Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE) - UH3 PHASE
Phase: NA
Conditions: Substance Use, HIV Infections, HCV Infection, Sexually Transmitted Infections (Not HIV or Hepatitis), Overdose, Drug, Opioid Use
Sponsor: April M Young

Document Coversheet
Study Title: Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic 
(CARE2HOPE) - UH3 PHASE 
Institution/Site: 
University of Kentucky 
Document (Approval/Update) Date:
IRB /
/2
NCT Number:
NCT04134767
IRB Number 
52439
Coversheet created: 
1 /2 /23 

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PROTOCOL TYPE (VERSION 4)
IMPORTANT NOTE: You will not be able to change your selections for "Which IRB" and "Protocol Process Type" after 
saving this section. If you select the wrong IRB or Protocol Process Type, you may need to create a new application.
See below for guidance on these options, or refer to ORI's "Getting Started" page. Please contact the Office of Research Integrity 
(ORI) at 859-257-9428 with any questions prior to saving your selections.
*Which IRB*
The Medical IRB reviews research from the Colleges of: 
Dentistry
Health Sciences
Medicine 
Nursing
Pharmacy and Health Sciences 
and Public Health.
The Nonmedical IRB reviews research from the Colleges of: 
Agriculture
Arts and Sciences 
Business and Economics
Communication and Information 
Design; Education
Fine Arts 
Law
and Social Work
Note: Studies that involve administration of drugs, testing safety or effectiveness of medical devices, or invasive medical procedures 
must be reviewed by the Medical IRB regardless of the college from which the application originates.
*Which Protocol Process Type*
Under federal regulations, the IRB can process an application to conduct research involving human subjects in one of three ways: 
by exemption certification
by expedited review. 
by full review;
The investigator makes the preliminary determination of the type of review for which a study is eligible. Please refer to ORI's "Getting
Started" page for more information about which activities are eligible for each type of review.
IRB Approval 
9/25/2023 
IRB # 52439 
IRB2

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EXPEDITED CERTIFICATION
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To Be Completed Only If Protocol is to Receive Expedited Review 
Applicability
A. Research activities that (1) present no more than *minimal risk to human subjects, and (2) involve only procedures listed in one or 
more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR
46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on 
this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the 
specific circumstances of the proposed research involve no more than minimal risk to human subjects.
B. The categories in this list apply regardless of the age of subjects, except as noted.
C. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably 
place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, 
or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and 
breach of confidentiality are no greater than minimal.
D. The expedited review procedure may not be used for classified research involving human subjects.
E. IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of 
the type of review—expedited or convened—utilized by the IRB.
*“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in 
and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological 
examination or tests. 45 CFR 46.102(i)
Check the appropriate categories that apply to your research project:
Study was originally approved by the full IRB at a convened meeting.
1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
A. Research on drugs for which an investigational new drug application is not required. (Note: Research on marketed drugs 
that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is 
not eligible for expedited review.)
B. Research on medical devices for which (i) an investigational device exemption application is not required*; or (ii) the 
medical device is cleared/approved for marketing and the medical device is being used in accordance with its 
cleared/approved labeling.**
* Study must meet one of the IDE Exempt categories listed on the Device Form Attachment.
** An approved Device used in research according to its approved labeling is considered Exempt from IDE requirements. 
NOTE: Select Category 1 for compassionate use medical device applications or individual patient expanded access 
investigational drug applications for which FDA has waived the requirement for full review.
2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
A. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not 
exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
B. From other adults and children* considering the age, weight, and health of the subjects, the collection procedure, the 
amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn 
may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 
2 times per week.
NOTE: Intravenous (IV), Port, Central, or any other lines are NOT eligible under this category even if the research involves 
“minimal risk”.
*In Kentucky, “child/children” refers to all individuals less than 18 years of age unless the individual(s) is/are legally 
emancipated. (See Informed Consent SOP for discussion of “Emancipated Individuals” under Kentucky state law.) 
Individuals less than 18 years of age who are not emancipated meet the federal definition for “child” (e.g., DHHS, FDA, and 
U.S. Department of Education). Children are defined in the HHS regulations as “persons who have not attained the legal age 
for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the 
research will be conducted.” If conducting research outside the state of Kentucky, you are responsible for complying with 
applicable state law.
3) Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
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A. Hair and nail clippings in a nondisfiguring manner; 
B. Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; 
C. Permanent teeth if routine patient care indicates a need for extraction; 
D. Excreta and external secretions (including sweat); 
E. Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying 
a dilute citric solution to the tongue; 
F. placenta removed at delivery; 
G. Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; 
H. Supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine 
prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; 
I. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; 
J. Sputum collected after saline mist nebulization. 
 
4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in 
clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be 
cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not 
generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: 
A. Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant 
amounts of energy into the subject or an invasion of the subject’s privacy; 
B. Weighing or testing sensory acuity; 
C. Magnetic resonance imaging; 
D. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, 
electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; 
E. moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate 
given the age, weight, and health of the individual. 
 
5) Research involving materials (data, documents, records, or specimens) that have been or will be collected solely for non- 
research purposes (such as medical treatment or diagnosis) as well as research involving existing information or specimens that 
were previously collected for research purposes, provided they were not collected for the currently proposed research. (Note: 
Some research in this category may qualify for Exempt review. This listing refers only to research that is not exempt.) 
(Note: If submission includes materials previously collected for either non-research or research purposes in a protocol for which 
IRB approval expired, you may check Category 5. However, a separate category must also be selected for prospective collection 
of data/specimens obtained solely for research purposes) 
 
6) Collection of data from voice, video, digital, or image recordings made for research purposes. 
 
7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, 
motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, 
interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: 
Some research in this category may be exempt from the HHS regulations for the protection of human subjects. This listing refers 
only to research that is not exempt.) 

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COVID19 CARE2HOPE UH3
PROJECT INFORMATION
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Title of Project: (Use the exact title listed in the grant/contract application, if applicable).
If your research investigates any aspect of COVID-19, please include "COVID19" at the beginning of your Project Title and Short Title
Short Title Description
Please use a few key words to easily identify your study - this text will be displayed in the Dashboard listing for your study.
Anticipated Ending Date of Research Project:
Maximum number of human subjects (or records/specimens to be reviewed)
After approval, will the study be open to enrollment of new subjects or new data/specimen collection?
  Yes  No
7/31/2024

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(Risk Level 1) Not greater than minimal risk
RISK LEVEL
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18
Attachments
Participant Demographics
SUBJECT DEMOGRAPHICS
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Age level of human subjects: (i.e., 6 mths.; 2yrs., etc..)
to
Study Population:
Describe the characteristics of the subject population, including age range, gender, ethnic background and health status. Identify the criteria for inclusion and 
exclusion.
Provide the following information:
A description of the subject selection criteria and rationale for selection in terms of the scientific objectives and proposed study design; 
A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group;
Justification for the inclusion of vulnerable groups such as children, prisoners, adults with impaired consent capacity, or others who may be vulnerable to 
coercion or undue influence.
Please consider these resources:
NIH Diversity Policy
FDA Diversity Guidance
CARE2HOPE covers the following counties: Rowan, Bath, Morgan, Menifee, Elliott, Lee, Owsley, Wolfe, Perry, Letcher, Leslie, Knott. We will recruit 
participants at all seven jails serving the 12 CARE2HOPE counties; these jails are either located in our CARE2HOPE counties (N=5; Rowan, Lee, Perry, 
Leslie, Letcher), or our counties have contracts with them to incarcerate their residents (N=2; Montgomery, Clark). To be eligible to take part in Project START- 
C2H, an individual must:
EITHER:
(1) be a participant in the CARE2HOPE longitudinal survey (IRB Protocol #43520) who consented to be contacted for future research; and
(2) be a resident of or anticipate being released to one of the 12 CARE2HOPE counties randomized to intervention or control data collection; and
(3) be incarcerated in a local jail and expected to be released in <21 days; 
OR:
(1) Be a resident of or anticipate being released to one of the 12 CARE2HOPE counties randomized to intervention or control data collection
(2) Have used opioids to get high in the 30 days before they were incarcerated, or have injected any drug to get high during that period;
(3) Be aged 18 or older
(4) be incarcerated in a local jail and expected to be released in <21 days
We have the opportunity to offer the intervention to individuals enrolled in the comparison counties who have completed 3-month surveys, and feel that offering 
them this intervention is an ethical best practice. We are not proposing any additional quantitative data collection with them, but these individuals will be eligible 
for qualitative interviews as part of our continuous quality improvement component.
Exclusion criteria are: (1) not speaking English fluently; (2) residence in or move to a county not randomized to intervention or control data collection within 21 
days of release; (3) transfer to prison; (4) having ever been convicted of or currently being charged with a violent crime (e.g., homicide, murder, rape and 
sexual assault, robbery, and/or felony assault); and (5) having been incarcerated for one year or more.
We anticipate that we will recruit 1200 individuals into the study (600 in the comparison group and 600 in the intervention group). The vast majority will be non- 
Hispanic White, aligned with the racial/ethnic composition of the area; slightly more than half will be men.
COVID-19 Policies
We are expanding the eligibility criteria to include individuals in community settings who report recent criminal justice involvement. To be eligible to take part in 
Project START-C2H, an individual must:
(1) Be aged 18 or older; and
(2) A resident of one of the 12 CARE2HOPE counties randomized to intervention or control data collection; and
(3) Have used opioids or have injected any drug to get high during the past 30 days (if incarcerated, on an ankle monitoring home incarceration program, out 
on bond, under warrant for arrest, arrested, court-involved, on pre-trial supervision, probation or parole, or enrolled in a substance use disorder treatment 
program, eligible if injected drugs or used opioids to get high in the 30 days before this particular involvement with the criminal justice system or substance use 
disorder treatment program), ); and
(4) Have been recently involved in the criminal justice system defined as being incarcerated in jail or prison, out on bond, under warrant for arrest, arrested, 
under pre-trial supervision, on probation or parole, court-involved, or incarcerated at home under an electronic monitoring program (i.e., digital jail) in the past 
30 days.
CQI
We will involve three groups of participants for CQI:
a) Pharmacists. Inclusion criteria: pharmacists from CARE2HOPE counties trained by the program on Vivitrol dispensing (one pharmacist per county, N=12).
Exclusion criteria: none
b) Study staff – Rural Health Navigators (REHNs). Inclusion criteria: program staff delivering the intervention to the participants (N=6). Exclusion criteria: none.
c) Current START-C2H participants. Inclusion criteria: 1) being a START-C2H trial participant; and 2) participation in at least two START-C2H health linkage
intervention sessions. Exclusion criteria: None.
(Note: REHNs are referred to as Re-Entry Health Navigators for our jail-based activities and Rural Health Navigators for our community-based activities.)
Indicate the targeted/planned enrollment of the following members of minority groups and their subpopulations. Possible demographic 
sources: Census Regional Analyst Edition, Kentucky Race/Ethnic Table, Kentucky Population Data. 
(Please note: The IRB will expect this information to be reported at Continuation Review time for Pre-2019 FDA-regulated 
Expedited review and Full review applications):
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Cisgender Man
Cisgender Woman 
TGNB/TGE 
Unknown/Not Reported
American
Indian/Alaskan
Native:
Asian: 0
0
Black/African
American:
Latinx:
Native
Hawaiian/Pacific
Islander:
White:
American
Arab/Middle
Eastern/North
African:
Indigenous
People Around
the World:
More than One
Race:
Unknown or Not
Reported:
If unknown, please explain why:
Indicate the categories of subjects and controls to be included in the study. You may be required to complete additional forms depending on 
the subject categories which apply to your research. If the study does not involve direct intervention or direct interaction with subjects, (e.g., 
record-review research, outcomes registries), do not check populations which the research does not specifically target. For example: a large 
record review of a diverse population may incidentally include a prisoner or an international citizen, but you should not check those categories 
if the focus of the study has nothing to do with that status.
Check All That Apply (at least one item must be selected)
ADDITIONAL INFORMATION:
Children (individuals under age
18)
Wards of the State (Children) 
Emancipated Minors 
Students
College of Medicine Students 
UK Medical Center Residents or
House Officers
Impaired Consent Capacity 
Adults
Pregnant Women/Neonates/Fetal
Material
Prisoners
Non-English Speaking (translated
long or short form)
International Citizens
Normal Volunteers
Military Personnel and/or DoD
Civilian Employees
Patients
Appalachian Population
Please visit the IRB Survival Handbook for 
more information on:
Children/Emancipated Minors
Students as Subjects 
Prisoners
Impaired Consent Capacity Adults 
Economically or Educationally 
Disadvantaged Persons
Other Resources:
UKMC Residents or House Officers 
[see requirement of GME] 
Non-English Speaking [see also the 
E-IRB Research Description section 
on this same topic]
International Citizens [DoD SOP may
apply]
Military Personnel and/or DoD Civilian
Employees
9
8
21
22
6
6
0
0
492
457
2
2

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Assessment of the potential recruitment of subjects with impaired consent capacity (or likelihood):
Check this box if your study does NOT involve direct intervention or direct interaction with subjects (e.g., record-review research, secondary 
data analysis). If there is no direct intervention/interaction you will not need to answer the impaired consent capacity questions.
Does this study focus on adult subjects with any conditions that present a high likelihood of impaired consent capacity or fluctuations in 
consent capacity? (see examples below)
Yes  No
If Yes and you are not filing for exemption certification, go to "Form T", complete the form, and attach it using the button below.
Examples of such conditions include:
Traumatic brain injury or acquired brain
injury
Severe depressive disorders or Bipolar 
disorders
Schizophrenia or other mental disorders 
that
involve serious cognitive disturbances 
Stroke
Developmental disabilities 
Degenerative dementias
CNS cancers and other cancers with 
possible CNS involvement
Late stage Parkinson’s Disease
Late stage persistent substance 
dependence
Ischemic heart disease 
HIV/AIDS
COPD
Renal insufficiency
Diabetes
Autoimmune or inflammatory disorders 
Chronic non-malignant pain disorders 
Drug effects
Other acute medical crises
Attachments

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Section 8 Page 1 of 5
PRISONERS
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SECTION 1.
For studies involving prisoners or people at risk of becoming involuntarily detained during the research (e.g., subjects with substance 
abuse history), respond to the following items. For information on restrictions and regulatory requirements, see ORI's Research
Involving Prisoners web page.
For research involving prisoners, the definition of minimal risk refers to the probability and magnitude of physical or psychological
harm that is normally encountered in the daily lives, or in the routine medical, dental or psychological examination of healthy persons.
Select the category below that best represents your research and explain why your research meets the criteria. 
Prisoner Categories
Category 1: My research involves the study of possible causes, effects, processes of incarceration, and of criminal 
behavior. (Processes of incarceration can be interpreted broadly to include substance abuse research, half-way houses, 
counseling techniques, criminal behavior, etc.)
Category 2: My research involves the study of prisons as institutional structures, or of prisoners as incarcerated 
persons. (This category is usually used fairly narrowly – i.e., looking at prisoner diet, conditions of prison, etc.)
Category 3: My research involves the study of conditions particularly affecting prisoners as a class. (This category 
is rarely used – e.g., vaccine trials, research on hepatitis, social and psychological problems such as alcoholism, drug addiction, 
sexual assaults. Minimal risk studies should not go under this category.)
Category 4: My research involves the study of practices, both innovative and accepted, which have the intent and 
reasonable probability of improving the health or well-being of the subject. (Rare for research involving placebo or control 
groups to fall in this category because of the difficulty in justifying improvement of the health or well-being of the subject being 
given placebo or in a control group.) Note: Contact the Office of Research Integrity at (859) 257-9428 for more information.
Epidemiologic Research Involving Prisoners [See also SECTION 3 below]
Explain the research practices that will be used in this study and how they are intended to improve the health and well-being 
of the participants:
The purpose of this study is to test the effectiveness of an intervention to reduce substance use and related harms 
among people re-entering the community from rural jails and to provide better linkage to services upon re-entry. The 
study focuses on people re-entering from rural jails because this group is at higher risk for substance use and related 
harms (particularly overdose) compared to the general population, but often lacks linkage to needed services or 
encounters barriers to services because of their criminal justice involvement and/or stigma associated with their 
substance use, incarceration, or other factors. Participants in this study will be incarcerated at the time of enrollment and 
intervention activities will take place upon their release to the community. This study presents no more than minimal risk 
for the following reasons: (1) The procedures to be used by this study will involve conventional social science research 
methods that are routine in studies of this type. The potential risks will be discussed with participants during recruitment 
contacts and during the informed consent process to assist them in making a voluntary decision as to whether they wish 
to participate in the study protocol. (2) The core of the protocol has been developed specifically for and field tested 
among justice-involved populations. Specifically, the intervention is based on a CDC-recognized, evidence-based 
intervention called START which has been used to reduce risk behavior among people re-entering communities from 
prison. (3) If participants are interested in participating in the study, they will work with the study staff and jail staff to 
determine a time and date that is convenient for our staff person to meet them in a confidential room (i.e., the attorney- 
client room). Once with the participant, our staff will re-review the signed consent form to remind participants of what is 
involved and to make sure that they do indeed want to participate. If they do not want to participate, the research staff 
person will cancel the appointment without any consequences to the participant. Once people screen eligible for the 
study, all study activities will be done in the private attorney-client room at the jail for confidentiality and privacy. (4) Study 
activities within jails are limited to administering questionnaires and conducting motivational interviewing. We will NOT be 
conducting urine drug screening or any other form of biologic testing in jails. (5) Although this is an experimental study 
with an intervention and comparison group, there is no traditional “control” group in which nothing is received. The 
comparison group in this study will receive overdose education and response training prior to release from jail and a 
comprehensive printed guide to local community resources. (6) As with any participant in the study, incarcerated 
participants will have the option to skip any intervention component or question they are not comfortable answering and 
to stop their survey at any time and still receive their full participant incentive. Incarcerated participants’ incentives for 
participation will be deposited directly into their commissary. (7) Consent forms emphasize that study participation 
should be voluntary and that participation in the study will not affect your relationship with any criminal justice, treatment, 
parole, or other agency that you are or may become involved with. In fact, the consent form states that participants may 
be removed from the study if staff learn that they are participating because they were pressured to do so by peers or jail 
staff. Of note, participants in Department of Corrections custody will also be required to complete a Kentucky 
Department of Corrections Research Consent Form provided to the PI by the Department of Corrections (see

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SECTION 2.
When an IRB is reviewing a protocol in which a prisoner will be a subject, the IRB must find and document justification that six additional 
conditions are met. Describe in the space provided how each condition applies to your research.
NOTE: If your study only involves epidemiologic research, you may insert "N/A" in each of the text boxes in this section (Section 2). 
Your response to Section 3 will determine appropriateness for "N/A" answers here.
Condition 1. Advantages acquired through participation in the research, when compared to the prisoners’ current situation, are not so 
great that they impair their ability to weigh risks.
Describe the possible advantages that can be expected for prisoner participants:
Condition 2. Risks are the same as those that would be accepted by non-prisoners.
Describe the possible risks that can be expected for prisoner participants and justify that they are the same as for non- 
prisoners:
Condition 3. Procedures for selection are fair to all prisoners and are immune from intervention by prison authorities in prisons; control 
subjects must be randomly selected.
a) Describe how prisoners will be selected for participation:
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will occur weekly, with one day dedicated to screening and assessment (with a follow-up visit to the jail for completion of 
assessments, if needed). Each week, a project staff person will visit the jail on a consistent day of the week chosen in 
collaboration with jail staff (i.e., to avoid court days and other standard events where inmate schedules may preclude 
participation). Before the staff person’s arrival, the jail staff will have invited all inmates who are expected to be released 
in the next 10 days who are returning to one of the 12 CARE2HOPE counties currently randomized to the intervention or 
control conditions to attend a group session to learn more about the study. The jail staff’s invitation to prospective 
participants will be in the form of a study handout (attached in Recruitment section of Research Description) that 
contains language emphasizing that attendance of the session is wholly voluntary and will not affect their probation, 
parole, or release terms. The handout will instruct the inmate to inform jail staff of their interest in attending the 
information session.
At the group session, staff will provide a brief overview of the study, including describing the certificate of confidentiality 
and eligibility screening process. After the overview, participants will have the ability to ask the REHN questions.
Following questions, the REHN will distribute paper copies of the screening survey (attached in Research Description) 
with a cover letter appended describing risks, benefits, and procedures involved in completing the screener (see 
Informed Consent section). The REHN will read the cover letter, screener instructions, and questions aloud to the group 
to support low-literate individuals. Individuals who consent will complete the screener. The screening survey will include 
questions to collect full name and date of birth so that staff can (1) accurately provide compensation on their 
commissary for completing the screening survey, (2) identify instances in which people complete the screening more 
than once so that they are not compensated for participation more than once, and (3) so that staff can extend invitations 
(via jail staff) to those who are eligible to meet with them to learn more about the study, go through the consent process, 
and complete a study intake.
The REHN will collect the screeners and thank the prospective participants for screening. Those that are eligible will 
work with the facility staff to determine a time and date that is convenient, and our staff person will meet them in a 
confidential room (i.e., the attorney-client room). Once with the participant, our staff will re-review the signed consent 
form to remind participants of what is involved and to make sure that they do indeed want to do their survey. If they do 
not want to participate, the research staff person will cancel the appointment without any consequences to the 
participant. Of note, the consent form is followed by a consent quiz to make sure that participants understand the 
procedures; one of the questions on the consent quiz asks if study participation will affect probation, parole, or release 
(true/false). If the participant fails the consent quiz, they will not be able to participate.
b) Describe what measures will be taken to prevent intervention by prison authorities in the selection process:

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Condition 4. Parole boards cannot take into consideration a prisoner’s participation in research. Informed consent must state 
participation will not impact parole.
Describe what measures are in place to ensure parole boards are not influenced by prisoners’ participation in research
and how prisoners will be told their participation (or refusal or withdrawal from) will not impact parole:
Condition 5. For studies that require follow-up, provisions are made including consideration for the length of individual sentences; 
informed consent must reflect provisions for follow-up.
Describe what provisions have been made for follow-up and how this information will be relayed to the prisoner
participants:
Condition 6. Information about the study is presented in a language understandable to prisoners.
Describe what efforts have been made to present information about the study in a language understandable to the 
prisoner population:
SECTION 3. Epidemiologic Research Involving Prisoners 
Only complete if applicable:
Effective June 20, 2003, DHHS adopted policy that allows waiver of the requirement for documenting applicability of a category (as 
found in Section 1 of this form) for certain epidemiologic research involving prisoners. This waiver applies to epidemiologic research on 
prisoners that presents no more than minimal risk and no more than inconvenience to the prisoner-subjects.
Check this box if your research meets all three criteria listed below, then provide justification in the space provided.
1. I request a waiver for meeting the category conditions under Section 1 of this form.
2. My research involves epidemiologic research intended to describe the prevalence/incidence of a disease by identifying all 
cases, or to study potential risk factor associations for a disease; and
3. Prisoners are not the sole focus of my research.

