Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK
Phase: NA
Conditions: HIV/AIDS, Pre-exposure Prophylaxis
Sponsor: University of Arkansas

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 1 
 
 
 
Study Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  
PrEP-LINK 
 
Principal Investigator:  
Nickolas Zaller, PhD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 820 
Little Rock, AR 72205 
Telephone:  501.686-8366 
Email:  ndzaller@uams.edu 
 
 
Sub-Investigator (s): 
Alex Marshall, PhD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot #820 
Little Rock, AR 72205 
Telephone:  501-526-6623 
Email:  SMARSHALL@uams.edu 
 
 
 
 
Study location: 
University of Arkansas for Medical Sciences; 
 
Pulaski County Detention Facility 
2900 South Woodrow 
 
Little Rock, AR 72204 
 
 
 
Central Arkansas Community Corrections Center 
 
4823 West 7th Street 
 
Little Rock, AR 72205 
 
 
 
East Central Arkansas Community Correction Center 
 
200 West Tyler Ave 
 
West Memphis, AR 72301 
 
 
Hidden Creek Opportunity Center 
 
10905 W. Markham St. 
 
Little Rock, AR 72211 
 
 
Quality Living Center 
 
3925 Asher Ave 
 
Little Rock, AR 72204 
 
 
 
 
 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 2 
 
Better Community Development, Inc. 
 
4604 West 12th Street 
 
Little Rock, AR 72204 
 
 
Recovery Centers of Arkansas 
 
9219 Sibley Hole Road 
 
Little Rock, AR 72209 
 
And  
 
6301 Father Tribou 
 
Little Rock, AR 72205 
 
 
 
 
 
 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 3 
Table of Contents 
 
Table of Contents ............................................................................................................ 3 
Background and Rationale .............................................................................................. 4 
Hypothesis and/or Specific Aims or Objectives ............................................................... 4 
Study Design and Procedures ......................................................................................... 6 
Study Population ........................................................................................................... 13 
Inclusion Criteria: ....................................................................................................... 14 
Exclusion Criteria ....................................................................................................... 14 
Risks and Benefits......................................................................................................... 14 
Data Handling and Recordkeeping ............................................................................... 15 
Data Analysis ................................................................................................................ 15 
Ethical Considerations ................................................................................................... 17 
Dissemination of Data ................................................................................................... 18 
References .................................................................................................................... 19 
 
 
 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 4 
Background and Rationale 
Criminal justice (CJ) involved individuals have extremely high prevalence of risk factors 
associated with HIV infection including poverty, substance use, transactional sex, high numbers 
of sex partners, high prevalence of sexually transmitted infections and mental illness. African 
Americans (AA) are at disproportionate risk for both incarceration and HIV infections. Arkansas 
incarcerates 1,020 people per 100,000 overall and 1,665 per 100,000 for African 
Americans, which substantially exceeds the 890 per 100,000 overall population in the 
United States.1-2 Pulaski County, where this study will take place, has an HIV prevalence of 
nearly 500 HIV cases per 100,000 population.3   
A growing body of evidence highlights the efficacy of a once daily medication, 
emtricitabine/tenofovir, also known as pre-exposure prophylaxis (PrEP), in reducing HIV 
acquisition.4-8  However, structural and social barriers can undermine optimal PrEP 
uptake, adherence, and retention in care and must be addressed especially among those 
with recent CJ experience. Recently incarcerated individuals often experience a lack of 
access to housing and employment, severance of social support, and discrimination—all of 
which are factors that can impede intervention efficacy and, therefore, must be incorporated into 
HIV prevention efforts. Thus, the primary goal of our proposed study is to develop a tailored 
PrEP intervention for CJ-involved populations, focusing on both individual and structural level 
factors, in order to reduce the risk for community based HIV acquisition.  We will focus our study 
on the largest county jail in Arkansas and the largest community corrections office in the state.  
Jails, in contrast to prisons, are facilities where individuals are detained pre-sentencing for 
relatively short periods of time (days to months).  Jail detainees are on the front lines of the HIV 
epidemic in the United States, yet barriers and facilitators to implementing PrEP – a highly 
effective intervention for reducing HIV risk – has not been studied in this critical population. 
There is also no research on PrEP uptake when offered as an intervention to individuals 
transitioning out of jail.  
We have assembled an Interprofessional team of researchers with expertise in criminal justice, 
HIV and behavioral health.  Our proposed study will: provide a novel exploration of facilitators 
and barriers to PrEP; allow us to target hard to reach populations, including men who have sex 
with men (MSM) and substance users (both of which are top funding priority groups for the 
National Institutes of Health) who experience intersecting markers of HIV risk; and inform 
regional, and possibly national, intervention approaches to combat the overlapping epidemic of 
HIV and incarceration. 
Specific Aims 
The specific aims of the project associated with this protocol are: 
Aim 1: Perform a qualitative assessment of facilitators and barriers to PrEP uptake 
among high-risk jail detainees, systems and interactor levels.  To achieve this aim we will 
conduct qualitative interviews with three distinct groups of stakeholders: 
1) Systems interviews (n=6); 
2) Interactor interviews (n=8); and 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 5 
3) Individual Key Informant interviews (n=20). 
Within each of these strata, we aim to collect data representing diverse perspectives with 
respect to interest, knowledge, attitudes, and barriers (including substance use) to PrEP uptake. 
We will also explore acceptability and feasibility of an intervention to link individuals being 
released from the Pulaski County jail to PrEP services. 
For the purposes of this protocol, Aims 2 and 3 are identical in terms of participant recruitment, 
enrollment and all study procedures (including data collection and participant follow up).  The 
primary objective of Aim 2 is to conduct a small pilot of the intervention study in order to make 
any necessary changes to any aspect of the study procedures.  If any changes are made, those 
changes will be submitted to the IRB for further review and approval prior to initiating Aim 3.  If 
no changes are made, this IRB protocol will serve as the protocol for both Aims 2 and 3.   
Aim 2: Develop the PrEP-LINK intervention and perform an open label evaluation with  
high-risk HIV negative individuals being discharged from the Pulaski County Jail or 
recently discharged from a correctional setting and reporting to a local Community 
Corrections facility or Re-Entry Center, including: Central Arkansas Community 
Corrections Center, East Central Arkansas Community Corrections Center, Hidden Creek 
Opportunity Center, Quality Living Center, Better Community Development, Inc., and 
Recovery Centers of Arkansas, .Directly informed from formative work (Aim 1), we will 
develop the PrEP-LINK intervention, which will include the use of a community health worker 
(CHW) and adherence counseling (based on ADAPT-ITT) approach to enhance PrEP care and 
overcome barriers to uptake in this population. We will then perform an open pilot with 
individuals recently released from a correctional facility 
Aim 3: Conduct a pilot RCT of the PrEP-LINK intervention among high-risk HIV negative 
individuals being released from the Pulaski County Jail or recruited within 30 days of 
release from a correctional facility. Based on the formative work in Aim 1 and open pilot 
evaluation in Aim 2, participants will be randomized to either the PrEP-LINK intervention, or 
enhanced standard of care arm.  Both arms will receive education about PrEP and referral to a 
community PrEP provider which exceeds the standards of care these individuals would 
otherwise receive.  
 
