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| Name | Class |
|---|---|
| Imperial College London | OTHER |
| Chelsea and Westminster NHS Foundation Trust | OTHER |
| University College, London | OTHER |
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Presently, there are few options for medically managing HIV-related painful peripheral sensory neuropathy (HIV-SN). Psychological treatments, including Cognitive Behavioural Therapy (CBT), represent a potentially viable addition to the treatment of painful HIV-SN. However, there is a scarcity of research on psychological treatment approaches for pain management in people with HIV. This study will use in-depth semi-structured interviews to examine the needs of people with painful HIV-SN for a psychologically-based pain management treatment that may be delivered over the Internet. Interview questions will examine participants' needs in terms of treatment content and delivery format. Men and women, ethnic minorities, and people who use recreational drugs will be sampled to ensure that interview responses reflect the views of people most commonly suffering from this condition. Approximately 30 people will be recruited for the study. The interviews will be audio recorded, transcribed verbatim, and coded to identify themes. The interview responses will be used to develop and tailor a version of CBT for people with painful HIV-SN. It is hoped that tailoring the treatment based on the qualitative interview responses will increase the acceptability of the treatment and will improve treatment adherence rates for a future study.
This report is independent research supported by the National Institute for Health Research (NIHR Post Doctoral Fellowship, Dr Whitney Scott, PDF-2015-08-059). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed a Semi-Structure Interview | Semi-structured interview performed at one occasion where the patient describes his/her experience living with painful peripheral neuropathy and his/her thoughts about a psychological treatment for managing pain. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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People with HIV and painful peripheral neuropathy. We will purposively sample men, women, ethnic minorities, and people who use recreational drugs .
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| Name | Affiliation | Role |
|---|---|---|
| Whitney Scott, PhD | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London | London | SE1 9RT | United Kingdom | |||
| Chelsea & Westminster Hospital NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31855944 | Background | Scott W, Garcia Calderon Mendoza Del Solar M, Kemp H, McCracken LM, C de C Williams A, Rice ASC. A qualitative study of the experience and impact of neuropathic pain in people living with HIV. Pain. 2020 May;161(5):970-978. doi: 10.1097/j.pain.0000000000001783. |
| Label | URL |
|---|---|
| Published peer-reviewed paper | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With HIV and Neuropathy | Participants with HIV and Neuropathy (this was a qualitative study and participants were not assigned to arms). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With HIV and Neuropathy | Participants with HIV and Neuropathy who completed semi-structured interviews. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Completed a Semi-Structure Interview | Semi-structured interview performed at one occasion where the patient describes his/her experience living with painful peripheral neuropathy and his/her thoughts about a psychological treatment for managing pain. | All participants were analysed | Posted | Count of Participants | Participants | Day 1 |
|
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not recorded. There was a risk management procedure that involved contacting the participants' GP if clinically meaningful distress or other symptoms were identified during the qualitative interviews. However, the frequency of contacting GPs to manage this risk was not systematically recorded as this was not an intervention study.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not recorded. There was a risk management procedure that involved contacting the participants' GP if clinically meaningful distress or other symptoms were identified during the qualitative interviews. However, the frequency of contacting GPs to manage this risk was not systematically recorded as this was not an intervention study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Not applicable. This is a qualitative study. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Whitney Scott | King's College London | 02071885421 | whitney.scott@kcl.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2017 | Sep 1, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| London |
| SW10 9NH |
| United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |