Clinical trial NCT02972606: OPEN Study: Pain Management Treatment Needs Interviews
Official title: Online Psychological Treatment for People With Painful HIV-related Peripheral Neuropathy (OPEN Study): Qualitative Investigation of Treatment Needs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Peripheral Neuropathy
Keywords: HIV
Peripheral Neuropathy
Chronic Pain
Qualitative Research
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Imperial College London
name: Chelsea and Westminster NHS Foundation Trust
name: University College, London
First posted: 2016-11-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with HIV and painful peripheral neuropathy. We will purposively sample men, women, ethnic minorities, and people who use recreational drugs .

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older.
* Living with HIV.
* A positive screen for peripheral sensory neuropathy, as indicated by: presence of self-reported bilateral foot pain and/or numbness in a symmetrical distribution.
* Positive screen for symptoms of neuropathic pain in the feet, as indicated by a score of greater than or equal to 3 on the patient reported outcomes section of the Neuropathic Pain Interview.
* Pain in the feet present most days for at least 3 months.
* Average pain intensity of greater than or equal to 4/10.
* Average interference of pain with daily activities is greater than or equal to 4/10.

Exclusion Criteria:

* Presence of excessive alcohol consumption, hypothyroidism, vitamin B12 deficiency, diabetes, exposure to isoniazid or chemotherapy drug treatment, or a known history of a neuropathy due to a cause other than HIV or antiretroviral treatment
* Unable to conduct interview in English.
* Current diagnosis of dementia or learning disability.
* Unwilling to provide written informed consent.

Primary outcomes:
measure: Number of Participants Who Completed a Semi-Structure Interview
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Whitney Scott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.