While we will develop the CHW intervention as part of Aim 2, this will be informed by work we 
have already completed through Aim 1, which was approved under a separate IRB protocol 
(#207297).  Once we have finalized the intervention content, we will conduct the Aim 2 open 
label evaluation in the exact same way as we will conduct the Aim 3 pilot RCT.  To reiterate, the 
rationale of the open label evaluation proposed in Aim 2 is to ensure that the intervention is 
appropriate and does not need additional revision prior to conducting the Aim 3 RCT.   
 
Description of the Community Health Worker (CHW) Intervention (Aims 2 and 3):  The 
intervention arm in both Aims 2 and 3 will receive additional support by a community health 
worker (CHW) who will assist with healthcare and social service navigation and will utilize 
adherence counseling techniques. The CHW we are employing is Ms. Timikia Jackson, who is a 
trained CHW with a strong knowledge base of both healthcare and social service systems in the 
greater Little Rock area.  As per the model our intervention is based upon (the national 
Transitions Clinic Network [TCN], which has 14 sites across the country), Ms. Jackson has a 
history of incarceration. Therefore, she can serve as a true peer to individuals who are enrolled 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 6 
into the study. The national TCN sites employ formerly incarcerated CHWs because these 
individuals are often able to develop close relationships with their peers who have also been 
formerly incarcerated thereby building a strong foundation of trust among a population with high 
levels of distrust of the medical system.  Ms. Jackson will be certified in HIV testing and risk 
reduction counseling.  For participants randomized to the intervention group, Ms. Jackson will 
assist individuals with employment, housing (if needed), referrals to mental health or substance 
use treatment, keeping track of medical appointments and medication adherence.  We 
anticipate that Ms. Jackson will be in contact with intervention arm participants at least once per 
week but the exact amount of contact for each participant will vary based on needs.  Ms. 
Jackson will be available during regular business hours (Monday-Friday, 9 AM until 5 PM).  If 
participants present to Ms. Jackson in crisis, she will refer them immediately to the Emergency 
Department, in the event of a medical or behavioral health emergency or the Pulaski County 
Regional Crisis Stabilization Center, which is operated by the UAMS Psychiatric Research 
Institute (PRI).  Ms.Jackson will be directly supervised by PI Dr. Zaller through weekly 
supervision meetings and biweekly phone check-ins.  Frequency of check-in may increase or 
decrease, as needed, during the course of the study period.  Ms. Jackson is considered 
research staff and has been trained in human subjects through the UAMS CITI program.        
 
