Improving Quality of Life for Adults Living With HIV and Chronic Pain

NCT05055596 | Completed Results DMC

• 1 other identifier: K23AT010099
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HIV Infections; Chronic Pain

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

  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?"

  Post-Intervention (Weeks 10-12)

Secondary Outcomes (2)

• Perceived Stress Scale (PSS)

  Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)

• Patient Health Questionnaire (PHQ-8)

  Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)

Study Arms (2)

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).

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.

Behavioral: Health Coaching

Interventions

Tai Chi BEHAVIORAL

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).

Gentle Movement

Health Coaching BEHAVIORAL

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.

Health Coaching

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Temple University: lead

Study Sites (1)

Temple University Kornberg School of Dentistry (TUKSoD)

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

HIV Infections; Chronic Pain

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Limitations and Caveats

This study is limited by small sample size, as it was a pilot study to assess the feasibility and acceptability of the mind-body intervention for chronic pain among adults with HIV. The sample size was not sufficiently large enough (i.e., "powered") to detect between-group differences over time.

Results Point of Contact

• Title: Eugene Dunne, PhD
• Organization: Temple University

eugene.dunne@temple.edu

215-707-9655

Study Officials

• Eugene M Dunne, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 24, 2021
• Study Start: November 30, 2021
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-02

Locations

US (1)