Getting Off: : A Theory-based mHealth Intervention for Methamphetamine-using MSM
Phase: NA
Conditions: Methamphetamine Abuse, HIV/AIDS
Sponsor: Friends Research Institute, Inc.

 
 
 
 
 
Getting Off: A Theory-based mHealth Intervention for 
Methamphetamine-using MSM 
 
 
Lay Title: Getting Off App 
 
 
 
 
Sponsored by: 
 
National Institute on Drug Abuse (NIDA) 
Grant # 1 R01 DA045562 
 
 
Clinical Trials #NCT03884946 
 
 
Cathy J. Reback, Ph.D. 
Principal Investigator 
Friends Research Institute, Inc. 
 
 
September 2, 2021 
 
 
 
 
 
 
 
 
 
RCT Version: 2.0 

 
2 
Table of Contents 
INVESTIGATOR ROSTER ......................................................................................................................3 
SITES PARTICIPATING IN THE PROJECT ..........................................................................................4 
GLOSSERY OF TERMS .........................................................................................................................5 
1.0 
STUDY OBJECTIVES ......................................................................................................... 8 
1.1 
Specific Aims ...............................................................................................................................8 
1.2 
Secondary Aim ............................................................................................................................8 
2.0  
INTRODUCTION .................................................................................................................. 8 
2.1  
Rationale ......................................................................................................................................8 
2.2  
Background .................................................................................................................................9 
3.0  
STUDY DESIGN ................................................................................................................ 12 
3.1 
Overview..................................................................................................................................... 12 
4.0 
STUDY SITE ...................................................................................................................... 13 
5.0 
PARTICIPANTS ................................................................................................................. 13 
5.1  
Inclusion Criteria ....................................................................................................................... 14 
5.2  
Exclusion Criteria ...................................................................................................................... 14 
6.0  
PROJECT PROCEDURES ................................................................................................ 14 
6.1 
Recruitment ............................................................................................................................... 15 
6.2 
Informed Consent Procedures ................................................................................................ 15 
6.3 
Enrollment Procedures ............................................................................................................ 16 
6.4 
Random Assignment ................................................................................................................ 16 
6.5 
Incentive Schedule .................................................................................................................... 16 
6.6 
Assessments ............................................................................................................................. 17 
7.0 
TIMELINE ........................................................................................................................... 18 
8.0  
STATISTICAL ANALYSES ............................................................................................... 19 
8.1  
General Analytical Approach ................................................................................................... 19 
8.2  
Advancement through the HIV Prevention or Care Continuum .......................................... 19 
8.3  
HIV Sexual Risk Behavior ........................................................................................................ 20 
9.0  
ANALYTIC APPROACH ................................................................................................... 21 
9.1  
Specific Aim 1a Analysis .......................................................................................................... 21 
9.2  
Specific Aim 1b Analysis ......................................................................................................... 21 
9.2  
Specific Aim 1c Analysis .......................................................................................................... 22 
10.0  
DATA COLLECTION AND CONFIDENTIALITY .......................................................... 22 
10.1  
Monitoring and Adverse Event Reporting .......................................................................... 23 
10.2  
Institutional Review Board (IRB) Review and Informed Consent .................................... 23 
REFERENCES ............................................................................................................................. 24 

 
3 
 
INVESTIGATOR ROSTER
 
 
Principal Investigator 
Cathy J. Reback, Ph.D. 
Senior Research Scientist, Friends 
Research Institute, Inc.  
Executive Director, Friends Community 
Center 
6910 Santa Monica Blvd. 
Los Angeles, CA 90038 
Phone: (323) 463-1601 
FAX: (323) 463-0126 
E-mail: reback@friendsresearch.org 
 
 
Co-investigator 
Jesse Fletcher, Ph.D. 
Research Scientist, Friends Research 
Institute, Inc.  
6910 Santa Monica Blvd. 
Los Angeles, CA 90038 
Phone: (323) 463-1601 
FAX: (323) 463-0126 
E-mail: jfletcher@friendsresearch.org 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consultant 
Adam Carrico, Ph.D. 
University of Miami 
Associate Professor, Public Health 
Sciences 
Don Soffer Clinical Research Center 1005 
1120 NW 14th St 
Miami, FL 33136 
Phone: (305) 243-6947  
Email: a.carrico@miami.edu 
 
Consultant 
Keith J. Horvath, Ph.D 
University of Minnesota 
Associate Professor, Department of 
Epidemiology & Community Health 
1300 S 2nd St 
Room 300 West Bank Office Building 
Minneapolis, MN 55454  
Phone: (612) 626-1799 
Email: horva018@umn.edu 
 
Consultant 
Raphael J Landovitz, M.D. 
UCLA Center for Clinical AIDS Research & 
Education  
Associate Professor of Medicine  
10880 Wilshire Blvd, Suite 1800 
Los Angeles, CA 90024  
Phone: (310) 794-3327 
FAX: (310) 794-6097 
Email: rlandovitz@mednet.ucla.edu

 
4 
SITES PARTICIPATING IN THE PROJECT 
 
 
 
Friends Community Center (FCC) 
A Division of Friends Research Institute, Inc. 
6910 Santa Monica Boulevard 
Los Angeles, CA 90038 
 
 

 
5 
GLOSSERY OF TERMS 
 
ACASI  
 
audio computer assisted self-interview 
 
AIDS  
 
acquired immunodeficiency syndrome 
 
APP 
 
 
mobile smartphone application 
 
ART 
 
 
antiretroviral therapy 
 
CAB 
 
 
community advisory board 
 
CAI 
 
 
condomless anal intercourse 
 
CBT 
 
 
cognitive behavioral therapy 
 
CDC 
 
 
Centers for Disease Control and Prevention 
 
DBS 
 
 
dried blood spot 
 
DSM-5  
 
Diagnostic and Statistical Manual of Mental Disorders-version 5 
 
FCC 
 
 
Friends Community Center 
 
FRI 
 
 
Friends Research Institute, Inc. 
 
