Expression of Stress Markers in MSM Living With HIV Receiving Contingency Management for Methamphetamine Use Disorder
Phase: NA
Conditions: Substance-Related Disorders, HIV
Sponsor: University of California, Los Angeles

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 1 of 42
Protocol Template Effective: 10 May 2016  
University of California, Los Angeles 
Michael Li, PhD, MPH 
Clinical Research Protocol 
Expression of stress markers in MSM living with HIV receiving contingency management for 
methamphetamine use disorder (a.k.a. “EXPRESS+”) 
 
Protocol Number: 
IRB#20-001564 
Version Date: 
07/08/2022 
Investigational Product: 
N/A 
IND Number: 
N/A 
Development Phase: 
 
Sponsor: 
Michael Li, PhD, MPH 
Department of Family Medicine 
10880 Wilshire Blvd, Ste. 1800, Los Angeles, CA 90024 
Funding Organization: 
National Institute on Drug Abuse 
Principal Investigator: 
Name: Michael Li, PhD, MPH 
 
Telephone: 310-794-8530 
 
Fax: 
 
 
E-mail: mjli@mednet.ucla.edu  
 
Coordinating Center: 
UCLA  
 
Approval: 
 
 
07/08/2022 
PI or Sponsor Signature (Name and Title)  
 
Date 
This confidential information about an investigational product is provided for the exclusive use of 
investigators of this product and is subject to recall at any time.  The information in this document 
may not be disclosed unless federal or state law or regulations require such disclosure.  Subject to the 
foregoing, this information may be disclosed only to those persons involved in the study who have a 
need to know, with the obligation not to further disseminate this information.   

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 2 of 42
Protocol Template Effective: 10 May 2016  
PROTOCOL AGREEMENT 
 
I have read the protocol specified below. In my formal capacity as Investigator, my duties 
include ensuring the safety of the study subjects enrolled under my supervision and providing 
National Institutes of Health with complete and timely information, as outlined in the protocol.  
It is understood that all information pertaining to the study will be held strictly confidential and 
that this confidentiality requirement applies to all study staff at this site. Furthermore, on behalf 
of the study staff and myself, I agree to maintain the procedures required to carry out the study in 
accordance with accepted GCP principles and to abide by the terms of this protocol. 
 
Protocol Number:   
 
Protocol Title:  Expression of stress markers in MSM living with HIV receiving contingency 
management for methamphetamine use disorder (a.k.a. “EXPRESS+”) 
 
Protocol Date:  07/08/2022 
 
 
07/08/2022 
Investigator Signature  
 
Date 
Michael Li, MPH, PhD / Postdoctoral Fellow (Appointment to Assistant Professor In-
Residence pending) 
Print Name and Title 
Site # 
 
 
Site Name 
UCLA Vine Street Clinic 
Address 
910 Vine Street 
 
Los Angeles, CA 90038 
Phone Number 
(323) 461-3106 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 3 of 42
Protocol Template Effective: 10 May 2016  
Table of Contents 
1 
BACKGROUND 
 
1.1 
Treatment of methamphetamine use disorder and management of HIV  
 
1.2 
A social genomics perspective on METH treatment outcomes  
 
2 
STUDY RATIONALE 
 
2.1 
Risk / Benefit Assessment 
 
3 
STUDY OBJECTIVES 
 
3.1 
Primary Objective 
 
3.2 
Secondary Objectives 
 
4 
STUDY DESIGN 
 
4.1 
Study Overview 
 
5 
CRITERIA FOR EVALUATION 
 
5.1 
Primary Efficacy Endpoint 
 
5.2 
Secondary Efficacy Endpoints 
 
5.3 
Safety Evaluations 
 
5.4 
Other Evaluations 
 
6 
SUBJECT SELECTION 
 
6.1 
Study Population 
 
6.2 
Inclusion Criteria 
 
6.3 
Exclusion Criteria 
 
7 
CONCURRENT MEDICATIONS 
 
7.1 
Allowed Medications and Treatments 
 
8 
STUDY TREATMENTS 
 
8.1 
Method of Assigning Subjects to Treatment Groups 
 
8.2 
Treatment Schedule 
 
8.3 
Measures of Treatment Compliance 
 
9 
STUDY PROCEDURES AND GUIDELINES 
 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 4 of 42
Protocol Template Effective: 10 May 2016  
9.1 
Clinical Assessments 
 
9.1.1 
Concomitant Medications 
 
9.1.2 
Demographics 
 
9.1.3 
Adverse Events 
 
9.2 
Clinical Laboratory Measurements 
 
9.2.1 
Urine drug testing 
 
9.2.2 
HIV viral load 
9.2.3 
COVID-19 immunoassay 
 
 
9.3 
Research Laboratory Measurements 
 
9.3.1 
Leukocyte transcriptome profiling – Conserved transcriptional response to 
adversity (CTRA)  
 
10 EVALUATIONS BY VISIT 
 
10.1 Screening (Visit S)  
 
10.2 Baseline (Visit B, one week before Visit 1.1)  
 
10.3 Weeks 1-3 (Visits 1.1-3.2)   
10.4 Week 4 (Visits 4.1-4.2) 
10.5 Weeks 5-7 (Visits 5.1-7.2) 
10.6 Week 8 (Visits 8.1-8.2) 
10.7 Week 12 (Visit 12.0) 
10.8 Early withdrawal appointment 
10.9 Baseline, Week 4, Week 8, and Week 12 (Only control group)  
11 ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION 
 
11.1 Adverse Events 
 
11.2 Serious Adverse Experiences (SAE) 
 
11.2.1 Serious Adverse Experience Reporting 
 
11.3 Medical Monitoring 
 
12 DISCONTINUATION AND REPLACEMENT OF SUBJECTS 
 
12.1 Early Discontinuation of Behavioral Intervention 
 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 5 of 42
Protocol Template Effective: 10 May 2016  
12.3 Withdrawal of Subjects from the Study 
 
12.4 Replacement of Subjects 
 
13 PROTOCOL VIOLATIONS 
 
14 DATA SAFETY MONITORING 
 
15 STATISTICAL METHODS AND CONSIDERATIONS 
 
15.1 Data Sets Analyzed 
 
15.2 Demographic and Baseline Characteristics 
 
15.3 Analysis of Primary Endpoint 
 
15.4 Analysis of Secondary Endpoints 
 
15.5 Interim Analysis 
15.6 Multivariate Analysis for Associations Between Endpoints 
15.7 Sample Size and Randomization 
 
16 DATA COLLECTION, RETENTION AND MONITORING 
 
16.1 Data Collection Instruments 
 
16.2 Data Management Procedures 
 
16.3 Data Quality Control and Reporting 
 
16.4 Archival of Data 
 
16.5 Availability and Retention of Investigational Records 
 
16.6 Monitoring 
 
16.7 Subject Confidentiality 
 
17 ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS 
 
17.1 Protocol Amendments 
 
17.2 Institutional Review Boards and Independent Ethics Committees 
 
17.3 Informed Consent Form 
 
17.4 Publications 
 
17.5 Investigator Responsibilities 
 
LIST OF ABBREVIATIONS 
 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 6 of 42
Protocol Template Effective: 10 May 2016  
AE 
adverse event 
CFR 
Code of Federal Regulations 
CRF 
case report form 
CTRA 
conserved transcriptional response to adversity
DMC 
Data Monitoring Committee 
DSMB 
Data Safety Monitoring Board 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
MA 
methamphetamine
MSM 
men who have sex with men
MUD 
methamphetamine use disorder
PI 
Principal Investigator 
SAE 
serious adverse experience 
SCID-5 
The Structured Clinical Interview for DSM-5
VL 
viral load 
 
 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 7 of 42
Protocol Template Effective: 10 May 2016  
 
PROTOCOL SYNOPSIS 
TITLE 
Expression of stress markers in MSM living with HIV receiving 
contingency management for methamphetamine use disorder (a.k.a. 
“EXPRESS+”) 
 
 
SPONSOR 
Michael Li, PhD, MPH 
 
 
FUNDING 
ORGANIZATION 
 
NUMBER OF SITES 
1 
 
 
RATIONALE 
Determining whether a patient is both feeling better and improving 
physiologically when treating people living with HIV (PLWH) for 
methamphetamine use disorder requires identification of a clinically 
significant measure separate from abstinence. This study will to 
address this challenge by testing a gene expression (mRNA) pattern 
identified by the field of social genomics, which may provide insight 
into both psychosocial health and biological processes that impact 
chronic disease risk in PLWH receiving MUD treatment.  
 
 
STUDY DESIGN 
This is a within-subjects, two-arm clinical trial with 35 HIV-positive 
MSM receiving contingency management for treatment of 
methamphetamine use disorder and 20 HIV-positive MSM serving as 
a non-substance-using healthy control (N=55 total). 
 
 
PRIMARY 
OBJECTIVE 
To investigate whether differences in CTRA expression (mRNA) 
coincide with differences in methamphetamine use and viral load over 
the course of 12 weeks in HIV-positive MSM with and without 
methamphetamine use disorder. 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 8 of 42
Protocol Template Effective: 10 May 2016  
 
 
SECONDARY 
OBJECTIVES 
 To investigate whether differences in seven psychosocial 
dimensions of drug addiction (Short Inventory of Problems 
Revised (SIP-R))—physical, social, intrapersonal, interpersonal, 
impulse control—are associated with differences in CTRA gene 
expression. 
 
To conduct an exploratory pilot investigation to determine the 
degree to which CTRA mediates the association between METH 
use and viral suppression. 
 
 
NUMBER OF 
SUBJECTS 
55 
 
 
SUBJECT 
SELECTION 
CRITERIA 
Inclusion Criteria 
HIV-positive MSM with MUD in the contingency management 
condition (N = 35) 
1. Assigned male sex at birth 
2. 18 to 45 years of age 
3. Reports having sex with men in the past 12 months. 
4. HIV-positive (confirmed by certification or by HIV rapid test) 
5. Has an HIV care provider (last seen in the past 12 months) 
6. Has a current antiretroviral prescription 
7. Meets the DSM-5 criteria for MUD using SCID-5 
8. Urine test is positive for MA within 30 days of their screening 
visit 
9. Seeking treatment for MUD. 
10. Ability to attend twice weekly appointments for drug testing 
and treatment 
HIV-positive MSM non-substance-using control (N = 20) 
1. Assigned male sex at birth 
2. 18 to 45 years of age 
3. Reports having sex with men in the past 12 months. 
4. HIV-positive (confirmed by certification or by HIV rapid test) 
5. Has an HIV care provider (last seen in the past 12 months)

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 9 of 42
Protocol Template Effective: 10 May 2016  
6. Has a current antiretroviral prescription 
 
Exclusion Criteria 
HIV-positive MSM with MUD in the contingency management 
condition (N = 35) 
1. Identifies as (cis- or transgender) female 
2. Reports another current or past substance use disorder 
3. Reports being in another intervention or clinical trial for 
substance use 
4. Positive test for opioids, cocaine, and/or MDMA 
HIV-positive MSM non-substance-using control (N = 20) 
1. Identifies as (cis- or transgender) female 
2. Positive test for MA, opioids, cocaine, and/or MDMA.   
3. Reports substance use (MA, opioids, cocaine, MDMA, 
hallucinogens, heavy alcohol use, and/or tobacco) in the past 6 
months  
4. Reports past or current substance use disorder  
 
 
BEHAVIORAL 
INTERVENTION 
Those with MUD (MA+/HIV+) will receive contingency 
management, a positive reinforcement behavioral treatment with 
escalating rewards for escalating rewards for consecutive negative 
urine tests, capped at a maximum of $30 per negative result.  
 
