A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV
Phase: EARLY_PHASE1
Conditions: Mental Health, Physical Health
Sponsor: Florida International University

 
Intervention Study 
Protocol  
 
 
 

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A Mind-Body Intervention to reduce symptoms among people aging with HIV (NCT03840525) 
 
Principal Investigator:  Gladys E. Ibañez, Ph.D., Associate Professor, Florida International University 
Supported by:  
The National Center for Complementary and Integrative Health  
 

 
Tool Revision History 
Version Number:3.0 
Version Date: June 25, 2019 
Summary of Revisions Made: Added more details for recruitment and screening, and all 
assessment interviews 
Version Number:4.0 
Version Date: September 2, 2019 
Summary of Revisions Made: Removed staff (Shika, Fein) and added new ones. 
Version Number: 5.0 
Version Date: November 20, 2019 
Summary of Revisions Made: Added new compensation for group attendance as well as 
transportation (Uber Health); as well as personnel changes. 
Version Number: 6.0 
Version Date: January 17, 2024 
Summary of Revisions Made: Removed Draft watermark; updated sample size from 72 to 48 (as 
approved by NIH); updated study design flowchart to reflect final sample; updated inclusion 
criteria to include reliable internet access; and procedures updated to reflect remote delivery 
changes due to covid-19.  
 
Version Number 7.0 
Version Date: March 5, 2024 
Summary of Revisions Made: updated the list of investigators by adding Dr Hu; added a note 
regarding the remote delivery of the intervention due to covid-19 in the Precis section.; removed 
duplicate objectives.

4 
 
 
TABLE OF CONTENTS 
Page 
 
FULL PROTOCOL TITLE ......................................................................................................... 1 
Tool Revision History ................................................................................................................. 3 
TABLE OF CONTENTS ............................................................................................................. 4 
STUDY TEAM ROSTER........................................................................................................... 6 
PARTICIPATING STUDY SITES ............................................................................................ 6 
PRÉCIS ....................................................................................................................................... 6 
1. STUDY OBJECTIVES ............................................................................................................. 7 
2. BACKGROUND AND RATIONALE .................................................................................... 8 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 8 
2.2 
Study Rationale ............................................................................................................... 8 
3. STUDY DESIGN ....................................................................................................................... 9 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .............................................. 11 
4.1 
Inclusion Criteria .......................................................................................................... 11 
4.2 
Exclusion Criteria ......................................................................................................... 12 
4.3 
Study Enrollment Procedures ....................................................................................... 12 
5. STUDY INTERVENTIONS .................................................................................................. 12 
5.1 
Interventions, Administration, and Duration ................................................................ 12 
5.2 
Handling of Study Interventions ................................................................................... 13 
5.3 
Concomitant Interventions ............................................................................................ 13 
5.4 
Adherence Assessment ................................................................................................. 13 
6. STUDY PROCEDURES ........................................................................................................ 16 
6.1 
Schedule of Evaluations ................................................................................................ 16 
6.2 
Description of Evaluations ............................................................................................ 19 
6.2.1 Screening Evaluation ................................................................................................ 19 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 19 
6.2.3 Blinding..................................................................................................................... 21 
6.2.4 Followup Visits ......................................................................................................... 21 
6.2.5 Completion/Final Evaluation .................................................................................... 21 

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7. SAFETY ASSESSMENTS ..................................................................................................... 22 
7.1 
Specification of Safety Parameters ............................................................................... 22 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 22 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 22 
7.4 
Reporting Procedures .................................................................................................... 23 
7.5 
Followup for Adverse Events and Safety Monitoring .................................................. 23 
8. INTERVENTION DISCONTINUATION ........................................................................... 23 
9. STATISTICAL CONSIDERATIONS .................................................................................. 23 
10. DATA COLLECTION AND QUALITY ASSURANCE .................................................. 25 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................... 25 
12. COMMITTEES..................................................................................................................... 26 
13. PUBLICATION OF RESEARCH FINDINGS .................................................................. 26 
I 

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STUDY TEAM ROSTER  
Co-Investigators 
Dr. Kristopher Fennie, New College of Florida 
Dr. Nan Hu, Florida International University 
Dr. Linda Larkey, Arizona State University 
Consultant 
Dr. Helen Lavretsky, consultant, UCLA 
Research Staff 
Laura Huertas, Graduate Research Assistant 
Alex Gomez, Graduate Research Assistant 
Micaela Lembo, Graduate Research Assistant 
 
Intervention Trainers 
Glory Ann Zapata 
Michelle Agudo 
PARTICIPATING STUDY SITES 
Borinquen Medical Centers of Miami-Dade, Miami, Florida. Contact person: Dr. Gracia 
Pridelines, Miami, Fl. Contact person: Eddie Orozco 
PRÉCIS  
This study aims to test the acceptability and feasibility of a remotely delivered tai chi/qigong 
intervention (TCQ) adapted to an ethnically diverse sample of older people living with HIV 
(PWH) in Miami, Florida. Note: the intervention was adapted to a remotely delivery due to 
Covid-19. 
 