GPS 
 
 
global positioning system 
 
HIPAA  
 
Health Insurance Portability and Accountability Act 
HIV 
 
 
human immunodeficiency virus 
 
IRB 
 
 
institutional review board 
 
MA 
 
 
methamphetamine 
 
mHealth 
 
mobile health 
 
MSM  
 
men who have sex with men 
 
MTL 
 
 
Molecular Testing Labs 
 
NIH 
 
 
National Institutes of Health 
 
PEP 
 
 
post-exposure prophylaxis 
 
PrEP  
 
pre-exposure prophylaxis 
 
RA 
 
 
research assistant 
 
RCT 
 
 
randomized controlled trial 

 
6 
 
SAE 
 
 
serious adverse event 
 
SOC 
 
 
stages of change 
 
STI 
 
 
sexually transmitted infection 
 
 
 

 
7 
 
SCHEMA 
 
Getting Off: 
A Theory-based mHealth Intervention for Methamphetamine-using MSM 
 
Lay Title: Getting Off App 
 
DESIGN 
Getting Off App is a randomized controlled trial (RCT) to assess the 
impact of Getting Off, a culturally competent Cognitive Behavioral 
Therapy-based app for reducing methamphetamine use, HIV sexual risk 
behaviors, and increase advancement along the HIV Prevention or Care 
Continuum, with the desired outcome of significant reductions in 
methamphetamine use and HIV sexual risk behaviors as well as 
increased odds of advancement along the HIV Prevention or Care 
Continuum among men who have sex with men (MSM), aged 18-65, who 
report using methamphetamine within the past year. 
Over the course of 30-days, participants are asked to complete 24 
intervention sessions in the Getting Off app derived from an existing, 
manualized, group-based intervention with established efficacy.  
The study will implement a two-arm RCT to determine intervention effects 
through comparison of participants who are given immediate access to 
the Getting Off app (Immediate Delivery [ID]) and participants who are 
given access to the Getting Off app after a delayed 30-day period 
(Delayed Delivery [DD]). 
DURATION 
 
30 days 
SAMPLE SIZE 
300 participants (n=150: Immediate Delivery / n=150: Delayed Delivery) 
POPULATION 
MSM who are between the ages of 18 and 65 years of age, who have 
used methamphetamine within the past 365 days, who have their own 
Android or iOS running smartphone with a current data plan, and who are 
able and willing to provide informed consent and comply with study 
requirements. 
 
 
 

 
8 
1.0 
STUDY OBJECTIVES 
 
1.1 
Specific Aims 
 
1.1.1 Specific Aim 1a: Conduct a RCT to evaluate reductions of methamphetamine use and HIV 
sexual risk behaviors, and increased advancement along the HIV Prevention or Care 
Continuum using a two-arm RCT to determine intervention effects through comparison of the 
Immediate Delivery [ID] (n=150) and Delayed Delivery [DD] (n=150) arms. 
 
1.1.2 Specific Aim 1b: Evaluate reductions in methamphetamine use and HIV sexual risk behaviors, 
and increased advancement along the HIV Prevention or Care Continuum using an observed 
treatment effects analysis powered for prospective sub-group analyses to compare longitudinal 
pre/post data from the pooled ID and DD arms (n=300);  
 
1.1.3 Specific Aim 1c: Evaluate reductions in methamphetamine use and HIV sexual risk behaviors, 
and increased advancement along the HIV Prevention or Care Continuum using a two-arm 
historical matched comparison design to evaluate the outcomes of the Getting Off app (ID+DD; 
n=300) relative to a matched sample of participants having previously attended the brick-and-
mortar group-based Getting Off intervention (n~600; total n=900). 
 
1.2 
Secondary Aim 
 
1.2.1 Secondary Aim 1: Determine the impact of structural- (e.g., housing insecurity, food 
scarcity, educational attainment, access to healthcare) and individual-level (e.g., homophobia, 
stigma, and discrimination) factors as moderators of intervention outcomes. 
 
2.0  
INTRODUCTION 
 
2.1  
Rationale  
 
Methamphetamine use among MSM is associated with increased rates of HIV prevalence and 
transmission, as well as substandard advancement along the HIV Prevention and Care 
Continua. Methamphetamine use among MSM is deeply integrated into socio-sexual networks 
including the use of smartphone apps and websites to find sexual partners. Given the growth of 
mobile health technology, it is no longer necessary or reasonable to limit methamphetamine 
treatment options to physical sites, clustered in urban areas, and administered using generic, 
non-tailored content. The project builds upon the established efficacy of our manualized 
methamphetamine-use treatment intervention, “Getting Off: A Behavioral Treatment Intervention 
for Gay and Bisexual Male Methamphetamine Users,” and the highly promising findings from 
the successful Stage I proof-of-concept study, to complete translation of Getting Off into a 
cross-platform (iOS and Android) app and assess the app’s efficacy and non-inferiority in a 
scientifically rigorous randomized trial. The Getting Off app, like the group-based intervention 
before it, will use the principles of Cognitive Behavioral Theory and Stages of Change to help 
MSM reduce or eliminate methamphetamine use and HIV sexual risk behaviors, and increase 
advancement along the HIV Prevention or Care Continuum (including uptake of HIV testing, 
pre-, and post-exposure prophylaxis [PEP/PrEP] and PrEP adherence and persistence for those 
who are HIV negative; ART uptake and adherence for those who are HIV positive).  
 

 
9 
2.2  
Background 
 
2.2.1 Methamphetamine Use and HIV among MSM  
 
MSM have elevated rates of methamphetamine use relative to non-MSM,1-3 as 
methamphetamine use is deeply integrated into the sexual identities and sexual behaviors of 
MSM in the United States,3-6 and permeates the venues most often associated with high-risk 
sexual behaviors among MSM.7-9 Use of methamphetamine by MSM before or during sex is 
associated with decreased behavioral inhibition and increased engagement in HIV risk 
behaviors,10-12 including condomless anal intercourse (CAI)13-16 with serodiscordant sexual 
partners.17-19 HIV prevalence is significantly higher among MSM who use methamphetamine,19-
21 and increases in concert with the intensity of methamphetamine use.22 Methamphetamine use 
has thus been identified by the CDC as a driving force of the HIV epidemic among MSM in the 
United States.12 Methamphetamine use is associated with poor antiretroviral therapy (ART) 
adherence and outcomes23-24 and reduced adherence to HIV post-exposure prophylaxis (PEP) 
and pre-exposure prophylaxis (PrEP) among HIV-positive/-negative MSM, respectively.25 In 
combination, the HIV Prevention and Care Continua address the National HIV/AIDS Strategy to 
reduce incidence and optimize care outcomes. Providing methamphetamine treatment to MSM 
is a public health imperative for addressing HIV/AIDS in the 21st century.  
 