 
CONTROL GROUP 
Those in the non-substance-using control condition (MA-/HIV+) will 
only not receive an intervention. They will only attend four 
appointments total after their screening to provide blood draws, urine 
samples, and complete their behavioral surveys.  
 
 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 10 of 42
Protocol Template Effective: 10 May 2016  
DURATION OF 
SUBJECT 
PARTICIPATION 
AND DURATION OF 
STUDY 
Each subject will be on study for up to 17 weeks 
Screening period: 1-4 weeks 
Baseline assessment: 1 week 
Treatment: 8 weeks  
Follow-up: 4 weeks after end of treatment 
The total duration of the study is expected to be 4 years.  1 year of 
rolling subject recruitment, 1 year for final subject follow-up, 1 year 
of biospecimen processing, and 1 year of analysis. 
 
 
CONCOMITANT 
MEDICATIONS 
NONE 
 
 
EFFICACY 
EVALUATIONS 
 
PRIMARY ENDPOINT 
 A gene expression (mRNA) pattern called the conserved 
transcriptional response to adversity (CTRA) will be measured 
using transcriptome profiling of leukocytes. 
SECONDARY 
ENDPOINTS 
 Negative urine tests for methamphetamine 
 HIV viral load from plasma 
OTHER 
EVALUATIONS 
 Plasma concentration of methamphetamine 
 Short Inventory of Problems Revised (SIP-R) 
 Sociodemographics – age, race, education level, sexual 
orientation, housing status, body mass index (BMI), smoking 
history, and heavy alcohol use history 
SAFETY 
EVALUATIONS 
 MA use frequency based on urine tests 
 HIV viral load 
 Incidence of adverse events 
PLANNED INTERIM 
ANALYSES  
This will be an NIH-funded study through the K01 mechanism. We 
have just received requested for Just In Time. When approximately 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 11 of 42
Protocol Template Effective: 10 May 2016  
50% of patients have completed the study through Week 4, an interim 
analysis for safety will be conducted when 25% of participants 
complete Week 4. Serious adverse events will be monitored by the 
investigators on an ongoing basis throughout the study. 
STATISTICS 
 
Primary Analysis Plan 
Using a linear mixed effects regression, we will test whether a 
negative MA urine test is associated with reductions in CTRA 
contrast scores across four time points—Visits B, 4.2 (Week 4), 8.2 
(Week 8), and 12.0 (Week 12 follow-up). We will use a time (days) 
by MA urine result interaction term to estimate difference in change 
in CTRA as a function of MA test result. Using a mixed effects 
logistic regression, we will test whether CTRA expression is 
associated with viral suppression (<200c/mL) across three time 
points— Visits B, 4.2 (Week 4), 8.2 (Week 8), and 12.0 (Week 12 
follow-up). We will include a time (days) by CTRA expression 
interaction term to test this association longitudinally. 
Rationale for Number 
of Subjects 
Power analysis for this pilot study indicates that a minimum of 135 
person-observations will be sufficient to test whether MA use or the 
psychosocial Short Inventory of Problems (SIP-R) are associated with 
CTRA expression, assuming a medium effect size of 0.15 and power 
level of .80. Additionally, a logistic model testing whether CTRA is 
associated with viral suppression would require a minimum of 154 
person-observations, assuming a power level of .80, a CTRA standard 
deviation of 1.44, mean centering of CTRA, and an odds ratio of 1.5. 
When modeling viral load as a continuous outcome, 135 person-
observations is the minimum to test whether CTRA is associated with 
viral load (c/mL), assuming a medium effect size of 0.15 and power 
level of .80. These analyses will include 55 participants over four 
measurements of CTRA, for a total of 220 person-observations (176 
person-observations at 80% retention), which is sufficient for these 
thresholds. 
 
 
 
 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 12 of 42
Protocol Template Effective: 10 May 2016  
1 BACKGROUND 
Contingency management (CM), which provides incentives that escalate in value for provision 
of consecutive biomarkers demonstrating drug abstinence, is an effective positive reinforcement 
approach to promoting abstinence from methamphetamine (MA) and other substances.  
1.1 
Treatment of methamphetamine use disorder and management of HIV 
Use of MA is disproportionately higher among men who have sex with men (MSM) than 
the general U.S. population (5.9% in HIV-negative MSM and 12.3% in HIV-positive MSM) (1, 
2).  Chronic MA use is linked to myriad health conditions including psychiatric disorders, 
cardiovascular disease, social problems, and infectious diseases such as HIV (25). MA use 
reduces adherence to antiretroviral therapy (ART) and engagement in HIV care (3, 4), and 
induces immune dysfunction (5). All of these factors can hamper people living with HIV 
(PLWH) from achieving and sustaining viral suppression, which contributes to forward HIV 
transmission. Reducing MA use is essential to managing HIV, reducing transmission, and 
maintaining health in PLWH with MA use disorder (MUD).  
 
There are no effective pharmacological treatments in place for MUD (40). The most robust 
treatments use behavioral approaches (41-43). Research in substance use intervention has 
demonstrated that contingency management (CM), which provides incentives that escalate in 
value for provision of consecutive biomarkers demonstrating drug abstinence, is an effective 
positive reinforcement approach to promoting abstinence from MA and other substances (6, 43-
49). CM is based on the theory that MUD or other substance disorder is due to sustained, high-
value drug reinforcement and that providing incentives that compete with drug reinforcement can 
successfully alter drug taking and produce sustained drug abstinence (15). 
1.2 
A social transcriptomics perspective on MA treatment and HIV 
With support from this K01, I will conduct a pilot investigation to determine whether a 
neurally regulated “stress” gene expression profile (mRNA) observable in circulating blood cells 
can serve as a clinically meaningful, non-abstinence-based endpoint for contingency 
management (CM) for MA use disorder (MUD) in MSM living with HIV. Ensuring that a patient 
is both feeling better and improving physiologically are fundamental tasks to addiction 
treatment, yet abstinence alone—based on urine tests—has been the standard clinical outcome 
for MA treatment (7, 32, 33). However, this outcome is incomplete, especially when seeking to 
determine whether treatment improved psychosocial health and attenuated the adverse biological 
processes linking drug use to chronic disease (33). Both of these aspects of health are important 
to understanding substance use treatment efficacy. Promoting psychosocial health and reducing 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 13 of 42
Protocol Template Effective: 10 May 2016  
distress may be important to long-term recovery from MUD, especially 
for PLWH with MUD (6, 7). Assessing biological patterns linked to 
MA use and pathogenesis may help in identifying individuals at 
particularly high risk for severe addiction and for development of MA-
related chronic disease (8, 9). Moreover, the lack of a currently 
accepted clinical endpoint beyond abstinence may be limiting the 
number of approved therapies for MUD, yet identification  
of such an endpoint remains a challenge for researchers (32, 33). 
I propose to assess a gene expression (mRNA) pattern called the 
conserved transcriptional response to adversity (CTRA), which may 
provide insight into changes in both psychosocial health and 
pathogenesis over the course of MA treatment. According to the field 
of social genomics, the CTRA is an intracellular pattern is marked by 
upregulated expression of pro-inflammatory genes (i.e., increases in 
mRNA) and downregulated expression of Type I interferon (IFN-I) and 
antibody-synthesis genes (i.e., decreases in mRNA) (9, 11-14) in 
response to negative psychosocial experiences such as emotional 
distress, isolation, and rejection, as well as compulsive and addictive behaviors (9, 11-14) (see 
Table 1). In contrast, experiences of eudaimonic well-being and sense of purpose and meaning 
are associated with low CTRA levels (15, 16). The CTRA is mediated by neurally-induced 
upregulation of inflammatory transcription factor activity (cAMP response element binding 
protein (CREB), nuclear factor kappa B (NF-κB), and activator protein 1 (AP-1)), and 
downregulated activity of interferon responsive transcription factors (IRF), which proximally 
induce these empirical differences in gene expression. As such, the CTRA profile can be 
assessed either by quantifying the activity of pre-specified sets of inflammatory and interferon-
related genes (i.e., mRNA transcripts), or by bioinformatic measures of transcription factor 
activation derived from genome-wide transcriptional profiling.  
It is important to note that although CTRA measurement involves the use of basic science 
techniques, its application largely lies in behavioral and psychosocial sciences that aim to expand 
understanding of the stress-disease relationship (9). Evaluation of this CTRA profile with MA 
addiction treatment outcomes represents a significant advancement and offers the opportunity to 
describe health enhancements from treatment beyond that offered solely by behavioral markers 
of abstinence.   
Many of the psychosocial problems that are comorbid with MA use are associated with 
CTRA expression. Socioeconomic challenges, discrimination, childhood trauma, and 
interpersonal conflict are associated with chronic MA use in MSM (34, 50-56) and are known 
drivers of CTRA expression (12, 14, 57-60). My pilot research has shown three-fold elevations 
Figure 1. CTRA expression 
in HIV-negative MSM who 
experienced 
homophobic 
victimization (10)

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 14 of 42
Protocol Template Effective: 10 May 2016  
in CTRA expression 
in HIV-negative MSM 
who experienced 
homophobic 
victimization (Figure 
1) (10), a problem also 
comorbid with MA 
use in MSM (34). The 
CTRA has also been 
shown to be related to 
the development of 
depressive and 
anxiety-related disorders (18-22), which are highly comorbid with MA use (23-25). Research on 
compulsive gaming also may suggest that CTRA is linked to addictive behaviors and dynamics 
(16). Participants who experienced internet gaming as compulsive 
, isolating, or dissatisfying had increases in their CTRA gene expression, while those who 
felt accomplishment and connectedness with online gamers had low CTRA levels (16).  
The CTRA also involves some of same gene regulatory pathways that contribute to MA-
related pathogenesis, such as those involving inflammation and innate antiviral responses 
(particularly relevant to PLWH). Chronic MA use in pre-clinical experiments and stimulation of 
inflammation using lipopolysaccharide (LPS) was shown to induce anxiety-like and sickness 
behaviors in adult rats, while neonatal exposure to LPS-induced inflammation was linked to 
behavioral sensitization to MA self-administration during adulthood (23, 24, 61, 62). Chronic 
MA use is also associated with increased CREB, AP-1, and NF-κB activation, transcription 
factors driving CTRA gene expression and likely involved in MA-induced inflammation (8, 28-
31). The CTRA has also been epidemiologically linked to inflammatory health problems such as 
cardiovascular disease (26, 27), a common cause of mortality in people with MUD (63, 64).  
Both chronic MA use and comorbid psychosocial problems such as HIV stigma and 
depression have been linked to the progression of HIV (65-67). One explanation for this may be 
their impact on poorer ART adherence (68), while another possibility is the mediating role of 
inflammation and/or impaired antiviral response on viremia (67, 69-73). Prior research has 
demonstrated that greater cytokine levels and activation of CTRA-related transcription factors 
such as NF-κB and CREB induce replication of HIV and predict increases in viral load (30, 74-
77). Conversely, HIV itself induces chronic inflammation and enhances risk of inflammatory-
related health conditions such as cardiovascular disease (78-80) and depression (81). Risk of 
these inflammatory conditions in PLWH is further exacerbated by comorbid MA use (69, 70). 
Table 1. CTRA gene expression and transcription factor activation in 
response to stress vs. well-being  
Stress 
response
Well-being 
response
Transcription 
factor
Genes expressed 
↑ 
↓ 
CREB,  
NF-κB, AP-1 
Inflammatory: IL1A, IL1B, IL6, IL8, TNF, 
PTGS1, PTGS2, FOS, FOSB, FOSL1, FOSL2, 
JUN, JUNB, JUND, NFKB1, NFKB2, REL, 
RELA, and RELB 
↓ 
↑ 
IRF 
Interferon: GBP1, IFI16, IFI27, IFI27L1-2, 
IFI30, IFI35, IFI44, IFI44L, IFI6, IFIH1, 
IFIT1-3, IFIT5, IFIT1L, IFITM1-3, IFITM4P, 
IFITM5, IFNB1, IRF2, IRF7-8, MX1-2, 
OAS1-3, and OASL 
Antibody synthesis: IGJ, IGLL1, and IGLL3

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 15 of 42
Protocol Template Effective: 10 May 2016  
For these reasons, measuring inflammatory patterns in CTRA may have clinical relevance to 
management of HIV and related chronic conditions in the context of MA treatment.  
However, the impact of IFN-I activity on HIV disease progression is less clear (82, 83). 
While IFN-I responses to acute HIV are involved in initial reduction of the virus (71, 72), 
prolonged IFN-1 activation can lead to immune dysregulation and T-cell exhaustion, and in turn, 
increased viral load (82, 83). As stated previously, CTRA gene expression involves threat/stress-
induced increases in inflammatory gene expression and decreases in IFN-1 and antibody gene 
expression, all of which are markers linked to HIV viral load. Whether physiologic patterns of 
IFN gene expression underlie the link between psychosocial health and the body’s management 
of HIV warrants investigation.  
 
2 STUDY RATIONALE 
There is a need for a biomarker measure than can serve as a clinically meaningful, non-
abstinence-based endpoint for contingency management (CM) for MA reduction in HIV-positive 
MSM with MA use disorder. MA use disorder is frequently comorbid with HIV infection in 
MSM, and adversely impacts management of HIV. Abstinence determined by urine testing has 
been the only standard clinical outcome for MA treatment, but provides an incomplete picture of 
patient recovery. The potential benefit of measuring the CTRA as a biomarker outcome linked to 
MA abstinence is that this measure may provide insight into both psychosocial health and 
biological patterns of pathogenesis as MSM living with HIV change their MA use. While MA 
abstinence is currently the primary outcome for treatment, the CTRA is a valid measure of both 
biological and psychosocial aspects of health, both of which are important to documenting 
substance use treatment efficacy. Promoting psychosocial health and reducing distress may be 
important to long-term recovery from MA use disorder, especially in PLWH (6, 7). Moreover, 
assessing biological patterns linked to MA use and pathogenesis may help in identifying 
individuals at particularly high risk for addiction and for development of MA-related chronic 
disease (8, 9). 
Despite the CTRA’s scope and nature, CTRA measurement should not be a substitute for 
directly asking MA-dependent patients how they are feeling/functioning. Rather, CTRA 
measurement should complement psychosocial self-reports and urine tests in substance use 
research, because it may help to identify patients who require additional intervention beyond the 
any single treatment approach (7, 32, 33). Assessing CTRA may also offset inaccuracies in self-
report measures caused by limited recall, social desirability bias, power of suggestion, or other 
misconceptions (9, 32). Methods used to measure CTRA are accessible using common 
technologies like those used to quantify HIV viral load. Findings from my proposed research 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 16 of 42
Protocol Template Effective: 10 May 2016  
may offer a framework to apply CTRA assessment to the treatment of more generalized 
populations affected by MUD, or for assessing outcomes in people receiving treatment for other 
substances such as opioids or other stimulants. Outside of addiction, CTRA assessment may also 
provide insight into stress-biology processes connecting HIV stigma, mental health problems, 
and chronic disease, challenges that to extend to broader communities of PLWH (84-86). 
2.1 
Risk / Benefit Assessment 
Risks 
Contingency management. Some clinicians may deem the use of monetary incentives to be 
too tempting for some patients to receive money, who may then go out and purchase drugs. This 
risk is mitigated by the lack of earnings from not being able to provide a urine sample negative 
for drug metabolite. That said, all participants are aware that they must abstain for the entire 
period of 8 weeks to earn the maximum amount, which can then be used to buy consumptive 
goods such as food, other essential items for their families, or hedonistic goods, such as tickets to 
movie theaters, to meals at restaurants or for other recreational activities. Most people with MUD 
seek treatment to improve their lives, for themselves and for their families, and so we will help to 
incentivize the money to be spent on life-improving factors as opposed to drugs. There is also 
risk that participants with MUD will not improve or possibly worsen during CM participation. 
Participants will receive referrals to additional services if they require further care following the 
study, and the PI (Dr. Li) will discuss participant follow-up care as needed (see Data and Safety 
Monitoring Plan).  
Blood Draws. The risks of the blood draws include pain, lightheadedness, fainting, and on 
rare occasions, infection. Possible bruising at the site of the needle puncture may also occur, and 
it will heal and disappear within days (several weeks at most.) Rarely, the vein may clot. The risk 
and discomfort are slight. Good venipuncture practices reduce the pain and likelihood of bruising 
and secondary infection. Precautions will be taken with participants who have a history of 
fainting during blood draws, such as having the patient lie down during the procedure.  
Urine testing for substance misuse. There are minimal risks to urine testing that include 
embarrassment or emotional discomfort following positive urine test results.  
Survey assessments. There is minor risk that completion of survey assessments may induce 
distress. Social consequences of research participation. The PI, Dr. Li, and the study site will 
make every effort to protect participant’s privacy and confidentiality. However, it is possible that 
involvement in the study could become known to others, and that social harms may result such 
as unfair or discriminatory treatment from the participant’s social network. All guidelines for the 
protection of Personal Health Identifiers will be followed. 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 17 of 42
Protocol Template Effective: 10 May 2016  
Protection against risks  
There is minor risk that completion of survey assessments may induce distress. In such 
instances, participants will meet with study staff members for debriefing. The PI, Dr. Li, will 
keep a record of the number and type of cases that require invoking a rescue protocol and discuss 
these with the Medical Director, Dr. Jesse Clark and mentor Dr. Steve Shoptaw for participant 
follow-up. Dr. Shoptaw is a licensed psychologist and will be on call in the rare case that mental 
health intervention is required.  
There is a risk that some participants may have a MA addiction that is too severe to be 
adequately treated on an outpatient basis or that for any reason does not respond to the CM 
program. At all points during the trial participants have access to treatment facilities instead of or 
in addition to the CM program. Those who wish to focus solely on treatment and not on research 
can withdraw from study participation at any time. Any unexpected events that arise during 
specimen collection, survey administration, or the contingency management program that caused 
harm and/or that affects the risk to all participants in the research will be reported on an annual 
basis to the IRB.  
 
Potential benefits 
Contingency management has been shown to effectively reduce relapse rates in those 
with substance abuse disorder, yet the specific underlying neurobiological mechanism of action 
for abstinence using this procedure is currently unknown. While other researchers have 
examined the effect of strengthening cognitive control of impulses in the executive function 
system of the prefrontal cortex, contingency management conversely aims to introduce new 
conditioned schedules within the mesolimbic reward system. Thus, we aim to see whether the 
receipt of money, as opposed to drugs can become more salient, and thus be linked to function of 
the reward system in those who have been dependent on MA.  
We do not anticipate any benefits to participants in the non-substance-using control 
condition. 
 
Importance of the knowledge to be gained  
Information gathered from this study will help to determine whether socially regulated 
gene expression can serve as a clinically meaningful, non-abstinence-based endpoint for 
contingency management (CM) for MUD in MSM living with HIV. The potential benefit of this 
measure as a non-abstinence endpoint to CM for MUD is that it provides information about both 
psychosocial health and the underlying stress-biology that exacerbates risk of chronic disease. 
Both of these aspects of health are important to understanding substance use treatment efficacy 
on a holistic level. Promoting psychosocial health and reducing distress may be important to 
long-term recovery from MUD, especially for PLWH with MUD. Assessing molecular patterns 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 18 of 42
Protocol Template Effective: 10 May 2016  
linked to MA use and pathogenesis may help in identifying risk and preventing development of 
MA-related chronic disease. Moreover, identification of a clinical endpoint beyond abstinence 
may facilitate future approval of therapies for MUD. 
3 STUDY OBJECTIVES 
3.1 
Primary Objective 
To investigate whether changes in CTRA gene expression coincide with changes in MA use and 
viral load over the course of 12 weeks in HIV-positive MSM with and without MUD. 
3.2 
Secondary Objectives 
 To investigate whether differences in seven psychosocial dimensions of drug addiction 
(Short Inventory of Problems Revised (SIP-R))—physical, social, intrapersonal, 
interpersonal, impulse control—are associated with differences in CTRA gene expression. 
 To conduct an exploratory pilot investigation to determine the degree to which CTRA 
mediates the association between MA use and viral suppression. 
4 
STUDY DESIGN 
4.1 
Study Overview 
The proposed study will be a two-arm clinical trial design of 55 MSM living with HIV, of 
whom 35 HIV-positive MSM with MUD (MA+/HIV+) will receive contingency management for 
MA reduction, and 20 HIV-positive, non-substance-using MSM (MA-/HIV+) will participate as a 
control.  There is extensive evidence that CM has greater efficacy than a non-contingent condition 
in the treatment of MUD (41-44, 46-49, 88), so it may raise ethical concerns to withhold CM from 
people with MUD who are willing to receive treatment. For this reason, this study uses a control 
of non-substance using HIV-positive (MA-/HIV+) MSM rather than a non-contingent yoked 
control of HIV-positive MSM with MUD (89). The use of a non-substance-using HIV-positive 
control will provide a baseline level of CTRA among HIV-positive MSM who do not have MUD 
or use other substances, which can be compared against CTRA levels in those with MUD. 
Screening data will be reviewed to determine subject eligibility.  Subjects who meet all inclusion 
criteria and none of the exclusion criteria will be entered into the study. The following treatment 
regimens will be used: 
● Contingency management twice weekly for 8 weeks, with post-treatment follow-up at Week 
12.  

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 19 of 42
Protocol Template Effective: 10 May 2016  
● Non-substance-using control will not receive a treatment, but will be evaluated at Baseline, 
Weeks 4, 8, and 12.  
The total duration of subject participation will be 14 weeks.  The total duration of the study is 
expected to be 4 years: 1 year of rolling subject recruitment, 1 year for final subject follow-up, 1 
year of biospecimen processing, and 1 year of analysis. 
5 CRITERIA FOR EVALUATION 
5.1 
Primary Efficacy Endpoint 
The primary efficacy endpoint is a gene expression pattern called the conserved transcriptional 
response to adversity (CTRA), measured using transcriptome profiling of leukocytes. We will 
test whether this gene expression pattern coincides with changes in MA use and psychosocial 
domains of addiction severity. 
5.2 
Secondary Efficacy Endpoints 
We will conduct negative urine tests for MA as a measure of abstinence. HIV viral load from 
will be quantified from plasma.  
5.3 
Safety Evaluations 
We will evaluate patients on MA use patterns using thrice weekly urine tests. Viral load will 
be taken at baseline, Week 4, Week 8, and Week 12 to determine HIV disease progression. 
We will report on incidence of adverse events 
5.4 
Other Evaluations  
We will assess psychosocial problems with substance use using the Short Inventory of 
Problems-Revised (SIP-R). Sociodemographics – age, race, education level, sexual 
orientation, housing status, body mass index (BMI), smoking history, and heavy alcohol use 
history. 
6 SUBJECT SELECTION 
6.1 
Study Population 
We plan to recruit 55 cisgender men who have sex with men (MSM) aged 18-45 living with 
HIV (confirmed by certification or by a 5th generation HIV screening assay) who reside in 
Los Angeles County who enroll into this study. Of these participants, 35 must meet the 
DSM-5 criteria for methamphetamine (MA) use disorder (MUD) (via Structured Clinical 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 20 of 42
Protocol Template Effective: 10 May 2016  
Interview for DSM-5 (SCID-5)) and have a positive urine test for METH during screening 
(MA+/HIV+), and 20 participants must qualify as a non-substance-using control (MA-
/HIV+).  
   
6.2 
Inclusion Criteria 
HIV-positive MSM with MUD in the contingency management condition (N = 35) 
1. Assigned male sex at birth 
2. 18 to 45 years of age 
3. Reports having sex with men in the past 12 months. 
4. HIV-positive (confirmed by certification or by HIV rapid test) 
5. Has an HIV care provider (last seen in the past 12 months) 
6. Has a current antiretroviral prescription 
7. Meets the DSM-5 criteria for MUD using SCID-5 
8. Urine test is positive for MA within 30 days of their screening visit 
9. Seeking treatment for MUD. 
10. Ability to attend twice weekly appointments for drug testing and treatment 
 
HIV-positive MSM non-substance-using control (N = 20) 
1. Assigned male sex at birth 
2. 18 to 45 years of age 
3. Reports having sex with men in the past 12 months. 
4. HIV-positive (confirmed by certification or by HIV rapid test) 
5. Has an HIV care provider (last seen in the past 12 months) 
6. Has a current antiretroviral prescription 
 
 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 21 of 42
Protocol Template Effective: 10 May 2016  
 
6.3 
Exclusion Criteria 
HIV-positive MSM with MUD in the contingency management condition (N = 35) 
1. Identifies as (cis- or transgender) female 
2. Reports another current or past substance use disorder 
3. Reports being in another intervention or clinical trial for substance use 
4. Positive test for opioids and/or cocaine 
 
HIV-positive MSM non-substance-using control (N = 20) 
1. Identifies as (cis- or transgender) female 
2. Positive test for MA, opioids, cocaine, and/or MDMA.   
3. Reports substance use (MA, opioids, cocaine, MDMA, hallucinogens, heavy alcohol use, 
and/or tobacco) in the past 6 months  
4. Reports past or current substance use disorder  
 
7 CONCURRENT MEDICATIONS 
All subjects should be maintained on the same medications throughout the entire study period, as 
medically feasible, with no introduction of new chronic therapies. 
7.1 
Allowed Medications and Treatments 
Standard therapy for HIV (i.e., antiretroviral therapy) is encouraged. 
 
 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 22 of 42
Protocol Template Effective: 10 May 2016  
8 STUDY TREATMENTS 
8.1 
Method of Assigning Subjects to Treatment Groups 
This is a non-randomized behavioral trial with a non-substance-using control group. HIV-positive 
MSM with methamphetamine use disorder who meet the criteria described above will be assigned 
to the contingency management treatment group. HIV-positive MSM who do not use substances 
and meet the criteria described above will be assigned to the non-substance-using control group.  
8.2 
Treatment Schedule  
 For those with METH use disorder (MA+/HIV+), treatment with CM commences at Visit 1.1, 
and visits will occur 2x 
weekly from Weeks 1-8 
for regularly urine drug 
tests (see Table 2). Those 
in the CM condition will 
receive 
escalating 
rewards 
for 
each 
consecutive 
negative 
urine 
test 
(Table 
2)starting at $10 and 
capping 
at 
$40. 
Participants will receive a 
$10 gift card for each 
visit brief visit where 
they provide urine tests. 
Each participant will be 
allowed to reschedule 
one 
appointment 
24 
hours or more in advance, 
to take place within 24 
hours of the original 
appointment. Following 
a missed appointment or 
relapse, a rapid reset to the participant’s highest reward level will take place by the second 
consecutive negative urine result. Cash compensation will be provided for key assessment visits 
at Baseline, Weeks 4, 8, and 12 as shown in Table 2. 
Table 2. Compensation for study visits and contingent rewards for 
negative urine tests 
  
Visit 
Cash for 
Assessment 
Visit
Gift Card for 
Urine Test 
Only Visit
Consecutive 
Negative 
Urine Tests
Contingent 
Reward 
Screen
S
$40
  
Baseline 
B
$50
  
Week 1 
1.1
$10
1 
$10 
1.2
$10
2 
$12 
Week 2 
2.1
$10
3 
$14 
2.2
$10
4 
$16 
Week 3 
3.1
$10
5 
$18 
3.2
$10
6 
$20 
Week 4 
4.1
$10
7 
$22 
4.2
$60
8 
$24 
Week 5 
5.1
$10
9 
$26 
5.2
$10
10 
$28 
Week 6 
6.1
$10
11 
$30 
6.2
$10
12 
$32 
Week 7 
7.1
$10
13 
$34 
7.2
$10
14 
$36 
Week 8 
8.1
$10
15 
$38 
8.2
$80
16 
$40
Week 12
12.0
$100
  
 
Subtotal 
$330 
$140 
 
$400 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 23 of 42
Protocol Template Effective: 10 May 2016  
Those in the non-substance-using control condition (MA-/HIV+) will only attend four 
appointments total after their screening—one appointment each week at baseline, and Weeks 4, 8, 
and 12. At these appointments, MA-/HIV+ controls will provide blood draws, urine samples, and 
complete their behavioral surveys. They will receive attendance compensation at these key visits 
identical to the CM group (Table 2). 
 
 
8.3 
Measures of Treatment Compliance 
Treatment compliance will be based on attendance and urine drug tests, thrice weekly for 8 
weeks. Each participant will be allowed to reschedule one appointment 24 hours or more in 
advance, to take place within 24 hours of the original appointment. Missed visits will be counted 
as a positive drug test. We will use the in vitro urine drug testing for rapid, simultaneous 
detection of MA, amphetamine, cocaine, opioids, and MDMA in urine.   
 
9 STUDY PROCEDURES AND GUIDELINES 
A Schedule of Events representing the required testing procedures to be performed for the 
duration of the study is diagrammed in Appendix 1. 
Prior to conducting any study-related activities, written informed consent and the Health 
Insurance Portability and Accountability Act (HIPAA) authorization must be signed and dated 
by the subject. 
9.1 
Clinical Assessments 
9.1.1 
Concomitant Medications 
All concomitant medication and concurrent therapies will be documented at Screening, Baseline, 
and at Visits 4.2, 8.2, and 12.0.  Dose, route, unit frequency of administration, and indication for 
administration and dates of medication will be captured. 
9.1.2 
Demographics  
Demographic information (date of birth, gender, race, and socioeconomic measures) will be 
recorded at Screening. 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 24 of 42
Protocol Template Effective: 10 May 2016  
9.1.3 
Adverse Events 
Information regarding occurrence of adverse events will be captured throughout the study. 
Duration (start and stop dates), severity/grade, outcome, treatment and relation to study drug will 
be recorded on the case report form (CRF). 
9.2 
Clinical Laboratory Measurements  
9.2.1 
Urine drug testing 
We will use in vitro urine drug testing for rapid, simultaneous detection of MA, amphetamine, 
cocaine, opioid, and MDMA in urine. At their screening visit and baseline visit (the week prior 
to intervention start), participants will provide a urine sample for drug testing. From Week 1 to 
Week 8, urine drug tests will be conducted 2x a week. One final urine drug test will be taken 
Week 12. Each participant will be allowed to reschedule one appointment 24 hours or more in 
advance, to take place within 24 hours of the original appointment. Prior to providing the urine 
specimen, participants empty their pockets and leave bags with a clinic staff member. To 
minimize attempts to provide false specimens, the participant will provide the urine sample while 
the pass-through specimen cabinet is open, prior to washing his hands. A temperature strip will 
verify the sample was provided in real-time, near body temperature. 
9.2.2 HIV viral load 
We will quantify viral load as count per milliliter of blood based on HIV RNA obtained from 
blood samples, and obtained at Visits B, 4.2, 8.2, and 12.0 (see Table 2). We will also compute a 
dichotomous variable of viral suppression, set at less than 200 c/mL. 
9.2.3 COVID-19 immunoassay 
We will conduct testing for SARS-CoV-2 (COVID-19) nucleocapsid at baseline and Visit 8.2 
(Week 8) as part of health monitoring and to assess for confounding by COVID-19 infection either 
before or during the study. 
 
9.3 
Research Laboratory Measurements 
9.3.1 Leukocyte Transcriptome Profiling – Conserved transcriptional response to 
adversity (CTRA) 
Biomarkers of immune functioning will be measured based on leukocyte transcriptome profiling 
from PBMCs. To quantify abundance of genes expressed, my collaborators and I will conduct 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 25 of 42
Protocol Template Effective: 10 May 2016  
supervised transcriptional profiling of participants from PBMCs using methods previously 
established and validated procedures of CTRA profiling (11, 90). Blood draws will be obtained 
via venipuncture at 4 visits: Baseline, Visit 4.2 (Week 4), Visit 8.2 (Week 8), and Visit 12.0 
(Week 12). PBMCs will be extracted at an external laboratory and stored at -70°C. The PBMC 
samples will be transferred to our clinical collaborators, Dr. Steven Cole and the UCLA Social 
Genomics Core Laboratory, where mRNA will be extracted using Qiagen RNeasy standard 
methods, converted to cDNA libraries using the mRNA-targeted Lexogen QuantSeq 3’ FWD 
enzyme system, and sequenced on an Illumina HiSeq 4000 instrument in the UCLA 
Neuroscience Genomics Core Laboratory, all following the manufacturers’ standard protocols. 
Sequencing will target >10 million 65 nt forward strand reads per sample, which will be mapped 
to the human transcriptome using the STAR aligner, quantified as gene transcripts per million 
mapped reads, log2-transformed for analysis, and further normalized if needed to standardize the 
expression of 11 pre-established housekeeping gene transcripts (91).  
 
10 EVALUATIONS BY VISIT 
Below is the schedule of study elements by study arm (i.e., contingency management group vs. 
non-substance using control (Table 3). Both groups have a screening and baseline visit.  
 
Table 3. Schedule of study elements by study arm
 
Visit
Element 
S 
B 
1.1 
1.2 
2.1 
2.2
3.1
3.2
4.1
4.2
5.1
5.2
6.1
6.2 
7.1 
7.2 
8.1
8.2
12.0
SCID-5 
▲◊ 
 
 
 
 
 
 
 
Screening 
survey and 
locator form 
▲◊ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drug test 
(MA, AMP, 
opioids, MDMA, 
cannabis) 
▲◊ 
▲◊ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲◊
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲◊
▲◊ 
Record/review 
HIV medications  
▲◊ 
▲◊ 
 
 
 
 
 
 
 
▲◊
 
 
 
 
 
 
 
▲◊
▲◊ 
HIV rapid test or 
certification 
▲◊ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Contingent 
Rewards 
 
 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
Plasma (for 
Viral load) 
 
▲◊ 
 
 
 
 
 
 
 
▲◊
 
 
 
 
 
 
 
▲◊
▲◊ 
PBMC (for 
transcriptome 
profiling) 
 
▲◊ 
 
 
 
 
 
 
 
▲◊
 
 
 
 
 
 
 
▲◊
▲◊ 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 26 of 42
Protocol Template Effective: 10 May 2016  
 
 
 
 
I. 
Those in the Contingency Management group will have the following visit activities: 
10.1 
Screening (Visit S) 
1. Review the study with the subject and obtain written informed consent 
2. Assign the subject a unique screening number 
3. Screening survey (self-reported demographics, behavior, and health data) and locator 
form 
4. Urine drug screening (participants must have a positive MA test within 30 days of this 
screening visit) 
5. Receive certification of HIV diagnosis or HIV rapid test 
6. Record HIV medications based on bottle(s) brought by participant 
7. Perform SCID-5 for DSM-5 diagnosis of methamphetamine use disorder 
8. Assign subject to contingency management or non-substance-using control. 
9. If necessary, participants may return within 30 days to complete any screening elements 
if not possible to complete in the main screening visit. 
 
10.2 
Baseline (Visit B, one week before Visit 1.1) 
1. Urine drug test 
2. Behavioral survey  
3. Blood draws (~50 mL total) for: 
a. PBMCs for transcriptome profiling (~34 mL) 
b. HIV viral load (~6 mL) 
c. COVID-19 immunoassay (~8.5 mL) 
4. HIV medications review 
5. Measure weight and height 
6. Record any adverse events 
Serum (for 
COVID-19 
immunoassay) 
 
▲◊ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
▲◊
 
Behavioral 
survey 
 
▲◊ 
 
 
 
 
 
 
 
▲◊
 
 
 
 
 
 
 
▲◊
▲◊ 
▲ = Contingency management (CM) for HIV-positive MSM with METH use disorder. 
◊ = Non-substance-using control of HIV-positive MSM.

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 27 of 42
Protocol Template Effective: 10 May 2016  
 
10.3 
Weeks 1-3 (Visits 1.1-3.2)  
1. Urine drug test 
2. Contingent rewards for negative urine test 
 
10.4 
Week 4 (Visits 4.1-4.2) 
Visit 4.1 
1. Urine drug test 
2. Contingent rewards for negative urine test 
Visit 4.2 
1. Urine drug test 
2. Contingent rewards for negative urine test 
3. Behavioral survey 
4. Blood draws (~40 mL total) for: 
a. PBMCs for transcriptome profiling (~34 mL) 
b. HIV viral load (~6 mL) 
5. HIV medications review 
6. Record any adverse events 
 
10.5 
Weeks 5-7 (Visits 5.1-7.2) 
1. Urine drug test  
2. Contingent rewards for negative urine test 
 
10.6 
Week 8 (Visits 8.1-8.2) 
Visit 8.1 
1. Urine drug test 
2. Contingent rewards for negative urine test 
Visit 8.2 
1. Urine drug test 
2. Contingent rewards for negative urine test 
3. Behavioral survey 
4. Blood draws (~50 mL total) for: 
a. PBMCs for transcriptome profiling (~34 mL) 
b. HIV viral load (~6 mL) 
c. COVID-19 immunoassay (~8.5 mL) 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 28 of 42
Protocol Template Effective: 10 May 2016  
5. HIV medications review 
6. Record any adverse events 
 
10.7 
Week 12 (Visit 12.0) 
1. Urine drug test 
2. Behavioral survey 
3. Blood draws (~40 mL total) for: 
a. PBMCs for transcriptome profiling (~34 mL) 
b. HIV viral load (~6 mL) 
4. HIV medications review 
5. Record any adverse events 
 
10.8 
Early withdrawal appointment 
1. Record any adverse events 
2. Record reason for withdrawal if initiated by participant 
3. Discuss reason for withdrawal if initiated by investigator 
4. Note that participant-initiated withdrawals do not have to occur in-person, and can occur 
over remote communication (e.g., phone or email) 
 
II. 
Those in the Non-substance-using Control group will only have 4 visits, which will 
have the same components listed below: 
 
10.9 
Baseline, Week 4, Week 8, and Week 12 (Only control group) 
1. Urine drug test 
2. Behavioral survey 
3. Blood draws (~50 mL total) for: 
a. PBMCs for transcriptome profiling (~34 mL) 
b. Plasma for HIV viral load (~6 mL) 
c. Serum for COVID-19 immunoassay (~8.5 mL) 
4. HIV medications review 
5. Record any adverse events 
 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 29 of 42
Protocol Template Effective: 10 May 2016  
11 ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION 
11.1 
Adverse Events 
An adverse event (AE) is any untoward medical occurrence in a clinical investigation of a patient 
administered a pharmaceutical product and that does not necessarily have a causal relationship 
with the treatment.  An AE is therefore any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom or disease temporally associated with the administration 
of an investigational product, whether or not related to that investigational product.  An 
unexpected AE is one of a type not identified in nature, severity, or frequency in the current 
Investigator’s Brochure or of greater severity or frequency than expected based on the 
information in the Investigator’s Brochure. 
The Investigator will probe, via discussion with the subject, for the occurrence of AEs during 
each subject visit and record the information in the site’s source documents.  Adverse events will 
be recorded in the patient CRF.  Adverse events will be described by duration (start and stop 
dates and times), severity, outcome, treatment and relation to study drug, or if unrelated, the 
cause. 
AE Severity 
AE severity will be based on the table below.  
Table 1.  AE Severity Grading 
Severity (Toxicity Grade) 
Description 
Mild (1) 
Transient or mild discomfort; no limitation in activity; no medical 
intervention or therapy required. The subject may be aware of the sign 
or symptom but tolerates it reasonably well. 
Moderate (2) 
Mild to moderate limitation in activity, no or minimal medical 
intervention/therapy required. 
Severe (3) 
Marked limitation in activity, medical intervention/therapy required, 
hospitalizations possible. 
Life-threatening (4) 
The subject is at risk of death due to the adverse experience as it 
occurred. This does not refer to an experience that hypothetically 
might have caused death if it were more severe. 
 
 
AE Relationship to Behavioral Intervention 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 30 of 42
Protocol Template Effective: 10 May 2016  
The risk of monetary rewards exacerbating meth use disorder is unlikely because participants 
cannot get money unless you test negative for drugs. A participant can only get the full amount 
of money if they abstain for all 8 weeks, so it is unlikely that the rewards will support further 
drug use. This money can be used to buy essential items, things to help family and friends, and 
things for enjoyment like restaurant meals and move tickets. Most people with METH 
dependence seek treatment to improve their lives, for themselves and for their families, and so 
we will help to incentivize the money to be spent on life-improving factors as opposed to drugs. 
There is also some risk that participants will not improve or possibly worsen during treatment, 
but because this is not a drug or biomedical treatment, it is difficult to attribute any adverse 
health events to the contingency management intervention. The relationship of an AE to the 
behavioral intervention should be assessed using the following the guidelines in Table 2. 
 
Table 2.  AE Relationship to Treatment 
Relationship 
to Intervention 
Comment 
 
Possibly 
There is no study drug. An event that follows a reasonable temporal sequence from 
administration of the contingency management intervention; that follows a common 
negative response pattern among some individuals treated with this intervention; but 
that could readily have been produced by a number of other factors. 
Unrelated 
An event that can be determined with certainty to have no relationship to the study 
intervention. 
11.2 
Serious Adverse Experiences (SAE) 
An SAE is defined as any AE occurring at any dose that results in any of the following 
outcomes: 
● death 
● a life-threatening adverse experience 
● inpatient hospitalization or prolongation of existing hospitalization 
● a persistent or significant disability/incapacity 
Other important medical events may also be considered an SAE when, based on appropriate 
medical judgment, they jeopardize the subject or require intervention to prevent one of the 
outcomes listed.  

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 31 of 42
Protocol Template Effective: 10 May 2016  
11.2.1 Serious Adverse Experience Reporting 
Study sites will document all SAEs that occur (whether or not related to study drug) per UCLA 
OHRPP Guidelines.  The collection period for all SAEs will begin after informed consent is 
obtained and end after procedures for the final study visit have been completed. 
In accordance with the standard operating procedures and policies of the local Institutional 
Review Board (IRB)/Independent Ethics Committee (IEC), the site investigator will report SAEs 
to the IRB/IEC.   
11.3 
Medical Monitoring 
Jesse Clark, MD should be contacted directly at these numbers to report medical concerns or 
questions regarding safety. 
Phone: 310-557-2273 
Pager: Call (310) 825-6301, provide operator with pager number 24690. 
12 DISCONTINUATION AND REPLACEMENT OF SUBJECTS 
12.1 
Early Discontinuation of Behavioral Intervention  
A subject may be discontinued from the contingency management intervention at any time if the 
subject, the investigator, or the Sponsor feels that it is not in the subject’s best interest to 
continue.  The following is a list of possible reasons for study treatment discontinuation:  
● Subject withdrawal of consent (or assent) 
● Subject is not compliant with study procedures 
● Adverse event that in the opinion of the investigator would be in the best interest of the 
subject to discontinue study treatment 
● Protocol violation requiring discontinuation of study treatment 
● Lost to follow-up 
● Sponsor request for early termination of study 
If a subject is withdrawn from treatment due to an adverse event, the subject will be followed 
and treated by the Investigator until the abnormal parameter or symptom has resolved or 
stabilized.   

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 32 of 42
Protocol Template Effective: 10 May 2016  
All subjects who discontinue study treatment should come in for an early discontinuation visit as 
soon as possible and then should be encouraged to complete all remaining scheduled visits and 
procedures. 
All subjects are free to withdraw from participation at any time, for any reason, specified or 
unspecified, and without prejudice. 
Reasonable attempts will be made by the investigator to provide a reason for subject 
withdrawals.  The reason for the subject’s withdrawal from the study will be specified in the 
subject’s source documents Refer to Section 10 for early termination procedures. 
12.3 
Withdrawal of Subjects from the Study 
A subject may be withdrawn from the study at any time if the subject, the investigator, or the 
Sponsor feels that it is not in the subject’s best interest to continue.   
All subjects are free to withdraw from participation at any time, for any reason, specified or 
unspecified, and without prejudice. 
Reasonable attempts will be made by the investigator to provide a reason for subject 
withdrawals.  The reason for the subject’s withdrawal from the study will be specified in the 
subject’s source documents.  As noted above, subjects who discontinue study treatment early 
(i.e., they withdraw prior to Visit 5.2) should have an early discontinuation visit, especially if 
initiated by the investigator. Refer to Section 10 for early termination procedures.  Subjects who 
withdraw after Visit 5.2 should be encouraged to come in for a final visit (and the procedures to 
be followed would include those for their next scheduled visit).   
12.4 
Replacement of Subjects 
Subjects who withdraw from the study before Visit 5.2 will be replaced.   
13 PROTOCOL VIOLATIONS 
A protocol violation occurs when the subject, investigator, or Sponsor fails to adhere to 
significant protocol requirements affecting the inclusion, exclusion, subject safety and primary 
endpoint criteria.  Protocol violations for this study include, but are not limited to, the following: 
● Failure to meet inclusion/exclusion criteria 
● Use of a prohibited treatment/intervention 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 33 of 42
Protocol Template Effective: 10 May 2016  
Failure to comply with Good Clinical Practice (GCP) guidelines will also result in a protocol 
violation. The Sponsor will determine if a protocol violation will result in withdrawal of a 
subject. 
When a protocol violation occurs, it will be discussed with the investigator and a Protocol 
Violation Form detailing the violation will be generated. This form will be signed by a Sponsor 
representative and the Investigator. A copy of the form will be filed in the site’s regulatory 
binder and in the Sponsor’s files. 
14 DATA SAFETY MONITORING 
A data and safety monitoring plan (DSMP) will be used to monitor good clinical research 
procedures regarding data and safety of participants. During data collection, the Principal 
Investigator (Dr. Li), and key personnel will monitor the practical aspects of the project to ensure 
that participants and the data are being protected, especially in conducting quality assurance of 
all informed consent documents in real time. All standard safety procedures and ethical practices 
will be adhered to per the IRB of the University of California, Los Angeles (UCLA) (a.k.a., 
Office of the Human Research Protection Program (OHRPP)), and will use secure, HIPAA-
compliant technology per UCLA Health Sciences information and technology (DGIT) standards. 
Dr. Li and key personnel will communicate regularly with UCLA OHRPP for coordinated 
review of ethical practices, safety procedures, and adherence to confidentiality/privacy 
agreements.  
Dr. Li will prepare administrative reports every month or more frequently as requested 
describing study progress including the following to review with primary mentor, Dr. Shoptaw, 
and co-mentor Dr. Clark:  
 Actual versus expected enrollment figures  
 Demographic and clinical characteristics 
 Missing visits and case report forms 
 Number and type of clinically significant/adverse events (CSEs), AEs and UPs 
 Randomly audited consent forms of five participants to determine whether they are 
available and properly executed. 
 Aggregate values of clinical laboratory results 
15 STATISTICAL METHODS AND CONSIDERATIONS 
Prior to the analysis of the final study data, a detailed Statistical Analysis Plan (SAP) will be 
written describing all analyses that will be performed.  The SAP will contain any modifications 
to the analysis plan described below.   

