Bookmark not defined. 
4.3. Outcome Measures ..............................................................................................................................................29 
Table 5. Outcome Measures ....................................................................................................................................29 

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4.4 Statistical Design and Power ..................................................................................................................................30 
4.4.1 Primary data analysis overview .......................................................................................................................30 
4.5. Subject participation duration: .............................................................................................................................31 
4.6. FDA regulated intervention: .................................................................................................................................31 
4.7. Dissemination Plan ...............................................................................................................................................32 
Conflict of Interest Policy.............................................................................................. Error! Bookmark not defined. 
Abbreviations and Special Terms .................................................................................................................................33 
Protocol Amendment History ......................................................................................................................................35 
Figure 1. Study Timeline ..................................................................................................................................................36 
 
 
 
 

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Section 1: Basic Information 
1.1. Study Title 
Leveraging Social Networks to Increase COVID-19 Testing Uptake: A Comparison of Credible Messenger 
and Chain Referral Recruitment Approaches 
 
1.2. Is this study exempt from federal regulations?  
No 
 
1.3. Exemption Number 
NA 
 
1.4. Clinical Trial Questionnaire 
1.4.a. Does the study involve human participants?  
Yes  
1.4.b. Are the participants prospectively assigned to an intervention?  
Yes  
1.4.c. Is the study designed to evaluate the effect of the intervention on the participants?  
Yes  
1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?  
Yes 
 
1.5. Provide the ClinicalTrials.gov Identifier for this trial, if applicable 
NCT04873401 
 
Statement of Compliance 
New York State Psychiatric Institute (NYSPI) Institutional Review Board (IRB) is duly constituted, has written 
procedures for initial and continuing review of clinical trials; prepares written minutes of convened meetings, and 
retains records pertaining to the review and approval process; all in compliance with requirements of FDA 
regulations 21 CFR Parts 50 and 56, HHS regulations 45 CFR 46, and International Conference on 
Harmonization (ICH) E6, Good Clinical Practice (GCP), as applicable. 
  
  
Investigator’s Signature 
  
  
X____________________________________ 
20 January 2023 
 
 

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Section 2. Study Population Characteristics 
 
Introduction: 
Study Rationale 
COVID-19 has severely impacted underserved populations and their communities. Higher incidence of COVID-
19, hospitalization and mortality, have been found in neighborhoods in NYC with high poverty rates, where HIV, 
HCV, opioid use and justice involvement/arrests are endemic. In Harlem, Washington Heights, and the South 
Bronx, where the proposed supplement will take place, rates of infection and mortality were some of the highest 
in NYC. Historically, those who use opioids and other substances inconsistently accessed services due to a 
confluence of structural (e.g., housing instability, stigma, discrimination, and lack of insurance) and individual-
level factors (e.g., mental illness; medical mistrust). Identification of positive cases requires widespread testing 
of this vulnerable yet “hidden” population.  
 
Guided by social cognitive theory (SCT), Andersen’s model of health care access and the EPIS framework, 
Specific Aims are: 1) Adapt two implementation strategies to support COVID-19 testing uptake and sustainability, 
adapting elements of existing efficacious social network-based interventions via a CBPR approach. 2) Examine 
and compare the efficacy of two sets of implementation strategies on (i) reach, (ii) testing uptake, (iii) service 
delivery (i.e. quarantine, medical care, contact tracing) and (iv) sustainability for individuals who use opioids and 
other drugs. Use of data drawn from Healthix, a public health information exchange, will supplement this 
comparison by generating a baseline of participant prior testing and health behavior to determine access to 
underserved populations as well as long-term influence on future testing behavior. 3) Elucidate and compare the 
system/organizational-, staff-, and individual-level factors that influence implementation (i.e. fidelity, 
acceptability, feasibility, sustainability) of the strategies to develop a plan for dissemination and scale-up in other 
CBOs who serve opioid and other substance using individuals in NYC. 
 
Background 
The present project aims to adapt and conduct a trial examining the ability of two recruitment strategies, chain- 
referral and credible messenger, proven efficacious in reaching hidden populations to improve HIV testing 
uptake, to reach those who use opioids and other substances in order to increase their uptake of onsite point of 
care COVID-19 testing that will be delivered in two community-based organizations (CBOs). The CBOs -- 
Alliance for Positive Change and Argus Health Inc -- have a well-established partnership with members of the 
parent grant team (Cohall, Wilson, Cohall, Gordon) following collaborations on numerous initiatives targeting 
HIV, HCV and STIs prevention, testing and treatment for over 15 years. These agencies have again agreed to 
work with the team on the proposed supplement and adapt the existing infrastructure in their agencies to now 
tackle COVID-19, which devastated the communities they serve in the initial wave of the COVID-19 epidemic in 
New York City. Argus and Alliance combined have had a presence in the communities of Washington Heights, 
Harlem and the South Bronx for over 50 years, and have subsequently developed considerable trust, support 
and “credibility” within these communities. It is this community presence that we will tap into as we adapt the two 
recruitment strategies. The staff and clients from these agencies have extensive experience developing and 
adapting programming and, guided by a community participatory based research approach, will partner with the 
research team in these adaptation efforts.  
 
The aims of the proposed supplement are independent of the parent grant, yet draw on the team, existing 
partnerships and our implementation expertise in the development of this new proposal. This investigation will 
provide much needed information to improve health outcomes and to identify effective system-level responses 
to prevent or arrest the spread of COVID-19 among the social networks of those who use opioids and other 
substances, a highly vulnerable and often overlooked population. 
 
2.1.1. Conditions or Focus of Study 
Condition 1: COVID-19 
Condition 2: Substance use 

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Condition 3: Opioid Use 
 
 
2.1.2. Study Aims 
Following a CBPR approach that builds on the expertise and community outreach infrastructure of Argus and 
Alliance, we propose to adapt two implementation strategies that have been proven to increase the reach, 
access, and uptake of HIV testing and related services in order to support the uptake and sustainability of point-
of-service (POS), onsite COVID-19 testing in CBOs that target underserved people who use opioids and other 
substances. Guided by social cognitive theory (SCT), Andersen’s model of health care access and the EPIS 
framework, the specific aims are to:  
 
 
 
 
 
 
 
Aim 1. Adapt two implementation strategies to support COVID-19 testing uptake and sustainability, 
adapting elements of existing efficacious social network-based interventions via a CBPR approach. 
 
 
Aim 2. Examine and compare the efficacy of two sets of implementation strategies on (i) reach, (ii) 
testing uptake, (iii) service delivery (i.e. quarantine, medical care, contact tracing) and (iv) sustainability for 
individuals who use opioids and other drugs. Use of data drawn from Healthix, a public health information 
exchange, will supplement this comparison  
by generating a baseline of participant prior testing and health behavior to determine access to underserved 
populations as well as long-term influence on future testing behavior. 
 
Aim 3. Elucidate and compare the system/organizational-, staff-, and individual-level factors that 
influence implementation (i.e. fidelity, acceptability, feasibility, sustainability) of the strategies to develop a plan 
for dissemination and scale-up in other CBOs who serve opioid and other substance using individuals in NYC.  
This investigation will provide much needed information to improve health outcomes and to identify effective 
system-level responses to prevent or arrest the spread of COVID-19 among the social networks of those who 
use opioids and other substances, a highly vulnerable and often overlooked population.  
 
 
2.2. Eligibility Criteria 
Sample 1: Testing Participants. Must endorse opioid or other substance abuse in the past 6 months and must 
speak English or Spanish; >18years.  
 
Sample 2: Staff Participants. Currently employed at either Argus or Alliance, including POLs participating in 
Peer programs. PI/PD will present the study to staff and interested staff will be asked to contact the research 
team. 
 
2.3. Age Limits 
Samples 1-2 
Minimum: 18 years 
Maximum: NA  
2.4. Inclusion of Women, Minorities and Children 
Inclusion of Women. There is no inclusion or exclusion of participants based on gender. Based on demographic 
and community/area data of Argus and Alliance clients, staff, and credible messengers we anticipate females 
will comprise approximately 40% of the sample.  
Inclusion of Minorities. We will not exclude participants based on ethnicity. Based on the demographic data of 
Argus and Alliance clients, staff, and credible messengers we anticipate 51% African American and 39% will be 
Hispanic.  
Inclusion Across the Lifespan. Children will not be enrolled. The proposed study involves those who are using 
opioids and other drugs and who are largely underserved and at risk for COVID- 19 infection. In NYS, the current 

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opioid epidemic does not center on those younger than 18 and currently, those at greatest risk for negative 
sequalae from complications due to COVID-19 are older than 18.  
 
2.5. Recruitment and Retention 
Recruitment of agency staff and credible messengers for staff surveys and focus groups. All agency staff will 
be invited to participate in the staff surveys; those staff and credible messengers directly involved in the 
recruitment strategies and on-site COVID-19 test delivery, either via educating testing participants and 
supervising credible messengers (staff) or recruiting peers in the community (credible messengers) will be 
invited to participate in the staff surveys and focus groups in the same way. The PI/PD will present the study to 
agency staff both in-person at a staff meeting and via email and interested staff will be asked to contact the 
research team. An email from the PI (with an attached information sheet) explaining the project and staff 
participation in the survey and focus group will be sent to agency leadership who will then distribute it to staff 
and Credible Messengers. These methods have been used successfully in our prior work with probation offices 
and treatment staff. The email will instruct interested staff to contact research staff directly to ask questions. 
For those interested in participating in focus groups, efforts will be made to schedule interviews at times that do 
not interfere with staff roles (e.g. lunch breaks; staff meetings). Considerable effort will be taken to ensure that 
staff do not feel coerced to participate. It will be emphasized to staff that participation (Y/N) is voluntary and will 
in no way affect their employment status. These procedures have been successfully used in PIs prior work 
recruiting justice and treatment staff. Retention and engagement activities will include small thank you gifts for 
participation in surveys, one at baseline and the other after study activities have been completed. We are 
unable to address staff-turnover which may impact on study retention.  
 
Recruitment of testing participants. Testing participants will be recruited in one of two ways: chain referral 
and credible messenger.  In the chain referral strategy, an initial set of n=8 “seed” participants are recruitment 
by staff of eligible clients receiving services at Argus and Alliance (n=16 total seeds). For clinic-based recruitment 
of “seeds”, participants will be recruited from among those individuals who use opioids and other drugs who are 
receiving services through Argus or Alliance; services do not need to be substance use related. (Following a 
brief training, these “seed” participants then recruit additional participants (“peer recruits”) from among their own 
peer networks of those known to use opioid or other drugs in community settings (peer- recruitment). “Seed” 
participants are given three unique, numbered coupons, which they can give to people they know (peers) who 
are also use opioids and other drugs. The coupons will have information, by which peers who are interested in 
participating in the study can contact the research team to be screened for eligibility. Participants will receive 
renumeration for each peer recruit who enrolls in the study by redeeming a coupon given to them by that 
participant. Peer-recruits then repeat the same process with members of their peer network.  
The credible messenger strategy involves leveraging the existing infrastructure at both Argus and 
Alliance, which includes credible messenger programs that are well-established, with considerable influence and 
impact within the respective communities served by these two agencies. The credible messengers within these 
programs have been trained to conduct community outreach to target individuals at increased risk for HIV, STIs, 
HCV and SUD and encourage testing and/or linkage to services. Interested credible messengers (n=4 from each 
site) will serve as messengers in the current study and will be trained to also include education about COVID-
19, ways to reduce risk as well as ways to increase motivation to test for COVID-19 at the respective clinics. 
Credible messengers will conduct community outreach, targeting those locations and venues where potentially 
credible participants are located, and will provide education and encourage these individuals to seek testing. 
The potential participants will be given a coupon which will be redeemed at the clinic when the participant is 
enrolled in the study after being determined as eligible.  
As testing participants are assessed once and then offered a test immediately thereafter, study retention 
is not a considerable focus of procedures. Participants recruited by chain-referral will be given a brief survey 
following their recruitment efforts to document number of attempts, time etc. This brief survey will occur at the 
visit when the participant comes to the clinic to receive payment for redeemed coupons that s/he distributed to 
peers; it is anticipated the payment will serve to adequately retain participants for the purpose of completing the 
brief survey. 
 