2.2.2 Methamphetamine Use and HIV Sexual Risk in MSM-targeted Digital Spaces  
 
MSM use smartphones for sexual partner selection, sexual health information, and sexual 
identity expression at a higher rate than non-MSM,26-31 and use smartphone applications 
(“apps”) to facilitate GPS-based sexual partner selection (e.g., Scruff, Grindr, Jack’d);32-34 such 
behaviors increase odds of both methamphetamine use and HIV sexual risk behavior.35 Young 
MSM report using such apps daily,27,29,36 and young, racial minority MSM are simultaneously 
both the group most at-risk for methamphetamine use and HIV infection as well as the group 
most likely to use smartphones.28-30,36 MSM living in rural areas rely on Internet resources and 
GPS-enabled smartphones for locating sexual partners.37 High rates of smartphone usage by 
young racial/ethnic minority and rural MSM dovetail cleanly with the current methamphetamine 
treatment and HIV risk reduction deficits evidenced in the United States health care system.28 
 
2.2.3 Public Health Significance of a Methamphetamine Use Intervention App for High-risk MSM  
 
The Getting Off app could broadly disseminate culturally competent methamphetamine use and 
HIV risk reduction content to large numbers of demographically and geographically diverse 
users who otherwise could not access such services, particularly racial/ethnic minority MSM and 
MSM living in rural areas. 28,45-46 Psychosocial factors (e.g., stigma) are the primary barriers 
discouraging MSM from accessing methamphetamine treatment,47-48 obstacles obviated through 
technology-based delivery. The ability to access treatment from a smartphone would eliminate 
embarrassment, homophobic prejudice, and/or any stigma associated with methamphetamine 
use and/or HIV sexual risk behaviors.48-49 Providing theory-driven, MSM-specific 
methamphetamine treatment, which integrates HIV risk reduction programming, reminders 
about HIV testing/PrEP/PEP, and information about HIV care (including ART reminders), will 
address a range of HIV-related health deficits and address key priorities set by the NIH 
HIV/AIDS research priorities and the National HIV/AIDS Strategy. Furthermore, the overall 
public health benefits could be tremendous as methamphetamine use has also been associated 
with major physical harm,50 dental disease,51 psychological harm,13,44,52 and neurological 
damage.53 The broader scientific community would benefit substantially from the knowledge that 

 
10
methamphetamine use and HIV sexual risk behaviors can successfully be reduced via remote 
intervention, and clinical practice could face a potential paradigm shift towards mobile content 
delivery for difficult-to-reach and/or stigmatized populations.  
 
Given the growth of mobile technology, it is no longer reasonable to limit methamphetamine 
treatment options to physical sites, clustered in urban areas, and administered using generic, 
non-tailored content. Only 1% of app-using MSM express a preference to participate in 
programming delivered in-person; 70% prefer content delivered via smartphone.26 The Getting 
Off intervention is particularly well-situated for translation into a mobile app-driven format, as it 
has been adapted to be carried out in community settings with peer counselors and does not 
require delivery via Masters’ level/experienced Cognitive Behavioral Therapy (CBT) counselors.  
 
2.2.4 Preliminary Studies: Developing and Evaluating the Group-based, Manual-driven 
Intervention 
 
Getting Off began as a MSM-specific, manual-driven intervention based on the theoretical 
principles and techniques of CBT, as originally incorporated in the Matrix Model.54 The original 
48-session, 16-week intervention was rigorously evaluated in two randomized controlled trials 
(RCT).38-41 In the first study, Getting Off was shown to significantly reduce HIV sexual risks 
compared to a mainstream CBT arm; all arms produced significantly more methamphetamine-
negative urine samples compared to the control arm.40 In the second study, Getting Off 
sustained greater reductions in methamphetamine use compared to a gay social support 
therapy control arm.41 In the third study, Getting Off was tailored to a 24-session, 8-week 
intervention and modified for implementation within the limited resources and capacity of 
community-based organizations while retaining significant reductions in methamphetamine use 
and HIV sexual risk.38,42 Since 2007, the tailored Getting Off intervention has been sustained as 
a service program with public health funding and has been adopted by multiple community sites 
and public health facilities nationally and internationally. The evolution of Getting Off towards 
greater scalability responds to the mHealth opportunity to advance treatment options into the 
digital sphere.  
 
2.2.5 Preliminary Studies: Summary of Stage I Findings 
 
During the proof-of-concept study, three focus groups (N=23) provided feedback from 
treatment-savvy participants who completed a minimum of 18/24 sessions (75%) of the group-
based Getting Off intervention. Based on focus group input, one-third of the manual intervention 
(8/24 sessions) was developed into an app format. Focus group participants provided very 
constructive feedback regarding their treatment experiences, offering valuable guidance for app 
development on session selection, adaptation of content, and app design. Participants 
emphasized the importance of interactivity and had specific suggestions about adapting 
manualized exercises to fit with and fully exploit the capabilities of mobile smartphone 
technology. Sample screenshots from the app are shown below.  
 
The initial eight sessions were developed using an iterative development process with close 
communication between Investigators and the technology team. A cross-platform app was 
developed that included the following content, features, and functionality: 1) HIV and 
methamphetamine health, prevention, and risk behavior information, including a risk calculator; 
2) behavioral self-assessments; 3) multimedia health promotion and educational information; 4) 
mobile-optimized interface; 5) avatar creation and personalization; 6) culturally competent (i.e., 
gay-specific content, themes, and pictures), user-friendly, and attractive interface; and, 7) 
passcode protected platform and HIPAA compliant data collection and storage.  

 
11
 
A feasibility pilot test was conducted on the original eight sessions. Participants (N=15) in the 
feasibility pilot test were 40% Caucasian/White, 33% African American/Black, and 27% 
Hispanic/Latino; 73% identified as gay and 27% identified as bisexual. Ages ranged from 25-55 
years (Mean=43; SD=9); 67% were HIV positive. Most (87%) met criteria for DSM-5 
methamphetamine use disorder (60% severe). In the past 30 days, 80% reported 
methamphetamine use, 67% reported sex with a casual male partner (Mean=1.7; SD=0.9), and 
25% reported sex with an anonymous male partner (Mean=2.5; SD=2.4). Pilot test participants 
were identified as similar to prospective app users; 53% (n=8) were out-of-treatment, current 
methamphetamine users and 47% (n=7) were methamphetamine users who had recently 
sought treatment for their methamphetamine use with no more than six months of recovery. 
Backend app user data indicated that average progression rates (i.e., how much of a session 
the participant completed) ranged from 62% (Recall) to 91% (Redefine), and the median 
completion rate for every session was 100% across all 15 participants. Twelve (80%) 
participants finished all sessions and completed both the initial and closing self-assessments; 
on average these participants reported improvements in self-esteem, social life, family life, drug 
Personalized Avatar  
Initial Assessment Translated from the Manual to the App 
Screenshots 
Top left: Each user can personalize his avatar by choosing facial structure, skin tone, hair, facial hair, clothing, and 
background. Bottom left: An example of the translation from manual to app. Right: Screenshots showing how the Getting Off 
app provides information on the stages of recovery from methamphetamine use, a risk calculator for methamphetamine use 
and high-risk sexual behaviors, a reflective exercise on disassociating sexual behaviors from methamphetamine use, and a 
goal-setting exercise to increase self-efficacy.  

 
12
use, and alcohol use. Follow-up interviews (n=14; 93%) indicated mean participant satisfaction 
rating was high (8.5/10). 
 
2.2.6 Preliminary Studies: Lessons Learned 
 
Three components addressed feasibility: 1) Physical location versus computer delivery: Could 
the Getting Off intervention, written to be delivered in a treatment clinic, be successfully 
delivered through an app?, 2) Clinical versus self-directed: Could the Getting Off intervention, 
originally designed to be delivered by a counselor, be self-directed? and, 3) Group versus 
individualized: Could the Getting Off intervention, originally designed for a group format, be 
individualized? Findings demonstrated proof-of-concept for the Getting Off app. Getting Off was 
easily delivered as a mHealth intervention; participants were engaged, were able to understand 
the CBT concepts, and thoroughly navigated through the sessions. Overall, satisfaction was 
very high. Areas for improvement that were identified: increased interactivity between the user 
and the avatar; an accumulation of points that could be used to “purchase” items to personalize 
and enhance the avatar (e.g., a computer, clothes, a dog); reduce text in certain sessions; and, 
increased gamification. 
 
2.2.7 Stage II Application Development in Response to Stage I Findings 
 
The Stage II development of the cross-platform Getting Off app will be based on focus groups 
and a beta usability pilot test; user feedback from the Stage I feasibility pilot test; current 
literature on app preferences among MSM; as well as state-of-the-art technology. To be 
reflective of the needs of MSM methamphetamine users, refinement of the first eight sessions 
and development of the remaining 16 sessions will focus on increased interactivity; 
personalization of avatar functionality; gamification in the form of earnable points (particularly 
but not limited to the “purchase” of items for the avatar); reduced text and increased images; the 
ability to view peer testimonials; links to Internet sites (particularly for local resources related to 
methamphetamine treatment, HIV/STI testing, PrEP/PEP, HIV care); increased information on 
PrEP/PEP; and, a self-administrated risk calculator. The app will be an interactive presentation 
of the Getting Off manual. Health content, behavioral self-assessments, “homework” 
assignments, and multimedia content will be integrated in a walk-through (i.e., step-by-step) 
manner where the consumer will be presented dynamic content, all under the guidance of a 
culturally competent, user-friendly, attractive interface. 
 
3.0  
STUDY DESIGN 
 
3.1 
Overview 
 
Getting Off App is a randomized controlled trial to assess the impact of Getting Off, a culturally 
competent Cognitive Behavioral Therapy-based app for reducing methamphetamine use, HIV 
sexual risk behaviors, and increase advancement along the HIV Prevention or Care Continuum, 
with the desired outcome of significant reductions in methamphetamine use and HIV sexual risk 
behaviors as well as increased odds of advancement along the HIV Prevention or Care 
Continuum among MSM, aged 18-65, who report using methamphetamine within the past year. 
The design of Getting Off App is illustrated in Figure 1. 
 
 
 

 
13
Figure 1: Getting Off App Study Design 
 
Following screening, informed consent and baseline assessments, participants will be 
randomized into one of two arms: Arm A: Immediate access to the Getting Off app (Immediate 
Delivery [ID]); or, Arm B: Participants will have access to the Getting Off app after a delayed 30-
day period (Delayed Delivery [DD]). Participants in both arms will receive the same Getting Off 
app and participants in both arms will be given 30-days to complete the 24 sessions; it is 
expected to take far less time to progress through the self-directed app than the group-based 
intervention. The randomized two-arm repeated measures design will assess participants at 1-, 
2- (DD arm only), 3-, 6-, and 9-months post-randomization to determine longitudinal intervention 
effects, observed treatment effects, and a historical comparison with a matched sample of 
participants who have attended the brick-and-mortar group-based Getting Off intervention (see 
Figure 1). The study will use an “intent-to-treat” design; participants will be assessed regardless 
of participation or retention. 
 
4.0 
STUDY SITE 
 
FCC, the community site for Friends Research Institute (FRI) and clinical site for the study, is in 
the MSM sex work district on the border of Hollywood and West Hollywood.  The location allows 
easy (walking distance and public transportation) access to methamphetamine-using MSM who 
congregate in the area.  FCC provides a full spectrum of HIV and substance abuse prevention 
service programs for out-of-treatment substance users and outpatient treatment for treatment-
seeking MSM methamphetamine users.  Most FCC program participants are current substance 
users, many are sex workers, persons of color, and homeless or living in a transitional living 
situation. The Getting Off service program has been operating at FCC since 2007. The RCT will 
be conducted at the study site, with the option to have the follow-ups conducted through a 
virtual platform. All participants will be required to visit the study site for their baseline 
assessment and enrollment. 
 
5.0 
PARTICIPANTS 
 

 
14
5.1  
Inclusion Criteria 
 
5.1.1 Self-identified MSM; 
 
5.1.2 Methamphetamine use within the past 365 days; 
 
5.1.3 Between 18 and 65 years of age; 
 
5.1.4 Resident of Los Angeles County; 
 
5.1.5 Has an iPhone 7 or later running iOS 10.0 or higher, or has an Android smartphone with a 
minimum 3 GB RAM running Android 6.0 or higher operating system, with a current data plan; 
 
5.1.6 Willing to download an experimental app; and has at least 2 GB of available storage 
memory on their smartphone; 
 
5.1.7 Willing and able to receive and self-administer at-home HIV/STI test kits or have the test 
kits completed in-person at the study site; 
 
5.1.8 Willing to provide informed consent; and 
 
5.1.9 Willing to comply with study requirements. 
 
 
5.2  
Exclusion Criteria 
 
5.2.1 Does not identify as a MSM; 
 
5.2.2 Has not used methamphetamine within the past 365 days; 
 
5.2.3 Under 18 years or over 65 years of age; 
 
5.2.4 Is not a resident of Los Angeles County; 
 
5.2.3 Does not have an iPhone 7 or higher running iOS 10.0 or higher, or an Android 
smartphone with a minimum 3 GB RAM running Android 6.0 or higher operating system; or 
does not have an active data plan; 
 
5.2.4 Unwilling to download an experimental app; or does not have at least 2 GB of available 
storage memory on their smartphone; 
 
5.2.5 Unwilling or unable to receive and self-administer at-home HIV/STI test kits or have the 
test kits completed in-person at the study site; 
 
5.2.5 Unwilling to provide informed consent; and 
 
5.2.6 Unwilling to comply with study requirements. 
 
6.0  
PROJECT PROCEDURES 
 

 
15
6.1 
Recruitment  
 
Four recruitment strategies are being utilized to ensure enrollment targets are met and a 
diversity of participants are enrolled. Furthermore, the diversity in recruitment strategies will 
foster a range in the sociodemographic profiles. All potential participants who inquire about the 
study are scheduled for an intake within 24-48 hours. 
 