Primary outcomes will include acceptability and feasibility of the intervention, as well as PrEP 
uptake. Secondary outcomes will include adherence and retention in PrEP-related medical care 
at three, six and 12 months. Results will inform a subsequent multi-site RCT to test efficacy of 
the intervention in improving PrEP uptake, adherence, and retention in care among transitioning 
out of jail. 
Between study aims 2 & 3 a total of 120 subjects will be consented with approximately 10 
for aim 2 and 110 for aim 3.  
NOTE:  For this IRB application, we are only seeking approval for activities related to 
AIMs 2-3.  AIM 1 was addressed in IRB #207297.   
Study Design and Procedures 
Human Subjects Involvement, Characteristics, and Design:  Given the scope of inquiry and 
proposed project’s aims, criminal justice (CJ) involved individuals are the human subjects of this 
project. Our research team understands that CJ-involved individuals represent a vulnerable 
population, as the correctional setting may be perceived as a coercive environment. Therefore, 
all research must be conducted with rigorous ethical standards and with numerous safeguards in 
place to protect participants. A 2006 Institute of Medicine report on research involving prisoners 
called for the following requirements: 
1) a risk-benefit approach, whereby the potential benefits of the research to the prisoners 
outweigh the potential risks; 
2) research should be conducted with “collaborative responsibility,” referring to the idea that 
the design and implementation of the research should include the input of all relevant 
parties (including prisoners and correctional administrators); 
3) voluntary informed consent must be obtained, and privacy maximized; and  

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 7 
4) research must be monitored throughout the course of the study in order to verify 
compliance with approved protocols and to detect and report adverse events. The 
research plan described in this application complies with all of these requirements. Below 
each aim and the relevant human participants’ involvement, characteristics and design 
are described. 
There will be two groups that participants can be assigned to if they choose to participate in the 
study. Each person will be randomly assigned to one of these groups.  One group will provide 
information about PrEP and HIV prevention and referral to PrEP clinics in the community.  The 
second group will the same as the first group but will also provide access to a CHW who will 
assist them with getting to a PrEP clinic and also helping them with other needs they may have. 
A member from the study team will review the informed consent documents with the prospective 
participants and ask them questions to make sure they are eligible to participate in this study 
(PrEP-LINK eligibility and demographic screening form).  Their responses to the prescreen form 
will not be shared with anyone outside of the study and will not contain any identifying 
information. They will be kept completely private, and will be in a password protected, encrypted 
database on a secured server at UAMS that can only be accessed by designated study staff. 
Before we collect this information, we ask that participants provide their name so that we can 
assign a 9-digit study-ID number to de-identify their responses.  Names will be stored separately 
from responses in locked filing cabinet in a secured office and will never be connected. At the 
end of the study, the link between the name and the study ID will be permanently destroyed. 
Random Assignment to Study Condition. Once qualified for the study, we will randomly assign 
them to one of the two study groups. Once assigned to a group, after the completion of the  
Table 4: Points of Contact for each Assessment for Aims 2 and 3 
Type of Visit 
Assessment 
Location 
Eligibility Screen 
Education and Screening for initial PrEP 
indication including HIV rapid testing or 
self-report of recent negative HIV test 
within correctional facility  
Pulaski County Jail, Central Arkansas 
Community Corrections Center, East 
Central Arkansas Community 
Corrections Center, Hidden Creek 
Opportunity Center, Quality Living 
Center, Better Community 
Development, Inc.  
Consent, Enrollment 
Baseline Research Assessment 
CED Core community site 
Presentation at PrEP Program for PrEP 
prescription dispensed 
Baseline Research Assessment 
Community based PrEP Provider 
PrEP intervention sessions 
Adherence assessment (self-report 
only), sexual risk ACASI, post-
incarceration issues and HIV risk only 
Community based PrEP provider or CED 
Core Community site 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 8 
Short-term follow up assessment 
Full assessment battery, including 
adherence assessment (self-report and 
clinical chart abstraction) 
CED Core community site 
Long-term follow up assessment 
Full assessment battery, including 
adherence assessment (self-report and 
clinical chart abstraction) 
CED Core community site 
 
baseline data collection measures the study research assistant will inform the community health 
worker and the participant to what group they were assigned to.  
The participants will take place in the following activities over the course of 12 months:  
 
An HIV test using the FDA-approved OraQUICK ADVANCE® Rapid HIV Antibody Tests 
or self-report of recent (within 12 months) HIV test within correctional facility. 
o If HIV rapid testing is completed during eligibility screening visit, during the 
testing process the participant will receive:  
(1) Pre-test counseling: A member of the research team, who has been trained 
by the Arkansas Department of Health to perform HIV counseling, will provide 
information on HIV and the meanings of a positive and negative test. Participants 
will have an opportunity to ask questions and will be offered prevention 
counseling.  
(2) HIV testing: To test for HIV, a member of the research team will use the FDA 
approved OraQUICK ADVANCE® Rapid HIV Antibody Test.  
(3) Post-test counseling: They will find out the results of their HIV test about 20 
minutes after being tested. A member of the research team will go over the 
results of the test and engage in routine post-test counseling. 
If tested positive for HIV, we will refer to the Arkansas Health Department for 
confirmatory testing and medical care. Study staff will also follow up to see if they 
received a confirmatory test. Additionally, any information collected up to that 
point will be destroyed and their participation in the study will be complete.  
o All participants will receive: 
(4) PrEP counseling: Following screening and after the completion of the 
baseline assessment survey, participants will receive information about PrEP 
using materials developed by the Centers for Disease Control and Prevention 
(CDC). This includesa brochure that lists local clinics where PrEP is available 
and how to make an appointment. 
 