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2.6. Recruitment Status 
Not recruiting 
 
2.7. Study Timeline 
Study timelines have been attached to the end of this protocol; the first timeline documents study activities by 
wave (Figure 1, pg. 36).  
 
2.8. Enrollment of First Subject 
03/18/2020 
 
Table 1. Inclusion Enrollment Table for RADx Participants 
 
Hispanic Ethnicity 
 
Hispanic or Latino (n = 334) 
Not Hispanic or Latino 
(n = 140) 
Prefer not to answer / 
Unknown (n = 12) 
Gender Identity Categories 
Gender Identity 
Categories 
Gender Identity Categories 
 
Man 
Wo
man 
Non-
binary/
Other 
Prefer 
not to 
answe
r 
Ma
n 
Wom
an 
Non-
binary/ 
Other 
Man 
Wom
an 
Non-
binary/ 
Other 
Unkno
wn 
Total 
Racial 
Categories 
 
 
 
 
 
 
 
 
 
 
 
 
American 
Indian/Alas
ka Native 
9 
1 
1 
0 
1 
1 
0 
2 
0 
0 
0 
15 
Asian 
2 
0 
0 
0 
1 
1 
0 
0 
0 
0 
0 
4 
Native 
Hawaiian 
or Other 
Pacific 
Islander 
4 
0 
0 
0 
0 
0 
0 
0 
0 
0 
0 
4 
Black or 
African 
American 
23 
6 
0 
0 
44 
22 
3 
2 
1 
0 
0 
101 
White 
19 
13 
1 
0 
30 
25 
1 
2 
0 
0 
0 
91 
Some other 
race 
138 
29 
3 
0 
3 
2 
0 
3 
0 
0 
0 
178 
More than 
one race 
11 
6 
1 
0 
2 
2 
0 
1 
0 
0 
0 
23 
Prefer not 
to answer 
44 
5 
0 
1 
1 
0 
0 
0 
0 
0 
0 
51 
Unknown 
14 
3 
0 
0 
1 
0 
0 
0 
0 
0 
1 
19 
Total 
264 
63 
6 
1 
83 
53 
4 
10 
1 
0 
1 
486 
 

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Table 2. Inclusion Enrollment Table for Staff Participants  
Racial Categories 
Ethnic Categories 
 
Not Hispanic or Latino 
Hispanic or Latino 
Total 
Female 
Male 
Female 
Male 
American Indian/Alaska Native 
0 
0 
0 
0 
0 
Asian 
0 
0 
0 
0 
0 
Native Hawaiian or Other Pacific Islander 0 
0 
0 
0 
0 
Black or African American 
2 
1 
1 
2 
6 
White 
0 
0 
0 
0 
0 
More than One Race 
0 
0 
1 
1 
2 
Total  
2 
1 
2 
3 
8 
 
 
Section 3. Protection and Monitoring Plans 
 
3.1.1(a) Human Subjects Involvement, Characteristics, and Design 
Scientific Rationale for Study Design 
The primary goals of this proposal are to 1) adapt and compare the efficacy of two evidence-based outreach and 
recruitment strategies that target and identify (reach) individuals who use opioids and other drugs to increase 
uptake of COVID-19 testing and related services (quarantine, treatment); and 2) document the organizational, 
staff and individual-level  factors that influence implementation (i.e. fidelity, acceptability, feasibility, sustainability) 
of the strategies to develop a plan for dissemination and scale-up in CBOs and other settings who serve opioid 
and other substance using individuals in New York City.  The subjects will be recruited from two areas in New 
York City (NYC), northern Manhattan (Washington Heights and Harlem) and the South Bronx, areas served by 
two community based organizations (CBOs) that specialize in SUD treatment and provide a wealth of supportive 
services for individuals who abuse substances: Argus and Alliance (see Facilities and Other Resources).. 
There are three phases to the proposed study:  
• 
Phase 1: Strategy Adaption, will comprise a series of meetings (n=8) attended by a  Working Group (WG) 
that will include n=7 members of the research team, n=10 members of the project Community Advisory Board 
(CAB), which will be assembled from interested members of the CABs of Argus and Alliance, and interested 
staff from both agencies. Using community-based participatory research (CBPR) approaches, the WG will 
develop protocols and materials (e.g. messaging, target locations, training protocols, visual materials) for 
two recruitment strategies that aim to encourage individuals who use opioids and other drugs to seek COVID-
19 testing.  As we will not be collecting data from WG members, nor will consent/assent be obtained for their 
participation, they are not considered human subjects. 
• 
Phase 2: Efficacy Test and Implementation Evaluation, a trial will be performed in which the two 
strategies will be compared with respect to reach, testing uptake and related services; we will aim to recruit 
500 participants who use opioids or other substances over an 8 month period of time (n=250 in each 
strategy).  Participants will be assessed upon enrollment into the study.  In addition, n=8 credible messengers 
(n=4 at each site), and n=20 staff members  at each site employed at our community partners agencies 
Alliance and Argus, will complete baseline and 12-month follow-up surveys, fidelity/feasibility checklists, 
PDSA cycle and will participate in a workgroup at the completion of Phase 2.  
• 
Phase 3: Sustainment, CBOs will implement the strategy proven efficacious based on outcomes, and we 
will examine their sustainment of the program. 

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• 
The two recruitment strategies used in Phase 2 are chain referral and credible messenger: 
1) In the chain referral strategy, an initial set of n=8 “seed” participants are recruitment by staff of eligible 
clients receiving services at Argus and Alliance (n=16 total seeds). For clinic-based recruitment of 
“seeds”, participants will be recruited from among those individuals who use opioids and other drugs 
who are receiving services through Argus or Alliance; services do not need to be substance use related. 
(Following a brief training, these “seed” participants then recruit additional participants (“peer recruits”) 
from among their own peer networks of those known to use opioid or other drugs in community settings 
(peer-recruitment).  “Seed” participants are given three unique, numbered coupons, which they can 
give to people they know (peers) who are also use opioids and other drugs. The coupons will have 
information, by which peers who are interested in participating in the study can contact the research 
team to be screened for eligibility. Participants will receive renumerationfor each peer recruit who 
enrolls in the study by redeeming a coupon given to them by that participant. Peer-recruits then repeat 
the same process with members of their peer network.  
2) The credible messenger strategy involves leveraging the existing infrastructure at both Argus and 
Alliance, which includes credible messenger programs that are well-established, with considerable 
influence and impact within the respective communities served by these two agencies. The credible 
messengers within these programs  have been trained to conduct community outreach to target 
individuals at increased risk for HIV, STIs, HCV and SUD and encourage testing and/or linkage to 
services.  Interested credible messengers (n=4 from each site) will serve as messengers in the current 
study and will be trained to also include education about COVID-19, ways to reduce risk as well as 
ways to increase motivation to test for COVID-19 at the respective clinics.  Credible messengers will 
conduct community outreach, targeting those locations and venues where potentially credible 
participants are located, and will provide education and encourage these individuals to seek testing.  
The potential participants will be given a coupon which will be redeemed at the clinic when the 
participant is enrolled in the study after being determined as eligible. 
 
 
Justification for Intervention 
Social network strategies effective at identifying hidden populations and improving access to HIV related services 
may improve uptake of COVID-19 testing. Social network interventions utilize existing patterns of relationships 
to accelerate behavior change have been successful in increasing the uptake of HIV testing among marginalized 
populations, including people who use drugs. Moreover, social network approaches successfully counter stigma, 
medical mistrust, and misinformation around HIV, making them uniquely suited for addressing similar issues in 
the context of COVID-19. Two distinct social network recruitment strategies, chain-referral and Popular Opinion 
Leader (POL or “credible messenger”) models may be promising for increasing rapid COVID-19 testing. In chain-
referral a discrete number of “seeds” are identified and incentivized to refer members of their social networks, 
who in-turn repeat the process. In POL models, popular and socially influential individuals with lived experience 
are trained to engage within formal and informal social networks to promote behavior change. Based on the 
efficacy of chain-referral and POL recruitment in the context of the HIV/AIDS epidemic, the success of these 
strategies to promote COVID-19 testing in underserved populations of substance users is highly plausible. Given 
the distinct differences of these strategies, it is important to contrast them to determine the comparative benefits 
of one approach over the other. 
 
Ongoing quality improvement (QI) to promote an adaptive response to an evolving epidemic and promote 
sustainability. Plan-do-study-act (PDSA) is an evidence-based, rapid-cycle change model for testing 
enhancements on a small scale before incorporating them on a larger scale. Training staff, and POLs to use 
data (e.g. testing uptake, client feedback) to monitor and improve program performance may be a useful tool to 
develop sustainable strategies that address a rapidly changing pandemic as well as incorporate new testing, 
treatment and prevention (i.e., vaccine) technology. 
 

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The theoretical approach will integrate Andersen’s Model, Social Cognitive Theory (SCT), and the Exploration 
Preparation Implementation Sustainability (EPIS) framework to understand contextual/system- and individual-
level factors that influence implementation of a community outreach and testing uptake approach. Andersen’s 
Model provides a framework to identify key domains to target when developing interventions to improve service 
utilization. 
 
We propose research to establish efficacy and sustainability of a community-social network outreach model that 
partners infectious disease health providers with community based organizations to successfully implement 
(reach, uptake, delivery and sustainment) COVID-19 rapid POS testing among a highly vulnerable and often 
underserved population, those who use opioids and other substances. Two distinct social network recruitment 
strategies, found efficacious for identifying HIV+/high risk populations and increasing uptake of HIV testing (cites) 
will be adapted and compared. Guided by the EPIS framework, SCT, and Andersen's model, this 2-year study 
will comprise three phases. In Phase 1: Adaptation of outreach recruitment strategies, we will work with our 
project CAB, via a CBPR approach, to adapt chain-referral and credible messenger strategies for uptake of 
COVID-19 testing, to finalize recruitment and on-site testing protocols, and to train the CAB in the new protocols 
and in continuous quality improvement strategies (Aim 1). In Phase 2: Strategy Efficacy Trial and Implementation 
Evaluation, we will compare the two strategies in a cross-over design at two CBOs, with initial strategy 
assignment randomly determined and rolled out for 4 months before the cross-over occurs. The comparison of 
chain-referral and credible messenger strategies is not to identify the statistical superiority of one sampling 
strategy in providing population estimates over the other, but instead to identify the ability of each recruitment 
strategy to reach the target population and increase uptake of COVID-19 tests. We will examine the impact of 
each strategy on (i) reach (recruitment of target population), (ii) COVID-19 testing/repeat testing, and (iii) service 
delivery (i.e. quarantine, medical care and contact tracing) among those who test positive for COVID-19 
(exploratory) (Aim 2). In Phase 3: Sustainment, CBOs will implement the strategy proven efficacious based on 
outcomes, and we will examine their sustainment of the program (Aim 2). Implementation evaluation will identify 
participant-, staff-, and organizational-level factors that influence the feasibility, acceptability, and sustainability 
of each strategy in these CBOs. Participants will be assessed just prior to receipt of testing. Argus and Alliance 
staff will be assessed before and after the roll-out of strategies (Aim 3). 
We will examine the impact of the intervention on (i) reach, (ii) testing uptake and (iii) service delivery (i.e. 
quarantine, medical care and contact tracing among COVID-19 positive cases); and (iv) sustainability for 
individuals who use opioids and other drugs as well as potential mediating/moderating variables from the 
Andersen, SCT and EPIS models. Data drawn from Healthix on prior and future COVID-19 testing will augment 
study data to determine access to underserved populations and influence on future testing behavior. RAs will 
conduct interviews in private rooms at Argus and Alliance. Participants will be assured that responses are 
confidential (see Human Subjects). Interviewers will be trained with established protocols, covering informed 
consent, confidentiality, reporting requirements, interview content, and cultural sensitivity.  
 
