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Completed

NCT Number: NCT04757987

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

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.

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Key information

Conditions

Chronic Pain Behavior Central Sensitisation Distress, Emotional HIV Hyperalgesia Immune System and Related Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pain

Other

As above

Primary outcomes

  1. Hopkins Symptom Checklist 25-item questionnaire

    Time frame: Baseline

    Psychosocial distress

  2. Provoked inflammatory response

    Time frame: Baseline

    Multiplex assay

  3. Brief Pain Inventory

    Time frame: Baseline

    Pain intensity

Secondary outcomes

  1. Secondary hyperalgesia (surface area)

    Time frame: Baseline assessment only

    Induced in a subgroup

  2. Brief Pain Inventory

    Time frame: Baseline

    Pain locations

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Collaborators

  • Brigham and Women's Hospital
  • Fogarty International Center of the National Institute of Health
  • University of Adelaide
  • University of Michigan

Registry information

Official study title

An Observational Study of Shared Variation and Reciprocal Influences: Distress, Immune Function and Pain in HIV.

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 17, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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