 
 
 
 
 
 
 
 
 

7 
 
 
1. STUDY OBJECTIVES 
The specific aims for the proposed study are as follows: 
 
Aim 1: Refine and culturally adapt a TCQ intervention protocol for a diverse sample of older 
PWH by conducting an expert panel (n=3), key informant interviews (n=10), a ‘dry run’ 
intervention (n=10), and 2 focus groups (n=10). 
 
Hypothesis 1: The TCQ intervention content, recruitment process, and adherence strategies will 
be determined to be culturally appropriate for a diverse sample of older PWH. 
 
Aim 2: Evaluate the acceptability of the TCQ intervention protocol for older PWH every week, 
2-week post-intervention, and 3 months follow up (n = 48). 
 
Hypothesis 2a: TCQ intervention sessions, home practice sessions, control condition, and 
adherence strategies (weekly phone call, newsletter, buddy system) will be rated acceptable 
among older PWH (> 80%). 
 
Hypothesis 2b: TCQ intervention and control conditions will have high acceptability (% 
recruited who enroll; % who attend all sessions; % who regularly do home practice sessions; % 
complete follow up) among older PWH. 
 
Aim 3: Evaluate the feasibility of the TCQ intervention protocol for older PWH every week, 2-
week post-intervention, and 3 month follow up (n = 48). 
 
Hypothesis 3a: Participants in the TCQ intervention will report use of the TCQ practice at 3 
months follow up (>80%). 
 
Hypothesis 3b: Trainers will report high feasibility of the TCQ intervention with clinic 
infrastructure and participant abilities (>80%). 
 
Hypothesis 3c: Trainers will show high intervention fidelity (>90%) as measured by the 
Intervention Fidelity Checklist. 
 
The clinical trial will aim to address AIM 2 and 3. 
 
Design and Outcomes   
This is an exploratory clinical trial in which participants will be randomized into 3 conditions: a 
tai chi/qigong intervention condition, a ‘sham’ qigong attention-control condition, and a standard 
of care group.  The trial is to test the acceptability and feasibility of both the intervention and the 
appropriateness of the control condition (primary outcomes). Assessments will be conducted at 
baseline, 2-week post intervention, and 3 months follow up. Measures include demographics, 
psychological and physical symptoms, acceptability, feasibility, and intervention fidelity 
measures. Psychological and physical health are secondary outcomes. 
 

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Interventions and Duration  
Both the intervention (qigong) condition and the sham qigong control condition will last 12 
weeks in duration. The third arm will be a standard of care wait-list control condition which 
receives nothing. In addition, participants will be asked to do a follow up assessment within 2 
weeks of completing the intervention; and again 3-month post intervention. In total, study 
participation should be approximately 6 months. 
Sample Size and Population  
The target population will be individuals living with HIV who are 50 years of age or older. The 
trial will enroll and randomize 48 participants into either the intervention or control conditions. 
Randomization procedures were determined by our data analyst and biostatistician; and is 
described in further detail below.  
 
2. BACKGROUND AND RATIONALE 
2.1. Background on Condition, Disease, or Other Primary Study Focus 
Half of those infected with HIV in the United States are over 501, and this will increase to 70% 
by 20202. Although death rates have decreased for all age groups, it has increased for older 
adults aged 60 and older. Over 60% of those HIV+ and over 50 are racial/ethnic minorities1. 
Older people living with HIV/AIDS (PWH) report a myriad of psychological and physical 
symptoms, more than do their younger HIV+ counterparts3. More symptoms lead to poorer 
medication adherence4 and higher viral load. Few interventions exist for older PWH5; only 2 
interventions on reducing depression and increasing coping symptoms6,7. None addressed 
physical symptoms.  
Mind-body interventions, like Tai chi and Qigong (TCQ) improves both physical and 
psychological health and might promote immune functioning8. TCQ is a series of slow, low-
impact meditative movements that integrates breath work, meditation, and stances. Using the 
National Center on Complementary and Integrative Health (NCCIH) Framework for Developing 
and Testing Mind and Body Interventions, we propose the refinement, acceptability and 
feasibility testing of a standardized mind body intervention – Tai Chi/Qigong Easy – shown 
efficacious with cancer patients, with an ethnically diverse population of older PWH (50 years of 
age or older). Participants will be recruited from Borinquen Health Clinic, a federally qualified 
health center in Miami, Florida. The intervention will be adapted to fit the cultural and HIV 
context; then participants will be randomly assigned to either a TCQ intervention, a sham 
Qigong (SQG) control condition, or a standard of care group.  
2.2.  Study Rationale 
Co-investigator, Dr. Larkey, has conducted extensive research on qi gong interventions trying to 
alleviate fatigue and other symptoms among breast cancer survivors. In an NCCAM funded pilot 
study (U01 AT002706-03: PI Larkey), 101 breast cancer survivors (BCSs) were randomized to a 
12-week Qigong/Tai Chi Easy (TCQ) intervention or sham Qigong (SQG) using similar, gentle 
movements without meditative state/breath focus) (publication accepted to Annals of Behavioral 
Medicine). Pre- and post-intervention data were collected for 87 women, mean age, 58.8, 

