Improving Quality of Life for Adults Living With HIV and Chronic Pain
Phase: NA
Conditions: HIV Infections, Chronic Pain
Sponsor: Temple University

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PROTOCOL TITLE:  
Improving quality of life for adults living with chronic pain  
PROTOCOL NUMBER:  
27743 (Version 4.1.22)  
PRINCIPAL INVESTIGATOR(S):  
Eugene Dunne, Ph.D.  
Oral Health Sciences  
Maurice H. Kornberg School of Dentistry  
Temple University  
3223 N. Broad St. Room L217  
Philadelphia, PA 19140  
GRANT NUMBER:   
K23AT010099  
 
1) Abstract of the study 
 
Persons living with HIV (PLWH) are at increased risk for chronic pain conditions, 
with prevalence rates estimated to be between 55-67%. While acute pain is a life-
sustaining biological response to tissue damage or injury, chronic pain is a separate 
condition that often causes significant physical and psychological suffering. Causes 
of chronic pain among PLWH include disease progression, the impact of the virus on 
immune and nervous system function, and medication side-effects. PLWH, like 
many other chronic pain patients, may be prescribed opioid medications, which have 
not been found to be effective in managing non-cancer related chronic pain. 
Additionally, the significant risk of dependence and overdose far outweigh the 
potential benefit of opioid medications for chronic pain. Governing bodies in 
medicine have called for non-pharmacological interventions to be considered front-
line treatment recommendations for chronic pain management. Mind-body 
interventions, such as mindfulness, yoga, and Tai Chi, have been shown to be 
effective at reducing pain symptoms and improving psychological outcomes for 
individuals with chronic pain. Unfortunately, few studies have examined the use of 
mind-body interventions for chronic pain management for PWLH, with even fewer 
using formative research to modify interventions to meet the unique needs of this 
vulnerable population. The research plan proposed in this application will address 
these gaps in the literature. This study will examine the feasibility and acceptability 
of a mind-body intervention, Qigong/Tai Chi Easy, for chronic pain management 
among PLWH. We will recruit 40 individuals from the Comprehensive HIV Program 
at Temple Health. Following informed consent, participants will be randomized to 
mind-body arm or health education control arm. Participants in both arms will 
complete baseline assessment followed by a 10-week intervention. The mind-body 
intervention group will meet weekly for 60-minute sessions and be provided with a 
video for at-home practice. The health education group will also meet weekly for 60 
minutes and be assigned weekly homework related to the topics discussed in 
session. At the conclusion of the 10 weeks, participants will complete at post-
intervention assessment. A 3-month follow up assessment will also be completed. In 
addition to feasibility (i.e., recruitment rates, retention) and acceptability (i.e., 
satisfaction ratings), we will assess pain symptoms (general and specific), perceived 
stress, depression, quality of life, and HIV medication adherence. We anticipate that 

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the study will demonstrate feasibility and acceptability as evidenced by adequate 
enrollment, retention, and satisfaction. Findings from the proposed study will be 
used to inform a future research grant with power to detect efficacy of the mind-body 
intervention for chronic pain management. 
 
 
2) Protocol Title 
 
Improving quality of life for adults living with chronic pain  
 
 
3) Sponsor / Funding 
This study is funded by the National Center for Complementary and 
Integrative Health (NCCIH) of the National Institutes of Health (NIH). 
 
4) Investigator 
Eugene M. Dunne, PhD 
Assistant Professor, Oral Health Sciences, Kornberg School of Public Health, 
Temple University 
 
5) Objectives 
 
The primary objective is to examine the feasibility and acceptability of Qigong/Tai 
Chi Easy for chronic pain management for people living with HIV. A small 
randomized pilot study (N = 40) will assess feasibility and acceptability of a 10-week 
Tai Chi intervention plus a video recording for at-home practice and a health 
education control group. This study will examine recruitment and retention, number 
of sessions attended, self-reported at-home practice of Tai Chi, and patient 
acceptability of the intervention and control conditions.  
 
6) Background  
 
Chronic pain is a significant public health concern in the United States, and it is the 
most common reason patients seek medical care in the United States, with more 
than 100 million pain cases per year1. Patients experiencing chronic pain often 
present to emergency departments2, which significantly increases costs to the 
individual and the healthcare system. Estimates of the healthcare costs of chronic 
pain range from $560 to $635 billion per year3. Chronic pain is a condition that lasts 
beyond an expected healing time, typically defined as 3-6 months4,5. Acute pain is a 
life-sustaining biological response to tissue damage or injury and can often be 
treated effectively with medications and physical therapies. Conversely, chronic pain 
is a condition that is often accompanied by physical and psychological suffering, 
helplessness, and maladaptive coping responses3,6. Chronic pain takes an 
emotional toll on the patient as they try to manage the long-term interference in 

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functioning. Patients with chronic pain often experience depressive symptoms and 
report decreased quality of life7,8. Similarly, stress processes and coping can alter 
the experience of pain, such that negative emotions may increase the severity of 
pain, while positive affect can reduce the experience of pain9. Approaches to 
address chronic pain management require both physical and mental components.   
Chronic pain commonly co-occurs for many of the 1.2 million persons living with 
HIV (PLWH) in the United States10-13 with a recent meta-analysis reporting rates 
ranging from 55% to 67%14; thus, between 660,000 and 804,000 PLWH are 
suffering with chronic pain conditions. Central or peripheral neuropathies account for 
nearly half of chronic pain conditions among PLWH; these neuropathies result from 
multiple mechanisms including disease progression, the impact of the virus on the 
nervous system, medication side effects, suppressed immune function, and AIDS-
related opportunistic infections14. Neuropathic pain related to damage to the nervous 
system caused directly by virus progression or medication side effects in PLWH is 
challenging to manage with poor response to analgesic medications12,16. Research 
also suggests that pain prevalence and severity increases with HIV disease 
progression17, such that patients with secondary infections related to HIV were twice 
as likely to report chronic pain compared to those who were effectively managing 
disease progression with antiretroviral medications. Additionally, PLWH are 
increasingly an “aging population” as highly effective antiretroviral medications allow 
for life expectancies similar to the general population. PLWH now face increasing 
rates of chronic pain conditions associated with aging, with musculoskeletal pain 
(e.g., chronic low back pain) being the second most common form of pain for PLWH. 
PLWH also have high rates of comorbid mental health and substance use 
conditions15, which are the strongest predictors of acute pain becoming chronic. 
Importantly, chronic pain is associated with missed clinic appointments and 
nonadherence to HIV antiretroviral medication (ART) among PLWH12. Managing 
chronic pain for PLWH can improve medication adherence, reduce suffering, 
improve quality of life, and lower healthcare costs. Chronic nonadherence to ART 
medications results in poorer health as indicated by biological outcomes (e.g., CD4 
count and viral load) and increases the risk of transmission to uninfected 
individuals18.  
HIV patients with chronic pain (like many pain patients) may be prescribed opioid 
medications to manage their severe pain symptoms. Clinical guidelines for chronic 
cancer-related pain management suggest the use of opioid analgesic therapy for 
patients with persistent moderate to severe pain intensity19,20. In the late 1990s, 
there was a realization that pain was being undertreated for PLWH and medical 
organizations called on health professionals to improve the management of pain 
through various initiatives, including labeling pain as the “fifth vital sign”21-23. 
Effective pain management became an ethical issue for physicians consistent with 
the principle of nonmaleficence, or “do no harm” to patients24. These events resulted 
in a dramatic increase in opioid prescriptions for chronic non-cancer pain 
treatment25. While opioid medications can be effective at treating acute pain, there is 
little evidence supporting their long-term use for treating non-cancer chronic pain26. 
The opioid epidemic is of great concern, and is partly attributable to the 
mismanagement of chronic pain conditions. Between 1999 and 2015, nearly 
200,000 overdose deaths have been attributable to prescription opioid 
medications27,28. As a result, the CDC has called on non-pharmacological 
interventions to be utilized as first-line treatments for chronic pain. Furthermore, the 

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opioid epidemic is becoming a driving force of HIV transmission, as individuals who 
misuse prescription drugs transition to heroin use and injection drug practices. The 
New England region has seen recent increases in HIV infections attributed to the 
opioid epidemic, following decades of progress in HIV medicine. Poor management 
of chronic pain and misuse of prescription opioids threaten the progress made by the 
HIV medical community. Access to evidenced-based, non-pharmacological 
interventions may improve pain control and reduce demand for prescription opioids. 
Comprehensive chronic pain management approaches often include 
psychological and mind-body interventions, such as cognitive behavioral therapies 
(CBT), relaxation-based techniques, yoga, or Tai Chi, all of which have moderate 
efficacy based on randomized controlled trials and meta-analyses29-33. Tai Chi has 
been used to treat both neuropathic and musculoskeletal pain, the two most 
common pain conditions among PLWH. Physical mechanisms of pain improvements 
resulting from Tai Chi include improved balance and reduction in neuropathy 
symptoms34, 35. Regarding musculoskeletal pain conditions, Tai Chi has been shown 
effective at improving pain symptoms related to low back pain and osteoarthritis36. 
Although neuropathic and musculoskeletal pain conditions are different in their 
etiology, the potential mechanisms for non-pharmacological pain management 
approaches are hypothesized to be similar; for example, increased physical 
movement can reverse the muscle atrophy often associated with chronic pain 
conditions related to maladaptive fear of movement (i.e., kinesophobia). Further, Tai 
Chi activates the relaxation response, which is associated with decreased stress and 
improved mood37. These combined physical and mental benefits are hypothesized to 
be the mechanisms for pain amelioration. Behavioral and mind-body interventions 
that involve relaxation yield a “top-down” control of pain, such that observed 
changes in cerebral gray matter are associated with enhanced cognitive reappraisal 
of pain38. Tai Chi, as a mind-body intervention for chronic pain, is hypothesized to 
improve management and coping related to neuropathic and musculoskeletal pain. 
While there are various long forms of Tai Chi, a modified shorter form of Qigong/Tai 
Chi Easy has been found to be efficacious in clinical trials for improving quality of life 
and fatigue39-42. Qigong/Tai Chi Easy, a low-intensity form of meditative movement, 
combines gentle movement, relaxing breath, and cultivates a meditative state40. The 
Qigong/Tai Chi Easy protocol also includes instruction for shaking of the hands and 
feet, which may bring awareness, circulation, and blood flow to areas affected by 
neuropathy for PLWH.  
Complementary and mind-body interventions have been of interest to PLWH; for 
example, a recent survey found that complementary and integrative approaches are 
commonly sought and used to manage symptoms associated with HIV43. However, 
there is a lack of research examining the efficacy of mind-body approaches for 
PLWH. Recently released recommendations for treatment of chronic pain in PLWH 
indicate that behavioral interventions have moderate evidence and should be 
considered as first line interventions44. However, the authors of these 
recommendations acknowledge that the vast majority of evidence was derived from 
studies with non-HIV samples. To date, only two studies have examined CBT for 
chronic pain in HIV samples45,46, yet neither study used formative research to 
optimize the intervention for PLWH. Interventions found to be efficacious in one 
chronic pain population may not translate to new populations, particularly clinical 
populations known to experience health disparities related to cultural or 
sociodemographic factors47. Failure to consider such differences may undermine 

