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

NCT07214077 | Not Yet Recruiting DMC

• 1 other identifier: 2025P002274
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Pain; Hiv

Keywords

Chronic Pain; Music; smartphone app

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Harmonized Healing App

EXPERIMENTAL

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; Behavioral: Psychoeducation

Control

ACTIVE COMPARATOR

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

Interventions

Harmonized Healing App BEHAVIORAL

A smartphone-driven music-based intervention designed to support daily or as-needed use of personalized music to manage and alleviate pain exacerbations.

Harmonized Healing App

Psychoeducation BEHAVIORAL

Educational materials on drivers of chronic pain in the context of HIV and strategies for pain management.

Control; Harmonized Healing App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• The Fenway Institute: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

MeSH Terms

Conditions

Chronic Pain; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Chai, MD, MMS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Chai, MD, MMS

CONTACT

8573136721; pchai@bwh.harvard.edu

Peevara Srimanus, MPH

CONTACT

8573136721; psrimanus@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 9, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: October 9, 2025

Record last verified: 2025-10