Supported Employment to Create a Community Culture of COVID-19 Rapid Testing Among People Who Inject Drugs: PeerConnect2Test
Phase: NA
Conditions: Health Behavior
Sponsor: University of Oregon

Page 1 of 19 
Version Date: 8.26.2024 
Research Protocol and Consent Form  
Supported Employment COVID-19 Rapid Testing for PWID 
NCT05984966 
Research Protocol Document Date: 8/26/2024 
Consent Document Date: 9/9/2024

Page 2 of 19 
Version Date: 8.26.2024 
Research Plan 
IMPORTANT: When completing this outline, please use the Research Plan Guidance for the content necessary to develop a 
comprehensive yet succinct Research Plan. Using the guidance to complete this outline will help facilitate timely IRB review. 
Study Title: 
Supported employment to create a community culture of SARS-CoV-2 rapid testing 
among people who inject drugs: PeerConnect2Test 
Protocol Number: STUDY00000657 
Principal Investigator: Camille Cioffi 
A.
Introduction and Background
This project uses a novel approach to adapt to the changing pandemic context; facilitation of rapid testing 
by people who inject drugs (PWID) via a supported employment program that trains PWID as participant 
peers (PP). PWID are vulnerable to contracting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-
2) and to the effects of the disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19) due to
structural disadvantage, health vulnerabilities, and stigmatization that prevents adequate access to medical
care.
The ever-changing nature of the pandemic, including new variants and the availability of new SARS-CoV-2 
vaccines, calls for strategies that can increase access to and uptake of testing among PWID. Rapid tests may 
offer an advantage over PCR tests for PWID experiencing structural vulnerabilities such as houselessness 
and lack of access to technology so that they can receive results in real-time and be quickly connected to 
needed resources. Accessibility of rapid testing for PWID has been previously limited by workforce 
shortages and the inability to reach PWID who need testing.  
We propose a novel community-engaged strategy to improve the accessibility of rapid tests through a 
supported employment program for PWID, Peer Connect2Test (PeerC2T), to become PP to distribute SARS-
CoV-2 rapid test kits to other PWID. We expect that PeerC2T will improve knowledge, self-efficacy, and 
health behaviors among PP (Aim 1). We will use the RE-AIM framework in Aims 2 and 3 to evaluate whether 
PeerC2T improves SARS-CoV-2 testing uptake among other PWID (RE; Aim 2) and identify intervention 
considerations (AIM; Aim 3). 
The overall goal of this project is to collaborate intentionally with HIV Alliance (HIVA) to develop a 
transformative community-driven intervention to promote widespread access to rapid testing among PWID. 
We will also collaborate with the RADx-UP Coordination and Data Collection Center. Findings will clarify the 
implications of supported employment programs for PWID for SARS-CoV-2 testing uptake among PWID and 
other public health efforts to improve health outcomes among PWID. Thus, findings from this study may 
have broad public health implications for leveraging supported employment programs for PWID to prevent 
the transmission of other infectious diseases.   
B.
Specific Aims/Study Objectives
Aim 1: Establish the PeerC2T supported employment program for PWID PP and evaluate the benefits
of PeerC2T on PP. Key benchmarks of Aim 1 are: a) written policies and procedures, and b) completion of a
mixed-methods study.
•
Aim 1a: Using Community Conversation Circles with PWID co-design the Peer Connect2Test
(PeerC2T) supported employment intervention, we will develop a supported employment
program leveraging equitable implementation practices. The low-barrier employment program

Page 3 of 19 
Version Date: 8.26.2024 
will include supportive supervision and ongoing support to PWID to learn workforce skills to 
become PP, to deliver COVID-19 rapid tests and related health information.  
•
Aim 1b: Using a mixed-methods approach, we will evaluate the benefits of PeerC2T on PP, by
conducting a pre-post and follow-up assessment of knowledge, self-efficacy, and behaviors
related to COVID-19.
Aim 2: Examine the Reach/Effectiveness of PeerC2T 
•
Aim 2a: Assess a) the percentage of PWID who test when approached by PP.
•
Aim 2b: Assess b) the individual structural determinants of health (e.g., healthcare access,
education, discrimination) as predictors of testing uptake among a subset of PWID who
complete a survey containing the RADx-UP common data elements.
Aim 3: Examine Adoption, Implementation, and Maintenance 
•
Aim 3a: Collect data from PP on the PeerC2T program to understand key considerations for
long-term program success.
•
Aim 3b: Collect data from HIVA staff on the PeerC2T program to understand key considerations
for long-term program success.
C.
Methods, Materials and Analysis
Aim 
Description 
Participants 
Compensation 
Aim 1a 
Community Conversation Circles 
160 
$30/meeting 
Aim 1b 
Surveys for PP 
150 (First cohort: 3 
times points; baseline, 
post-training, 3 month 
follow up; second 
cohort: 2 time points; 
baseline and 3 month 
follow up) 
First Cohort: $20 
x 3 = $60 
+$30 for the 
Common Data 
Elements Survey = 
$90 
Second Cohort: 
$20 x 2 = $40 
+$30 for the 
Common Data 
Elements Survey = 
$70 
Aim 1b/ 
Aim3a 
Interviews with PP (benefits of 
the program and 
implementation considerations) 
40 (subset) 
$50 
Aim 1b/ Aim 
3a 
PP Interview Theme Analysis 
up to 150 
$30 
Aim 2a 
PeerC2T Reach 
1000 
none 
Aim 2b 
PeerC2T Effectiveness (common 
data elements survey) 
750 
$30 
Aim 3b 
Interviews on Implementation 
with HIVA Staff 
20 
$50 
Aim 1a: Community Conversation Circles 
Methods & Materials 
For Aim 1a, we will facilitate Community Conversation Circles (i.e., focus groups with flexible attendance) 
with PWID to co-design the supported employment program. Community Conversation Circles will be 

 
 
Page 4 of 19 
Version Date: 8.26.2024 
held in Lane, Marion, Josephine, and Douglas counties. Each county will hold meetings up to two times. 
We expect no more than 20 people to attend each group meeting per county (4 counties x 2 meetings 
each x 20 participants = N = 160). Participants can attend one or both groups. To facilitate Community 
Conversation Circles, we will leverage the syringe exchange advisory group meetings HIV Alliance 
already hosts in Lane, Douglas, Josephine, and Marion counties. Snacks are currently provided at these 
meetings by HIV Alliance. The meetings occur in a private meeting space in either HIV Alliance office 
locations or church locations where syringe exchange is held. At the time of consent, participants will 
also be asked to provide their HIV Alliance ID which includes the first two letters of the city they were 
born in, the first two letters of their last name, and their date of birth. This will allow us to track 
attendance in a way that is comfortable to participants. At the second meeting of each group, we will 
collect HIV Alliance ID on a sign in sheet to track who attends. We intend to track attendance so that we 
can ensure we have a signed consent form from each individual without asking them to re-consent. 
We will also collect a brief survey with demographic information for NIH reporting purposes including 
race, ethnicity, and gender at the first meeting. Participants will also be invited to share their contact 
information if they would like to receive a reminder about the next Community Collaboration Circle. 
As these are regularly scheduled meetings that staff members from HIV Alliance normally facilitate, the 
circles will be co-facilitated by a member of the UO study team and a staff member from HIV Alliance. All 
aspects of the circles related to research will be conducted by the UO research team. Circles will not be 
audio-recorded and instead will have at least 2 additional research staff on site to take notes and 
document information provided. Each circle will take up to 2 hours and will include a discussion of the 
topics/questions described below. Topics may change slightly based on feedback from the Community 
Conversation Circles planning team which includes the study team and HIV Alliance staff. Data will be 
analyzed by summarizing the themes from each listening circles for consideration when developing 
PeerC2T program materials. As the only data source for the meeting will be meeting notes, there is no 
identifiable information connected to the participant information other than their attendance at the 
meeting.   
 