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Justify how the research presents no more than minimal risk and no more than inconvenience to the subjects: 
 
 
 
SECTION 4. Prisoners are not the targeted population 
Only complete if applicable: 
 
Although prisoners may not be the target population for your research, a subject could become a prisoner during the course of the 
study (particularly if studying a subject population at high-risk of incarceration). 
 
Note: If you did not receive IRB approval for involvement of prisoners, and a subject becomes a prisoner during the study, all 
research activities involving the now-incarcerated participant must cease until IRB approval has been issued for their 
continuation in the research. If you need IRB approval for a prisoner subject to continue participation in your research, select and 
complete the applicable category from Section 1, complete section 2 and this section, then submit for IRB review. 
 
In special circumstances where it is in the best interest of the subject to remain in the research study while incarcerated, the IRB 
Chairperson may determine that the subject may continue to participate in the research prior to satisfying the requirements of 
Subpart C. However, subsequent IRB review and approval of this completed form is required. 
 
 
Prisoners are not a target population for my research, but a subject became a prisoner during the study and I am seeking IRB 
approval so the subject can continue participation in the research. 
 
 
Explain the importance of continuing to intervene, interact, or collect identifiable private 
information during the participant’s incarceration: 
 
 
SECTION 5. Kentucky (KY) Department of Corrections (DoC) Approval 
 
Review the following conditions and determine whether any apply to your study: 
 
active recruitment of participants from a correctional facility (prison, jail, or community corrections institution); 
active recruitment of individuals under community supervision from a state probation and parole office. 
If any of the above conditions apply to your research, refer to the Kentucky Department of Corrections Policy and Procedures, 
Management Information and Research (Chapter 5) for information about submitting a proposal for DoC approval of research including 
the DoC approved Research Consent and Research Agreement (5.1.G.1). 
If your research involves a certificate of confidentiality or the Department of Corrections is directly involved in the study as a sponsor (or 
otherwise), contact David Kinsella, Legal Counsel, at David.Kinsella@uky.edu, or 859-323-1161, for additional information. 

52439
Section 9 Page 1 of 6
INFORMED CONSENT/ASSENT PROCESS/WAIVER
0 unresolved
comment(s)
For creating your informed consent attachment(s), please download the most up-to-date version listed in "All Templates" under the 
APPLICATION LINKS menu on the left, and edit to match your research project.
Additional Resources:
Informed Consent/Assent Website
Waiver of Consent vs. Waiver of Signatures
Sample Repository/Registry/Bank Consent Template
Consent/Assent Tips:
If you have multiple consent documents, be sure to upload each individually (not all in a combined file).
If another site is serving as the IRB for the project, attach the form as a “Reliance Consent Form” so the document will not receive 
a UK IRB approval stamp; the reviewing IRB will need to stamp the consent forms.
Changes to consent documents (e.g., informed consent form, assent form, cover letter, etc...) should be reflected in a 'tracked 
changes' version and uploaded separately with the Document Type "Highlighted Changes".
It is very important that only the documents you wish to have approved by the IRB are attached; DELETE OUTDATED FILES --
previously approved versions will still be available in Protocol History.
Attachments that are assigned a Document Type to which an IRB approval stamp applies will be considered the version(s) to be 
used for enrolling subjects once IRB approval has been issued.
Document Types that do NOT get an IRB approval stamp are:
"Highlighted Changes", 
"Phone Script", and 
"Reliance Consent Form",
"Sponsor's Sample Consent Form".
How to Get the Section Check Mark
1. You must:
a) provide a response in the text box below describing how investigators will obtain consent/assent, and
b) check the box for at least one of the consent items and/or check mark one of the waivers
2. If applicable attach each corresponding document(s) as a read-only PDF.
3. If you no longer need a consent document approved (e.g., closed to enrollment), or, the consent document submitted does not 
need a stamp for enrolling subjects (e.g., umbrella study, or sub-study), only select "Stamped Consent Doc(s) Not Needed".
4. After making your selection(s) be sure to scroll to the bottom of this section and SAVE your work!
Informed Consent Process:
Using active voice, describe how investigators will obtain consent/assent. Include: 
the circumstances under which consent will be sought and obtained
the timing of the consent process (including any waiting period between providing information and obtaining consent)

52439
Section 9 Page 2 of 6
 
 
who will seek consent 
how you will minimize the possibility of coercion or undue influence 
the method used for documenting consent 
if applicable, who is authorized to provide permission or consent on behalf of the subject 
if applicable, specific instruments or techniques to assess and confirm potential subjects’ understanding of the information 
 
Note: all individuals authorized to obtain informed consent should be designated as such in the E-IRB "Study Personnel" section of 
this application. 
Special considerations may include: 
 
Obtaining consent/assent for special populations such as children, prisoners, or people with impaired decisional capacity 
Research Involving Emancipated Individuals 
If you plan to enroll some or all prospective subjects as emancipated, consult with UK legal counsel prior to submitting this 
application to the IRB. Include research legal counsel’s recommendations in the "Additional Information" section as a separate 
document. 
Research Involving Non-English Speaking Subjects 
For information on inclusion of non-English speaking subjects, or subjects from a foreign culture, see IRB Application Instructions 
for Recruiting Non-English Speaking Participants or Participants from a Foreign Culture. 
Research Repositories 
If the purpose of this submission is to establish a research repository describe the informed consent process. For guidance 
regarding consent issues, process approaches, and sample language see the Sample Repository/Registry/Bank Consent 
Template. 
 
The REHN will provide a brief overview of the study and of the certificate of confidentiality. After the overview, participants will have 
the ability to ask the REHN questions. Before providing the screening surveys to the group, the REHN will then read the Screening 
Survey Cover Letter (attached in Informed Consent section) aloud, and participants will be given a hard copy. The cover letter will 
describe the risks and benefits of taking part in the screening, and will note in particular that (1) a certificate of confidentiality protects 
their data; and (2) their decision about participating has no bearing on their legal status. It will review the contents of the screening 
form, and the screening’s anticipated duration. There will be no screening items capturing information that might require mandated 
reporting. Individuals will have time to ask the REHN questions about the screening process. Individuals who are interested in being 
screened can complete the survey and keep a copy of the cover letter. Of note, the KY Department of Corrections does require that 
all incarcerated individuals complete a general DOC consent form (see DOC Consent Form attached in Informed Consent section) 
granting permission to participate in research and require that a copy of that consent form be deposited with the KY DOC 
headquarters. To protect participant confidentiality and avoid revealing to DOC staff who screened eligible and participated, we will 
administer the DOC consent form to all individuals attending the study overview session, rather than only to those who screen eligible. 
Therefore, jail officials and administrators who maintain a copy of those forms will not be able to decipher which participants screened 
eligible, participated, or refused to participate. 
 
Individuals who screen eligible and are interested in learning more about the study will complete a second consent form in a one-on- 
one session. This session will be held in the Attorney/Client room. Jail staff are not allowed in these rooms during the sessions. 
Some rooms have video cameras (though none have audiorecorders). The REHN will ensure that the participant is facing away from 
the camera. The REHN will give a copy of the CARE2HOPE Phase 2 consent form (attached in Informed Consent section) to the 
participant and will review it aloud, the REHN will ask whether the person has any questions and answer them to the best of his/her 
ability. The REHN will then administer a brief quiz (see Consent Quiz attached in Additional Materials) about the contents of the 
consent forms to ensure that the individual is cognitively able to understand study risks at the time; individuals who fail the quiz will not 
be enrolled in the study. 
 
Individuals who pass the quiz and are interested in taking part in CARE2HOPE will sign the IRB-approved consent form. Regardless 
of whether they consent, all individuals will be given a copy of the informed consent document. This document describes the study 
purpose, potential risks, and PIs' and IRBs' contact information for follow up questions. The consent document will also contain a 
statement informing participants that their name and contact information may be released without their consent to appropriate state 
authorities in instances that are required by state law (e.g., if they inform study staff that they are wanting to end their life or someone 
else’s life, are abusing a child). 
 
Participants can opt out of taking this full copy (which will discuss drug use, and thus might jeopardize confidentiality) and instead take 
a sheet that lists PI and IRB contact information. Signed consent forms will be kept in a locked cabinet in a locked office at the UK 
study field site in Morehead or the office rented in the local health department. Only IRB-approved study personnel will have access 
to the locked filing cabinets containing consent forms. 
 
As explicitly stated in the consent form, participation is completely voluntary and there are no penalties or prejudice of any kind for not 
participating in the study. The informed consent will stress the voluntary nature of the study and the ability to withdraw from the study at 
any point. If the participant agrees to participate in the study, data collection will begin. Non-English speaking persons are not eligible 
for participation; therefore, the consent will only be in English. Of note, this study is automatically protected by a Federal Certificate of 
Confidentiality (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html). 
 
Individuals who do not consent will be allowed to leave without penalty. 
 
Participants will not undergo another consent process post-release. However, participants will re-review the consent form with the 
REHN in the first post-release session, confirm with participants whether they still want to continue and REHNs will offer to provide 

Section 9 Page 3 of 6
 
 
another copy of the consent form if the participant wants. 
52439 
 
COVID-19 Policies 
Jail 
Individuals who are recruited in the jail via Zoom or by phone, screen eligible, and are interested in learning more about the study will 
complete the informed consent process. The REHN will review the consent form aloud with the individual and then answer any 
questions. The REHN will then administer a brief quiz about the contents of the consent forms to ensure that the individual is able to 
understand study risks at the time. Individuals who fails the quiz will not be enrolled in the study. Individuals who pass the quiz and are 
interested in taking part in CARE2HOPE will provide verbal consent, which the REHN will document on the IRB-approved consent 
form. 
 
Community 
The informed consent process for individuals recruited from the community (as well as all other research procedures) will take place 
in person as COVID restrictions allow. If the participant is not able to visit the study office (or another mutually agreed-upon location) 
or all research activities are reverted to remote only due to COVID-19 restrictions, informed consent will be completed online over 
UK Zoom, which is HIPAA compliant, or over the phone. We will check with the person if they are located in a private area where no 
one can overhear or see documents shared via Zoom or in hardcopies. If the person is not comfortable with the degree of privacy 
they have, the REHN will reschedule the meeting. The REHN will then administer a brief quiz about the contents of the consent forms 
to ensure that the individual is able to understand study risks at the time. Individuals who fails the quiz will not be enrolled in the study. 
A copy of the quiz is attached under research procedures. 
 
CQi 
The only research activity related to the CQI component is a one-time interview. We will use cover letters for each category of 
participants (CARE2HOPE participants, pharmacists and REHNs). These cover letters will include all applicable elements of 
informed consent, including information on data collection procedures, risks, participants rights and confidentiality measures. We will 
review these cover letters with the participants at the start of the interview. 
Participants are encouraged to call the PI or research staff if any questions arise during the course of the research. Phone numbers 
for the PI and staff, as well as for the Office of Research Integrity (ORI) are included in the consent form. It is expected that providing 
contact information of the PIs will offer a safe, confidential, and reliable channel for participants to express problems, concerns or 
questions. 
 
Request for Waiver of Informed Consent Process 
 
 
If you are requesting IRB approval to waive the requirement for the informed consent process, or to alter some or all of the 
elements of informed consent, complete, Section 1 and Section 2 below. 
 
Note: The IRB does not approve waiver or alteration of the consent process for greater than minimal risk research, except 
for planned emergency/acute care research as provided under FDA regulations. Contact ORI for regulations that apply to 
single emergency use waiver or acute care research waiver (859-257-9428). 
 
SECTION 1. 
Check the appropriate item: 
I am requesting a waiver of the requirement for the informed consent process. 
 
I am requesting an alteration of the informed consent process. 
If you checked the box for this item, describe which elements of consent will be altered and/or omitted, and justify the 
alteration. 
SECTION 2. 
Explain how each condition applies to your research. 
a) The research involves no more than minimal risk to the subject. 
b) The rights and welfare of subjects will not be adversely affected. 
c) The research could not practicably be carried out without the requested waiver or alteration. 
d) Whenever possible, the subjects or legally authorized representatives will be provided with additional pertinent information 
after they have participated in the study. 
e) If the research involves using or accessing identifiable private information or identifiable biospecimens, the research could 
not practicably be carried out without using such information or biospecimens in an identifiable format. 
Private information/specimens are “identifiable” if the investigator may ascertain the identity of the subject or if identifiers 
are associated with the information (e.g., medical records). This could be any of the 18 HIPAA identifiers including dates 
of service. 
If not using identifiable private information or identifiable biospecimens, insert N/A below. 

52439
Section 9 Page 4 of 6
 
 
 

52439
Section 9 Page 5 of 6
Request for Waiver of Signatures
If you are requesting IRB approval to waive the requirement for signatures on informed consent forms, your research 
activities must fit into one of three regulatory options:
1. The only record linking the participant and the research would be the consent document, and the principal risk would be 
potential harm resulting from a breach of confidentiality (e.g., a study that involves participants who use illegal drugs).
2. The research presents no more than minimal risk to the participant and involves no procedures for which written consent 
is normally required outside of the research context (e.g., a cover letter on a survey, or a phone script).
3. The participant (or legally authorized representative) is a member of a distinct cultural group or community in which 
signing forms is not the norm, the research presents no more than minimal risk to the subject, and there is an appropriate 
alternative mechanism for documenting that informed consent was obtained.
Select the option below that best fits your study.
If the IRB approves a waiver of signatures, participants must still be provided oral or written information about the study.
To ensure you include required elements in your consent document, use the Cover Letter Template as a guide. There is 
an English and a Spanish version.
Option 1
Describe how your study meets these criteria:
a) The only record linking the participant and the research would be the consent document:
b) The principal risk would be potential harm resulting from a breach of confidentiality (i.e., a study that involves subjects 
who use illegal drugs).
Under this option, each participant (or legally authorized representative) must be asked whether (s)he wants to sign a 
consent document; if the participant agrees to sign a consent document, only an IRB approved version should be 
used.
Option 2
Describe how your study meets these criteria:
a) The research presents no more than minimal risk to the participant:
b) Involves no procedures for which written consent is normally required outside of the research context (i.e. a cover 
letter on a survey, or a phone script):
Option 3
Describe how your study meets these criteria:
a) The subject (or legally authorized representative) is a member of a distinct cultural group or community in which 
signing forms is not the norm.

Section 9 Page 6 of 6
There is an appropriate alternative mechanism for documenting that informed consent was obtained.
52439

Section 10 Page 1 of 3
STUDY PERSONNEL
0 unresolved comment(s)
Do you have study personnel who will be assisting with the research?
After selecting 'Yes' or 'No' you must click the 'Save Study Personnel Information' button. 
 
Yes
No
Manage Study Personnel
Identify other study personnel assisting in research project:
The individual listed as PI in the 'PI Contact Information' section should NOT be added to this section.
If the research is required for a University of Kentucky academic program, the faculty advisor is also considered study personnel and should be listed below.
***Residents and students who are PI’s are encouraged to designate the faculty advisor or at least one other individual as a contact with an editor role (DP).***
Role: DP = Editor (individual can view, navigate, and edit the application for any review phase (IR, CR/FR, MR) or 'Other Review", and submit Other Reviews on behalf
of the PI.)
Role: SP = Reader (individual can view and navigate through the currently approved application only.)
To add an individual via the below feature:
Search for personnel;
Click "select" by the listing for the person you want to add;
For each person, specify responsibility in the project, whether authorized to obtain informed consent, AND denote who should receive E-IRB notifications (contact
status).
NOTE: Study personnel must complete human subject protection (HSP) and Responsible Conduct of Research (RCR) training before implementing any
research procedures. For information about training requirements for study personnel, visit UK’s HSP FAQ page, the RCR Getting Started page, or contact
ORI at 859-257-9428. If you have documentation of current HSP training other than that acquired through UK CITI, you may submit it to ORI
(HSPTrainingSupport@uky.edu) for credit.
Study personnel assisting in research project:
Last Name
First
Name
Responsibility In
Project
Role
A 
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
Updated
SFI
Alexander
Rhonda
Data Collection
SP
Y
N
P
Y
05/06/2022
Y
N
07/17/2019
N
Babalonis
Shanna
Co-Investigator
SP
Y
N
PhD
P
Y
02/21/2023
Y
N
07/17/2019
N
Burchett
Anne
Data
Analysis/Processing
SP
N
N
P
Y
07/05/2022
Y
N
08/15/2022
N
Cooper
Hannah
Co-Investigator
SP
Y
N
ScD
N
Y
03/03/3000
N
07/17/2019
N
Dschaak
Zachary
Data
Analysis/Processing
SP
N
N
P
N
08/10/2020
Y
N
09/03/2020
N
Duff
Madeline
Data
Analysis/Processing
SP
N
N
S
Y
06/01/2022
Y
N
08/15/2022
N
Fadanelli
Monica
Project
Assistance/Support
SP
N
N
N
Y
03/03/3000
N
08/27/2021
N
Falk
Dylan
Data
Analysis/Processing
SP
N
N
N
Y
03/03/3000
N
06/23/2021
N
Feil
Dakotah
Data
Analysis/Processing
SP
N
N
N
Y
03/03/3000
N
07/29/2021
N
Freeman
Edward
Project
Assistance/Support
SP
N
N
P
Y
06/12/2023
Y
N
06/02/2020
N
Fuller
Grayson
Data
Analysis/Processing
SP
N
N
P
Y
03/15/2023
Y
N
09/17/2021
N
Greenwood
Harris
Data
Analysis/Processing
SP
N
N
N
Y
03/03/3000
N
06/23/2021
N
Grospitch
Ashley
Data
Analysis/Processing
SP
N
N
P
Y
08/25/2023
Y
N
08/15/2022
N
Gugerty
Paige
Data
Analysis/Processing
SP
N
N
N
Y
03/03/3000
N
07/29/2021
N
Havens
Jennifer
Co-Investigator
SP
N
N
PhD
P
Y
05/11/2022
Y
N
07/17/2019
N
Holt
Colton
Data
Analysis/Processing
SP
N
N
S
Y
08/11/2022
Y
N
08/15/2022
N
Hurlburt
Sarah
Data Collection
SP
Y
N
P
Y
03/05/2021
Y
N
03/05/2021
N
Ibragimov
Umed
Project
Assistance/Support
SP
N
N
N
Y
03/03/3000
N
02/21/2020
N
Jahangir
Tasfia
Data
Analysis/Processing
SP
N
N
N
Y
03/03/3000
N
05/16/2023
N
Jones-Harrell
Carla
Project
Assistance/Support
SP
N
N
N
Y
03/03/3000
N
08/19/2020
N
Kesich
Zora
Data Collection
SP
Y
N
N
Y
03/03/3000
N
02/04/2022
N
52439

