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

University of Cape Town (UCT)

Status: Completed

Conditions: Immune System and Related Disorders; HIV; Chronic Pain; Distress, Emotional; Central Sensitisation

Treatments: Other: Pain

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04757987

764/2019

K43TW011442 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

107 participants in 2 patient groups

Pain-free

Description:

Report persistent pain at enrolment

Persistent pain

Description:

Report no pain at enrolment

Treatment:

Other: Pain