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reproducibility and acceptability of the intervention. HIV and chronic pain are 
stigmatized health conditions, increasing barriers to safe and effective pain 
management48. Using formative research to modify a pain management protocol 
may improve acceptability by addressing HIV-specific pain experiences and 
disparities related to the intersecting stigmas of HIV and chronic pain.   
Theoretical Framework. Mind-body interventions, including Tai Chi, are 
effective at improving chronic pain management49-52, and may be particularly helpful 
for PLWH. Tai Chi is a practice that integrates gentle physical movements, relaxing 
breathing, and mindfulness meditation53. Randomized trials and meta-analyses 
examining the use of Tai Chi indicate benefits for patients with chronic conditions, 
including osteoarthritis, rheumatoid arthritis, low back pain, and fibromyalgia33,50,53-56. 
Tai Chi practice improves psychological outcomes and stress responses37,58, and 
may enhance immune function59,60. Mechanisms of action for these health benefits 
can be explained by the relaxation response and psychoneuroimmunology (PNI) 
theory61,62. This theory postulates that stress management interventions, such as Tai 
Chi, may result in positive changes to stress processes, psychological changes, and 
behavior change. With respect to chronic pain, Tai Chi may alleviate stress 
associated with chronic health management and reduce kinesophobia, the fear that 
inhibits physical movement due to fear of exacerbating pain or re-injury63,64. The 
present study will focus on the psychological and behavioral aspects of the PNI 
model (highlighted by red outline in Figure 1). We expect that subsequent research 
will be able to explore down-stream aspects of the model if the proposed research is 
promising. For instance, this seminal project will allow subsequent studies to explore 
improvements in cortisol and catecholamine levels associated with Tai Chi. 
Literature on PNI suggests stress management interventions are associated with 
normalization of the sympathetic nervous system (SNS) and hypothalamic pituitary 
adrenal axis65. In addition to enhancing pain management, resulting improvements 
in physical and immune function may slow disease progression.  
This program of chronic pain research is consistent with the strategic priorities of 
NCCIH. Further, NIH’s Office of AIDS Research (OAR) has prioritized research that 
examines highly comorbid conditions within the context of HIV. The current 
application aligns with cross-cutting priorities for OAR by addressing chronic pain, 
which can improve medication adherence, a critical component of the Treatment as 
Prevention (TasP) mission. The goal of TasP is to reduce the incidence of HIV 
transmission by optimizing the HIV care continuum and medication adherence, such 
that PLWH achieve undetectable viral loads (Undetectable = Untransmittable66). 
Additionally, the Federal Pain Research Strategy (FPRS)67 calls for the development 
of non-pharmacological interventions for chronic pain management. The FPRS 
highlights the need for tailored interventions for high-risk groups. PLWH are the ideal 
population to meet these priorities, as individuals with HIV are historically from low-
SES and minority communities and experience significant stigmatization and health 
disparities68. While a single study has examined the use of Tai Chi to improve stress 
management for PLWH69, no study has examined the use of Tai Chi as a chronic 
pain management intervention for PLWH.  
 
7) Setting of the Human Research 
 
Participants for this study will be recruited from the Comprehensive HIV Program 
(CHP) at Temple Health. When feasible, a member of the research team will meet 

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with interested participants at the CHP in a private office to describe the study in 
detail and obtain signed informed consent. To increase reach and access, screening 
of participants can also occur via telephone call with the study coordinator and 
eligible participants can provide electronic signature for consent. Subsequent study 
visits will occur at the Temple University Kornberg School of Dentistry (TUKSoD). 
Assessments will occur in private research assessment rooms and intervention 
groups will take place in a private group room on the 4th floor of the TUKSoD 
building. To address potential barriers to retention during the ongoing COVID-19 
pandemic, participants will be offered the opportunity to attend intervention and 
control groups virtually through secure HIPAA-compliant Zoom meetings and can 
complete assessments remotely. Study staff will encourage participants to attend in-
person, but recognize that the pandemic is an evolving situation that requires 
flexibility in intervention delivery and assessments.   
 