6.1.1 Online recruitment 
 
Both website- and app-based online recruitment will be utilized. Banner ads/digital flyers will be 
placed on gay websites, apps, and social media sites that specifically target MSM such as 
Adam4Adam, Jack’d, Grindr, Craigslist.org. FCC has established relationships with online 
venues that cater to MSM, which will enable a successful and robust Internet-based recruitment 
strategy. 
 
6.1.2 Street- and Venue-based Outreach  
 
The Research Coordinator and Research Assistant (RA) will utilize a semi-structured time-
space sampling methodology to conduct street- and venue-based outreach identified through 
the Community Advisory Board (CAB) and ongoing community mapping as locations where 
methamphetamine-using MSM congregate (e.g., parks, street corners, cruising locations, sex 
clubs, bathhouses, churches, shelters, food lines, social services agencies).  
 
6.1.3. Poster Advertisement 
 
Posters that introduce the study will be posted throughout FCC and at local community-based 
organizations to inform potential participants that they can contact the RA for further information 
regarding the research study.  
 
6.1.4 Long-chain Referral Sampling 
 
Current study participants will be asked to recruit potential new participants. Current participants 
will receive $2 when they bring a potential participant to the site and $18 if an eligible participant 
enrolls. 
 
6.2 
Informed Consent Procedures 
 
During the enrollment session, the Research Coordinator or RA describes the study in detail to 
the potential participant. If the potential participant is deemed eligible and is interested in 
participating, he is administered the Informed Consent Form. Participants must pass an 
informed consent quiz verifying his full understanding of study procedures (e.g., length of study 
participation, incentive schedule). Participants will be informed of procedures for ensuring their 
confidentiality, including the issuance of a Certificate of Confidentiality by the federal 
government; the use of numbers and codes  rather than participants’ names; and the 
maintenance of a cloud-based HIPAA compliant (secure and encrypted) commercial data 
website (Qualtrics.com). Participants will be given the contact numbers of both the Principal 
Investigator and Western IRB to answer questions about the study or one’s rights as a human 
subject. 
 

 
16
6.3 
Enrollment Procedures 
 
After the Informed Consent Form for the study has been read, any questions have been 
answered, the informed consent quiz has been passed, and the participant has electronically 
signed the consent form, a Research Coordinator or RA will deliver the baseline assessment, 
which takes approximately 60-90 minutes. To maximize accurate disclosure of high-risk and 
sensitive behaviors, data is collected via an audio computer-assisted self-interview (ACASI). 
Studies have demonstrated that disclosure rates of perceived stigmatized behaviors are 
increased through ACASI assessments. After the ACASI is completed, participants will be 
instructed to download the Getting Off app on to their smartphone. Once access to the app is 
granted (determined by randomization), participants will have 30-days to complete the 24 
sessions. 
 
6.4 
Random Assignment 
 
Following informed consent and completion of the baseline assessment, participants will be 
randomized to either the ID or DD arm through a computerized variable-balanced block 
randomization procedure. Recent work with MSM with substance use disorder (predominantly 
methamphetamine) at FCC revealed treatment outcomes to be associated with participant 
substance use histories and sociodemographics. A variable-balanced procedure will thus 
provide multivariate balance among the characteristics known or expected to influence 
outcomes. The randomization procedure will balance across age (<34, ≥34), race/ethnicity 
(Caucasian/White, all other race/ethnicities), HIV serostatus (+, -), and SOC 
(contemplation/preparation, action/maintenance). 
 
6.5 
Incentive Schedule 
 
Incentives are comprised of 1) incentives for baseline assessment ($40 gift card); 2) incentives 
for completing follow-up assessments [$50 gift card for completing the 1-month follow-up 
assessment, the 2-month follow-up assessment (DD arm only), the 3-month follow-up 
assessment, the 6-month follow-up assessment, and the 9-month follow-up assessment]; 3) 
incentives for self-administering and returning the at-home HIV/STI test kits within 45 days of 
receipt [$50 gift card for returning after the 3-month assessment, after the 6-month assessment, 
and after the 9-month assessment] and 4) a $2 gift card when an active participant brings a 
potential participant to the site to screen for eligibility, and an additional $18 gift card if the 
potential participant is eligible and enrolls (maximum of three eligible and enrolled participants 
per active participant). Participants randomized into the ID arm can thus earn a maximum of 
$450 in gift cards. Participants randomized into the DD arm can earn a maximum of $500 in gift 
cards. 
 
All participants may earn up to $50 in gift cards each time they provide all requested biological 
marker samples or test results at the follow-ups, if conducted at-home and returned within 45 
days of receiving the kit. HIV-positive participants may earn a $20 gift card for returning a 
complete at-home test kit for Chlamydia, N. gonorrhea and Syphilis. If the DBS sample is 
insufficient for processing the Syphilis test, participants will be asked to provide results of a 
recent (within 3 months) Syphilis test from their medical provider, or to come to the study site for 
an in-person blood draw. HIV-positive participants may earn the additional $30 gift card (totaling 
$50 in gift cards) for providing recent (within 3 months) HIV viral load test results from their 
medical provider, or by coming to the study site for a blood draw. HIV-negative participants may 
earn the full $50 gift card for returning a complete at-home test kit for Chlamydia, N. gonorrhea, 
Syphilis and HIV. Including, an additional DBS card for PrEP (TDF/FTC or TAF/FTC), if 

 
17
appropriate. If the DBS sample(s) is insufficient, only a $20 gift card will be dispersed, and the 
participant will be asked to provide results of a recent Syphilis and TDF/FTC or TAF/FTC 
adherence test (both within 3 months) from their medical provider, or to come to the study site 
for an in-person blood draw to earn the additional $30 gift card (totaling $50 in gift cards). 
 
6.6 
Assessments 
 
6.6.1 Assessments Overview 
Behavioral assessments will be conducted at baseline and follow-ups. Follow-up assessments 
will be conducted at 1-, 2- (for those randomized to the DD condition only), 3-, 6-, and 9-months 
post-randomization to measure methamphetamine use, HIV sexual risk behaviors, and 
advancement along the HIV Prevention or Care Continuum. 
 
6.6.2 Behavioral Assessments 
 
6.6.2.1 DSM-5 Methamphetamine Use Disorder contains the DSM-5 diagnostic items necessary 
to make a determination of mild, moderate, or severe methamphetamine use disorder. This 
information will determine the app’s utility for consumers at various levels of methamphetamine 
use. DSM-5 diagnostic criteria for other substance use disorders will also be collected. 
Administered at baseline only. 
 
6.6.2.2 University of Rhode Island Change Assessment (URICA) is a brief, self-administered 
inventory used to assess the participant’s current position regarding readiness for change (e.g., 
precontemplation, contemplation, action). Administered at all time points. 
 
