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Not yet recruiting NCT07214077

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

No phase Interventional Chronic Pain Hiv

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Harmonized Healing App, Psychoeducation.
Who it may be relevant to
Registry conditions: Chronic Pain, Hiv. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Intervention Feasibility: Recruitment [Time frame: Month 3 Study Visits]
  • Intervention Feasibility: Enrollment [Time frame: Month 3 Study Visits]
  • Intervention Feasibility: Attrition [Time frame: Month 3 and Month 6 Study Visits]
  • Intervention Feasibility: Adherence to Assessment Battery [Time frame: Month 3 and Month 6 Study Visits]
  • Intervention Feasibility: FIM [Time frame: Month 3 Study Visit]
  • Intervention Acceptability: Fidelity [Time frame: Month 3 Study Visit]
  • Intervention Acceptability: Engagement (Percentage of days used) [Time frame: Month 3 Study Visit]
  • Intervention Acceptability: Engagement (Minutes engaged per week) [Time frame: Month 3 Study Visit]
  • Intervention Acceptability: AIM [Time frame: Month 3 Study Visit]
  • Intervention Acceptability: Qualitative Exit Interviews [Time frame: Month 3 Study Visit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07214077 · 2025P002274

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