8) Resources Available to Conduct the Human Research 
The present study aims to recruit 40 patients from the Comprehensive HIV 
Program. The CHP provides treatment to 1,100 adults living with HIV in the 
Philadelphia area. Based on conservative estimates of pain conditions in this 
group (~50%), there are approximately 550 patients at the CHP who may 
meet inclusion criteria for this study. Given these estimates, we anticipate a 
successful recruitment for this pilot trial.  
This research is supported by an NIH K23 Career Development Award, which 
provides 75% effort through April 2024 for the PI (Dr. Dunne) to achieve the 
goals of this project.  
Staff on this project will include Dr. Eugene Dunne, a research assistant, a 
health education interventionist, and a tai chi instructor. Dr. Dunne is a clinical 
psychologist (licensed in Rhode Island and Pennsylvania) and behavioral 
medicine researcher with over ten years of experience working on NIH-
funded research studies. All study staff will complete CITI training in 
social/behavioral human subjects research, HIPAA trainings, and good 
clinical practice training. Dr. Dunne will monitor all study procedures under the 
guidance of his K23 mentorship team.  
 
9) Study Design 
a) Recruitment Methods 
Recruitment. The recruitment strategy will be informed by patient and provider 
responses to in-depth qualitative interviews from Aim 1. Providers at the CHP will 
give prospective participants a brief overview of the study and ask for permission to 
introduce the patient to study staff. Study staff will review medical records for 
upcoming visits to determine which patients may meet study eligibility criteria (i.e., 
medical records indicate that patient is HIV positive and has a chronic pain 
condition) and inform providers in advance of their appointments. Study personnel 
will inform the HIV provider via email that they have a patient with an upcoming visit 
who meets the basic eligibility criteria (e.g., HIV and chronic pain diagnoses), and 
invite the provider to share basic information about the study if the provider believes 

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the patient would be a good candidate (e.g., physically able to participate safely). 
Patients will have the option to call the research team or request that the research 
team call them directly. A trained research assistant will reach out to patients by 
phone to provide more detailed study information and schedule a time to conduct the 
informed consent process. Recruitment material will also be available in the CHP 
waiting room (see attached recruitment flyer in appendix). The flyer will provide a 
telephone number for potential participants to call study staff and a QR code that 
can be scanned with a smartphone camera. The QR code will link to Qualtrics where 
potential participants can enter their contact information and request a callback from 
study stuff. Identifying information will be permanently removed from study files if 
patients decline screening questions or do not consent to participate. De-identified 
data (e.g., age, gender, race/ethnicity) will be retained for the purpose of assessing 
feasibility to recruit a diverse patient population.  
 
Ryan White: As an additional recruitment strategy, we will screen patients with 
upcoming appointments at the dental school. It is estimated that approximately 700 
adults living with HIV receive care at Temple Dental School. A query will be 
programmed in the dental medical record (axiUm) to identify patients with upcoming 
appointments. Using a similar process as described above, we will contact the 
dental providers, informing them that their patients may be eligible for this study. We 
will include a copy of the study flyer that providers can share with their patients. It is 
expected that many of these patients will be insured through the Ryan White 
program, and thus we have requested approval from the Philadelphia Department of 
Public Health prior to programming the query. Similar to our existing IRB-approved 
recruitment strategy, we will screen the medical record to confirm HIV and chronic 
pain diagnoses.    
b) Inclusion and Exclusion Criteria 
Inclusion Criteria 
Participants must meet all of the following inclusion criteria to participate in this 
study: 
1. age 45 and older;  
2. HIV positive status based on clinical records;  
3. chronic pain condition based on clinical records;  
4. English speaking;  
5. physically able to participate in a Tai Chi program;  
Exclusion Criteria 
Participants meeting any of the following will not be eligible to participate: 
1. Inability or unwillingness to provide informed consent  
2. Inability or unwillingness to engage in 10-week intervention; 
3. Non-English speaking; 
4. Active substance use disorder, per self-report; 
5. Acutely suicidal or psychotic; 
6. Self-reported participation in another research study related to chronic-pain 
 
c) Local Number of Subjects 

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It is anticipated that 40 participants will be enrolled.  
 
d) Study Timelines 
It is anticipated that participants will be enrolled in the study for six months 
from the time of first contact to the final follow up visit. Please see Table 1 
below for timeline of assessments.  
1. Following consent, participants will complete a baseline assessment, 
which may last about 30 minutes.  
2. After baseline assessment, participants will be randomized to 
intervention or control; 
3. Next, participants will attend 10 weekly, one-hour group sessions. 
4. After attending their final group, participants will return to complete the 
full questionnaire battery again.  
5. Three months after the final group, participants will return to complete 
a final follow up assessment.  
 
