An Observational Study of Shared Variation and Reciprocal Influences: Distress, Immune Function and Pain in HIV.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Provoked inflammatory response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-positive with viral suppression
- •report either persistent pain or no pain at enrolment
排除标准
- •pregnancy
- •acute psychiatric condition requiring urgent care
- •cognitive impairment preventing full participation
结局指标
主要结局
Provoked inflammatory response
时间窗: Baseline
Multiplex assay
Hopkins Symptom Checklist 25-item questionnaire
时间窗: Baseline
Psychosocial distress
Brief Pain Inventory
时间窗: Baseline
Pain intensity
次要结局
- Secondary hyperalgesia (surface area)(Baseline assessment only)
- Brief Pain Inventory(Baseline)
研究者
Victoria Madden
Senior lecturer
University of Cape Town