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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
A smartphone-driven music-based intervention designed to support daily or as-needed use of personalized music to manage and alleviate pain exacerbations.
Educational materials on drivers of chronic pain in the context of HIV and strategies for pain management.
Intervention Feasibility: Recruitment
Intervention feasibility will be assessed by the proportion of eligible individuals from the available recruitment pool.
Time frame: 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.
Time frame: Month 3 Study Visits
Intervention Feasibility: Attrition
Intervention feasibility will be assessed by the proportion of participants retained at each follow-up visit.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 3 Study Visit
Intervention Acceptability: Engagement (Percentage of days used)
Intervention engagement will be assessed by the proportion of days with app use.
Time frame: Month 3 Study Visit
Intervention Acceptability: Engagement (Minutes engaged per week)
Intervention engagement will be assessed by minutes of app engagement per week.
Time frame: 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.
Time frame: 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.
Time frame: Month 3 Study Visit
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