A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults
Phase: NA
Conditions: HIV
Sponsor: University of Minnesota

STUDY PROTOCOL 
 
A TECHNOLOGY-DELIVERED PEER-TO-PEER 
SUPPORT ART ADHERENCE INTERVENTION FOR 
SUBSTANCE-USING HIV+ ADULTS 
 
NCT02704208 
APRIL 2, 2018 
 
 

PROTOCOL TITLE: A Technology-Delivered Peer-to-Peer Support ART Adherence 
Intervention for Substance-using HIV+ Adults 
VERSION DATE: 4/2/18 
 
 
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INSTRUCTIONS: 
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PROTOCOL TITLE: 
A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for 
Substance-using HIV+ Adults 
PRINCIPAL INVESTIGATOR or FACULTY ADVISOR: 
Keith J. Horvath 
EpiCH 
612-626-1799 
horva018@umn.edu 
STUDENT INVESTIGATOR: 
n/a 
VERSION NUMBER/DATE: 
Initial ETHOS migration - August 16, 2017 
Original date of UMN IRB approval (IRB Code 1504S69721) – January 13, 2016  
 
 

PROTOCOL TITLE: A Technology-Delivered Peer-to-Peer Support ART Adherence 
Intervention for Substance-using HIV+ Adults 
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REVISION HISTORY 
 
Revision # 
Version Date Summary of Changes 
Consent Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: A Technology-Delivered Peer-to-Peer Support ART Adherence 
Intervention for Substance-using HIV+ Adults 
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Table of Contents 
After completing your protocol, right click on the Table of Contents below and select 
“Update Field.” If prompted, select “Update entire table.” This will automatically 
update the protocol sections and page numbers for you. Do this also each time you 
modify your protocol after initial approval. 
 
1.0 
Objectives ................................................................................................................ 7 
2.0 
Background .............................................................................................................. 7 
3.0 
Study Endpoints/Events/Outcomes .......................................................................... 8 
4.0 
Study Intervention(s)/Interaction(s) ....................................................................... 11 
5.0 
Procedures Involved ............................................................................................... 12 
6.0 
Data Banking ......................................................................................................... 16 
7.0 
Sharing of Results with Participants ...................................................................... 16 
8.0 
Study Duration ....................................................................................................... 17 
9.0 
Study Population .................................................................................................... 17 
10.0 Vulnerable Populations .......................................................................................... 17 
11.0 Number of Participants .......................................................................................... 18 
12.0 Recruitment Methods ............................................................................................. 18 
13.0 Withdrawal of Participants .................................................................................... 20 
14.0 Risks to Participants ............................................................................................... 20 
15.0 Incomplete Disclosure or Deception ...................................................................... 21 
16.0 Potential Benefits to Participants ........................................................................... 21 
17.0 Data Management .................................................................................................. 22 
18.0 Confidentiality ....................................................................................................... 23 
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants .................... 24 
20.0 Provisions to Protect the Privacy Interests of Participants .................................... 27 
21.0 Compensation for Research-Related Injury ........................................................... 27 
22.0 Consent Process ..................................................................................................... 27 
23.0 Setting .................................................................................................................... 28 
24.0 Multi-Site Research ............................................................................................... 29 
25.0 Resources Available ............................................................................................... 29 
26.0 References .............................................................................................................. 31 
 

PROTOCOL TITLE: A Technology-Delivered Peer-to-Peer Support ART Adherence 
Intervention for Substance-using HIV+ Adults 
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ABBREVIATIONS/DEFINITIONS 
Include any abbreviations or definitions for key or technical terms you use in your 
protocol. 
 
• AIDS 
 
 
Acquired Immunodeficiency Syndrome 
• ART                             
Antiretroviral Therapy  
• AUDIT 
 
 
Alcohol Use Disorders Identification Test 
• BSSS-4 
 
 
Brief Sensation Seeking Scale 
• CASI 
 
 
Computer Assisted Self-Interview 
• CES-D 
 
 
Center for Epidemiologic Studies Depression Scale 
• CFR 
 
 
Code of Federal Regulations 
• CHEST 
 
 
Center for HIV Educational Studies & Training 
• HIPAA 
 
 
Health Insurance Portability and Accountability Act 
• HIV 
 
 
Human Immunodeficiency Virus 
• IMB 
 
 
Information-Motivation-Behavioral Skills 
• IMB-AAQ  
 
IMB ART Adherence Questionnaire 
• IRB 
 
 
Institutional Review Board 
• MASRI 
 
 
Medication Adherence Self-report Inventory 
• MSM                            
Men who have Sex with Men 
• NICHD 
 
 
National Institute of Child Health and Development 
• NIDA 
 
 
National Institute on Drug Abuse  
• NIH 
 
 
National Institutes of Health 
• NYC 
 
 
New York City 
• PI  
 
 
Principal Investigator 
• PLWH                           
People Living With HIV 
• OHRP 
 
 
Office for Human Research Protections 
• RCG                            
Radiant Creative Group 
• RCT                            
Randomized Controlled Trial 
• SMS 
 
 
Short Message Service 
• SSL                              
Secure Sockets Layer 
• TWM                            
Thrive With Me 
• UMN                             
University of Minnesota 
• VL                                 
Viral Load 
• YO                                
Years Old 
 

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STUDY SUMMARY 
 
Study Title 
A Technology-Delivered Peer-to-Peer Support ART 
Adherence Intervention for Substance-using HIV+ 
Adults 
Study Design 
Randomized Controlled Trial 
Primary Objective 
Primary aims (Aims 1 and 2) are to examine the 
efficacy of the online and mobile-enabled TWM 
intervention in a full-scale randomized controlled trial. 
Secondary Objective(s) 
Aim 3 (a secondary aim) is to examine the effects of 
the intervention on theory-based change processes 
(i.e., IMB factors and social support) for improving 
VL, ART adherence, and substance use outcomes. 
Primary Study Intervention 
or Interaction 
The “Thrive with Me” (TWM) intervention is a 
technology-delivered peer-to-peer social support 
intervention grounded in the Information, Motivation, 
and Behavioral Skills (IMB) model for HIV-positive 
men who have sex with men (MSM). In addition to 
asynchronous peer-to-peer support capabilities, the 
TWM intervention provides participants with 
Antiretroviral Therapy (ART) adherence self-
monitoring tools, medication dose reminders, and 
HIV-related informational content. 
Study Population 
HIV-positive men who have sex with men 
Sample Size (number of 
participants) 
400 
Study Duration for 
Individual Participants 
12 months 
 
 
 

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1.0 
Objectives 
1.1 Purpose: 
The “Thrive with Me” (TWM) intervention is a technology-delivered peer-
to-peer social support intervention grounded in the Information, Motivation, 
and Behavioral Skills (IMB) model for HIV-positive men who have sex 
with men (MSM). In addition to asynchronous peer-to-peer support 
capabilities, the TWM intervention provides participants with Antiretroviral 
Therapy (ART) adherence self-monitoring tools, medication dose reminders, 
and HIV-related informational content. The study will be based on the 
encouraging findings of the TWM pilot study (completed in 2011) and the 
need for novel, evidence-based effective ART adherence interventions.  
2.0 
Background 
2.1 Significance of Research Question/Purpose:  
Fifty thousand persons are estimated to be infected with HIV in the 
US each year [1]. In 2011, men who have sex with men (MSM) 
accounted for 65% of all new infections and were the only 
transmission group for which HIV infections did not show a year-
over-year decline [1]. Current US Guidelines for the Use of 
Antiretroviral Agents [2] state that undetectable viral load (VL) “is 
the most important indicator of initial and sustained response to 
ART” (p. C-5), which requires that people living with HIV (PLWH) 
demonstrate sufficient and sustained adherence to antiretroviral 
therapy (ART). Optimal ART adherence reduces excess morbidity 
and mortality among PLWH [3] and lowers the probability of 
forward transmission to sexual partners [4]. However, it is estimated 
that only between 19-25% of all PLWH and 27% of MSM with HIV 
are virally suppressed [5, 6]. Despite the disproportionate burden of 
HIV in MSM communities, only 2 of 10 medication adherence 
interventions included in CDC’s Compendium of Evidence-based 
Behavioral Interventions are tailored to MSM; one is a provider 
implemented approach evaluated over a decade ago and the other is 
an intensive one-on-one counseling approach. Clearly, advancing 
targeted and innovative ART adherence interventions for HIV-
positive MSM remains a high priority [7].  
Technology-based ART adherence approaches have proliferated in 
recent years [8, 9] due to the widespread adoption of technology 
across sociodemographic groups [10], their ability to reach a broad 
audience, and their low implementation costs [11]. However, recent 
computerized ART adherence interventions [12, 13] are individually 
delivered and fail to leverage peer-to-peer interactivity that has come 
to symbolize Web 2.0 [14]. Peer-to-peer support is a recommended 
strategy to improve ART adherence [7], is widely used by PLWH 