6.6.2.3 Admission/Follow-up Form collects demographic information, housing status, food 
security, educational attainment, alcohol and other drug use history, family and social history, 
legal status, HIV status, location on the HIV Prevention or Care Continuum, experiences with 
stigma and/or discrimination, and general and mental health status. The full form will be 
administered at baseline, an abbreviated version at all follow-up time points. 
 
6.6.2.4 Substance Use Frequency is a brief assessment, developed by Dr. Cathy Reback 
(Principal Investigator) that assesses substance use, injection drug use, and injection protocols 
in the past 30 days. Administered at all time points. 
 
6.6.2.5 Behavioral Questionnaire – Amphetamine (BQA)-Abbreviated Version gathers 
information on HIV-related drug and sexual risk behaviors, assesses self-efficacy for sexual 
behavior change, and collects detailed information on discrete sexual behaviors (with primary or 
non-primary partners and whether or not the behavior occurred under the influence of 
methamphetamine and/or other substances), as well as episodic data about participants’ most 
recent sexual encounters. Administered at baseline, and an abbreviated version is administered 
at all follow-up time points. 
 
6.6.2.6 PrEP Uptake and Adherence is a brief assessment, developed by Dr. Cathy Reback 
(Principal Investigator), that gathers information of PrEP readiness, initiation and adherence to 
access advancement along the HIV Prevention Continuum. Administered at all time points. 
 
6.6.2.7 ART/HIV Care is a brief assessment, developed by Dr. Cathy Reback (Principal 
Investigator), that gathers information of HIV care and ART medication adherence to access 
advancement along the HIV Care Continuum. Administered at all time points. 
 

 
18
6.6.3. Biomarker Assessments 
 
6.6.3.1 HIV-antibody Test. HIV-negative and status unknown participants will receive a 
fingerstick DBS test at 3-month intervals, as recommended by the CDC for high-risk individuals. 
Participants who show documentation of HIV-positive serostatus are not given a HIV-antibody 
test. If the test is reactive, then the participant will be presumed positive for HIV antibodies and 
referred for additional evaluation and treatment. If the DBS sample is rejected by the lab or if the 
quantity of blood is insufficient, participants will be asked to come to the study site to have the 
test performed via fingerstick blood test using the INSTI HIV 1/HIV 2 antibody test, or to provide 
a copy of recent results (within 3 months) from their medical provider. Conducted at baseline 
and at the 3-, 6-, and 9-month follow-up time points (if previously tested HIV-negative or status 
is unknown). 
 
6.6.3.2 STI Testing. Participants will be tested for urinary N. gonorrhea and Chlamydia, 
pharyngeal and rectal swabs will be taken for N. gonorrhea and Chlamydia, and syphilis will be 
tested by fingerstick DBS. Positive STI results will be reported per state guidelines and will be 
immediately referred to care. If the DBS sample is rejected by the lab or if the quantity of blood 
is insufficient, participants will be asked to come to the study site to have the test performed via 
intravenous blood draw or to provide a copy of recent results (within 3 months) from their 
medical provider. Conducted at baseline and at the 3-, 6-, and 9-month follow-up time points. 
 
6.6.3.3 Virologic Control for HIV-positive Participants. As indicated by an undetectable HIV-1 
level via intravenous blood draw, which has a threshold for undetectability = <30 copies/mL will 
be performed by Foundation Laboratory. Viral load testing through Foundation Laboratory may 
be bypassed if participants can provide recent (within 3 months) lab results from their medical 
provider. Conducted at baseline and at the 3-, 6-, and 9-month follow-up time points. 
 
6.6.3.4 Dried Blood Spot (DBS) for HIV-negative Participants who Report PrEP Uptake. A blood 
sample will be collected and a DBS analysis for intra-erythrocytic TFV-DP will be performed by 
Molecular Testing Labs. Conducted at baseline and at the 3-, 6-, and 9-month follow-up time 
points. 
 
6.6.4. Follow-up Locator Questionnaire 
 
6.6.4.1. Health Study Locator Questionnaire. The locator form was originally developed by 
UCLA Integrated Substance Abuse Programs (ISAP) investigators for the Methamphetamine 
Treatment Project to facilitate contact with the participant during intervention and follow-up and 
has been modified by the Principal Investigators for MSM.  The form asks participants to give 
consent for follow-up and to provide names, addresses, email and Internet site profiles, 
particularly social network sites, and phone numbers of relatives and friends who can reach the 
participant in emergencies. Information is also collected on where (libraries, clubs, bars) and 
with whom the participant associates (i.e., social network), and a physical description, including 
tattoos, scars, and birthmarks. 
 
7.0 
TIMELINE 
 
The timeline and research procedures are presented in Table 1. 
Table 1. Timeline and Activities 

 
19
 
 
8.0  
STATISTICAL ANALYSES 
 
8.1  
General Analytical Approach  
 
All primary outcomes are operationalized and assessed in at least two discrete ways, increasing 
accuracy of measurements, reducing concerns of fully missing data, and allowing for post-hoc 
comparisons of concurrent validity across assessment modalities (see Table 2 for all outcome 
operationalizations). Descriptive statistics will be calculated and provided for all outcomes, with 
specific metrics chosen based on the distributional properties of each variable (e.g., counts and 
percentages for nominal variables; means and standard deviations for parametric continuous 
variables; ranges and medians for non-parametric continuous variables). Diagnostic (i.e., DSM-
5), psychosocial (e.g., URICA), barriers and facilitators (e.g., housing insecurity, lack of 
transportation), and/or sociodemographic variables will be tested for significant association with 
study outcomes (i.e., advancement through the HIV Prevention or Care Continuum, 
methamphetamine use, HIV sexual risk behaviors), with specific tests of association chosen 
based on the distributional properties of the outcome variables in question. All variables 
demonstrating significant statistical association with one or more of the study outcomes will be 
included as statistical covariates in all multivariate outcome analyses associated with Specific 
Aims 1a-1c, and will additionally be included in exploratory sub-group analyses to test for 
moderating effects on treatment response and/or contingent effects among subsets of 
participants. Primary outcome analyses for Specific Aims 1a, 1b, and 1c will be carried out using 
mixed effects Generalized Linear Model (GLM) equations.  
 