9 
 
 
completing the intervention (15% attrition) on the primary outcome, fatigue, and several other 
symptom and mood related factors. Fatigue was significantly decreased for TCQ compared to 
SQG (p = 0.013). The estimated effect size (Cohen’s D) was 0.56, suggesting a “medium” effect, 
which is remarkable when one considers that the comparison group was confirmed to have the 
same level of exertion and was perceived as equally beneficial. Other symptoms/mood factors 
(depression, sleep quality, cognitive function) significantly improved from pre-to-post TCQ 
intervention (with higher values but not significantly more than the SQG intervention) indicating 
small effect sizes for these symptoms ranging from .19-.31.  In another study, dissemination of 
TCQ through community sites93 was demonstrated through a successful “practice leader” 
training model where the Tai Chi Easy form was formalized, manualized, and standardized 
for implementation across the US (18 sites). A significant decrease in stress was found pre- to 
post-intervention using the Perceived Stress Scale (PSS)94: PSS scores (10 items, alpha = .88) 
decreased from 1.28 to 1.20 with 4 indicating higher stress on a scale of 0-4, (t = 3.03, df 299, p 
= .03).  
 
Individuals living with HIV suffer from multiple psychological and physical symptoms. Dr. 
Ibañez is currently collecting data on a cohort of HIV+ individuals at multiple sites in Florida. 
Preliminary data analysis shows that the older PWH in this cohort is experiencing both physical 
and psychological symptoms:  26% severe anxiety; 29% severe depression; and 22% had 
physical health problems. However, 45% of those over 50 reported that physical health problems 
did not limit their physical activities, which suggest that a mind body intervention is feasible 
physically. 
 
3. STUDY DESIGN 
 
This is a 3-arm randomized clinical trial with a tai chi/qigong intervention, a ‘sham’ qigong 
control, and a standard of care wait list control condition. Both the intervention and control 
groups will be conducted online via Zoom videoconferencing (note: the in-person intervention 
was adapted to a virtual delivery due to Covid). The primary outcomes are the acceptability and 
the feasibility of the tai chi/qigong intervention for an older population living with HIV. The 
secondary outcomes are the reduction of psychological and physical symptoms. Participants 
(n=48) will be consented and baselined and randomized into either the qigong or the ‘control 
groups. The intervention duration is 12-weeks, 2x/week for the first 2 weeks, followed by 1 
session per week. See below for a flowchart of the study design. Table 1 describes the tai 
chi/qigong intervention and the sham qigong control conditions. 
 
 
 
 
 
 
 
 
 
 
 

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Table 1. Descriptive characteristics of the TCQ Intervention and Control Conditions 
 
 
Qigong/Tai Chi Easy 
Sham Qigong 
Standard of Care  
Intervention Features 
Low impact physical 
activity 
Focus on breath 
Meditative State 
Incidental Social 
Support 
Low impact physical 
activity with 
same/similar 
movements as TCQ 
intervention 
Incidental Social 
Support 
No Exercise/Activity 
Program 
Dose/Frequency 
12-weeks, 1/week 60 
min class 
(2x per week in first 2 
weeks) 
Approx. 2 ½ hours 
home practice/week 
12-weeks, 1/week 60 
min class 
(2x per week in first 2 
weeks) 
Approx. 2 ½ hours 
home practice/week 
n/a 
Controls for 
Unique focus; breath 
and meditative state 
Low impact physical 
activity 
n/a 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 1. Flowchart depicting Study Design.
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1.  Inclusion Criteria 
 50 years of age or older 
 Must be HIV positive 
 Able to provide consent 
 Willing to participate the length of the study 
 Have reliable internet access 

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4.2.  Exclusion Criteria 
 Regular involvement with mind-body interventions (yoga, tai chi, qigong) 
in the last 12 months (i.e., weekly practice for 3 months within the last 12 
months) 
 Not being able to stand for 10 minutes 
 
4.3.  Study Enrollment Procedures  
Participants will be recruited either via Borinquen staff and recruitment flyers posted throughout 
the clinics as well as other partnering agencies and by using a professional recruiting service 
(Trialfacts) to conduct online recruiting.  
Screening. Potential participants will be screened for eligibility using the IRB approved screener 
form and script (see Appendix). If potential participant is recruited via online, Trialfacts will 
provide the contact information and set up a time for research staff to call the participant. If 
determined eligible, the research interviewer will explain the study further and will fill out the 
Appointment and Scheduling Form. This form will be used to schedule the baseline assessment 
and will be placed in the participant study folder. Either the research coordinator or person 
screening will add the baseline appointment in the shared Qigong study google calendar. As part 
of the scheduling for baseline assessments, the interviewer will ask the participant to send a 
picture of their latest lab results for two reasons: 1) to confirm HIV status; and 2) to collect viral 
load data. The research coordinator should discuss with the PI when it was not possible to 
confirm HIV status. If found ineligible, the screener form will be kept in a separate folder, which 
will hold all ineligible screeners. 
5. STUDY INTERVENTIONS  
5.1.  Interventions, Administration, and Duration  
 