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[15], and has enormous immediate appeal as a generalizable 
intervention approach. Furthermore, peer support interventions 
provide unique social incentives to maintain high engagement in 
ART adherence interventions.  
2.2 Preliminary Data:  
To address the lack of generalizable interventions for MSM and leverage 
innovations in Internet and peer-to-peer social media, our team developed 
and piloted the “Thrive with Me” (or TWM) technology-delivered and 
theoretically-grounded peer-to-peer social support intervention [16] to 
improve ART adherence among HIV-positive MSM. In addition to direct 
peer-to-peer communication features, participants were given options for 
self-monitoring ART adherence, receiving ART dose reminders, and 
viewing relevant online HIV informational content. Among the 123 MSM in 
the pilot, 90% were retained at 1month follow-up, and participants rated the 
intervention high in perceived information and system quality, usefulness, 
and overall satisfaction (Means>5.0 on a 1-7 scale). Men randomized to 
receive the TWM intervention showed improvement across all ART 
adherence outcomes compared to control participants, with greatest benefits 
for current drug-using MSM. 
2.3 Existing Literature:  
See sections 2.1 and 26.0. 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: 
Primary Aim 1: Determine the efficacy of the TWM intervention to 
increase the proportion of virally suppressed HIV-positive MSM at post-
intervention time points. 
H1: A higher proportion of participants in the TWM intervention than 
control participants will have undetectable VL at post-intervention time 
points. 
 
Primary Aim 2: Assess whether the TWM intervention is most beneficial 
for HIV-positive MSM who report recent drug use at baseline compared to 
HIV-positive MSM who do not.  
H2: Recent drug-using participants in the TWM intervention will 
demonstrate greatest improvements in VL and self-reported ART adherence 
at post-intervention time points compared to non-drug-using participants. 
 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): 
Secondary Aim 3: Examine the effects of the TWM intervention on theory-
based change process (i.e., IMB factors and social support) for improving 
VL, ART adherence, and drug use outcomes. 

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H3: Tailored adherence information, motivation for adherence, adherence 
behavioral skills, and peer social support will be associated with VL 
suppression and improved ART adherence and drug use outcomes.  
 
 
3.3.   Additional information about study design and endpoints  
 
Primary aims (Aims 1 and 2) are to examine the efficacy of the online and 
mobile-enabled TWM intervention in a full-scale randomized controlled 
trial. HIV-positive adults (all men who have sex with men [MSM]) with 
detectable HIV viral load (VL) residing in New York City will be 
randomized to receive the TWM intervention or an information-only 
HIV/ART intervention for a 6-month period. Recruitment will be stratified 
by recent drug use, such that half will report recent illicit drug use. HIV VL, 
validated self-reported ART adherence, and intervention utilization 
measures will be collected at baseline, post-intervention, and 6-, and 12-
month follow up. We hypothesize that participants in the TWM intervention 
will demonstrate significant improvements in self-reported ART adherence 
and VL at each follow-up time point compared to control participants, with 
greatest improvements among recent drug users. 
 
We will use an experimental research design to assess the effects of the 
TWM intervention on HIV VL and self-reported ART adherence among the 
total sample, drug-using participants, and non-drug-using participants.  Data 
collected from participants will only be used for the purposes of this study.  
Data will be collected in the form of biologic specimens (blood AND urine) 
and computerized surveys to assess socio-demographic variables, 
psychological measures, and behavioral measures (e.g., drug use, ART 
adherence). Biological specimens and computerized surveys will be 
collected on-site at the Center for HIV Educational Studies and Training 
(CHEST) at Hunter College in New York City (NYC). 
 
The primary outcome measure is biological viral load (VL) at each 
assessment period. Specifically, blood draws will be taken at baseline, 
immediate post-intervention, 6- and 12-month post-intervention follow-up 
assessment points to assess the effects of the TWM intervention on VL, the 
most important biological marker for adherence. Blood will be drawn by a 
certified phlebotomist at the CHEST in NYC and analyzed by Quest 
Diagnostics. Plasma VL is considered undetectable at <20 copies/mm3 and 
we will provide test results to participants after each visit. 
Men will take urine screens at each assessment time point to assess for the 
following illicit substances: cocaine, methamphetamines, marijuana, opiates, 
and PCP, using the Integrated E-Z Split Key Cup II-5 panel (Innovacon 
Laboratories). This test is capable of detecting drugs from one to four days 
after use, except for chronic marijuana use, which can be detected for up to 

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30 days. Although the urine toxicology procedures will not permit objective 
verification of self-report for the entire follow-up interval, it will provide 
some means of verifying abstinence versus non-abstinence from drugs.  
Research staff at CHEST have extensive experience in collecting and 
processing urine samples.  
 
A full list of survey items are attached with this application (Measures). The 
primary biological measure (VL) will be examined against self-reported 
ART adherence items (collected via computerized surveys). Items adapted 
from the Medication Adherence Self-report Inventory (MASRI) (see 
attached survey items) will be used to assess dimensions of ART adherence 
in the past 30 days, including the percentage (0-100%) of overall ART 
correctly taken and the percentage of ART taken within 2 hours of the 
correct dose time.  
 
Secondary outcome measures will include a) self-reported adherence 
information, motivation, and behavioral skills by completing the IMB-AAQ 
which is a 33-items measure that assess adherence-related information and 
b) a modified version of two social support questionnaires to assess social 
support. 
 
Other Self-Report Measures: The following self-report measures will also 
be collected as part of the TWM trial: 
 
• Demographic and Medical Variables. Common demographic (e.g., 
gender, age, race/ethnicity, income, educational attainment, 
employment status) and medical (years since HIV/AIDS diagnosis, 
time on ART, and medication side-effects) variables will be adapted 
from prior online studies by this study group.  
• Substance Use. Items will be adapted from those used in the TWM 
pilot study to assess recent (past 5 months) and lifetime illicit drug 
use and patterns of illicit drug use (i.e., frequency, location, and 
circumstances of use). The AUDIT (10-item alcohol abuse scale) 
will be used assess problematic alcohol use. 
• Empirically-derived Psychosocial Risk Factors for Poor Adherence. 
We will assess a broad range of mental health factors with widely-
used and validated standardized scales, including the CES-D (10-
item depression scale) [14], HIV Symptom Index scale, Perceived 
Stress Scale (14-items), the Brief Sensation Seeking Scale (BSSS-4) 
and a 6-item Life Chaos scale, and HIV Stigma scale. 
• Technology Use and Internet Knowledge. Participants will indicate 
how often they access the Internet and for what purposes. Internet 
knowledge will be assessed with the iKnow measure. Smart phone 
use will be assessed by asking participants what data plan they have 
(e.g., unlimited vs. limited vs. no data plan), what mobile phone 