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 34 of 42
Protocol Template Effective: 10 May 2016  
15.1 
Data Sets Analyzed 
All eligible patients who are enrolled into the study and attend the first study visit (the Safety 
Population) will be included in the safety analysis. 
15.2 
Demographic and Baseline Characteristics 
Sociodemographic and behavioral covariates will include age, race, education level, sexual 
orientation, employment, income, body mass index (BMI) which is a known risk factor for 
inflammatory gene expression and a standard biological covariate in social genomics analysis 
(11, 98-100), smoking history, heavy alcohol use history.   
15.3 
Analysis of Primary Endpoint 
Using mixed effects linear regression and marginal plots, we will estimate, graph, and compare 
trajectories of CTRA gene expression between those with methamphetamine use disorder in the 
contingency management (MA+/HIV+) and non-substance-using control (MA-/HIV+) 
conditions. 
15.4 
Analysis of Secondary Endpoints 
Using two separate mixed effects logistic regressions and marginal plots, we will estimate, 
graph, and compare probabilities of a negative urine test and viral suppression over time between 
those with methamphetamine use disorder in the contingency management (MA+/HIV+) and 
non-substance-using control (MA-/HIV+) conditions.  
15.5 
Interim Analysis 
Interim analysis will take place on the primary and secondary endpoints after all participants 
complete of Week 4 of the study using the modeling approaches described above. Additionally, 
an interim analysis for safety will be conducted when 25% of participants complete Week 4. 
15.6 
Multivariate Analysis for Associations Between Endpoints 
Associations between MA use, CTRA gene expression, and viral suppression. All models in Aim 
1 will adjust for age, race, education, employment, housing, and mRNA encoding markers of major 
leukocyte subsets (e.g., CD4). We will also assess for confounding by COVID-19 infection 
detected by immunoassay, liver function, and type of ART prescription. MA use and CTRA. Using 
a linear mixed effects regression, we will test whether a negative MA urine test is associated with 
reductions in CTRA contrast scores across four time points—Visits B, 4.2, 8.2, and 12.0. We will 
use a time (days) by MA urine result interaction term to estimate difference in change in CTRA as 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 35 of 42
Protocol Template Effective: 10 May 2016  
a function of MA test result. CTRA and viral load. Using a mixed effects logistic regression, we 
will test whether CTRA gene expression is associated with viral suppression (<200c/mL) across 
three time points—Visits B, 4.2, 8.2, and 12.0. We will include a time (days) by CTRA gene 
expression interaction term to test this association longitudinally. We will also test whether CTRA 
and viral load are reciprocally associated using dynamic panel data modeling with maximum 
likelihood (102-104). This approach will allow us to simultaneously test whether CTRA is 
associated with viral load at subsequent observations, and account for whether CTRA is affected 
by prior values of viral load (102-104).  
Associations between psychosocial indicators of substance use severity and CTRA. Using a linear 
mixed effects regression, I will test whether the seven domains of the Addiction Severity Index 
(ASI) is associated with reductions in CTRA contrast scores across four time points—Visits B, 
4.2, 8.2, and 12.0. I will use a time (days) by ASI domain score interaction term to estimate change 
in CTRA as a function of changes in ASI scoring. We will control for age, race, education, and 
mRNA markers of major leukocyte subsets.  
Indirect associations between MA use, CTRA, and viral suppression. I will use propensity 
scores to test the degree to which CTRA mediates the association between MA use and viral 
suppression (105, 106). The general theory is that we would compute propensity score for 
CTRA—the probability of having a particular CTRA level—to compare participants who used 
MA with those who would have had the same value of the CTRA had they used MA. 
15.7 Sample Size and Randomization 
This study will enroll 55 participants, who will be evaluated for the course of 14 weeks, 
including screening. Power analysis for this pilot study indicates that a minimum of 135 person-
observations will be sufficient to test whether MA use or the psychosocial Addiction Severity 
Index (ASI) are associated with CTRA gene expression, assuming a medium effect size of 0.15 
and power level of .80. Additionally, a logistic model testing whether CTRA is associated with 
viral suppression would require a minimum of 154 person-observations, assuming a power level 
of .80, a CTRA standard deviation of 1.44, mean centering of CTRA, and an odds ratio of 1.5. 
When modeling viral load as a continuous outcome, 135 person-observations is the minimum to 
test whether CTRA is associated with viral load (c/mL), assuming a medium effect size of 0.15 
and power level of .80. These analyses will include 55 participants over four measurements of 
CTRA, for a total of 220 person-observations (176 person-observations at 80% retention), which 
is sufficient for these thresholds. 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 36 of 42
Protocol Template Effective: 10 May 2016  
16 DATA COLLECTION, RETENTION AND MONITORING 
16.1 
Data Collection Instruments 
The Investigator will prepare and maintain adequate and accurate source documents designed to 
record all observations and other pertinent data for each subject treated with the study drug.   
Study personnel at each site will enter data from source documents corresponding to a subject’s 
visit into the protocol-specific electronic Case Report Form (eCRF) OR paper CRF when the 
information corresponding to that visit is available.  Subjects will not be identified by name in 
the study database or on any study documents to be collected by the Sponsor (or designee), but 
will be identified by a site name, subject number and initials. 
For eCRFs: If a correction is required for an eCRF, the time and date stamps track the person 
entering or updating eCRF data and creates an electronic audit trail.  For paper CRFs:  If a 
correction is made on a CRF, the study staff member will line through the incorrect data, write in 
the correct data and initial and date the change. 
The Investigator is responsible for all information collected on subjects enrolled in this study.  
All data collected during the course of this study must be reviewed and verified for completeness 
and accuracy by the Investigator.  A copy of the CRF will remain at the Investigator’s site at the 
completion of the study. 
16.2 
Data Management Procedures 
The data will be entered into a validated database.  The Data Management group will be 
responsible for data processing, in accordance with procedural documentation.  Database lock 
will occur once quality assurance procedures have been completed. 
All procedures for the handling and analysis of data will be conducted using good computing 
practices meeting FDA guidelines for the handling and analysis of data for clinical trials. 
16.3 
Data Quality Control and Reporting 
After data have been entered into the study database, a system of computerized data validation 
checks will be implemented and applied to the database on a regular basis.  Queries are entered, 
tracked, and resolved through the EDC system directly.  The study database will be updated in 
accordance with the resolved queries.  All changes to the study database will be documented. 
16.4 
Archival of Data 
The database is safeguarded against unauthorized access by established security procedures; 
appropriate backup copies of the database and related software files will be 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 37 of 42
Protocol Template Effective: 10 May 2016  
maintained.  Databases are backed up by the database administrator in conjunction with any 
updates or changes to the database.   
At critical junctures of the protocol (e.g., production of interim reports and final reports), data for 
analysis is locked and cleaned per established procedures. 
16.5 
Availability and Retention of Investigational Records 
The Investigator must make study data accessible to the monitor, other authorized 
representatives of the Sponsor (or designee), IRB/IEC, and Regulatory Agency (e.g., FDA) 
inspectors upon request.  A file for each subject must be maintained that includes the signed 
Informed Consent, HIPAA Authorization and Assent Form and copies of all source 
documentation related to that subject.  The Investigator must ensure the reliability and 
availability of source documents from which the information on the CRF was derived. 
All study documents (patient files, signed informed consent forms, copies of CRFs, Study File 
Notebook, etc.) must be kept secured for a period of two years following marketing of the 
investigational product or for two years after centers have been notified that the IND has been 
discontinued.  There may be other circumstances for which the Sponsor is required to maintain 
study records and, therefore, the Sponsor should be contacted prior to removing study records for 
any reason. 
16.6 
Monitoring 
Monitoring visits will be conducted by representatives of the Sponsor according to the U.S. CFR 
Title 21 Parts 50, 56, and 312 and ICH Guidelines for GCP (E6).    By signing this protocol, the 
Investigator grants permission to the Sponsor (or designee), and appropriate regulatory 
authorities to conduct on-site monitoring and/or auditing of all appropriate study documentation. 
16.7 
Subject Confidentiality 
In order to maintain subject confidentiality, only a site number/name, subject number and subject 
initials will identify all study subjects on CRFs and other documentation submitted to the 
Sponsor.  Additional subject confidentiality issues (if applicable) are covered in the Clinical 
Study Agreement. 
17 ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS 
The study will be conducted according to the Declaration of Helsinki, Protection of Human 
Volunteers (21 CFR 50), Institutional Review Boards (21 CFR 56), and Obligations of Clinical 
Investigators (21 CFR 312). 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 38 of 42
Protocol Template Effective: 10 May 2016  
To maintain confidentiality, all laboratory specimens, evaluation forms, reports and other records 
will be identified by a coded number and initials only.  All study records will be kept in a locked 
file cabinet and code sheets linking a patient’s name to a patient identification number will be 
stored separately in another locked file cabinet.  Clinical information will not be released without 
written permission of the subject, except as necessary for monitoring by the FDA.  The 
Investigator must also comply with all applicable privacy regulations (e.g., Health Insurance 
Portability and Accountability Act of 1996, EU Data Protection Directive 95/46/EC). 
17.1 
Protocol Amendments 
Any amendment to the protocol will be written by the PI: Li.  Protocol amendments cannot be 
implemented without prior written IRB/IEC approval except as necessary to eliminate immediate 
safety hazards to patients.  A protocol amendment intended to eliminate an apparent immediate 
hazard to patients may be implemented immediately, provided the IRBs are notified within five 
working days. 
17.2 
Institutional Review Boards and Independent Ethics Committees 
The protocol and consent form will be reviewed and approved by the IRB/IEC of each 
participating center prior to study initiation.  Serious adverse experiences regardless of causality 
will be reported to the IRB/IEC in accordance with the standard operating procedures and 
policies of the IRB/IEC, and the Investigator will keep the IRB/IEC informed as to the progress 
of the study.  The Investigator will obtain assurance of IRB/IEC compliance with regulations. 
Any documents that the IRB/IEC may need to fulfill its responsibilities (such as protocol, 
protocol amendments, Investigator’s Brochure, consent forms, information concerning patient 
recruitment, payment or compensation procedures, or other pertinent information) will be 
submitted to the IRB/IEC.  The IRB/IECs written unconditional approval of the study protocol 
and the informed consent form will be in the possession of the Investigator before the study is 
initiated.  The IRB/IECs unconditional approval statement will be transmitted by the Investigator 
to the Sponsor or designee prior to the shipment of study supplies to the site.  This approval must 
refer to the study by exact protocol title and number and should identify the documents reviewed 
and the date of review. 
Protocol and/or informed consent modifications or changes may not be initiated without prior 
written IRB/IEC approval except when necessary to eliminate immediate hazards to the patients 
or when the change(s) involves only logistical or administrative aspects of the study.  Such 
modifications will be submitted to the IRB/IEC and written verification that the modification 
was submitted and subsequently approved should be obtained.   