Semi-structured Community Collaboration 
Circle Topics for Meeting 1 
Semi-structured Community Collaboration 
Circle Topics for Meeting 2 
1. Introduction/ice breaker/study background 
(who is the funder, who is conducting the 
research, what are we hoping to do) (10 min) 
2. Establishing group norms (10 min, e.g., 
what do you need from each other and the 
research team to feel safe? What do you need 
to feel like the process has been rewarding?) 
3. What kind of support would you like from 
an employer? What are the things that have 
made you feel successful in previous work?  
4. The goal of the funding is to make sure we 
can get COVID-19 rapid tests to people who 
need it. We are currently thinking this would 
happen during street outreach, meaning you 
would go out with a peer street outreach 
worker to hand out rapid tests. How would 
1. Recap of group norms 
2. Brief overview of the study 
3. Overview of what has been created based on 
feedback since the last meeting and reactions 
(e.g., training manual highlights/training plan, 
policy highlights, shifts available, what does the 
work look like in practice) 
4. How will we know that this program has made 
a difference in the lives of people who are 
employed by HIV Alliance?  
5. How will we know this program has made a 
difference in the lives of the people receiving the 
services (e.g., COVID-19 rapid tests)? 

Page 5 of 19 
Version Date: 8.26.2024 
you envision doing that or how have you 
done that already in your community? 
5. Is this something you would be interested
in applying for? What training would you need
to feel successful?
6. Part of the goals of this program is to help
people who need employment gain
marketable skills while also earning income.
What are some ways HIV Alliance could
support you in addition to paying you for
your time?
Aim 1b: Surveys for PP 
Methods & Materials: 
PP hired as part of the HIVA Supported Employment program will be invited to participate in two or 
three surveys related to their experiences as PPs. The first cohort (recruited through 8/1/24) will have 
the opportunity to complete three surveys. The second cohort (recruited after 8/1/24) will have the 
opportunity to complete 2 surveys. The second cohort will have one less survey opportunity because 
they will not have the option to complete the training that the second survey was based upon. 
All three surveys will be conducted via Qualtrics. A member of the research team will reach out to each 
PP via phone, text, email, social media, or in person to schedule a time to complete each survey. 
Participants will be offered the option to complete the surveys in person (at an HIVA location or a private 
community location easy for them to access), on their own online, or over the phone with a member of 
the research team.  We will also collect information from HIV Alliance on the trainings the PP receives 
and the number and type of shifts the PP works.  
Purpose 
Timepoint 
Constructs/Measures 
Survey 
Length 
PP 
Baseline 
Survey 
PWID current knowledge, 
self-efficacy, and 
behaviors related to 
COVID-19 self and 
community prevention, 
characteristics of the 
individuals who become 
PP 
After onboarding, 
prior to beginning 
training 
-
Knowledge
-
Self-efficacy
-
Behavior
-
Overall well-being
(flourishing scale)
-
CDE Survey
(intervention
moderators)
20 minutes 
PP Post- 
Training 
Survey 
Understand immediate 
gains in knowledge, self-
efficacy, and behavioral 
intentions related to 
COVID-19 self and 
community prevention  
Two weeks after 
onboarding or 
immediately upon 
completion of the 
first two steps of PP 
training (whichever is 
completed last) 
-
Knowledge
-
Self-efficacy
-
Behavioral
intentions
-
System Usability
Scale (SUS)
20 minutes 
PP Follow-
Up Survey 
Understand sustainment 
in knowledge, self-
efficacy, behavior, and 
Three months after 
completing 
onboarding 
-
Knowledge
-
Self-efficacy
-
Behavior
20 minutes 

 
 
Page 6 of 19 
Version Date: 8.26.2024 
chance in overall well-
being and other 
contextual factors 
- 
Overall well-being 
(flourishing scale) 
- 
System Usability 
Scale (SUS) 
 
- 
The “Knowledge”, and “Self-efficacy” measures have been developed specifically for this study based 
on skills taught in the supported employment training. 
- 
The “Behavior” measure was adapted from questions from the Preventative Medicine Attitudes and 
Activities Questionnaire. 
- 
The “Behavior Intentions” measure was adapted from the same questions from the Preventative 
Medicine Attitudes and Activities Questionnaire with response options reframed based on how 
often they intend to engage in the behavior. 
- 
The “System Usability Scale” in an existing measure that will be adapted used to measure training 
satisfaction and intervention satisfaction. 
- 
The “Overall well-being” measure from the “Flourishing scale” is an existing measure that will be 
used to measure the respondent’s self-perceived success in important areas such as relationships, 
self-esteem, purpose, and optimism.  
- 
The “Common Data Elements (CDE) Survey” is a measure required by our funder, the National 
Institutes of Health for all Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) 
projects.  
 
As part of Aim 2b (detailed in the Aim 2b section), PPs who engage in community outreach of PWID to 
offer rapid COVID-19 tests will also hand out flyers to any person who has been offered testing, 
regardless of whether the individual decides to take a test. The flyers will include a space for the PP to 
put a code word that links the Aim 2b participant to the PP that they received information from. Adding 
this study code will allow us to identify if there are differences based on the PP that impact whether 
people choose to complete testing or not. The code word used on flyers will be different than the 
unique study ID provided to the participant. The consent form will acknowledge this process and note 
the unique way the project will identify them through flyers that they distribute to PWID so that we can 
track who is calling after their outreach. The Aim 1b HIPAA Authorization form will also include 
permission for the UO research team to share this code with HIV Alliance to reduce the amount of 
identifiers shared with HIV Alliance. To minimize the risk of coercion, we will clarify that there are no 
incentives for handing out flyers or for getting people to take a test. 
 
Analysis: 
We will use repeated measures approaches (e.g., repeated measures analysis of variance, paired t-
tests) to evaluate change in knowledge, self-efficacy, behavior, and overall well-being by comparing 
baseline scores to scores obtained during the post-training and 3-month follow-up assessments. Change 
in baseline to post-training scores will inform on immediate gains realized from the training. Change in 
study outcomes at baseline to the 3-month follow-up assessment will test for maintenance of gains 
observed at post-training or identify changes that take longer to manifest (e.g., overall well-being). Using 
paired t-tests to estimate power and the parameters outlined above, we have sufficient power (>.80) to 
detect medium effects (d = .46) for pre- to post-training and 3-month follow-up change. We will conduct 
ancillary analyses to bolster our confidence in the internal validity of the quasi-experimental design. 
First, we will analyze dose-response based on time spent engaged in the training to determine whether 
the amount of training is significantly associated with change in the outcome measures. Second, we will 
examine if those who report greater satisfaction with the PeerC2T employment program will have 
greater improvement in baseline- to post-training and 3-month follow-up test scores using residual gain 
score analysis. Finally, treating PP post-training satisfaction as a process variable, we will assess 

 
 
Page 7 of 19 
Version Date: 8.26.2024 
correlations between the satisfaction ratings. To the extent that there is sufficient variability in training 
satisfaction, positive associations between these measures and change in baseline to post-training and 
3-month follow-up scores will provide support for the acceptability and effectiveness of the training. We 
have sufficient power to detect correlations between medium to large effects (r = .42).  Program 
feasibility benchmarks are: (a) meaningful pre- to post-training and 3-month follow-up differences 
(Cohen’s d > .46) in PP knowledge, self-efficacy, behaviors, and well-being; (b) high ratings for PP 
satisfaction and program acceptability (mean ratings of > 5 on 7-point scale) and at the 75th percentile 
or greater on the SUS.  Benchmarks are based recommended effect sizes of at least d >.25 to 
demonstrate meaningful change; and SUS score normative distributions associated with “high” 
acceptability.  
 