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carrier they use (e.g., Verizon, AT&T, Sprint), and the frequency of 
use of smartphone features (e.g., SMS messaging, accessing the 
Internet on their smartphone). 
• Intervention Acceptability. Intervention acceptability items will be 
drawn from prior research by this research team and from the 
System Usability Scale. Users will be asked to rate the intervention 
on system quality, information quality, their overall satisfaction with 
the application and their beliefs about whether the application 
improved their health behaviors.  
• Finally, user engagement in the TWM intervention will be assessed 
by: a) frequency of log-ins; b) among log-ins, whether the log-in was 
via computer, smartphone, or tablet (to assess whether use or 
outcomes differ by modality by which the intervention is accessed); 
b) frequency of message posting and responding to other 
participants’ posts; c) frequency of updating medication adherence, 
drug use, and mood self-monitoring graphs; c) frequency of viewing 
articles, videos, and links; d) frequency of SMS medication 
reminders. Among control participants, the number of weekly 
informational webpages opened and time spent on each weekly 
webpage will be tracked during the trial period.  
 
The combination of using an experimental design to compare the TWM 
intervention to control arm participants, and collecting biological, 
computerized self-report survey data, and user engagement data will allow 
us to examine the full range of potential effects of the TWM intervention on 
participant's physical and mental health. 
 
 
 
4.0 
Study Intervention(s)/Interaction(s) 
4.1 Description:  
The TWM intervention has two major components: an individualized self-
monitoring component and a social support component. For the self 
monitoring component, users can enter their daily ART medications into a 
private profile page. Many men will only take one dose of medication per 
day, while others may take multiple doses. Men can then customize how 
they would like to set up SMS medication reminders. Based on the 
participant's preferred time, a daily text message will be sent 5 minutes after 
the participant is supposed to take their medication. Participants can choose 
from standardized language from our website for this text message or they 
can customize the language for further discretion. The standard language 
will ask: "Have you taken your dose today? Respond "1" yes, respond "2" 
no skipping today, respond "3" remind me again in an hour." Participants 
will then be asked how they feel at the moment and will be given a choice of 

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5-6 common emotions (happy, sad, anxious/worried, angry, tired). 
Responses collected via text message will be synched directly to 
participants' private profile page and they will be able to view their 
adherence and mood tracking throughout the course of the intervention. 
Once a week we will ask participants to log-in to the website directly to 
report substance abuse for the week. Participants will be asked to check 
which days they used alcohol; which days they used marijuana; and which 
days they used other drugs. Participants will be able to view their 
medication adherence, mood, and substance use for the entire week on the 
same screen.  
 
The social support component of the website is a social network page 
similar to Facebook, but with targeted content being placed in the feed. 
TWM intervention staff will create approximately 300 "Thrive Tips" based 
on addressing barriers identified in the IMB-AAQ survey (all participants 
take the IMB-AAQ at baseline and this survey is included in the attached 
appendices under Measures) . Participants will see 4 unique Thrive Tips per 
day posted to their daily feed. If a participant has identified specific barriers 
to medication adherence (e.g. fear of someone seeing them take their 
medications), the Thrive Tips associated with their identified barriers will be 
highlighted differently in their personal feed to draw more attention to them. 
Participants can comment on the Thrive Tips to start discussions with other 
members, or they can start their own topics of discussion. Research staff 
may also pose questions to the group to spur discussion among members. 
Research staff will monitor the page daily for hostile interactions or 
misinformation. Hostile interactions can be flagged by users or admins and 
removed. In the pilot trial of TWM, admins found that other users would 
often correct misinformation in a prompt manner and research staff rarely 
had to step in. Our intention is for users to create community throughout 
these interactions and also to demonstrate leadership in the group by either 
starting topics, sharing information, and/or correcting misinformation with 
minimal guidance from research staff. Participants will be able to privately 
message with research staff through the TWM website. Participants will not 
be able to privately message each other through the website.  All 300 Thrive 
Tips will be made available over the course of the first 75 days of the 
intervention. After the first 75 days, the intervention group will take another 
IMB-AAQ through the TWM website to see if their medication adherence 
barriers have changed. The 300 Thrive Tips will be re-ordered and released 
4 per day for the remaining 75 days of the intervention.  
 
5.0 
Procedures Involved 
5.1 Study Design: 
Based in the results of the TWM pilot study, we will evaluate the TWM 
intervention in a randomized controlled efficacy trial (RCT). Recruitment 

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will be stratified by drug use, such that half of participants will report illicit 
drug use in the prior 5 months at baseline (see inclusion criteria in Section 
9.1). MSM will be recruited in New York City metropolitan area, screened, 
and randomized to receive either the TWM intervention or HIV-information 
only control condition. VL, validated self-report ART adherence, and drug 
use will be collected at baseline, immediate post-intervention, and 6- and 
11-month post intervention to test the study hypotheses. 
 
5.2 Study Procedures:  
Partners: 
Key partners for the study and their roles are as follows: 
• CHEST, Subcontractor – CHEST will manage recruitment, screening, 
training, and retention of participants. They have received IRB 
approval through the City University of New York. 
• Rivet Amico, Co-Investigator and Subcontractor – Rivet will only 
have contact with participants in extenuating circumstances (if 
multiple people from the UMN study team are not available, which has 
not occurred thus far in the study) and will otherwise only have access 
to de-identified data. She has received IRB approval through the 
University of Michigan. 
• Christina Sun, Collaborator – Christina will conduct qualitative data 
analysis and will only have access to de-identified data. She will 
receive IRB approval through Portland State University. 
 
Usability Testing: 
Before the full RCT begins, we will conduct pilot/usability testing with 10 
HIV positive men recruited by CHEST staff in New York City. Participants 
recruited for usability testing will be scheduled for an in-person appointment 
at CHEST. At this visit they will sign the consent form and take the baseline 
survey using Qualtrics. CHEST staff will then give the participant a unique 
username and password for the TWM website and ensure they can log-in. 
The participants will then be given a task list of actions they need to perform 
on the website (i.e. start a discussion topic, share and comment on a Thrive 
Tip, create a profile, etc.) over the course of 1-2 weeks. After that period is 
over, they will return to CHEST to complete a 45 minute interview with the 
PI, project coordinator, and a CHEST staff member. While a CHEST staff 
member will be present to facilitate, an in-person telephone interview 
between the project coordinator and the participant will be held. Both the 
task list and interview questions are attached to this application (Website 
Tasks and Usability Interview Questions). The interview is intended to illicit 
feedback on programmatic components, not to draw out personal 
information regarding medication adherence, sexual behaviors or substance 

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use. Responses from usability testing will be used to complete development 
of the TWM website and make any final changes before launch.  
Randomized Clinical Trial: 
Persons interested in the study will be scheduled for an in-person 
appointment at CHEST to complete the screener items, baseline VL blood 
draw, and urine samples for drug use. Participant-identifying information, 
including informed consent forms, locator forms, or any file linking ID 
numbers to names are kept in locked cabinets at all times at CHEST. 
Secure (i.e., using SSL encryption and online survey software supported by 
the University of Minnesota) online survey software will be used to collect 
baseline and follow-up self-reported data, and will be managed by research 
staff at the University of Minnesota.  Participants may be asked to sign a 
HIPPA Authorization/Release form, that (if signed) will grant permission 
for research staff to obtain the participant’s medical record. As stated in the 
consent form, HIPPA authorization will only be sought in the rare event 
that viral load is unable to be evaluated or requires confirmation. 
Participants will be contacted and informed that their healthcare provider is 
going to be contacted before such contact is made. Participants are not 
required to sign the HIPPA Authorization/Release form.  
 
