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An Observational Study of Distress, Immune Function, and Pain in HIV.

Completed
Conditions
Immune System and Related Disorders
Central Sensitisation
Chronic Pain
Distress, Emotional
HIV
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
Inclusion Criteria
  • HIV-positive with viral suppression
  • report either persistent pain or no pain at enrolment
Exclusion Criteria
  • pregnancy
  • acute psychiatric condition requiring urgent care
  • cognitive impairment preventing full participation

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Hopkins Symptom Checklist 25-item questionnaireBaseline

Psychosocial distress

Provoked inflammatory responseBaseline

Multiplex assay

Brief Pain InventoryBaseline

Pain intensity

Secondary Outcome Measures
NameTimeMethod
Secondary hyperalgesia (surface area)Baseline assessment only

Induced in a subgroup

Brief Pain InventoryBaseline

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
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