 
10) 
Study Endpoints 
 
Endpoint. The study will end after all participants have completed the 3-month 
follow up.  
 
Stopping rules. Due to the physical nature of the intervention, and the chronic pain 
participant population, individuals who report adverse events (AEs) related to Tai Chi 
will be informed about their option to withdraw from the study. Given the low risk of 
Tai Chi, a gentle movement, no stopping rule has been identified. If the Independent 
Monitoring Committee (IMC) raises any issues in the conduct or safety of the study 
protocol, prompt action including considering the interruption of the study will be 
considered. Given the low risk of this study, no interim analyses are proposed. 
 
11) 
Procedures Involved in the Human Research 
 
Pilot RCT procedures: Once enrolled, participants will complete baseline 
assessment and be randomized based on a random number sequence created 
using a research randomization program (www.randomizer.org).  
 
Intervention. The 20 participants assigned to the experimental group will be invited 
to attend 10 weekly Tai Chi sessions facilitated by an expert in mind-body practice. 
Intervention groups will last approximately 60 minutes. They will take place at 
Temple Dental School, which offers private group intervention rooms and a 
convenient parking garage. We will utilize a Qigong/Tai Chi Easy protocol, as this is 
a simple form that can be easily learned and disseminated (if acceptable and 
efficacious). The manual is modifiable and changes can be made based on 
information learned in formative research. Participants will also be provided with a 

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DVD and web link to view at home for daily Qigong/Tai Chi Easy practice. The video 
will be a Qigong/Tai Chi Easy session led by our expert facilitator.   
 
Control Condition. Participants in the time- and attention-matched control condition 
will be invited to participate in a 10-session health education program. The 
information contained in the program will be adapted from a previously developed 
health education control group manual created by Dr. Carey for an HIV population. 
Additional health education material will be based on information learned in the 
qualitative interviews in the formative phase of this study. The manual will not target 
pain or antecedents of pain (e.g., mobility, stress, mood). Examples of session 
material include the following: sleep hygiene, healthy diet, sun safety, and healthy 
homes. A Masters/Doctoral level professional with experience in health psychology 
will be recruited from Temple or the community to facilitate the control condition 
groups. Sessions will last 60 minutes.  
 
Retention. Retention strategies will be optimized based on information learned from 
qualitative interviews conducted in Aim 1. In addition, we will collect patient locator 
information, including phone number, email address, mailing address, and contact 
information of up to three trusted family members or friends. Contact information will 
be kept separate from study data. Participants will be able to drop out of the study at 
any time. Those who discontinue will be asked if they are willing to provide reasons 
for drop out to inform future study design. Additionally, compensation plan will 
incentivize retention, such that baseline and post-intervention assessment will offer 
$30 each, while the 3-month follow-up will compensate participants $40. Participants 
will also receive modest compensation ($5) for attending in-person groups to offset 
the cost of travel, up to $50 if all 10 groups are attended. 
 
Feasibility Measures. To assess recruitment feasibility, we will track number of 
participants screened, eligible, and enrolled. Intervention and retention feasibility will 
be calculated based on number of intervention sessions attended and number of 
follow-up visits completed. Rates of missing data will also be considered for 
feasibility.  
 
Acceptability Measures. We will adapt the Client Satisfaction Survey to assess 
participant ratings of the recruitment, retention and intervention procedures. Likert-
type ratings will include how helpful and enjoyable participants found the Tai Chi 
intervention and instructors and if they would recommend the intervention program 
to a friend. We will also elicit detailed responses using open-ended questions.  
 
Fidelity Assessment. Following the formative phase of the intervention, we will 
develop treatment fidelity checklists based on the primary components of the 
Qigong/Tai Chi Easy protocol and the Health Education control group. Group 
sessions will be video recorded for the purpose of ensuring the instructors are 
delivering the interventions correctly. Video recordings will be temporarily stored on 
the secure Temple University servers, which will only be accessed by password-
protected computers. Videos will be permanently deleted as soon as possible, after 
study staff ensures the instructor is covering the necessary components in each 
session.  

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A trained RA will complete the fidelity checklist immediately after each session and 
enter the data in a secure database. RA will review with the PI to ensure any 
challenges are addressed promptly.  
 