Aim 1b/3a: Interviews for PP 
Methods & Materials: 
Of the PPs who complete a baseline survey in Aim 1b, 40 participants will be chosen to complete a one-
time semi-structured interview with a member of the research team. We will use purposeful sampling to 
recruit PPs with diverse experiences, based on their reported demographics, to complete interviews 
about their experiences with the HIVA Supported Employment program.  
 
The interviews will take place over the phone, zoom or in person at a private location, depending on the 
preference of the PP. Interviews will be audio recorded for subsequent transcription.  
 
The interview recordings will be transcribed using a transcription service. The transcription service 
requires all employees, staff members and contractors to sign non-disclosure agreements and 
confidentiality agreements as outlined in the submitted “Landmark Data Security” document.  
 
Participants under this aim that were consented prior to the team’s decision to use the transcription 
service will be contacted and re-consented using the updated consent that includes information about 
the transcription service. For participants that do not consent to this change in transcription plan, a 
member of the research team will transcribe their interview in keeping with the original consent 
statement and their audio recording will not be shared outside of the study team. 
 
 
 
Purpose 
Timepoint 
Constructs/Measures 
Interview 
Length 
PP 
Interviews 
Overall impact of the 
PeerC2T on PP from the 
PP perspective including 
how the program has 
impacted them 
3 months post-
training 
- 
Perceptions of 
program benefits (Aim 1b)  
- 
Information about 
implementation (Aim 3a) 
30-45 minutes 
 
- 
Interviews will include questions developed for this project that can be triangulated with quantitative 
data on the way PeerC2T changed their understanding of COVID-19 and SARS-CoV-2 rapid testing 
and flourishing. In relation to Aim 1b, questions will include the extent to which PeerC2T (a) provided 
PWID with purpose and meaning; (b) helped them create more meaningful social relationships; (c) 
provided opportunities for engaging with society in a positive way; (d) helped PP feel competent and 
capable; and (e) facilitated optimism about the future.  In relation to Aim 3a, interviews will include 
questions to understand (a) how PP viewed their role; (b) any adaptations PPs made when delivering 
the PeerC2t intervention; (c) reasons for adaptations; and (d) mental health status including 
opportunities for integrating mental health support into the SE program. 

 
 
Page 8 of 19 
Version Date: 8.26.2024 
 
Analysis: 
Content analysis techniques will be used to analyze the transcript text. Coding of text will proceed in two 
stages. First, a topical indexing coding dictionary will be developed to identify the text pertaining to 
topics generated. Following the procedures our team has previously successfully used in formative 
research, data management and data reduction will be accomplished using the NVivo text-analysis 
software that supports coding, organization, searching, and retrieval of qualitative data. A detailed 
coding scheme will be developed to capture the content, themes, or sentiment of responses within 
topics. Specific themes (i.e., content codes) within central concepts will be identified by the evaluation 
team, and all text pertaining to a specific topic will be coded individually by trained coders. Coder 
reliability for content will be determined through interrater comparisons of at least 20% of the randomly 
chosen text in major topical categories.  
 
Aim 1b/3a: PP Interview Analysis Activity 
Methods & Materials: 
 
Any participant peer that is or has been enrolled in the HIVA Supported Employment program will be 
invited to participate in this additional activity. Participating in this activity will be completely optional. 
 
The analysis activity will take place in person, in private areas at HIVA locations in Roseburg and Eugene. 
The analysis activity is intended to be a group activity but will still take place in an one-on-one way if only 
one participant peer chooses to attend at a time. We will hold one or two analysis activity groups at each 
location (Roseburg and Eugene) over the course of the study. Each analysis activity group will last up to 2 
hours (the length of participant usual engagements in the HIVA supported employment program). 
 
During the analysis activity, participants will be asked for their perspectives on the grouping of themes 
and provide insight on their interpretations. Participants will be provided with de-identified existing 
interview data from a different location (i.e., participants from Eugene will review data from Roseburg 
participants and participants from Roseburg will review data from Eugene participants). Interview data 
will be deidentified via the process described in the Data Disposition section of this research plan. Each 
participant will be given a set of quotes to read and asked what they think the quote is saying, and what 
it’s telling them about well-being or how the program has contributed to participant well-being. As 
participants respond, we will write the themes in a list on a whiteboard. After themes are developed, the 
group will work together to agree on a set of no more than 12 themes to use to group all quotes. After 
themes are agreed upon, we will ask participants to take a set of quotes and sort them into the chosen 
themes where they think they most fit. The analysis activities will not be audio-recorded and instead will 
have at least one additional research staff on site to take notes and document information provided. 
 
At the end of the research activity, we will collect all quotes handed out and discard them at PSI. 
 
 
 
Aim 2a: PeerC2T Reach 
Methods & Materials: 
In Aim 2a, we will assess the percentage of PWID who accept a test kit when approached by PP. HIVA will 
oversee the distribution of rapid tests through the Supported Employment program and will report 
aggregate program data back to the research team.  
HIVA routinely collects demographic information from people requesting services. For each person PPs 
approach and offer testing, the PP will tally that a person was offered testing and document whether 

 
 
Page 9 of 19 
Version Date: 8.26.2024 
they agreed to testing or not. These programmatic administrative data will be provided back to the 
research team in aggregate for reporting purposes to NIH. Because this information is program data 
and we will not be collecting any identifiers, these participants would not be considered engaged in 
research and will not complete a consent form.  
All people approached about testing will receive a flyer that invites them to participate in a survey 
(described under Aim 2b).  
Using the processes outlined above, we anticipate that PP will reach out to 1,000 PWID to offer testing.  
Analysis: 
PP will reach out to at least 1,000 PWID, track the number of individuals who agree and do not agree 
to rapid testing, and we will compute the percentage who accept the kit and agree to self-test. We based 
the proposed non-probability target of PWID on a sample frame of 4,804 unique syringe exchange clients 
HIV Alliance reported in 2021. With the proposed sample of 1,000, we will be 95% confident that the true 
population percentage of HIV syringe exchange clients who agree to self-test will be within a ± 3% margin 
of error of the sample estimate. If we are not successful in obtaining the full target sample, we would still 
be within a ± 4% margin of error in our sample estimate with approximately half the proposed target 
sample (n = 534). 
 
Aim 2b: PeerC2T Effectiveness 
Methods & Materials: 
As stated above, PPs will provide a flyer to all people approached about testing that invites them to 
participate in a research survey. Potential participants can reach out via the study phone number or 
come to an HIVA event or the HIVA office to take the survey. Potential participants will receive 
information about times from the study team either on the flyer or via text, call, email, or social media. If 
a participant prefers an alternative meeting location and time, they will be able to contact the study 
team and the team will make alternate arrangements. The flyer will be provided to the study team and 
each flyer will have a unique identifier printed to ensure only people who have been engaged by the 
PWID PP can participate. We will also only allow individuals to take the CDE survey one time and will 
create a secure searchable database for research assistants to verify whether an individual has 
completed a survey in the past to verify eligibility. PP will not be eligible to complete the survey. People 
who have taken the survey will not be prohibited from becoming a PP in the future. 
 
