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

An Observational Study of Shared Variation and Reciprocal Influences: 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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; HIV; Distress, Emotional; Central Sensitisation; Immune System and Related Disorders
• Intervention / Treatment: Other: Pain

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.

• Study Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • [City Withheld Due To Risk To Participants], Western Cape, South Africa, 7784
      • Community Health Clinic [name withheld due to risk to participants]

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic in South Africa.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pain-free; Report persistent pain at enrolment
Persistent pain; Report no pain at enrolment	Other: Pain; As above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hopkins Symptom Checklist 25-item questionnaire	Psychosocial distress	Baseline
Provoked inflammatory response	Multiplex assay	Baseline
Brief Pain Inventory	Pain intensity	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary hyperalgesia (surface area)	Induced in a subgroup	Baseline assessment only
Brief Pain Inventory	Pain locations	Baseline

Collaborators and Investigators

• Sponsor: University of Cape Town
• Collaborators: University of Michigan; Brigham and Women's Hospital; Fogarty International Center of the National Institute of Health; University of Adelaide
• Investigators: Principal Investigator: Victoria J Madden, PhD, University of Cape Town

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 14, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Chronic pain; Mental health; Innate Immune Response; Hyperalgesia, secondary
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 764/2019; K43TW011442 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The final dataset will include demographic, health history, psychological, and physiological data. An important priority when considering sharing of these data is participant confidentiality, particularly considering the stigma and personal social risk associated with HIV+ status in South Africa. If the data can be adequately stripped of identifiers so as to eliminate risk to participants, then the final, de-identified data set will be made available to qualified users through a data sharing platform, and subject to a sharing agreement that includes (1) a commitment to using the data only for research purposes and not to identify any individual participant; and (2) a commitment to securing the data using appropriate computer technology.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No