Biological Data Acquisition and Transmission. Blood draws will be 
collected at CHEST during the baseline, immediate post-intervention, 6-, 
and 12-month post-intervention visit to assess the effects of the TWM 
intervention on viral load, the most important biological marker for 
adherence. Blood will be drawn by a certified phlebotomist at CHEST and 
analyzed by Quest Diagnostics. Plasma VL is considered undetectable at 
<20 copies/mm3 and we will provide test results to participants after each 
visit. We have successfully used this procedure with MSM in prior studies. 
The urine sample will be tested for metabolites of methamphetamines, 
cocaine, ecstasy, marijuana, and opiates using the Integrated E-Z Split Key 
Cup II- 5 Panel (Innovacon Laboratories). Though studies have consistently 
supported the validity of self-reported drug use assessment instruments, 
research has shown that when individuals are informed that their self-
reported behavior will be validated through biological measurement, they 
are more likely to accurately report their behaviors. All biological specimen 
samples collected will be destroyed as soon as they are tested. Results from 
the blood and urine screens will be entered into Qualtrics and tied to the 
participant's study ID and will never be included in the person's medical 
record. Attached to this application is a screenshot from CHEST regarding 
how they enter HIV outcomes into Qualtrics (Sample HIV Outcomes 
Measures); please note that the University of Minnesota logo will appear on 
all TWM survey screens.   

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Men who meet eligibility criteria will be guided through the consent 
process. Trained research staff at CHEST will meet in an assessment room 
with participants and will be available to answer any questions on the 
consent form. Signed paper consent forms will be stored in a separate, 
locked file cabinet at our research center, CHEST. Next, they will complete 
a computer-assisted baseline survey (using Qualtrics, which is online survey 
software supported by the University of Minnesota) which is anticipated to 
take 30-45 minutes. The baseline survey will include questions about 
medication adherence, engagement in care, demographic characteristics, 
social support, mental health, and intervention content and features. 
Following well-established security protocols by this research team, data 
will be stored electronically, with identifying information (e.g., name, e-
mail address, contact information) stored separately on a secure server from 
other responses. Identifying information and other data will be linked by a 
unique computer-generated number that will be kept in a third table and 
stored separately from the other two tables. The PI, the project statistician, 
the project coordinator, and key CHEST staff involved in enrollment and 
retention will have access to identified data. Other team members will have 
access only to the de-identified dataset.  
Next, men will be randomized to the TWM intervention or control group 
using a blinded randomization process. The sample will be stratified by 
recent drug use and non-recent drug use. Those assigned to the TWM 
intervention will be shown example webpages of the intervention, given 
basic training on how to navigate the intervention, and given the opportunity 
to ask questions they have about the website. Control condition assigned 
participants will be shown example webpages they will receive during the 
intervention period. 
After the baseline visit, participants will have access to the TWM or control 
intervention components. Those in the control arm will receive weekly 
emails with links to web pages containing information on living with HIV 
and tips for improving quality of life. These web pages will not be 
specifically focused on improving medication adherence. Control 
participants will receive approximately 25 emails of unique content over the 
course of five months.   
Upon entering the TWM intervention, men will be guided through a series 
of pages in which they will create a unique username (not containing 
identifying information) and password to use throughout the study. Men will 
be able to choose from pre-designed icons for a profile image that will 
accompany their username when they post on the TWM website. 
Participants in the treatment arm will have access to the full intervention for 
5 months. After 5 months, participants will no longer have access to the 
social support component of the website and they will no longer receive 
SMS reminders. They will still have access to the Thrive Tips and their self-
monitoring personal profile page while the website is online. The TWM 

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intervention website is currently being developed. Screenshots from the 
pilot trial of TWM (NIH R34 MH083549) are attached to this application 
(Appendix E: Screenshots from TWM Feasibility Trial). The intervention 
for the full-scale RCT is modeled after the pilot screen shots.  
5.3 Follow-Up:  
After the intervention period, men will contacted by CHEST study staff to 
schedule an in-person appointment to complete the immediate post-
intervention survey (also using Qualtrics), VL blood draw, and drug urine 
screen. The same procedure will be used to schedule men for their 6- and 
12-month post-intervention visits. If a participant moves out of the area 
served by CHEST, they will be offered the option to consent to take any 
remaining follow-up surveys remotely, and to complete any remaining viral 
load tests with their healthcare provider or at a central lab and have the 
results sent to CHEST. 
6.0 
Data Banking 
The following identifiers are collected and maintained during the duration 
of the study: names, telephone number, birthdate, and email address. It is 
necessary to record identifiers since payment to subjects will be through 
Amazon that will be sent to their e-mail accounts. In addition, such 
information will be collected to successfully enact the retention protocols 
described in the grant proposal. 
Participants demographic and survey data will be identified by a unique 
number. The identification number will not be linked to the participant’s 
identity or contact information in any way. The contact information will 
be stored in a separate electronic file from the participant’s demographic 
and survey data, with the two files being linked by a separate “linking file” 
stored in a separate location. 
Identifiable study data will be destroyed 1 year after the completion of the study. 
We established this timeframe in the event participants have follow-up questions 
regarding their participation in the study. De-identified study data will be kept for 
7 years after the completion of the study, which is in accordance with NIH policy. 
Three copies of the de-identified dataset will be maintained (a working one and 
two archived at different sites). 
7.0 
Sharing of Results with Participants 
Results will be shared with participants in several ways. First, we will publish the 
results of studies resulting from this study. We will attempt to publish them in 
Open Access journals (as we did with the results from Aim 1) so that anyone may 
access those articles. In addition, we will make available a summary of study 
results to participants who request it. 

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Upon request, results of viral load tests will be shared with participants by 
CHEST staff. 
8.0 
Study Duration 
Individuals in the intervention arm will have access to the site for 5 months, and 
will complete follow up after 12 months. The total anticipated duration of the 
study, including analysis is from 7/1/15-5/31/20. 
9.0 
Study Population 
9.1 Inclusion Criteria:  
1) 18+ years of age;  
2) Male gender;  
3) Sex with 1+ men in the prior year;  
4) Diagnosis of HIV and currently prescribed ART;  
5) Self-reported detectable VL in past 12 months OR self-reported 
problems with HIV medication adherence; 
6) Residing in the New York City metropolitan area and availability meet 
with project staff at each assessment time point; and  
7) English-speaking (since the intervention will be in English).  
8) Self-reported recent drug use (the sample will be stratified by recent 
drug use and non-recent drug use) 
9.2 Exclusion Criteria:  
1) 17 years of age or younger;  
2) Not male gender;  
3) 0 male sex partners in the prior year;  
4) No diagnosis of HIV and/or not currently prescribed ART;  
5) No self-reported detectable VL in past 12 months OR self- reported 
very good/excellent HIV medication adherence; 
6) Residing outside of the New York City metropolitan area and/or no 
availability meet with project staff at each assessment time point; and  
7) Non-English-speaking (since the intervention will be in English). 
9.3 Screening: 
Persons interested in the study will be scheduled for an in-person 
appointment at CHEST to complete the screener items, baseline VL blood 
draw, and urine samples for drug use. Those that meet the inclusion criteria 
and do not meet the exclusion criteria will be guided through the consent 
process and randomized. 
10.0 Vulnerable Populations 
10.1 Vulnerable Populations: Identify which of the following populations will be 
involved in this study. (You may not include members of the populations 

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below as participants in your research unless you indicate this in your 
inclusion criteria above.) 
☐ Children 
☐ Pregnant women/Fetuses/Neonates 
☐ Prisoners 
☐ Adults lacking capacity to consent and/or adults with diminished 
capacity to consent, including, but not limited to, those with acute 
medical conditions, psychiatric disorders, neurologic disorders, 
developmental disorders, and behavioral disorders 
☐ Non-English speakers 
☐ Those unable to read (illiterate) 
☐ Employees of the researcher 
☐ Students of the researcher 
☒ None of the above 
10.2 Adults lacking capacity to consent and/or adults with diminished capacity to 
consent: 
N/A 
10.3 Additional Safeguards:  
N/A 
11.0 Number of Participants 
11.1 Number of Participants to be Consented:  
410 
12.0 Recruitment Methods 
12.1 Recruitment Process:  
In order to recruit at least 20 eligible men per month during the full 
randomized controlled trial, research staff at CHEST will use multiple 
approaches, all coordinated by the Director of Recruitment who has several 
years of experience recruiting MSM for RCTs at CHEST. First, two 
recruiters will be utilized for active field-based recruitment efforts. They 
will target venues such as gay bars, community events, and HIV clinic 
settings. Potential participants will be given project related materials, and 
can call later for an appointment, provide contact information for a CHEST 
staff member to call them to schedule the in-person baseline visit, or 
schedule the appointment at the time of recruitment, depending on the venue 
and interests of the participant. Rigorous efforts will be undertaken to ensure 
that recruitment staff maintain adherence to the study protocols, and 
recruiters receive extensive training in how to approach potential 
participants and follow strict written guidelines regarding ethics and 

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professional conduct. All recruitment images and text for flyers, palm cards, 
and online banner ads are attached (Recruitment Materials).  
Recruiters work in pairs to ensure their safety and adherence to protocol. 
Recruiters utilize palm cards with information about the study, and conduct 
on-site preliminary screening via iPads. After each recruitment shift, 
recruiters complete a report to facilitate the overall monitoring of the 
recruitment process. Second, a passive recruitment strategy through 
advertising will be developed by our consultant, who has been leading 
marketing efforts for intervention trials at CHEST for over ten years. 
Advertisements will be run in publications targeting MSM in NYC, 
brochures will be developed for distribution at HIV clinics and AIDS 
service organizations, and online recruitment will be conducted via 
Facebook postings. 
Men recruited for usability testing will be recruited using similar methods as 
described above.  
12.2 Source of Participants: 
Participants will be recruited through a combination of the active and 
passive recruitment strategies described above, both from the community 
and from CHEST’s network. 
12.3 Identification of Potential Participants:  
Participants will self-identify in response to banner ads, flyers, or targeted 
outreach by CHEST recruiters. 
12.4 Recruitment Materials: 
Recruitment materials will include palm cards, flyers, and web ads, samples 
of which are attached. 
12.5 Payment:  
Participants will be offered $50 in cash for every study visit at baseline, 6-
month, and 12-month follow-up. In addition, we will offer a $25 Amazon 
gift card raffle each week for participants who engage with the TWM 
intervention in a weekly basis. Thus, participants could possibly earn up to 
$750 if they won the raffle each time (which is highly unlikely). However, 
realistically, participants will earn $200 for completing the assessments and 
possibly a $25 Amazon raffle if they are chosen in a given week. Raffle 
winners will receive their gift card code via email. 
Participants in the usability testing group will be given $50 cash at each 
study visit, baseline and follow-up interview. Payment to subjects will be 
made during each visit (baseline, 6-month, and 12-month follow-up) and 
will be administered by CHEST staff. Each study visit will provide the 
opportunity to earn $50 and therefore the payment will not be prorated. 

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Subjects will be paid during each assessment period and therefore 
participants will be paid only for those assessments they present for. If a 
participant has elected to continue to participate in the study after moving 
out of the study area, payment for follow-up visits will be sent by electronic 
Amazon gift card. 
13.0 Withdrawal of Participants 
13.1 Withdrawal Circumstances: 
Due to its social nature the intervention website will be monitored regularly 
by study staff. If a participant is found to be behaving in an inappropriate or 
abusive manner, or is not acting in accordance with the community 
guidelines established on the site, the study coordinator will reach out to the 
individual about modifying their behavior. If an individual continues to 
disrupt the experiences of other participants they may be withdrawn from 
the site. Participants may also choose to withdraw themselves from study 
participation at any time. 
13.2 Withdrawal Procedures:  
When a participant is withdrawn for any reason, data collection will cease 
and no further follow-up will occur. For control participants, CHEST staff 
will record the reason for their withdrawal and remove them from the email 
list for the control emails and cease follow-up. For intervention participants, 
CHEST will record the reason for their withdrawal and cease follow-up, and 
UMN staff will terminate the participant’s access to the TWM site. Data that 
has been already collected will be deleted at the request of the participant. 
13.3 N/A 
14.0 Risks to Participants 
14.1 Foreseeable Risks:  
We identified the following 6 items as possible risks to subjects: 
1) By misspelling a web address or “surfing” the net, some individuals may 
unintentionally go to the study website. We deem this unlikely as we 
will use the prefix “https:” to prohibit persons from coincidentally 
viewing the site, and we intend to recruit from a website that is explicitly 
for HIV-related information. Nonetheless, if someone were to 
mistakenly view the study website home page, we anticipate that the 
information contained on the homepage will be benign to viewers. 
2) Potential participants or participants enrolled in the study may have 
concerns about others finding out about their HIV status or other 
personal behavior (e.g., sexual behavior). We anticipate that the 
likelihood of this occurring is high given that a major feature of the 
intervention is for participants to network with one another and that 
eligibility for enrollment in the study requires participants to identify as 

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a HIV+. Subjects will be informed during the consent process of the 
basic features of the intervention and those who are not comfortable 
interacting with other HIV+ persons will be encouraged to not 
participate in the study. Those who do enroll will be given the option of 
utilizing intervention features with which they feel comfortable, 
although utilization of all features will be encouraged. 
3) Participants may feel discomfort in answering personal questions during 
the assessments and/or revealing aspects of themselves during the 
intervention period with other participants. Similar to #2 above, the 
nature of the assessment and intervention is such that participants will be 
encouraged to provide personal information about themselves and 
therefore the likelihood of this occurring is high. During the 
assessments, participants will given the option to choose a “refuse to 
answer” response, and, during the intervention, participants can divulge 
as little or much about their personal history as they choose. We 
anticipate that these steps will ensure that risk to the participant is 
minimized to his comfort level. 
4) Participants may receive hostile communications or incorrect 
information from other participants during the course of the intervention. 
It is possible that some participants may respond aggressively or with 
hostility to other participants. Likewise, although well-intended, 
participants may provide inaccurate information about adherence or its 
risk factors to other participants by interactions through the website 
message boards/social networking wall.  
5) Participants may be concerned about the security of their data, 
particularly since it is collected and stored electronically. Our study team 
has significant experience developing security protocols for Internet-
based studies, and we will take a variety of steps to ensure participant 
security, including using a dedicated server behind a firewall, encryption 
of data, separation of identifiers from responses, and password-protected 
access to data. Therefore, we believe that this risk will be minimal. 
6) Discomfort or infection due to phlebotomy.   
14.2 Reproduction Risks: 
N/A 
14.3 Risks to Others: 
N/A 
15.0 Incomplete Disclosure or Deception 
15.1 Incomplete Disclosure or Deception:  
N/A 
16.0 Potential Benefits to Participants 
16.1 Potential Benefits: 

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Potential Benefits. Participation in the TWM arm may provide participants 
with information and exercises that help them build peer social support, 
monitor their medication adherence and HIV-related care appointments, and 
develop skills. Participants in the control group may gain basic knowledge 
about medication adherence and links to outside resources. In either the 
experimental or control condition, the primary benefit is access to health 
information that may assist participants to improve adherence and quality of 
life. Secondary benefits include positive feelings related to having assisted 
in the development and testing of a novel Internet-based adherence 
intervention, and if proven effective, the future availability of this 
intervention to others. 
17.0 Data Management 
17.1 Data Analysis Plan: 
Analyses will be performed using Stata/SE v13 or later. The study 
design is a 2 (Condition: Intervention vs Control) X 4 (Time: 
baseline, immediate post-intervention, 6-, and 12-month post-
intervention) randomized trial, with Condition a between-subjects 
effect and Time a within-subjects effect. The two primary outcomes 
are dichotomous: undetectable VL (undetectable=VL<20 
copies/mm3 vs. detectable=VL>20 copies/mm3) and adherence to 
ART (high adherence>=90% adherence vs. low adherence<90% 
adherence). Mixed-effect logistic regression models will be used to 
test hypotheses. These models will include main effects for 
Condition and Time and the Condition*Time interaction (a 3 degree-
of-freedom comparison; the overall test of the hypothesis) and 
model-based rate-ratios and risk differences will be estimated. We 
will also estimate a series of single degree-of-freedom comparisons 
(using planned contrasts) to estimate the effect of the intervention on 
adherence at immediate post-intervention, and at 11- and 17-month 
follow-ups points relative to baseline.  
The multilevel model will accommodate missing values in the 
outcome over time without dropping participants. Multiple 
imputation will be implemented, as necessary, to deal with missing 
covariate data.  We will investigate confounder imbalance address 
any imbalances by modeling covariates or, if necessary, propensity 
score matching. We will primarily estimate effects as ITT, but will 
also examine as treated estimates, always being clear what we report 
and why. Efficacy of the TWM intervention will be indicated by a 
statistically discernable improvement in ART adherence and viral 
load at 10-month post intervention assessment. We will graph 
observed and predicted values for easy interpretation.   

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We will investigate whether there is greater benefit from the TWM 
intervention for drug-using participants compared to non-drug-using 
participants. We will use the approach describe above with the two 
additional factors, self-reported current (past 5 months) drug use and the 
interaction with intervention (and time). In a similar manner, we will 
conduct exploratory analyses to identify other baseline participant risk 
groups for which the intervention is most beneficial. In addition, for 
participants in the TWM intervention, we will examine the effect of type 
and amount of intervention exposure (i.e., which component usage are 
related to outcomes) on improvement in ART adherence. All models will be 
altered and examined for robustness to specification. 
17.2 Power Analysis:  
With N=400 (200 I, 200 C) and baseline undetectability of approximately 
60%, at any single time point are powered to detect an approximately 14% 
difference in detectability. If both groups have approximately 60% 
undetectability at baseline, and we assume that the Intervention group will 
sustain that going forward, we could detect a difference of 14% 
undetectability at 5 months. Specifically, 60% undetectability in the 
Intervention group and 46% undetectability in the Control group at 5 
months. 
17.3 Data Integrity: N/A 
18.0 Confidentiality 
18.1 Data Security:  
In this study, all paper consent forms will be stored at CHEST in a locked 
file cabinet in Dr. Jeffrey Parsons’ office. All other paper documents will be 
stored in a filing cabinet used by the study team, and thus accessible to all 
the investigators. Original documents about subjects that could identify a 
subject will be kept in a separate locked filing cabinet in the PI’s office. 
Nearly all of the data will be collected electronically by either entering it in 
Qualtrics or collected through the TWM intervention website. That data will 
be stored on a secure password protected UMN server. 
Data are collected and stored on University of Minnesota servers. 
Identifying information are separated from their data into distinct tables. 
Participant information is stored at the time of enrollment and identification 
numbers are generated by computer. Only the PI, project statistician and 
project coordinator have access to this identifying information, protected in 
a password-protected database. All data stored within computer files will be 
password protected behind a firewall to ensure that access is available only 
to those directly involved in the study analysis. Only data that has been 
stripped of all personal identifying information is made available to study 
investigators. At study completion, the link between the identifying 

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information and their data is destroyed, as is contact information. Two sets 
of the cleaned data set will be maintained—one working copy at the 
University of Minnesota computer system and one on a password protected 
drive stored in a locked filing cabinet. This approach ensures that the data 
survives in the event of failure of the computer system. Finally, all study 
investigators and staff will have completed the CITI Course in the 
Protection of Human Research Subjects online training in research ethics to 
ensure that all staff are compliant with confidentiality training. 
Data collected from surveys, blood draws for VL, and urine screens will be 
entered into Qualtrics. Qualtrics is the preferred survey and screening tool 
for the University of Minnesota because it "meets stringent information 
security requirements" including a password protected log-in based on our 
institution's x500 system. Participants will be assigned a user ID upon 
enrollment. Enrollment data with identifying information will be de-coupled 
from survey responses and records of VL and substance use. The TWM 
website will use an https URL and entry into the website is also password 
protected.   
19.0 Provisions to Monitor the Data to Ensure the Safety of 
Participants 
The PI is responsible for monitoring adverse events occurring during 
the study. In the event the PI is unavailable, Dr. Erickson has overall 
responsibility during his absence. The role of the person responsible is 
to: 1) to identify the concern, 2) activate an appropriate response 
(consulting where ever possible) to minimize the adverse event, and 3) 
ensure the adverse event is reported to the responsible authority in a 
timely manner.  
Anticipated adverse events:  In this behavioral research, the risks as a 
result of participation are considered minimal and primarily involve a) 
emotional discomfort due to the sensitive nature of the questions asked 
in the surveys and the information presented, as well as the features 
available in the intervention, b) the potential for hostile interactions 
with other participants, c) obtaining inaccurate information about 
adherence from other participants, and d) the risk of loss of 
confidentiality.  Because this study includes individuals living with 
HIV/AIDS, there is also the potential for a participant to become 
physically ill during participation at the study site. 
Emotional discomfort: Emotional discomfort may be identified in two 
ways. First, participants may directly correspond with project staff and 
report emotional discomfort. Second, emotional distress may be 
identified through daily monitoring of user-generated content during 
the intervention. To address the risk of participant distress, all 

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participants are given information on how to contact the PI, the project 
coordinator, and the human subjects protection program. Situations in 
which emotional distress is noted through daily monitoring, study staff 
will contact the participant directly via e-mail and/or telephone. If such 
contact is made, the PI or project coordinator will assess the degree of 
emotional discomfort and either reassure the participant or provide 
resource information to locate a mental health provider for counseling. 
The PI and project coordinator will be available at any point to assist 
with locating an appropriate mental health provider. When indicated, 
the investigator will ask for permission to phone the participant at an 
appropriate follow-up time (e.g., the next day) to ensure any potential 
adverse event is followed-up adequately. If the project coordinator is 
handling the matter, he is responsible for informing the PI as soon as 
logistically possible that an adverse event may have occurred. All 
reasonable steps will be taken to ensure that the participant’s 
confidentiality is protected while attempting to facilitate the 
appropriate level of care.  
Hostile interactions: We will use the daily monitoring as an 
opportunity to flag hostile interactions between participants. Hostile 
interactions between participants will be handled by, first, reminding 
the participants in the interaction of the “group rules” regarding 
appropriate interactions.  If the hostility continues, the offending 
participants will be given a warning that the continued hostility will 
result in withdrawal from the study if it continues. On the third 
offense, the offending participant will be withdrawn from the study. 
Text containing hostile exchanges will be removed from the study 
website and unavailable to view. 
Inaccurate adherence information: We have established a daily 
monitoring protocol to review user-created content for inaccurate 
adherence information (in addition to emotional discomfort arising 
from hostile interactions or intervention activities). In cases in which 
inaccurate information is found in the forums, project staff will post a 
comment on the forum that provides accurate information on the topic. 
Risk of loss of confidentiality: The protections against loss of 
confidentiality have been summarized in the protection against risks 
section above. The PI is the person primarily responsible for ensuring 
that no loss of confidentiality occurs. Any loss of confidentiality that 
occurs despite these protections will be dealt with on a case-by-case 
basis. We would expect to hear about any loss of confidentiality in one 
of the following ways: 