For participants who engage in testing, we will include a HIPAA authorization to confirm the test results 
with HIVA. The HIPAA authorization will be bi-directional so that we can share that the participant was 
engaged in the research and HIVA can confirm whether a test result is in their records. 
 
The Aim 2b survey will be conducted via Qualtrics. Participants will be offered the option to complete 
the surveys in person (at an HIVA location or a private community location easy for them to access), on 
their own online, or over the phone with a member of the research team.   
 
 
Purpose 
Timepoint 
Constructs/Measures 
Survey 
Length 
HIV 
Alliance 
ID 
To request information 
about rapid testing 
uptake 
After being offered 
COVID-19 testing from 
a PP and connecting 
with the research 
team to complete the 
survey. 
First Name 
Last Name 
Date of Birth 
City of Birth 
1 minute 
PP Follow-
Up Survey 
To assess structural 
determinants of health 
- 
CDE Survey 
(including healthcare 
20 minutes 

 
 
Page 10 of 19 
Version Date: 8.26.2024 
(Common 
Data 
Elements 
Survey) 
as predictors of testing 
uptake among PWID. 
access, educational 
attainment, social 
relationships, 
discrimination, 
income, food security 
and housing stability) 
 
- 
The “Common Data Elements (CDE) Survey” is a measure required by our funder, the National 
Institutes of Health for all Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) 
projects.  
 
Analysis: 
 
To test whether social determinates of health (e.g., healthcare access, education, and discrimination) 
predict the uptake of PWID who agree to rapid testing, we will use logistic regression models estimated 
with a logit link. We will report odds ratios and 95% confidence intervals. We will first estimate univariate 
models to evaluate the unique effects of each SDOH. Next, to evaluate the unique contribution of SDOH 
in the context of multiple SDOH, we will estimate a multivariable model and include any univariable 
predictor associated with uptake of rapid testing at p <.30. Although we have no specific hypotheses 
regarding the interactive effects of SDOH, we will explore how the intersection of SDOH may contribute 
to the likelihood of rapid testing. We will add pairs of SDOH variables, informed on from the univariable 
and multivariable logistic regression models, and the multiplicative interaction term between the SDOH 
variables will address whether the level of one SDOH affected the magnitude of another SDOH on 
testing uptake. We will probe all significant interactions by computing sample-estimated intercepts and 
slopes of the log odds of the outcomes at conditional levels of one of the SDOH. Power estimates based 
on logistic regression models demonstrated there is sufficient power to detect odds ratios as small as 
1.88 or greater, small to medium effects for Aim 2b. 
 
Aim 3b: Implementation HIVA Staff 
Methods & Materials: 
In Aim 3b, we will examine the adoption, implementation, and maintenance of the supported 
employment program through examining administrative program data routinely collected by HIVA (e.g., 
number of clients served by each program total and number of clients reached by PP) and semi-
structured interviews with HIVA staff (n=20) following program implementation.  
 
HIVA staff who are involved in the supported employment program will be invited to participate in a 
one-time semi-structured interview with a member of the research team. Interviews will take place over 
the phone, zoom or in person in a private space, depending on the preference of the HIVA staff 
member. Interviews will be audio recorded for subsequent transcription.  
 
The interview recordings will be transcribed using a transcription service. The transcription service 
requires all employees, staff members and contractors to sign non-disclosure agreements and 
confidentiality agreements as outlined in the submitted “Landmark Data Security” document.  
 
 
Constructs/Measures 
Interview 
Length 
HIVA Staff 
Interviews 
- 
Satisfaction with supported employment program 
- 
Willingness to integrate program into practice if funding 
was available 
30 minutes 

 
 
Page 11 of 19 
Version Date: 8.26.2024 
- 
Ways the development of the supported employment 
program changed policies and practices within HIVA 
 
- 
Interviews will include questions developed for this project that will be coded to look for themes that 
are congruent and incongruent with program adoption, implementation and maintenance.   
 
Analysis: 
Content analysis techniques will be used to analyze the transcript text. Coding of text will proceed in two 
stages. First, a topical indexing coding dictionary will be developed to identify the text pertaining to 
topics generated. Following the procedures our team has previously successfully used in formative 
research, data management and data reduction will be accomplished using the NVivo text-analysis 
software that supports coding, organization, searching, and retrieval of qualitative data. A detailed 
coding scheme will be developed to capture the content, themes, or sentiment of responses within 
topics. Specific themes (i.e., content codes) within central concepts will be identified by the evaluation 
team, and all text pertaining to a specific topic will be coded individually by trained coders. Coder 
reliability for content will be determined through interrater comparisons of at least 20% of the randomly 
chosen text in major topical categories.  
 
D. Research Population & Recruitment Methods 
Aim 1a: Community Conversation Circles 
Research Population.  People who are 18 years or older and are utilizing HIV Alliance’s syringe 
exchange services in Lane, Marion, Josephine, or Douglas counties will be recruited to participate in this 
phase of the research.  
 
We will not include prisoners in our research population. Given our recruitment methods, incarcerated 
individuals will not be recruited for the initial community circles (people must be present in person at 
the initial meeting to be involved in the project). Given our contact methods for future circles require 
people to have access to a phone or internet, it’s unlikely that we would be able to contact participants 
who become incarcerated after the initial meeting. If a participant becomes incarcerated during the 
study, we will not continue to assess them. 
 
Inclusion Criteria. Participants must be: 1) 18 years or older, 2) Utilizing HIV Alliance’s syringe exchange 
program, 3) Able to speak and understand English. 
 
Recruitment Methods. The initial Community Conversation Circle for each cohort will be pre-scheduled 
by the study team. Within a week prior to the first scheduled circle, members of the research staff will 
be present in person at HIV Alliance syringe exchange sites in the targeted counties to hand out flyers to 
people utilizing syringe exchange services, invite them to participate in the upcoming circle and answer 
questions they have about participation. Participants will be notified that we will enroll the first 20 
people to show up to the initial meeting and will begin enrolling people 30 minutes prior to the 
scheduled meeting time. Recruitment materials (Phase 1 Flyer) will include details about the initially 
scheduled Community Conversation Circle. 
Within a week prior to each scheduled cohort meeting, members of the study team will be present at 
HIV Alliance syringe exchange sites in the targeted counties handing out flyers (Phase 1 Flyer) about the 
upcoming meeting and inviting people to participate.  

 
 
Page 12 of 19 
Version Date: 8.26.2024 
Participant Enrollment. We aim to enroll up to 160 participants into Community Conversation Circle 
cohorts. We will have an opportunity for up to 20 participants to participate in each cohort but 
anticipate groups may be smaller than that. 
Compensation. Participants will receive $30 in the form of a gift card or cash for each meeting they 
attend. The availability of cash will be informed by the Prevention Science Institute business manager.  
Participants will be able to choose between Fred Meyer or Grocery Outlet gift cards. Gift cards will be 
provided immediately following the group meeting. 
 
Aim 1b: Surveys for PP 
Research Population. People who are 18 years of age or older and are hired to work as Participant 
peers (PPs) for the Supported Employment program at HIVA will be recruited to participate in this phase 
of research.  
Inclusion Criteria. Participants must be: 1) 18 years or older, 2) Hired as a PP for HIVA’s Supported 
Employment program, 3) Able to speak and understand English. 
Recruitment Methods. Potential participants will attend an onboarding/enrollment event at HIVA after 
seeing program outreach flyers (not research flyers). The onboarding/enrollment event is to onboard 
with HIV Alliance and is not directly related to the research.  
At the time of each onboarding/enrollment event, participants will be notified that the Supported 
Employment program is being offered as part of a research study in conjunction with the University of 
Oregon. The onboarding manager at HIVA will ask the PP to sign a release of information (ROI) that 
allows them to notify the UO team of the new PPs onboarding including their contact information. PPs 
will have the option to decline signing the ROI if they express they are not interested in being contacted 
about the research. For the PPs who sign the ROI, once contact information is received by the research 
team, a member of the team will reach out to the PP via phone, text, email, social media, or in person to 
schedule a time to meet (virtually or in person) and discuss the research opportunity.   
Participant Enrollment. We aim to enroll up to 150 PPs in this phase of our research.  
Compensation. Participants will receive $20 for each survey they complete for a total possible 
compensation of $60 for program survey completion. They will also be able to complete the common 
data elements survey for an additional $30 (the same survey Aim 2b participants complete). 
Compensation will be provided in the form of gift cards or cash and will be provided to the participant 
following the completion of each survey. Compensation will be provided in person, via mail, or 
electronically via email, social media, or phone. 
 
Aim 1b/3a: Interviews for PP 
Research Population. A subset of people who are 18 years of age or older and are hired to work as PPs 
for the Supported Employment program at HIVA will be invited to participate in qualitative interviews.  
Inclusion Criteria. Participants must: 1) Be 18 years or older, 2) Be hired as a PP for HIVA’s Supported 
Employment program, 3) Have worked as a PP for at least 1 month, 4) Have completed at least 3 shifts, 
5) Be able to speak and understand English. 
Recruitment Methods. We will use purposeful sampling to recruit PPs with diverse experiences early 
on and later in program establishment to complete interviews about their experiences with the HIVA 
Supported Employment program. Selected participants will be invited via email, text, phone, social 
media, or in person to schedule and complete a semi-structured interview at the time of their 3-month 
follow- up survey.  
Participant Enrollment. We aim to enroll up to 40 PPs in this phase of our research.  
Compensation. Participants will receive $50 for completing the semi-structured interview. 
Compensation will be provided in the form of gift cards or cash and will be provided to the participant 
following the completion of the interview. Compensation will be provided in person, via mail, or 
electronically via email, social media, or phone.  

 
 
Page 13 of 19 
Version Date: 8.26.2024 
 
Aim 1b/3a: PP Interview Analysis Activity 
Research Population. People who are 18 years of age or older and are hired to work as PPs for the 
Supported Employment program at HIVA and are participating in the program at the time of the analysis 
activity will be invited to participate in the PP Interview Analysis Activity.  
Inclusion Criteria. Participants must: 1) Be 18 years or older, 2) Be hired as a PP for HIVA’s Supported 
Employment program, 3) Be able to speak and understand English. 
Recruitment Methods. HIVA staff will let participant peers who are participating in the program at the 
time of the analysis activity know that the UO will be on site for one of the program’s regularly 
scheduled engagements and will tell participants they can attend this activity instead of the usual 
engagement if they choose to participate.  
Participant Enrollment. As all participant peers who are or have been enrolled in the HIVA Supported 
Employment program will be eligible to join these activities, we pay enroll up to 150 participant peers in 
these activities. That said, we anticipate a much smaller sample will attend and participate.  
Compensation. Participants will receive $30 for participating in the interview analysis activity. 
Compensation will be provided in the form of gift cards or cash and will be provided to the participant 
following the completion of the activity. Compensation will be provided in person.  
 
 
Aim 2a: PeerC2T Reach 
Because the data collected for this aim are aggregate program data from HIVA and identifiers will not be 
included, these participants are not considered engaged in the research.  
 
Aim 2b: PeerC2T Effectiveness 
Research Population. People who are 18 years or older and were offered COVID testing from a PP in 
Lane, Marion, Josephine, or Douglas counties will be recruited to participate in this phase of the 
research. 
Inclusion Criteria. Participants must be: 1) 18 years or older, 2) Have been previously offered COVID 
testing from a project PP, 3) Able to speak and understand English. 
Recruitment Methods. All people approached by PPs in Aim 2a will be given a flyer that invites them to 
participate in a survey. The flyer will include specified times that the participant can come to HIVA to 
complete their survey or will provide the option to contact the study team to set up alternative 
arrangements or identify other potential times when research teams may be on site. 
Participant Enrollment. We aim to enroll 750 participants in Aim 2b with at least 175 participants being 
people who agreed to complete COVID testing and at least 100 participants being people who declined 
COVID testing.   
Compensation. Participants will receive a $30 gift card or cash upon completion of the survey. 
Compensation will be provided in person, via mail, or electronically via email, social media, or phone. 
 
Aim 3b: Implementation HIVA Staff 
Research Population. HIVA staff members who are involved in the supported employment program 
will be invited to participate in this phase of the research. 
Inclusion Criteria. Participants must be: 1) A staff member at HIVA, 2) Have participated in the 
development and/or implementation of the supported employment program.  
Recruitment Methods. Research staff will reach to staff members at HIVA via email, phone, social 
media, or in person to invite them to participate. The first 20 eligible staff who express interest in 
participating will be invited to participate.  
Participant Enrollment. We expect to complete interviews with up to 20 HIVA staff members.  

 
 
Page 14 of 19 
Version Date: 8.26.2024 
Compensation. Participants will receive $50 in gift card, cash, or check upon completion of the 
interview. Compensation will be provided in person, via mail, or electronically via email, social media, or 
phone.  
 
E. Informed Consent Process 
Consent Practices Across All Aims: 
All consented participants will be assured that their participation in the study is voluntary and that if 
they choose to participate, they can change their minds at any time. To ensure understanding, 
participants will be encouraged to ask any questions they have about the consent form and/or their 
participation in the study. They will be informed about potential benefits and harms. For participants 
who complete study activities at multiple time points, ongoing consent will be ensured through 
reminding participants that their participation is voluntary and giving them space to ask any questions 
about study activities or to re-review the consent at any time. Members of the research team providing 
consent will complete training with the Project Coordinator prior to consenting participants.  
 
Due to a Qualtrics update, there is now an option for participants to type in their name in Qualtrics and 
Qualtrics will create a “signature” on their behalf. This new feature is helpful as it increases the 
accessibility of the digital signature for those who struggle to sign on a device. That said, this option will 
only be used when a consent or HIPAA authorization is collected in person where the participant’s 
identity can be verified in person by the team member collecting the consent or HIPAA authorization.  
 
Optional Phone Consent: 
Participants that do not have access to a device with internet or request researcher support in signing the 
consent form will have the option of completing the consent process over the phone with a member of the 
research staff. Because some parts of this research may take place virtually, it is not feasible to have research 
personnel in person in every situation and we are requesting a waiver of documentation of informed consent 
for participants who choose this method of consent. For participants who cannot complete a consent online 
or request researcher support in documenting consent, a research staff member will read the consent to the 
participant over the phone and receive oral consent from the participant. Research staff will document oral 
consent via the consent form in Qualtrics by typing the participant’s name and including in parentheses after 
the name "(Verbal consent; signed by [researcher name])”. Research staff will offer the option of sending a 
copy of the consent form to the participant via mail or email for their records.  We are requesting a waiver of 
documentation of written informed consent for participants completing consent via phone who cannot 
access an internet supported device to sign the consent or otherwise ask for research support in signing the 
consent.  
 
The waiver of documentation of consent will not apply to participants who are completing a consent process 
that includes a HIPAA form (Aim 1b surveys for participant peers or Aim 2b for PWID who complete testing). 
We acknowledge that a waiver of documentation of consent cannot apply to HIPAA forms. 
 