The Tai Chi/Qi gong Made Easy Intervention (TCQ). The TCQ intervention is 
standardized, manualized, and has a formal training program for instructors form the Institute of 
Integral Qigong and Tai Chi (IIQTC). We will follow a ‘train the trainers’ model, in which Dr. 
Larkey, who is an IIQTC Senior Trainer, will train 3-4 instructors on the intervention. The 
intervention content includes a series of repeated and easy to learn movements that are also the 
forms known to be linked to health benefits (Jahnke, et al., 2010). A DVD and manual 
demonstrating a core set of 10 exercises have been professionally produced and will be given to 
participants to help promote their practice at home. As part of the proposed study, we will 
translate and professionally produce a video (for home practice) in Spanish for Spanish speaking 
participants. This video will be in either a DVD format or streaming via YouTube. 
 
 
The Sham Qigong is a physical activity- and attention-control group that uses similar 
types of movements that are part of the TCQ intervention, but without the meditative state and 
breath focus that is present in the TCQ group. It also has a video, participant manual, and 
instructor guidelines for teaching. Dr. Larkey has been fully trained and experienced in this 

13 
 
 
protocol and will teach the research coordinator and 1-2 facilitators on how to use the video, 
manual, and practice. Dr. Larkey will observe their practice via the video-recordings of the 
sessions and will oversee the respective fidelity checks. Both the TCQ intervention and the Sham 
qigong control group, will be revised based on the qualitative work done in the intervention 
refinement phase. Dr. Larkey will review at least 10% of all sessions and hold monthly phone or 
video calls with trainers to review feedback. 
 
Adherence/Incentive Strategies: Based on some of the elements of social cognitive theory 
(SCT), we will use role-modeling and social support, and intrinsic reward to help participants 
adhere to the intervention. These strategies are the following: 1) the instructor will communicate 
with each participant when they come to the session to reinforce self-efficacy; and 2) a monthly 1 
page newsletter will be emailed to all participants (or handed out at classes) with success stories, 
participant adherence to intervention, and positive health outcomes of participants. In addition, the 
research coordinator will make 2 weekly phone calls as a reminder of upcoming sessions and to 
assess the participant’s at-home practice. In addition, there will be monetary incentives for 
participating in each of the assessments and the intervention. We will provide a $30 in cash for 
the baseline and 2 weeks follow up assessments each; and $50 for the 3 months follow up 
assessment. If participants attend at least 75% of the sessions, the 2 weeks follow up assessment 
incentive will go up to a $50.  
 
5.2 Handling of Study Interventions  
The TCQ intervention and SQG intervention has been used previously and is a standardized tai 
chi/qigong intervention including a manual of operations. This manual describes detailed 
instructions on how to deliver the TCQ and sham qigong intervention. The standard of care 
group will simply be no exercise or activity. Previous studies using the TCQ and sham qigong 
conditions show that blinding of the intervention was successful. Participants in both control 
conditions will be offered the TCQ class after their 3 months follow up assessment. 
5.3 Concomitant Interventions  
Not Applicable.  
5.4 Adherence Assessment  
Satisfaction surveys will be administered to each participant in the TCQ and in the SQG groups 
to assess adherence to the intervention (or control) group. Surveys will ask about their 
satisfaction with the groups, trainer, intervention content, home practice, video, the in-class 
‘buddy’, and newsletter. Surveys will be administered before and after each session. The survey 
before each session will ask about the previous group they attended, and the survey administered 
after each session will assess satisfaction about that class. 
Because acceptability and feasibility are the primary outcomes of the study, specific benchmarks 
were identified and approved by NCCIH to determine acceptability and feasibility. These are 
listed in the table below. 
 
 
 

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Table 2. Acceptability and Feasibility Benchmarks and Assessments 
Aspects of Acceptability 
being Measured (adapted 
from Sekhon, et al (2017)[49] 
Definition 
Benchmark 
Burden 
Discontinuation/non-
attendance 
< 20% of TCQ and the sham 
qigong condition will drop 
out at 3 months follow up 
Ethical Consequences 
Any side effects with 
intervention 
< 10% of participants will 
report any physical soreness 
or difficulties in doing qigong 
Experience 
Participant’s experience and 
satisfaction 
>80% qigong participants 
will perceive intervention 
positively 
>80% qigong participants 
will rate it very satisfactory or 
satisfactory 
Affective Attitudes 
Participants attitudes toward 
the intervention 
>80% of participant in qigong 
condition will report positive 
attitudes about it (very 
good/good) 
Opportunity Costs 
Adherence and participation 
Participants in both qigong 
and sham conditions will 
attend at least 75% of all 
sessions. 
Participants in the qigong 
condition will adhere to home 
practice at least 75% of the 
time expected (i.e., 112 out of 
150 minutes/week) 
Intentions 
Willingness to participate 
>80% qigong participants 
would be willing to 
participate again 
>80% qigong participants 
intend to continue qigong 
practice 
Aspects of Feasibility being 
Measured (adapted from 
Bowen, et al., 2009 [50] 
Definition 
Benchmark 
Demand 
Likelihood that intervention 
will be used 
>80% of qigong participants 
will report any qigong 
practice in the past week 
Implementation 
Can the intervention be 
implemented in a setting, 
often a real-world setting 
Trainers will execute 
intervention >80% of the time 
>80% of trainers will rate 
resources needed to 
implement as very good/good 

