An Observational Study of Distress, Immune Function, and Pain in HIV.
- Conditions
- Immune System and Related DisordersCentral SensitisationChronic PainDistress, EmotionalHIV
- Registration Number
- NCT04757987
- Lead Sponsor
- University of Cape Town
- Brief Summary
This case-control study focuses on pain in HIV, which is common despite antiretroviral therapy and compromises quality of life, mental health and daily functioning. Specifically, it will investigate the relationships between psychosocial distress, inflammation and pain in HIV.
- Detailed Description
We plan to recruit 100 people and follow them for 6 months, taking repeated measures. Participants who report persistent pain at enrolment will be assessed at 0 (baseline), 2, 4, and 6 months. Participants who report no pain at enrolment will be assessed at 0 (baseline) and 6 months. All participants will also be invited to participate in weekly remote assessment of selected self-reported outcomes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
- HIV-positive with viral suppression
- report either persistent pain or no pain at enrolment
- pregnancy
- acute psychiatric condition requiring urgent care
- cognitive impairment preventing full participation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hopkins Symptom Checklist 25-item questionnaire Baseline Psychosocial distress
Provoked inflammatory response Baseline Multiplex assay
Brief Pain Inventory Baseline Pain intensity
- Secondary Outcome Measures
Name Time Method Secondary hyperalgesia (surface area) Baseline assessment only Induced in a subgroup
Brief Pain Inventory Baseline Pain locations
Trial Locations
- Locations (1)
Community Health Clinic [name withheld due to risk to participants]
🇿🇦[City Withheld Due To Risk To Participants], Western Cape, South Africa
Community Health Clinic [name withheld due to risk to participants]🇿🇦[City Withheld Due To Risk To Participants], Western Cape, South Africa