Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Frailty, Functional Impairment, Falls, and Fractures (4F) Fall Prevention Intervention Pilot Study
Phase: NA
Conditions: HIV Infection, Alcohol Consumption, Falls, Accidental, Falls
Sponsor: Boston University

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Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Frailty, Functional Impairment, Falls, and 
Fractures (4F) Fall Prevention Intervention Pilot Study 
 
 
 
 
ClinicalTrials.gov number: NCT04804579 
H-41041 
Protocol Version Number: 1.0 
Protocol Version Date: 9-22-2021 
Funding Mechanism:  National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
 
Principal Investigator: Theresa W. Kim, MD 
 
Phone: 617-414-1936 
 
E-mail: therkim@bu.edu 
 
 
 
 
Detailed Statistical Plan pages 18-19 
 
 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
This document is confidential and the property of Boston University Medical Campus. No part of it 
may be transmitted, reproduced, published, or used by other persons without prior written 
authorization from the study sponsor. 
 
 

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TABLE OF CONTENTS 
 
1 
List of Abbreviations……………………………………………………………………………..….…….....3 
2 
Protocol Summary……………………………………………………………………………….……….…....3 
3 
Background/Rationale & Purpose…………………………………………………………………….…4 
 
3.1      Background Information………………………………………………………………….…..…..4 
 
3.2      Rationale and Purpose…………………………………………………………………….………..4 
4 
Objectives ………………………………………………………………………………………………….…..….5 
 
4.1      Study Objectives……………………………………………………………………………….…..….5 
 
4.2      Study Outcome Measures……………………………………………………………….……..…5 
5 
Study Design………………………………………………………………………………………….…..….…...5 
6 
Potential Risks and Benefits……………………………………………………………………….….……6 
 
6.1       Risks……………………………………………………………………………………………….….…….6 
 
6.2       Potential Benefits………………………………………………………………………….…….……8 
 
6.3       Analysis of Risks in Relation to Benefits………………………………………….…...……8 
7 
Study Subject Selection……………………………………………………………………………….….……9 
 
7.1       Inclusion Criteria…………………………………………………………………………….….……..9 
 
7.2       Exclusion Criteria……………………………………………………………………………….……..9 
8 
Study Procedures…………………………………………………………………………………………..…….9 
 
8.1        Recruitment………………………………………………………………………………………..…..9 
 
8.2        Phone Screening………………………………………………………………………………..……9 
 
8.3        Baseline Assessment……………………………………………………………………….…......9 
 
8.4        Intervention Arm……………………………………………………………………………….……11 
 
8.5        Control Arm……………………………………………………………………………………….…..11 
 
8.6        Scheduling……………………………………………………………………………………….……..12 
 
8.7        Educational Components…………………………………………………………………….….12 
 
8.8        Intervention Process………………………………………………………………………….……14 
 
8.9        Phone Check Ins………………………………………………………………………………….….15 
10 
Adverse Events Reporting……………………………………………………………………………….....16 
11 
Data Monitoring…………………………………………………………………………………………….…..16 
12 
Data Handling & Record Keeping…………………………………………………………………….….17 
 
12.1       Confidentiality…………………………………………………………………………..…….…….17 
13 
Statistical Plan………………………………………………………………………………………………..…..18 
14  
Literature References……………………………………………………………………………………….…19 

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1 
List of Abbreviations 
Abbreviation 
Abbreviation definition 
ARCH 
Alcohol Research Collaboration on HIV/AIDS 
ASI 
Addiction Severity Index  
BEDAC 
Biostatistics and Epidemiology Data Analytics Center  
HACCX 
HIV-associated comorbidity and complications 
PLWH 
People living with HIV infection 
RA 
Research Assistant 
RC 
Research Coordinator 
 
 
 
 
2 
Protocol Summary 
Title: 
Boston Alcohol Research Collaboration on HIV/AIDS (ARCH) Frailty, 
Functional Impairment, Falls, and Fractures (4F) Fall Prevention 
Intervention Pilot Study 
Population: 
Up to 50 participants from the Boston ARCH 4F Study 
Intervention: 
The fall prevention intervention has 3 main components: home 
exercises, virtual group sessions and weekly phone check-ins. Home 
exercise will be customized to match the current fitness level of 
participants. Participants will be asked to complete assigned 
exercises 3 times per week. Additionally, there will be a weekly 
virtual group session led by an occupational therapist member of 
the study team trained in group facilitation via Zoom. The virtual 
group sessions will be used to help answer any questions and lead a 
discussion around challenges related to falls. Finally, a member of 
the research team will check-in with participants once per week to 
answer any remaining questions that participants have, provide 
individual feedback on exercises, and set up reminders for the 
upcoming week. Reminders will be tailored to the individual 
participant's needs to remind the participant to complete the 
intervention's components. 
Objectives: 
To examine the association between alcohol use and falls and 
fractures and whether frailty mediates these associations in people 
living with HIV (PLWH). 
Design/Methodology: 
The Fall Prevention Pilot will recruit participants from the Boston 
ARCH 4F Study to test the acceptability and feasibility of a 
randomized trial of a 10-week virtual intervention to reduce fall risk 
PLWH who consume alcohol. Eligible cohort participants with an 
elevated risk for falls will be randomized to either the intervention 
or control (usual care plus educational brochure). 
Total Study Duration: 
1 year 
Subject Participation Duration: 10 weeks  

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3 
Background/Rationale & Purpose 
 
3.1 
Background Information 
 
Up to a third of middle-aged people living with HIV infection (PLWH) experience falls each year.1 
Although not well-described in PLWH, falls are the most common cause of non-fatal injury in the US (8 
million falls per year; 2.6 million treatment episodes; 750,000 hospitalizations, 22,000 deaths)2,3 and the 
cost in the elderly is enormous ($20 billion/year), mostly from emergency department visits and 
hospitalizations (which have risen 50% in 7 years).2 Falls are a common and significant problem in PLWH, 
and alcohol is a potent risk factor, increasing risk up to 17X.1,4–11  Alcohol, illicit drug use, and 
polypharmacy likely contribute to falls (e.g. from over-sedation and risk-taking behavior), risk factors for 
falls (e.g. frailty), and fall consequences (e.g. fracture, need for acute healthcare use). Interventions are 
needed to address falls in PLWH who use alcohol but none have been tailored for this population. 
  