If they decide to initiate PrEP, they will be prescribed PrEP medications 
by a physician in accordance with routine clinical care at their local PrEP 
clinic in the community. 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 9 
Only participants who test negative for HIV on their rapid test will be eligible to participate in the 
study. Individuals in the jail with a preliminary positive HIV test result will be immediately 
referred to the jail medical division, operated by TurnKey, Inc. for confirmatory testing.  
Individuals tested in the community will be immediately referred to the Arkansas Department of 
Health for confirmatory testing. 
o A baseline assessment survey (SEE: PrEP-LINK Baseline Battery) to be used during all 
3 data collection time points (baseline, 6-month and 12-month) 
o The baseline assessment survey will ask questions about education, job status, 
criminal justice history, substance use, sexual behaviors, and other behaviors 
which may put individuals at risk for HIV, in addition to questions on knowledge 
and interest in PrEP. 
o The baseline assessment survey includes the following measures and it to be 
used in both Specific Aims 2 & 3:  
Measure Name 
Citation 
Baseline 
Battery 
Page 
Number 
Notes 
PrEp-LINK Cover 
Sheet 
Compiled for this study by the PIs 
1 
For 
internal 
tracking 
purposes 
Demographics 
 
Compiled for this study by the PIs 
2-5 
 
Criminal Justice 
Involvement 
History  
 
Compiled for this study by the PIs 
5-6 
 
Health Insurance  
 
Compiled for this study by the PIs 
6 
 
HIV Sex Risk 
Perception 
 
Compiled for this study by the PIs 
7 
 
Income (ASI Lite) 
 
McLellan, A.T., Luborsky, L., O’Brien, C.P. & Woody, G.E. 
(1980). An improved diagnostic instrument for substance 
abuse patients: The Addiction Severity Index. Journal of 
Nervous & Mental Diseases, 168, 26-33 
8-9 
 
PrEP Knowledge ( 
PrEP Knowledge 
Scale, RADAR) 
 
Parsons, J. T., Rendina, H. J., Lassiter, J. M., Whitfield, T. H., 
Starks, T. J., & Grov, C. (2017). Uptake of HIV pre-exposure 
prophylaxis (PrEP) in a national cohort of gay and bisexual 
men in the United States: the motivational PrEP 
cascade. Journal of acquired immune deficiency syndromes 
(1999), 74(3), 285. 
 
10 
 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 10 
PrEP Attitude 
McLellan, A.T., Luborsky, L., O’Brien, C.P. & Woody, G.E. 
(1980). An improved diagnostic instrument for substance 
abuse patients: The Addiction Severity Index. Journal of 
Nervous & Mental Diseases, 168, 26-33 
 
11 
 
PrEP Use 
 
Morgan E, Moran K, Ryan DT, Mustanski B, Newcomb ME. 
Threefold increase in PrEP uptake over time with high 
adherence among young men who have sex with men in 
Chicago. AIDS Behav. 2018; 22(1):3637-3644. 
 
12-14 
 
PrEP Adherence  
 
Chesney M.A., Ickovics J.R., Chambers D.B., Gifford, A.L., 
Neidig, J., Zwickl, B., & Wu, A.W.  
(2000). Self-reported adherence to antiretroviral 
medications among participants in HIV clinical  
trials: the AACTG adherence instruments. AIDS Care - 
Psychological and Socio-Medical Aspect  
of AIDS/HIV, 12, 255-266. 
 
Centers for Disease Control and Prevention. (2015). Medical 
Monitoring Project (MMP). Retrieved December 17th, 
2017, from 
https://www.cdc.gov/hiv/pdf/statistics/systems/mmp/CDC-
HIV-MMP-Questionnaire-2015-2017-EN.pdf 
 
Morgan E, Moran K, Ryan DT, Mustanski B, Newcomb ME. 
Threefold increase in PrEP uptake over time with high 
adherence among young men who have sex with men in 
Chicago. AIDS Behav. 2018; 22(1):3637-3644. 
 
 
15-16 
 
HIV Attitudes 
(Perceived Risk of 
HIV Scale) 
 
Napper, L.E., Fisher, D.G., & Reynolds, G.L.(2012). 
Development of the Perceived Risk of HIV Scale. AIDS and 
Behavior, 16(4), 1075-1083. 
 
17-18 
 
HIV Risk – 30 Days 
(Texas Christian 
University 
HIV/Hepatitis Risk 
Assessment) 
 
Simpson, D.D., Camacho, L.M., Vogtsberger, K.N., Williams, 
M.L., Stephens, R.C., Jones, A., & Watson, D.D. (1994). 
Reducing AIDS risks through community outreach 
interventions for drug injectors. Psychology of Addictive 
Behaviors, 8, 86–101. 
 
19-20 
 
Alcohol  Use  
(AUDIT) 
 
Martin S, Glynn TR. Alcohol Use Disorder Identification Test. 
In: The SAGE Encyclopedia of Alcohol: Social, Cultural, and 
Historical Perspectives. ; 2015. 
doi:10.4135/9781483331096.n19 
21-22 
 
Substance Use 
(ASI Lite) 
McLellan, A.T., Luborsky, L., O’Brien, C.P. & Woody, G.E. 
(1980). An improved diagnostic instrument for substance 
23-28 
 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 11 
abuse patients: The Addiction Severity Index. Journal of 
Nervous & Mental Diseases, 168, 26-33 
Drug Overdose  
 
Compiled for this study by the PIs 
29-30 
 
Trauma 
(Traumatic Life 
Events Checklist) 
Based on Life Events Checklist by: Gray, M., Litz, B., Hsu, J., 
& Lombardo, T. (2004). Psychometric properties of the Life 
Events Checklist. Assessment, 11, 330-341. doi: 
10.1177/1073191104269954v 
Weathers, F.W., Blake, D.D., Schnurr, P.P., Kaloupek, D.G., 
Marx, B.P., & Keane, T.M. (2013). The Life Events Checklist 
for DSM-5 (LEC-5). Instrument available from the National 
Center for PTSD at www.ptsd.va.gov 
 
31-32 
 
Depression 
(Patient Health 
Questionnaire – 9 
item version for 
Depression 
Symptoms) 
 
Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The Phq‐
9. Journal of general internal medicine, 16(9), 606-613. 
 
33 
 
Discrimination 
(Major 
Experiences of 
Discrimination 
Scale) 
 
 
Williams, D.R., Yu, Y., Jackson, J.S., & Anderson, N.B. (1997). 
Racial differences in physical and mental health: 
Socioeconomic status, stress, and discrimination. Journal of 
Health Psychology, 2(3), 335 -351 
 
34-37 
 
Healthcare Access 
 
National Health Interview Survey(CDC, 2018) 
38-42 
 
Health and 
Utilization 
RAND-36 Item Health Survey, ASI Lite, Medial Mistrust 
Survey, Commonwealth survey, survey on Disparities in 
quality of Health Care 2001 
43-44 
 
Medical Mistrust 
 
Medical Mistrust Index v2.2 
45-47 
 
Social Support 
(Multidimensional 
Scale of Perceived 
Social Support) 
 
Zimet, G.D., Dahlem, N.W., Zimet, S.G. & Farley, G.K. (1988). 
The Multidimensional Scale of Perceived Social Support. 
Journal of Personality Assessment, 52, 30-41. 
 
48 
 
Civic Engagement  
 
Compiled for this study by the PIs 
49 
 
 
o HIPAA Authorization Form 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 12 
o This will be completed at baseline to allow the research team to collect 
medical records at the end of participation in the intervention regarding 
when participant first started taking PrEP medication and how often 
participant took PrEP medication.  
o The following will be collected from the PrEP Clinic during participation in 
the study (12 months).  
 When participant first started taking PrEP medication  for HIV 
prevention 
 How often participant took PrEP medication for HIV prevention 
o Medical Records Release (HIPAA Release of Information to UAMS) 
o This will be collected at any time throughout the study once a participant 
has selected a specific PrEP provider, for medical records to be collected 
by UAMS for the duration of their participation in the intervention regarding 
PrEP initiation and adherence. 
 
Follow-Up Assessments. Everyone will be asked to do follow-up assessments below: 
3 Month Locator Check in:  
After 3 months, a member of the study team will contact the participant to see how they are 
doing (PrEP-LINK Locator Form).  
6 Month Assessment (Visit 2): 
Participants will complete a survey that will take approximately one hour at a public location in 
Little Rock that is convenient for them (See: PrEP-LINK Baseline Battery). This may be UAMS, 
local PrEP clinic, a public library, or other private meeting room. This may also take place over 
the phone, Zoom, FaceTime, or other platform preferred by the participant to allow for social 
distancing during the Covid-19 pandemic. 
9 Month Locator Check in:  
After 9 months, a member of the study team will contact them to see how they are doing (PrEP-
LINK Locator Form). 
12 Month Assessment (Visit 3): 
Participants will complete a survey that will take approximately one hour at a public location in 
Little Rock that is convenient for them (See: PrEP-LINK Baseline Battery). This may be UAMS, 
local PrEP clinic, a public library, or other private meeting room. This may also take place over 
the phone, Zoom, FaceTime, or other platform preferred by the participant to allow for social 
distancing during the Covid-19 pandemic. 
 
