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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04757987

Enrollment

107

Registered

2021-02-17

Start date

2021-02-11

Completion date

2022-05-31

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Chronic pain, HIV, Innate Immune Response, Mental health, Hyperalgesia, secondary

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.

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.

Interventions

OTHERPain

As above

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026