CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 7
  • Adults aged 18 years or older
  • Living with HIV
  • Bilateral foot pain and/or numbness in symmetrical distribution
  • Neuropathic pain score ≥3 on Patient Reported Outcomes section of Neuropathic Pain Interview
Key exclusion· 4
  • Alternative neuropathy causes: excessive alcohol consumption, hypothyroidism, vitamin B12 deficiency, diabetes, isoniazid or chemotherapy exposure, or known neuropathy from non-HIV/non-antiretroviral cause
  • Unable to conduct interview in English
  • Current diagnosis of dementia or learning disability
  • Unwilling to provide written informed consent

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02972606
NCT02972606N/ACompleted

Online Psychological Treatment for People With Painful HIV-related Peripheral Neuropathy (OPEN Study): Qualitative Investigation of Treatment Needs

King's College London·observational·Posted Nov 23, 2016·Updated Jan 11, 2023

In Brief

An observational study for HIV and Peripheral Neuropathy. Completed, enrolled 26 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 23, 2016
Enrollment StartNov 1, 2016
Primary CompletionJul 31, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.6 years ago