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>80% of trainers will report 
positive effects on population 
Practicality 
Extent to which an 
intervention can be delivered 
given the limited resources 
>80% of trainers will report 
participant’s ability to do the 
intervention as very 
good/good 
Integration 
Extent to which the 
intervention fits the system 
>80% of trainers will 
perceive intervention fits the 
clinic infrastructure as very 
good/good 
>80% of trainers perceive the 
sustainability of the 
intervention as very 
good/good 

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6. STUDY PROCEDURES  
 
Table 2. Measures and time of administration 
Assessments 
# of items/alpha 
Screen 
Baseline
Weekly/During 
Intervention 
Post 
Intervention 
3 
month 
Follow 
up 
Eligibility 
     Age, HIV status (self-report/lab test) 
     Any mind-body practice in past   
         12 months      
     GAIN Cognitive Impairment  
     Can stand up for 10 min 
 
 
 
 
6-items 
 
X 
 
X 
X 
X 
 
 
 
 
Demographics and Covariates85,86 
     HIV related stigma 
     Social Support Scale 
     DAST 
     AUDIT 
 
6-items/ α= .75 
 
X 
 
 
X 
X 
 
 
 
 
X 
X 
 
 
 
X 
X 
Psychological Symptoms87,88 
     Depression Anxiety & Stress Scale 
(DASS-21)  
 
21 items/  
 
 
X 
 
 
 
X 
 
X 
Physical Symptoms89,90 
     The Revised Sign & Symptom Check-
List for HIV (Holzemer )  
     HIV-related Fatigue Scale (MAF) 
 
 
45 items; α=.71- .91 
 
 
 
X 
X 
 
 
 
X 
X 
 
 
X 
X 
Adherence91 
     5-item Adherence questions MMAS-8 
     Viral load (from participants) 
 
 
 
X 
X 
 
 
X 
X 
 
X 
X 
Feasibility 
     # approached (if face-to-face) 
     # screened 
     # eligible 
     # consented and enrolled 
 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
 
 
 
 

17 
 
 
 
 
 
 
     # refused to participate 
     Reasons for refusal 
     # randomized into study 
     % attended TCQ and control sessions 
     % completed home practice 
     % completed FU assessments 
X 
X 
X 
 
 
 
 
 
 
 
 
X 
X 
X 
X 
 
 
X 
X 
 
 
 
 
 
X 
Acceptability 
     Satisfaction surveys per session      
     Satisfaction with adherence strategies 
(weekly calls, buddy system, etc) 
 
 
 
 
X  
 
X 
 
Feasibility of implementation in clinic 
setting (trainers) 
 
 
 
 
 
 
X 
 
Intervention Fidelity  
     Meditative Movement Inventory 
(participants) 
Intervention Fidelity Checklist 
 
9 items; α = .86-.90 
 
 
 
 
 
X 
 
X 
 

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6.2 Description of Evaluations  
6.2.1 Screening Evaluation and Process 
These evaluations occur to determine if the candidate is eligible for the study.    
Screening 
A brief screening tool will be used to determine eligibility. It will include the following items:  
- 
How old are you? (must be 50 or over) 
- 
Are you HIV positive? (must be positive) 
- 
Have you regularly participated (weekly for 3  months in the last 12 months) in 
any mind-body or alternative forms of exercise such as yoga, tai chi, qigong, or 
meditation in the last 12 months? (must answer no) 
- 
They must pass the GAIN Cognitive Impairment Scale (based on scoring 
instructions) to determine if they are able to go through the consenting process 
and trial 
- 
Can you stand for more than 10 minutes at a time? (answer must be yes) 
- 
Do you have reliable internet access? 
 
Research staff will be screening persons over the phone. During the screening process, all 
persons screened will not provide their names. They will be given a screening ID number and, if 
found eligible, the interviewer will ask for a first name only, phone number, and will schedule 
the person for a baseline assessment during which they will be consented and enrolled into the 
study. People screened and found eligible will be scheduled for a baseline assessment within 2 
weeks of the screening. Appointments will be entered into the study google calendar. No names 
will be used to set the appointments in the calendar. Only screening ID numbers will used to hold 
appointment times. If found ineligible, their screener form will be kept in a folder in a locked 
filing cabinet (see Appendix for the Screener form and script).  
   
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
The enrollment date is the date of the baseline assessment. At this assessment, the participant 
will be consented, complete all baseline assessments, and then randomized into one of three 
conditions. Assessments will be administered using RedCAP. 

