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

NCT04757987 | Completed

• 2 other identifiers: 764/2019K43TW011442
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; HIV; Distress, Emotional; Immune System and Related Disorders; Central Sensitisation

Keywords

Chronic pain; HIV; Innate Immune Response; Mental health; Hyperalgesia, secondary

Outcome Measures

Primary Outcomes (3)

• Hopkins Symptom Checklist 25-item questionnaire

  Psychosocial distress

  Baseline

• Provoked inflammatory response

  Multiplex assay

  Baseline

• Brief Pain Inventory

  Pain intensity

  Baseline

Secondary Outcomes (2)

• Secondary hyperalgesia (surface area)

  Baseline assessment only

• Brief Pain Inventory

  Baseline

Study Arms (2)

Pain-free

Report persistent pain at enrolment

Persistent pain

Report no pain at enrolment

Other: Pain

Interventions

Pain OTHER

As above

Persistent pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic in South Africa.

You may qualify if:

• HIV-positive with viral suppression
• report either persistent pain or no pain at enrolment

You may not qualify if:

• pregnancy
• acute psychiatric condition requiring urgent care
• cognitive impairment preventing full participation

Sponsors & Collaborators

• University of Cape Town: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Brigham and Women's Hospital: collaborator
• University of Adelaide: collaborator
• University of Michigan: collaborator

Study Sites (1)

Community Health Clinic [name withheld due to risk to participants]

[City Withheld Due to Risk to Participants], Western Cape, 7784, South Africa

Location

Related Publications (2)

• Madden VJ, Mqadi L, Arendse G, Bedwell GJ, Msolo N, Lesosky M, Hutchinson MR, Peter JG, Schrepf A, Parker R, Edwards RR, Joska JA. Provoked cytokine response is not associated with distress or induced secondary hyperalgesia in people with suppressed HIV. Pain. 2025 Dec 1;166(12):e830-e843. doi: 10.1097/j.pain.0000000000003748. Epub 2025 Aug 7.

  PMID: 40788259 DERIVED

• Madden VJ, Msolo N, Mqadi L, Lesosky M, Bedwell GJ, Hutchinson MR, Peter JG, Parker R, Schrepf A, Edwards RR, Joska JA. Study protocol: an observational study of distress, immune function and persistent pain in HIV. BMJ Open. 2022 Jun 3;12(6):e059723. doi: 10.1136/bmjopen-2021-059723.

  PMID: 36691234 DERIVED

MeSH Terms

Conditions

Chronic Pain; Psychological Well-Being; Hyperalgesia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Study Officials

• Victoria J Madden, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 17, 2021
• Study Start: February 11, 2021
• Primary Completion: November 24, 2021
• Study Completion: May 31, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

ZA (1)