Efficacious interventions for the elderly exist12,13; however, fall prevention interventions developed for 
the elderly generally do not address alcohol, other drugs, HIV medications, and HIV-associated 
comorbidity, but they would likely need to in order to be successful in PLWH. A focus on risks, including 
the interplay of common exposures (e.g. alcohol, illicit drugs, medications) and mediators (e.g. frailty), is 
therefore critical in order to develop tailored preventive interventions to reduce falls and related 
morbidity effective for PLWH. 
 
3.2 
Rationale and Purpose  
 
Study Rationale: 
Falls are a common and significant problem among PLWH for various reasons.1,4–11 Antiretroviral therapy 
(ART) can control HIV viremia even in substance use-affected populations. But HIV-associated 
comorbidity and complications, in the context of possible premature aging —or more accurately—the 
earlier development of comorbidities in PLWH seen in older adults without HIV infection, now 
contribute to substantial impairment in people with HIV infection. These complications, including Frailty 
and impaired physical Function, can contribute to Falls and Fractures, and can be hastened by alcohol, 
illicit drug use, and polypharmacy (5+ medications). Fall prevention interventions developed for the 
elderly generally do not address alcohol, other drugs, or HIV medications, but would likely need to in 
order to be successful in PLWH. A focus on risks, including the interplay of common exposures (e.g. 
alcohol, illicit drugs, medications) and mediators (e.g. frailty), is therefore critical in order to develop 
tailored preventive interventions to reduce falls and related morbidity effective for PLWH.  
  
Purpose: 
This study is being conducted to assess the acceptability and feasibility of conducting a randomized trial 
of a 10-week virtual intervention aimed at reducing fall risk in PLWH who consume alcohol. This pilot 
trial will be used to inform feasibility of this study design prior to conducting a large-scale trial. To 
achieve this, we propose to recruit up to 50 participants from the Boston ARCH 4F Study, 40 of whom 

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will be randomized, to pilot test this fall prevention intervention. Further, we will assess the 
acceptability and feasibility of the intervention component by assessing number of virtual group 
intervention sessions attended and administering the Client Satisfaction Questionnaire (CSQ-8)14 at the 
conclusion of the intervention. 
 
4 
Objectives 
 
4.1 
Study Objectives 
 
The primary aim of the intervention is to assess acceptability and feasibility of a randomized trial of a 10-
week virtual fall prevention intervention. 
 
4.2 
Study Outcome Measures 
 
4.2.1 
Primary Outcome Measures 
 
To assess intervention acceptability and feasibility, the primary outcomes include number of weekly 
intervention sessions attended (out of 10 sessions) and overall satisfaction with the intervention 
[assessed at study conclusion using the Client Satisfaction Questionnaire (CSQ-8)].14   
 
4.2.2 
Secondary Outcome Measures 
There are also several secondary outcome measures: 
• 
Falls from participant self report, defined as an unexpected event, including a slip or a trip, in 
which a participant lost their balance and landed on the floor, ground, or lower level, or hit an 
object like a table or a chair.  
• 
Physical Function measured using the Short Physical Performance Battery assessment 
• 
Frailty phenotype15, which includes measures of exhaustion, low activity, weight loss, slowed 
walking, weak grip.  
 
• 
Alcohol and other drug use from self report measured using the validated Addiction Severity 
Index (ASI)16–18 
 
5 
Study Design 
 
The Boston ARCH 4F Fall Prevention Pilot is a sub-study of the Boston ARCH 4F Study, a longitudinal 
cohort study of 251 HIV infected men and women who have a spectrum of alcohol and other drug use. 
The Boston ARCH 4F study aim is to examine the association between alcohol use and falls and fractures 
and whether frailty mediates these associations in people living with HIV (PLWH). The Fall Prevention 
Pilot will recruit participants from the Boston ARCH 4F Study to test the acceptability and feasibility of a 
randomized trial of a 10-week virtual intervention to reduce fall risk PLWH who consume alcohol. 

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Eligible cohort participants with an elevated risk for falls will be randomized to either the intervention or 
control (usual care plus educational brochure).  
 
Standardized assessments will be administered to all participants in-person at Boston University Medical 
Campus (BUMC) to assess various domains including fall risk, fear of falling, physical performance 
measures (such as grip strength, balance, and gait speed), substance use, and other related measures at 
baseline and at trial completion. The fall prevention intervention has 3 main components: home 
exercises, virtual group sessions and weekly phone check-ins. Home exercise will be customized to 
match the current fitness level of participants. Participants will be asked to complete assigned exercises 
3 times per week. Additionally, there will be a weekly virtual group session led by an occupational 
therapist member of the study team trained in group facilitation via Zoom. The virtual group sessions 
will be used to help answer any questions and lead a discussion around challenges related to falls. 
Finally, a member of the research team will check-in with participants once per week to answer any 
remaining questions that participants have, provide individual feedback on exercises, and set up 
reminders for the upcoming week. Reminders will be tailored to the individual participant's needs to 
remind the participant to complete the intervention's components. 
 