 
Note about Clinical Trials Compliance: 
For aims that meet the definition of a clinical trial, the consent forms include language indicating that a 
description of the clinical trial will be available on clinicaltrials.gov as required by US law. In concordance 
with Health and Human Services (HHS) and National Institutes of Health (NIH) requirements, we will: 
- 
Register the study in clinicaltrials.gov no later than 21 calendar days after the enrollment of the first 
participant (this has been completed)  

 
 
Page 15 of 19 
Version Date: 8.26.2024 
- 
Make all consent forms will be made publicly available on clinicaltrials.gov within 60 days after the 
last study visit by any participant 
- 
Provide our study results within 1 year of study completion on the clinicaltrials.gov website 
 
Aim 1a: Community Conversation Circles 
Upon arriving for the initial Community Conversation Circle, participants will be provided with the 
consent form on paper and will be asked if they would prefer to read the form themselves or to have a 
member of the research team review the form with them. If a participant chooses to review the form 
independently, a member of the research team will be available to answer questions while the 
participant reviews the consent. A member of the UO research team will also review the consent form, 
prior to facilitating the group discussion. Participants will be given a copy of the consent form to keep.  
 
Aim 1b: Surveys for PP: 
Prior to beginning the baseline survey, participants will be provided with a consent form to complete via 
Qualtrics. Participants will be asked whether they would prefer to read the forms themselves or have a 
member of the research team review the form with them. If the participant chooses to review the form 
independently, a member of the research team will be available to answer questions. Participants will be 
offered a paper copy of the consent form or an emailed copy of the consent form to keep. If the 
participant prefers to complete the consent process over the phone, the research team member will 
send the link to sign the consent via email, social media, or text message, or document the participant 
consent as outlined under “optional phone consent” above. Participants will also be asked to complete 
an information sharing agreement that allows the study team to receive employment records and 
services records from HIV Alliance. This agreement will be signed on Qualtrics using the signature 
function on Qualtrics or documented via Qualtrics as outlined under “optional phone consent” above. 
 
Aim 1b/3a: Interviews for PP 
Prior to completing the interview, participants will be provided with a consent form to complete via 
Qualtrics. Participants will be asked whether they would prefer to read the forms themselves or have a 
member of the research team review the form with them. If the participant chooses to review the form 
independently, a member of the research team will be available to answer questions. Participants will be 
offered a paper copy of the consent form or an emailed copy of the consent form to keep. If the 
participant prefers to complete the consent process over the phone, the research team member will 
send the link to sign the consent via email, social media, or text message, or document the participant 
consent as outlined under “optional phone consent” above. This agreement will be signed on Qualtrics 
using the signature function on Qualtrics. 
 
Aim 1b/3a: PP Interview Analysis Activity 
Upon arriving for the analysis activity, participants will be provided with the consent form on paper and 
will be asked if they would prefer to read the form themselves or to have a member of the research 
team review the form with them. If a participant chooses to review the form independently, a member 
of the research team will be available to answer questions while the participant reviews the consent. A 
member of the UO research team will also review the consent form, prior to facilitating the group 
discussion. Participants will be asked to sign and date the consent form if they choose to be a part of the 
study. Participants will be given a copy of the consent form to keep.  
 
Aim 2a: PeerC2T Reach 
Because data collected for this aim are aggregate program data from HIVA and identifiers will not be 
included, these participants are not considered engaged in the research. We will not consent people 
who participant peers are interacting with/inviting to take a rapid test in this aim of the project. 

 
 
Page 16 of 19 
Version Date: 8.26.2024 
 
Aim 2b: PeerC2T Effectiveness 
Prior to beginning the survey, participants will be provided a consent form to complete via Qualtrics. 
Participants will be asked whether they would prefer to read the forms themselves or to have a member 
of the research team review the form with them. If a participant chooses to review the form 
independently, a member of the research team will be available to answer questions while the 
participant reviews the ROI and consent. Participants will be offered a paper copy of the consent form or 
an emailed copy of the consent form to keep. If the participant prefers to complete the consent process 
over the phone, the research team member will send the link to sign the consent via email, social media, 
or text message, or document the participant consent as outlined under “optional phone consent” 
above. Participants will also be asked to complete an information sharing agreement that allows the 
study team to receive information about the participant’s COVID-19 rapid testing from HIV Alliance. This 
agreement will be signed on Qualtrics using the signature function on Qualtrics or documented via 
Qualtrics as outlined under “optional phone consent” above.  
 
Aim 3b: Implementation HIVA Staff 
Prior to completing the interview, participants will be provided with a consent form to complete via 
Qualtrics. Participants will be asked whether they would prefer to read the forms themselves or have a 
member of the research team review the form with them. If the participant chooses to review the form 
independently, a member of the research team will be available to answer questions. Participants will be 
offered a paper copy of the consent form or an emailed copy of the consent form to keep. If the 
participant prefers to complete the consent process over the phone, the research team member will 
send the link to sign the consent via email, social media, or text message using the signature function on 
Qualtrics, or document the participant consent as outlined under “optional phone consent” above. 
 
F. Provisions for Participant Privacy and Data Confidentiality 
 
1. Privacy (all aims) 
Common data elements survey data from syringe exchange participants will be provided to the 
Coordination and Data Collection Center (CDCC). Data will only be shared with CDCC if syringe exchange 
participants consent to participate in the study. Data from all syringe exchange participants that consent 
to the study will be shared. Common data elements data will be shared using secure processes and 
procedures as designated by the CDCC. The research team will not have access to HIVA client protected 
health information. 
 
2. Data Disposition (all aims) 
For all identifiable data, consents, and HIPAA Authorization are programmed with the survey questions 
but identifying information (names on consent/HIPAA) will be stripped from the data at earliest 
opportunity. All data will be retained and stored for the duration of record storage but will be de-
identified with a “code key” following study completion by assigning a new ID to the data. This code key 
will be kept separate from the data and the de-identified data on the secure file server at the Prevention 
Science Institute and destroyed within 1 year of study completion to ensure all data are cleaned and 
there is no loss of linked data. Data will be maintained by the research study team. Data will be 
transmitted between the research team and HIVA using encrypted, secure email. Data will only be 
transmitted for participants for whom the research team has consent and HIPAA authorization for 
sharing of testing data.  
 
Contact information will be stored for the duration of the project. In the consent form, we have included 
a statement allowing for re-contact of participants to invite them to participate in other research studies 

 
 
Page 17 of 19 
Version Date: 8.26.2024 
for which they may be eligible. No contact information or identifiable data will be shared with other 
research projects but a member of this research team may contact participants about other studies.   
 
3. Confidentiality (all aims) 
All research data will be stored at the Prevention Science Institute using standard security techniques 
(password protected file folders on the University’s Prevention Science Institute secure server).  
 
Data collected through Qualtrics is protected by Qualtrics’ high-end firewall systems. Their servers are 
scanned regularly to ensure that any vulnerabilities are quickly found, and patched, and complete 
penetration tests are performed yearly. Their confidential system component design uses multiple 
checks to certify that packets from one subsystem can only be received by a designated subsystem. 
Access to systems to severely restricted to specific individuals, whose access is monitored and audited 
for compliance. Qualtrics uses TLS encryption for all transmitted data, and they protect surveys with 
passwords and HTTP referrer checking. Qualtrics’ services are hosted by trusted data centers that are 
independently audited using the industry standard SSAE-16 method. When the results of this project are 
published, participant names will not be used. Data will remain in Qualtrics during the data collection 
process. When the data collection process has concluded and all data have been downloaded from 
Qualtrics, we will delete all study records linking identifying information to data in Qualtrics. Access to 
this data through Qualtrics will be restricted to staff members who require access for data or participant 
management.  
 