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Baseline Assessment 
Research staff will call all participants scheduled for a baseline assessment the day before the 
assessment to confirm attendance. All assessments are done via phone due to Covid restrictions. 
Assessors should have: 
- 
Participant study folder labeled with assigned PID number 
- 
Baseline checklist 
- 
Informed Consent Form 
- 
Monetary incentive with log form (if paying participants at the time of interview) 
- 
List of computer-generated randomized group assignments (Only Research 
coordinator will provide to assessors) 
The participant study folder should also include the adverse event form, follow up visit checklist, 
and study completion forms for future use as applicable. 
Consenting Procedure. The baseline assessment begins with the consenting process. The research 
interviewer will be well-trained on the consenting process as well as the baseline measures. The 
interviewer will provide the participant with the informed consent form to read, but the interviewer 
will also explain the purpose of the study and will summarize the main points (e.g., procedures to 
expect; confidentiality will be maintained; they can stop participation at any time; participation 
will not affect treatment at Borinquen or Pridelines (if recruited from clinics); incentives will be 
provided, and any risks and benefits to participation). Consent forms will be available in English 
or Spanish. The Spanish consent forms will be back translated. At the end of the consenting 
process, the interviewers will ask participants if they have any questions. All consents will be 
verbal consent and done via the phone. Forms must be signed by the interviewer (as a witness) and 
will be stored separate from any other data or identifying information in a locked file cabinet in 
the FIU midtown research office which is locked nightly. 
Once the participant signs the consent form, the research assistant sends participant a Qualtrics 
link to attach a photo of their most recent lab report or medication bottle (this is to confirm status), 
completes the locator form with the participant, and then begins the interviewer-administered 
RedCAP survey. The photos will be stored in Qualtrics secure server. 
The Locator Form is used to help remind participants about upcoming groups, to assess 
acceptability via phone calls, and schedule participants for their follow up appointments. The 
locator form will be part of the baseline assessment and administered using RedCAP.  
Baseline Measures. The following are all the baseline measures by domains that will be 
administered via RedCAP (see the Appendix for detailed scale items): 
- 
Demographics 
- 
Covariates (HIV stigma, social support, alcohol use, drug use) 
- 
Psychological symptoms (depression, anxiety, general distress) 
- 
Physical symptoms (HIV symptoms scale, HIV fatigue scale) 
 

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Randomization 
Once the baseline assessment is complete, each participant will be assigned by the research 
coordinator to one of three conditions. A randomization scheme will be developed in SAS, 
generating group assignments. Randomized group assignments will then be in the format of a list 
kept by the research coordinator. After each baseline assessment, the research coordinator will 
look at the randomization list and assign the participant to the next group assignment on the list. 
Only the research coordinator will know the group assignment. Randomization will be tested 
after baseline assessments are all complete by comparing demographics across conditions. 
6.2.3 Blinding 
The participants will be blind to their condition, except for the group that receives the standard of 
care (which is no group). The study will be promoted as a “Gentle Empowering Movement” 
program about wellness, or The G.E.M. Study. Those in the sham qigong intervention will not be 
able to tell if they are in the intervention or in the control group. The research interviewer will 
also be blind to group assignment. 
6.2.4 Follow-up Visits 
There will be 2 follow-up visits: at 2 weeks post intervention and at 3-month post intervention. 
One week after a cohort has ended, research staff will begin to schedule the 2 week FU 
assessments. These assessments are on RedCAP and will also include some acceptability 
measures. Interviewers should begin the 2 week follow up by going over the locator form and 
confirm if information is still accurate. Then, interviewer should administer the RedCAP survey 
via phone. At the end of the interview, each participant will set up a time to come to the office to 
pick up their incentive (NOTE: Prior to the 2 week follow up assessments, the research 
coordinator confirms whether participant attended more than 75% of the group sessions or not in 
order to determine the incentive level).  
For the 2-week post intervention, the following will be assessed: 
 Covariates (HIV stigma, social support, alcohol use, drug use) 
 Psychological symptoms (depression, anxiety, general distress) 
 Physical symptoms (HIV symptoms scale, HIV fatigue scale) 
 Acceptability Measures  
 Feasibility Measures 
6.2.5 Completion/Final Evaluation 
 
- 
For the 3 months follow up assessment: 
- 
Covariates (HIV stigma, social support, alcohol use, drug use) 
- 
Psychological symptoms (depression, anxiety, general distress) 
- 
Physical symptoms (HIV symptoms scale, HIV fatigue scale) 
- 
Acceptability Measures  
- 
Feasibility Measures 

21 
 
 
 
At the 3 month follow up, interviewers will administer the survey questions on RedCAP. Once 
the appropriate level of incentives is provided to participant, the interviewer will complete the 
Study Completion Form. This form will be placed in the participant study folder. If the 
participant completing the study is from either of the control conditions, they will be offered the 
TCQ intervention. 
 
Weekly assessments 
In addition, acceptability and feasibility will be assessed every week either in person regarding 
each session or via the weekly calls. Weekly calls will ask about adherence to home practice; and 
acceptability of home practice, and satisfaction with the intervention. A brief satisfaction survey 
will be administered to each participant after each group session.  
 