6 
Potential Risks and Benefits 
 
6.1 
Risks 
Potential risks for participants include psychological stress from the research interviews or from 
recognizing health disorders during the interviews or tests, loss of confidentiality, and social harms. 
These are minimal risks, consequences are not likely, and will be minimized further. 
Psychological stress from research interviews or study visits:  Participants may experience psychological 
stress from talking about their health or from recognizing health disorders during the assessments or 
intervention components. Participants may get tired during the visits. Additionally, participants may find 
it inconvenient to take time for the visits, and they may find it inconvenient to be contacted by study 
staff when they remind participants of an upcoming research visit. Participants will not be explicitly 
asked questions about self-harm and/or suicidal ideation as a part of this research study. However, if 
active/current suicidal ideations are identified via research assessment or expressed by participants 
during study visits, study physicians are available to respond to participant concerns with referrals as 
needed (remotely if during a remote visit or in-person if during an in-person interview). This process will 
be determined prior to the visit taking place, per recommendation of the staff facilitating the visit or 
phone call.  
Discomfort from exercise assignments: Participants may experience muscle soreness, discomfort, and 
fatigue after completing the exercise assignments. There is the unlikely risk that a participant could get 
injured while doing the exercise assignments. However, all exercise assignments will be tailored to the 
individual's needs and skill levels, and study staff will make sure the participant has been provided with 
thorough instructions/demonstrations on how to properly do the exercises before they are instructed to 
proceed with doing the exercise assignments on their own. Participants are welcome to ask any 
questions during virtual group sessions or weekly phone check-ins. 
Loss of confidentiality: Loss of confidentiality by someone seeing the responses to interview assessments 
is potentially the most serious risk of the proposed study, though it is very unlikely because specific 
procedures will be implemented to prevent such disclosure. In addition, much of the most sensitive 
information (HIV and alcohol use) is already in medical records and the additional increase in risk of 

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recording it for research purposes, particularly given the protections in place for such records that is far 
greater than clinical records, is small. There is a risk that participants may experience loss of 
confidentiality when research assistants make attempts to contact them for follow-up. All participants 
will be informed and provide their consent for the study to reach them through contacts they have 
provided as a part of the Boston ARCH 4F study (the participant will be linked to the Boston ARCH 4F 
study through their unique Study ID number). When research assistants attempt to make any contact to 
the participant or other contacts, all communications will be identified as coming from a “health study,” 
not an alcohol abuse or HIV study. When study visits (such as group meetings or individual check-ins) are 
conducted via phone or confidential video conference, study staff will advise participants to take 
precautions to minimize the risk of a breach of confidentiality such as participating in the study visit in a 
private location. Participants will be provided the option to keep their camera off during study visits, if 
they would like. Prior to virtual group meetings, study staff will ask all participants not to talk about the 
discussions outside the group, and research study staff will remind the participants to respect the 
privacy of fellow participants and not repeat what is said in the group meetings to others. Participants 
will be asked to only provide their first name or a pseudonym.  
  How risks will be minimized. 
Loss of confidentiality: To assure confidentiality, research data collection and data entry forms will be 
labeled only with the unique Boston ARCH 4F Study ID number, and will contain no other individual 
identification. Only the written informed consent forms, participant locator information, and a master 
list of participants and participant study identification numbers will have the participant number and 
identifying information on them. There will be only one master list of names and identification numbers. 
These data will be kept in a secure electronic environment accessible to the principal investigator, the 
study research staff and data managers. Study staff will use the tracking information that the 
participants provided during the Boston ARCH 4F study, and study staff will confirm that the tracking 
information is up to date and accurate. Computer data will be password protected, and accessible only 
to research assistants needing the information for follow-up purposes. When study visits (such as group 
meetings or individual check-ins) are conducted via phone or confidential video conference, study staff 
will advise participants to take precautions to minimize the risk of breach of confidentiality. Study staff 
will remind participants that they should participate in study activities in a private location. Participants 
will be provided the option to keep their camera off, if they would like. Prior to virtual group meetings, 
we will remind participants that they should not talk about the discussions outside the group. All of 
these procedures are likely to be effective, based on our experience with similar studies. Comments on 
the home exercise YouTube videos have been disabled to further protect participant confidentiality.  
Psychological stress: The minimal risk of psychological distress from interviews and study visits will be 
minimized by using trained interviewers and a standardized interview process. To further minimize this 
risk, we will enroll participants who understand the study and are willing to participate. Participation is 
voluntary and participants can withdraw at any time. Additionally, we will take steps to mitigate the risk 
of psychological stress during the weekly virtual group sessions. The occupational therapist member of 
the research team is trained using Zoom to facilitate group sessions and will re-direct any inappropriate 
questions or topics. Each virtual group session will begin with a reminder of best practices and available 
resources. For example, we will remind participants that they are welcome to leave the group meeting 
at any time and follow up with a study team member if they experience psychological stress during the 
group session without any penalty. Study staff will be available by phone if undue stress arises, and they 
will be able to make recommendations or referrals as appropriate. Study team members will have a list 
of mental health and alcohol use resources that can be provided to participants who inform a study 

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team member that they are experiencing psychological distress as a result of the research study. 
Participants will also be reminded that phone check-ins can be used as an opportunity to discuss 
experiences of psychological distress, and participants are welcome to save sensitive or uncomfortable 
topics for discussion during the phone check in rather than the virtual group session.  
Discomfort from exercise assignments: Participants will only be assigned exercises that have been 
tailored to their individual needs, skill level, and goals, which will be determined during the baseline 
assessment. The exercises and modifications will be demonstrated during the first virtual group session. 
We will ask that participants only perform the exercises exactly as instructed, and they should not do 
any exercises that make them feel uncomfortable (not including general muscle soreness or fatigue, 
which is a common and temporary risk). Video demonstrations of the exercises and modifications will be 
available on YouTube as "unlisted" videos that can be accessed only through a direct link that we will 
provide participants.  Participants can refer to these demonstrations at any time. Participants will also 
be encouraged to discuss any discomforts that have resulted from exercise assignments with members 
of the research team during weekly virtual group meetings and phone check-ins.  
Plans for ensuring necessary medical or professional intervention in the event of adverse effects to 
participants: If consequences arise due to research procedures (e.g., distress, anxiety, suicidal thoughts) 
the physician investigators will be available to assess participants and make appropriate interventions or 
referrals based on the clinical circumstances, immediately. This will be done either remotely or in 
person, whichever mode reflects the research activity being conducted. Three study physicians have 
extensive clinical experience with patients with substance use disorders and related mental health 
complications that arise, two have clinical expertise with HIV infection. 
 
6.2 
Potential Benefits 
 
Participants in the control group may benefit from receiving educational information related to falls and 
alcohol use. 
  
Participants in the intervention group may benefit from the intervention components of the study. They 
may gain strength from weekly exercises, which may put them at lower risk for experiencing a fall. 
Participants may benefit from discussing their experiences related to falls and alcohol use with other 
peers during weekly virtual group meetings, and participants may benefit from discussing their 
experiences with falls and alcohol use with an occupational therapist member of the research team 
during the weekly phone check-ins. 
 
6.3 
Analysis of Risks in Relation to Benefits 
The principal risks of this study are loss of confidentiality and psychological stress. We will take an 
abundance of caution to protect the confidentiality of participants, and participants will be reminded of 
best practices prior to each weekly virtual group session. Participants will be provided various 
opportunities to discuss psychological distress with trained study staff and physician investigators. These 
risks are outweighed by the potential benefits that participants may receive from the intervention. 
 Participants who are assigned to the control arm may benefit from the provided educational materials. 
 Participants who are assigned to the intervention arm may benefit from weekly virtual group sessions 
and phone check-ins. These sessions will provide participants with the opportunity to discuss challenges 

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related to falls and alcohol use and ideas for overcoming these challenge. During preliminary qualitative 
research, Boston ARCH 4F participants expressed that group meetings and individual check-ins would be 
beneficial. Additionally, the home exercises may improve strength and balance in the participants. 
Furthermore, this intervention is tailored to address fall risk and alcohol use in this specific population, 
and it has the potential to reduce falls among PLWH who use alcohol more than a traditional fall 
prevention program. 
 The benefits outweigh the risks. 
 
7 
Study Subject Selection 
 
7.1 
Subject Inclusion Criteria 
 
• 
Male or female at least 18 years old 
• 
Prior or current participant in the Boston ARCH 4F Cohort 
• 
Any alcohol consumption in the last 30 days using Addiction Severity Index 
• 
Deemed a Fall Risk using the CDC STEADI Fall Risk Assessment Form19 
• 
Has reliable access to a phone or computer with internet connection 
 
7.2 
Subject Exclusion Criteria 
 
• 
Requires wheelchair for mobility 
 
8 
Study Procedures 
 
8.1      Recruitment-  Up to 50 participants will be recruited to the Fall Prevention Pilot study from the 
Boston ARCH 4F Study cohort. To identify potentially eligible participants, the Boston University Medical 
Campus (BUMC) Biostatistics and Epidemiology Data Analytics Center (BEDAC) will generate a list of 
potentially eligible participants from the Boston ARCH 4F cohort who previously (at prior Boston ARCH 
4F Study cohort assessments) endorsed alcohol use and fall history based on responses to the Addiction 
Severity Index (ASI) and the AIDS Clinical Trials Group (ACTG) Fall History Questionnaire.20–22 Participants 
who have not provided their written informed consent to be contacted about other research studies will 
be excluded from this list. Research assistants (RAs) and the research coordinator (RC) approach 
participants on this list for phone screening.  
 
8.2    Phone Screening of Eligibility -The RAs and RC will reach out to Boston ARCH 4F participants who 
have been identified as potentially eligible based on the criteria described above. Participants interested 
in the study, if they agree, will be screened over the phone by interview/questionnaire for eligibility. If 
the participant meets all inclusion criteria and does not meet any exclusion criteria, they will be offered 
participation in the Boston ARCH 4F Fall Prevention Intervention Pilot Study. All eligible participants will 
be informed about the study and their written consent will be sought.  
 
8.3    Baseline Assessment - Enrolled participants will complete a baseline research interview (a series of 
questionnaires to assess fall history and efficacy, substance use, prescription medications, physical and 
social environment, food security, and frailty) and physical assessments (physical function measures 

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including grip strength, short physical performance battery, and vision acuity) in-person at BUMC with 
an RA or RC. Additionally, an occupational therapist member of the study team will conduct the 
Canadian Occupational Performance Measure to assess the participant's exercise-related skills, needs, 
and goals.  
 
If a participant's baseline is scheduled to occur more than 2 weeks (14 days) after the initial screening 
questionnaire was administered, an RA or RC will re-administer the screening questionnaire with the 
participant to confirm eligibility prior to conducting informed consent and the baseline research 
interview. The RA will re-administer the screening questionnaire within 24 hours prior to the scheduled 
baseline assessment. If the participant does not meet eligibility criteria based on the re-administered 
screening questionnaire assessment, then the participant is ineligible for the study, and they will be 
instructed to not attend their scheduled baseline assessment. However, if the RA is unable to get in 
touch with the participant prior to the scheduled baseline assessment, and the participant arrives at 
BUMC campus for the assessment, then the RA may re-administer the screening questionnaire in-
person. If the participant does not meet eligibility criteria based on the re-administered screening 
questionnaire assessment, then the participant is ineligible for the study, the baseline questionnaire will 
not be administered, and the participant will be compensated $15 for their time. 
 
 If the participant's baseline research interview is scheduled within 2 weeks (14 days) after the initial 
screening questionnaire was administered, the RA or RC will not re-administer the screening 
questionnaire prior to completing the informed consent and the baseline research interview. However, 
if a participant reports no past 30 day alcohol use during the baseline research interview, the participant 
will be considered ineligible for the study and will not be randomized to either the intervention or 
control arm of the Fall Prevention Pilot, and no further follow-up will occur with the participant unless 
he or she is re-screened and determined eligible at a later date. The participant will still, however, be 
compensated for the baseline research study visit. 
 
At the end of the baseline assessment, the RAs or RC will inquire about the participant's general 
availability, which will be used to identify the times during which the intervention's weekly group check-
ins will be held and determine whether the participant will be randomized. A participant will not be 
randomized if they have limited availability that cannot be accommodated. This decision will be made 
on a case-by-case basis. Additionally, after the baseline assessment has been administered, the RAs or 
RC will provide participants with technological assistance that may be helpful prior to the intervention. 
Although not all participants who complete a baseline assessment will be randomized to the 
intervention arm, the baseline assessment will be the only point of in-person contact prior to initiating 
the intervention. Therefore, the RAs or RC will utilize this in-person time point to provide technological 
assistance with Zoom, such as setting up the Zoom app on a personal cell phone or computer, 
demonstrating the process of calling into a Zoom conference room (with or without the Zoom app), and 
identifying Zoom features that may be beneficial to understand (such as turning video and audio on and 
off). This technological assistance will be completely voluntary. Study staff will remind participants that 

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they will only use Zoom during the Fall Prevention Pilot study if they are assigned to the intervention 
arm.  
 
The baseline assessment will take approximately 2 hours to complete.  
 
8.4     Intervention Arm Assignment/Randomization 
 
Randomization: Once at least 6 participants have completed the baseline assessment, which we expect 
to occur between 2 and 4 weeks after study staff administer the first participant's baseline assessment, 
they will be randomized to either the intervention or control group using an automatic REDCap 
randomization module. These participants will be randomized in the "first wave" to either the 
intervention or control group using a 1:1 ratio on the factor of sex. The "first wave" of participants will 
be informed of their randomization assignment by study staff via phone call and will proceed with their 
assignment within the next week. After the "first wave" of participants are randomized, study staff will 
continue to screen and conduct baseline assessments for randomization in the "second wave" (similar to 
the first wave, the second wave will aim for n of at least 6). It will be acceptable for recruitment to occur 
over multiple randomization waves until recruitment goals have been met (to reach n=40 randomized 
participants). Procedures for subsequent recruitment wave(s) will be conducted in the same manner as 
the first wave. Participants will be randomized and informed of their randomization assignment after 
the baseline assessments for that wave have been conducted, which we expect to occur between 2 and 
4 weeks after study staff administer the first baseline assessment of each subsequent wave. 
 
In the event that study staff determine that the availability provided by a participant at baseline is too 
limited and cannot be accommodated (e.g., matched with other participants' availability so that two 
weekly group meeting days/times can be identified), that participant will not be randomized. This 
procedure is in place because a participant's limited availability will impact the participant's ability to 
participate in an entire component of the intervention (weekly virtual group meetings). During the 
subsequent wave(s) of recruitment and baseline assessments, study staff may re-contact participants 
who were enrolled in the Fall Prevention Pilot during a previous recruitment wave but were not 
randomized to a study arm due to limited availability at the time of the previous recruitment wave. Any 
participants who are re-contacted and provide an increased level of availability that study staff believe 
can be accommodated (e.g., matched with other participants' availability so that two weekly group 
meeting days/times can be identified) may be randomized during a subsequent wave(s).  This will be 
determined on a case-by-case basis.  
 
8.5    Control Arm Assignment 
 
Participants who are assigned to the control arm will be informed of their assignment via phone call. 
Study staff will explain that being in the control group means that they will be receiving educational 
materials on fall prevention and alcohol use. The participant’s mailing address will be confirmed, and the 
educational materials will be mailed by certified mail (or emailed, depending on participant preference) 

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to their preferred address. The educational materials will only be mailed once, unless the participant 
misplaces the educational materials and requests to have study staff re-mail (or re-email, depending on 
participant preference) the educational materials.  
 
Intervention Arm Assignment: Participants who are assigned to the intervention arm will be informed of 
their assignment via phone call. Study staff will explain that being in the intervention group means that 
they will be participating in a 10-week intervention, which includes weekly home-based exercises, a 
weekly phone check-in, and weekly virtual group sessions. During this phone call, study staff will also 
obtain detailed availability from each participant, which will be used to schedule the weekly virtual 
group sessions.  
 
8.6   Scheduling 
 
Virtual Group Session:  Virtual group session scheduling will occur in waves that align with the waves of 
randomization. After the "first wave" of randomization has occurred, study staff will reach out to all 
participants (at least 3) who have been assigned to the intervention arm to request days and times at 
which they are available and/or unavailable to participate in study activities. This availability will be used 
to help study staff identify the time slots in which the weekly virtual group sessions will be held. Once 
time slots for weekly virtual group sessions have been identified (up to two time slots), study staff will 
reach out to participants via phone call to schedule each participant for one of the two weekly virtual 
group sessions. Study staff will aim to assign an equal number of participants to each weekly virtual 
group session time slot; however, an equal allocation of participants to each group is not required. An 
unequal number of participants may be assigned to each group, provided that there are at least 3 
participants assigned to the smallest group. Furthermore, study staff may also choose to assign all 
participants to one weekly virtual group session time slot if all participants' availability aligns with the 
same time slot or if having two groups would not allow for the minimum required number of 
participants (at least 3 per group). Procedures for scheduling the two additional weekly virtual group 
sessions for the subsequent wave(s) of randomized participants will be conducted in the same manner 
as the "first wave" of randomized participants.  
 
Phone Check-in: Participants will be scheduled for their initial phone check-in when study staff contact 
the participants via phone call to schedule the participants for one of the two weekly virtual group 
sessions. The first phone check-in will be scheduled to occur between the first and second weekly virtual 
group sessions. During each weekly phone check-in, study staff will schedule the participant for the next 
week's phone check-in. 
 
Conflicts and Rescheduling: If a participant experiences a scheduling conflict with a scheduled group 
session, they will miss that visit. Study staff will inquire about the upcoming week during a participant's 
weekly phone check-ins. Participants who indicate that they will have a scheduling conflict with their 
assigned weekly virtual group session time will be offered participation in the other group for that week 
only. Further, if a participant experiences a scheduling change that causes them to be unavailable for 

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either of the 2 group sessions, the participant will miss the group meetings. However, the participant 
will to continue to participate in the intervention by attending the weekly phone check-ins and 
conducting the weekly exercise assignments, and participants will be encouraged to attend future 
virtual group meetings if they experience a schedule change that allows for their attendance. The 
weekly virtual group meeting sessions will be combined into one session if weekly participation drops 
below 3 participants per session for at least two consecutive weeks. 
  
8.7   Educational Component (Control Group Only) 
 
Fall Prevention and Alcohol Use Educational Materials: The RAs and RC will call participants to inform 
them that they have been randomly assigned to the control group, and as a result they will be receiving 
educational materials about fall prevention and alcohol use. The RAs and RC will provide the participant 
with a brief overview of the educational materials that they will receive. The educational materials will 
be sent to the participant by certified mail (or by email, if this is the participant's preferred method) 
within one week of being informed of their randomization arm assignment. The educational materials 
will only be mailed once, unless the participant misplaces the educational materials and requests to 
have study staff re-mail (or re-email, depending on participant preference) the educational materials.  
 
8.8   Intervention Process (Intervention Group Only) 
 
Note: None of the below research activities will be recorded (audio or visual).  
 
Virtual Group Session via Video/Phone: Weekly virtual group sessions will be held at up to two time 
points each week. Participants will be assigned to one of up to two time points and will be asked to 
attend the virtual group session for about 30 minutes each week for 10 weeks. The weekly virtual group 
sessions will be led by a licensed  occupational therapist member of the study team, who is trained  in 
group facilitation via Zoom. RAs will help coordinate and schedule the sessions with participants. 
Participants will have the option of using video or phone to participate (use of video will be 
encouraged). If two groups were scheduled at the outset of the intervention and any of the groups 
decrease in attendance to only two people, the two groups will be combined to form one group that will 
meet for the remaining weeks of the intervention period. 
 
The group sessions will be led by experienced occupational therapists who have been trained in group 
theory and facilitation as well behavioral health and fall prevention. The social learning model will be 
used as the theoretical basis for all groups. Situated learning theory, which is derived from social 
learning theory, posits that behavior results from interaction between the person and the situation. The 
learner is placed in contexts (the intervention group and practicing at home) that allow for simulated 
and actual application to everyday situations, whereas peers enhance the learning experience with 
feedback. In social situations, individuals gain motivational support from others and access both 
expertise and collaborative thinking, increasing opportunities to acquire and apply new knowledge. This 
approach has successfully been used in effectiveness studies with individuals who were homeless, 

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mentally ill, had an intellectual disability, as well as across a wide age span from 12-79 years of age. 
Group participants functioning at a variety of levels are likely to benefit from others’ experiences of 
completing the intervention activities and identifying strategies to follow through with 
recommendations. 
 
The occupational therapist member of the study team will begin each group by reviewing the purpose 
and reminding participants that they can choose how much to share or not share. The purpose will be 
described as a forum to share their experiences with the intervention, discuss any falls during the week 
and identify strategies to address any challenges. The discussion will begin with a quick check in with 
each group member to provide a structured opportunity for every participant to speak at least once 
during the group. The check in will be a brief structured question such as, “Identify one exercise you 
liked doing this week and one that you might have had some difficulty with.” This structure gives the 
participants permission to have challenges with the intervention to help alleviate discomfort or 
embarrassment with having to initiate this topic. It also ensures that every group member participates 
verbally should they be less active in the remainder of the discussion. Based on the check in responses, 
the occupational therapist member of the study team will facilitate a group discussion among 
participants that encourages them to share strategies and commonalities with each other. Group 
members find advice from peers to be more valid than from a professional. The occupational therapist 
member of the study team will use their expertise to ensure the conversation stays on the topic of falls 
and intervention strategies and to correct any misinformation that might be shared. The therapist will 
have a list of common topics to interject if the participants exhaust their own concerns or if the group 
conversation veers off course. Topics will include common issues related to fall prevention such as 
identifying and removing environmental obstacles, finding time to complete exercise, maintaining good 
nutrition to support physical health, and how to speak with your doctor about medication side effects 
such as dizziness, etc. Finally, group time may be spent reviewing exercises if needed. If individuals raise 
concerns that cannot be addressed in the group due to time or because the topic is beyond the scope of 
the group, they will be redirected to their individual session or another resource.   
 
Independent Home Exercises: Home based exercises will be tailored to each participant’s individual 
needs and skill sets, which will be determined at the baseline assessment. The general categories of the 
exercises include air squats, bicep curls, burpees, and single leg stands. Links to the exercises can be 
found below. Participants will complete assigned exercises on their own at home and will be instructed 
to record the exercises they complete on the Home Exercise Form, which is a tool for personal use by 
the participant and will not be returned to the study team. The exercise assignments will take about 30 - 
60 minutes to complete per time the participant exercises. During the first virtual group sessions, an 
occupational therapist member of the study team will describe and demonstrate the assigned exercises. 
Participants may use this time to ask questions about the exercises. Further, if a participant was unable 
to attend the first virtual group session, the assigned exercises will be demonstrated by an occupational 
therapist member of the study team during the first phone check-in. In the case that assigned exercises 
will be demonstrated at the first phone check-in, the phone check-in will occur using Zoom instead of 
phone call.  

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Participants will be able to refer back to video demonstrations of the assigned exercises on a YouTube 
channel called "Boston ARCH Home Exercises". The YouTube channel will include videos of occupational 
therapist members of the study team demonstrating the assigned exercises. The videos on the YouTube 
channel will remain at a visibility status of "unlisted", which means they can only be accessed by a URL. 
Comments on the videos have been disabled. Study staff will provide participants with the limited 
access URLs at the first virtual group session, phone check-in, or by email upon participant request. 
Participants will be encouraged to keep the limited access URLs private and not share the links with 
people outside of the study.  
URLs: 
https://youtu.be/BGR69rKSMCA 
https://youtu.be/mfrOBDuRP7M 
https://youtu.be/2IeSb2UXsm4 
https://youtu.be/3ypbuWluf3M 
  
8.9    Individual Check-In via Phone Call 
 
The phone check-in will occur between the first and second weekly virtual group sessions, and follow-up 
check-ins will occur once weekly after the initial check-in for the entirety of the intervention period, for 
a total of 10 weekly check-in calls. These phone calls will be conducted with an occupational therapist 
member of the study team. As the study's primary aim is to assess acceptability and feasibility, there is 
no set limit of missed weekly check-ins that triggers dropping participant from the study. If a participant 
stops participating in weekly exercises, the occupational therapist conducting the weekly check in with 
the participant will inquire as to the reasons why the participant stopped completing the exercises. This 
feedback will be used to modify the exercises going forward (e.g., frequency, intensity). Additionally, 
individualized reminders (e.g. phone alarm, calendar update) for the various intervention components 
will be set during the individual check-ins.  
 