 
End-of-Study Definition 
This study will be stopped prior to its completion if: (1) the intervention is associated with adverse effects that 
call into question the safety of the intervention such as increased rates of COVID-19 infection; (2) difficulty in 
study recruitment or retention, or enrollment of participants will significantly impact the ability to evaluate the 
study endpoints; (3) any new information becomes available during the trial that necessitates stopping the trial; 
or (4) other situations occur that might warrant stopping the trial. 
 
Human Subjects Characteristics 
Setting. Participants will be recruited from Washington Heights, Harlem two neighborhoods in northern 
Manhattan, the Lower East Side, a neighborhood in southern Manhattan, and the South Bronx, the locations and 
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substance using clientele, we anticipate participants will comprise 64% male, 51% African American, 39% 
Hispanic. 
Randomization. Just prior to the onset of Phase 2, the chain referral strategy will be randomly assigned (50:50) 
to a clinic in order to begin the first roll out.  After the initial roll out and plan-do-study-act cycle (PDSA), the 
assignment will be switched such that the chain referral is then implemented at the other site. 
Testing Participants.  We anticipate enrolling n=500 participants across both strategies in an 8 month period of 
time.   Based on demographic characteristics of the neighborhoods where recruitment will occur in addition to 
current demographics of the substance using clientele of Argus and Alliance, we anticipate participants will 
comprise 64% male, 51% African American, 28% Hispanic. Inclusion/exclusion criteria. All participants, 
regardless of recruitment strategy, must 1) be >18 years of age; 2) endorse opioid or other substance abuse in 
the past 6 months, and 3) speak English or Spanish.  Those who deny history of substance use (but will be 
offered COVID-19 testing), or present with intoxication that prevents meaningful study participation at the time 
of enrollment will be excluded. Individuals too intoxicated to participate, but otherwise willing and eligible will be 
rescheduled up to two times. Finally, those recruited by peer chain referral (see 3.7.2) who test positive for 
COVID-19 will be excluded from participating in the recruitment of other individuals until such time as they receive 
a negative nucleic acid COVID-19 test. This more stringent assessment of non-infectiousness is being used 
given the likely inclusion of immunocompromised individuals in the study groups. 
Agency staff and credible messengers.  We will enroll n=2 staff and n=8 credible messengers across both sites.  
Based on current staffing demographics we anticipate staff will be 50% female, 50% Hispanic; 50% white, and 
credible messengers will be 63% male; 70% Hispanic; 60% White. Inclusion/exclusion criteria: staff must be 1) 
>18 years old; 2) employed by either Argus or Alliance 
 
3.1.1(b) Study Procedures, Materials, and Potential Risks 
Research data will be drawn from 1) self-completed questionnaires, 2) staff focus groups, 3) participant 
responses to process measures, 4) Healthix health data management information system, 5) analysis of saliva 
Phase 2.   
Staff surveys. At the beginning of Phase 2, staff and credible messengers will complete brief surveys. Guided 
by EPIS, Andersen and SCT, surveys will collect data on theoretically-defined inner-, outer-, and individual-level 
factors that may influence the implementation of the recruitment strategies and testing. Surveys will capture 
demographics and professional history, and attitudes and knowledge regarding COVID-19, risk reduction 
behaviors and testing. Surveys will be available in paper/pencil format as well online via Redcap link; surveys 
will be administered again at the end of Phase 2 with similar content as well as items on palatability and felt-
utility of the different strategies. 
Test participant surveys.  Following consent and study enrollment, all participants will complete a brief 
assessment consisting of structured survey examining predisposing and enabling factors (e.g. mental health, 
substance use, social support/capital), social-cognitive factors (COVID-19 attitudes, knowledge perceived risk, 
stigma) and structural variables (e.g. housing security; food insecurity) and a social network inventory. A social 
network inventory will be adapted from previous inventories.1,2 The inventory will consist of a set of standard 
“alter generators,” which are questions asking participants to list names, pseudonyms or initials of individuals 
within their social networks (“alters”) who fit certain descriptions (e.g. friends, loved ones, drug sharing partners, 
people who provide material support, etc.). Once alters have been generated and listed in an anonymized 
fashion, additional questions are asked about each alter to assess their age, frequency of interaction and duration 
of the relationship. Participants will also be asked about alters’ drug use, as well as previous disclosures of 
COVID-19 exposure or seropositivity between the participant and his/her alters. RAs will conduct interviews in 
private rooms at either Argus or Alliance locations. At the end of this survey the participant will receive COVID-
19 testing; brief follow-up interviews will occur for those participants included in the chain-referral recruitment 
strategy when they return to receive compensation for redeemed coupons.   