Individuals who are eligible and willing to participate will be involved in the study for 12-months. 
All participants will complete 3 in-person interviews every 6 months and will receive $40 for their 
initial visit and $40 for the 6-month and 12-month follow up visits. Participants will also complete 
2 brief phone check-ins between interviews, after which they will receive an additional $10 
during their next in-person visit. Participants completing each interview and check-in will receive 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 13 
$140 for their time. During the first and last study visit, participants will need to complete a 
saliva/spit based HIV screening test.  
Maintaining Contact. Because the study will take place over about 12 months after the 
participant’s enrollment date, it will be important for us to be able to keep in contact with them. 
During each visit, we will ask for information that will help us contact them in the community in 
order to schedule study related appointments. We will ask for many ways to try to reach the 
participant’s in case their phone number is disconnected or changed. We will contact them 
regularly to update your contact information. Participants will be considered to have missed a 6 
or 12 month assessment 60 days after the target assessment date, and will be eligible 30 days 
before target assessment date. Research staff will make at least 3 contact attempts to reach 
participants for the 3 month and 9 month locator check in, with the goal of updating contact 
information. 
Study Population 
Participants will be enrolled in the proposed PrEP-LINK intervention who are HIV-uninfected 
and detained in the Pulaski County jail or individuals who are within 30 days of having been 
released from a correctional setting.  We will work with jail staff to identify individuals who are 
within 2 weeks of discharge and will conduct screenings among these individuals to determine 
study eligibility. We will also work with Central Arkansas Community Corrections and local re-
entry centers to identify individuals who have been released from incarceration within 30 days. 
Because many types of HIV related risks are present in this population (e.g. MSM or PWID), we 
will recruit participants from the following groups: MSM, PWID and heterosexual non-substance 
users (more participants may be enrolled, as needed).  For the final two categories, (PWID and 
heterosexuals), we will recruit equal numbers of men and women. The recruitment will be 
completed when 120 individuals have been consented to have 100 participants complete the 
protocol.  
Inclusion criteria include: 1) being at least 18 years old; 2) having at least one self-reported HIV 
risk factor; and 3) currently incarcerated in the Pulaski County Jail or recently released (within 
30 days) from a correctional facility and residing in Central Arkansas.  We will employ three 
primary methods of recruitment. The first will be educational groups in which a member of the 
study team will conduct weekly health related education sessions in the jail pertaining to HIV 
and prevention. Promotion of this health and wellness class will be conducted by fliers being 
posted in the jail facility outlining how detainees can enroll in the class provided by UAMS.  We 
will indicate to both jail staff and to potential participants (during the beginning of each session) 
that these sessions are research related and strictly voluntary.  We will also clearly state to jail 
staff to specifically tell jail detainees that participation in these session is voluntary and that the 
sessions are part of an ongoing research study. Among individuals who participate in these 
sessions, a member of the study team will approach potential participants individually, briefly 
explain the purpose and procedures for the intervention, and ask them if they wish to participate 
in the baseline interview expected to last about 60 to 90 minutes. The second method of 
recruitment will be through local Community Corrections facilities and re-entry centers. Ms. 
Jackson will hold educational sessions at the recruitment sites (either in person or over Zoom 
for safety during the Covid-19 pandemic) where she will inform people about the study and 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 14 
conduct eligibility screeners with those who are interested, with the help of Research Assistants.   
All procedures will be reviewed by the UAMS institutional review board before the study begins.  
The PI has significant experience (nearly 15 years) with CJ-related research protocols. 
Inclusion Criteria: 
1) Age greater than or equal to 18 at study enrollment 
2) Able to understand and speak English and to provide written and verbal informed consent. 
3) Able to provide reliable pieces of locator information (e.g. mailing address, phone number, 
email address, places frequently visited, etc.) 
4) HIV negative confirmed through an on-site rapid HIV test or self-reported recent (within 12 
months) negative HIV test within a correctional facility 
5) Recently released from the Pulaski County Regional Detention Facility into the community 
and not into another detention facility or recently released (within 30 days) from a 
correctional facility and residing in Central Arkansas. 
6) At substantial risk for HIV as determined by CDC/WHO PrEP guidelines, which includes 
engaging in any of the following behaviors in the last six months: 
 
Having condomless vaginal or anal sex with more than one partner, 
 
Having a sex partner with one or more HIV risk (e.g. PWID, a sex worker), 
 
Being diagnosed with a STI, 
 
Reporting history of sharing injection material/equipment, or 
 
Having a sexual partner who is HIV positive.  
Exclusion Criteria 
Potential participants unable to provide informed consent, including people with severe mental 
illness requiring immediate treatment or with mental illness limiting their ability to participate 
(e.g., dementia), will be excluded. 
Risks and Benefits 
While the risks related to human subjects’ participation in this study are minimal, we 
acknowledge that the possibility of harm to participants does exist.  We recognize that 
participants will be asked to provide potentially sensitive information (including illicit substance 
use and sexual risk behaviors and criminal justice involvement) and therefore may experience 
discomfort, anxiety, or stress in responding to certain study questions. As such, as part of the 
informed consent procedure, participants will be advised that their answers will be confidential, 
and issues discussed will in no way impact their criminal justice status, nor ability to obtain or be 
referred to medical care or social services. At the start of the interview, participants will be 
informed that they can skip and refuse to answer any questions that they may find 
uncomfortable or embarrassing. 
The potential benefits to participants include reduction in risk of HIV acquisition with use of pre-