Assessment. Participants in the intervention and control conditions will complete 
the same assessments at three time-points (baseline, post-intervention, 3-month 
follow-up). The RA will be present to assist with the assessment, answer questions, 
and provide detailed information about next steps in the study (e.g., Tai Chi or 
Health Education sessions). The assessment will be designed so that it can be 
completed in ≤ 30 minutes. Demographic information (i.e., age, race/ethnicity, 
education, income, marital status) will be assessed at baseline only. Additionally, 
participants will complete measures of pain, quality of life, stress, depression, and 
medication adherence at baseline, post-intervention, and 3-month follow-up. The 
assessment plan reflects the theoretical model, depicted in Figure 1; it will be 
strengthened based upon the proposed training and in response to feedback 
received during the qualitative phase (Aim 1). The Brief Pain Inventory – Short Form 
and the Pain Catastrophizing Scale (PCS) will be used to assess pain and pain-
related physical and psychological outcomes. Specific pain types will be assessed 
using the Subjective Peripheral Neuropathy Screen Questionnaire and the Örebro 
Musculoskeletal Pain Screening Questionnaire. The WHO-Quality of Life-Brief 
(WHO-QoL-BREF) will be used to assess quality of life and has been specifically 
developed for use in HIV populations. Given the stress associated with managing 
chronic health conditions, the Perceived Stress Scale will be included to assess 
frequency and severity of stressful situations. Similarly, depression is highly 
comorbid in this population, thus the Patient Health Questionnaire will be used to 
assess depressive symptoms. Medication adherence will be assessed using a 
validated brief 3-item measure for PLWH, which assesses number of days missed, 
difficulty following instructions, and self-rating of medication adherence in the past 
30 days. The Meditative Movement Inventory will be used to assess uptake of Tai 
Chi movements and potential benefits. Lastly, at the start and conclusion of each 
intervention session, participants will be asked to rate their pain on a visual analog 
scale, to assess average chronic pain rating before session and changes in pain 
following Tai Chi. Participants will receive a $30 gift card as compensation for 
completing each of the baseline and post-intervention assessment, and will receive 
a $40 gift card for completing the assessment at 3-month follow-up. Participants will 
be compensated $5 per in-person group attended to offset the cost of travel, up to 
$50 of all groups are attended. In sum, participants can earn up to $150. 
 
Data Analyses. Descriptive statistics (e.g., means, standard deviations, 
frequencies) will be calculated to summarize participant characteristics. Between-
group differences (experimental vs control) in baseline characteristics will be 
assessed using t-tests (for continuous variables), chi-squared tests (for categorical 
variables) and non-parametric tests as appropriate.  Primary outcomes of interest for 
this pilot study will be feasibility and acceptability. Feasibility will be calculated as a 
percentage eligible, consented, randomized, and retained. To determine feasibility of 
the intervention, we will calculate the percentage of Tai Chi sessions attended. 
Feasibility data will be compared between intervention and control conditions using 
t-tests. We will consider the intervention feasible if at least 80% retention is 
achieved. Acceptability will be calculated as mean satisfaction ratings of the 

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intervention and instructors. Intervention will be considered acceptable if overall 
satisfaction scores are in the favorable range on Likert-type responses. This study is 
not powered to detect statistical differences in self-reported pain or psychosocial 
outcomes. Nonetheless, we will estimate effect sizes for between-group differences 
as a means of detecting possible effects. Using a series of longitudinal models 
(mixed effects models for continuous outcomes, generalized estimating equations 
for binary outcomes), we will estimate effects of condition on mean pain 
and  psychosocial outcomes post-intervention and 3-month follow-up, controlling for 
baseline and any variables not balanced by randomization. Interest is in estimating 
effect sizes rather than strict statistical hypothesis testing. We will also explore 
possible mediators (using a product of coefficients approach to estimate path 
coefficients) and moderators (using longitudinal models), including sex as a 
biological variable. Response rates and missing data will inform subsequent trials. 
Analyses will be conducted using an intent-to-treat approach.  Proposed longitudinal 
models use a likelihood based approach estimating and thus make use of observed 
data without directly imputing missing outcomes.  Lastly, the proposed research will 
consider pain type as a potential confounder and/or moderator when examining 
outcome data, and future studies with adequate power will determine if Tai Chi 
results in varying levels of efficacy for management of different types of pain (e.g., 
neuropathic vs. musculoskeletal). 
Data Management. The investigators are responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. All study data will be 
entered and stored on secure university-based servers and only accessed through 
password protected computers. Paper records will be stored in locked file cabinets in 
a locked office. Only the PI and Data Manager will have access to study files. All 
source documents will be completed in a neat, legible manner to ensure accurate 
interpretation of data.  The investigators will maintain adequate case histories of 
study subjects. This study will use Qualtrics software for secure management of 
data. Participant identifiers will be kept separate from study data. The database will 
be secured with password protection. Electronic communication with outside 
collaborators will involve only unidentifiable information. We will keep an electronic 
audit trail to show changes to data after original entry including the date/time and 
user making the change. The research assistant will provide the PI with weekly 
reports during enrollment periods to monitor enrollment. This report will contain 
deidentified data and group assignment. No interim data analysis is proposed. Final 
data analysis will be conducted by the PI in collaboration with a consultant 
biostatistician. Final study data reported will be shared with the study oversight 
committee and NCCIH.  
 