7. SAFETY ASSESSMENTS  
7.1 
Specification of Safety Parameters 
See below 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
All safety parameters will be assessed, recorded, and analyzed by the research team through 
weekly meetings between the PI and staff; monthly investigator meetings; and the DSMB 
meetings every 6 months. Safety issues will be part of every DSMB agenda. There will be a 
protocol in place for addressing safety issues (See DSMB Plan).  
7.3 
Adverse Events and Serious Adverse Events  
Serious Adverse Events (SAE): An experience occurring during study participation that may 
involve imminent danger to the participant or others. For this study, SAEs include the following 
events that occur after entrance into the study:  
 Death, serious injury, a life-threatening experience, drug overdose, or suicide 
attempt 
 Hospitalization or prolongation of hospitalization (including medical or 
psychiatric hospitalization) 
 Persistent or significant disability or incapacity 
 An unanticipated event that, in the PI’s judgement, represents a significant hazard 
or potentially serious harm to research participants or others. 
 
Adverse Events (AE): An untoward experience occurring during study participation that does 
not rise to the level of an SAE. For this study, specific AEs include the following events that 
occur after entrance into the study:  
 Increased substance use, medical problems, emotional problems, or victimization 

22 
 
 
 Significant physical or emotional pain, homicidal thoughts, or suicidal thoughts 
 Breach of confidentiality 
 An unanticipated event that, in the PI’s judgement, represents a non-serious 
adverse event that nonetheless resulted in increased risk to research participants or 
others 
7.4 
Reporting Procedures 
 
See below 
7.5 
Follow-up for Adverse Events and Safety Monitoring 
All research and intervention staff will be trained on the definitions of SAEs and AEs and its 
reporting procedures. Staff will notify the PI immediately after the occurrence of an SAE or AE. 
Weekly meetings between staff and investigators will have SAEs and AEs as an agenda item. All 
SAEs and AEs will be reviewed by the PI for severity and whether it is attributed to the 
intervention. SAEs will be reported to NCCIH and to the FIU IRB within 24 hours, with a 
written report within 48 hours. For all SAE’s, the Event Report Form will be completed by the 
PI. The research coordinator will keep a log of all adverse events, unanticipated problems, and 
protocol deviations on the Adverse Event Log Form. All AEs that occur during the study will be 
documented and reported by the investigators to NCCIH and the FIU IRB at the time of their 
continuing annual reviews. Participants that suffer an SAE or AE due to the study and still want 
to continue participating in the study, may do so if the PI agrees that continued participation is 
safe. 
8. INTERVENTION DISCONTINUATION  
If a review of adverse events shows significant harms or if there is any breach of confidentiality, 
the study will be stopped, and a review of existing procedures will be conducted.  
 
9. STATISTICAL CONSIDERATIONS  
9.1. Data Analysis Plan 
Randomization. 48 participants will be randomized into one of three treatment groups 
each with 24 participants.  A stratified block randomization scheme will be used.  Stratification 
by language preference will ensure even distribution across groups, if needed.  Four blocks of 18 
will facilitate timing of ‘cohorts’ to enhance logistics of treatment implementation.  
Randomization will be done through the Plan Procedure in SAS®, using a random seed.    Upon 
enrollment, the recruiter will assign the participant to the treatment group according to the sheet.  
Blinding.  For logistical reasons the study will be partially single blinded.  Those 
randomized to the TCQ and sham conditions will be blinded to which group they were assigned, 
whereas the standard of care control group will know they are assigned to the control condition 
based on format and content of the condition.   Data collectors will also be blinded to group 
assignment at baseline.  Only the PI and the research coordinator will know group assignment.  
 
Data Analysis of Aims 2 and 3. Data obtained through RedCAP software will be 
imported into SAS® version 9.4.  Instruments will be coded according to their respective scoring 

23 
 
 
instructions.  Unless specified by the instrument, missing items will be imputed based on 
averaging values within the instrument for a given individual, if no more than 15% of items are 
missing.  If more than 15% of items for an individual are missing, that instrument will be set to 
missing for the individual. 
 
This is a pilot study to assess feasibility and acceptability of an intervention adapted to a 
different population.  As such, analyses will be primarily descriptive; hypotheses will not be 
assessed through statistical significance, in accordance with recommendations for analysis of 
pilot studies99.  Feasibility, acceptability, and clinical (physical and psychological) outcomes will 
be described through proportions, means, and changes over time.  95% Confidence Intervals (CI) 
will be calculated to estimate precision.  Regarding clinical outcomes, we will focus on 
estimating treatment effect sizes and respective 95%CI, which will help to determine the sample 
size needed for a larger scale RCT. Baseline demographic and clinical characteristics, including 
stigma, social support, and depressive symptoms, will be summarized by treatment condition, 
and compared for even distribution of characteristics to assess effectiveness of the 
randomization.   
 