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Staff, credible messenger and CAB member focus group.  At the end of Phase 2, interested agency staff, credible 
messengers and CAB members will be invited to participate in two focus groups to understand staff attitudes 
and perspectives on integration of each recruitment strategy and COVID-19 testing and related services into 
ongoing agency workflow; changes in job role, performance, or load.  Staff focus groups will be run separately 
from CM/CAB member group and will be conducted in a private room at the home agency. The focus groups will 
each take approximately 1 hour to complete. Focus groups will be digitally recorded and transcribed, with the 
participants’ consent, to facilitate the coding and analysis of these data. 
Process measures: During Phase 2, participants recruited via chain-referral or credible messengers will complete 
a process measure, created for the study, consisting of a brief set of questions to monitor for potential ethical 
concerns arising among participants during the recruitment process. These questions will be defined during the 
intervention development process in Phase 1 and will address issues related to any unwanted disclosure of 
sensitive information, perceived or actual coercion or other potential psychological harms.  Staff and CMs will 
complete a series of checklists capturing fidelity and feasibility of either recruitment method and delivery of the 
on-site testing. 
Biological samples: During Phase 2 participants recruited via chain-referral or credible messenger will be asked 
to provide biological samples for COVID-19 testing, namely anterior nasal swabs for the BD VeritorTM SARS CoV 
2 and Cepheid Xpert SARS CoV 2 testing platforms. Further details of the testing process can be found in Section 
3.3 Testing Capacity. 
Healthix (MIS) data: In Phase 2, participants will be asked to provide informed consent for disclosure of their 
HIPAA-protected health information (PHI) that is stored in Healthix, the large public NYC based health 
information exchange (HIE).  Participant data drawn from Healthix will include prior and future (12m after end of 
Phase 2) COVID-19 test dates, location of testing, and results. This will improve our understanding of the 
potential unique reach of our underserved population recruitment strategy, the frequency and temporality of  
repeat testing, and the future impact of any project derived mitigation strategies to reduce barriers to appropriate 
testing in SUD populations. The inclusion of serologic test results also holds the potential of facilitating future 
COVID-19 vaccine initiatives, including the identification of high-risk members of the cohort without evidence of 
serologic immunity - if such immunity is found to be a reliable predictor of future risk.     
Potential risks and risk related to the generalized global pandemic of COVID-19: 
The physical risks of study participation are minimal as the biologic material that will be collected is limited to a 
one-time self collection of anterior nasal samples by us of nasal swabs. There is an additional minimal risk of 
exposure to SARS-CoV-2 associated with study participants  proximity to another individual during recruitment 
activities and during testing, though this minimal risk will be mitigated by the use of appropriate PPE. To the 
extent possible, this research will be conducted in-person in coordination with in-person visits to Alliance and 
Argus for clinical and other related services (eg housing, vocational support) that are otherwise necessary. It will 
therefore involve a minimal additional risk of exposure to SARS-CoV-2 that is equivalent to the risk associated 
with any additional social contact between any two individuals. 
 There may also be several privacy-related and psychological risks associated with this study: (1) the risk a 
participant may reveal sensitive information about themselves; (2) the risk a participant may feel coerced into 
participating or may attempt to coerce others into participating during peer-recruitment; (3) the risk of contact 
between participants in treatment/recovery for substance use disorders and their peers who are actively using 
substances; (4) the risk a participant may reveal sensitive information about individuals who have not consented 
to be in the study; (5) the risk of an unintended breach of confidentiality; and (6) the risk of discomfort in 
participating in study procedures. Each of these risks is discussed below: 
1) Participants may reveal sensitive information in this study regarding their substance use, mental health, 
motivation to receive treatment for substance use disorders, and relationships to members of their social 
networks, perceived risk of infection of COVID-19, risk reduction behaviors and social and socioeconomic 
impact of COVID-19. Interviews will take place in private offices at clinical sites. For all interviews, it is 
possible that subjects may experience feelings of distress when answering questions concerning these 
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doing so, it is possible that sensitive information about the participant may come up as a topic of 
conversation with those they are attempting to recruit. This may cause feelings of distress if unexpected 
or unwanted. 
2) Participants may also feel coerced into participating, believing that their decision to participate (yes/no) 
may affect, either positively or negatively, their ability to receive COVID-19 testing or other services. 
Conversely, it is also possible that during the recruitment process, participants or credible messengers 
might attempt to coerce others to enroll in the study. 
3) Some participants may be engaged in treatment for substance use disorders or otherwise attempting to 
abstain from substance use (i.e. in recovery) at the time they engage in peer-recruitment. During the 
study, participants will be asked to focus recruitment on individuals they believe to be actively using 
substances. Therefore, it is possible that participants in recovery will have contact with peers who are 
actively using substances, which they would not otherwise have. Such contact may cause participants to 
experience cravings to return to active use. 
4) Participants may reveal sensitive information about individuals who have not consented to participate in 
the study in one of two ways: a) while completing social network inventories, participants will be asked 
sensitive questions about their social network contacts who, in most cases, will not themselves be 
enrolled in the study; and b) during peer-recruitment, participants may ask social contacts about their 
substance use behavior, treatment access and COVID-19 risk and testing behaviors. 
5) Staff and credible messenger participants will be asked to complete questionnaires about their 
organization’s mission, structure, culture/climate, resources. Participants will not be asked questions that 
would put them at risk of criminal or civil liability or damage to financial standing, employability or 
reputation. Some organizational culture and climate questions, although not structured or intended to do 
so, could invite negative opinions critical of leaders, supervisors and/or coworkers and the risk of 
accidental disclosure of their responses may create discomfort for respondents or may increase the risk 
of repercussions to participants from supervisory staff who may be present in the focus group. In addition 
to being asked to complete surveys and/or to be interviewed, the work- related interactions of staff 
participants may be observed and other data related to quality assurance (e.g. activities that occur within 
Interagency work group meetings) will be collected. 
6) Unintended breach of confidentiality may occur during the collection, storage or analysis of study data. 
When collecting data via the Internet for staff interviews as opposed to face-to-face, there is a risk for 
potential linking of work emails to study IDs, and thereby to other responses, when participants sign up 
for and complete the online staff survey. To an extent, these risks are mitigated by advantages with 
respect to data quality when collecting data via the Internet as opposed to face-to-face. Web-based 
surveys offer substantial advantages regarding cost and speed96.  
7) Finally, although unlikely, it is possible that some participants may experience emotional discomfort by 
the questions they are asked in the interview sessions.  
3.1.2 ADEQUACY OF PROTECTION AGAINST RISKS  
3.1.2(a) Recruitment and Informed Consent 
Staff, Credible Messenger and CAB recruitment 
Staff will be eligible if they are currently employed at either Argus or Alliance, including Credible Messengers 
and CAB members. PI/PD will present the study to agency staff both in-person at a staff meeting and via email 
and interested staff will be asked to contact the research team. An email from the PI (with an attached information 
sheet) explaining the project and staff participation in the survey and focus group will be sent to agency 
leadership who will then distribute it to staff, Credible Messengers and CAB members. These methods have 
been used successfully in our prior work with probation offices and treatment staff. The email will instruct 
interested staff to contact research staff directly to ask questions. For those interested in participating in focus 
groups, efforts will be made to schedule interviews at times that do not interfere with staff roles (e.g. lunch breaks; 
staff meetings). Considerable effort will be taken to ensure that staff do not feel coerced to participate. It will be 
emphasized to staff that participation (Y/N) is voluntary and will in no way affect their employment status. These 
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Staff, CAB and Credible Messenger consent 
For all activities, the consent process will involve an information sheet included with the staff survey or distributed 
before the beginning of the focus group. In the recruitment email and on the information sheet, participants will 
be informed that their participation in staff surveys and/or focus groups is voluntary and that they may discontinue 
their participation in the research at any time. The consent forms will describe all aspects of the study, including 
that each the survey will last about 30 minutes, focus group about 1 hour, and explain that confidentiality will be 
maintained unless concerns about the participant warrants reporting, such as suicidality, homicidality or child 
abuse/neglect. Participants will also be told that any disclosed, observed, or inferred child abuse/neglect must 
be reported to the New York State Registry. Participants will also be notified that we have obtained a Federal 
Certificate of Confidentiality. This Certificate protects the investigators from having to release the names or other 
identifying characteristics of research participants. To respect agencies who request staff not be paid for 
research work conducted during clinic time, they will receive a small thank you gift only for participation in surveys 
and focus groups. 
Testing Participant Recruitment is described in Section 3.1.1(a) 
Testing participant consent: 
Written informed consent will be obtained from all testing participants at the time of enrollment. The consent 
process will take place in a private office at either alliance or Argus without any agency staff present. Potential 
participants will be assured that their decisions about participation (yes or no) will in no way affect current or 
future services received at these agencies. Consent will be obtained either by RAs. Potential participants will be 
observed for signs of active intoxication that might interfere with their capacity to meaningfully consent to 
participation (e.g. excessive drowsiness, slurred speech, etc.). For those who are excluded due to excessive 
intoxication, clinical staff will be notified immediately, and the individual will be assessed by a medical provider 
for risk of impending overdose (intranasal naloxone and other supplies for emergency response are readily 
available at both clinical sites). Appropriate medical care or observation will be provided by clinical staff as 
indicated based on that assessment. If the individual is not determined to be at immediate risk of overdose, he 
or she will be asked to reschedule enrollment for a later date. Up to three attempts will be made to obtain informed 
consent from participants who are excessively intoxicated. If informed consent cannot be obtained by the third 
attempt due to excessive intoxication, the individual will be excluded from participation. 
The consent forms will describe all aspects of the study and explain that confidentiality will be maintained unless 
concerns about the participant warrants referral to a mental health provider, such as active suicidal or homicidal 
ideations. Participants will also be notified that we have obtained a Federal Certificate of Confidentiality. This 
Certificate protects the investigators from having to release the names or other identifying characteristics of 
research participants. Sufficient time will be allowed for questions about the consent forms or about the study in 
general. The consent forms will also specify the expected range of financial incentives for study participation. At 
the time of enrollment, participants will also be asked to provide consent for disclosure of HIPAA-protected health 
information (PHI) located in Healthix. All consent forms for all phases of study participation will be developed in 
accordance with the Internal Review Board (IRB) at New York State Psychiatric Institute. 
3.1.2(b) Protection Against Risk 
Measures will be taken to address the specific risks associated with study participation mentioned above as well 
as general measures to ensure that the research is conducted at the highest standards of research ethics and 
responsibility. 
Measures to address specific risks: 
1) The risk a participant may reveal sensitive information about themselves: The study will involve a careful 
protocol outlining the responsibilities of the interviewers, which will be reviewed with all research staff to 
ensure coordination of management strategies that best meet the participant's needs and well-being. 
This protocol will mitigate the risk that disclosure of sensitive information results in psychological distress 
by: a) including an informed consent process that provides advanced warning about the sensitive nature 
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questions that cause discomfort, b) maintaining privacy and confidentiality, and c) attending to emotional 
responses and providing breaks or emotionally supportive statements as needed. Research staff will be 
trained in Mental Health First Aid (for which training and certification are offered free of charge by the 
New York City Department of Health and Mental Hygiene), and emergency protocols will be in place for 
responding to severe emotional responses involving threatened or actual aggressive or self-harming 
behavior. 
Additionally, specific measures will be taken to mitigate the risk of unwanted disclosures during the peer-
recruitment process. First, chain-referral participants will be instructed to focus peer-recruitment efforts 
on peers with whom they have already had mutual disclosures of substance use at the time of enrollment. 
Second, all participants participating in peer-recruitment or Credible Messenger recruitment will be asked 
about any new disclosures of their substance use or other sensitive information. Participants will complete 
a brief process measure related to ethical concerns related to their recruitment and will include questions 
about unwanted, unintended and/or distressing disclosures of sensitive information. Finally, content will 
be created during strategy adaptation to guide participants in making informed decisions about health-
related disclosures and anticipating and managing their consequences.  
2) The risk a participant may feel coerced into participating or may attempt to coerce others into participating 
during peer-recruitment: The utmost care will be taken to ensure that participants do not feel coerced in 
anyway and that they understand taking part in the proposed studies are voluntary. Specifically, during 
informed consent of potential participants the research staff will emphasize that their choice whether or 
not to be in this study will not impact either their own ability the ability of those who recruited them to 
receive services at either Argus or Alliance. Though enrollment will occur in private offices located at 
Argus and Alliance, agency staff will not be present for the informed consent process. Furthermore, 
research staff will make explicitly clear that the research study is not a part of usual care at those clinical 
sites.  
The prospect of coercion by study participants during peer-recruitment has long been a consideration for 
studies using respondent-driven sampling (RDS), which serves as the basis for the peer-recruitment 
protocols planned for the proposed study. However, in a comprehensive review of ethical and regulatory 
concerns related to the use of RDS in scientific research, the authors found that the empirical literature, 
concerns related to coercion by study participants are offset by appropriate safeguards, including: a) 
limiting amount of reimbursement per peer-recruitment coupon; b) limiting the maximum number of 
coupons per participant; c) asking individuals redeeming coupons about perceived coercion; and d) 
having research staff obtain informed consent for new peer-recruits.10 
3) The risk of contact between participants in treatment/recovery for substance use disorders and their 
peers who are actively using substances: As with the risk of disclosures above, the risk of cravings to 
return to active substance use among participants in recovery will monitored through process measures 
in Phase 2. Similarly, content for the recruitment strategies will also be created in Phase 1 that helps to 
help participant recruits anticipate, mitigate and manage potential cue-associated cravings resulting from 
peer-recruitment efforts. 
4) The risk a participant may reveal sensitive information about individuals who have not consented to be 
in the study: During the social network inventory, alters identified by participants will be anonymized in a 
manner mutually agreed upon and understandable by the research staff and the participant. For example, 
alters will be listed by first name and last initial, first and last initial only, a nickname used by the alter or 
a pseudonym invented by the participant. While the age of each alter will also be elicited, no other 
personal identifiers (e.g. date of birth, address, etc.) will be elicited about alters. Therefore, while sensitive 
information will be disclosed about individuals who have not consented to participate in the study, the 
risk of breach of confidentiality to those individuals will be minimized. It is worth noting that our proposed 
approach is comparable to “ring vaccination,” which was instrumental in smallpox eradication, as well as 
contact tracing and partner notification which have been used successfully to interrupt the transmission 
of HIV and other sexually transmitted diseases The ethical application of these techniques by public 
health programs is predicated on the balance between beneficence and privacy concerns.13 While this 

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balance differs for the purposes of this research study, there are two relevant considerations: a) the 
ultimate objective of this research project is to develop a technique that can and will be applied by public 
health programs; and b) we are minimizing privacy risks by only collecting data about non-participants in 
a de-identified form (full surnames will not be collected for alters).  
In order to minimize the risk that participants will ask social contacts about sensitive information during 
peer-recruitment, participants will be instructed to focus peer-recruitment efforts on peers who are known 
by the participant to be someone who uses opioids and other drugs and with whom they have already 
had mutual disclosures of a substance use at the time of enrollment. 
5) The risk of an unintended breach of confidentiality: To address concerns of breach of confidentiality, all 
study documents and data will be maintained in password-protected computer files or stored in an 
electronically secured database. Any paper copies of documents will be maintained in locked file cabinets 
and transferred in locked document carrier bags. Participant consent forms and ID logs will be kept in a 
separate location in a locked cabinet. Transcriptions and audio digital files will be identified by ID numbers 
only and not connected with the participants’ names or IDs. Digital recordings will be erased, and source 
documents will be shredded.  
6) The risk of discomfort in participating in study procedures: The structured assessments and qualitative 
interview techniques to be employed in this study are used widely in behavioral research.77-79,105-107 In 
addition, research staff who are administering the structured assessments, interviews and behavioral 
sessions will be trained to inquire about and address any feelings of discomfort among participants, and 
all participants will have access to the PI in case of any concerns. 
The risk of discomfort associated with COVID-19 testing is minimal when using nasal swabs, as detailed 
in Section 3.3, compared to COVID-19 testing that utilizes nasopharyngeal or mid-turbinate swabs or 
phlebotomy for COVID-19 serologic assessment. Any discomfort would be mild and transient and most 
study subjects are expected to not experience any overt discomfort at all. In order to minimize any risk 
study subjects will be instructed by project staff in the appropriate technique of sample self-collection. 
Staff will be available to assist in the collection of the sample if the study subject exhibits any concerns 
about their ability to self-collect the sample.  
 
