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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757987
• Other study ID #: 764/2019
• Secondary ID: K43TW011442
• Status: Completed
• Start date: February 11, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2023
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 31, 2022
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Pain
As above

Locations

Country	Name	City	State
South Africa	Community Health Clinic [name withheld due to risk to participants]	[City Withheld Due To Risk To Participants]	Western Cape

Sponsors (5)

Lead Sponsor	Collaborator
University of Cape Town	Brigham and Women's Hospital, Fogarty International Center of the National Institute of Health, University of Adelaide, University of Michigan

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hopkins Symptom Checklist 25-item questionnaire	Psychosocial distress	Baseline
Primary	Provoked inflammatory response	Multiplex assay	Baseline
Primary	Brief Pain Inventory	Pain intensity	Baseline
Secondary	Secondary hyperalgesia (surface area)	Induced in a subgroup	Baseline assessment only
Secondary	Brief Pain Inventory	Pain locations	Baseline