Aim 2: Evaluate the acceptability of the TCQ intervention protocol for older PWH every week, 
2-week post-intervention, and 3 months follow up (n = 48). 
 
Aim 3: Evaluate the feasibility of the TCQ intervention protocol for older PWH every week, 2-
week post-intervention, and 3 month follow up (n = 48). 
 
Similar data analysis will be conducted for both acceptability and feasibility. To address 
acceptability among participants, we will use data from the satisfaction survey which will be 
administered weekly during the intervention and at post-intervention.  Individual items from the 
survey such as percent sessions attended, frequency of home practice sessions, average length of 
home practice sessions, and questions on opinion of the intervention sessions, home practice 
sessions, and video, will be plotted over time to examine variability of acceptability measures 
over time.  Next, participant’s average score over the intervention period will be averaged.  
These averages, as well as the items from the post-intervention satisfaction survey will be 
categorized into acceptable, borderline acceptable, or not acceptable.  Cutoffs will be based on 
the approved benchmarks.  From these data we will determine the proportion of participants who 
rate the intervention as acceptable.  To estimate precision, 95%CI will be calculated using 
Wilson’s score method, which uses asymptotic variance and is appropriate for small sample 
sizes100. If the proportion of participants who rate the intervention as acceptable is 80% or 
greater, we will consider the intervention acceptable.  If it is not, we will evaluate the width of 
the confidence interval to determine variability, as well as look specifically at each item to 
determine what aspects are deemed unacceptable. Feasibility will be measured by assessing the 
study retention rate, whether it is feasible for participants to do the movements, and whether it is 
feasible to deliver the intervention remotely.  
 
 

24 
 
 
10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
Research staff (research coordinator, graduate assistants) will conduct interviews using REDCap 
software and computer-assisted personal interviewing (CAPI) techniques via phone. All 
measures are in the Appendix. 
10.2 Data Management  
Any data that needs to be entered or downloaded, acceptability measures and session attendance 
information will be done at the FIU research offices and under the supervision of Dr. Ibañez and 
the research coordinator. Data collected at the three main assessment timepoints (baseline, 2-
week post intervention, 3-month follow up) does not require data entry since it is collected via 
laptops using RedCap software. The staff handling project data will also be fully trained in 
confidentiality procedures and safeguards. All staff will be required to complete CITI Human 
Subjects, and Good Clinical Practice training. Interview data will be stored on encrypted drives, 
password protected computers. Weekly, all data will be downloaded onto the FIU Sharepoint 
drive for added protection and deleted from the individual laptop, if applicable. Quantitative data 
will be stored in REDCap and in the study’s FIU Sharepoint folder. 
10.3 
Quality Assurance  
10.3.1 Training 
The staff handling project data will be fully trained in confidentiality procedures and safeguards. 
All staff will be required to complete CITI Human Subjects and Good Clinical Practice training. 
10.3.3 Metrics 
n/a 
10.3.4 Protocol Deviations 
The PI will meet with the research coordinator weekly to discuss any issues and/or potential 
protocol deviations. In addition, the PI or the research coordinator will randomly select 
participant files to review consent forms and relevant data for deviations. Any deviations will be 
immediately reported to the research team, IRB, and NCCIH. 
10.3.5 Monitoring 
Consent forms and other data reviews will be done by the PI at least once a week, or as needed. 
Intervention fidelity assessment will also be done by Dr. Larkey at least once a month, or as 
needed.  
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 
Institutional Review Board (IRB) Review  
This protocol and the informed consent documents and any subsequent modifications will be 
reviewed and approved by the FIU IRB. 

25 
 
 
11.2 
Informed Consent Forms 
A verbal consent will be obtained from each participant. The consent form will describe the 
purpose of the study, the procedures to be followed, and the risks and benefits of participation. 
Participants who are not able to provide their consent will be excluded from the study. 
Consenting will occur at the baseline assessment time point but before initiating the assessment.  
11.3 
Participant Confidentiality  
Any data, forms, reports, video recordings, and other records that leave the site will be identified 
only by a participant identification number (Participant ID, PID) to maintain confidentiality. All 
records will be kept in a locked file cabinet. All computer entry and networking programs will be 
done using PIDs only. Information will not be released without written permission of the 
participant, except as necessary for monitoring by IRB or NCCIH. All data will be stored in the 
FIU research office or on FIU SharePoint drive. Consent forms will be stored in a locked filing 
cabinet in the FIU research office space which is locked nightly but separate from the data. Data 
collected via laptops will be encrypted and stored on a cloud server (i.e., SharePoint at FIU). 
11.4 
Study Discontinuation  
The study may be discontinued at any time by the IRB, or the NCCIH as part of their duties to 
ensure that research participants are protected.  
12. COMMITTEES 
There is a Data Safety Monitoring Board (DSMB) established for this clinical trial. It will meet 
every 6 months to review the progress of the clinical trial; and determine if discontinuation or 
continuation is justified.  
13. PUBLICATION OF RESEARCH FINDINGS  
Any presentation, abstract, or manuscript will be made available for review by all investigators, 
and with NCCIH as needed or requested.