In addition to the above specific measures, this study protocol will follow the recommendations of the 
President’s National Bioethics Advisory Commission. Procedures will accommodate fiduciary responsibility to 
protect our subjects’ autonomy and welfare, respect their expectations for confidentiality and yet produce 
reliable information. 
Six steps will be taken to minimize risk:  
1) A Certificate of Confidentiality issued by the federal government will be obtained for this study. The 
Certificate protects the data from subpoena and thus prevents the data from being used against the 
participant. 
2) All data will be coded with identification numbers. There will be no names on any questionnaires, audio 
files or research forms. A master list connecting identification numbers and subjects’ names will be kept 
in a separate computer file with access limited to the PI. These data will be stored on a computer 
separate from that used for any other project endeavors. Tracking information will also be kept on a 
different computer than issued for data analyses. The master list is only used to coordinate data 
collection. In addition, all staff will receive training on confidentiality issues and be certified in the handling 
of human subjects in research, including HIPAA regulations. The PI will review all interview materials to 
ensure that all personal identifiers have been removed prior to submission to the data management 
team.  
3) Participants may experience feelings of discomfort during study procedures (e.g. assessments, 
interviews, intervention sessions) when answering questions about substance use, HCV serostatus, 
HIV/HCV risk behaviors, motivation to receive treatment for substance use disorders, criminal justice 
involvement and relationships to members of their social networks. Interviewers will be trained to help 
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training and certification in Mental Health First Aid (see above). Referral to mental health resources can 
be made on either a routine or urgent basis as needed through clinical staff at both Argus and Alliance. 
In addition, Drs. Elkington and Ms R. Cohall are licensed clinical psychologist and social worker, 
respectively, and will be available via cell phone to provide clinical backup in emergencies. 
4) All participants will be informed that they do not need to answer questions or participate in intervention 
activities if they feel uncomfortable doing so. If they chose to answer study questions, all participants 
will be informed that their responses will not be shared with Argus or Alliance staff, except under specific 
circumstances (see below in Step 5). This will help safeguard against feelings of coercion. 
5) The limits of confidentiality will be clearly explained to all participants of the current study. Confidentiality 
will be maintained unless it is revealed that a participant is suffering from a severe and active mental 
disorder, where he or she is in danger of hurting him/herself or others. Participants will be told that in 
such cases, a Argus or Alliance staff member will be informed. These limits of confidentiality will be 
expressed to the participants repeatedly during the course of this study: before and during the consent 
procedure, before participation in the proposed intervention, and again before any of the assessments 
begin.  
6) In non-emergent situations, a "Service Information Sheet" will be distributed listing addresses and phone 
numbers where mental health and substance abuse services can be obtained. During the receipt of 
CVOID-19 testing, following the assessment, participants may express an interest in referral to 
substance use treatment services, or  mental health services. In such cases, the participant will be asked 
for their permission to share this information with Alliance/Argus clinical staff. If permission is not granted, 
individuals will be encouraged to self-refer. Encouraging self-referrals is appropriate in situations where 
the risk to the individual is not life-threatening or potentially dangerous to others and may encourage 
participants to obtain help for problems that would otherwise be ignored.  
 
The risk of SARS-CoV-2/COVID-19 exposure: This research will be conducted in accordance with all infection 
control policies of state and local health authorities as well as guidelines for social distancing released by the 
Centers for Disease Prevention and Control. In order to comply with these mandates, we will take a set of 
measures throughout the conduct of this research, regardless of the phase of reopening present in New York 
State at the time data collection begins. Additionally, anticipating that there may be further waves of workplace 
restrictions (i.e. "shut-downs" or "New York on Pause" executive order), other measures will be put in place 
depending on the reopening phase present in New York State at the time of data collection. We will outline these 
measures separately as follows: 
Measures to be in place regardless of the phase of reopening: 
1. Research staff will wear surgical or cloth masks covering their nose and mouth at all times during 
any contact with research participants 
2. Research staff will wash their hands with soap and water for ≥ 20 seconds upon arrival at Argus 
and Alliance. Research staff will again wash their hands and/or use hand sanitizer immediately 
prior to beginning contact with a potential research participant. Research staff will again wash 
their hands with soap and water for ≥ 20 seconds after completing contact with any research 
participant. 
3. At the beginning of each meeting with research participants (or potential research participants), 
research staff members will offer the participant a disposable surgical mask and hand sanitizer 
for their personal use and reinforce the use of masks throughout the research visit. Nitrile gloves 
will also be available upon request by a participant. 
4. The private space where research assessments are conducted will be set up to allow 6 feet of 
physical space between research participants and research staff. 
5. Research staff members will recommend that participants adhere to social distancing guidelines 
during all peer-recruitment attempts, favoring contact by phone or video conference over in 
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6. If at all possible, research visits will be coordinated with pre-scheduled in-person visits to 
consolidate risk 
Measures contingent on reopening phase: 
In the event of a repeat "shut-down" or return to the previous "New York on Pause" executive order, all in-
person research visits will stop. Furthermore, all participants who have received chain-referral coupons will be 
contacted and instructed to stop all in-person attempts at peer-recruitment. In accordance with recent 
experience we expect a phased reopening would allow the safe resumption of research activities after the 
initial (Phase 1) reopening phase is successfully completed, i.e. during Phases 2-4 of NYS’ reopening protocol. 
Phase 1 reopening: 
If New York State remains in Phase 1 of reopening at the time of data collection or in the event of a repeat 
"New York on Pause" order with subsequent Phase 1 of reopening, in-person research visits will only 
occur if they can be timed to coincide with in-person medical follow up that is deemed essential by the 
medical providers of Argus. Research visits that cannot be coordinated to coincide with necessary in-
person medical follow up will be delayed. 
Phase 2-4 reopening: 
All measures outlined above to adhere to social distancing guidelines will be maintained. No additional 
measures will be taken for Phases 2-4, at which point research participation will pose considerably less 
risk than other business activities allowed under health department guidelines (e.g. hair salons, non-
essential retail, etc.) 
 
3.1.2(c) Vulnerable populations: 
This study will not involve recruitment of fetuses, neonates, pregnant women, children, or other institutionalized 
individuals as research subjects. However, individuals who use opioids and other substances themselves may 
be considered a vulnerable population. We include members of this vulnerable population as research 
participants, because our study aims contribute directly to addressing a critical health need in this population. 
We would not be able to answer our specific research questions without the direct involvement of individuals 
who use opioids and other substances. 
 
3.1.3 POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECT AND OTHERS. 
The benefits of this study include the potential for improved identification of vulnerable and underserved 
populations enrolled in this study and increasing their linkage to and uptake of COVID-19 testing and related 
services as necessary.   Moreover, via a social network approach, the propose research may be able to interrupt 
the spread of COVID-19 throughout a social network by testing asymptomatic persons who would ordinarily not 
seek testing, treatment or services 
3.1.4 IMPORTANCE OF THE KNOWLEDGE TO BE GAINED 
People who use opioids and other drugs have a very high burden of COVID-19, yet these individuals are often 
overlooked and not adequately provided care and services.  In this evolving global pandemic, as testing and 
treatments advance and novel approaches come online, strategies that successfully enable community outreach 
to these most vulnerable populations and yet can pivot to incorporate novel and cutting-edge technologies are 
necessary. Social network-based peer-recruitment has been successfully used for HIV prevention programs in 
various high risk populations. The proposed study will explore the potential for two peer-recruitment strategies, 
one which harnesses endogenous peer support (chain referral) and one which leverages exogenous peer 
support (credible messenger) to identify which can achieve greater reach and resulting uptake of COVID-19 
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3.2 Single IRB plan  
The protocol will not require a Single IRB (sIRB) as this not a multi-site study that will use the same protocol to 
conduct non-exempt human subjects research at more than one domestic site.  The NYSPI IRB will serve as the 
IRB of record for the proposed study.   
 
RESOURCE SHARING PLAN (DATA SHARING PLAN)  
The proposed research will include data from n=500 testing participants and n=20 community-based 
organizations (CBOs) agency staff and credible messengers who will be recruited from two CBOs. Alliance for 
Positive Change (Alliance) and Argus Community Inc (Argus). In addition, data will include medical records of 
testing participants drawn from Healthix. The final dataset will include self-reported demographic, behavioral, 
health, treatment service use, organizational-level and implementation data from surveys and focus-groups 
completed by CBO staff, credible messengers and testing participants.  
Even though the final dataset will be stripped of identifiers prior to release for sharing, disclosure of opioid or 
other substance use and a positive COVID status is potentially highly stigmatizing. Thus, we will make the data 
and associated documentation available to users under a data-sharing agreement among the user and the study 
PI (Elkington) that provides for (1) a commitment to using the data only for research purposes; (2) a commitment 
to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning 
the data after analyses are completed. We will also draw on the expertise of the consortium, particularly the 
CDCC as well as the study’s Performance and Safety Monitoring Board (See Section 3.3) to guide us in 
evaluating users’ proposals for working with these data. Data will be made available under these conditions only 
after the main study outcome papers have been accepted for publication.  
We will provide CDCC with access to all de-identified data, under provisions that safeguard privacy and 
confidentiality, generated under this award, subject to the rules specified under a standard Certificate of 
Confidentiality which will cover the work of our research team. Data will also be made available for external 
monitoring if required by NIDA/NIH’s agreement with other Federal agencies. In accordance with the plan 
outlined in the RADX-UP RFA, our plans include submission of annual progress reports to the designated NIDA 
Program Official, for results to be reported at least semi-annually to the CDCC and to NIDA. We also commit to 
providing the CDCC with timely, accurate data to facilitate the ability of the CDCC to provide NIDA with accurate 
data-driven updates of consortium progress and facilitate creation of a cohesive data set with shared data 
definitions, formats, etc. detailed in data dictionaries as required, along with data on effective testing uptake 
strategies.  
 
3.3. Data and Safety Monitoring Plan  
3.3.1 Safety Monitoring Framework  
Data and safety will be monitored on several levels.  At the first level, the Principal Investigator, Dr. Elkington, 
will have ultimate responsibility for reviewing conduct of the study and data produced from it, including the 
reporting of any adverse events to the IRB of the New York State Psychiatric Institute (single IRB of record).  At 
the second level, the project will use a Performance and Safety Monitoring Board (PSMB), as described below.  
Adverse events and results of PSMB reviews also will be reported to the NIDAs program officer, as described 
below. All research protocols will be approved by New York State Psychiatric Institute IRB and NIDA.   
Data to be collected and monitored includes demographics, a variety of attitudinal/beliefs toward COVID-19 risk 
and infection transmission, and organizational functioning via surveys, focus groups and  medical records on 
COVID-19 test dates, location of testing, and results drawn from Healthix,  the large public NYC based health 
information exchange (HIE). 
    
3.3.2 Data Monitoring  
Interim Analysis Plans: The DSMB will review safety reports quarterly (see below).  More frequent meetings will 
be scheduled if indicated by interim findings.   A written summary will be submitted to the IRB following each 
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The data analyst will conduct interim analyses quarterly to verify that recruitment is consistent with projections. 
To support ongoing quality assurance and uniformity in data collection, interim analyses will also be conducted 
to examine patterns of missing data from surveys. Analyses to assess the psychometric properties of the 
measures will be conducted following the first implementation cycle. These data will be made available to the 
DSMB. In addition, data from the Site Recruitment Monitoring Form will be made available to the DSMB for 
monitoring of recruitment and participation rates for all assessments, as well as refusal and attrition rates and 
study progress.  
 
Stopping Rules:  This study will be stopped prior to its completion if: (1) the intervention is associated with 
adverse effects that call into question the safety of the intervention such as increased rates of COVID-19 
infection; (2) difficulty in study recruitment or retention, or enrollment of participants will significantly impact the 
ability to evaluate the study endpoints; (3) any new information becomes available during the trial that 
necessitates stopping the trial; or (4) other situations occur that might warrant stopping the trial.  
 
