HIVNCT02972606
OPEN Study: Pain Management Treatment Needs Interviews
An observational study of HIV and Peripheral Neuropathy, run by King's College London at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Peripheral Neuropathy
- How many people
- 26 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2016to 31 Jul 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with HIV and painful peripheral neuropathy. We will purposively sample men, women, ethnic minorities, and people who use recreational drugs .
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
King's College London
London, SE1 9RT
Chelsea & Westminster Hospital NHS Foundation Trust
London, SW10 9NH
About this study
Official title: Online Psychological Treatment for People With Painful HIV-related Peripheral Neuropathy (OPEN Study): Qualitative Investigation of Treatment Needs
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.
Read the 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.
- Conditions
- HIV, Peripheral Neuropathy
- Keywords
- HIV, Peripheral Neuropathy, Chronic Pain, Qualitative Research
- Medical subject headings
- Peripheral Nervous System Diseases, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Chelsea and Westminster NHS Foundation Trust, University College, London
- Responsible party
- Sponsor
- Investigators
- Whitney Scott, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972606
- Sponsor's protocol ID
- 205949
- Status last verified
- Sep 2016
- First submitted
- 18 Nov 2016
- Last updated
- 11 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31855944
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Psychological Treatment for People With Painful HIV-related Peripheral Neuropathy (OPEN Study): Qualitative Investigation of Treatment Needs
- ClinicalTrials.gov ID
- NCT02972606
- Acronym / sponsor ID
- 205949
- Conditions
- HIV, Peripheral Neuropathy
- Keywords
- HIV, Peripheral Neuropathy, Chronic Pain, Qualitative Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Imperial College London, Chelsea and Westminster NHS Foundation Trust, University College, London
- Study start
- Nov 2016
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Posted 11 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with HIV and painful peripheral neuropathy. We will purposively sample men, women, ethnic minorities, and people who use recreational drugs .
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Who Completed a Semi-Structure Interview
Time frame: Day 1
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31855944Scott 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.
- Published peer-reviewed paperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Whitney Scott, PhD principal investigator
King's College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Peripheral Neuropathy, run by King's College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Completed a Semi-Structure Interview (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02972606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.