Section 10 Page 2 of 3
52439
Last Name
First
Responsibility In
Role
A
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
SFI
Name
Project
C
Updated
King
Annelise
Data
SP
N
N
S
Y
06/01/2022
Y
N
08/15/2022
N
Analysis/Processing
Kollitz
Julia
Data
SP
N
N
S
Y
09/09/2023
Y
N
08/27/2021
N
Analysis/Processing
Komro
Kelli
Co-Investigator
SP
N
N
PhD
N
Y
03/03/3000
N
07/18/2019
N
Lane
Kenneth
Data Collection
SP
Y
N
P
Y
11/04/2022
Y
N
10/24/2019
N
Lawson
Lauren
Data
SP
N
N
P
Y
08/19/2023
Y
N
09/17/2021
N
Analysis/Processing
Littleton
Kelsey
Project
SP
N
N
N
Y
03/03/3000
N
02/04/2021
N
Assistance/Support
Livingston
Melvin
Data
SP
N
N
PhD
N
Y
03/03/3000
N
07/18/2019
N
Analysis/Processing
Lofwall
Michelle
Co-Investigator
SP
Y
N
MD
P
Y
06/29/2023
Y
N
07/17/2019
N
Love
Lauren
Data Collection
SP
Y
N
N
Y
03/03/3000
N
02/04/2022
N
Pieczykolan
Maybrier
Lisa
Data Collection
SP
Y
N
P
Y
05/06/2022
Y
N
04/12/2021
N
Oliver
Cindy
Data Collection
SP
Y
N
P
Y
03/02/2022
Y
N
03/03/2022
N
Oser
Carrie
Co-Investigator
SP
Y
N
PhD
P
Y
12/08/2021
Y
N
07/03/2019
N
Peddireddy
Snigdha
Data
SP
N
N
N
Y
03/03/3000
N
09/17/2021
N
Analysis/Processing
Plaisance
Karma
Data
SP
N
N
N
Y
03/03/3000
N
06/12/2023
N
Analysis/Processing
Rippetoe
Patricia
Co-Investigator
SP
Y
N
P
Y
11/30/2020
Y
N
07/17/2019
N
Freeman
Robbins
Sarah
Project
SP
Y
N
P
Y
11/07/2020
Y
N
10/24/2019
N
Jane
Assistance/Support
Rose
Lana
Data Collection
SP
Y
N
P
Y
12/14/2022
Y
N
10/24/2019
N
Staton
Christa
Co-Investigator
SP
Y
N
PhD
P
Y
05/26/2021
Y
N
07/03/2019
N
Tabor
Joy
Project
SP
N
N
P
Y
07/12/2021
Y
N
09/25/2023
N
Assistance/Support
Vickers-Smith
Rachel
Project
SP
Y
N
P
Y
05/31/2023
Y
N
09/03/2020
N
Assistance/Support
White
Carol
Study Coordinator
DP
Y
Y
MPH
P
Y
04/27/2023
Y
N
08/19/2019
N
Wilson
Jordan
Data
SP
N
N
P
Y
03/18/2021
N
N
09/08/2020
N
Analysis/Processing
Xie
Kevin
Data
SP
N
N
P
Y
02/13/2023
Y
N
07/19/2021
N
Analysis/Processing
Cooper
Daniel
Data
SP
N
N
P
N
01/09/2019
N
Y
05/26/2021
N
Analysis/Processing
Green
Travis
Data Collection
SP
Y
N
P
N
03/05/2018
N
Y
05/26/2021
N
Hurst
Jennifer
Data Collection
SP
Y
N
P
Y
01/17/2022
Y
Y
04/25/2023
N
Jones
Veronica
Study Coordinator
SP
Y
N
P
Y
02/24/2022
Y
Y
04/25/2023
N
Knipp Conn
Kandi
Data Collection
SP
Y
N
P
Y
05/05/2021
Y
Y
04/25/2023
N
Littleton
Kia
Data Collection
SP
Y
N
P
Y
07/27/2023
Y
Y
04/25/2023
N
Lucas
Ripley
Project
SP
Y
N
P
N
12/07/2018
N
Y
05/26/2021
N
Assistance/Support
Mackey
Judy
Data Collection
SP
Y
N
P
Y
01/12/2021
Y
Y
04/25/2023
N
Mansfield
Russell
Data
SP
N
N
N
Y
03/03/3000
Y
07/19/2021
N
Analysis/Processing
Mullins
Amanda
Data Collection
SP
Y
N
P
N
02/13/2019
Y
05/26/2021
N
Powell
Phillip
Data Collection
SP
Y
N
P
Y
03/28/2022
Y
Y
04/25/2023
N
Stamper
Roscoe
Data Collection
SP
Y
N
P
N
10/03/2018
Y
05/26/2021
N
Tully
Damien
Data
SP
N
N
N
Y
03/03/3000
Y
03/18/2021
N
Analysis/Processing
Vanlandingham
Emily
Data Collection
SP
Y
N
P
N
10/30/2019
Y
05/26/2021
N
VanMeter
Connor
Project
DP
N
N
P
Y
10/10/2022
Y
Y
05/26/2021
N
Assistance/Support

Section 10 Page 3 of 3
52439
Last Name
First
Responsibility In
Role
A
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
SFI
Name
Project
C
Updated
Vermes
Ellen
Data
SP
N
N
N
Y
03/03/3000
Y
05/26/2021
N
Analysis/Processing
Vickers Smith
Rachel
Data
SP
N
N
N
N
01/04/2018
Y
05/21/2020
N
Analysis/Processing
Wright
Kasey
Data Collection
SP
Y
N
P
N
10/28/2019
Y
05/26/2021
N

52439
Section 11 Page 1 of 23
 
 
 
RESEARCH DESCRIPTION 
0 unresolved 
comment(s) 
 
 
 
You may attach a sponsor’s protocol pages in the “Additional Information” section and refer to them where necessary in 
the Research Description. However, each prompt that applies to your study should contain at least a summary paragraph. 
Pro Tips: 
 
Save your work often to avoid losing data. 
Use one of the attachment buttons in this section or under the Additional Information section to include supplemental 
information with your application. During the document upload process, you will be able to provide a brief description 
of the attachment. 
Background 
 
Include a brief review of existing literature in the area of your research. You should identify gaps in knowledge that should be addressed 
and explain how your research will address those gaps or contribute to existing knowledge in this area. For interventional research, 
search PubMed and ClinicalTrials.gov for duplicative ongoing and completed trials with same condition and intervention(s). 
 
The project described in this protocol is the 2nd phase of a 2-phase project, titled CARE2HOPE. The overarching aim of 
CARE2HOPE is to build evidence-based, community-rooted public health responses to the epidemics of non-medical prescription 
opioid (NMPO) and heroin injecting, overdoses (ODs), and HCV, and to imminent HIV outbreaks, in 12 rural Appalachian Kentucky 
counties at the epicenter of these intertwined national crises. The project is biphasic in design, as required by the UG3/UH3 funding 
structure, with a 2-year assessment phase (UG3) followed by a 3-year intervention phase (UH3) that is informed by results of the 
assessment. The UG3 phase began in August 2017 and is described in the approved IRB protocol # 43520. Briefly, in the UG3 we 
were guided by harm reduction principles, the Risk Environment Model, and Community/ Academic Partnerships (CAPs), with study 
aims to: (1) Assess and enhance each community’s readiness to improve the local risk environment. (2) Examine the strengths, 
resources, needs, and gaps of each community’s risk environment. (3) Select one EB-CRP that responds to local needs and 
strengths, using elements of Intervention Mapping. The UG3 protocol will remain active as some surveys and biologic testing will 
continue throughout the UH3 phase. 
 
The current IRB protocol #52439 covers the 3-year UH3 phase which begins August 1, 2019. Although both phases are united under 
a common overarching study purpose, the two phases are submitted as separate IRB protocols because they differ in study design 
(UG3 phase involved coalition engagement, surveys, and interviews; the UH3 phase involves a community-level randomized trial of a 
health navigation intervention) and because the addition of the UH3 procedures to the UG3 would make the already complex protocol 
unwieldy. The decision to submit the phases as separate IRB protocols was made in consultation with IRB staff. 
 
Background and Significance for Project 
 
An “implementation chasm” – defined as gap between advances in scientific knowledge and the application of this knowledge in 
medical and public health programs -- exists for drug-related health services in most rural areas. A landmark 2015 Kentucky law, 
however, allowed this largely rural state to start closing this chasm: this law permitted syringe service programs (SSPs) to operate, 
expanded access to naloxone, and provided Good Samaritan protections. These policy changes have allowed 8 of the 12 counties to 
open SSPs. Harm reduction interventions, however, have yet to be adequately deployed in these 12 hard-hit counties. Previous and 
ongoing research by the scientific team reveal that in these counties access and linkage to medications for opioid use disorder 
(MOUD) are suboptimal; challenges to MOUD dispensing exist; naloxone access is poor, and partnerships among local justice, harm 
reduction, and SUD treatment programs are virtually nonexistent. High percentages of PWUD continue to overdose, and to engage in 
HIV and HCV risk behaviors. 
 
This project continues to bridge the implementation chasm in these 12 counties. In the UH3, we will analyze the effectiveness of an 
evidence-based community response project, using an innovative stepped-wedge community randomized trial. Specifically, we will 
conduct an evidence-based, multilevel health navigation intervention that is designed to reduce SUD and increase engagement in the 
SUD care cascade; reduce vulnerability to HIV, STIs, and HCV and increase engagement in the HIV, STI, and HCV care cascades; 
and reduce vulnerability to overdose deaths among adults who use drugs and are leaving local jails. We will target individuals leaving 
jails, a high risk but almost entirely neglected population. The intervention is based on enhancements to START, a CDC-recognized, 
evidence-based, individual-level intervention designed to reduce HIV/STI/HCV risk. 
 
COVID-19 Policies 
Because of COVID-19 related pauses in the study and related barriers, we are changing the trial duration from three years to two 
years. To accommodate this shorter time period, we are modifying the study design from a stepped-wedge trial to a case crossover 
trial and we are expanding our eligibility criteria to include individuals in the community recently involved with the criminal justice system. 
 
CQI 
We are adding a continuous quality improvement (CQI) component to assess the implementation of CARE2HOPE health linkage 
(START-C2H) and pharmacy-based medication for opioid use disorder (MOUD-C2H) interventions. The CQI will be led by Hannah 
Cooper, Multiple Principal Investigator and Umed Ibragimov, Co-Investigator, both at Emory University. 
 
Objectives 

52439
Section 11 Page 2 of 23
COVID-19 Policies
List your research objectives. Please include a summary of intended research objectives in the box below.
Study Design
Describe and explain the study design (e.g., observational, secondary analysis, single/double blind, parallel, crossover, deception, etc.).
Clinical Research: Indicate whether subjects will be randomized and whether subjects will receive any placebo.
Community-Based Participatory Research: If you are conducting community-based participatory research (CBPR), describe 
strategies for involvement of community members in the design and implementation of the study, and dissemination of results from 
the study.
Qualitative research: Indicate ranges where flexibility is needed, if a fixed interview transcript is not available, describe interview 
topics including the most sensitive potential questions.
Research Repositories: If the purpose of this submission is to establish a Research Repository (bank, registry) and the material
you plan to collect is already available from a commercial supplier, clinical lab, or established IRB approved research repository, 
provide scientific justification for establishing an additional repository collecting duplicate material. Describe the repository design 
and operating procedures. For relevant information to include, see the UK Research Biospecimen Bank Guidance or the UK
Research Registry Guidance.
This study will test the effects of an intervention to reduce substance use and related harms among people re-entering the community 
from rural jails. This study will compare people in a re-entry health navigation intervention with a comparison group of people who will 
get overdose education in jail. Everyone will take part in follow-up surveys after release. The intervention sessions and data collection 
will be delivered by project staff called “Re-entry Health Navigators” or “REHNs”. Intervention and comparison conditions are 
described in more detail in the Research Procedures section.
Participants are assigned to one of the two groups by chance based on when they are released from jail and when their county is 
randomly chosen to start the project. In August 2019, we will randomize each of the 12 study counties to a start date. Four counties will 
be randomized to start the project each year, as shown in the Timeline and Study Design Figure. Four counties will be randomized to 
start the intervention each year. In each wave, four counties will be randomized to start 6 months of enrollment into a control condition, 
followed by 6 months of enrollment into the intervention condition, with follow-up data collection on both extending 6 months beyond 
enrollment. We anticipate an average enrollment of 25 participants per county per quarter, with a total final sample size for the trial of 
1200 (n=600 intervention, n=600 control). After a county has met its target enrollment in both conditions, the intervention and 
comparison activities will no longer be offered in that county.
The stepped-wedge trial design is pragmatic and ethical. It is difficult to implement multicomponent interventions with fidelity in several 
communities simultaneously because of their scope. Stepped-wedge trials are thus pragmatic for tests of multicomponent 
interventions. They are also the most ethical trial design available for the proposed study. The intervention has proven effectiveness, 
though in other contexts. It is thus unethical to withhold an intervention entirely from one set of counties, as would happen in a 
traditional randomized trial with intervention and control groups.
COVID-19 Policies
We are changing the trial duration from three years to two years. To accommodate this shorter time period, we are modifying the study 
design from a stepped-wedge trial to a case crossover trial. We will randomize the 12 counties to two groups of six counties each 
versus three groups of four counties each. All counties will start at the same time. During months 1-6, counties randomized into Group 
1 will receive the intervention, while counties randomized to Group 2 will serve as the comparison group. In Months 7-12, Group 1 
counties will shift to the comparison group, and Group 2 counties will receive the intervention. In Months 13-18 we will conduct follow- 
up assessments in all counties. Months 19-24 will be devoted to data analysis and dissemination of the findings.
CQI
The CQI will involve one-time individual qualitative interviews to be conducted remotely (via videoconferencing). Each participant will 
take part in one interview only. Our target start date is February 2022. Data collection will occur in Months 1-5, data analysis will

Section 11 Page 3 of 23
Attachments
commence at the same time and will continue until Month 8. Months 8-9 will be devoted to dissemination of the findings.
Subject Recruitment Methods & Advertising
Describe how the study team will identify and recruit subjects. Please consider the following items and provide additional information as 
needed so that the IRB can follow each step of the recruitment process.
How will the study team identify potential participants? 
Who will first contact the potential subjects, and how?
Will you use advertisements? If so, how will you distribute those?
How and where will the research team meet with potential participants?
If applicable, describe proposed outreach programs for recruiting women, minorities, or disparate populations. 
How you will minimize undue influence in recruitment?
Attach copies of all recruiting and advertising materials (emails, verbal scripts, flyers, posts, messages, etc.).
For additional information on recruiting and advertising: 
IRB Application Instructions - Advertisements
PI Guide to Identification and Recruitment of Human Subjects for Research
START-C2H Recruitment: We will recruit participants and hold the first START-C2H session at the seven jails serving the 12 
CARE2HOPE counties. Aligned with START protocols and similar to other team members’ NIDA-funded studies in this area (IRB 
Protocol #43727), participant recruitment will occur in jail. Recruitment in the jail will occur weekly, with one or multiple sessions per 
week (depending on the needs of the jail) dedicated to screening and assessment (with a follow-up visit to the jail for completion of 
assessments, if needed). Each week, a project staff person will visit the jail on a consistent day(s) of the week chosen in collaboration 
with jail staff (i.e., to avoid court days and other standard events where inmate schedules may preclude participation). There will be 
three options for informing people about the study information sessions depending on whether jailers are able to provide lists of 
people nearing release to research staff in a timely fashion: (1) In jails where jailers are able to provide lists of people nearing release 
to research staff, staff will drop off envelopes for individuals who are within 21 days of release and ask jail staff to put them in the 
individuals’ mailboxes (envelopes will be labeled with the individual’s names). The envelope will include the recruitment letter (see 
attachments). The recruitment letter will be personalized for individuals who are participants in the CARE2HOPE longitudinal survey 
(IRB Protocol #43520) who consented to be contacted for future research (see attachments). Staff will obtain the names of these 
individuals from lists provided by the jail and/or jail databases. (2) In jails where jailers are not able to provide staff with up to date and 
timely information about people nearing release, the following will occur: Before the staff person’s arrival, the jail staff will have invited 
all inmates who are expected to be released in the next 21 days who are returning to one of the 12 CARE2HOPE counties currently 
randomized to the intervention or control conditions to attend a group session to learn more about the study. The jail staff’s invitation to 
prospective participants will be in the form of a study handout (see Jail Handout attached in Research Procedures secstion) that 
contains language emphasizing that attendance of the session is wholly voluntary and will not affect their probation, parole, or release 
terms. The handout will instruct the inmate to inform jail staff of their interest in attending the information session. (3) Staff will review jail 
databases weekly to identify individuals with addresses in our study counties. Research staff will work with the jail staff, asking them to 
provide the recruitment letter in the mailboxes of individuals who meet the county criterion.
At the group sessions, staff will provide a brief overview of the study, including describing the certificate of confidentiality and eligibility 
screening process. After the overview, participants will have the ability to ask the REHN questions. Following questions, the REHN will 
distribute paper copies of the screening survey (see Screener Appendix in Data Collection section) with a cover letter appended 
describing risks, benefits, and procedures involved in completing the screener (see Informed Consent section). The REHN will read 
the cover letter, screener instructions, and questions aloud to the group to support low-literate individuals. Individuals who consent will 
complete the screener. The screening survey will include questions to collect full name and date of birth so that staff can extend 
invitations (via jail staff) to those who are eligible to meet with them to learn more about the study, go through the consent process, and 
complete a study intake.
The REHN will collect the screeners, thank the prospective participants for screening, remind them that those who are eligible will be 
contacted later in the day to schedule a one-on-one appointment with the staff person to review the consent form, discuss the study, 
and if consent is granted, complete the intake process for the study (described below).
For individuals who participate in the screening session, who meet all eligibility criteria except “be incarcerated in a local jail and 
expected to be released in <21 days” but are interested in participating in the study, we will obtain their permission to contact them 
again closer to their release date to see if they are still interested in the study. If permission is provided, the REHN assigned to the 
local jail,will work closely with the jailer regarding the individual’s release date and to arrange a time to meet with the potential participant 
again. The REHN will confirm the individual is still interested in the study; if so, the screening form will be completed again, ensuring 
the individual meets the eligibility criteria. If all criteria are met, the REHN will review the consent form, discuss the study, and if consent 
is granted, complete the intake process for the study.
COVID-19 Policies 
Jails
Recruitment in jails make take place via Zoom or by phone depending on jail capacity if in-person meetings are not allowed per 
COVID-19 policies. We will work closely with each jail, providing them with a stack of recruitment packets and recruitment letters. The
52439

Section 11 Page 4 of 23
 
packet will include the recruitment script, screener cover letter, UK consent form and the DOC consent form. Each REHN will work with 
jail staff to identify individuals who might be eligible, provide the recruitment letter in these individual’s mailboxes, and schedule a 
recruitment session if an individual is interested in learning more about the study. 
We will host the recruitment session using UK Zoom, which is HIPAA compliant or by phone. We will work closely with jail staff 
responsible for coordinating Zoom and phone sessions to schedule a recruitment session and to ensure the following: 
• A confidential space will be available. 
• For Zoom, a unique Zoom meeting ID will be provided to jail staff when the recruitment session is scheduled. The waiting room 
feature will be enabled prior before the individual joins the session. The individual will join with video. The REHN will read aloud all 
applicable documents and screen share these documents with the individual. 
• For phone calls, the REHN will provide jail staff their dedicated phone number that the individual will use to call the REHN; the REHN 
will read aloud all applicable documents. 
• At the start of the session, jail staff will provide the recruitment packet to the individual and the individual will confirm that that they are 
in a confidential space, free of foot traffic and feel comfortable completing the session. If these criteria are not met, study staff will end 
the session. Staff will reschedule the session if the individual is interested. 
During the recruitment session, staff will provide a brief overview of the study (recruitment presentation text) including describing the 
certificate of confidentiality and eligibility screening process. The jail staff will remain in the room. After the overview, participants will 
have the ability to ask the REHN questions. If the individual is interested in screening for the project, the individual will sign the DOC 
consent and the jail staff will sign as well. The jail staff will then leave the room and the REHN will continue with the screening process 
including reading the screener cover letter, completing the screener form, and completing the applicable county quiz, ensuring the 
individual is from the study county. If the individual is eligible, the REHN will immediately conduct the informed consent process. If the 
individual is not eligible, the REHN will let them know that they are not eligible and the session will end. 
 
