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

Sponsor
University of Cape Town (Other)
Overall Status
Recruiting
CT.gov ID
NCT04757987
Collaborator
Fogarty International Center of the National Institute of Health (NIH), Brigham and Women's Hospital (Other), University of Adelaide (Other), University of Michigan (Other)
100
Enrollment
1
Location
10.3
Anticipated Duration (Months)
9.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
An Observational Study of Shared Variation and Reciprocal Influences: Distress, Immune Function and Pain in HIV.
Actual Study Start Date :
Feb 11, 2021
Anticipated Primary Completion Date :
Dec 23, 2021
Anticipated Study Completion Date :
Dec 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Pain-free

Report persistent pain at enrolment
Persistent pain

Report no pain at enrolment

Other: Pain
As above

Outcome Measures

Primary Outcome Measures

  1. Hopkins Symptom Checklist 25-item questionnaire [Baseline]

    Psychosocial distress

  2. Provoked inflammatory response [Baseline]

    Multiplex assay

  3. Brief Pain Inventory [Baseline]

    Pain intensity

Secondary Outcome Measures

  1. Secondary hyperalgesia (surface area) [Baseline assessment only]

    Induced in a subgroup

  2. Brief Pain Inventory [Baseline]

    Pain locations

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Community Health Clinic [name withheld due to risk to participants] [City Withheld Due To Risk To Participants] Western Cape South Africa 7784

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Victoria J Madden, PhD, University of Cape Town

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Victoria Madden, Senior lecturer, University of Cape Town
ClinicalTrials.gov Identifier:
NCT04757987
Other Study ID Numbers:
  • 764/2019
  • K43TW011442
First Posted:
Feb 17, 2021
Last Update Posted:
Oct 4, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Victoria Madden, Senior lecturer, University of Cape Town
Chronic pain
HIV
Innate Immune Response
Mental health
Hyperalgesia, secondary
Additional relevant MeSH terms:
Chronic Pain

Study Results

No Results Posted as of Oct 4, 2021