Post-Study Assessment-  After the 10 week intervention is complete, all randomized participants 
(intervention and control groups) will be asked to complete a post-study interview (a series of 
questionnaires to assess fall history and efficacy, substance use, prescription medications, physical and 
social environment, food security, and frailty) and physical assessments (physical function measures 
including grip strength, short physical performance battery, and vision acuity) in-person at BUMC with 
an RA or RC. Additionally, an occupational therapist member of the research team will conduct the 
Canadian Occupational Performance Measure. The post-study assessment will take approximately 2 
hours to complete.  The RAs and RC will reach out to participants approximately 8-9 weeks after 
randomization to schedule the post-study assessment, and the post-study assessment will be completed 
approximately 10 weeks  (up to 14 weeks) after randomization.   
 
9    Informed Consent  
 

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Consent will be sought by trained research staff under the supervision of the study investigators. 
Research study staff will have a conversation with the potential participant about the study, reviewing 
all pertinent elements of informed consent. If potential participants wish to review the information and 
consider their options they may do so and return to enroll at a later date if they remain eligible. Written 
consent will be documented. Consent will be obtained when potential participants arrive for their first 
research interview. Their clinical care will not be interrupted or interfered with. Research staff will 
review the elements of consent with participants (that this is a research study, description of the study 
procedures including that their study ID will link information from the Fall Prevention Pilot to the Boston 
ARCH 4F Study, that we will use contact information that was provided for the Boston ARCH 4F study, 
the risks and discomforts, the benefits, the alternative to participating in the study including to not 
participate in the research, the purpose and duration of the study, confidentiality, and that participation 
is voluntary). After research staff review the elements of consent with participants, they will use a 
"teachback" process among all participants to ensure participant comprehension. The study will begin 
immediately after informed consent by an RA. 
 
10. Adverse Event Reporting 
 
This study is not greater than minimal risk. Unanticipated Problems, Adverse Events, and protocol 
deviations will be reported to the IRB as required by IRB policies. The Principal Investigator at BU 
Medical Campus will report all adverse events and Unanticipated Problems to the IRB in compliance 
with IRB policy, Federal/State regulations, and sponsor requirements (as applicable). 
 
11.  Data Monitoring 
 
The PI will be responsible for ongoing quality control.  This includes all aspects of the study related to 
safety, but also data integrity and protocol compliance.  Quality control will include self-audits of data 
collection and storage as well as compliance with the informed consent procedure.  The review of data 
and procedures may result in early termination of the study, amendment of the protocol or data 
collection plans, or amendment of study forms.  The IRB will be notified and all amendments approved 
prior to study implementation.  In addition, the participants will be notified of any significant new 
findings that develop during the course of research (e.g., other potential risks) that may affect their wish 
to continue participation in the study.   
 
The study clinicians, research coordinator, and Principal Investigator will monitor study progress 
including enrollment, adherence to inclusion/exclusion criteria and study protocol, as well as any 
adverse events. The Principal Investigator will be responsible for ensuring that adverse events are 
reported to the local Institutional Review Board in compliance with local and federal requirements. Any 
changes to the protocol will be made in accordance with local IRB policies. The Principal Investigator will 
supervise all study activities, including those of the research coordinator and co-investigators, and will 
be available 24 hours a day by page or telephone. 
 
12.     Data Handling and Record Keeping 
 

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12.1   Confidentiality 
 
The study ID number assigned to participants in the pilot study will be the same study ID number used in 
Boston ARCH 4F. This ID number is the only link that connects their identifiers (e.g. names) in the 
tracking database (information required to contact and follow participants) and the separate study 
database. This code is stored in a separate secure database accessible only to study staff and 
investigators. 
 We will communicate with participants via phone, BU Zoom Meetings for HIPAA, or BU Teams, and 
when using BMC email, we will type "secure" in the subject line which creates a secure messaging 
system, or for BU email we will use the BU approved DataMotion SecureMail email service. We note 
that since technology changes frequently, it is possible that BMC and BU's secure email systems could 
change and if they do, we will follow BU or BMC IT procedures for such emails. Similarly, if a new secure 
platform recommended for such communications becomes supported by BU and BMC and/or 
recommended by the IRB we will use those platforms. One problem that arises with secure email is that 
it is very difficult for participants to use, particularly the most vulnerable subjects, who have less 
advanced technology available to them. Thus, if the patient or research subject has agreed, we shall use 
non-secure communications. In those cases, communication will generally be limited to the minimal 
detail necessary, and participants will be informed that they should delete messages and take care to 
keep their information not visible to others on their devices. Please note that this language is based on 
BU IRB recommendations, and applies to all sections describing participant contact. 
 Data Management and Security to Protect Privacy: The Biostatistics and Epidemiology Data Analytics 
Center (BEDAC) will assure high quality forms, monitor data quality, and track and link the multiple data 
sources. Data will be linked and entered using multiple checks. BEDAC will develop data collection forms 
and questionnaires, implement procedures for quality control, and provide statistical programming and 
collaborate in report writing and presentation of study results. 
 Data will be collected by interview via web-based data capture system on tablets. Study staff in 
collaboration with BEDAC will design, develop and maintain the electronic data collection forms, and 
underlying SQL database systems, and implement procedures for data quality control, including multiple 
checks for entered data. Study staff will use the same secure electronic data capture system that has 
been successfully implemented in the Boston ARCH 4F study for tracking and contact information. 
Electronic data collection forms will be designed to read easily, have clear instructions, preprogrammed 
skip patterns, real-time range checks and internal logic to minimize missing data, resulting in “cleaner” 
data at capture. The website and accompanying database is located on secure, password-protected 
servers, behind the Boston University firewalls. The web and database servers use Secure Socket 
Layering (SSL) to ensure data security and confidentiality. Servers incorporate RAID hard drives for data 
redundancy. A separate web server dedicated for Cold Fusion applications is also available. Hard copies 
of the signed informed consent form will be stored in locked filing cabinets and locked offices at Boston 
University School of Public Health. 
 Data transmission will be protected through SSL encryption. Eligibility for participants will be verified by 
the web data capture application. For the pilot trial, allocation is concealed from study staff and 
participants until the assignment is made to avoid interviewer bias. BEDAC will maintain data 
management protocols and analytic plans. Study staff will use the Boston ARCH 4F participant tracking 
system that includes an innovative real-time crosscheck used in prior studies to prompt contact with 
participants when they appear for care. Because the server is part of the BUMC network, only 