8.2  
Advancement through the HIV Prevention or Care Continuum 
 
Advancement through the HIV Prevention or Care Continuum will be assessed at all time points 
throughout the study, and will be operationalized dichotomously (i.e., yes/no achievement of 
one of the steps on either the HIV Prevention or Care Continuum; e.g., viral suppression), and 

 
20
as a counted variable (e.g., consecutive DBS results indicating successful PrEP adherence). 
Power calculations related to advancement through either continuum will assume a 30% 
probability of achievement of at least one of the steps on either the HIV Prevention or Care 
Continuum (equivalent to ~1:2 odds of advancement). Methamphetamine use outcomes will be 
assessed repeatedly (i.e., at all time points) and will be operationalized dichotomously (e.g., 
methamphetamine-metabolite-free urine sample), as a counted variable (i.e., number of 
methamphetamine-metabolite-free urine samples provided), and as a continuous variable (i.e., 
Treatment Effectiveness Score [total number of methamphetamine-metabolite-free sample 
divided by total samples possible]). Power calculations related to methamphetamine use 
outcomes assume an 80% probability of methamphetamine use during the pre-intervention 
period for participants in the DD arm (equivalent to 4:1 odds of use).  
 
8.3  
HIV Sexual Risk Behavior 
 
HIV sexual risk behavior outcomes will be assessed at all time points throughout the study, and 
will be operationalized dichotomously (e.g., incident STI via biomarker testing), as a counted 
variable (e.g., number of days/times engaged in CAI in the past 30 days), and as a continuous 
variable (e.g., a HIV risk severity index generated from multiple factor-analyzed items). Power 
calculations for engagement in HIV sexual risk behaviors assume a 65% probability of 
engagement during the pre-intervention period for participants in the DD arm (equivalent to ~2:1 
odds of engagement). Multivariable inferential analyses of dichotomous outcomes will take the 
form of GLMs employing the Bernoulli family and logit link function; counted outcomes will be 
analyzed with GLMs employing the Poisson-log or negative binomial link functions as 
distributional patterns dictate (note: if data evidence an over-representation of zeros or an 
overdispersion of variance, zero-inflated Poisson and/or negative binomial analyses may be 
substituted); continuous outcomes will be analyzed using GLMs employing the identity link and 
Gaussian family functions and assume a single covariate unless otherwise stated (note: 
iteratively reweighted, bootstrapped, or jack-knifed estimation procedures may be used in 
Gaussian models if sensitivity analyses indicate undue influence from outliers). Mixed effects 
GLM models are considered the best linear unbiased estimators for repeated measures data 
employing non-parametric and/or limited dependent variables. All power calculations are 
premised on tests of association across two time points (e.g., baseline with app completion; app 
completion with brick-and-mortar program completion), providing the most conservative 
estimate of minimum detectable effect (MDE) size estimations; all power calculations assume α 
≤ 0.05 (two-tailed), and 1 – β = 0.80. 
 
  Table 2: Instruments, Targets, Variable Operationalizations, and Minimum Detectable Effects 

 
21
 
9.0  
ANALYTIC APPROACH 
 
9.1  
Specific Aim 1a Analysis 
 
Aim 1a, which begins the efficacy trial, is a two-arm, non-blinded RCT whereby half of all 
participants are randomly assigned to receive the Getting Off app immediately (ID arm; n=150; 
equivalent to an “active intervention” arm) and half are randomly assigned to receive the app 
after a 30-day delay (DD arm; n=150; equivalent to a “control” arm). The proposed analytical 
model allows for causal analysis of intervention effects. Power Calculations for Specific Aim 1a: 
estimated RCT MDEs for HIV Prevention or Care Continuum outcomes related to Specific Aim 
1a are: 1) dichotomous (Di)—Odds Ratio (OR) = 1.97; 2) counted (Cu)—Incidence Rate Ratio 
(IRR) = 1.51; 3) continuous (Co)—f2 = 0.03; for methamphetamine use outcomes: 1) Di—OR = 
0.48; 2) Cu—IRR = 0.85; 3) Co—f2 = 0.05; for HIV sexual risk behaviors outcomes: 1) Di—OR 
= 0.52; 2) Cu—IRR = 0.78; 3) Co—f2 = 0.05. 
 
9.2  
Specific Aim 1b Analysis  
 
Aim 1b completes the efficacy trial by doubling the size of the analytical sample and allowing for 
highly accurate specification of observed treatment effects; it is a single-arm, pooled (i.e., 
ID+DD) observed treatment effects analysis whereby data points from the ID arm are paired 
with their analytical comparators from the DD arm (i.e., ID enrollment data with DD 1-month 
post-enrollment data; ID 1-month post-enrollment data with DD 2-months post-enrollment data); 
Table 2: Instruments, Targets, Variable Operationalizations, and Minimum Detectable Effects (1 - β = 0.80; α = 0.05, two-tailed) 
Instrument 
Target 
Variable Operationalizations 
Power-- Minimum Detectable Effects 
Dichotomous  
(Di) 
Count  
(Cu) 
Continuous 
(Co) 
Model 1— 
RCT  
(Aim 1a; 
n=150/n=150) 
Model 2— 
Tx Effects  
(Aim 1b;  
N = 300) 
Model 3— 
Matched Comparison  
(Aim 1c;  
N = 300/N ~ 600) 
DSM-5 
(MA) 
Diagnosis of  
MA Use Disorder 
Presence/Absence 
of MA Use 
Disorder 
# of Diagnostic 
Criteria 
Endorsed 
N/A 
Potential Statistical Controls; Exploratory Sub-Group Analyses 
URICA 
Stage of Change/ 
Readiness for 
Change 
Above/Below 
"Action" Stage 
N/A 
URICA 
Score(s) 
Potential Statistical Controls; Exploratory Sub-Group Analyses 
Admissions 
   & 
Follow-up  
Form 
Sociodemographics;  
HIV Status and Tx 
History, Barriers & 
Facilitators 
Sexual Identity; 
HIV Status; 
Linked/Unlinked; 
Housing Insecurity 
Prior Drug 
Treatment 
Episodes; 
Symptomology 
Age; Income 
Potential Statistical Controls; HIV-Related Sub-Group Analyses; 
Barrier/Facilitator Moderator Analyses 
HIV Prevention or 
Care Continuuma 
HIV Test; PrEP 
Uptake; Advance 
along HIV 
Prevention or Care 
Continuum 
# of HIV 
Prevention or 
Care Continua 
Steps 
Completed 
N/A 
Di: OR = 1.97;  
Cu: IRR = 1.51;  
Co: f2 = 0.03 
Di: OR = 1.61; 
Cu: IRR = 1.35 
Di: OR = 1.52;  
Cu: IRR = 1.30;  
Co: f2 = 0.01 
Biomarker 
Tests (UA, 
VL, DBS, 
HIV/STI) 
MA Use, HIV 
Prevention/Care 
Continuum 
Outcomes, Sexual 
Risk Behavior 
Incident STI 
/Incident HIV 
Log reductions 
in HIV VL; 
DBS Analysis 
of PrEP 
Treatment 
Effectiveness 
Score 
Variable 
Variable 
Variable  
Substance 
Use Freq. 
MA Use 
Use/Non-use 
Days of Use 
N/A 
Di: OR = 0.48;  
Cu: IRR = 0.85;  
Co: f2 = 0.03 
Di: OR = 0.59;  
Cu: IRR = 0.89;  
Co: f2 = 0.01 
Di: OR = 0.62;  
Cu: IRR = 0.90;  
Co: f2 = 0.01 
BQA 
HIV Sexual  
Risk Behavior 
CAIb 
# CAIb 
Episodes 
HIV Sexual 
Risk Scale 
Di: OR = 0.52;  
Cu: IRR = 0.78;  
Co: f2 = 0.03 
Di: OR = 0.63;  
Cu: IRR = 0.85;  
Co: f2 = 0.01 
Di: OR = 0.66;  
Cu: IRR = 0.87;  
Co: f2 = 0.01 
Locator  
Contact Information 
  