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• Loss of confidentiality secondary to attempt to subpoena.  
Should someone attempt to subpoena our data, the PI will 
immediately activate our emergency response protocol. This 
protocol includes informing the university attorneys, our IRB 
office, and the project officer at NIH, that a legal attempt is 
being made to subpoena a person’s data. In the first instance, 
the PI is responsible for seeking legal advice on how to 
respond to the request. Where a specific participant is named, 
the PI shall ask the NIH project officer, our IRB, and our legal 
advisor whether or not to inform the subject that an attempt to 
subpoena his data has been made.   
• Loss of confidentiality secondary to theft, hacking or other 
illegal activity. During the course of the study, if we discover 
that despite security precautions our computer system has been 
hacked, or if someone has illegally gained access to any data, 
then the PI will try to determine to what extent the hacking has 
been successful. The investigator is responsible for informing 
the President’s office, the University of Minnesota attorneys, 
our IRB, the NIH project officer, and, if deemed appropriate, 
our police department. The PI, in consultation with the above 
persons, is responsible for determining what action, if any, is 
appropriate. It is anticipated that in the unlikely event such an 
action occurred, we would first attempt to contact every subject 
to inform them that their data may have been hacked, and 
second, where a person or agency is suspected of having 
illegally gained access to confidential materials, to seek legal 
recourse to prevent further use or distribution of the data. Upon 
reasonable suspicion that our database has been hacked, all 
data collection shall be suspended until such time that the 
incident has been reviewed and a secure mechanism of 
continuing to obtain and store data has been re-established. 
• Death occurring during the study. AIDS, by definition is a life-
threatening condition. We may anticipate some loss to follow-up due 
to death. We expect notification of death to come primarily when all 
attempts to contact the participant have failed, and we call their contact 
person. In such cases, we will identify ourselves as “calling from the 
Hunter College, trying to locate <<person’s name>> in regard to a 
study we are conducting.” Requests for information about the study 
will be politely declined since they could constitute a threat to 
confidentiality. Where contacts report a participant has died, it will be 
our practice to express our sympathies to the person, thank them for 
providing the information, and to terminate the call, as soon as 
propriety allows. While IRB requirements for clinical studies include 
to report all deaths during a study, such requirement do not pertain to 
the evaluation of behaviorally-based Internet-based interventions. 

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Hence, we will seek permission from our IRB not to report deaths 
occurring during the follow-up phase of the study, but instead to log 
these as natural events to be reported at the end of the study. 
20.0 Provisions to Protect the Privacy Interests of Participants 
20.1 Protecting Privacy: 
During assessments with CHEST NYC, participants will be given the option 
to choose a “refuse to answer” response, and, during the intervention, 
participants can divulge as little or much about their personal history as they 
choose. We anticipate that these steps will ensure that risk to the participant 
is minimized to his comfort level. In online interactions with the site, users 
will post and comment under anonymous usernames and site guidelines will 
prohibit the posting of personal information or identifiable photographs. 
20.2 Access to Participants:  
In-person access to participants will be limited to trained staff at CHEST 
who interact with them in-person at CHEST offices or by telephone. Online 
access to participants will be limited to trained staff at CHEST and UMN 
who will interact with them virtually through the password protected TWM 
interface and through occasional general e-mails (i.e., when we need to 
reach participants about the prize drawing) that do not reveal the nature of 
the study and protect the privacy of the participants. 
21.0 Compensation for Research-Related Injury 
21.1 Compensation for Research-Related Injury:  
N/A 
21.2 Contract Language:  
N/A 
22.0 Consent Process 
22.1 Consent Process (when consent will be obtained):  
Men who meet eligibility criteria will be guided through the consent process 
by trained research staff at CHEST. All study staff will undergo a thorough 
training and certification procedures prior to protocol implementation, 
including mandatory Protection of Human Subjects training in research 
ethics. The initial training will be conducted in-person by Dr. Horvath and 
will include an overview of the study, detailed explanation of the study 
protocol, and discussion of specific protocol components. Study staff will be 
observed at least twice a year to determine whether appropriate protocols are 
being followed. If protocols are not followed, retraining will be done as 
needed.  

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• Persons will be asked to do the following to assess understanding of 
the study: 
• Please describe this study in your own words. 
• Please describe what you will be asked to do during the study. 
• Please describe your rights as a research participant. 
• Please describe what will happen to you should you choose to 
withdraw from this research study. 
Participants will be told during the consent process that his participation in 
this study is purely voluntary and that he has the right to withdraw from the 
study at any time. Participants will also be informed that their relationship 
with CHEST or the University of Minnesota will not be affected in any way 
should they choose to withdraw or not participate in the study. Finally, 
participants will be assessed as to their understanding of the voluntary 
nature of this study. 
22.2 Waiver or Alteration of Consent Process (when consent will not be 
obtained, required information will not be disclosed, or the research 
involves deception):  
N/A 
22.3 Non-English Speaking Participants:  
N/A 
22.4 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 
years of age): 
N/A 
22.5 Cognitively Impaired Adults, or adults with fluctuating or diminished 
capacity to consent: 
N/A 
22.6 Adults Unable to Consent: 
N/A 
23.0 Setting 
23.1 International Research:  
N/A 
23.2 Community Based Participatory Research: 
N/A 
23.3 Research Sites:  
The partner site for this study will be Hunter College Center for HIV 
Educational Studies and Training (CHEST; Director: Dr. Jeffrey Parsons). 
CHEST is a behavioral research center in New York City with a 17-year 

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history of recruitment, enrollment, and retention of MSM and PLWH into 
behavioral intervention trials. CHEST is well prepared to carry out the 
proposed study activities, has expertise in optimizing retention for follow-up 
assessments, and has capacity to conduct on-site VL testing and urine drug 
screening, having done this for numerous NIH funded RCTs. After gaining 
approval from UMN IRB, CHEST will also submit an IRB application to 
their IRB (City University of New York). CHEST will be responsible for 
recruitment, on-site VL testing and urine drug screening, and training of 
participants when they begin using the site. 
24.0 Multi-Site Research 
24.1 Study-Wide Number of Participants:  
410 
24.2 Study-Wide Recruitment Methods:  
Participants will be recruited through banner ads on a number of social 
networking sites including those that are specifically for MSM (sample ads 
attached), and by CHEST. CHEST will utilize both active (e.g., direct 
outreach) and passive (e.g., advertising in clinic settings, internet-based) 
recruitment approaches to effectively recruit HIV+ MSM into the trial. 
24.3 Study-Wide Recruitment Materials:  
Sample flyers, banner ads, and palm cards are attached. 
24.4 Communication Among Sites:  
N/A 
24.5 Communication to Sites:  
The study coordinator and CHEST will hold weekly phone calls to discuss 
general updates, and any issues will be promptly communicated between the 
University of Minnesota research team and CHEST by email. Interim and 
final results will be shared electronically as appropriate. 
25.0 Resources Available 
25.1 Resources Available:  
Recruitment Feasibility: Men residing in the New York City metropolitan 
area will be recruited by CHEST staff to participate in this study. New York 
City was chosen as an ideal location to conduct the study because of the 
high numbers of HIV-infected MSM residents and since only 38% of 
residents with HIV are estimated to be virally suppressed. CHEST utilizes 
both active (e.g., direct outreach) and passive (e.g., advertising in clinic 
settings, internet-based) recruitment approaches to effectively recruit HIV+ 
MSM into intervention trials; and their field-based recruitment efforts are 
successful in enrolling substance users. In addition, they have had success 
with field-based recruitment in AIDS service organizations (ASOs) in 