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 15 
exposure prophylaxis. If effective, the proposed intervention is likely to substantially improve 
adherence to PrEP and thereby increase the efficacy of the medication in preventing HIV 
seroconversion, particularly among individuals with criminal justice experience. Reduction in the 
incidence of HIV infection among individuals enrolled is also likely to lead to decreased 
transmission in the community as a whole. Study participants will be compensated for their 
participation. Some may feel empowered by being involved in research that may impact 
correctional and community health policy and practice and may enjoy the interaction with 
members of the study team.  
Data Handling and Recordkeeping 
Protecting Confidentiality: All members of the research team will treat participant data with the 
strictest attention to confidentiality. Data will be collected from participants in settings in the 
community and in correctional facilities in such a way that neither privacy nor confidentiality is 
compromised. All records and data will be safeguarded in accordance with the policies of the 
participating IRB. Questionnaires will not include participants’ name or any other identifying 
information.  Data for this phase of the study will be brief eligibility screens study (see Appendix 
PrEP-LINK eligibility and demographic screening form) and the baseline surveying tool (see 
Appendix PrEP-LINK Baseline Battery).  Only members of the study team (PI Dr. Zaller, co-Is Dr. 
Marshall and the study RAs, Heather Horton and Brooklyn Tody) will have access to the data. At 
the conclusion of the study, the data will be stored electronically until analyses are completed.  
Electronic Data will be kept for the requisite 7 years, as per UAMS administrative guidelines.   
Before we collect any information, we ask that participants provide their name so that we can 
assign a 9-digit study-ID number to de-identify their responses. Names will be stored separately 
from responses in locked filing cabinet in a secured office and will never be connected. At the 
end of the study, the link between the name and the study ID will be permanently destroyed. 
The participant ID link file will be kept separately in a password-protected folder/document on a 
secure UAMS server. All locator forms will be stored separately from the responses and 
destroyed at the completion of data collection.  
Data Analysis 
Measures. The primary intervention measures, including common measure across both studies 
are provided above in the description of Aim 2.  As part of Aim 3, data will be collected at all 
follow-up time points (3, 6 and 12 months) by the study RA. Additional measures are provided 
below. 
Additional Secondary Measures for Aim 3  
1) PrEP adherence. Self-reported PrEP adherence will supplement clinical chart 
abstraction. An assessment of the optimal period for self-reported antiretroviral adherence 
(using electronic monitoring data as the standard for predictive validity) found that longer time 
periods (e.g., 30 days versus 4 days) were more accurate for assessing adherence than shorter 
time periods.51 Therefore, we will use adherence over a 30-day period as self-reported 
adherence outcome. 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 16 
2) HIV risk behaviors/behavioral adjustment. Participants’ HIV-transmission risk 
behaviors will be assessed with the TCU HIV/AIDS Risk Assessment, which is designed 
specifically for CJ-involved individuals,52 at all three data collection time points. We will collect 
more detailed data on sexual behaviors, including number of sexual partners, sexual activities, 
and condom use based on EXPLORE study measures. These measures are valid and reliable 
among high-risk men.53 
3) Substance use. Participants’ alcohol use will be measured with the Alcohol Use 
Disorders Identification Test - Consumption (AUDIT-C) and the Addiction Severity Index - Lite 
(ASI-Lite), both of which have been validated for use with diverse populations (e.g., African 
American, Hispanic/Latino, and White).56  
Data analysis. Data analysis will focus on the feasibility, acceptability, and preliminary 
efficacy of the PrEP-LINK pilot intervention. 
 The feasibility of the intervention will be determined by the proportion of participants 
who are screened, enrolled, and subsequently complete the PrEP-LINK intervention.  To 
determine the feasibility of conducting an RCT, we will track the number of jail-involved 
individuals who express interest in the study and who are determined eligible for participation.  
Among these, we will calculate the percentages of those who reported being interested who 
were actually eligible; the number eligible who were successfully recruited and consented; 
randomized; and assessed at baseline, 3, 6, and 12 months (enrollment and completion of 
study related activities for >80% will indicate study feasibility).  We will relay in individual 
detainees self-reporting in interest in participating in the study in the following ways.  Firstly, the 
study CHW will be conducting weekly educational sessions.  At the end of these sessions, 
individuals can disclose through an evaluation form whether or not they are interested in the 
study and if they are, a member of the study team will set up a follow up appointment to assess 
eligibility.  The second way is direct referrals from the medical staff who may, with the 
permission of the detainee, make a referral to the study for eligibility assessment.  The third 
method of recruitment will be through local Community Corrections facilities and re-entry 
centers. The study CHW will hold educational sessions at the recruitment sites (either in person 
or over Zoom for safety during the Covid-19 pandemic) where she will inform people about the 
study and conduct eligibility screeners with those who are interested, with the help of the 
research team.  
 