Community 
Community participants will be recruited through: a) Probation, Parole and Pre-Trial Services Offices; b) digital jails; c) peer referral; d) 
existing CARE2HOPEand PROUD-R2 (Peer-Based Retention of People Who Use Drugs in Rural Research) participants who have 
consented to be contacted to learn about future studies; e) harm reduction and social service programs serving people who use 
drugs; and f) community-based organizations. 
a) Recruitment via Probation, Parole and Pre-Trial Services Offices. 
Probation, parole, and pre-trial supervision officers will share the recruitment flyer specific to probation, parole, and pre-trial services 
with their clients. 
We continue to collaborate with the Department of Corrections (DOC) for recruitment strategies. The DOC uses an online and mobile 
phone app to communicate with people who are on community supervision (probation and parole, etc.). We recently received approval 
from DOC to provide text messaging scripts to the vendor who disseminates content to enrollees through their text messaging 
platform (scripts attached). The vendor will send our text message to all app service enrollees in our target counties at a no more than 
monthly frequency. As described in the script, individuals who receive the message will be instructed to contact our team if they are 
interested in the study. We will not have access to enrollees' personal information; all text messaging will be managed by DOC's 
approved vendor. This strategy is analogous to the IRB-approved forms of DOC outreach via email, phone, and flyers in that 
information is provided to individuals who then have the ability to decide whether to contact the team about the study. 
b) Digital jails. 
We will share our recruitment flyer with programs who supervise individuals incarcerated at home under an electronic monitoring 
program (i.e., digital jail). The administration of these programs varies by county. These programs are administered either through the 
jail or through the Court. We will identify the point of contact for each county and work directly with these individuals to share flyers. 
c) Peer referral. 
We will encourage enrolled participants to refer their potentially eligible peers to study staff. Each participant will be compensated $10 
per eligible referral. We will cap the number of eligible referrals that a single participant can make to three persons, which will also limit 
the compensation amount the referring participant may receive. This policy will be implemented by REHNs who will ask the referred 
individuals the name of the person who referred them and check this information against the participant database. 
d) Recruitment via existing study cohorts. 
Study staff will contact participants enrolled in Kentucky CARE2HOPE (IRB # 43520), this protocol (CARE2HOPE UH3 Phase), and 
PROUD-R2, who gave their consent to be contacted about future studies. Note that PROUD-R2 is a collaborative project with Oregon 
Health and Science University (main site) and the Ohio State University and under the purview of the University of Utah IRB (IRB 
00117831). We implemented IRB # 52430 in November 2019 randomizing the first four counties in the stepped-wedge design to the 
control group including Leslie, Letcher, Menifee, and Perry counties. These counties are randomized to the intervention group with the 
new study design. All participants currently enrolled will now be eligible for the intervention. 
e) Recruitment via programs working with people who use drugs. 
We will ask staff at local syringe service programs, substance use disorder treatment facilities and other health and social service 
providers to distribute recruitment flyers with the study information to their participants. 
f) Social service and public health organizations: We will actively engage with social service and public health organizations to reach 
potential participants. This engagement will include: 1) With agency permission, we will have a REHN staff member on site at the 
agency or just outside the agency describing the study to agency clients and inviting them to be screened to learn if they are eligible. 
2) With agency permission, we will have a REHN staff member provide a presentation about the study to agency clients as applicable. 
g) We will also host picnics with boxed meals periodically to recruit potential participants. These events will be held outside in parks, 
parking lots (with permission of store attendant/owner), and other public locations where community members can meet project staff 
and learn about the study through conversations with staff and through study flyers disseminated by staff. Interested individuals will be 
invited to join staff at seats that are spaced 6 feet apart. Staff will tell individuals about the study. When individuals wish to be screened, 
REHN staff will either connect them to another REHN via phone to be screened, or screen them personally. If other community 
members are present, screenings will happen at least 20 feet from the picnic area to preserve confidentiality. Eligible and interested 
individuals will then schedule an appointment for an enrollment and baseline visit. 
 
Paper copies of the pre-screening survey will be available for staff to complete with interested individuals should they not have their 
52439 

Section 11 Page 5 of 23
 
 
 
52439 
laptop and access to the electronic screener during any recruitment event. Staff will then follow-up with the individuals to let them know 
if they are potentially eligible/not eligible; if eligible, staff will ask if the individual would like to complete the screener. Interested 
individuals may also complete the pre-screening survey themselves if preferred due to limited time, share with staff, who will then 
follow-up with them to let them know if they are potentially eligible/not eligible; if eligible, staff will ask if the individual would like to to 
complete the screener. Staff will store completed paper screeners in a lock box and then in a locked filing cabinet in their field office 
upon return. 
 
Once we enroll 15 individuals in a county, we will place a hold on additional recruitment efforts for that county; however, we will resume 
recruitment again when all intervention counties are switched to control and all control counties are switched to intervention per our 
study design (cross-over trial). 
 
6/28/22 Modification - Study staff will contact participants currently enrolled in comparison counties and offer them enrollment in the 
intervention group. 
 
CQI 
Pharmacists: Using the contact information from the program records, Graduate Research Assistants, Emory University, will invite the 
pharmacists trained by CARE2HOPE study on Vivitrol dispensing via e-mails and follow-up phone calls. 
REHNs (research study staff): Graduate Research Assistants, Emory University, will invite the REHNs to take part via e-mail and follow- 
up phone calls. To avoid undue pressure, REHNs’ decisions to enroll or refuse to participate will be kept confidential from the study 
leadership and management team (MPIs Young and Cooper, Project Director, White and Project Manager, Lane). 
START-C2H participants: We will stratify the study roster from the REDCap database by county (n=12), then by gender (women and 
men), then by pharmacy-based Vivitrol participation status (Yes or No), resulting in 48 strata). Next, we will randomly select one 
participant from each stratum and will contact them using contact information from the study database. We will invite these individuals 
via phone; if a participant from a particular stratum refuses to participate, we will randomly select a replacement from the same stratum. 
Prior to the phone calls by the research assistants, our Re-entry Health Navigators (REHNs) will notify all eligible participants (i.e., 
those who participated in at least two START-C2H health linkage intervention sessions) about the forthcoming CQI interviews. This 
notification will be sent via text message to participants’ phones using contact information from the study database or through 
Facebook Messenger (private CARE2HOPE account). This short notification will inform the participants that CARE2HOPE research 
assistants will call them to invite the for the interview and clarify that participation is voluntary. The notification text is proved as an 
attachment. Each REHN, will provide their own phone numbers as part of the text. 
COVID-19 Policies 
We will use UK PR-approved flyers to recruit individuals from the community. We will post flyers in places where potentially eligible 
people may gather, including, but not limited to homeless shelters, grocery stores, Walmart stores, etc. We will also continue to work 
with jails, asking them to distribute flyers in the personal effects of individuals incarcerated. Individuals who are interested in learning 
more about the study can scan the QR code on the flyer to access an online eligibility survey through REDCap. If a potential participant 
is eligible, they will be asked to submit their contact information and the study team member will contact them. A copy of the survey is 
attached. UK-PR approved flyers including one for the community in general and one specifically for probation, parole, and pre-trial 
services are attached. We will provided business cards to Syringe Service Programs and other agencies as requested to enclose with 
packets provided to their clients. Given the volume of potential clients, it’s more cost effective to print business cards than flyers for 
the packets. The content is the same as the UK PR and IRB-approved flyer with the exception of an additional number for screening. 
We are collaborating with the Department of Corrections to increase awareness about our study. DOC staff will provide a brief 
description about our study when they meet with a client in-person, via text or email messages, and through letters. CARE2HOPE 
study staff will provide the letters (printed on UK letterhead) and flyers in sealed envelopes to DOC staff who will then address the 
envelopes and send to potentially eligible clients. Scripts are provided for each of these strategies. 
 
We will advertise the study on our CARE2HOPE facebook page using our approved community flyer. Additionally, we will promote the 
study through paid advertisement through Facebook Ads. Our approved flyer will be used for the ad and we will target our 12 study 
counties. We will advertise the study through radio ads in our study counties. We will also promote the study through newspaper ads, 
use a flyer that highlights key information about the intervention, use a flyer focusing on rural health issues, and use yard signs in varied 
locations. To enhance our retention efforts, we will use a flyer for reminding participants about follow-up appointments. 
 
We will encourage participants to make referrals to the study. Participants will receive $10 per eligible referral, up to three, for a total of 
$30. We will ask study participants to give a coupon to each referral, allowing us to track the number of individuals who are eligible and 
ineligible. The coupon number is a unique alpha numeric code that study staff will assign and track through an excel file. The referral 
coupon is attached. 
 
Attachments  
Attach Type 
File Name 
 
Advertising 
Pre-Screening Survey 110421 - Clean.pdf 
Advertising 
Scripts for Radio - PR Clean 091621.pdf 
Advertising 
Scripts for Radio Ads - PR Approval 091621.pdf 
Advertising 
Business Cards Version 2 100821 - Clean.pdf 
Advertising 
Business Cards Version 2 100821 - PR Approval.pdf 
Advertising 
Classified Ads for Newspapers 100821 - Clean.pdf 
Advertising 
Classified Ads for Newspapers 100821- PR Approval.pdf 
Advertising 
Follow Up Appointment Flyer Template 100821 - Clean.pdf 
Advertising 
Follow Up Appointment Flyer Template 100821 - PR Approval.pdf 
Advertising 
Intervention Flyer 100821 - Clean.pdf 
Advertising 
Intervention Flyer 100821 - PR Approval.pdf 

Section 11 Page 6 of 23
 
 
 
52439 
Advertising 
Radio Ads Version 2 100821 - Clean.pdf 
 
Advertising 
Community Flyer Version 2 100821- Clean.pdf 
Advertising 
Community Flyer Version 2 100821- PR Approval.pdf 
Advertising 
Rural Health Study Flyer 101521.pdf 
Advertising 
Yard Sign 101521.pdf 
Advertising 
Flyer Cookout 072721 - Clean.pdf 
Advertising 
Flyer Cookout 072721 - PR Approval.pdf 
Advertising 
Facebook Ad 081621 - PR Approval.pdf 
Advertising 
Facebook Ad 081621 - Clean.pdf 
Advertising 
DOC Scripts 031921 - Clean.pdf 
Advertising 
DOC Letter 031821.pdf 
Advertising 
Flyer Community 021121 - Clean.pdf 
Advertising 
Flyer Probation, Parole, Pre-Trial Flyer 021121 - Clean.pdf 
Advertising 
Business Cards 021121 - Clean.pdf 
Advertising 
Referral Coupon.pdf 
Advertising 
Flyer - Community 120220 - PR Approval.pdf 
Advertising 
Flyer - Probation, Parole, Pre-Trial 120220 - PR Approval.pdf 
Advertising 
DOH and Social Service Agencies Scripts 042621.pdf 

Section 11 Page 7 of 23
 
Back to Top 
 
Research Procedures 
 
Describe how the research will be conducted. 
 
What experience will study participants have? 
What will study participants be expected to do? 
How long will the study last? 
Outline the schedule and timing of study procedures. 
Provide visit-by-visit listing of all procedures that will take place. 
Identify all procedures that will be carried out with each group of participants. 
Describe deception and debrief procedures if deception is involved. 
Differentiate between procedures that involve standard/routine clinical care and those that will be performed specifically for this 
research project. List medications that are explicitly forbidden or permitted during study participation. 
 
This study will test the effects of an intervention to reduce substance use and related harms among people re-entering the community 
from rural jails or in the community. This study will compare people in a re-entry health navigation intervention with a comparison group 
of people who will get overdose education in jail or in the community. Everyone will take part in follow-up surveys for up to 6 months 
after release. The intervention is a health navigation intervention designed to reduce SUD and increase engagement in the SUD care 
cascade; reduce vulnerability to HIV, STIs, and HCV and increase engagement in the HIV, STI, and HCV care cascades; and reduce 
vulnerability to overdose deaths among adults who use drugs and are leaving local jails. The intervention is based on enhancements to 
START, a CDC-recognized, evidence-based, individual-level intervention designed to reduce HIV/STI/HCV risk. Individuals enrolled in 
the intervention arm will also be referred by the REHN to pharmacy-based Vivitrol administration services supported by the Kentucky 
Opioid Response Effort (a SAMHSA-funded, state level program); this is described in more detail below. 
 
Overview of START 
 
START, in its original format, is a manualized, six-session individual-level intervention that evidence indicates reduces vulnerability to 
HIV and STIs among people who are returning to the community from correctional settings. START has been adapted over the last 
several months for use with individuals who have been released into the community after being involved with the criminal justice 
system (i.e. spending time in a correctional institution or on probation or parole). START originally was designed to have 6 sessions: 
two with inmates before release from jail and 4 in the community after release. The modified version of START consists of 4 
intervention visits that all take place in the community. 
 
START core components: (1) Hold pre- and post-release program sessions with clients transitioning back to the community from a 
correctional setting; this component has been modified to included individuals who have been criminal justice involved in the last thirty 
days who are living in communities covered by our project; (2) Use a client-focused incremental risk reduction approach; (3) Use 
assessment & documentation tools to provide structure; (4) Hire program staff that are familiar with HIV/STIs/HCV prevention and with 
the specific needs of people being released; (5) Staff /client relationships must be maintained post-release; in the case of those 
individuals recruited from the community the relationship must be built and maintained in the community setting; (6) Conduct enrollment 
and schedule four intervention visits in the community over the span of 3 months that: a. give HIV/STI/HCV information; b. review 
client’s HIV/STI/HCV risk; c. identify transitional needs; d. develop a personalized risk reduction and transitional plan; e. make 
facilitated referrals; (7) Schedule four post-release sessions, or for those enrolled in the community, post-enrollment sessions, to 
review and update the risk reduction/transitional plan(s) and provide facilitated referrals; (8) Provide fentanyl education, asking 
participants to watch a 4-minute educational video for FTS cited in previous research and available on YouTube at 
https://www.youtube.com/watch?v=gIovAAV-Amg, assess fentanyl knowledge through a quiz (attached), and provide fentanyl test 
strips at the first post-release session or for those enrolled in the community, the first post-enrollment session; and, provide fentanyl 
test strips and condoms at each subsequent post-release session or for those enrolled in the community, post enrollment sessions; 
(9) Actively maintain contact with clients. 
 
START supports incremental risk reduction and transitions through motivational interviewing (MI) and facilitated referral. Aligned with 
harm reduction principles, MI is a non-confrontational approach that encourage thoughtful reflection on personal drug use, sexual 
relationships, and their consequences in the context of personal values and goals; it is an evidence-based approach to engage clients 
in their own ongoing process of change. In a facilitated referral, intervention staff are far more involved in connecting participants to 
services than is typical. Rather than simply handing a participant a pamphlet, in facilitated referral staff have already identified a specific 
contact at the referring agency, and may actively set up appointments for participants with this individual; in addition, they may organize 
transportation to and from the appointment, as needed. 
 
CARE2HOPE’s enhancements to START 
We will modify START a priori as follows: 
1) Though originally designed for young men, START has been successfully applied to women leaving correctional settings. We will 
implement START with all genders. 
2) START’s post-release sessions primarily occurred in homes and community venues, such as restaurants. Staff who will deliver 
START will be stationed at UK-leased space within or near the local department of health (DOH) and/or virtually. 
3) To enhance START’s impact on drug use and HIV/HCV-related harms (e.g., IDU frequency), we will integrate the NIDA Standard 
HIV intervention into START, including rapid HIV and HCV antibody testing and counseling. The NIDA Standard has been 
demonstrated to reduce drug use frequency, high-risk injection practices, and sexual risk. 
4) START was not designed to reduce overdoses. We will provide an education video, How to Use Narcan (Naloxone), developed by 
the University of Kentucky HEALing Communities Study Team. Participants will receive naloxone, at their baseline visit or their first 
52439 

Section 11 Page 8 of 23
 
intervention visit for those recruited in the jail.. Interventionists will encompass OD in risk reduction MI. Additional naloxone will be given 
to give participants in the event that they use/lose their Narcan, enter treatment, then leave treatment and have no Narcan. 
 
The project will start with the first intervention visit once someone is released or, for those recruited in the community, after their 
baseline surveys and biological testing for HIV, HCV and drug screen have been completed, followed by 3 more intervention visits, at 
1 month*, 2, and 3-months* (*in person, others by phone, unless in-person is needed). These sessions are described in detail below. 
 
Pre-release Enrollment and Assessment (Session 1) 
 
After recruitment (described above, see Jail Handout attached) and screening (described in sections above, Screening Survey 
attached in Data Collection section), we will conduct a one-on-one session to go through the consent process (described above) and 
conduct participant intake. To strengthen participant confidentiality, this session will take place in the Attorney/Client room in each jail 
and at the local REHN office for those recruited from the community. The Attorney/Client rooms provide privacy, and no correctional 
officers are allowed inside. CARE2HOPE staff use these rooms to conduct interviews with incarcerated survey participants in the 
current IRB-approved protocol (#43520). These rooms have a video camera (but no audio recorder), and staff have been trained to 
ensure that the participant’s back is to the camera. In rare circumstances, this first meeting may be held in the community for those 
who were incarcerated at screening, if the individual leaves shortly after the recruitment session. The goals of this session are: 
(1) To complete the consent process and enroll the individual in the study; complete the locator form to assist with follow-up; and set 
up the post-release appointment or baseline 2 appointment for those recruited in the community. The consent is described in sections 
above. The locator form is described in the data collection section. At the close of the session, the second session will be scheduled 
and the participant will be given an appointment card (see attachments, post-release appointment card) with the appointment date, 
location, time, and staff contact information. The card will also be provided in a sealed envelope to jail staff so that they can place it 
with the individual’s personal effects that they receive upon release. 
 
(2) To conduct risk-reduction planning: The participant will complete START’s risk reduction assessment (see Risk Assessment 
appendix), which assesses knowledge of and engagement in drug and sexual risk behaviors. Based on this assessment, the REHN 
will work with the participant to develop a risk-reduction plan. The REHN will use diverse counseling microskills (reflective listening, 
affirmations, summaries) to build rapport and highlight possible directions for change. Participants will be administered the NIDA- 
modified ASSIST (NIDA, 2009) to measure high risk opioid use, including injection and OUD, prior to entering jail; we have used this 
measure in our team’s other NIDA-supported studies in jails (R01DA033866, R34DA045856, PI: Staton); see NIDA ASSIST 
appendix. The participant and the REHN will then set risk-reduction goals that are attainable, and create a plan for attaining those goals 
and strategies to overcome related barriers. 
 
(3) To deliver OD prevention intervention: Given the high risk of OD post-release, participants will watch an educational video. When 
allowed by jail leadership, naloxone will be provided to jail staff to include with the participants’ CARE2HOPE appointment reminder 
and personal effects upon release (i.e., so that it is immediately available rather than the participant having to wait until the first in- 
person visit to receive it). Naloxone will be provided to participants recruited in the community at their baseline visit. All participants will 
receive a handout describing Good Samaritan & Naloxone Laws in Kentucky. 
 
(4) Next, the participant will complete a transitional needs assessment to identify immediate release challenges. The REHN will work 
with the participant to create a transitional plan to address critical life needs at re-entry, such as housing and food; and, for those 
recruited in the community, challenges they have faced since release. A risk and needs assessment will be completed to create a 
transitional plan identifying needs and resources the participant deems most important. After the session, the REHN will initiate the 
process of linking the participant to needed services. Efforts will include contacting known individuals at relevant agencies to learn if 
slots are available, re-confirm eligibility criteria, and reserve a slot if possible; the REHN may need to develop new relationships at new 
agencies. 
 
Pre-release Assessment (Session 2) 
During this session, the REHN will meet with the participant in the Attorney/Client room to complete the baseline survey (Part 2). 
Depending on the participant's release date, this visit might take place post-release. For those recruited in the community, the baseline 
sessions will take place in the REHNs office. 
 
Post-release, DOH-centered Session 
 
REHN staff will monitor public jail logs to determine when a participant is released from jail. After the participant is released from jail, 
per START protocols and following locator procedures approved by the UK IRB in Protocol #43520, the REHN will remind participants 
of each upcoming meeting, via text message, Facebook messenger, or phone (depending on the participant’s preference, per the 
locator form). The purposes of this first, in-community session are to: 
 
(1) Conduct the HIV and hepatitis C education following the NIDA Standard Intervention protocol, with HIV and HCV testing and 
counseling. The NIDA Standard is a single-session structured, evidence-based intervention designed to educate high-risk PWUD 
about HIV/HCV and encourage adoption of safer practices. It includes rapid HIV and HCV testing, and includes education on HIV/HCV 
transmission, identifying risk behaviors and risk reduction; and the importance of referrals to treatment, and has evolved to suit 
incarcerated populations. Following currently approved CARE2HOPE protocol (#43520) for survey participants, participants can opt 
into or out of HIV and HCV testing. Testing and counseling protocols will be identical to those currently approved in the CARE2HOPE 
protocol (#43520) and are described in the Data Collection section below. People recruited in the community will receive testing as 
part of the baseline visit. 
 
(2) Provide harm reduction materials: The REHN will distribute naloxone (unless provided in jail to be distributed with personal effects 
upon release; see above), fentanyl test strips, and condoms. 
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Section 11 Page 9 of 23
 
(3) Connect with DOH services: A great strength of the proposed intervention is that, as noted, many services – often including SSP – 
are available on site at each DOH. The REHN will review the wide range of services offered by the DOH that might be relevant to the 
participant or their family. For each needed DOH service, including SSP, the REHN will walk the participant down the hall to meet 
relevant DOH staff to learn about the service. Participants will also be linked to DOH staff who can provide confidential, on-site testing 
for chlamydia, gonorrhea, and syphilis. Study staff will not have access to the results of DOH testing and services. 
 