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 39 of 42
Protocol Template Effective: 10 May 2016  
The IRB/IEC must be informed of revisions to other documents originally submitted for review; 
serious and/or unexpected adverse experiences occurring during the study in accordance with the 
standard operating procedures and policies of the IRB; new information that may affect 
adversely the safety of the patients of the conduct of the study; an annual update and/or request 
for re-approval; and when the study has been completed. 
17.3 
Informed Consent Form  
Informed consent will be obtained in accordance with the Declaration of Helsinki, ICH GCP, US 
Code of Federal Regulations for Protection of Human Subjects (21 CFR 50.25[a,b], CFR 50.27, 
and CFR Part 56, Subpart A), the Health Insurance Portability and Accountability Act (HIPAA, 
if applicable), and local regulations. 
The Investigator will prepare the informed consent form, assent and HIPAA authorization and 
provide the documents to the Sponsor or designee for approval prior to submission to the 
IRB/IEC.  The consent form generated by the Investigator must be acceptable to the Sponsor and 
be approved by the IRB/IEC.  The written consent document will embody the elements of 
informed consent as described in the International Conference on Harmonisation and will also 
comply with local regulations. The Investigator will send an IRB/IEC-approved copy of the 
Informed Consent Form to the Sponsor (or designee) for the study file. 
A properly executed, written, informed consent will be obtained from each subject prior to 
entering the subject into the trial.  Information should be given in both oral and written form and 
subjects must be given ample opportunity to inquire about details of the study.  If appropriate 
and required by the local IRB/IEC, assent from the subject will also be obtained.  If a subject is 
unable to sign the informed consent form (ICF) and the HIPAA authorization, a legal 
representative may sign for the subject.   A copy of the signed consent form will be given to the 
subject and the original will be maintained with the subject’s records. 
17.4 
Publications  
The preparation and submittal for publication of manuscripts containing the study results shall be 
in accordance with a process determined by mutual written agreement among the study Sponsor 
and participating institutions.  The publication or presentation of any study results shall comply 
with all applicable privacy laws, including, but not limited to, the Health Insurance Portability 
and Accountability Act of 1996.  
17.5 
Investigator Responsibilities 
By signing the Agreement of Investigator form, the Investigator agrees to: 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 40 of 42
Protocol Template Effective: 10 May 2016  
1. Conduct the study in accordance with the protocol and only make changes after notifying 
the Sponsor (or designee), except when to protect the safety, rights or welfare of subjects. 
2. Personally conduct or supervise the study (or investigation). 
3. Ensure that the requirements relating to obtaining informed consent and IRB review and 
approval meet federal guidelines, as stated in § 21 CFR, parts 50 and 56. 
4. Report to the Sponsor or designee any AEs that occur in the course of the study, in 
accordance with §21 CFR 312.64. 
5. Ensure that all associates, colleagues and employees assisting in the conduct of the study are 
informed about their obligations in meeting the above commitments. 
6. Maintain adequate and accurate records in accordance with §21 CFR 312.62 and to make 
those records available for inspection with the Sponsor (or designee). 
7. Ensure that an IRB that complies with the requirements of §21 CFR part 56 will be 
responsible for initial and continuing review and approval of the clinical study. 
8. Promptly report to the IRB and the Sponsor (or designee) all changes in the research activity 
and all unanticipated problems involving risks to subjects or others (to include amendments 
and IND safety reports). 
9. Seek IRB approval before any changes are made in the research study, except when 
necessary to eliminate hazards to the patients/subjects. 
10. Comply with all other requirements regarding the obligations of clinical investigators and all 
other pertinent requirements listed in § 21 CFR part 312. 
 
 
 
 
 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 41 of 42
Protocol Template Effective: 10 May 2016  
 
APPENDIX 1.  COMPENSATION AND REWARDS 
 
Compensation for study visits and contingent rewards for negative 
urine tests 
  
Visit 
Cash for 
Assessment 
Visit   
Gift Card for 
Urine Test 
Only Visit
Consecutive 
Negative 
Urine Tests
Contingent 
Reward 
Screen 
S 
$40 
Baseline  
B 
$50 
Week 1 
1.1 
  
$10
1
$10 
1.2 
  
$10
2
$12 
Week 2 
2.1 
  
$10
3
$14 
2.2 
  
$10
4
$16 
Week 3 
3.1 
  
$10
5
$18 
3.2 
  
$10
6
$20 
Week 4 
4.1 
 
$10
7
$22 
4.2 
$60 
8
$24 
Week 5 
5.1 
  
$10
9
$26 
5.2 
  
$10
10
$28 
Week 6 
6.1 
  
$10
11
$30 
6.2 
  
$10
12
$32 
Week 7 
7.1 
  
$10
13
$34 
7.2 
  
$10
14
$36 
Week 8 
8.1 
 
$10
15
$38 
8.2 
$80 
16
$40
Week 12 
12.0 
$100 
 
Subtotal  
$330  
$140 
$400 
 
 
 
 

Michael Li, PhD, MPH |  
Confidential 
 
 
Version #: 2.1 
Version Date: 07/08/2022 
(IRB#20-001564) 
Page 42 of 42
Protocol Template Effective: 10 May 2016  
APPENDIX 2. STUDY ELEMENTS 
 
 
 
 
Schedule of study elements by study arm and visit number
 
Visit
Element 
S 
B 
1.1 
1.2 
2.1 
2.2
3.1
3.2
4.1
4.2
5.1
5.2
6.1
6.2 
7.1 
7.2 
8.1
8.2
12.0
SCID-5 
▲◊ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening 
survey and 
locator form 
▲◊ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drug test 
(MA, AMP, 
opioids, MDMA, 
cannabis) 
▲◊ 
▲◊ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲◊
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲◊
▲◊ 
Record/review 
HIV medications  
▲◊ 
▲◊ 
 
 
 
 
 
 
 
▲◊
 
 
 
 
 
 
 
▲◊
▲◊ 
HIV rapid test or 
certification 
▲◊ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Contingent 
Rewards 
 
 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
Plasma (for 
Viral load) 
 
▲◊ 
 
 
 
 
 
 
 
▲◊
 
 
 
 
 
 
 
▲◊
▲◊ 
PBMC (for 
transcriptome 
profiling) 
 
▲◊ 
 
 
 
 
 
 
 
▲◊
 
 
 
 
 
 
 
▲◊
▲◊ 
Serum (for 
COVID-19 
immunoassay) 
 
▲◊ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
▲◊
 
Behavioral 
survey 
 
▲◊ 
 
 
 
 
 
 
 
▲◊
 
 
 
 
 
 
 
▲◊
▲◊ 
▲ = Contingency management (CM) for HIV-positive MSM with METH use disorder. 
◊ = Non-substance-using control of HIV-positive MSM.

 
 
UNIVERSITY OF CALIFORNIA LOS ANGELES 
CONSENT TO PARTICIPATE IN RESEARCH 
 
Expression of stress markers in MSM living with HIV receiving contingency management 
for methamphetamine use disorder (a.k.a. “EXPRESS+”) 
 
Short Title: EXPRESS+ 
 
INTRODUCTION  
 
Michael Li, PhD, UCLA Vine Street Clinic, and the UCLA Center for Behavioral and Addiction 
Medicine are conducting a research study on methamphetamine treatment and its impact on 
immune function and mental health. This study is being funded by the National Institute on Drug 
Abuse (NIDA), which is part of the National Institutes of Health.  
 
Research studies are voluntary and include only people who choose to take part. Please take 
your time about deciding whether to participate in this study. Before deciding, you can:  
 
 
Discuss this study with family and friends  
 
Discuss it with a regular physician or request a second opinion  
 
If you have any questions, you can ask the researchers for more information before deciding to 
participate. Contact information is provided at the end of this document. 
 
 
KEY INFORMATION:  
 
The following is a short summary of this study to help you decide whether or not to be a part of 
this study. More detailed information is listed later on in this form. 
 
 
WHY AM I BEING INVITED TO TAKE PART IN A RESEARCH STUDY? 
 
We invite you to take part in a research study because you: 
 were assigned male at birth and do not identify as (cis- or transgender) female 
 are between 18 and 45 years of age 
 reports having sex with men in the past 12 months 
 are HIV-positive 
 have an HIV care doctor who you saw in the past 12 months 
 have a current prescription for HIV medication 
 
To receive treatment for meth use in this study, you must: 
 
be willing to participate in a behavioral treatment, which involves 2 visits a week for 8 
weeks 
 
meet the diagnosis for meth use disorder  
 
have a positive urine test for meth 
 
NOT be in treatment for another substance disorder 
 
NOT have another past or current substance use disorder (i.e., other than meth) 
 
test negative for opioids and cocaine 
 

Page 2 of 8 
 
To be a part of the non-substance using group, you must: 
 
test negative for meth, opioids, cocaine, and MDMA 
 
report NO substance use (meth, opioids, cocaine, MDMA, hallucinogens, heavy alcohol 
and/or tobacco) in the past 6 months 
 
report NO past or current substance use disorder 
 
 
WHAT SHOULD I KNOW ABOUT A RESEARCH STUDY? 
 
 
Someone will explain this research study to you. 
 
Whether or not you take part is up to you. 
 
You can choose not to take part. 
 
You can agree to take part and later change your mind. 
 
Your decision will not be held against you. 
 
You can ask all the questions you want before you decide. 
 
You can discuss this study with friends and family. 
 
You can also discuss it with your health care doctor or request a second opinion. 
 
 
WHY IS THIS RESEARCH BEING DONE? 
 
It is important to understand whether a patient is feeling better and whether their health is 
improving as they go through treatment for methamphetamine use disorder. This is especially 
important in people living with HIV impacted by meth use. This study uses a behavioral 
treatment called “contingency management”, which motivates and rewards quitting meth. This 
study will look also at immune markers in the blood to see how the immune system reacts to 
treatment.  
 
 
HOW LONG WILL THE RESEARCH LAST AND WHAT WILL I NEED TO DO?  
 
We expect that you will be in this research study for 14 weeks. If you qualify for treatment for 
meth use disorder, you will visit the clinic 2 days a week for 8 weeks during treatment, then 
come back for a check-up 4 weeks after the end of treatment. You have a urine test at each 
visit. You will get a blood test and take a survey at 4 of those visits. 
 
If you do not use any drugs and qualify for the control group, you will only have 4 visits, about 4 
weeks apart. At these visits, you will get a urine test, blood test, and take a survey.   
 
More detailed information about the study procedures can be found under “WHAT WILL 
HAPPEN IF I TAKE PART IN THIS STUDY?” 
 
 
WHAT KINDS OF RISKS OR DISCOMFORTS COULD I EXPECT? 
 
Contingency management: Some people may think that rewarding patients with money for 
abstaining from drugs is too tempting, and will be used to purchase drugs. This risk is unlikely 
because you cannot get money unless you test negative for drugs. That said, you can only get 
the full amount of money if you abstain for all 8 weeks. This money can be used to buy essential 
items, things to help family and friends, and things for enjoyment like restaurant meals and 

Page 3 of 8 
 
move tickets. Most people with METH dependence seek treatment to improve their lives, for 
themselves and for their families, and so we will help to incentivize the money to be spent on 
life-improving factors as opposed to drugs. There is also some risk that you will not improve or 
possibly worsen during treatment. We will refer you to additional services if they require further 
care following the study and discuss this plan with Dr. Li as needed. 
 
Blood draws. The risks of the blood draws include pain, lightheadedness, fainting, and on rare 
occasions, infection. Possible bruising at the site of the needle puncture may also occur, and it 
will heal and disappear within days (several weeks at most.) Rarely, the vein may clot. The risk 
and discomfort are slight. Good venipuncture practices reduce the pain and likelihood of 
bruising and secondary infection. Precautions will be taken with you if you have a history of 
fainting during blood draws, such as having the patient lie down during the procedure. 
 