 The acceptability of the intervention will be determined with descriptive statistics of the 
participants’ acceptability ratings, including whether they think the intervention is acceptable. 
Acceptability is define as > 80% of participants expressing high satisfaction with the intervention 
based on the Client Satisfaction Questionnaire - Revised. We will also review data collected by 
the study staff about time spent on the intervention and the ease of following the research and 
intervention protocols.  
 
The preliminary efficacy of the intervention will be determined by assessing the primary 
outcome of PrEP uptake by looking at the medical charts of the participants. A secondary 
outcome will be PrEP adherence defined by participants who were adherent to the medication 
determined by self-report at 3, 6, and 12 months. Following intent-to-treat (ITT) principles, all 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 17 
randomized participants will be included in data analyses. Standard bivariate analytic 
techniques, such as Spearman rank-order correlations, odds ratios, and Fisher's exact tests, will 
be used to assess preliminary associations between the intervention and each measure of PrEP 
uptake and to identify factors associated with the outcomes. Generalized linear regression 
models will be informed by these bivariate analyses. 
In addition, we will test the randomization process by comparing the baseline 
demographic and confounding variables of the participants in each arm with Fisher's exact test 
for dichotomous variables, chi-square tests for nominal variables, t-tests for normally distributed 
continuous variables, and Wilcoxon signed-rank tests for non-normally distributed continuous 
variables, with statistical significance determined at alpha < 0.05. Any variable for which 
randomization does not result in equal proportions in each arm will be incorporated into the 
multiple-regression models as a potential confounding variable. Attrition effects will be evaluated 
by testing whether systematic differences exist between those participants who complete the 
research versus those who drop out. Thus, we can determine any potential bias introduced by 
attrition from the study. 
The primary analysis will compare uptake of PrEP by looking at the medical charts of the 
participants and self-reported behaviors of PrEP usage at the 3, 6, and 12 month visits between 
the study arms. Changes in self-reported adherence (verification with clinical chart abstraction, 
including lab tests for serum levels of medications), sexual behavior adjustment, post-
incarceration contextual variables, and substance use will also be examined. Moreover, group 
differences in PrEP uptake, time-to-uptake, and number of PrEP clinic appointments kept will be 
compared. All analyses will use two-tailed tests of significance, with significance at alpha = 0.05. 
We will use generalized linear models with properly chosen link functions to analyze longitudinal 
data for each study aim. These models will be estimated with generalized estimating equations 
that use robust standard error estimates57,58; they provide an extension of regression analysis to 
the case of correlated or repeated observations and allow for the inclusion of categorical and 
count-dependent variables and for appropriate modeling of covariance structures when 
observations are correlated across time.  
Power Calculations. Because this is a pilot study, the primary emphasis will be on the 
acceptability and feasibility of the two arms; hence, power is limited to determine efficacy of the 
intervention. We used GPower59 software to estimate the difference in proportions between the 
two groups, with respect to PrEP-LINKage, that could be detected with 80% power. Given 40 
participants per group (total n = 80), one-tailed alpha = .05, and a proportion of 0.5 for the 
control group, we will have 80% power to detect a 0.26 difference in proportions between 
groups. 
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations 
and University of Arkansas for Medical Sciences research policies and procedures.  This 
protocol and any amendments will be submitted and approved by the UAMS Institutional 
Review Board (IRB) to conduct the study.   

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 18 
The informed consent process will include a detailed verbal description of the study by a study 
staff member. The study staff will ask participants a series of questions to ensure that the 
information contained in the consent form is clearly understood by the participants prior to 
consenting to participation. Study staff will emphasize that participation is voluntary. Potential 
subjects will participate in an item-by-item reading of the consent from with the study staff 
person. 
The consent process will take place in a quiet and private room (either in a small conference 
room in the jail, Community Corrections and re-entry centers, or in a community location), and 
participants may take as much time as needed to make a decision about their participation. The 
consent process may also take place over the phone, Zoom, FaceTime, or other platform 
preferred by the participant to allow for social distancing during the Covid-19 pandemic. 
Participation privacy will be maintained and questions regarding participation will be answered. 
No coercion or undue influence will be used in the consent process.   
 
In addition, we have a Certificate of Confidentiality from the National Institutes of Health. The 
purpose of this certificate is to protect the identity of research subjects participating in studies that 
collect sensitive information. Because this application proposes to collect detailed HIV sexual and 
substance use behavior among those with criminal justice system involvement, a Certificate of 
Confidentiality is necessary.  
 
Dissemination of Data 
Results of this study may be used for presentations, posters, or publications. The publications 
will not contain any identifiable information that could be linked to a participant. 
 
 

Title: 
Linking High-Risk Jail Detainees to HIV pre-exposure Prophylaxis:  PrEP-LINK 
PI: 
Zaller, Nickolas 
Site: 
University of Arkansas for Medical Sciences 
 
Version #: 6.0 
 
IRB# 239250 
Date:  06/08/2022 
Page 19 
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