(4) Create the risk-reduction plan and the transitional plan. Goal sheets and risk reduction plans (for SUD, HIV, HCV, and ODs) will be 
created to assess risk behaviors and needs and identify current concerns which will be assessed and ranked. Plans and Goal Sheets 
will be revised as needed. If the participant is on probation or parole, the REHN will review the supervision document with the 
participant to learn its stipulations (e.g., no buprenorphine, no positive tests for any illegal drug). As proposed by the START manual, 
this document will become a part of the participant’s weighing of advantages and disadvantages of particular post-release risk 
reduction and transition strategies. Consistent with START’s harm reduction philosophy, the REHN will work with the participant to 
determine the level of support needed to connect successfully to health and social services. Some may be comfortable contacting 
programs independently; others may need the REHN to make the appointment on their behalf and/or to organize or provide 
transportation. 
 
(5) Connect with medication for opioid use disorder: Individuals who express interest in medication for opioid use disorder (i.e., 
buprenorphine, methadone, and/or extended release naltrexone) will be referred to local providers for services, including pharmacies. 
In intervention counties, CARE2HOPE has partnered with the Kentucky Opioid Response Effort (KORE) to support pharmacy-based 
extended-release naltrexone (i.e., Vivitrol) administration under the leadership of College of Pharmacy faculty member, Dr. Patricia 
Freeman. Pharmacy-based Vivitrol administration is currently within the authorized scope of practice for pharmacists in Kentucky. 
However, few pharmacies in the state offer it. Dr. Freeman and her colleagues are currently funded by the KORE to offer technical 
assistance and support to pharmacists interested in initiating Vivitrol administration in their pharmacies. Dr. Freeman and KORE have 
agreed to include CARE2HOPE counties as a target area for training and technical assistance and to do so in a sequence/timing that 
aligns with the timing that counties are randomly assigned to the intervention group. This effort will improve the capacity of pharmacists 
to provide Vivitrol to everyone in the community, including to those involved in CARE2HOPE. 
 
At the end of this session, the next visit will be scheduled, and the locator form reviewed and updated. 
Post-release Month 1, Month 2, and Month 3 Sessions 
The 1 month and 2 month sessions will take place in-person. The REHN will review the participants risk reduction plan, troubleshoot 
issues the participant has been having with completing their goals and the risk reduction plan will be revised as needed. The Month 3 
session will be in person, as well, to facilitate troubleshooting, data collection, and urine testing. Reminders will be sent as described 
above for the first intervention session. The Month 3 session will be in person, as well, to facilitate troubleshooting, data collection, and 
urine testing. Reminders will be sent as described above for the first post-release session. These sessions will be used to monitor 
and enhance the implementation of the risk reduction plans. The REHN will partner with the participant to consider progress and alter 
plans, as needed. Specifically, the REHN and the participant will: (1) Review and revise the risk reduction and transitional plan together; 
and (2) Discuss and address facilitators and barriers to implementing the risk reduction and transitional plans, and connect to services 
as needed. The REHN will provide fentanyl test strips and condoms during in-person sessions. 
 
Comparison Condition 
 
We will initiate the comparison group in each county six months before the intervention begins. The current “treatment as usual” 
condition for most individuals, especially individuals not entering parole/probation supervision, is to provide no post-release services. 
Given the high risk of overdose post-release, we will conduct a pre-release overdose intervention with the comparison cohort. 
Individuals recruited in the community will receive overdose education during their baseline visit as well. Overdoses are not a primary 
study outcome, and it would be unethical to withhold overdose education from this cohort. Six months before the intervention starts in a 
county, REHNs will use the same pre-release recruitment, consent, and enrollment protocols (including eligibility criteria, except 
individuals must live in counties that are currently randomized to the comparison group) as proposed for the intervention condition. As 
with START’s original evaluation, we will administer a single session, pre-release intervention for the comparison group; if someone is 
recruited in the community, they will receive this visit as well. . Specifically, the comparison group participants will complete the a 
training with people demonstrating how to respond to an overdose and narration on preventing, recognizing, and responding effectively 
to an opioid OD, accompanied by information about Kentucky’s Good Samaritan Law and Naloxone Access Law. REHNs will answer 
questions after the video. Individuals will receive a Community Resource Guide at this visit. 
 
As in the intervention group, comparison group participants will complete assessments at pre-release (two sessions), for those 
recruited in the community this will happen at the REHNs office, and at 3 months and 6 months weeks post-release (post-enrollment 
for those recruited in the community). Surveys will be identical to those delivered to the intervention cohort, as will incentives. No 
interventions will be delivered at these follow up appointments. Retention efforts for comparison participants will be identical to those 
for intervention participants (described previously). 
 
COVID-19 Policies 
Pre-Release Assessment (Session 1). We will work closely with each jail, providing them with a stack of Pre-Release Assessment 
packets. If an individual is eligible, agrees to participate in the project, and provides verbal consent, the REHN will move immediately to 
the Pre-Release Assessment (Session 1). If time does not permit, then the REHN will work with the jail staff to reschedule this 
session. During this assessment, the REHN will: 
1) Read the script designed to build rapport with the participant given the session will be less personable than an in-person session. 
2) Complete the Baseline Part 1 survey. 
3) Share the How to Use Narcan (Naloxone) Educational Video. For phone interviews, the REHN will read aloud the Care2Hope Narcan 
52439 

Section 11 Page 10 of 23
 
Patient Brochure and answer any questions the participant might have. This pamphlet is new and provided in all attachments. The 
REHN will explain to the participant that, at their first in-person meeting, the REHN will play the How to Use Narcan (Naloxone) 
Educational Video 
4) Read the Good Samaritan Law document and answer any questions the participant might have. 
5) Complete the Locator Form with the participant. 
6) Schedule the second Pre-Release Assessment within 7 days of the first assessment. 
Following the session, The REHN will work with jail staff to let them know which individuals need the Pre-Release Assessment packet. 
Jail staff will add the packet to the participant’s personal belongings. The packet will include the following: 
• A business card with the contact information for the REHN on it with a note letting the participant know that they should contact the 
REHN to set-up their post-release visit and to get their incentive card mailed to them if they elected to not get their incentive placed on 
their commissary. 
• How to use Narcan (Naloxone) Patient Brochure 
• Good Samaritan Law Handout 
• Resource guide 
• How to Use your Incentive Card Handout 
• Certificate of Confidentiality One-Pager 
 
Pre-Release Assessment (Session 2). During this session, the REHN will complete the Baseline Part 2 survey with the participant via 
Zoom or by phone. 
 
All post-release sessions including completion of surveys may be held via phone due to polices related to the COVID-19 pandemic. 
Phone calls may be conducted through Facebook Messenger if the participant provided permission to be contacted by Facebook 
Messenger on the locator form. We will message individuals to set-up their follow-up appointment and in the message, ask their 
permission to conduct the follow-up interview via Messenger. We will only conduct phone (or video) interviews via Messenger if 
permission is provided and we will update their locator form. The locator form is routinely updated either in-person or by phone. The 
REHN may conduct these phone sessions remotely in the privacy of their home or in their office depending on current COVID-19 
policies at the time of the session. If the session is conducted remotely, the REHN will conduct all activities in a private space, using 
their UK cell phone, laptop, and earbugs (or some other type of headset) and the study participant will also be in a private setting of 
their choice. The REHN will ask the study participants to answer a short security assessment at the time he/she schedules the session 
to ensure the individual is a study participant (see attachment in data collection section). If the individual does not answer all questions 
correctly, the REHN will not continue. If the individual answers all questions correctly, additional questions will be asked. These same 
questions will be repeated at the time of the phone session, confirming the identity of the study participant based on the initial 
responses provided. 
 
Follow-up sessions including completion of surveys may take place in the jail via Zoom. We will host the interview using UK Zoom, 
which is HIPAA compliant. We will work closely with jail staff responsible for coordinating Zoom sessions to schedule the interview and 
to ensure the following: 
• A confidential space will be available. 
• A unique Zoom meeting ID will be provided to jail staff when the interview is scheduled. 
• The waiting room feature will be enabled prior before the participant joins the session. 
• The participant will join with video so study staff can confirm the individual’s identity; once confirmed, the video will be disabled. 
• At the start of the session, the participant will confirm that they are in a confidential space, free of foot traffic and feel comfortable 
completing the interview. If these criteria are not met, study staff will end the session. The participant will be encouraged to follow-up 
with study staff once released from jail. If all criteria are met, prior to starting the interview, study staff will inform the participant how 
confidentiality will be protected via Zoom, for example, using UK Zoom, which is HIPPA compliant and that the waiting room will be 
enabled during the interview. There is a chance that jail staff could be close to the confidential space and potentially overhear so we 
cannot guarantee confidentiality completely. 
 
Retention efforts are described in the data collection section. In addition to the locator form, we will also send reminder letters to study 
participants, reminding them about follow-up appointments or to contacts provided by study participants. Letters for phone calls due to 
COVID-19 and for normal operations are attached. We will distribute flyers in varied locations in the community as reminder that study 
participants are eligible for follow-up surveys as an additional strategy to ensure retention. 
 
6/28/22 Modification: As noted in the data collection section, we will drop the 6-month follow-up surveys for newly recruited participants 
once approved by the IRB. 
 
CQI 
We will collect data via 1:1 interviews using semi-structured interview guides. All interviews will be conducted over Zoom or Facebook 
Messenger with participants located in a private area of their choosing. The participants who cannot secure a private area for the 
interview will have an option to attend the online interview from one of the study offices following COVID-19 safety protocols. We will 
not record participants’ names or other personal identifiers (except for voice recording). All interviews will be audio-recorded and 
transcribed verbatim. To ensure confidentiality of REHN data, the interviews with REHN staff will be conducted by Graduate Research 
Assistants, Emory; the study leadership and management team (Cooper, Young, White and Lane) will not have access to REHN 
interview transcripts. Interviews with the pharmacists and intervention participants will also be conducted by Graduate Research 
Assistants, Emory. The interviews will take about 60 to 90 minutes. There will be no follow-up with the participants. The audio- 
recordings will be stored at encrypted and password-protected computer network until the end of CAER2HOPE study and then will be 
deleted. 
Participant interview guide: we are expanding the interview domains covered to include the perceived effectiveness of the intervention. 
These qualitative data will complement quantitative data on intervention effectiveness, by illuminating perceived pathways through 
which the intervention might (or might not) have worked, and also allow us to explore participant perceptions of effectiveness. The 
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Section 11 Page 11 of 23
 
 
 
52439 
revised guide is attached (data collection section). 
 
Attachments  
Attach Type 
File Name 
 
ResearchProcedures 
Participant Notification Text 033022.pdf 
ResearchProcedures 
Recruitment Email Text and Phone Scripts 020422.pdf 
ResearchProcedures 
Screener 081721 - Clean.pdf 
ResearchProcedures 
Fentanyl Quiz 061521.pdf 
ResearchProcedures 
Naloxone Brochure 120420.pdf 
ResearchProcedures 
Intervention Individual Risk and Needs Assessment 111820.pdf 
ResearchProcedures 
Rapport Script.pdf 
ResearchProcedures 
C2H Retention Flyer 061020 - Clean.pdf 
ResearchProcedures 
C2H Retention Flyer 061020 - PR Approval.pdf 
ResearchProcedures 
Pre-Appointment (Normal Operations).pdf 
ResearchProcedures 
Pre-Appointment (phone).pdf 
ResearchProcedures 
Missed Appointment (Normal Operations).pdf 
ResearchProcedures 
Missed Appointment (phone).pdf 
ResearchProcedures 
Letter to Contact (Normal Operations).pdf 
ResearchProcedures 
Letter to Contact (phone).pdf 
ResearchProcedures 
Recruitment Presentation Text 031820 - Clean.pdf 
ResearchProcedures 
Recruitment Letter - Personalized for G2H.pdf 
ResearchProcedures 
Jail Handout Good Samaritan and Naloxone Laws - Clean.pdf 
ResearchProcedures 
recruitment letter.pdf 
ResearchProcedures 
Jail Handout - PR Approval 101719.pdf 
ResearchProcedures 
Jail Handout - PR Clean 101719.pdf 
ResearchProcedures 
NIDA Modified ASSIST.pdf 
ResearchProcedures 
Pre-release Appointment Card.pdf 
ResearchProcedures 
Post-release Appointment Card.pdf 
 
Data Collection & Research Materials 
 
In this section, please provide the following: 
 
Describe all sources or methods for obtaining research materials about or from living individuals (such as specimens, records, 
surveys, interviews, participant observation, etc.), and explain why this information is needed to conduct the study. 
For each source or method described, please list or attach all data to be collected (such as genetic information, interview scripts, 
survey tools, data collection forms for existing data, etc.). 
If you will conduct a record or chart review, list the beginning and end dates of the records you will view. 
 
Process data tracked by staff: Fidelity will be assessed through the Project Manager who will review case notes for 10% of randomly 
selected sessions. Reach will be assessed calculating the percent of eligible individuals who enroll (e.g., the # enrolled divided by the 
number of individuals who screen eligible for START-C2H). Dose will be assessed by calculating the percent of START-C2H sessions 
attended. START-C2H’s immediate impact will be assessed via the START-C2H participants’ survey data (described below) to assess 
immediate impacts on linkage to services. 
 
Survey administration: START-C2H comparison condition and intervention participants will complete longitudinal data collection at pre- 
release session 1 (baseline part 1), at pre-release session 2 (baseline part 2) within 7 days of session 1, three months post-release, 
and 6 months post-release. Longitudinal data collection will be completed in the community for those recruited in the community. 
Baseline survey data will be collected in the jail or community (session 1) after enrollment and consent, in jail or community (session 2) 
within 7 days of session 1. Sections of the baseline survey will be repeated at START-C2H’s in-person session, post-release or post- 
enrollment for those recruited in the community, including at 3-month session and in-person 6-month session, to assess change over 
time. Participants will complete surveys using computer assisted personal interviewing (CAPI); CAPI has been used previously in jails 
(and outside of jail) to assess START and is effective with low-literacy populations. In CAPI, the survey is displayed to study staff on a 
computer screen and the computer program lists the questions and responses and the study staff reads them aloud to the participant 
in person or by phone. We will use timeline follow-back methodology to improve participant recall (see attachment, Timeline Follow 
Back, for example of how this method is applied). To avoid social desirability and other forms of reporting bias, portions of the survey 
will be administered by an off-site staff person (i.e., rather than by the participant's re-entry health navigator) via UK's HIPAA-compliant 
instance of the web-conferencing platform called Zoom. Zoom is a cloud-based platform for video and audio conferencing, 
collaboration, chat, and webinars across mobile devices, desktops, telephones, and room systems (similar to Skype). UK supports 
two instances of Zoom -- one that is HIPAA compliant and one that is not HIPAA. UK has a signed Business Associate Agreement, 
providing a separate instance of Zoom that is HIPAA compliant. Data collection is possible as Zoom users can share their screens. 
Study staff will open a copy of the survey via Zoom, allowing a participant to view and answer questions orally while the staff member 
records the answer. Administration of the survey will take place in a private room to ensure privacy and confidentiality of data. 
 
Survey content: Prospective participants will complete a screening survey (described above, see Screening Survey attached) to 
determine eligibility. Surveys (see START-C2H Survey appendix) will capture the following domains: (1) sociodemographic 
characteristics; (2) all possible behavioral targets; and (3) health and social service engagement. The survey will closely resemble that 

Section 11 Page 12 of 23
 
used in the currently approved CARE2HOPE study under IRB protocol #43520. Of note, the survey instructions will clearly indicate 
that time periods at baseline refer to time before incarceration and, when repeated for follow-up visits, recall periods will be adjusted 
accordingly (i.e., language referring to lifetime or past 6 month behavior will be changed to past 3 months). Surveys will take 45-60 
minutes to complete (survey administration methods are described above). 
 
Drug screening: We will conduct Urine or saliva drug Screens at the 1-week, 3-month, and 6-month appointments. We will not conduct 
drug screening in the jail. As in CARE2HOPE UG3 phase (Protocol #43520), we will use HomeHealth’s iCup Drug Test that tests for 
13 drugs including opiates (heroin and morphine), buprenorphine, methadone, oxycodone, as well as various stimulants, sedatives, 
and other drugs. For saliva test, we will use SalivaConfirm (TestCountry, San Diego, CA) drug screening kit that detects 10 types of 
illicit drugs in the sample in 10 minutes. 
 
HIV Testing: The REHN will conduct HIV testing using the rapid-rapid protocol approved for HIV surveillance and confirmatory testing 
by the state health department and CDC. Participants will be tested using rapid INSTI HIV 1/HIV 2 Rapid AntibodyTest (bioLytical 
Laboratories, USA), which is a 60-second immunoassay for the detection of HIV-1 and HIV-2 antibodies in blood obtained from finger 
stick (sensitivity: 99.6, specificity: 99.3) followed by confirmatory re-testing with the Sure Check® HIV-1/2 Antibody Test (ChemBio 
Diagnostic Laboratories, Medford NY) on blood obtained from finger stick (sensitivity: 99.8, specificity: 99.9). When a participant tests 
HIV positive on BOTH of the rapid tests, they are considered to be confirmed as HIV positive and therefore require reporting to the 
state health department. Participants are informed of this reporting requirement and procedures involved in a case investigation in their 
informed consent form. Upon a positive test, we will complete the KY DPH’s HIV Case Report form found here: 
http://chfs.ky.gov/NR/rdonlyres/36B936F0-AD69-4B95-83A7-FE4E37201364/0/AdultCaseReportForm2016.pdf. We will fill in the 
participant’s name and contact information, information about our facility, participant demographic data, residential data, risk behavior 
data, treatment history, and testing history. We will not complete the section describing children of the participant. The REHN will 
complete a facilitated referral to their district Ryan White Part B HIV care coordinator for participants who test positive on both tests. 
More detail about safety precautions and referrals are described in sections below. 
 
HCV testing. REHNs will use the OraQuick® HCV Rapid Antibody Test (OraSure, Bethlehem, PA), a 20-minute indirect immunoassay 
test to detect HCV antibodies in blood from fingerstick. Participants who test positive for HCV will be referred to UK Kentucky Clinic 
Digestive Diseases and Nutrition (859-323-0079) or St. Claire Regional Medical Center in Morehead, KY or encouraged to visit their 
primary care doctor for confirmatory (HCV RNA) testing. 
 
Locator form. The locator form shown in the Locator Form Appendix (attached) is identical to the existing CARE2HOPE locator form 
approved under IRB protocol (#43520). The form is a strong retention tool tailored to this population. This form queries contact 
information for the participant and multiple key network members, and seeks consent to contact network members as needed. 
Participants can opt into using Facebook messenger for retention contacts. Our locator form asks participants to indicate whether they 
give permission for us to contact them via private messenger on social media (i.e., Facebook messenger) and IRB-approved 
language informing participants about privacy issues surrounding the use of social media. Additionally, we will use the locator form to 
obtain limited contact information from individuals from the community who screen eligible and are interested in participating in the 
study. We will only obtain their phone number, an alternate phone number, and social media information to ensure we can reschedule 
individuals who do not show up for their first appointment. The locator form will be completed in REDCap. We will attempt to reach an 
individual once a week for four weeks; if we cannot reach them after four attempts, we will delete the record in REDCap. 
 
COVID-19 Policies. 
We will offer all participants in the intervention arm HIV and HCV testing. Research staff will perform testing as described above in the 
office. However, if a participant prefers, we will help them perform the test using a self-test kit, or we we will make a referral to a local 
health department. 
 
Testing is offered in the local health departments through UK’s Kentucky Income Reinvestment Program (KIRP) with UK staff based at 
the health departments. The Kentucky Cabinet for Health and Family Services' Department for Public Health and UK established KIRP 
to improve health care delivery via disease education, prevention, treatment and professional services for persons living with HIV 
through collaborations with existing Ryan White HIV/AIDS funded programs and harm reduction programs at local health departments. 
Testing is offered through collaboration with the harm reduction programs. 
 
For participants who prefer to test themselves, we will offer home-based (self-test) HIV and HCV testing and drug screening to be 
completed in-person at the study office. If the participant does not feel comfortable coming to the office or all research activities are 
remote only due to COVID-19 restrictions, we will offer to meet the participant at a mutually agreed-upon location or their home to 
complete home-based (self-test) HIV and HCV testing. 
 
For home-based (self-test) HIV testing we will use FDA-approved OraQuick In-Home HIV Test (OraSure Technologies, Inc., 
Bethlehem, PA) that tests for HIV antibodies in human saliva (gum swab) with 91.67% sensitivity and 99.9% specificity, with results 
ready in 20 minutes. For home-based (self-test) HCV testing we will use EverlyWell HCV human antibody test (Everlywell, Inc., Austin, 
TX), which requires finger stick to obtain blood for a dry spot sample that will be mailed to a laboratory for processing. Both sensitivity 
and specificity for this test are above 99%. We will conduct saliva drug test using SalivaConfirm (TestCountry, San Diego, CA) drug 
screening kit that detects 10 types of illicit drugs in the sample in 10 minutes. 
 