Data and Safety Monitoring. An Independent Monitoring Committee (IMC) has 
been formed for the purpose of clinical trial safety monitoring. The members of the 
IMC are not associated with this research project and work independently of the PI, 
Dr. Eugene Dunne, and his mentors. They are not part of the key personnel involved 
in this grant. No member of the Committee has collaborated or co-published with the 
PI within the past three years. They are qualified to review the patient safety data 
generated by this study because of their unique expertise. The three members 
selected for the IMC are Drs. Tao Liu, Christopher Schmid, and Rani Elwy. These 

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members have been selected for their expertise in biostatistics (Liu, Schmid), HIV 
and infectious disease (Liu), mind-body research (Elwy), and clinical trials evaluation 
(Schmid). The CVs of all members of the IMC have been submitted to NCCIH for 
their review and approval. De-identified progress reports, including recruitment, 
retention/attrition, and AEs will be provided to the IMC semi-annually. In addition, the 
reports will address (1) whether AE rates are consistent with pre-study assumptions; 
(2) reason for dropouts from the study; (3) whether all participants met entry criteria; 
(4) whether continuation of the study is justified on the basis that additional data are 
needed to accomplish the stated aims of the study; and (5) conditions whereby the 
study might be terminated prematurely.  
 
12) 
Risks to Subjects 
 
This is a mind-body, behavioral intervention study and should pose minimal risk 
to study participants. Nonetheless, untoward events may result in the following 
potential risks:  
1. Injury or increase in pain resulting from physical movements during Tai Chi 
practice; 
2. Emotional discomfort while participating in intervention or while responding to 
assessments; 
3. Breach of confidentiality; 
3a. Additional risk due to virtual study activities. 
 
To reduce the potential for risk to participants, we will actively collect information 
and monitor for intervention-related symptoms. We present here the measures 
we plan to undertake to minimize potential untoward events that may occur as a 
result of participation in this study. 
1. Injury or increase in pain resulting from physical movements during Tai 
Chi practice: While Tai Chi consists of gentle and fluid movements, the 
physical nature of Tai Chi (or any exercise intervention) could increase risk of 
injury for participants. Further, participants will be diagnosed with a chronic 
pain condition, which may be exacerbated by physical movements. Special 
precautions will be considered to protect against this risk. First, the instructor 
for the proposed study is a highly recommended Tai Chi expert and former 
behavioral medicine researcher. Second, we will develop the intervention 
manual to include movements that pose the smallest risk of pain or injury. 
Participants will be informed that they are welcome to take breaks and skip 
movements as needed. Lastly, participants will be reminded that they are free 
to withdraw from the study for any reason. The research assistant will assess 
each participant’s pain level at the conclusion of each Tai Chi session to 
ensure the safety of participants prior to leaving. If, for any reason, a 
participant is in need of medical attention, the participant would be escorted to 
Temple University Hospital located on the Health Sciences campus.  
2. Emotional discomfort while participating in intervention or responding 
to assessments: Psychological distress while responding to questions 
related to living with chronic pain is possible, though unlikely. Participants will 

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be encouraged to report to the study staff any such discomfort or side effects 
that might occur during the intervention sessions or assessments. The 
principal investigator is a doctoral-level clinical psychologist with training in 
dealing with psychological distress and crises. In the event that a patient 
presents signs of severe psychological discomfort during assessments or 
interventions, the RA will contact that PI and the participant will be welcomed 
to discontinue until a later date or withdraw from the study at any time.  
3. Breach of confidentiality. Participant confidentiality will be maintained 
through several strategies. Participants will be assigned a unique study 
identification number. The only individuals who will have access to 
participants’ identifiers will be the PI, RA, and data manager. Data will be 
protected by the use of locked file cabinets in secured office space, use of 
password-protected computers, and storing data on internal encrypted 
servers. Only study personnel will have access to the secure study folders. 
Group interventions increase risk to participant confidentiality. Participants will 
be informed of the importance of group confidentiality during the informed 
consent process and during the first intervention group session. Research 
staff will instruct group members not to share the names or personal 
information of group members outside of the intervention environment, 
including with family members. Additionally, reminders will be stated at the 
beginning of each intervention session. 
a. Virtual Study Activities: we recognize that utilizing virtual platforms 
adds an additional layer of risk to confidentiality. Using the video-
conferencing software in a non-secure environment puts the 
participants’ privacy and confidential information at risk. We will use all 
possible methods to protect the privacy and confidentiality of study 
participants, including (but not limited to) using HIPAA-compliant video 
conferencing software, password protected virtual meetings and the 
use of waiting rooms to only allow access to known participants. 
Participants will be instructed to only access virtual events from a 
private location, to reduce unintentional risk of bystander observation. 
If non-participants are observed in the vicinity of virtual attendees, the 
participant will be moved to a waiting room for further discussion or 
removed from the meeting. An example of a situation where only 
temporary removal (e.g., use of waiting room) would be appropriate 
include a participant’s child accidently coming into the room. In these 
cases, participants can resume group attendance after remedying the 
interruption. In addition, recorded videos will be deleted as soon as 
possible. 
4. COVID-19 Pandemic considerations: when required by national/local 
authorities or university policy, participants will be required to wear a mask 
while on campus or in clinical spaces. All CDC-recommended guidance will 
be followed with regards to sanitizing study space and maintaining physical 
distancing. The rooms in TUKSoD have been assessed for safe capacity 
limitations.  