  
  
  
aHIV Prevention Continuum (HIV testing and PrEP/PEP uptake) and HIV Care Continuum (link, ART adherence, virological suppression).  
bCAI: Condomless Anal Intercourse includes both receptive and insertive anal intercourse, and will be assessed by partner type (e.g., main, casual, exchange) 

 
22
the proposed analytical model provides increased analytical power for HIV subgroup and/or 
contingency analyses, given the greater number of persons receiving the intervention relative to 
the proposed RCT model (i.e., N=300 receiving the app). Power Calculations for Specific Aim 
1b: estimated pre-/post-test observed treatment effect MDEs for HIV Prevention or Care 
Continuum outcomes related to Specific Aim 3b are: 1) Di—OR = 1.61; 2) Cu—IRR= 1.35; for 
methamphetamine use outcomes: 1) Di—OR = 0.59; 2) Cu—IRR = 0.89; 3) Co—f2 = 0.01; for 
HIV sexual risk outcomes: 1) Di—OR = 0.63; 2) Cu—IRR = 0.85; 3) Co—f2 = 0.01. 
 
9.2  
Specific Aim 1c Analysis  
 
Aim 1c provides a non-inferiority trial against the group-based, brick-and-mortar intervention 
upon which the app is based, and will be a historical matched comparison analysis whereby 
pooled data from the proposed study (i.e., ID+DD, N=300) is contrasted against historical data 
from participants who have attended the brick-and-mortar Getting Off intervention after 2012 
(N~600; matched according to age, race/ethnicity, and HIV status [see Random Assignment]). 
The proposed analytical model allows for non-inferiority analyses comparing the relative 
efficacies of brick-and-mortar vs. mHealth delivered intervention content. Power Calculations for 
Specific Aim 1c: estimated historical matched comparison MDEs for HIV Prevention or Care 
Continuum outcomes related to Specific Aim 3c are: 1) Di—OR = 1.52; 2) Cu—IRR = 1.30; 3) 
Co—f2 = 0.01; for methamphetaminue use outcomes: 1) Di—OR = 0.62; 2) Cu—IRR = 0.90; 3) 
Co—f2 = 0.01; for HIV sexual risk outcomes: 1) Di—OR = 0.66; 2) Cu—IRR = 0.87; 3) Co—f2 = 
0.01. 
 
10.0  DATA COLLECTION AND CONFIDENTIALITY 
 
Data are collected for the purposes of this study; no other use will be made of the data. All 
assessment data will be collected via an ACASI administered by the Qualtrics system. All 
materials will be stored in Qualtrics’ commercial cloud-based databases that are HIPAA 
compliant (secure and encrypted), which means all personal identifiers and any information that 
can be combined by any reasonable person to identify unique individuals will be stripped from 
the research record. Research materials are directly obtained from participants. Identification 
necessary to follow these individuals will be collected in order to maintain high follow-up rates 
necessary to answer the scientific aspects of the study.  
 
The study consent form will inform participants of confidentiality guidelines. Strict confidentiality 
will be maintained; records that have personal identifiers (i.e., follow-up locator information) will 
be stored in a separate encrypted file from the assessment. Only the research team assigned to 
the follow-up of the participants will have access to non-anonymous records, and only for the 
purpose of contacting participants with reminders of their follow-up assessment. All research 
data are maintained in databases. No presentation or publication of the study results will refer to 
participants individually. Manuscripts published regarding this work will be based on the 
accumulated database. Additionally, the federal Certificate of Confidentiality, issued to all NIH-
funded grants, protects subjects’ records against subpoena. Exceptions to confidentiality for 
participants is any information that would lead to suspicion of child abuse, suspected abuse or 
neglect of elderly individuals, or dependent or vulnerable adults, or threat of imminent action on 
suicidal or homicidal ideation, which must be reported to the appropriate authorities. Participants 
will be informed of these exceptions during the informed consent process. In addition, 
representatives from the IRB will have limited access to the research record (e.g., to monitor the 
integrity of the research record). 
 

 
23
10.1  Monitoring and Adverse Event Reporting 
 
Adverse event reporting will follow the FRI policy.  Serious adverse events (SAEs) include any 
of the following outcomes for the participant: 1) death; 2) acute life-threatening incidents; 3) 
hospitalization or the prolongation of a hospitalization; or 4) persistent or significant disability.  
SAEs may be communicated to the Principal Investigator by participants or staff, or may be 
observed directly by the Principal Investigator.  SAEs will be reported regardless of whether 
they are considered project-related. 
 
10.1.1 Regulatory Updates. The Principal Investigator will report any information related to 
unanticipated risks or new information that may change the risk-benefit ratio to the Western IRB.  
This information may come from the current project or findings from other projects or studies.  
Any changes in the protocol or consent as a result of this information will be promptly reported 
to the Western IRB.  The Principal Investigator will also report any irregularities in the conduct of 
the project such as participant enrollment, obtaining informed consent, and data collection and 
processing. 
 
10.1.2 Criteria for Premature Project Discontinuation. A participant may request to be self-
withdrawn from study participation. A participant may be withdrawn from study participation by 
the Principal Investigator should a psychological condition make the risk to benefit balance of 
study participation unfavorable for the participant. The project may be discontinued at any time 
by NIH, or other government agencies as part of their duties to ensure that participants are 
protected.    
 
10.2  Institutional Review Board Review and Informed Consent 
 
This protocol, the informed consent document and any subsequent modifications will be 
reviewed and approved by the Western IRB, which is responsible for oversight of the study.  An 
electronically signed consent form will be obtained from each participant.  The consent form will 
describe the purpose of the project, the procedures to be followed, and the risks and benefits of 
participation.  A copy of the consent form will be emailed to the participant, and this fact will be 
documented in the participant’s record. 
 
 

 
24
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