HIV InfectionsNCT05055596
Improving Quality of Life for Adults Living With HIV and Chronic Pain
A study testing Tai Chi and Health Coaching in people with HIV Infections and Chronic Pain, run by Temple University at 1 site in United States.
Trial summary
Chronic pain is highly comorbid among the 1.2 million persons living with HIV, with recent prevalence estimates ranging from 55-67%. Needed are evidenced-based non-pharmacological interventions to improve chronic pain management and reduce the demand for opioids in the United States. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- HIV Infections, Chronic Pain
- What is being tested?
- Tai Chi and Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 45 and older;
- HIV positive status based on clinical records;
- chronic pain condition based on clinical records;
- English speaking;
- physically able to participate in a Tai Chi program
Who cannot join
- Inability or unwillingness to provide informed consent
- Inability or unwillingness to travel to Temple Dental School;
- Inability or unwillingness to engage in 10-week intervention;
- Non-English speaking;
- Active substance use disorder;
- Acutely suicidal or psychotic;
- Self-reported participation in another research study related to chronic-pain
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Kornberg School of Dentistry (TUKSoD)
Philadelphia, Pennsylvania, 19140
About this study
Chronic pain is highly comorbid among the 1.2 million persons living with HIV, with recent prevalence estimates ranging from 55-67%. Needed are evidenced-based non-pharmacological interventions to improve chronic pain management and reduce the demand for opioids in the United States. The proposed research will address this need by examining the feasibility and acceptability of Tai Chi as a mind-body intervention for chronic pain management in an HIV population.
Read the detailed description
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. The researchers 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), the researchers will assess pain symptoms (general and specific), perceived stress, depression, quality of life, and HIV medication adherence. The researchers anticipate that 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.
- Conditions
- HIV Infections, Chronic Pain
- Being tested
- Tai Chi, Health Coaching
- Medical subject headings
- HIV Infections, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
Qigong/Tai Chi Easy is a manualized intervention with formal training for instructors through the Institute of Integral Qigong and Tai Chi (IIQTC). The protocol can be modified based on participant needs and physical abilities. Qigong/Tai Chi Easy uses a series of repeated and simple-to-learn movements (rather than long forms with complicated choreography).
Health CoachingBehavioural
The Health Education group will be adapted from a previously developed time and attention control condition used in HIV research. Additional health education material will be based on information learned in the qualitative interviews conducted prior to the start of this study. Examples of session material include the following: sleep hygiene, healthy diet, sun safety, and healthy homes.
| Study group | Role | What they receive |
|---|---|---|
| Gentle Movement | Experimental | This is the active intervention arm. Qigong/Tai Chi Easy is a manualized intervention with formal training for instructors through the Institute of Integral Qigong and Tai Chi (IIQTC). The protocol can be modified based on participant needs and physical abilities. Qigong/Tai Chi Easy uses a series of repeated and simple-to-learn movements (rather than long forms with complicated choreography). Receives: Behavioral: Tai Chi |
| Health Coaching | Active comparator | This is the time and attention active comparator control group arm: The Health Education group will be adapted from a previously developed time and attention control condition used in HIV research. Additional health education material will be based on information learned in the qualitative interviews conducted prior to the start of this study. Examples of session material include the following: sleep hygiene, healthy diet, sun safety, and healthy homes. Receives: Behavioral: Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity - Brief Pain Inventory
Participants will be asked to rate their pain, ranging from 0, no pain, to 10, most extreme pain, on average in the past week. Higher scores indicate worse pain.
Measured: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Pain Interference - Brief Pain Inventory
A self-report of impairment in mobility, impairment in activities of daily living, mood, and pain-related anxiety/fear. The pain interference subscale score is the average of 7 items, with responses that range from 0-10. Higher scores indicate worse pain interference.
Measured: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Feasibility to Execute Study Protocol
Ability to recruit and retain participants through intervention and follow-up assessments
Measured: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Participant Satisfaction Questionnaire (PSQ) - Acceptability
Participant self-reported satisfaction with intervention components. Response to question: "How would you rate your overall satisfaction with this program?"
Measured: Post-Intervention (Weeks 10-12)
Secondary outcomes (2)
Perceived Stress Scale (PSS)
The Perceived Stress Scale is a measure of self-reported stress in the past month. There are 13 items and responses range from 0 (never) to 4 (very often). A total score is calculated and can range from 0 to 52, with higher scores indicated a greater degree of perceived stress.