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connections from users authenticated from the domain controller are accepted, thus providing a secure 
environment for all data. Specifically, the policies for computer systems security implemented at BUMC 
are as follows: 
Provide physical security of data. The server resides in the same building as the BUMC Office of 
Information Technology (OIT) servers. The lobby of the building in which the systems reside is 
under the security purview of the Boston University General Services Security Office and is 
under surveillance. All central systems are physically secured behind two card-access doors with 
access to the primary door restricted to key personnel in the OIT. Access through the primary 
door is also protected by a keypad alarm system that is tied directly into the on-site central 
emergency response security control center. Written policies exist for contingencies to provide 
access to the room to those not explicitly authorized. 
Provide virtual security via connectivity. Internal access to all systems is done via MicroSoft 
Challenge Handshake Authentication Protocol. With the exception of internet provider-based 
services, external client access must first gain access to the internal network before connecting 
to the systems. This connection is initiated via a Virtual Private Network connection using Point-
to-Point Tunneling Protocol or through the University's modem pool which require Kerberos 
authentication. All web-based mail is encrypted with high-encryption domestic SSL. 
All data are protected with disaster recovery via several methods: 
Hardware redundancy: Several stages of redundancy exist at the hardware level to minimize 
failure: Dual-redundant power supplies exist on each disk array; hot-spare disk is configured to 
automatically self-heal in the event of a disk failure in the array; emergency power generators 
ensure a 100% electrical uptime; and uninterrupted power supplies present the systems with 
conditioned steady-state power. 
Data backup: Backups are completed daily over the BUMC network using both on-site and off-
site disk-based backup devices. 
Data Security: All data are stored on servers that are password-protected. To protect against 
security breaches, data will be electronically encrypted so that only the intended recipient can 
decode. 
 BEDAC will use Microsoft SQL Server software for all database development and storage, providing a 
secure environment for data storage. They will work closely with the BUMC Office of Information 
Technology (OIT) to secure institutional hardware, software, and network services for data transmission, 
storage, and archiving to support all URBAN ARCH Consortium research activities. 
 The BUMC OIT and BEDAC are physically located in the same building; all web and database servers 
used by BEDAC will be housed in a secure, professionally managed server room under the control of the 
BUMC OIT. Staff from BEDAC and BUMC OIT work to continually enhance their systems, procedures and 
processes to ensure compliance with industry and government standards for data security. All central 
systems are secured physically behind locked doors with access restricted to key personnel in the BUMC 
OIT. All databases will be backed up automatically on a nightly basis. 
 
13.  Statistical Plan 
We will enroll up to n=50 participants to accommodate any situation in which an enrolled participant is 
not randomized to the intervention or control group. We aim to randomize up to n=40 participants 

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(approximately 20 randomized to the study intervention and approximately 20 randomized to the 
control group).  
The goal of this pilot is to describe feasibility of the proposed trial and intervention and obtain 
preliminary estimates of falls related outcomes.  This pilot is not intended to provide adequate statistical 
power for a formal comparison of the intervention and control groups on falls-related outcomes.   
Confidence intervals for mean number of sessions attended, for those participants randomized to the 
intervention, will have a width of 0.44 standard deviations, and assuming approximately 80% of the 
approximately n=40 study participants complete follow-up, a confidence interval for the percent 
completing the study will have a width of 12 percentage points.  While this pilot is not intended to test 
differences between the intervention and control groups, a t-test comparing means across groups (for 
example, on frailty scores) requires a large effect (corresponding to a Cohen’s d of 1.0) to achieve 80% 
power, assuming 80% follow-up. 
To describe acceptance of the intervention among those randomized to intervention, mean and 95% 
confidence intervals will be provided for the number of sessions attended and overall satisfaction with 
the intervention.  Compliance with the study protocol will be described the percent and 95% confidence 
of participants completing the study follow-up evaluation (of all participants).  Estimates of intervention 
effects will be described through odds ratios and 95% confidence intervals for any falls during the 
intervention period, using logistic regression to control for baseline fall history.  Mean differences and 
95% confidence intervals for physical function score at the end of the study period, controlling for 
baseline physical function score, will be estimated through linear regression models.   
 
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3. Varon AJ, Smith CE. Essentials of Trauma Anesthesia. Cambridge University Press; 2012. 
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HIV-Uninfected Women: Updated Results From the Women’s Interagency HIV Study. JAIDS J Acquir 
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review and meta-analysis. AIDS. 2013;27(12):1949-1957. doi:10.1097/QAD.0b013e328361d241 
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20. Erlandson KM, Zhang L, Ng DK, et al. Risk Factors for Falls, Falls With Injury, and Falls With Fracture 
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21. Erlandson KM, Plankey MW, Springer G, et al. Fall frequency and associated factors among men and 
women with or at risk for HIV infection. HIV Med. 2016;17(10):740-748. doi:10.1111/hiv.12378 
22. Sharma A, Hoover DR, Shi Q, et al. Longitudinal Study of Falls among HIV-Infected and Uninfected 
Women: The Role of Cognition. Antivir Ther. 2018;23(2):179-190. doi:10.3851/IMP3195