3.3.3 Management and Reporting of Adverse Events (AEs), Serious Adverse Events (SEAs) and 
Unanticipated Problems (UP). 
This study will use the NIH Reportable Events Policy definition of Adverse Events (AEs), Serious Adverse Events 
(SAEs) and Unanticipated Problems Involving Risk to Subjects (UP). 
 
We will define and measure risk as indicated in the table below. 
 
Table 3.3a. Method of Ascertainment of Serious and Adverse Events, and Unanticipated Problems for STAFF 
(Sample 2)  
oh 
 
Reportable Event 
 
What they are in 
the study 
Method of 
Ascertainment 
Reporting Requirements 
IRBs 
PSMB 
NIDA PO 
Death 
- Employee/staff 
death during study 
operations 
We will ask peer 
supervisors, site 
coordinators and 
agency leadership 
to report any deaths 
as soon as they 
learn of them. 
ASAP, but 
no later 
than 3 
working 
days 
Immediately 
ASAP, but no 
later than 3 
working days 
SAEs 
- Employee injury 
requiring 
hospitalization 
during study 
events 
We will monitor 
these directly at 
study events that 
research staff are 
present at, and ask 
employee 
leadership/staff/pee
rs to report them if 
we are not in 
attendance. 
ASAP, but 
no later 
than 3 
working 
days, 
regardless 
of whether 
SAE is 
study-
related 
ASAP, but 
no later 
than 3 
working 
days 
 
ASAP, but no 
later than 3 
working days 
 
Other AEs 
- Employment 
discipline for 
improper handling 
of participant 
We will document 
these events, when 
we learn of them, 
per peer 
supervisors/CBO 
Annually. 
Note that 
documenta
tion of 
these 
events 
Tri-Annually 
Tri-Annually 
 

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- Employee 
distress related to 
managing a 
participant 
positive for 
COVID-19 
- Staff breach of 
confidentiality 
leadership and peer 
to self-report. 
must also 
indicate 
whether 
they are 
thought to 
be study 
related and 
why or why 
not. 
Unexpected AEs 
An AE whose 
nature, severity, 
or frequency has  
not previously 
been identified. 
Also includes any 
adverse event that 
results in a 
participant’s  
withdrawal from 
the study; or is 
due to a deviation 
in the research 
protocol 
 
We will ask all 
study staff to raise 
concerns that they 
have directly via 
email. 
ASAP, but 
no later 
than 5 
working 
days. 
Immediately 
if related to 
study. Tri-
Annually if 
not related 
to study. 
Immediately if 
related to study. 
Tri-Annually if 
not related to 
study. 
Unanticipated 
Problems that are 
Not AEs 
Incidents or 
outcomes that  
occur during 
human  
subjects research 
that are not AEs, 
but that involve 
social or 
economic harm 
(instead of 
physical or 
psychological 
harm), or are 
problems that 
place subjects or 
others at 
increased risk of 
harm, but where 
no harm occurs. 
We will ask all 
study staff to raise 
concerns that they 
have directly in-
person or via email. 
ASAP, but 
no later 
than 5 
working 
days. 
If MPIs 
deem the 
event likely 
to affect 
participants
, it must be 
reported to 
the IRB 
immediatel
y. 
Immediately 
if related to 
study. Tri-
Annually if 
not related 
to study. 
ASAP, but no 
later than 3 
working DAYS 
Protocol 
Violations 
Deviations from 
the IRB-approved 
study procedures, 
as outlined in the 
Protocol Summary 
Form that has 
received review 
and approval by 
We will meet 
internally once a 
week to review 
study activities and, 
if we determine we 
have violated our 
protocol, we will 
record the incident 
Within 2 
weeks of 
staff 
becoming 
aware of 
the 
violation; 
no later 
Annually 
Annually- 
Should be 
included in the 
full data report 

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the IRB. A 
significant 
protocol deviation 
would be a 
deviation that 
increases the risk 
to participants or 
others, or 
decreases the 
potential benefits 
of the study, 
undermines the 
scientific integrity 
of the study, or 
occurs more than 
once 
and remediate 
immediately. 
than 5 
days if the 
violation 
results in 
an 
unanticipat
ed 
problem. 
IRB-or-PSMB 
determined 
suspension 
Any suspension or 
termination of 
approval must be 
reported including 
a statement of the 
reason(s) for the 
action. 
We will comply with 
IRB, DSMB, and 
NIMH procedures 
and guidance. 
3 business 
days 
3 business 
days 
3 business days 
 
Table 3.3b Method of Ascertainment of Serious and Adverse Events, and Unanticipated Problems for 
TESTING PARTICIPANTS (Sample 1) 
 
Reportable Event 
 
What they are in 
the study 
Method of 
Ascertainment 
Reporting Requirements 
IRBs 
PSMB 
NIDA PO 
Death 
- Suicide event 
- Non-suicide 
death during study 
operations 
− 
Death by 
overdose 
Via peer 
supervisors, site 
coordinators and 
agency leadership 
self- report any 
deaths as soon as 
they learn of them. 
Note: follow-up 
appointment status 
update 
ASAP, but no 
later than 3 
working days 
Immediately 
ASAP, but 
no later than 
3 working 
days 
SAEs 
- Suicide attempt 
following 
disclosure of 
suicidal ideation 
during 
assessment 
 
- Participant 
transport to 
Participants who 
endorse suicidal 
ideation and 
present as high-risk 
after emergency 
protocol is enacted 
may be referred to 
emergency services 
ASAP, but no 
later than 5 
working days, 
regardless of 
whether SAE 
is study- 
related. 
ASAP, but 
no later than 
3 working 
days 
ASAP, but 
no later than 
3 working 
days 

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emergency 
services 
Non-lethal 
Overdose 
 
by study staff if 
applicable.  
We will follow-up 
with participants 
who initially 
endorse suicidal 
ideation and are 
determined to be 
low-risk 3-7 days 
from their initial visit 
to assess suicidal 
risk. If participant 
self-reports suicide 
attempt we will 
document the SAE 
and report it as 
required, and link 
participant to 
mental health 
services. 
Other AEs 
- Distress related 
to a COVID-19 
positive test 
- Remission 
(substance use) 
following 
recruitment 
- Coercion into 
participating by 
peer recruit 
- Breach of 
confidentiality 
We will ask all 
study staff to raise 
concerns that they 
have directly in-
person or via email 
and we will also ask 
about any potential 
problems during our 
check-in calls with 
CBO leadership 
and peer 
supervisors. 
 
Annually. 
Note that 
documentatio
n of these 
events must 
also indicate 
whether they 
are thought to 
be study 
related and 
why or why 
not. 
Tri-Annually 
Tri-Annually 
Unexpected AEs 
An AE whose 
nature, severity, 
or frequency has 
not previously 
been identified. 
Also includes any 
adverse event that 
results in a 
participant’s  
withdrawal from 
the study; or is 
due to a deviation 
in the research 
protocol 
We will ask all 
study staff to raise 
concerns that they 
have directly in-
person or via email 
and we will also ask 
about any potential 
problems during our 
check-in calls with 
CBO leadership 
and peer 
supervisors. 
ASAP, but no 
later than 5 
working days. 
Immediately 
if related to 
study. Tri-
Annually if 
not related 
to study. 
Immediately 
if related to 
study. Tri-
Annually if 
not related to 
study. 

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Unanticipated 
Problems that are 
Not AEs 
Incidents or 
outcomes that  
occur during 
human  subjects 
research that are 
not AEs, but that 
involve social or 
economic harm 
(instead of 
physical or 
psychological 
harm), or are 
problems that 
place subjects or 
others at 
increased risk of 
harm, but where 
no harm occurs. 
We will ask all 
study staff to raise 
concerns that they 
have directly in-
person or via email 
and we will also ask 
about any potential 
problems during our 
check-in calls with 
CBO leadership 
and peer 
supervisors. 
 
ASAP, but no 
later than 5 
working days. 
If MPIs deem 
the event 
likely to affect 
participants, it 
must be 
reported to 
the IRB 
immediately. 
Immediately 
if related to 
study. Tri-
Annually if 
not related 
to study. 
ASAP, but 
no later than 
3 working 
days 
Protocol 
Violations 
Deviations from 
the IRB-approved 
study procedures, 
as outlined in the 
Protocol Summary 
Form that has 
received review 
and  approval by 
the IRB. A  
significant 
protocol deviation 
would be a 
deviation that  
increases the risk 
to participants or 
others, or 
decreases the 
potential benefits 
of the study, 
undermines the 
scientific integrity 
of the study, or 
occurs more than 
once 
We will meet 
internally weekly to 
review study 
activities and, if we 
determine we have 
violated our 
protocol, we will 
record the incident 
and remediate 
immediately. 
Within 2 
weeks of staff 
becoming 
aware of the 
violation; no 
later than 5 
days if the 
violation 
results in an 
unanticipated 
problem. 
Annually 
Annually-
Should be 
included in 
the full data 
report. 
IRB-or-DSMB 
determined 
suspension 
Any suspension or 
termination of 
approval must be 
reported including 
a statement of the 
reason(s) for the 
action. 
We will comply with 
IRB, DSMB, and 
NIMH  procedures 
and guidance 
3 business 
days 
3 business 
days 
3 business 
days 
 

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3.3.3.1.Protocols for preventing/mitigating specific risks. Participant distress will be managed by supervising 
clinical staff at either Argus or Alliance. Should additional assistance be required, supervising clinical personal 
within either agencies will contact the PI Elkington, a licensed clinical psychologist, who will provide further 
assistance.  Risks associated with breaches of confidentiality and resulting retribution due to staff responses are 
a concern. Breaches of confidentiality are unlikely, given the PI’s commitment to and experience in maintaining 
participant confidentiality.  Breaches are not anticipated at NYSPI/CUMC offices, because as a research facility, 
standards for maintaining participant confidentiality have been rigorously maintained since we began research.  
Breaches might nonetheless occur.  During the informed consent process, participants will be told of the 
confidentiality procedures that are in place, but will be informed that a breach is still possible, however rare, 
despite these procedures.  Should a breach occur, four steps will be taken.  First, the participant  will be informed 
as to the nature of the breach, and its possible ramifications. Second, the PI will immediately notify the NIDA 
Project Officer and the IRB.  Third, the PI will review existing confidentiality safeguards to determine why and 
how the breach occurred (outlined below).  Fourth, the PI will halt data collection until such time that the IRB can 
review existing procedures as to their quality and completeness.  The following steps are in place to guard 
against breaches of confidentiality and to protect confidentiality of research data:   
1) Provisions in all protocols will be made to ensure that a) all participants review IRB approved consent 
(information) forms, b) all surveys are conducted on-line via secure login and data held on a secure server 
or conducted via pen/paper at the participants choice of location and pace , c) no personal identifying 
information is collected on data forms, d) all administrative data collected are stripped of identifying 
information, e) no public data files contain any HIPPA identifiers, f) participants understand the voluntary 
nature of study participation, g) all data collected are kept in a secured, locked area with access by only 
certified research staff, and h) all approvals and documentation from the IRB and other approval entities 
are easily accessible by the PIs and research coordinators. 
2) All staff in focus groups, or any study related meetings, will be asked will be asked to respect the 
confidentiality and privacy of the other participants 
3) The research data will be collected electronically (Healthix, participant survey data, recording of 
coupons). Only trained researchers will be involved in data extraction efforts and delivery of survey forms 
to study sites.  All project staff are required to obtain the NIH web-based certification for protection of 
human subjects and to sign statements of confidentiality. All staff will be aware of the NYSPI/CUMC 
confidentiality agreements, the NIH Confidentiality Certificate, and their responsibilities regarding the 
Certificate’s special protections.  Staff members that leave the project will be reminded of their continuing 
obligations to maintain confidentiality. The team has internal procedures to ensure that all staff are aware 
of federal and state statutes and regulations regarding confidentiality of data. 
4) Completed surveys will be downloaded from the web to a secure drive or hand delivered or mailed 
securely to NYSPI/CUMC offices.  Research questionnaires will be coded with a unique number only.  
The unique ID number will appear on all records in lieu of personal names or other identifying information.  
Separate follow-up locator forms with identifying information will be digitally stored on password protected 
servers at NYSPI/CUMC offices.  Unique file numbers linking questionnaires with locator forms and 
identifiers will be stored on the PIs computer in a password protected file NYSPI/CUMC servers.  Data 
from agency records (Healthix) will be provided to the NYSP team via secure data transfer.  Any 
identifiable data will be removed from these data before transferring them to project files; the unique ID 
number associated with the individual will also be used exclusively with these data.  The research team 
will not release any individually-identifiable data back to the agencies involved in the research.   
5) Any data entry and verification/clean will occur on secure NYSPI/CUMC servers under the supervision 
of the data manager. Computerized copies of research data will be kept on a password protected hard 
drive maintained by the Data Manager; back-up copies will be kept in locked files at the NYSPI/CUMC 
offices.  The project statistician, Dr. Shea, will ensure that it will not be possible to reconstruct participant 
identities from the data collected.  Security of the data is maintained through the use of secure servers 
and regular backups, including off-site storage.  On a quarterly basis, the PI will meet with the project 