After data are entered, they will be stored electronically on a private server and will be directly uploaded 
only while using secure wifi. If the data must be transferred, they will be transferred using a secure 
client server. Study researchers and the students they supervise may be granted access to the de-
identified data after signing a data use agreement, in order to complete analyses. Records will be kept 
for up to 3 years after the study has been completed.  
 
Research funded by NIH automatically has a Certificate of Confidentiality associated with it. This is 
added protection against forced disclosure of research information in circumstances of subpoena. 
 
Note about Paper Forms (relevant to Aim 1a only): 
Data collected on paper forms will be collected by researchers upon completion before the beginning of 
the initial circle discussion for each cohort. Research staff will store the completed forms in a bag that 
they will keep on their person for the duration of the circle and will transport them back to PSI for 
locked storage after the circle ends.   
Paper files will be stored in locked cabinets at PSI. Entrances to staff and data storage areas are locked 
and accessible only to authorized staff.    
 
 
Note about transcription procedures (relevant to Aim 1b/3a and Aim 3b): 
Interview recording data will be transcribed using a transcription service. The transcription service has 
strict data privacy and security measures in place to protect client confidentiality as detailed in the 
submitted “Landmark Data Security” document. The document discusses processes to keep data secure 
during data transfer as well as internal processes to secure data including requiring all employees, staff 
members and contractors to sign non-disclosure agreements and confidentiality agreements. 
  
 
G. Potential Research Risks of Discomforts to Participants (all aims) 
The overall risk involved in the project is minor, given the goals of the research. 

Page 18 of 19 
Version Date: 8.26.2024 
Potential risks and discomforts involved in participation include (1) possible violation of confidentiality. 
This risk is unlikely but possible. To minimize this risk, all records obtained from participants will be kept 
strictly confidential. To ensure strict confidentiality, data will not include identifiers. Additionally, for 
Community Conversation Circles, the consent form will detail that while our group norms will include a 
conversation about confidentiality, we cannot guarantee that others in the group will not share what 
they share.  
The funding agency required a Data Safety Monitoring Plan for this research at the time of funding 
proposal. A copy of the DSMP submitted to the funder is included in our RAP submission.  
There is no established Data and Safety Monitoring Board/Committee (DSMB/C) as noted in the DSMP. 
H. Potential Benefits of the Research (all aims)
This study has the potential to identify a strategy that could positively improve the lives of PWID who are
trained as participant peers for the supported employment program. It also has the potential to reach
people in need of testing for SARS-CoV-2 infection among a hard-to-engage, underserved population at
high risk for SARS-CoV-2 transmission and severe illness, if infected.
I. Investigator Qualification, Roles and Training (all aims)
1. Investigator Qualification
PI: Camille Cioffi, Ph.D., Cioffi is a Research Assistant Professor at the Prevention Science Institute at the
University of Oregon. She has experience in providing leadership and support to multicomponent and 
multi-site projects, including her role on the P50 Center of Excellence and several RADx-UP grants 
through the National Institutes of Health. On the P50 Center of Excellence, she has worked closely with 
community-based agencies to establish research to practice partnerships and has provided support on 
the administrative core to improve coordination between the center components which includes service 
on the data science core and science communication committee. Cioffi has worked extensively with Dr. 
Leve engaging in weekly meetings in her various roles. Along with her publications on public health 
research and implementation science, her commitment to bridging the gap from research to practice is 
exemplified in her involvement with the federal Research-to-Policy Collaboration, service to Oregon 
Health Authority collaborations, and co-instruction of Implementation Science coursework.  
2. Roles and Research Duties
The Investigators will provide oversight of all project activities and data analysis, as well as training and
supervision of research staff.
  
The Research Coordinator (RC) will lead day-to-day research activities, communications with PI and Co-PI,
training and supervising research assistants, ensuring high quality data collection and data entry, and
secure data transfer and storage.  
The Data Managers will clean data to prepare for analysis and maintain the participant database.  
  
The Research Assistants (RAs) will facilitate recruitment and consent procedures, facilitate paper data
collection, complete data entry of paper data, take notes on community conversation circles and
communicate with participants about follow up activities.   
  
3. Training and Oversight  
All research staff who will have contact with participants and/ or data will complete the CITI Human
Subjects and GCP training courses, to ensure proper understanding of ethics involved in human subject

Page 19 of 19 
Version Date: 8.26.2024 
research. Prior to engaging with participants, research assistants will be trained by the Research 
Coordinator in the following:    
1.
obtaining consent and appropriately answering consent related questions   
2.
maintaining participant confidentiality including appropriate handling of data collection, data
management and reporting procedures   

Informed Consent - Peer Connect 2 Test: PP Surveys 
Page 1 
Version 9.9.2024 
Consent for Research Participation 
Title: 
Peer Connect 2 Test: Participant Peer Surveys 
Sponsor: 
National Institute on Drug Abuse (NIDA) 
Researcher(s): 
Camille Cioffi, University of Oregon 
Leslie Leve, University of Oregon 
Researcher Contact Info: Coordinator: Kasie Josi 
Phone: 541-346-0449; Email: kjosi@uoregon.edu 
You are being asked to participate in a research study. The box below highlights key information about this 
research for you to consider when making a decision whether or not to participate. Carefully consider this 
information and the more detailed information provided below the box. Please ask questions about any of 
the information you do not understand before you decide whether to participate. 
Key Information for You to Consider 
•
Voluntary Consent. You are being asked to volunteer for a research study.  It is up to you
whether you choose to participate or not.  There will be no penalty or loss of benefits to
which you are otherwise entitled if you choose not to participate or discontinue
participation.
•
Purpose. The purpose of this research is to evaluate the supported employment program
for community rapid COVID-19 testing provided by people who inject drugs.
•
Duration. It is expected that your participation will last about 20 minutes per survey and
you will be asked to complete two surveys over about 3 months. You will also be asked to
complete a common data elements survey, required by our funder, at the same time as
when you take the first survey. You receive $20 for each of the two regular surveys and $30
for taking the common data elements survey for a total of $70.
•
Procedures and Activities. You will be asked to complete two surveys with questions
about your knowledge, behaviors, thoughts, and feelings related to the supported
employment program and trainings.
•
Risks. The only risk to participating in this research would be disclosure of your
information. However, because of the precautions we are taking to protect your
information, these risks are unlikely.
•
Benefits. Some people may appreciate having the opportunity to share their lived
experiences and provide program feedback. We also hope that information gained from
this study will help develop a meaningful supported employment program for people who
might face barriers to employment such as current drug use or criminal legal system
involvement. You might not personally benefit from this research.
•
Alternatives. Participation is voluntary and the only alternative is to not participate.