After the baseline survey, if the participant does not feel comfortable coming to the office or all research activities are remote only due 
to COVID-19 restrictions, the REHN will meet the participant at a mutually agreed-upon location or at their home. The REHN will bring a 
biological test kit (HIV, HCV and drug tests) and harm reduction kit (nasal Naloxone spray, Naloxone brochure, Good Samaritan and 
Naloxone Laws, resource guide, information on incentive card and Certificate of Confidentiality). The REHN will drop the package off at 
the participants’ home (placing the kit on a porch or car hood to permit social distancing) or will meet at a mutually agreed-upon location 
that is safe, following social distancing rules to avoid COVID-19 exposure for participants and staff. If the REHN is conducting 
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Section 11 Page 13 of 23
52439
HIV/HCV testing, the REHN will conduct pre-test HIV/HCV counselling over the phone. The participant will be asked to collect 
biospecimens (oral swabs for HIV and drug testing, finger stick for HIV testing) in their home or at a in a mutually agreed-upon location 
that is safe (e.g. a gas station restroom or in their car). The participant will provide the completed test kits to the REHN following social 
distancing rules (e.g., placing the completed kits on their porch or the REHN’s car hood). The drug test and HIV test will be read by the 
REHN, while HCV test will be sent to a lab for processing. If HIV or HCV tests are positive, the participant will be referred to the 
Department of Health for confirmatory testing.
During 3-month and 6-month data collection waves we will conduct drug screening only, so the REHN will bring drug screening kit only. 
CQI
Interview guides for the qualitative interviews are attached.
6/28/22 Modification: We will drop the 6-month survey for newly recruited participants once approved by the IRB.
Attachments
Attach Type
File Name
DataCollection
Qualitative Interview Guide 040222 - Pharmacist.pdf
DataCollection
Qualitative Interview Guide 040222 - REHN.pdf
DataCollection
Baseline Survey Part 1 081721 - Clean.pdf
DataCollection
Baseline Survey Part 2 081721 - Clean.pdf
DataCollection
3 Month Survey 051021 - Clean.pdf
DataCollection
6 Month Survey 061121.pdf
DataCollection
Locator 031821 - Clean.pdf
DataCollection
Security Assessment 111820 - Clean.pdf
DataCollection
Timeline Follow-Back.pdf
DataCollection
Script for Rehab and Others Facilities 013120.pdf
DataCollection
Qualitative Interview Guide 062822 Participants - Clean.pdf
Resources
Describe the availability of the resources and adequacy of the facilities that you will use to perform the research. Such resources may 
include:
Staffing and personnel, in terms of availability, number, expertise, and experience;
Computer or other technological resources, mobile or otherwise, required or created during the conduct of the research; 
Psychological, social, or medical services, including equipment needed to protect subjects, medical monitoring, ancillary care, or 
counseling or social support services that may be required because of research participation;
Resources for communication with subjects, such as language translation/interpretation services.
Potential Risks & Benefits
Risks
Describe any potential risks – including physical, psychological, social, legal, ability to re-identify subjects, or other risks. Assess 
the seriousness and likelihood of each risk.
Which risks may affect a subject’s willingness to participate in the study?
Describe likely adverse effects of drugs, biologics, devices or procedures participants may encounter while in the study. 
Qualitative research - describe ethical issues that could arise while conducting research in the field and strategies you may use to 
handle those situations.
Describe any steps to mitigate these risks.
Benefits
Describe potential direct benefits to study participants – including diagnostic or therapeutic, physical, psychological or emotional, 
learning benefits. This cannot include incentives or payments.
State if there are no direct benefits.
Describe potential benefits to society and/or general knowledge to be gained.
Describe why potential benefits are reasonable in relation to potential risks. If applicable, justify why risks to vulnerable subjects are 
reasonable to potential benefits.

Section 11 Page 14 of 23
 
The procedures to be used by this study will involve conventional social science research methods that are routine in studies of this 
type. The potential psychological risks will be discussed with participants to assist them in making an informed decision as to whether 
they wish to participate in the survey. These potential psychological risks are primarily related to being asked questions in the surveys 
about illegal behaviors that they do not feel comfortable answering. There is also a risk that there may be a breach of confidentiality of 
their survey. Every effort will be taken to ensure that this does not happen. No files – hard copy or electronic – will be stored in the jail. 
REHN records for client sessions will be completed and stored in the research field office. Confidentiality issues will be stressed 
during informed consent, which will include the description of a federal Certificate of Confidentiality, which provides an additional layer 
of human subject protection. Participants will also be assured that their survey answers will not be made available to any representative 
of the jail or criminal justice system. 
 
Of note, the KY Department of Corrections does require that all incarcerated individuals complete a general DOC consent form 
granting permission to participate in research and require that a copy of that consent form be deposited with the KY DOC 
headquarters. To protect participant confidentiality and avoid revealing to DOC staff who screened eligible and participated, we will 
administer the DOC consent form to all individuals attending the study overview session, rather than only to those who screen eligible. 
Therefore, jail officials and administrators will not be able to decipher which participants screened eligible, participated, or refused to 
participate. It is possible, that a study participant may experience anxiety, emotional distress, or other negative reactions due to the 
content of the screening questions. Based on our experiences working with this population, such occurrences are rare. However, with 
the participant’s permission, they will be referred to the medical staff at the jail for additional help and support related to psychological 
distress. The Community Resource guide also contains information on mental health and substance abuse services in the community. 
 
Potential psychological risks will be communicated during the informed consent process to help people make an informed decision as 
to whether they wish to participate. Some participants may be uncomfortable about discussing drug-related health concerns, social 
service needs, and related goals with REHNs; connecting with services at unfamiliar agencies may also be challenging, particularly if 
staff at those agencies stigmatize them for their substance use disorder. They may also be uncomfortable answering personal 
questions about stigmatizing and in some cases illegal behaviors (drug use, condomless sex), health outcomes (ODs, HIV, HCV), and 
PWUD-related healthcare service use. If these data, or data on the results of the urine test administered at baseline, were accessed 
by people outside of the study, the participant could experience legal actions, social stigma, or other social sanctions (e.g., job loss). 
The START intervention may also cause distress, as participants seek to reconcile goals with realities, and discuss personal sexual 
and drug-related behaviors. In addition, individuals who test positive for HIV or HCV may experience considerable distress. If 
confidentiality were breached, participants may experience stigma, lose their job or housing, or be ostracized. 
 
Participants in the intervention group will receive the nasal spray naloxone (Narcan) to carry with them in case they encounter someone 
who has an opioid overdose or in case they have an opioid overdose and a friend can use the naloxone to respond. Additional 
naloxone will be given to participants in the event that they use/lose their Narcan, enter treatment, then leave treatment and have no 
Narcan. Research staff will show a short video that shows how to use the naloxone kit and perform rescue breathing. Research staff 
will answer questions and will provide a handout explaining how to use it and possible side effects (see attached Naloxone handout; 
note: this is the same handout approved by Kentucky Pharmacists Association for use by pharmacists when distributing naloxone). In 
the consent form, participants are informed that naloxone temporarily reverses the effects of opioid overdose and is not a substitute 
for emergency medical care and that they should call 911 if they witness an overdose. They are also informed that naloxone can cause 
side effects, including but not limited to sudden opioid withdrawal symptoms and that the signs and symptoms of an opioid emergency 
can return after the nasal spray is given. They are also informed that naloxone only works on opioid-related overdoses and has no 
effect on people who are not using opioids. Witnessing an overdose can cause physical, psychological, or emotional problems such 
as anxiety or depression. If a participant administers naloxone, they may experience additional physical, psychological, or emotional 
problems because the naloxone effects may wear off and overdose symptoms could return, the person may experience side effects, 
and/or the person may become irritable or violent. These risks are explained in the consent form. In addition, the consent form 
explains that Kentucky’s Good Samaritan law is supposed to protect them from being charged or prosecuted for drug or paraphernalia 
possession if they call 911 because they witness an overdose and stay with that person. But in rare cases, law enforcement may arrest 
them if you have warrants for another crime or if they have a search warrant or if they are unfamiliar with the law. Participants are also 
informed that if people find out that they have naloxone, it might cause embarrassment and could hurt their standing with people in the 
community who have a negative attitude toward people who use drugs and/or toward naloxone. 
 
Comparison group: Protocols will be identical to those described for the intervention group, but the comparison group members will 
not take part in any intervention aside from the naloxone training, including HIV or HCV testing. Risks and benefits will be limited to 
those pertaining to data collection, as described above. 
 
Collection of Biological Specimens: The biological procedures to be used by this study will involve conventional medical research 
methods that are routine in studies of this type. The potential psychological risks will be discussed with participants during the consent 
process to assist them in making an informed decision as to whether they wish to participate in this part of the study. First, there is the 
potential for receiving a "false positive" on HIV/HCV testing. This potential is statistically remote because every positive HIV/HCV test 
result will be confirmed through a confirmatory test. Second, depression is likely when a subject receives a positive result. Similarly, 
there are emotional liabilities in some cases associated with receiving a negative test result (relief versus survivor's guilt). In either 
case, post test counseling will be provided and referral to the appropriate human service resources will be offered. The potential risks 
for a subject revealing her positive serostatus, or experiencing a breach of confidentiality, will also be discussed during post test 
counseling. These risks involve loss of employment or insurance, rejection by family or friends, and others. The immediate risks 
associated with the finger pricks and blood draw are slight pain and local bleeding at the site, and are comparable to those incurred 
during routine medical care. 
Intervention group participants: The proposed study has potential benefits. First, individuals will have opportunity to be screened for 
risk behavior including injection drug use and risky sexual activity and receive feedback on results. Second, the study REHN will share 
important prevention intervention information with high-risk PWUD during the transition from jail to the community with the overall goal of 
reducing risk behavior and increasing community service utilization. Third, participants will receive an interactive training with animated 
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Section 11 Page 15 of 23
Available Alternative Opportunities/Treatments
Describe alternative treatments or opportunities that might be available to those who choose not to participate in the study, and which 
offer the subject equal or greater advantages. If applicable, this should include a discussion of the current standard of care treatment(s).
Back to Top
Records, Privacy, and Confidentiality
Specify where the data and/or specimens will be stored and how the researcher will ensure the privacy and confidentiality of both. 
Specify who will have access to the data/specimens and why they need access.
Describe how data will be managed after the study is complete:
If data/specimens will be maintained, specify whether identifiers will be removed from the maintained information/material. 
If identifiers will not be removed, provide justification for retaining them and describe how you will protect confidentiality.
If the data/specimens will be destroyed, verify that this will not violate retention policies and will adhere to applicable facility 
requirements.
If this study will use de-identified data from another source, describe what measures will be taken to ensure that subject identifiers are 
not given to the investigator.
If applicable, describe procedures for sharing data/specimens with collaborators not affiliated with UK. 
For additional considerations:
Return of Research Results or Incidental Research Findings
HIPAA policies
FERPA policies
Procedures for Transfer agreements
Information regarding multi-site studies
NIH Genomic Data Sharing (GDS) Policy
Digital Data
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Section 11 Page 16 of 23
 
separate, double-password protected database on the secure HIPAA-compliant server at the UK College of Public Health and Rollins 
School of Public Health at Emory University. We will store handwritten notes recorded during the survey and signed consent forms in a 
locked filing cabinet in a locked office in the UK College of Public Health. Audio recorders will be wiped of audiofiles after data have 
been uploaded to the server; if participants mention specific people by name, we will delete this part of the recording prior to uploading 
it (unless it is a public figure); notetakers will not record names in their notes (except those of public officials). Participants will not be 
identified by name in analytic data files. Research data will be reported in aggregate form only. The study is protected by a federal 
Certificate of Confidentiality, which will protect the investigators from being forced to release any identifying data, even under a court 
order or a subpoena 
 
All staff will sign a confidentiality agreement, stating that they will not disclose information about participants to others outside the study 
team. 
 
Data sharing with the University of Washington Data Harmonization Coordinating Center (DCC) and within the Rural Opioid Initiative 
(ROI) consortium: Data from Kentucky CARE2HOPE are required to be submitted to the University of Washington as part of the NIH- 
funded Rural Opioid Initiative (ROI) data harmonization project. The University of Washington Data Harmonization Coordinating Center 
will be harmonizing data across 8 ROI studies in order to create new, harmonized datasets to be used for analyses across the 
consortium. The University of Washington and other ROI grantees will perform data analyses on these data for peer-reviewed 
publication. University of Kentucky and Emory investigators for this grant may be included as authors on manuscripts using these data. 
The harmonized datasets will be provided to other ROI grantees as required for analysis and will be considered under the umbrella of 
mandated DCC activities. 
 
Once data are at the DCC it will be harmonized with data from the other 7 NIH-funded ROI sites to create new, harmonized datasets to 
be used for analyses across the consortium. Both the University of Washington and other ROI grantees will perform analyses on 
harmonized data sets, but no third parties outside of the ROI will be given access to this harmonized data. Harmonized datasets will be 
built to specific project concept proposals (i.e. will contain only necessary and pertinent data elements), and all project proposals must 
be reviewed and approved by the ROI consortium's Publications Working Group before distribution of the customized dataset. 
 
All data submitted to the DCC will be de-identified with the exception of zip code, city name, and county of residence. The consent 
form specifes that identifying data will not be shared with other researchers with the exception of zip code, city name, and county 
residence (What Else Do I Need To Know Section). The consent also specifies that data will be shared with the University of 
Washington Data Coordinating Center. Data will be uploaded to the ROI Upload Server through a web interface. Access to the 
interface is controlled by usernames and passwords. Access is assigned to individual, designated ROI study staff by the University of 
Washington DCC. Staff are associated with their own studies only, and each ROI study may upload and manage its own data but is not 
able to view data from other studies. The web page uses the HTTPS protocol to transfer ROI data files securely to the Upload Server. 
HTTPS transfers are encrypted using Transport Layer Security (TLS, the successor to SSL), protecting the data enroute to the server. 
The Upload Server is managed in accordance with the DCC’s information security policies (https://uwcirg.github.io/hipaa-policies), and 
authorization for specific DCC staff is based on their project-related needs and responsibilities. 
 
We will also submit transcriptions for audio-recorded interviews to the DCC using the same protocol for transferring files securely. 
A Certificate of Confidentiality has been obtained from the National Institute of Health which, under federal law, prohibits all data 
collected during the course of a study protocol from being used in any legal or criminal proceedings. Participants will receive a copy of 
the consent showing the Certificate provisions and safeguards. 
 
All research data will be kept in locked file cabinets at the University of Kentucky College of Public Health in Office 211c at 111 
Washington Avenue. Each participant will receive a unique identifying number. All research data collection instruments will be identified 
by this number only. The master list matching identifiers to specific participants will be maintained in a double-password protected 
database on a server at the Center on Drug and Alcohol Research at the University of Kentucky. Research data will be reported in 
aggregate form only without names or identifying information. 
During interview and survey administration, should any participant feel uncomfortable answering any question, he or she will be free to 
abstain from answering that question or any other question. Likewise, participants can end their participation in intervention activities 
(e.g., START-C2H goal setting, or HIV testing and counseling) at any time, or choose not to engage in any component of the 
intervention they wish. 
 
All study staff will be trained in Human Subjects protocols and will have passed the appropriate Collaborative Institutional Training 
Initiative (CITI) exams on human subjects research. Research staff will not press participants to answer questions that seem to be 
distressing to them. During interview administration, should any participant feel uncomfortable answering any question, he or she will 
be free to abstain from answering that question or any other question. In addition, research staff will respond to participants who show 
or express psychological distress and/or suicidal or homicidal thoughts by following the procedure Distressed and Suicidal/Homicidal 
Participants that has been a standard operating procedure in previous NIDA-funded trials (e.g., R01 DA027068). To offset the risk of 
distress associated with the data collection, all participants who express an interest will be provided with an information sheet on local 
resources. The list of referral agencies will include mental health centers, substance abuse facilities and support groups, and 
counseling facilities. Participants will receive the name of the referral agency, location, telephone number, fee, if applicable, statement 
describing the agency and the work that they do. If participants wish, we will assist them to make contact with services; however, we will 
not disclose any information about participants to referral agencies. The consent document will also contain a statement informing 
participants that their name and contact information may be released without their consent to appropriate state authorities in instances 
that are required by state law (e.g., if they inform study staff that they are wanting to end their life or someone else’s life, or are abusing 
a child). Furthermore, a Certificate of Confidentiality has been granted to this study automatically (see 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html). Under the Certificate of Confidentiality, section 301(d) of the 
Public Health Service Act (42 U.S.C. 241(d)) prohibits all data collected during the course of a study protocol from being used in any 
legal or criminal proceedings. Participants will receive a copy of the NIH Notice NOT-OD-17-109 granting the Certificate of 
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Section 11 Page 17 of 23
Project START-C2H In-Jail Eligibility Screening, Consent, and Assessment: All participants who consent to participate and complete
Confidentiality if so requested.
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All research staff on this project will attend an intensive training that covers topics including human subjects protection and issues that 
could arise during jail-based data collection. Prior to any member of the research staff initiating contact with research participants, they 
will also be trained in the following areas: 1) Understanding the project grant (background, application, and aims); 2) Demonstrated 
understanding of all interview data collection forms; 3) Understanding how all forms are filed, both electronic and material (i.e. exact 
location, computer drive, folders, and which electronic files need to be password protected); 4) Understanding which type of events 
need to be reported and the process of reporting (e.g., emotional reports related to incidence of victimization or violence, adverse 
events reporting, exclusions after consent was obtained, cases of child abuse, active suicidal/homicidal ideation, releasing information, 
etc.); 5) Jail security training and familiarity with the environment (scheduling interview rooms, general etiquette); and 6) Interview and 
follow-up retention techniques (building participant rapport, tracking via weekly letters and phone calls, flexibility of interview times, 
dates, and locations, etc.). Training tasks will be organized by a checklist which will be completed during orientation. Staff will also 
complete training by the Kentucky Department of Corrections that covers codes of conduct for people visiting/working in correctional 
facilities and provides training on personal safety and on the importance of ensuring that all materials brought into the jail are also taken 
out of the jail by the interviewers (e.g., pens, study materials, etc.). Consistent with other studies led by Co-Is Oser and Staton involving 
justice-based populations, a two-day training session for REHNs (study interventionists) is proposed, in addition to on-going 
supervision for quality control to assure consistent delivery of services. The training approach will follow the procedures outlined by 
Carroll & Nuro (2002) which incorporates the following session content: 1) Overview; 2) Discussion of issues, including re-entry 
service coordination approaches; 3) Intervention goals and targeted behavior; 4) Discussion of similar approaches; 5) Specifications 
for intervention session content; and 6) Format for delivery and structure. Weekly clinical supervision will be provided by Dr. Staton and 
will focus on general clinical issues as well as intervention adherence issues. Individual sessions will be reviewed for adherence to the 
approach and will highlight fidelity.
REHNs will attend Project START trainings, offered through the CDC, to ensure that they understand how to ethically implement the 
intervention with fidelity to the original design.
REHNs will attend an HIV certification program offered by the Kentucky Cabinet for Health and Family Services to become certified 
HIV counselors. In addition, all staff will attend an in-house training sessions at the UK Center on Drug and Alcohol Research hosted 
by the PI (Young) on how to use the INSTI and SureCheck HIV 1/2 Test specimen collection kits, and OraQuick® HCV Rapid Antibody 
Test. Staff will undergo training on how to respond to participants who show or express psychological distress and/or suicidal or 
homicidal thoughts. In addition, all study staff will undergo training on how to respond to participants who show or express 
psychological distress and/or suicidal or homicidal thoughts (e.g., facilitated by board certified psychiatrist, Co-I Michelle Lofwall). The 
procedure will follow the protocol for Distressed and Suicidal/Homicidal Participants that has been a standard operating procedure in 
previous NIDA-funded trials (e.g., R01 DA027068).
People who test negative will be provided with an information sheet on local resources. The list of referral agencies will include mental 
health centers, substance abuse facilities and support groups, and counseling facilities. Participants will receive the name of the 
referral agency, location, telephone number, fee, if applicable, statement describing the agency and the work that they do. If 
participants wish, we will assist them to make contact with services; however, we will not disclose any information about participants to 
referral agencies. The consent document will also contain a statement informing participants that their name and contact information 
may be released without their consent to appropriate state authorities in instances that are required by state law (e.g., if they inform 
study staff that they are wanting to end their life or someone else’s life, are abusing a child).
Participants who test positive for HIV will be referred to their district Ryan White Part B HIV care coordinator. To maximize linkage to 
care, research staff performing testing will offer to call a Patient Services Coordinator at the UK Bluegrass Care Clinic (BCC; the HIV 
clinic serving Appalachian Kentucky) to set up an intake appointment on the participant's behalf while the participant is present. The 
BCC accepts all forms of private and public insurance and has grant funding to support services for uninsured patients. Participants 
who test positive for HCV will be referred to UK Kentucky Clinic Digestive Diseases and Nutrition (859-323-0079) or St. Claire 
Regional Medical Center in Morehead, KY or encouraged to visit their primary care doctor for confirmatory (HCV RNA) testing.
Each individual will receive a unique identifying number and the screener form will be identified by this number only. The master list 
matching identifiers to specific participants will be maintained in a double-password protected database on the secure HIPAA- 
compliant server at the UK Center on Drug and Alcohol Research. Screener data will be reported in aggregate form only. Participants 
will not be identified by name in analytic data files. All electronic research data will be kept on the HIPAA-compliant server at the UK 
Center on Drug and Alcohol Research.
A Data Safety Monitoring Board will oversee the study.
UK IRB policies state that IRB-related research records must be retained for a minimum of 6 years after study closure. Do 
you confirm that you will retain all IRB-related records for a minimum of 6 years after study closure?
Yes  No
Payment
Describe the incentives (monetary or other) being offered to subjects for their participation. If monetary compensation is offered, 
indicate the amount and describe the terms and schedule of payment. Please review this guidance for more information on payments to 
subjects, including restrictions and expectations.