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5. Other considerations: Depression and Suicidality. Given the elevated rates 
of depression among persons living with HIV, and those with chronic pain, 
study staff will be vigilant of potential suicidality reported by participants. If 
severe depression or suicidal ideation, intent, or plan is reported during 
assessment or intervention sessions, the principal investigator will conduct a 
suicide assessment and triage appropriately. If intent and plan are stated, PI 
will escort participant to the emergency room, if participant is willing. 
Otherwise, PI will inform participant that he is required to call 911 for the 
participant’s safety. 
6. Other considerations: Staff Training. Research personnel, including the 
principal investigator, interventionists, and research assistant, will receive 
extensive training in the responsible conduct of clinical research. Dr. Michael 
Carey (Brown University), the primary mentor on this award and a licensed 
psychologist with 30 years of research and clinical experience in HIV and 
related socially sensitive topics, will oversee the training and provide 
supervision of the PI. Dr. Tellez will also provide local training at TUKSoD, 
including online NIH- and Hospital-based modules, directed readings, and 
team meetings. Topics will include maintaining confidentiality, safe use of 
protected health information, duty to warn and required reporting laws, and 
cultural sensitivity.  
 
13) 
Potential Benefits to Subjects 
 
There are no direct benefits to subjects for participating in this study. However, it 
is plausible that participants will benefit from both the Tai Chi and the Health 
Education groups. Participants assigned to the intervention condition will have 
the opportunity to participate in Tai Chi group classes with an expert instructor. 
Additionally, the health education classes used in this study have been well-
received by participants in previous studies.  
 
14) 
Privacy and Confidentiality 
 
As this is a clinical treatment study, it will use patients’ protected health 
information (PHI). A HIPAA Authorization Form is uploaded as part of this 
application. 
 
As in any type of treatment or clinical research program, patients' privacy must 
be carefully guarded and respected. All written identifying information (signed 
recording consent forms, contact information) will be stored in locked files or 
digitally on a HIPAA-compliant network. Remaining data will be stored in 
password-protected computer files on a HIPAA-compliant network. One file will 
contain patient names and associated research identification numbers; at the end 
of the study, this file will be destroyed. All other data will reside in a file identified 
by subject identification numbers and from which other identifying information will 
have been removed, so the link between these data and subject identifiers will 
have been severed.  

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All research staff on the project will be educated about the importance of strictly 
respecting patients' rights to confidentiality and will have completed training 
concerning proper practice in accordance with HIPAA regulations.  
 
Data files will be accessible only to the investigators and research assistants 
directly connected with the study. Only members of the research team will review 
the data. To help patients feel at ease, staff will emphasize their right to ask 
questions throughout the study and to abstain from any aspect of the research 
which makes them uncomfortable. During group sessions, all participants will be 
reminded of the importance of respecting the confidentiality of all group 
members.  
 
No PHI data will be shared with persons unassociated with the project. When the 
results of this protocol are published, data are presented in aggregate and no 
individual identifying information is included. 
 
15) 
Economic Burden to Subjects 
 
There is no anticipated economic burden for participating in this research.  
 
16) 
Subject Compensation 
 
Participants will receive a $30 gift card as compensation for completing each of 
the baseline and post-intervention assessments, and will receive a $40 gift card 
for completing the assessment at 3-month follow-up. Participants may also be 
compensated $5 per in-person group attended to off-set the financial burden of 
traveling or parking. In sum, participants can earn up to $150. 
 
17) 
Consent Process 
 
Participants who are eligible and interested in participating will meet with the PI 
or RA to be provided with detailed information about the nature of the study. If an 
in-person meeting is not possible, the consent process can be conducted over 
the phone or HIPAA-compliant video conferencing and signed electronically. If 
remote consenting is used, study staff will remain on the phone or video 
conference throughout the process to ensure that the eligible participant is able 
to receive and open the email containing the consent form, read and understand 
the consent form, and have an opportunity to ask any questions prior to signing 
and emailing the form back to the study team. An explanation of the study will 
also be registered on ClinicalTrials.gov website. The PI or RA will review the 
Informed Consent form with eligible participants, providing details verbally and in 
writing. Participants will be informed that the study is voluntary, will not impact 
their standard clinical care, and they can withdraw at any time without penalty. 
The PI or RA obtaining consent will provide opportunities for participants to ask 

Protocol 
 
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questions at any time. Participants who are in agreement will sign the IRB-
approved informed consent form and HIPAA authorization form to permit study 
staff to access electronic medal record information. Participants will be provided 
with a copy of the forms for their personal records. This copy can be provided 
physically or electronically (via email), depending on participant preference. 
Electronically signed forms will be stored in secure study folders on the Temple 
network. They will also be printed and stored with in-person signed consent 
forms in locked filing cabinets in secured office space in TUKSoD, and kept 
separate from study data. 
 
18) 
Vulnerable Populations 
 
Not applicable. Individuals who are vulnerable to coercion or undue influence will 
not be included in the human subjects activities described herein.  
 
 
 

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