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enrolling HIV+ MSM men of color who are not engaged in clinic-based 
care, but rely on services offered by ASOs. In previous intervention trials 
with substance using HIV+ MSM, more than 50% of enrolled participants 
were men of color. 
In order to recruit and enroll 20 eligible men per month, CHEST will use 
multiple approaches, all coordinated by our Director of Recruitment who 
has several years experience recruiting MSM for RCTs at CHEST. First, 
two recruiters will be utilized for active field-based recruitment efforts. 
They will target venues such as gay bars, community events, and HIV clinic 
settings. Potential participants will be given project related materials, and 
can call later for an appointment, provide contact information for a CHEST 
staff member to call them to schedule the in-person baseline visit, or 
schedule the appointment at the time of recruitment, depending on the venue 
and interests of the participant. Rigorous efforts will be undertaken to ensure 
that recruitment staff maintain adherence to the study protocols, and 
recruiters receive extensive training in how to approach potential 
participants and follow strict written guidelines regarding ethics and 
professional conduct. The first several recruitment shifts are monitored by 
the Director of Recruitment, and random spot-checks will be made on 
subsequent trips. Recruiters work in pairs to ensure their safety and 
adherence to protocol. Recruiters utilize palm cards with information about 
the study, and conduct on-site preliminary screening via iPads. After each 
recruitment shift, recruiters complete a report to facilitate the overall 
monitoring of the recruitment process. Second, a passive recruitment 
strategy through advertising will be developed by our consultant, who has 
been leading our marketing efforts for intervention trials at CHEST for over 
ten years. Advertisements will be run in publications targeting MSM in 
NYC, brochures will be developed for distribution at HIV clinics and AIDS 
service organizations, and online recruitment will be conducted via banner 
ads, pop-ups on social apps, craigslist postings, and through listserv and e-
blast advertising.   
 
CHEST Facilities:  
 
Adequate office space will be provided for study staff at CHEST’s research 
space in midtown Manhattan. CHEST is within close proximity (walking 
distance) to a variety of health and community service providers including 
the NYC Department of Health. Further, because CHEST is located in 
central Manhattan, there is minimal travel time between community and 
health service providers who may be further away (e.g., in Queens, the 
Bronx, Brooklyn, Jersey City, Staten Island). This proximity has resulted in 
established linkage agreements between CHEST and community providers 
(i.e., referring participants, linking them to care), a vast array of resources 
for CHEST to recruit potential participants and spread the word about 

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research opportunities at CHEST, and in rapidly disseminating our findings 
to our community partners (i.e., in disseminating our findings and 
identifying community-based needs, our team regularly meets with 
community providers across NYC). CHEST has maintained NYC-based 
office space for over 15 years, moving to a newly renovated space in 2012. 
In addition to the space at CHEST, facilities are also available at Hunter 
College, and the CUNY Graduate Center located three blocks away.  
 
At CHEST, staff members are provided with a desk, computer (equipped 
with password encryption), telephone, high-speed internet access, and 
printer. CHEST maintains all necessary office equipment including copy-
machine, fax, teleconference capabilities, LCD overhead projector 
(necessary for project meetings and staff training/supervision), and dynamic 
network computer server (where electronic files are securely backed up). 
CHEST maintains full capacity to operate as a research space in tandem to 
an office environment (e.g., full conference room for project-related 
meetings and trainings, office space for staff, private waiting area for 
participants, and private interview rooms). The private interview rooms vary 
in size and are all equipped with a computer, video camera and digital voice 
recorder. Each project maintains a secure-locked storage and filing cabinet 
to house physical copies of participant information (e.g., consent forms).  
 
Important for both project administration and individual career and skills 
development, CHEST has established protocols in place for training, 
supervision, and monitoring of data collection and analysis, for the ethical 
conduct of research, and for mentorship.  In addition, extensive protocols 
have been established with regard to recruitment of research participants and 
intervention fidelity monitoring. 
 
Resources for Participants: 
 
Names, descriptions, and contact information for crisis hotlines and local 
assistance programs are provided on the TWM website for users who may 
need them, and users are directed to them as needed. 
 
 
26.0 References 
1. Centers for Disease Control and Prevention. HIV Surveillance Report, 
2011.  [cited 2014 August 14]; Available from: 
http://www.cdc.gov/hiv/topics/surveillance/resources/reports/. 
2. Panel on Antiretroviral Guidelines for Adolescents and Adults. 
Guidelines for the use of antiretroviral agents in HIV-1-infected adults 
and adolescents. Department of Health and Human Services. 2014  
[cited 2014 August 20]; Available from: 
http://aidsinfo.nih.gov/ContentFiles/Adultand AdolescentGL.pdf. 

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Intervention for Substance-using HIV+ Adults 
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Revised: April 2, 2018 
3. The Antiretroviral Therapy Cohort Collaboration, Life expectancy of 
individuals on combination antiretroviral therapy in high-income 
countries: a collaborative analysis of 14 cohort studies. The Lancet, 
2008. 372(9635): p. 293-299. 
4. Cohen, M.S., et al., Prevention of HIV-1 Infection with Early 
Antiretroviral Therapy. New England Journal of Medicine, 2011. 0(0). 
5. Gardner, E.M., et al., The Spectrum of Engagement in HIV Care and its 
Relevance to Test-and-Treat Strategies for Prevention of HIV Infection. 
Clinical Infectious Diseases, 2011. 52(6): p. 793-800. 
6. Centers for Disease Control and Prevention. HIV in the United States: 
The Stages of Care. 2012  [cited 2013 July 17]; Available from: 
http://www.cdc.gov/nchhstp/newsroom/docs/2012/Stages-of-
CareFactSheet-508.pdf. 
7. Thompson, M.A., et al., Guidelines for Improving Entry Into and 
Retention in Care and Antiretroviral Adherence for Persons With HIV: 
Evidence-Based Recommendations From an International Association of 
Physicians in AIDS Care Panel. Annals of Internal Medicine, 2012. 
156(11): p. 817-833. 
8. Pellowski, J.A. and S.C. Kalichman, Recent Advances (2011-2012) in 
Technology-Delivered Interventions for People Living with HIV. Curr 
HIV/AIDS Rep, 2012. 
9. Saberi, P. and M.O. Johnson, Technology-Based Self-Care Methods of 
Improving Antiretroviral Adherence: A Systematic Review. PLoS ONE, 
2011. 6(11): p. e27533. 
10. Pew Internet and American Life Project. Internet User Demographics: 
As of January 2014, 87% of American adults use the internet. 2014  
[cited 2014 August 14]; Available from: 
http://www.pewinternet.org/data-trend/internet-use/latest-stats/. 
11. Page, T.F., et al., A Cost Analysis of an Internet-Based Medication 
Adherence Intervention for People Living With HIV. JAIDS Journal of 
Acquired Immune Deficiency Syndromes, 2012. 60(1): p. 1-4 
10.1097/QAI.0b013e318250f011. 
12. Fisher, J.D., et al., Computer-based intervention in HIV clinical care 
setting improves antiretroviral adherence: the LifeWindows Project. 
AIDS Behav, 2011. 15(8): p. 1635-46. 
13. Kurth, A.E., et al., Computerized counseling reduces HIV-1 viral load 
and sexual transmission risk: findings from a randomized controlled 
trial. J Acquir Immune Defic Syndr, 2014. 65(5): p. 611-20. 
14. Duggan, M. and A. Smith. Social Media Update 2013. 2014  [cited 2014 
August 20]; Available from: Available at: 
http://pewinternet.org/Reports/2013/Social-Media-Update.aspx. 
15. Horvath, K., et al., Technology Use and Reasons to Participate in Social 
Networking Health Websites among People Living with HIV in the US. 
AIDS and Behavior, 2012. 16(4): p. 900-910.