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NCT Number: NCT07214077

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Psychoeducation

Behavioral

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

Primary outcomes

  1. Intervention Feasibility: Recruitment

    Time frame: Month 3 Study Visits

    Intervention feasibility will be assessed by the proportion of eligible individuals from the available recruitment pool.

  2. Intervention Feasibility: Enrollment

    Time frame: Month 3 Study Visits

    Intervention feasibility will be assessed by the proportion of eligible individuals who consent and enroll, and the proportion of the target sample size achieved.

  3. Intervention Feasibility: Attrition

    Time frame: Month 3 and Month 6 Study Visits

    Intervention feasibility will be assessed by the proportion of participants retained at each follow-up visit.

  4. Intervention Feasibility: Adherence to Assessment Battery

    Time frame: Month 3 and Month 6 Study Visits

    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.

  5. Intervention Feasibility: FIM

    Time frame: Month 3 Study Visit

    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.

  6. Intervention Acceptability: Fidelity

    Time frame: Month 3 Study Visit

    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.

  7. Intervention Acceptability: Engagement (Percentage of days used)

    Time frame: Month 3 Study Visit

    Intervention engagement will be assessed by the proportion of days with app use.

  8. Intervention Acceptability: Engagement (Minutes engaged per week)

    Time frame: Month 3 Study Visit

    Intervention engagement will be assessed by minutes of app engagement per week.

  9. Intervention Acceptability: AIM

    Time frame: Month 3 Study Visit

    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.

  10. Intervention Acceptability: Qualitative Exit Interviews

    Time frame: Month 3 Study Visit

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peevara Srimanus, MPH

CONTACT

[email protected]

8573136721

Peter Chai, MD, MMS

CONTACT

[email protected]

8573136721

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • The Fenway Institute

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Oct 9, 2025
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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