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staff to review and monitor data safety and monitoring procedures.  The PI provide the logistical and 
operational support for DSMB meetings.     
3.3.3.2 Protocol for identifying and tracking individual staff SAEs, AEs and UPs.  Adverse events may be 
ascertained (1) by direct report of a participant during a planned research visit or activity, (2) interaction with 
research staff, or (3) as reported by agency leadership to research staff. All events, regardless of how 
ascertained, will be recorded by the research Project Director in an AE/SAE log as they occur. The master copy 
of the log will be updated and stored on RFMH/CUMC secure servers.   Upon learning of an SAE, AE or UP, 
research staff will be instructed to inform the PI as soon as possible (but within 48 hours of discovery) and get 
the necessary information for completing the Negative Event Incident Report. The PI reviews the Negative Event 
Incident Report and adds additional information as necessary, and submit it to the DSMB (See below), the NIDA 
Program Official, and to the IRBs as required. The PI will ensure that SAEs AEs and UPs are followed until a 
final disposition of the event is made and a final report on the SAE, AE or UP is filed with the DSMB. If a study 
participant withdraws from the study or the PI/co-Is decide to discontinue a participant due to an SAE, the PI will 
monitor the participant until (1) a resolution is reached; (2) the SAE is determined to  be clearly unrelated to the 
study intervention; or (3) the SAE results in death. Using the rating system for SAEs , the PI will evaluate each 
SAE or unanticipated AE to determine whether it is related to the study, whether it affects the risk/benefit ratio of 
the study, and whether modification to the protocol or the consent form is required. 
 
3.3.3.3 Protocol for reporting of adverse events. Events that are serious or unexpected must be recorded using 
the ethics committees’ SAE/Unexpected Event forms and submitted to the New York State Psychiatric Institute 
(NYSPI) IRB within 5 working days from the time that research staff becomes aware of the SAE or AE (See 
Table). The PI must review the SAE form and sign and date the form; the PI will be responsible for informing the 
NYS Psychiatric Institute (Columbia University) IRB and the NIDA Program Officer. 
Regular monitoring of the study will be undertaken by the PI and other research designated staff (e.g. PD) every 
three months to ensure that all study procedures are being adhered to, that record-keeping is accurate, and that 
adverse events are being identified and followed up. Below we summarize types of events and reporting 
requirements.  
 
3.3.4 DSMB Project Review.  While the PI (Elkington) will have ultimate responsibility for reviewing conduct for 
the study and data emanating from it, including the reporting of any adverse events to the Institutional Review 
Boards of Columbia University/the New York State Psychiatric Institute (NYSPI), the Data Safety Monitoring 
Board as assembled by the CDCC through the RADx-UP consortium will meet to review this project at least once 
each year in addition to reviewing quarterly data safety reports prepared by the research.  After the meeting, the 
DSMB members present written feedback to the research. This feedback will be shared with NIDA program 
officers, and with the respective IRBs.    
 
3.4 Overall Structure of the Study Team   
The multi-disciplinary team of senior researchers and clinicians has expertise with hard-to-reach, urban, 
populations (Elkington, A.Cohall, Wilson, Gordon); HIV/HCV prevention, testing, including community 
outreach (Elkington, A.Cohall, R. Cohall, Wilson, Gordon); chain-referral and peer recruitment procedures 
(Wilson); implementation evaluation and rapid QI to inform procedures and implementation of evidence-based 
approaches (Elkington, Wilson, Cohall) and CBPR (A.Cohall, Wilson, Elkington). The research team at 
embraces engagement of community partners in all service and research programs and team members have 
extensive experience with community collaboration.  
 
Community Partners and Academic-Community Partnership Structure. 
Community partners (see Facilities and Resources). For the RADX initiative, we will build upon this sturdy 
framework and collaborate with both governmental and community-based agencies. We will engage 
representatives from the NY State Department of Health (NYDOH) and NY State Office of Addiction Services 
and Supports (OASAS). On a local level, we will work with two community-based organizations which are part 

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of the OASAS network: Argus Community Inc. (Argus) and the Alliance for Positive Change (Alliance). 
Argus has been in operation since 1967. Annually, they serve over 15,000 clients. Their services include: HIV 
and HCV prevention and linkage to care, rapid testing, substance abuse treatment, syringe access, behavioral 
health services, nutrition and housing support, legal services, and peer street outreach. Alliance  has been in 
operation since 1990. Annually, they serve over 7,000 clients at six sites. Specific services include: 
comprehensive HIV care coordination, syringe exchanges, outpatient substance use treatment, reentry support 
services for the formerly incarcerated, HIV and HCV screening, and mental health services. Further, they operate 
a Peer Training Institute which annually trains 350 people living with HIV, HCV and substance use to become 
prevention/harm reduction peer interns.  
 
Roles of Partners (see Letters of Support) 
NYSDOH: will be involved in our scientific advisory board (SAB) and will ensure that study related COVID-
19 testing, contact tracing, and referrals meet local, state, and federal regulations and evolving best practices.   
OASAS: will be involved in our SAB and in working with our team to consider how to replicate the program 
into other OASAS sites, if additional funding is obtained. 
Alliance and Argus: These community partners have well-established programs serving vulnerable 
populations. Their successful models for reaching community members with multiple co-morbidities through 
utilization of innovative street outreach and peer navigators will be adapted for the proposed study.  
CUIMC: CUIMC partners have considerable experience in utilizing multiple media platforms to educate, 
engage vulnerable populations to engage in care, and substantial expertise providing clinical services at a  
leading medical institutions in the US. A notable strength of this application is a 15-year history of collaboration 
with proposed community partners. CUIMC partners will assist in developing educational and training content, 
recommending COVID screening tools, and reviewing emerging testing technologies for possible utilization.  
 
Decision-making structure. Using lessons learned from prior academic-community partnerships, leadership 
from community partner organizations (Lowy-Argus; and Duke-Alliance) and CUIMC (Elkington, Gordon, Cohall, 
Wilson) were involved in the initial development of the proposed project and will continue to collaborate for the 
duration of the project. This team will meet monthly via Zoom to review program implementation and make 
necessary adjustments. Broad project outcomes, timelines and implementation plans will be set by community 
partner leaders in collaboration with CUIMC investigators. On a day-to-day basis, site coordinators will 
coordinate activities and supervise social network recruitment within each agency and will collaborate with the 
project director at CUIMC.  Periodically, program partners will meet with both the Community Advisory Board 
(CAB) and SAB to obtain feedback and advice. 
 
Community (CAB) and Scientific Advisory Boards (SAB). CAB. Alliance and Argus have CABs who provided 
input on the proposed project. If funded, representatives from both boards will form a project-specific CAB who 
will meet bi-monthly with partner leaders and CUIMC researchers throughout the study. Initially, they will be 
involved in developing the structure and implementation of the project. They will then assist in reviewing project 
outcomes and advising on modifications, as necessary. The SAB will comprise C. Gonzalez, MD, Associate 
Medical Director for Science and Policy, NYS DOH, M. Manseau, MD, Chief of Medical Services, OASAS, M. 
Sobieszczyk, MD, Chief, Division of Infectious Disease, CUIMC and S. Whittier, MD, Director of Clinical 
Microbiology, CUIMC. The SAB will meet quarterly with leadership from both community organizations and 
CUIMC researchers. They will review project outcomes and suggest modifications, as necessary. Further, they 
will assist project leadership in sustainability and dissemination efforts. 
 
 
Section 4. Protocol Synopsis  
4.1. Brief Summary  
We propose research to establish efficacy and sustainability of a community-social network outreach model that 
partners infectious disease health providers with community based organizations to successfully implement 
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and often underserved population, those who use opioids and other substances. Two distinct social network 
recruitment strategies with demonstrated efficacy identifying hidden populations and increasing uptake of HIV 
testing will be adapted and compared. Guided by the EPIS framework, social cognitive theory, and Andersen’s 
model, this study comprises three phases. Phase 1: Adaptation of outreach recruitment strategies, we will work 
with our project community advisory board (CAB) to adapt chain-referral and credible messenger strategies for 
uptake of COVID-19 testing, to finalize recruitment and on-site testing protocols, and to train the CAB in the new 
protocols and in continuous quality improvement strategies (Aim 1). Phase 2: Strategy Efficacy Trial and 
Implementation Evaluation, we will compare the two strategies in a cross-over design at two community based 
organizations (CBOs) with long standing history of serving hard-to-reach populations in their communities. We 
will examine the impact of each strategy on (i) reach (recruitment of target population), (ii) COVID-19 
testing/repeat testing, and (iii) service delivery (i.e. quarantine, medical care and contact tracing) among those 
who test positive for COVID-19 (exploratory) (Aim 2). Phase 3: Sustainment, CBOs will implement the strategy 
proven efficacious based on outcomes, and we will examine their sustainment of the program (Aim 2). 
Implementation evaluation will identify participant-, staff-, and organizational-level factors that influence the 
feasibility, acceptability, and sustainability of each strategy in these CBOs. (Aim 3). This investigation will provide 
much needed information to improve health outcomes and to identify effective system-level responses to prevent 
or arrest the spread of COVID-19 among the social networks of those who use opioids and other substances, a 
highly vulnerable and often overlooked population. Until the advent of treatment or a vaccine, our ability to contain 
COVID-19 must rely on widespread identification of (asymptomatic) positive cases, their subsequent quarantine, 
and contact tracing of those potentially exposed. Therefore testing efforts must be targeted to those highly 
vulnerable yet unserved populations, including individuals who use opioids and other substances. These 
individuals may have poor respiratory or pulmonary health due to substance use (e.g. opioids, 
methamphetamine), which may make them more susceptible to the virus. Also, these individuals are more likely 
to have been incarcerated, or reside on the street, in shelters, or in crowded accommodation, further placing 
them at risk for transmission. 
 
