Harmonized Healing: Personalized Music Interventions to Address Chronic Pain in People Living With HIV

The goal of this randomized controlled trial is to understand the feasibility and acceptability of a music-based mobile application to address chronic pain in people with HIV. Participants in the intervention group will use the Harmonized Healing music app daily, or as needed, for 3 months. Participants in the control group will receive psychoeducation on chronic pain and strategies for pain management. All participants will attend monthly follow-up visits during the 3-month intervention period, and an additional follow-up visit at Month 6.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Hiv
• Intervention / Treatment: Behavioral: Harmonized Healing App; Behavioral: Psychoeducation

Detailed Description

Harmonized Healing is a novel, smartphone-driven, music-based behavioral intervention designed to help manage chronic pain in people with HIV. This two-arm pilot randomized controlled trial will enroll 60 individuals living with HIV and chronic pain. Participants will be randomized to receive either Harmonized Healing plus psychoeducation (intervention arm) or psychoeducation alone (control arm). Those in the intervention arm will be asked to use the Harmonized Healing music app daily, or as needed, for 3 months. Participants in both groups will attend monthly study visits during the 3-month intervention period, and one additional follow-up visit at Month 6.

The primary objective of this pilot study is to evaluate the feasibility and acceptability of the Harmonized Healing app. In addition, qualitative feedback will be collected from participants who used Harmonized Healing to better understand their experiences with the intervention and participation in the study.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Chai, MD, MMS; Phone Number: 8573136721; Email: pchai@bwh.harvard.edu
• Study Contact Backup: Name: Peevara Srimanus, MPH; Phone Number: 8573136721; Email: psrimanus@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult ≥ 18 years old
• Owns a smartphone
• Living with HIV
• Currently prescribed antiretroviral therapy (ART) for HIV
• Experience with chronic pain (determined by self-reported pain of ≥3 on the Brief Pain Inventory for at least 3 months)

Exclusion Criteria:

• Have a significant hearing loss
• HIV-negative
• Have been prescribed naltrexone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Harmonized Healing App; Participants will receive psychoeducation related to drivers of chronic pain in the context of HIV and tips for managing pain, and the Harmonized Healing app. Participants will use the app at least once daily, or as needed, to manage and alleviate pain exacerbations for 3 months.	Behavioral: Harmonized Healing App; A smartphone-driven music-based intervention designed to support daily or as-needed use of personalized music to manage and alleviate pain exacerbations.; Behavioral: Psychoeducation; Educational materials on drivers of chronic pain in the context of HIV and strategies for pain management.
Active Comparator: Control; Participants will receive psychoeducation related to drivers of chronic pain in the context of HIV and tips for managing pain. Participants will review the information at least once before each monthly visit (Month 1 to 3 Visits).	Behavioral: Psychoeducation; Educational materials on drivers of chronic pain in the context of HIV and strategies for pain management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility: Recruitment	Intervention feasibility will be assessed by the proportion of eligible individuals from the available recruitment pool.	Month 3 Study Visits
Intervention Feasibility: Enrollment	Intervention feasibility will be assessed by the proportion of eligible individuals who consent and enroll, and the proportion of the target sample size achieved.	Month 3 Study Visits
Intervention Feasibility: Attrition	Intervention feasibility will be assessed by the proportion of participants retained at each follow-up visit.	Month 3 and Month 6 Study Visits
Intervention Feasibility: Adherence to Assessment Battery	Intervention feasibility will be assessed by the proportion of participants who completed the assessment battery at each study visit. In the intervention condition, this includes the proportion of EMA completion.	Month 3 and Month 6 Study Visits
Intervention Feasibility: FIM	The Feasibility of Intervention Measure (FIM) is a 4-item Likert feasibility scale ranging from 1 (Completely disagree) to 5 (Completely agree). A mean score is calculated, resulting in a continuous score with higher scores indicating greater intervention feasibility.	Month 3 Study Visit
Intervention Acceptability: Fidelity	Intervention fidelity will be assessed by adherence to assigned study activities. In the intervention arm, this includes the proportion of days adherent to the prescribed app use. In the control arm, this includes the proportion of psychoeducation reviews completed before monthly visits.	Month 3 Study Visit
Intervention Acceptability: Engagement (Percentage of days used)	Intervention engagement will be assessed by the proportion of days with app use.	Month 3 Study Visit
Intervention Acceptability: Engagement (Minutes engaged per week)	Intervention engagement will be assessed by minutes of app engagement per week.	Month 3 Study Visit
Intervention Acceptability: AIM	The Acceptability of Intervention Measure (AIM) is a 4-item Likert agreeability scale ranging from 1 (Completely disagree) to 5 (Completely agree). A mean score is calculated, resulting in a continuous score with higher scores indicating greater intervention acceptability.	Month 3 Study Visit
Intervention Acceptability: Qualitative Exit Interviews	Intervention acceptability will be assessed via qualitative interviews exploring participants' lived experiences using the Harmonized Healing app, including facilitators and barriers to use, and engagement with the app.	Month 3 Study Visit

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); The Fenway Institute
• Investigators: Principal Investigator: Peter Chai, MD, MMS, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: October 2, 2025
• First Posted (Estimated): October 9, 2025

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Pain; smartphone app; Music
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 2025P002274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Identifying information may be redacted and data shared based on reasonable request from researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No