Urine testing for substance use: There are minimal risks to urine testing that include 
embarrassment or emotional discomfort following positive urine test results. 
 
Survey assessments: There is minor risk that completion of survey assessments may induce 
distress. 
 
Social consequences of research participation: Dr. Li and the research team will make every 
effort to protect your privacy and confidentiality. However, it is possible that involvement in the 
study could become known to others, and that social harms may result such as unfair or 
discriminatory treatment from other people. All guidelines for the protection of Personal Health 
Identifiers will be followed. 
 
 
ARE THERE ANY BENEFITS IF I PARTICIPATE? 
 
Contingency management has been shown to effectively reduce relapse rates in those with 
meth use disorder, yet the specific way this affects the brain is not fully understood. We aim to 
see whether money can be more appealing than drugs, and activate the brain’s rewards system 
in those who have been dependent on methamphetamine. We do not anticipate any benefits to 
participants in the non-substance-using control condition. 
 
Information gathered from this study will help identify other ways to monitor response to meth 
treatment besides just abstinence. This study will look at immune markers in the blood, which 
may help clinicians and scientist monitor risk of disease and improvement in the body. Also, 
having another way to measure treatment response may help in the approval of new therapies 
for meth use disorder.   
 
 
WHAT OTHER CHOICES DO I HAVE IF I DO NOT WANT TO PARTICIPATE? 
 
Your participation in this research is voluntary. If you choose not to participate, this will not affect 
your relationship with your doctor or your access to other services. If you choose to participate 
now, you can change your mind and withdraw from the study at any time. 
 
 
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?  
 
55 people will take part in this study at UCLA.   

Page 4 of 8 
 
WHAT WILL HAPPEN IF I TAKE PART IN THIS STUDY?  
 
Before you begin the study: 
Before you begin the study, you will need to review this form carefully, ask any questions, and 
sign this form. 
 
During the study: 
 
Screening (Visit S) 
If you agree to participate in this study, you will continue with the Screening. This will take about 
1-2 hours, and include the following: 
 
Confirm HIV status based on paperwork or HIV rapid test (oral swab optional) 
 
Urine drug test 
 
Short survey about your background, behavior, and mental and physical health 
 
Interview about your meth use (only if you report a meth use problem) 
 
Record HIV medications and doctor 
 
A research associate may suggest scheduling you again within 30 days of this screening 
visit to complete any activities that could not be feasibly completed at this visit. 
 
Baseline (Visit B) 
This visit will take about 1-2 hours, and include the following:  
 
Urine drug test 
 
Blood draws (50 mL total) to check:  
o HIV viral load (6 mL) 
o Immune functioning (34 mL) 
o Past COVID-19 infection (8.5 mL) 
 
Detailed survey about your background, behavior, and mental and physical health 
 
Review of HIV medications 
 
If you meet the criteria for treatment of meth use disorder you will have standard contingency 
management visits for treatment. These should be brief and take between 20-40 minutes. You 
will have 2 visits a week (Monday + Thursday or Tuesday + Friday) for 8 weeks, which will 
include the following: 
 
Urine drug test. You will get a $10 gift card for providing a urine test at these visits, 
regardless of the result.  
 
Cash reward for negative tests. You will get $10 for your first negative drug test. For 
each negative test you get in a row, the reward will increase by $2, capped at a 
maximum of $40 per negative test. If you get a positive drug test or miss a visit, you 
will not get a cash reward and the next reward will reset to $10. Your reward level will 
go back to your highest level by the second negative test in a row. You are allowed 
to reschedule 1 visit with 24 hours or more notice, which must take place within 24 
hours of the original appointment. 
 
The second visit of Week 4. You will have: 
 
Urine drug test 
o If in the contingency management group, this includes rewards for negative urine 
tests as described above.  
 
Blood draws (40 mL total) to check:  
o HIV viral load (6 mL) 
o Immune functioning (34 mL) 

Page 5 of 8 
 
 
Detailed survey about your background, behavior, and mental and physical health 
 
Review of HIV medications 
 
The second visit of Week 8. You will have: 
 
Urine drug test 
o If in the contingency management group, this includes rewards for negative urine 
tests as described above.  
 
Blood draws (~50 mL total) to check:  
o HIV viral load (6 mL) 
o Immune functioning (34 mL) 
o Past COVID-19 infection (8.5 mL) 
 
Detailed survey about your background, behavior, and mental and physical health 
 
Review of HIV medications 
 
 
Week 12 follow-up. Four weeks after the last day of treatment, you will have one last check-up 
visit with: 
 
Urine drug test 
 
Blood draws (40 mL) to check:  
o HIV viral load (6 mL) 
o Immune functioning (34 mL) 
 
Detailed survey about your background, behavior, and mental and physical health 
 
Review of HIV medications 
 
The study procedures include routine tests for treating and monitoring your condition and the 
results of these routine tests will be provided to you. 
 
 
CAN THE RESEARCHERS REMOVE ME FROM THIS STUDY?  
 
The researchers may end your participation in this study for a number of reasons, such as if 
your safety and welfare are at risk, if you do not follow instructions or if you miss scheduled 
visits. The researchers or the study sponsor might also decide to stop the study at any time. 
 
If you decide to stop being in the study, or are removed from the study, or the study is stopped 
the researcher may ask you to come in for one final visit or complete an exit interview over the 
phone.  
 
 
HOW WILL INFORMATION ABOUT ME AND MY PARTICIPATION BE KEPT 
CONFIDENTIAL? 
 
The researchers will do their best to make sure that your private information is kept confidential. 
Information about you will be handled as confidentially as possible, but participating in research 
may involve a loss of privacy and the potential for a breach in confidentiality. Study data will be 
physically and electronically secured.  As with any use of electronic means to store data, there 
is a risk of breach of data security.   
 
Use of personal information that can identify you: 

Page 6 of 8 
 
All data collection procedures will take place at the UCLA Vine Street Clinic. Each blood 
sample, urine sample, and survey response will be given a unique identifier code, which will link 
separately to personal information such as the participant’s name, date of birth, contact 
information, and visit notes. 
 
How information about you will be stored: 
Paper copies of this highly confidential information will be maintained in locked storage, 
accessible to key research personnel in at UCLA Vine Street Clinic, and given the ID code as a 
reference. All assayed samples will refer to the ID code only, and personal information will be 
kept separately in secure storage within a locked medical record room. Blood draws of 125 mL 
will be taken via venipuncture and labeled with the UIC. PBMCs will be extracted, ID code 
labeled, and stored at -70°C at UCLA Vine Street Clinic’s biorepository. The PBMC samples will 
be transferred our clinical collaborators, Dr. Steven Cole and the UCLA Social Genomics Core 
Laboratory for assaying. Urine samples will also be ID code-labeled and tested for simultaneous 
detection of METH, cocaine, opiates, and cannabis in urine using in vitro drug screen by CLIA-
waived, Inc. Electronic survey data will refer to the ID code, and will be saved in a password 
protected folder on external back-up hardware, accessible only to key research personnel while 
data are being collected. Datasets used for statistical analysis will only refer to the ID code.  
 
People and agencies that will have access to your information: 
 
The research team, authorized UCLA personnel, the study sponsor, and regulatory agencies 
such as the Food and Drug Administration (FDA), may have access to study data and records 
to monitor the study.  Research records provided to authorized, non-UCLA personnel will not 
contain identifiable information about you. Publications and/or presentations that result from this 
study will not identify you by name. 
 
Employees of the University may have access to identifiable information as part of routine 
processing of your information, such as lab work or processing payment. However, University 
employees are bound by strict rules of confidentiality. 
 
How long information from the study will be kept: 
 
The researchers intend to keep the research data and records until the study is over and then 
transfer the data to a research database, which will be kept indefinitely for future research. This 
database will be housed by the UCLA Center for Behavioral and Addiction Medicine in a locked 
UCLA Health Secure hard drive and/or UCLA Health Secure cloud storage.  
 
 
USE OF DATA AND SPECIMENS FOR FUTURE RESEARCH  
 
My data and/or specimens, including de-identified data and/or specimens may be kept for use in 
future research. 
 
 
WILL I BE PAID FOR MY PARTICIPATION?  
 
You will be compensated for your time and effort for study visits in cash or gift card equivalent, 
for the following visits: 
 
$40 for Screening 
 
$50 for Baseline  

Page 7 of 8 
 
 
$60 for Week 4 (for those getting contingency management, Friday, Visit 4.2) 
 
$80 for Week 8 (for those getting contingency management, Friday, Visit 8.2) 
 
$100 for Week 12 (follow-up) 
 
Use of My Specimens: 
 
 
Any specimens (e.g., blood, urine) obtained for the purposes of this study will become the 
property of the University of California. Once you provide the specimens you will not have 
access to them. The University may share your specimens in the future with other 
researchers or outside institutions. Information that identifies you will not be shared with 
anyone outside of UCLA. The specimens will be used for research and such use may result 
in inventions or discoveries that could become the basis for new products or diagnostic or 
therapeutic agents. In some instances, these inventions and discoveries may be of potential 
commercial value and may be patented and licensed by the University. You will not receive 
any money or other benefits derived from any commercial or other products that may be 
developed from use of the specimens. 
 
 
WHO CAN I CONTACT IF I HAVE QUESTIONS ABOUT THIS STUDY? 
 
The Research Team: 
You may contact Dr. Michael Li at (310) 794-8530 with any questions or concerns about the 
research or your participation in this study. Additionally, you may contact mSTUDY staff at the 
UCLA Vine Street Clinic at (323) 461-3106 with any questions or concerns. 
 
UCLA Office of the Human Research Protection Program (OHRPP): 
If you have questions about your rights while taking part in this study, or you have concerns or 
suggestions and you want to talk to someone other than the researchers about the study, you 
may contact the UCLA OHRPP by phone: (310) 206-2040; by email: 
participants@research.ucla.edu or U.S. mail: UCLA OHRPP, Box 951406, Los Angeles, CA 
90095-1406. 
 
Public Information about this Study: 
ClinicalTrials.gov is a website that provides information about federally and privately supported 
clinical trials. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, 
as required by U.S. Law. This website will not include information that can identify you. At most, 
the website will include a summary of the results. You can search this website at any time.  
 
 
WHAT ARE MY RIGHTS IF I TAKE PART IN THIS STUDY?  
 
Taking part in this study is your choice. You can choose whether or not you want to participate. 
Whatever decision you make, there will be no penalty to you and you will not lose any of your 
regular benefits. 
 
 
You have a right to have all of your questions answered before deciding whether to take 
part. 
 
Your decision will not affect the medical care you receive from UCLA. 
 
If you decide to take part, you can leave the study at any time.  

Page 8 of 8 
 
 
If you decide to stop being in this study you should notify the research team right away. The 
researchers may ask you to complete some procedures in order to protect your safety.  
 
If you decide not to take part, you can still get medical care from UCLA. 
 
 
HOW DO I INDICATE MY AGREEMENT TO PARTICIPATE? 
 
If you want to participate in this study you should sign and date below. You have been given a 
copy of this consent form and the Research Participant’s Bill of Rights to keep.  You will be 
asked to sign a separate form authorizing access, use, creation, or disclosure of health 
information about you. 
 
 
 
 
SIGNATURE OF THE PARTICIPANT  
 
______________________________________ 
Name of Participant 
 
______________________________________ 
______________________ 
Signature of Participant 
 
 
 
 
Date 
 
 
SIGNATURE OF PERSON OBTAINING CONSENT 
 
______________________________________ 
_______________________ 
Name of Person Obtaining Consent  
 
 
Phone 
 
______________________________________ 
______________________ 
Signature of Person Obtaining Consent 
 
 
Date