4.2. Sample Size Determination  
Power calculations assume that we will be able to recruit 500 participants in total (250 recruited in each strategy) 
for this supplement study over Phases 2a and 2b. We also assume alpha (type I error rate) of 0.05. Our primary 
outcome of interest is testing occurrence. Based on zip-code level testing data, the average baseline testing in 
the communities of interest (i.e., northern Manhattan, the Bronx) is 7842.2/100,000. If we assume t that one of 
the methods of recruitment will have a testing rate similar to this baseline average, we will have > 80% power to 
detect an approximately 8 percentage point difference in testing among the recruitment strategies (7.8% vs. 
16.1%) corresponding to an odds ratio of 2.27, a moderate effect size.  
 
 
4.3. Outcome Measures 
Table 5. Outcome Measures 
Name 
Type 
Time Frame 
Description 
Reach 
Primary 
Baseline 
# of coupons redeemed; (secondary # 
redeemed/# distributed) 
Testing Uptake 
Primary 
Baseline 
Y/N; (secondary # redeemed/# distributed) 
Service Delivery 
(exploratory): 
Quarantine 
Medical care 
Contact tracing 
Primary 
Baseline 
For positive test results only: 
Y/N self-quarantine 
Y/N (date 1st apt) 
Y/N (Agreed to provide names/addreses of 
network) 

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Acceptability; 
Sustainability 
Primary 
Baseline 
Continued recruitment; testing beyond 
Implementation phase 
Feasibility 
Primary 
Baseline 
Recruitment and testing delivery facilitators and 
barriers; 
Fidelity 
Primary 
Baseline 
Recruitment and testing protocol TBD during 
Phase 1 
Organizational 
Climate, support 
and functioning, 
leadership 
Secondary 
Baseline and 
post 
implementation 
Innovation/Flexibility; Organization support; 
Communication, Job satisfaction 
Staff 
Demographics 
Secondary 
Baseline and 
post 
implementation 
Gender, age, race/ethnicity, position, job tenure, 
education 
COVID-19 
knowledge 
/attitudes 
Secondary 
Baseline and 
post 
implementation 
a) knowledge of symptoms b) subjective 
effectiveness of safety practices c) subjective 
safety/unsafety of activities d) vaccination 
acceptability e) COVID-19 stigma 
Perceived 
potential 
sustainability of 
testing program 
Secondary 
Baseline and 
post 
implementation 
Program Sustainability Assessment Tool: Political 
support, Partnerships, Capacity, Evaluation, 
Communications, (20 items; (.79-.92) 
 
 
4.4 Statistical Design and Power  
Participants 
Testing Participants: participants will endorse opioid or other substance abuse in the past 6 months, and must 
speak English or Spanish; they will be clients at either Argus or Alliance or recruited via chain-referral or credible 
messenger strategies. 
Staff/Credible Messenger Participants will be currently employed at either Argus or Alliance, including Credible 
Messengers. N=500 testing participants and n=20 staff will be recruited. Main study outcome data are to be 
drawn from study developed testing database and form participant and staff surveys. 
 
 
4.4.1 Primary data analysis overview 
Primary data analysis overview.  
1. Examine and compare the efficacy of two sets of implementation strategies on (i) reach, (ii) testing uptake, 
(iii) service delivery (i.e. quarantine, medical care, contact tracing) and (iv) sustainability for individuals who 
use opioids and other drugs. Use of data drawn from Healthix, a public health information exchange, will 
supplement this comparison by generating a baseline of participant prior testing and health behavior to 
determine access to underserved populations as well as longterm influence on future testing behavior  
a) We hypothesize that chain-referral will demonstrate better (i) reach, (ii) testing uptake, (iii) service 
delivery and (iv) sustainability compared to credible messenger.  
b) Analytic approach: For our primary (dichotomous) outcome the form of the logistic model will be 
used to examine the differences in testing uptake (reach, service delivery and sustainability) 
between credible messenger an chain-referral.  
2. 2)  Elucidate and compare the system/organizational-, staff-, and individual-level factors that influence 
implementation (i.e. fidelity, acceptability, feasibility, sustainability) of the strategies to develop a plan for 

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dissemination and scale-up in other CBOs who serve opioid and other substance using individuals in NYC.  
a) Example hypothesis: As an illustrative example, we hypothesize that housing instability will be 
negatively associated with testing uptake.  
b) Analytic approach. Implementation features related to acceptability, sustainability, feasibility, and 
fidelity will be assessed at both the staff- and individual-level. The logistic model will take the form 
logit(pi) = 𝛽𝛽0 + 𝛽𝛽RecStr(Recruitment Strategy)𝑖𝑖 + 𝛽𝛽Site(Site)𝑖𝑖 + 𝛽𝛽TimeCon(Time Constraint)𝑖𝑖 where 
pi is the probability of being tested post-recruitment for the ith individual. This model assesses the 
effect of a time barrier on the likelihood of getting testing while controlling for the differing recruitment 
strategies and sites.  
 
Consortium Data Reporting. We will use our existing protocols for data checking, cleaning, and data editing 
and/or will rely on those proposed by the Coordination and Data Collection Center (CDCC) as relevant to ensure 
that collected data are clean and in compliance with confidentiality protections (e.g., de-identified) before they 
are forwarded to the CDCC for pooled analysis. We commit to providing the CDCC with timely, accurate data on 
number of tests conducted, their results, and subsequent actions taken. We will also provide data on effective 
implementation recruitment strategies to facilitate dissemination across the broader consortia. 
 
 
4.5 Statistical Analyses 
 
4.5.1 Analysis overview and main outcomes. The primary outcome of interest comparing the strategies will be 
testing occurrence (yes vs. no) as an indicator of testing uptake. An important secondary outcome will be reach 
measured through the number of coupons redeemed. Prior to the main analysis, all variables will be examined 
for distribution and outliers. Continuous outcomes will be described through means and standard deviations, while 
dichotomous and categorical outcomes will be described through proportions. 
 
4.5.2 Statistical analysis for Aim 2. Models that compare the effect of recruitment strategy on outcomes related to 
reach, testing uptake, and service delivery will adjust for measures assessed at baseline (e.g., baseline substance 
use, testing history). For our primary (dichotomous) outcome (testing uptake) logistic regression will be used: logit 
(pi= 𝛽𝛽𝛽𝛽0 + 𝛽𝛽𝛽𝛽RecStr(Recruitment Strategy)𝑖𝑖𝑖𝑖 + 𝛽𝛽𝛽𝛽Site(Site)𝑖𝑖𝑖𝑖 + 𝛽𝛽𝛽𝛽SubUse(Substance Use)𝑖𝑖𝑖𝑖 + 𝛽𝛽𝛽𝛽 TestHis 
(Testing History), thus be 𝛽𝛽𝛽𝛽RecStr which will estimate the differential effect of chain-referral vs. POL recruitment 
on testing uptake. The model will be adapted for secondary outcomes. Sensitivity analyses will stratify the 
analyses by time to determine if recruitment strategy effects differed before and after the cross-over. Demographic 
characteristics and other variables related to the Andersen, SCT, and EPIS models will be examined as potential 
mediators/moderators. 
4.5.3 Statistical analysis for Aim 3. Implementation features related to acceptability, sustainability, feasibility, 
and fidelity will be assessed at both the staff- and individual-level. As an illustrative example, we will consider 
whether participants endorse time constraints and the association with testing uptake. The logistic model will 
take the form logit(pi) = 𝛽𝛽𝛽𝛽0 + 𝛽𝛽𝛽𝛽RecStr(Recruitment Strategy)𝑖𝑖𝑖𝑖 + 𝛽𝛽𝛽𝛽Site(Site)𝑖𝑖𝑖𝑖 + 𝛽𝛽𝛽𝛽TimeCon(Time 
Constraint)𝑖𝑖𝑖𝑖 where pi is the probability of being tested post-recruitment for the ith individual. This model 
assesses the effect of a time barrier on the likelihood of getting testing while controlling for the differing 
recruitment strategies and sites.  
 
4.6. Subject participation duration:  
N/A 
 
4.7. FDA regulated intervention:  
No 
 

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4.8. Dissemination Plan 
Tangible products from the proposed research study will include protocols that detail chain referral and credible 
messenger strategies and training protocols on said strategies as well as quality improvement process training 
manuals, specifically plan-do-study-act.  All protocols/manuals will contain relevant materials developed (and 
tested) during the study that will support the scale up of the social network recruitment strategies of hard to 
reach/hidden populations in CBOs.  
We plan to use our research findings and deliverables to develop a plan such that the efficacious strategy can 
be brought to scale across similar CBOs in New York City with the CAB and Credible Messengers (if applicable) 
serving as the external facilitating/training body. At the end of Year 2, we will convene a Dissemination Work 
Group comprising key community stakeholders, from a broad range of service systems (e.g. faither -based 
leaders, treatment centers, vocational programs) from across NYC to (1) review effectiveness and 
implementation findings; (2) understand what resources are required, and that already exist, to support the 
delivery of the recruitment and testing model. In addition, findings will be published in academic research 
journals.  The study will be registered in ClinicalTrials.gov rapidly after the receipt of the Notice of Award and 
results will be submitted to ClinicalTrials,gov according to the policy. We will include a specific statement on all 
study consent forms that informs participants that clinical trial information (data from the proposed study) will be 
posted (in aggregate and de-identified fashion) at ClinicalTrials.gov. NYSPI has an internal policy in place, in 
which personnel within each Division monitor reporting of studies on ClinicalTrials.gov for their Division and 
approach any PIs if results are tardy, incomplete etc. This ensures that clinical trials registration and results 
reporting occur in compliance with policy requirements. 
 
4.9 Conflict of Interest Policy 
All participating scientific staff will be required to comply with the NYSPI’s conflict of interest policy that requires 
the identification of any “potential” conflicts to the study team and DSMB here and in any presentation or article.   
The main things to declare so far include:  
• 
The proposed work will be completed with financial support from NIDA grant no. UG1DA050071-S1 
 
 

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Abbreviations and Special Terms 
The list below includes abbreviations utilized in this template. However, this list should be customized for each 
protocol (i.e., abbreviations not used should be removed and new abbreviations used should be added to this 
list). Special terms are those terms used in a specific way in the protocol. For instance, if the protocol has 
therapist-participants and patient-participants, those terms could be included here for purposes of consistency 
and specificity.  
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
BH 
Behavioral Health 
CRC 
Clinical/Behavioral Health Research Core 
CFR 
Code of Federal Regulations 
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Core 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
EBI 
Evidence-Based Interventions 
eCRF 
Electronic Case Report Forms 
EPIS 
Exploration, Preparation, Implementation, 
Sustainment 
FDA 
Food and Drug Administration 
FFR 
Federal Financial Report 
GAIN 
Global Appraisal of Individual Needs 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH 
International Council on Harmonization  
IRB 
Institutional Review Board 
ITT 
Intention-To-Treat 
JDAI 
Justice Diversion Alternatives Initiative 
JJ 
Juvenile Justice 
JRC 
Justice Research Core 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MIS 
Management Information Systems 
MMC 
Milestone Monitoring, Coordination and Finance Core 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
NSSI 
Non-Suicidal Self Injury 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
PO 
Probation Officer 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 

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SB 
Suicidal Behavior 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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Protocol Amendment History 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a description 
of the change and rationale. A Summary of Changes table for the current amendment is located in the Protocol 
Title Page.  
 
Ver 
Date 
Source 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 

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Figure 1. Study Timeline