Informed Consent - Peer Connect 2 Test: PP Surveys 
Page 2 
Version 9.9.2024 
Who is conducting this research?  
The University of Oregon is partnering with the HIV Alliance to conduct this research. The University of 
Oregon is asking for your consent to this research. The study is funded by the National Institutes of Health 
(NIH). The NIH is part of the  United States Department of Health and Human Services. The NIH’s purpose is 
to find new knowledge that will lead to better health for everyone.  
Why is this research being done? 
The goal of this project is to collaborate with HIV Alliance to develop and evaluate a transformative 
community-driven supported employment program for community rapid COVID-19 testing provided by 
people who inject drugs. Findings will clarify the implications of supported employment programs for 
people who inject drugs for COVID-19 testing uptake and other public health efforts to improve outcomes 
for people who inject drugs. You are being asked to participate because you were hired as a participant peer 
(PP) for HIV Alliance’s supported employment program. About 150 people will take part in this research.  
What happens if I agree to participate in this research? 
Surveys: If you agree to participate in this research, you will complete two brief surveys. Each survey will take 
about 20 minutes to complete and will include questions about your knowledge, behaviors, thoughts, and 
feelings related to the supported employment program and training and understanding of COVID-19 
prevention. 
You will have the option to complete each survey in person at HIV Alliance or a private community location, 
on your own online, or over the phone with a member of the research team. You can skip any question that 
you don’t want to answer, and you can stop participating at any time.  
Survey Timeline: 
-
Survey 1: Prior to beginning training for the HIV Alliance supported employment program
-
Survey 2: Three months after completing your onboarding to the HIV Alliance supported
employment program, you will be asked to complete a second survey.
Common data elements survey: You will also be invited to participate in the common data elements survey 
that is required by our funding agency for which you would receive an additional $30 gift card. 
Program Information: In addition to completing surveys, the research team will collect information from HIV 
Alliance about your engagement in the supported employment program including the trainings that you 
have completed and the number, types of shifts you have worked, the peer support services you have 
received, and any other services you have received from HIV Alliance.  
Outreach Tracking: As part of the supported employment program, you may engage in community outreach 
to offer community members rapid COVID-19 testing. During this process, you may hand out flyers with 
information inviting people to participate in a different portion of this study, The flyers you hand out will 
include a space for a code word that is specific to you. We will use this code word to track the outreach you 
complete and aid in understanding how differences in outreach impact testing. The code word on your 
flyers will be different from the unique ID that we will use to track any other data about you in this study. 
There are no incentives to you for handing out flyers or getting people to take a test.  

 
 
Informed Consent - Peer Connect 2 Test: PP Surveys 
 
Page 3 
Version 9.9.2024 
Interview: Some people involved in this research will be invited to participate in an additional interview at the 
same time as Survey 2. If you are invited to complete this interview, we will ask you to complete a separate 
consent form with details about this additional study activity.  
We will tell you about any new information that may affect your willingness to continue participation in this 
research. 
What happens to the information collected for this research? 
Information collected for this research will be used to understand impact of the supported employment 
program on people who participate in the program and the broader community. We may publish/present 
the results of this research, however, we will keep your name and other identifying information confidential.  
Identifiers will be removed from identifiable private information collected in this research. After the removal 
of identifiers, the information may be used for future research or distributed to another investigator for 
future research without obtaining additional consent. Any results of this research that are made public will 
be in aggregate form only and never include information that can be linked back to you.  
As described in more detail below, if you chose to participate, we will share your data with the National 
Institutes of Health (NIH) and the Duke Clinical Research Institute (DCRI) to combine and store the data 
collected from everyone taking part in RADx-UP studies. The University of Oregon, NIH, and DCRI will keep 
your data secure. Your data will stay in a password-protected secure electronic system and only staff 
responsible for maintaining the security of your data will be able to see this information. 
We will keep your contact information for the duration of the project and may contact you to invite you to 
participate in other studies that you may be eligible for during and after your participation in this study. We 
will not share your contact information with anyone outside of our research team and do not have to 
participate in any other research studies that you are not interested in. You may request we stop contacting 
you about other research studies at any time by responding to outreach in writing.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 
This Web site will not include information that can identify you. At most, the Web site will include a summary 
of the results. You can search this Web site at any time.  
How will my privacy and data confidentiality be protected? 
We will take measures to protect your privacy and the security of your personal information including: 
- 
Conducting research in a private setting 
- 
Storing consent forms, and surveys on our secure server 
- 
Strictly limiting access to our secure server to authorized research staff involved in the project 
- 
Assigning a unique identifier instead of including identifying information on surveys 
The University of Oregon and National Institutes of Health will make every effort to keep your data secure. 
Your data will be stored on secure, password protected file servers at the University of Oregon, the Duke 
Clinical Research Institute (DCRI), or the National Institutes of Health (NIH). Despite these precautions to 
protect the confidentiality of your privacy and information, we can never fully guarantee your privacy or the 
confidentiality of all study information.  

 
 
Informed Consent - Peer Connect 2 Test: PP Surveys 
 
Page 4 
Version 9.9.2024 
Individuals and organizations that conduct or monitor this research may be permitted access to and inspect 
the research records. These individuals and organizations include the Institutional Review Board at the 
University of Oregon who reviewed this research, the DCRI, or the NIH. 
The research team includes individuals who are mandatory reporters. If the research team has reasonable 
cause to suspect abuse or neglect of a child or adult, a report may be required under Oregon State Law. In 
such a case, the research team may be obligated to breach confidentiality and may be required to disclose 
personal information. 
This research is covered by a Certificate of Confidentiality from NIH. The researchers with this Certificate 
may not disclose or use information, documents, or biospecimens that may identify you in any federal, 
state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as 
evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, 
documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires disclosure (such as 
to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings, see above); if you have consented to the disclosure, 
including for your medical treatment; or if it is used for other scientific research, as allowed by federal 
regulations protecting research subjects.   
What if I want to stop participating in this research? 
Taking part in this research study is your decision. Your participation in this study is voluntary. You do not 
have to take part in this study, but if you do, you can stop at any time.  You have the right to choose not to 
participate in any study activity or completely withdraw from continued participation at any point in this 
study without penalty or loss of benefits to which you are otherwise entitled.  Your decision whether or not 
to participate will not affect your relationship with the researchers, the University of Oregon or HIV Alliance. 
If you decide to leave this research, please contact the research team so that the investigator can remove 
your information from the contact list so you will not be asked to continue completing surveys and you will 
not be invited to participate in other future studies. 
Will I be paid for participating in this research? 
You will receive $20 after completing each of the two surveys for a total of $40 if you complete both 
program surveys. You will also receive an additional $30 for completing the common data elements survey. 
Altogether, you could receive up to $70 if you participate in all of the study surveys. You will receive each 
payment in person, or we will arrange with you the best way to send or give you the payment if you 
complete the surveys remotely.  
Who can answer my questions about this research? 
If you have questions, concerns, or have experienced a research related injury, contact the research team 
at: 
Kasie Josi 
 
541-346-0449 
 
kjosi@uoregon.edu 
 

 
 
Informed Consent - Peer Connect 2 Test: PP Surveys 
 
Page 5 
Version 9.9.2024 
An Institutional Review Board (“IRB”) is overseeing this research. An IRB is a group of people who perform 
independent review of research studies to ensure the rights and welfare of participants are protected.  UO 
Research Compliance Services is the office that supports the IRB.  If you have questions about your rights or 
wish to speak with someone other than the research team, you may contact: 
Research Compliance Services 
5237 University of Oregon 
Eugene, OR 97403-5237 
(541) 346-2510 
ResearchCompliance@uoregon.edu 
 
STATEMENT OF CONSENT 
I have had the opportunity to read and consider the information in this form.  I have asked any questions 
necessary to make a decision about my participation.  I understand that I can ask additional questions 
throughout my participation. 
I understand that by signing below, I volunteer to participate in this research.  I understand that I am not 
waiving any legal rights.  I have been provided with a copy of this consent form. I understand that if my 
ability to consent or assent for myself changes, either I or my legal representative may be asked to re-
consent prior to my continued participation in this study. 
I consent to participate in this study.  
(Collected on QUALTRICS.) 
 
  
  
 
Name of Adult Participant 
Signature of Adult Participant 
 
Date