Measured: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Patient Health Questionnaire (PHQ-8)
The PHQ-9 is a commonly used measure of depression with strong psychometric properties for clinical populations. The scale consists of 8 items, with responses ranging from 0 (not at all) to 3 (nearly every day). Total scores are calculated and possible scores range from 0 to 24, with higher scores indicated more depressive symptoms.
Measured: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start30 Nov 2021
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Eugene M Dunne, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055596
- Sponsor's protocol ID
- K23AT010099
- Other IDs
- K23AT010099
- Status last verified
- Feb 2026
- First submitted
- 2 Sep 2021
- Last updated
- 18 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life for Adults Living With HIV and Chronic Pain
- ClinicalTrials.gov ID
- NCT05055596
- Acronym / sponsor ID
- K23AT010099
- Conditions
- HIV Infections, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Posted 18 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic pain is highly comorbid among the 1.2 million persons living with HIV, with recent prevalence estimates ranging from 55-67%. Needed are evidenced-based non-pharmacological interventions to improve chronic pain management and reduce the demand for opioids in the United States. The proposed research will address this need by examining the feasibility and acceptability of Tai Chi as a mind-body intervention for chronic pain management in an HIV population.
Detailed description
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. The researchers 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), the researchers will assess pain symptoms (general and specific), perceived stress, depression, quality of life, and HIV medication adherence. The researchers anticipate that 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gentle Movement | Experimental | Behavioral: Tai ChiThis is the active intervention arm. Qigong/Tai Chi Easy is a manualized intervention with formal training for instructors through the Institute of Integral Qigong and Tai Chi (IIQTC). The protocol can be modified based on participant needs and physical abilities. Qigong/Tai Chi Easy uses a series of repeated and simple-to-learn movements (rather than long forms with complicated choreography). |
| Health Coaching | Active comparator | Behavioral: Health CoachingThis is the time and attention active comparator control group arm: The Health Education group will be adapted from a previously developed time and attention control condition used in HIV research. Additional health education material will be based on information learned in the qualitative interviews conducted prior to the start of this study. Examples of session material include the following: sleep hygiene, healthy diet, sun safety, and healthy homes. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 45 and older;
- HIV positive status based on clinical records;
- chronic pain condition based on clinical records;
- English speaking;
- physically able to participate in a Tai Chi program
Key exclusion criteria (7 listed)
- Inability or unwillingness to provide informed consent
- Inability or unwillingness to travel to Temple Dental School;
- Inability or unwillingness to engage in 10-week intervention;
- Non-English speaking;
- Active substance use disorder;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiQigong/Tai Chi Easy is a manualized intervention with formal training for instructors through the Institute of Integral Qigong and Tai Chi (IIQTC). The protocol can be modified based on participant needs and physical abilities. Qigong/Tai Chi Easy uses a series of repeated and simple-to-learn movements (rather than long forms with complicated choreography). | Behavioural | Gentle Movement |
| Health CoachingThe Health Education group will be adapted from a previously developed time and attention control condition used in HIV research. Additional health education material will be based on information learned in the qualitative interviews conducted prior to the start of this study. Examples of session material include the following: sleep hygiene, healthy diet, sun safety, and healthy homes. | Behavioural | Health Coaching |
Primary outcome
Pain Intensity - Brief Pain Inventory
Time frame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Participants will be asked to rate their pain, ranging from 0, no pain, to 10, most extreme pain, on average in the past week. Higher scores indicate worse pain.
Pain Interference - Brief Pain Inventory
Time frame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
A self-report of impairment in mobility, impairment in activities of daily living, mood, and pain-related anxiety/fear. The pain interference subscale score is the average of 7 items, with responses that range from 0-10. Higher scores indicate worse pain interference.
Feasibility to Execute Study Protocol
Time frame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Ability to recruit and retain participants through intervention and follow-up assessments
Participant Satisfaction Questionnaire (PSQ) - Acceptability
Time frame: Post-Intervention (Weeks 10-12)
Participant self-reported satisfaction with intervention components. Response to question: "How would you rate your overall satisfaction with this program?"
2 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Patient Health Questionnaire (PHQ-8)
Time frame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene M Dunne, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Health Coaching in people with HIV Infections and Chronic Pain, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity - Brief Pain Inventory (time frame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.