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NCT04757987 Clinical Trial

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
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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