Section 11 Page 18 of 23
the two in-jail assessments will receive $25 for their time to complete the first assessment and $10 to complete the second
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assessment.. This amount has been used previously by CARE2HOPE staff for a similar time commitment and is commensurate with 
the burden and not coercive in this context. As is currently approved by the UK IRB and Kentucky Department of Corrections for 
CARE2HOPE UG3 phase (Protocol #43520), participants can receive their incentive by staff depositing the money into their 
commissary account upon departure from the facility. Staff obtain a receipt for the deposit for record keeping. If the jail's policy is to 
withdraw jail fees from the commissary account (thereby creating a situation where participants may not directly receive their research 
incentives), the staff will deposit the funds in their in-jail phone account (if shielded from fees) or provided the incentive in the form of 
cash or gift card with their personal belongings upon release.
Post-release Intervention and Data Collection: Participants will be compensated $25 for completion of 3-month and $25 for 
completion of 6-month follow-up surveys. Participants who update or verify their locator information between the baseline and 3-month 
and between the 3-month and 6-month follow-up will receive $10 each time (total of $20). Additionally, participants who refer individuals 
to the study and who screen eligible, will be offered $10 for each referral, up to 3 individuals (total of $30)This incentive structure and 
amounts are consistent with the IRB-approved CARE2HOPE UG3 (Protocol #43520). These amounts are commensurate with other 
studies, and not coercive. Payments will be made in cash for surveys completed in-person. Payments will be made by mailed cash 
card (e.g., electronic Visa card) for surveys completed by phone. Payments for follow-up surveys completed in jail (i.e., if a person is 
re-incarcerated) will be made on their commissary account, in-jail phone account, or provided in form of cash or gift card with personal 
belongings upon release (depending on policy of jail, as described above).
COVIID-19 Policies
Pre-Release. If surveys are completed in the jail via Zoom or by phone, the incentive cash card cannot be provided to the participant 
directly until in-person meetings resume. However, the individual will be offered two options to receive payment: the REHN will place 
the incentive amount on their commissary account using an online app available through the jail or the REHN will mail the card with the 
incentive amount after their release.
Participants recruited from the community will be compensated $25 for Baseline Part 1, $10 for Baseline Part 2, $25 for the 3-month 
follow-up, and $25 for the 6-month survey. Participants who update or verify their locator information between baseline and 3-month 
and between 3-month and 6-month follow-up will receive $10 each time (total of $20). Additionally, participants who refer individuals to 
the study and who screen eligible, will be offered $10 for each referral, up to 3 individuals (total of $30). Participants in the intervention 
arm only will be compensated $15 for HIV and HCV home-based (self-test) testing (optional). The total amount a participant will be 
compensated will be $120-$150.
CQI
We will offer all categories of participants (pharmacists, REHNs and CARE2HOPE participants a $30 Western Union card as a 
compensation for their time and effort.
Costs to Subjects
Include a list of services and/or tests that will not be paid for by the sponsor and/or the study (e.g., MRI, HIV). Keep in mind that a 
subject will not know what is “standard” – and thus not covered by the sponsor/study – unless you tell them.
Data and Safety Monitoring
The IRB requires review and approval of data and safety monitoring plans for greater than minimal risk research or NIH-funded/FDA- 
regulated clinical investigations.
If you are conducting greater than minimal risk research, or your clinical investigation is NIH-funded, describe your Data and Safety 
Monitoring Plan (DSMP). Click here for additional guidance on developing a Data and Safety Monitoring Plan.
If this is a non-sponsored investigator-initiated protocol considered greater than minimal risk research, and if you are planning on 
using a Data and Safety Monitoring Board (DSMB) as part of your DSMP, click here for additional guidance for information to 
include with your IRB application.

Section 11 Page 19 of 23
 
after data have been uploaded to the server. Qualitative interviews will be recorded on recorders that can be password protected. 
 
Each participant will receive a unique identifying number and all research data collection instruments will be identified by this number 
only. The master list matching identifiers to specific participants will be maintained in a double-password protected database on the 
secure HIPAA-compliant server at the UK Center on Drug and Alcohol Research. Research data will be reported in aggregate form 
only. Participants will not be identified by name in analytic data files. 
 
All staff will sign a confidentiality agreement, stating that they will not disclose information about participants to others outside the study 
team. 
 
Procedures for preventing and addressing breaches of confidentiality: If a breach is identified, the PIs will immediately inform the UK 
IRB; NIH will be informed as decided by the UK IRB. Next steps will depend on the nature of the breach. Examples of possible steps 
include: retraining staff in confidentiality protocols; firing a staff member for a serious violation or repeated minor violations, despite 
training; or informing UK IT of a threat to HIPPA protections. 
 
Potential Adverse Events Reporting Procedure and Database: Adverse events (AEs) that may occur during data collection may 
include violation of confidentiality, discomfort due to assessment procedures, embarrassment in disclosing sensitive personal 
information, disclosure of information about current and/or intended physical harm to persons; current and/or intended abuse of 
children that would be reported to a child welfare agency; and/or an investigation of such allegations(s) that could ensue, 
dissatisfaction with the assessment procedures, and dissatisfaction with the intervention activities. Serious adverse events (SAE) may 
also occur in our study population of people who use drugs and could include infections, hospitalizations, overdose, and death. AEs 
and SAEs events following randomization will be recorded on an Adverse Events Log. All potential adverse events will be reviewed as 
to the assigned treatment group and further classified by severity (life-threatening, serious, non-serious) and expected vs. unexpected. 
Expected adverse events, determined by consensus with the DSMB, will be monitored at each enrolling site, reported to overseeing 
agencies as required by federal regulations and local requirements, and reviewed periodically by the independent DSMB. 
 
Adverse events will be reported to the NIDA Project Officer in the annual progress report. This report will describe the event, when it 
occurred, the study arm of the participant, and the outcome/resolution. If there were no AEs, we will so state in the progress report. 
 
SAEs will be reported to the NIDA Project Officer within 24 hours of the event by email. This notification will include a brief explanation 
of the SAE and when it occurred. Within 72 hours of the event, we will send a follow up email that describes the date of the event, what 
occurred, actions taken by project staff, planned follow up (if any), the intervention group/study arm of the affected participant, whether 
the event appears to be related to the intervention, and whether participant will continue in the study. We will create a standard form to 
use for these communications. 
 
Interim Analyses of Efficacy Data. We have proposed interim analyses of Project START-C2H data after approximately 50% the 
Project START-C2H participants have been recruited. During the first DSMB meeting, convened in the pre-implementation phase for 
Wave 1, the DSMB will work with the study statistician to establish stopping rules for this study. If there are large differences in serious 
adverse events or outcomes in blinded group comparisons, the DSMB may request that the statistician present an unblinded analysis 
of interim results to the DSMB who will determine if these rules and met and if the study can continue. 
 
Trial stopping rules. The DSMB will determine if we should stop the trial. The DSMB will meet during the pre-implementation phase for 
Wave 1 to determine stopping rules. 
 
All AEs will be reported to NIDA at least once per year as a part of the annual progress report. This report will describe the event, when 
it occurred, the study arm of the participant, and the outcome/resolution. If there were no AEs, a statement that no AEs occurred will be 
included in the progress report or communicated to NIDA in writing. 
 
SAEs will be reported to NIDA within 24 hours of the event by email. The notification will include a brief explanation of the SAE and 
when it occurred. A written follow up will be sent within 72 hours of the event. The written follow up will include information on the date 
of the event, what occurred, actions taken by project staff, planned follow up (if any), the intervention group/study arm of the affected 
participant, whether the event appears to be related to the intervention, and whether participant will continue in the study). 
 
Reporting of IRB actions to NIDA: All IRB actions will be reported to NIDA. The IRB director will provide guidance as to whether the 
action is reported in the progress report, or more rapidly, following SAE protocols described above. 
 
Data Safety Monitoring Board (DSMB): The DSMB will be convened prior to initiation of the trial and will decide stopping rules, review 
the final protocol and consent process prior to trial implementation, and will provide input and approval. DSMB activities will include 
reviewing emerging trial data, and making recommendations about the trial’s conduct, including possibly stopping the trial. At the close 
of each meeting, the DSMB will make one of four recommendations: continue as is, continue but with specific modifications; stop 
temporarily until specific conditions are met; or terminate. The PIs will report DSMB activity as part of their annual project progress 
report to NIDA. 
 
The DSMB will meet via teleconference to review protocol changes, data collection procedures, evaluate the benefit and risk ratio to 
participants, and review and approve the statistical analysis plan for the study. The DSMB will advise the PIs if a change in the protocol 
is warranted and at each visit, will formally vote to allow the study to continue. The DSMB may vote to discontinue the study due to 
safety concerns. 
 
A report on DSMB meetings and activities will be sent to NIDA within a month after each DSMB meeting. The update will include the 
following: meeting dates (past and upcoming if known), meeting minutes or summary, current board membership, changes in 
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Section 11 Page 20 of 23
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Future Use and Sharing of Material (e.g., Data/Specimens/Information)
If the material collected for this study will be used by members of the research team or shared with other researchers for future studies, 
please address the following:
list the biological specimens and/or information that will be kept
briefly describe the types, categories and/or purposes of the future research 
describe any risks of the additional use
describe privacy/confidentiality protections that will be put into place 
describe the period of time specimens/information may be used
describe procedures for sharing specimens/information with secondary researchers 
describe the process for, and limitations to, withdrawal of specimens/data
Are you recruiting or expect to enroll Non-English Speaking Subjects or Subjects from a Foreign Culture? (does not include short 
form use for incidentally encountered non-English subjects)
Yes  No
Non-English Speaking Subjects or Subjects from a Foreign Culture
Recruitment and Consent:
Describe how information about the study will be communicated to potential subjects appropriate for their culture, and if necessary, 
how new information about the research may be relayed to subjects during the study.
When recruiting Non-English-speaking subjects, provide a consent document in the subject’s primary language. After saving this 
section, attach both the English and translated consent documents in the “Informed Consent" section.
Cultural and Language Consultants:
The PI is required to identify someone who is willing to serve as the cultural consultant to the IRB.
This person should be familiar with the culture of the subject population and/or be able to verify that translated documents are 
the equivalent of the English version of documents submitted.
The consultant should not be involved with the study or have any interest in its IRB approval.
Please include the name, address, telephone number, and email of the person who agrees to be the cultural consultant for 
your study.
ORI staff will facilitate the review process with your consultant. Please do not ask them to review your protocol separately.
For more details, see the IRB Application Instructions on Research Involving Non-English Speaking Subjects or Subjects from a 
Foreign Culture.
Local Requirements:
If you will conduct research at an international location, identify and describe:
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ethics review requirements for human subject protection
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Section 11 Page 22 of 23
Does your study involve HIV/AIDS research and/or screening for other reportable diseases (e.g., Hepatitis C, etc…)? 
Yes No
HIV/AIDS Research
If you have questions about what constitutes a reportable disease and/or condition in the state of Kentucky, see ORI’s summary 
sheet: “Reporting Requirements for Diseases and Conditions in Kentucky" [PDF].
HIV/AIDS Research: There are additional IRB requirements for designing and implementing the research and for obtaining 
informed consent. Describe additional safeguards to minimize risk to subjects in the space provided below.
For additional information, visit the online IRB Survival Handbook to download a copy of the "Medical IRB's requirements for 
Protection of Human Subjects in Research Involving HIV Testing" [D65.0000] [PDF], and visit the Office for Human Research
Protections web site for statements on AIDS research, or contact the Office of Research Integrity at 859-257-9428.
HIV testing will be carried out using the rapid-rapid protocol recently approved for HIV surveillance and confirmatory testing by the 
Kentucky Department for Public Health and CDC. KY DPH guidelines on this were released in April 2016 (see 
http://chfs.ky.gov/dph/epi/HIVAIDS/prevention.htm). First, participants will be tested using rapid INSTI HIV 1/HIV 2 Rapid 
AntibodyTest (bioLytical Laboratories, USA), which is a manually performed, visually read, 60-second immunoassay for the 
detection of HIV-1 and HIV-2 antibodies in blood obtained from finger stick (sensitivity: 99.6, specificity: 99.3). This test will be 
followed by Sure Check® HIV-1/2 Antibody Test (ChemBio Diagnostic Laboratories, Medford, NY) on blood obtained from finger 
stick (sensitivity: 99.8, specificity: 99.9). These tests are approved for use in rapid testing in non-clinical settings by CDC 
(https://www.cdc.gov/hiv/pdf/testing/rapid-hiv-tests-non-clinical.pdf). Post test HIV counseling will be used, per CDC protocols. All 
interviewers will attend an HIV certification program offered by the Kentucky Cabinet for Health and Family Services to become 
certified HIV counselors. In addition, all interviewers will attend in-house training sessions at the Kentucky Department for Public 
Health on how to use the INSTI and SureCheck HIV 1/2 Test specimen collection kits, and OraQuick® HCV Rapid Antibody Test.
All research participants will be consented with the IRB approved interviewing consent form to ensure that they are informed of 
limitations to confidentiality about the self-reported data they provide. Under the terms of Kentucky statute, the legal duty falls on 
medical personnel responsible for diagnosing and treating HIV, not non-medical staff who are involved as epidemiological 
researchers (see 902 KAR 2:020). However, we will report infections to the state health department and participants will be 
informed of this in the informed consent document.
When a participant tests HIV positive on BOTH of the rapid tests, they are considered to be confirmed as HIV positive and 
therefore require reporting to the state health department. Participants are informed of this reporting requirement and procedures 
involved in a case investigation in their informed consent form. Upon a positive test, we will complete the KY DPH’s HIV Case 
Report form found here: http://chfs.ky.gov/NR/rdonlyres/36B936F0-AD69-4B95-83A7-
FE4E37201364/0/AdultCaseReportForm2016.pdf. We will fill in the participant’s name and contact information, information about 
our facility, participant demographic data, residential data, risk behavior data, treatment history, and testing history. We will not 
complete the section describing children of the participant. Following protocols given to us by the state health department, we will 
mail the form to the state health department. Upon receipt of the form, the state health department will provide the information to 
the state’s Disease Intervention Specialist (DIS) team and a DIS officer make contact with the participant (usually occurs within a 
few days). The DIS officer will meet with the participant to review the information and to initiate the process of contact tracing.
To maximize linkage to care for participants, research staff will offer to call a Patient Services Coordinator at the UK Bluegrass 
Care Clinic (BCC) to set up an intake appointment on the participant's behalf while the he/she is present. BCC accepts all forms of 
private and public insurance and has grant funding to support services for uninsured patients. The REHN will conduct facilitated 
referrals to a range of other needed medical and social services, with discussions during follow-up visits about additional needs 
and barriers to linkage to care.
People who test negative will be provided with an information sheet on local resources. The list of referral agencies will include 
mental health centers, substance abuse facilities and support groups, and counseling facilities. Participants will receive the name 
of the referral agency, location, telephone number, fee, if applicable, statement describing the agency and the work that they do. If 
participants wish, we will assist them to make contact with services; however, we will not disclose any information about 
participants to referral agencies. The consent document will also contain a statement informing participants that their name and 
contact information may be released without their consent to appropriate state authorities in instances that are required by state 
law (e.g., if they inform study staff that they are wanting to end their life or someone else’s life, are abusing a child).
Biosample collection staff will undergo training on how to respond to participants who show or express psychological distress 
and/or suicidal or homicidal thoughts. In addition, all study staff will undergo training on how to respond to participants who show or 
express psychological distress and/or suicidal or homicidal thoughts (e.g., facilitated by board certified psychiatrist, Co-I Michelle 
Lofwall). The procedure will follow the protocol for Distressed and Suicidal/Homicidal Participants that has been a standard 
operating procedure in previous NIDA-funded trials (e.g., R01 DA027068).
COVID-19 Policies.
We will offer all participants in the intervention arm HIV and HCV testing. Research staff will perform testing as described above in 
the office. However, if a participant prefers, we will help them perform the test using a self-test kit, or we we will make a referral to a 
local health department.
HIV and HCV testing are only offered to participants in the intervention arm. Testing is offered in the local health departments 
through UK’s Kentucky Income Reinvestment Program (KIRP) with UK staff based at the health departments. The Kentucky
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PI-Sponsored FDA-Regulated Research
Is this an investigator-initiated study that:
1) involves testing a Nonsignificant Risk (NSR) Device, or
2) is being conducted under an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)? 
Yes No
PI-Sponsored FDA-Regulated Research
If the answer above is yes, then the investigator assumes the regulatory responsibilities of both the investigator and sponsor. The 
Office of Research Integrity provides a summary list of sponsor IND regulatory requirements for drug trials [PDF], IDE regulatory 
requirements for SR device trials [PDF], and abbreviated regulatory requirements for NSR device trials [PDF]. For detailed 
descriptions see FDA Responsibilities for Device Study Sponsors or FDA Responsibilities for IND Drug Study Sponsor- 
Investigators.
Describe the experience/knowledge/training (if any) of the investigator serving as a sponsor (e.g., previously held an 
IND/IDE); and
Indicate if any sponsor obligations have been transferred to a commercial sponsor, contract research organization (CRO), 
contract monitor, or other entity (provide details or attach FDA 1571).
IRB policy requires mandatory training for all investigators who are also FDA-regulated sponsors (see Sponsor-Investigator
FAQs). A sponsor-investigator must complete the applicable Office of Research Integrity web based training, (drug or device) 
before final IRB approval is granted.
Has the sponsor-investigator completed the mandatory PI-sponsor training prior to this submission? 
Yes No
If the sponsor-investigator has completed equivalent sponsor-investigator training, submit documentation of the content for the 
IRB’s consideration.
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Section 12 Page 1 of 1
HIPAA De-identification Certification Form 
HIPAA
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Is HIPAA applicable?
Yes  No
(Visit ORI's Health Insurance Portability and Accountability Act (HIPAA) web page to determine if your research falls under the HIPAA 
Privacy Regulation.)
If yes, check below all that apply and attach the applicable document(s): 

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Section 13 Page 1 of 2
STUDY DRUG INFORMATION
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comment(s)
The term drug may include:
FDA approved drugs,
unapproved use of approved drugs, 
investigational drugs or biologics,
other compounds or products intended to affect structure or function of the body, and/or
complementary and alternative medicine products such as dietary supplements, substances generally recognized as safe (GRAS) 
when used to diagnose, cure mitigate, treat or prevent disease, or clinical studies of e-cigarettes examining a potential therapeutic 
purpose.
Does this protocol involve a drug including an FDA approved drug; unapproved use of an FDA approved drug; and/or an 
investigational drug?
Yes  No
If yes, complete the questions below. Additional study drug guidance.
LIST EACH DRUG INVOLVED IN STUDY IN THE SPACE BELOW
Drug Name:
Note: Inpatient studies are required by Hospital Policy to utilize Investigational Drug Service (IDS) pharmacies (Oncology or
Non-Oncology). Use of IDS is highly recommended, but optional for outpatient studies. Outpatient studies not using IDS
services are subject to periodic inspection by the IDS for compliance with drug accountability good clinical practices.
Indicate where study drug(s) will be housed and managed: 
Investigational Drug Service (IDS) UK Hospital
Other Location:
Is the study being conducted under a valid Investigational New Drug (IND) application?
Yes  No
If Yes, list IND #(s) and complete the following:
IND Submitted/Held by:
Sponsor: 
Investigator:
Other:
Held By: 
Held By: 
Held By:
Checkmark if the study is being conducted under FDA’s Expanded Access Program (e.g., Treatment IND) 
or if this is an Individual Patient Expanded Access IND (FDA Form 3926).
FDA's Expanded Access Program Information for Individual Patient Expanded Access INDs, and attach the 
following:
FDA Form 3926;
FDA expanded access approval or correspondence;
Confirmation of agreement from manufacturer or entity authorized to provide access to the product. 
For guidance and reporting requirements at the conclusion of treatment see the Expanded Access SOP.
Complete and attach the required Study Drug Form picking "Study Drug Form" for the document type. Any

Section 13 Page 2 of 2
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Section 14 Page 1 of 2
Device Name:
Is the study being conducted under a valid Investigational Device Exemption (IDE),
Humanitarian Device Exemption (HDE) or Compassionate Use?
IDE/HDE Submitted/Held by:
FDA expanded access approval or sponsor’s authorization;
An independent assessment from an uninvolved physician, if available;
STUDY DEVICE INFORMATION
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comment(s)
A DEVICE may be a:
component, part, accessory;
assay, reagent, or in-vitro diagnostic device; 
software, digital health, or mobile medical app;
other instrument if intended to affect the structure or function of the body, diagnose, cure, mitigate, treat or prevent disease; or 
a homemade device developed by an investigator or other non-commercial entity and not approved for marketing by FDA.
For additional information, helpful resources, and definitions, see ORI's Use of Any Device Being Tested in Research web page.
Does this protocol involve testing (collecting safety or efficacy data) of a medical device including an FDA approved device, 
unapproved use of an approved device, humanitarian use device, and/or an investigational device?
Yes  No
[Note: If a marketed device(s) is only being used to elicit or measure a physiologic response or clinical outcome, AND, NO data will 
be collected on or about the device itself, you may answer “no” above, save and exit this section, (Examples: a chemo drug study 
uses an MRI to measure tumor growth but does NOT assess how effective the MRI is at making the measurement; an exercise study 
uses a heart monitor to measure athletic performance but no safety or efficacy information will be collected about the device itself, nor 
will the data collected be used for comparative purposes against any other similar device).]
If you answered yes above, please complete the following questions.
LIST EACH DEVICE BEING TESTED IN STUDY IN THE SPACE BELOW

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Section 14 Page 2 of 2
Does the intended use of any research device being tested (not clinically observed) in this study meet the regulatory definition of
Significant Risk (SR) device?
Yes. Device(s) being tested in this study presents a potential for serious risk to the health, safety, or welfare of a subject and
(1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in 
diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents 
a potential for serious risk to the health, safety, or welfare of a subject.
No. All devices being tested in this study do not present a potential for serious risk to the health, safety, or welfare of 
subjects/participants.
Complete and attach the required Study Device Form, picking the "Study Device Form" for the document type. Any 
applicable device documentation (e.g., Manufacturer information; patient information packet; approved labeling; FDA 
correspondence, etc.) should be attached using "Other Device Documentation" for the document type.

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Section 15 Page 1 of 2
Schools/Education Institutions
Other Medical Facilities
RESEARCH SITES
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comment(s)
To complete this section, ensure the responses are accurate then click "SAVE".
A) Check all the applicable sites listed below at which the research will be conducted. If none apply, you do not need to check any 
boxes.
Correctional Facilities 
Home Health Agencies 
International Sites
Research activities conducted at performance sites that are not owned or operated by the University of Kentucky, at sites 
that are geographically separate from UK, or at sites that do not fall under the UK IRB’s authority, are subject to special 
procedures for coordination of research review. Additional information is required (see IRB Application Instructions - Off- 
Site Research web page), including:
A letter of support and local context is required from non-UK sites. See Letters of Support and Local Context on the 
IRB Application Instructions - Off-Site Research web page for more information.
Supportive documentation, including letters of support, can be attached below.
NOTE: If the non-UK sites or non-UK personnel are engaged in the research, there are additional federal and 
university requirements which need to be completed for their participation. For instance, the other site(s) may need 
to complete their own IRB review, or a cooperative review arrangement may need to be established with non-UK

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Section 15 Page 2 of 2
sites.
Questions about the participation of non-UK sites/personnel should be discussed with the ORI staff at (859) 257- 
9428.
List all other non-UK owned/operated locations where the research will be conducted:
Describe the role of any non-UK site(s) or non-UK personnel who will be participating in your research.
Attach Type
File Name
-IRB Authorization Agreement
Young IAA Emory.pdf
-Letter of Support & Local Context LOS - Appalachian Wellness Center.pdf
B) Is this a multi-site study for which you are the lead investigator or UK is the lead site?
Yes  No
If YES, describe the plan for the management of reporting unanticipated problems, noncompliance, and submission of protocol 
modifications and interim results from the non-UK sites:
C) If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, then it is considered 
multisite research and IRB reliance issues will need to be addressed. This may include national multi-center trials as well local studies 
involving sites/personnel external to UK. If you would like to request that the University of Kentucky IRB (UK IRB) serve as the lead 
IRB for your study, or if you would like the UK IRB to defer review to another IRB, please contact the IRBReliance@uky.edu.

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Section 16 Page 1 of 2
RESEARCH ATTRIBUTES
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Indicate the items below that apply to your research. Depending on the items applicable to your research, you may be required to 
complete additional forms or meet additional requirements. Contact the ORI (859-257-9428) if you have questions about additional 
requirements.
Not applicable
Check All That Apply
Academic Degree/Required Research 
Alcohol/Drug/Substance Abuse Research 
Biological Specimen Bank Creation (for sharing) 
Cancer Research
CCTS-Center for Clinical & Translational Science 
Certificate of Confidentiality
Clinical Research 
Clinical Trial - Phase 1 
Clinical Trial
Collection of Biological Specimens for internal banking and use 
(not sharing)
Community-Based Participatory Research 
Deception
Educational/Student Records (e.g., GPA, test scores) 
Emergency Use (Single Patient)
Gene Transfer 
Genetic Research
GWAS (Genome-Wide Association Study) or NIH Genomic Data 
Sharing (GDS)
Human Cells, Tissues, and Cellular and Tissue Based Products 
Individual Expanded Access or Compassionate Use 
International Research
Planned Emergency Research Involving Exception from 
Informed Consent
Recombinant DNA
Registry or data repository creation 
Stem Cell Research
Suicide Ideation or Behavior Research 
Survey Research
Transplants
Use, storage and disposal of radioactive material and radiation 
producing devices
Vaccine Trials
For additional requirements and information:
Cancer Research (MCC PRMC)
Certificate of Confidentiality (look up 
"Confidentiality/Privacy...")
CCTS (Center for Clinical and Translational 
Science)
Clinical Research (look up "What is the definition 
of....)
Clinical Trial
Collection of Biological Specimens for Banking
(look up "Specimen/Tissue Collection. ")
Collection of Biological Specimens (look up 
"Specimen/Tissue Collection. ")
Community-Based Participatory Research (look 
up "Community-Engaged. ")
Data & Safety Monitoring Board (DSMB)
*For Medical IRB: Service Request Form for 
CCTS DSMB
Data & Safety Monitoring Plan
Deception*
*For deception research, also go to the E-IRB 
Application Informed Consent section, 
checkmark and complete "Request for Waiver 
of Informed Consent Process"
Emergency Use (Single Patient) [attach
Emergency Use Checklist] (PDF)
Genetic Research (look up "Specimen/Tissue 
Collection. ")
Gene Transfer
HIV/AIDS Research (look up "Reportable 
Diseases/Conditions")
Screening for Reportable Diseases [E2.0000]
(PDF)
International Research (look up "International & 
Non-English Speaking")
NIH Genomic Data Sharing (GDS) Policy (PDF)
Planned Emergency Research Involving Waiver
of Informed Consent*
*For Planned Emergency Research Involving 
Waiver of Informed Consent, also go to the E- 
IRB Application Informed Consent section, 
checkmark and complete "Request for Waiver 
of Informed Consent Process"
Use, storage and disposal of radioactive material 
and radiation producing devices

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Section 16 Page 2 of 2
 
 
 

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Section 17 Page 1 of 2
FUNDING/SUPPORT
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If the research is being submitted to, supported by, or conducted in cooperation with an external or internal agency or funding program, 
indicate below all the categories that apply. 
Not applicable
Check All That Apply
Grant application pending
(HHS) Dept. of Health & Human Services 
(NIH) National Institutes of Health 
(CDC) Centers for Disease Control &
Prevention
(HRSA) Health Resources and Services 
Administration
(SAMHSA) Substance Abuse and Mental 
Health Services Administration
(DoJ) Department of Justice or Bureau of 
Prisons
(DoE) Department of Energy
(EPA) Environmental Protection Agency 
Federal Agencies Other Than Those Listed
Here
Industry (Other than Pharmaceutical 
Companies)
Internal Grant Program w/ proposal 
Internal Grant Program w/o proposal 
National Science Foundation
Other Institutions of Higher Education 
Pharmaceutical Company
Private Foundation/Association
U.S. Department of Education 
State
Other:
Click applicable listing(s) for additional requirements and information: 
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control & Prevention
(HRSA) Health Resources & Services Administration
(SAMHSA) Substance Abuse & Mental Health Services
Administration
Industry (Other than Pharmaceutical Companies) [IRB Fee Info] 
National Science Foundation
(DoEd) U.S. Department of Education
(DoJ) Department of Justice or Bureau of Prisons
(DoE) Department of Energy Summary and Department of Energy
Identifiable Information Compliance Checklist
(EPA) Environmental Protection Agency
Specify the funding source and/or cooperating organization(s) (e.g., National Cancer Institute, Ford Foundation, Eli Lilly 
& Company, South Western Oncology Group, Bureau of Prisons, etc.):
Add Related Grants

Section 17 Page 2 of 2
Grant/Contract Attachments
Assurance/Certification Attachments
The research involves use of Department of Defense (DoD) funding, military personnel, DoD facilities, or other DoD resources. 
(See DoD SOP and DoD Summary for details)
Yes
No
Additional Certification: (If your project is federally funded, your funding agency may request an Assurance/ Certification/Declaration 
of Exemption form.) Check the following if needed:
Protection of Human Subjects Assurance/Certification/Declaration of Exemption (Formerly Optional Form – 310)
If required by your funding agency, upload your grant using the "Grant/Contract Attachments" button.
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Section 18 Page 1 of 1
Additional Information
Radioactive Drug Research Committee (RDRC)
Graduate Medical Education Committee (GME)
Graduate Medical Education Committee (GME) 
OTHER REVIEW COMMITTEES
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If you check any of the below committees, additional materials may be required with your application submission.
Does your research fall under the purview of any of the other review committees listed below? [If yes, check all that apply and attach
applicable materials using the attachment button at the bottom of your screen.]

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Section 19 Page 1 of 1
Additional Materials:
Protocol/Other Attachments
ADDITIONAL INFORMATION/MATERIALS
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comment(s)
Do you want specific information inserted into your approval letter? Yes No 
Approval Letter Details:
If you wish to have specific language included in your approval letter (e.g., serial #, internal tracking identifier, etc…), type that 
language in the box below exactly as it should appear in the letter. The text you enter will automatically appear at the top of all 
approval letters, identical to how you typed it, until you update it. Don't include instructions or questions to ORI staff as those will 
appear in your approval letter. If these details need to be changed for any reason, you are responsible for updating the 
content of this field.
Attach Type File Name
Other
Summary of Adverse and Serious Adverse Events.pdf
Other
Modification Request Memo 092123.pdf
NOTE: Instructions for Dept. of Health & Human Services (DHHS)-approved protocol] 
If you have password protected documents, that feature should be disabled prior to uploading to ensure access for IRB review.
To view the materials currently attached to your application, click “All Attachments” on the left menu bar.

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Section 20 Page 1 of 1
First
Name
Last
Name
Role
Department
Date
Signed
SIGNATURES (ASSURANCES)
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comment(s)
Introduction
All IRB applications require additional assurances by a Department Chairperson or equivalent (DA), and when applicable, a Faculty 
Advisor or equivalent (FA). This signifies the acceptance of certain responsibilities and that the science is meritorious and deserving of 
conduct in humans. The person assigned as DA should not also be listed in the Study Personnel section, and the individual assigned 
as FA should be listed in the Study Personnel section.
For a list of responsibilities reflected by signing the Assurance Statement, refer to "What does the Department Chairperson’s
Assurance Statement on the IRB application mean?"
For a detailed illustration of how to complete this section, please review the short online video tutorial "Signatures
(Assurance) Section - How to Complete." Otherwise, follow the steps below.
Required Signatures:
April
Young
Principal
Investigator
Erin
Haynes
Department
Authorization
Dept Of 
Epidemiology
Dept Of 
Epidemiology
07/03/2019
12:17 PM
07/03/2019
01:34 PM
Principal Investigator’s Assurance Statement
I understand the University of Kentucky's policies concerning research involving human subjects and I agree:
1. To comply with all IRB policies, decisions, conditions, and requirements;
2. To accept responsibility for the scientific and ethical conduct of this research study;
3. To obtain prior approval from the Institutional Review Board before amending or altering the research protocol or 
implementing changes in the approved consent/assent form;
4. To report to the IRB in accord with IRB/IBC policy, any adverse event(s) and/or unanticipated problem(s) involving risks to 
subjects;
5. To complete, on request by the IRB for Full and Expedited studies, the Continuation/Final Review Forms;
6. To notify the Office of Sponsored Projects Administration (OSPA) and/or the IRB (when applicable) of the development of 
any financial interest not already disclosed;
7. Each individual listed as study personnel in this application has received the mandatory human research protections 
education (e.g., CITI);
8. Each individual listed as study personnel in this application possesses the necessary experience for conducting research 
activities in the role described for this research study.
9. To recognize and accept additional regulatory responsibilities if serving as both a sponsor and investigator for FDA 
regulated research.
Furthermore, by checking this box, I also attest that:
I have appropriate facilities and resources for conducting the study;
I am aware of and take full responsibility for the accuracy of all materials submitted to the IRB for review;
If applying for an exemption, I also certify that the only involvement of human subjects in this research study will be in the 
categories specified in the Protocol Type: Exemption Categories section.
If applying for an Abbreviated Application (AA) to rely on an external IRB, I understand that certain items above (1, 3, 4, 7-8) 
may not apply, or may be altered due to external institutional/IRB policies. I document my agreement with the Principal 
Investigator Reliance Assurance Statement by digitally signing this application.
*You will be able to "sign" your assurance after you have sent your application for signatures (use Submission section). Please notify the 
personnel required for signing your IRB application after sending for signatures. Once all signatures have been recorded, you will need 
to return to this section to submit your application to ORI.
View/Sign
View/Sign

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Section 20 Page 2 of 2
Department Authorization

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Section 21 Page 1 of 1
 
 
 
SUBMISSION INFORMATION 
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comment(s) 
 
Each Section/Subsection in the menu on the left must have a checkmark beside it (except this Submission section) indicating the 
Section/Subsection has been completed. Otherwise your submission for IRB review and approval cannot be sent to the Office of 
Research Integrity/IRB. 
If applicable, remember to update the Approval Letter Details text box under the Additional Information section 
 
If your materials require review at a convened IRB meeting which you will be asked to attend, it will be scheduled on the next available 
agenda and you will receive a message to notify you of the date. 
If you are making a change to an attachment, you need to delete the attachment, upload a highlighted version that contains the changes 
(use Document Type of "Highlighted Changes"), and a version that contains the changes without any highlights (use the appropriate 
Document Type for the item(s)). Do not delete approved attachments that are still in use. 
Your protocol has been submitted. 

Statistical Design and Power 
We will explore intervention effects on PWUD using: (1) longitudinal quantitative data from START-
C2H participants; and (2) qualitative data with PWUD START-
perceived effectiveness, and the perceived pathways through which it operates.  
 
Exploratory Quantitative Analysis of START-C2H survey data:  
Our community randomized trial consists of clustered data with participants nested within counties. To 
bly-
models. The covariance matrix for all observations within a county may be written as the Kronecker product of 
the compound symmetric covariance matrix for participants nested within county and a 2 by 2 residual 
covariance matrix for repeated measures nested within participants. Implementing the covariance model can 
be done in both PROC MIXED (for continuous measures) and PROC GLIMMIX (for categorical measures) in 
SAS by specifying a random intercept for county, and a compound symmetric residual matrix across time 
(repeated measures within participant). To estimate change in our primary outcomes due to the intervention we 
will begin by analyzing models of the following f
represents the appropriate link function for outcome y, Time is a pre-post indicator variable , and Int is an 
 in slope between the 
intervention and control group. While our primary outcomes can be approximated as normally distributed, the 
link function g() will be modified as necessary to properly model the distribution for each outcome. 
Missing Data. We will use multiple imputation to account for non-response over time and potential 
attrition. Additional augmentation variables found to be predictive of missingness will also be included in the 
imputation model. Ten imputations will be implemented. Additionally, we will use multiple imputation by 
chained equations to allow for imputation of non-normally distributed variables. All imputation analyses will be 
done using PROC MI and PROC MIANALYZE in SAS. 
Power. We estimated the statistical power to preliminarily detect a change in our outcomes using 
PROC GLMPOWER in SAS v9.4., accounting for autocorrelation within participants and nesting within 
counties. We estimate power for a multivariate model equivalent to our planned repeated measures models 
previously described. Because these analyses are exploratory (due to the smaller-than-anticipated sample 
size), we set the alpha to 0.10. Based on existing data, we assume a within-county ICC of 0.05 and a within-
person autocorrelation of 0.35. We estimate power for all outcomes as approximately Gaussian. We further 
assume a type-1 error rate of 0.10, 12 counties, and 20 participants per county. At these sample sizes and with 
an exploratory p-value=0.10, we achieve statistical power of 0.80 for standardized mean of 0.55, or moderate 
sized effects with an alpha=0.10. 
 
Qualitative data analysis with START-C2H intervention cohort:  
Qualitative Analysis Plan: We will use constructivist grounded theory (CGT) methods to develop 
grounded theories about the perceived relationships and pathways linking (or failing to link) the intervention and 
changes in primary and secondary outcomes (or lack thereof). CGT provides rigorous methods that will (1) 
foster discovery; (2) elicit rich descriptions 
of each intervention component; (3) support the creation of grounded theories about perceived pathways 
through which these phenomena influence one another; and (4) support comparisons of #1-#3 by participant 
age gender etc. We will use 3 CGT stages: open coding, axial coding, and theoretical coding.  
Open coding: The open coding stage is designed to develop a rich understanding of salient phenomena 
by systematically and comprehensively labelling and defining concepts of interest in the transcripts. In the open 
coding process, Cooper and the GRA will iterate between developing code labels, code definitions, and 
codebooks independently (to enhance feasibility), and meeting to develop consensus (to enhance validity); they 
will double code every 3rd transcript. Line-by-line analyses, conducted in NVIVO, will both explore intervention 
components and primary and secondary outcomes, and also be open to discovering new phenomena that are 
salient to the aims.  
Axial Coding: The purpose of Axial Coding is to develop high-level categories that are more abstract 
Axial Coding, categories are defined, and their properties and dimensions identified (i.e., their characteristics 
and the ways in which they vary, respectively). The GRA and Cooper will iterate between independent 
analyses of open-coded transcripts, and consensus building about emerging learnings. They will independently 
develop a Category Memo for each emerging category that (1) defines it; (2) identifies and defines its 
properties and dimensions and possible subcategories; (3) inventories associated codes; and (4) describes 
how the category differs from other similar categories under development. Cooper and the GRA will meet 

definitions, properties, and dimensions. Categories will be expanded as additional transcripts undergo open 
coding, and offer new evidence.  
Theoretical coding: Theoretical coding is designed to develop grounded theories that describe how 
categories relate to one another along properties and dimensions. Here, grounded theories will explore the 
perceived pathways through which each intervention component is affecting each outcome, and also explore 
ruptures in anticipated pathways (e.g., perhaps FTS distribution does not seem to protect against overdose). 
We expect to have a separate grounded theory for each intervention component 
outcome dyad. We will start 
with foundational analytic questions, drawn from CGT: What are the perceived pathways through which 
C
hat Contingencies must be present 
for these pathways to operate? What Conditions rupture the pathways linking an intervention component to an 
outcome? 
on 
Relational 
Statements succinctly describe relationships between or among two or more categories along their properties 
and dimensions. We will test each relational statement using a chart, in which each axis is a property that 
 whether categories or their 
posited relationships need to be amended. Learnings will be recorded in Relational Memos. 
We will use the constant comparison method to systematically compare findings across participant 
subgroups (e.g., defined by gender, houselessness status). To support these comparisons, we will color-code 
each relational chart by these subgroup characteristics. When we find variation across subgroups, we will return 
to the data to identify conditions and contingencies that may explain these variations, and expand relational 
statements accordingly, or the categories they link. As needed, we will present different sets of relational 
statements for specific subgroups. These relational statements will form the foundations of grounded theories 
ex
which it does (or does not) operate to change primary and secondary outcomes, for particular subgroups.  
 
Triangulating across qualitative and quantitative findings: We will use joint displays to systematically compare 
and contrast qualitative and quantitative findings for each intervention component/outcome relationship (e.g., 
preliminary [i.e., p<0.10] hypothesis test results about the relationship of receiving FTS to subsequent overdose 
vs. qualitative grounded theory about this same relationship). When qualitative and quantitative findings both 
suggest an ameliorative relationship, we will conclude that the available evidence supports a beneficial effect. 
When both find an adverse relationship, we will conclude that the evidence indicates a harmful effect. When 
neither suggests a relationship, we will conclude that the evidence indicates no effect. When quantitative and 
qualitative results diverge, we will return to the qualitative and quantitative data to learn if we can resolve this 
discrepancy. Qualitative data may illuminate an unexpected confounder for the quantitative hypothesis test. 
Alternatively, qualitative data may suggest that the intervention only has an effect in one subgroup (e.g., 
individuals residing in counties with more services) and the quantitative findings reach a null conclusion 
because the quantitative sample is small, and includes both people who do and do not live in such counties. We 
will seek to systematically explore all divergences using these tables, and seek to refine relational statements 
and grounded theories accordingly. We will rely solely on qualitative data to learn whether the intervention effect 
is attenuated in a subgroup (e.g., women), given that the quantitative sample is underpowered to detect effect 
moderation.