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| Name | Class |
|---|---|
| The Fenway Institute | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Chai, MD, MMS | Contact | 8573136721 | pchai@bwh.harvard.edu | |
| Peevara Srimanus, MPH | Contact | 8573136721 | psrimanus@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter Chai, MD, MMS | Brigham and Women's Hospital | Principal Investigator |
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Identifying information may be redacted and data shared based on reasonable request from researchers.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Psychoeducation | Behavioral | Educational materials on drivers of chronic pain in the context of HIV and strategies for pain management. |
|
| 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 |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |