Center for Aging and Serious Illness, Division of Geriatrics and Palliative Care, Massachusetts General Hospital, Boston, MA, USA.
VA HSR&D Center for Health Information and Communication, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
Contemp Clin Trials. 2023 Jun;129:107163. doi: 10.1016/j.cct.2023.107163. Epub 2023 Mar 21.
Behavioral interventions for chronic pain among people with HIV (PWH) are understudied, with great potential to improve pain and function. Chronic pain is an important comorbidity that affects between 30% and 85% of PWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve virologic suppression. However, to date, there are few effective and scalable interventions for chronic pain in PWH.
This manuscript outlines the protocol for a randomized control trial of a novel theory-based pain self-management intervention, "Skills TO Manage Pain" (STOMP), developed for and tailored to PWH versus enhanced usual care controls. STOMP is a 12-week intervention developed from prior work on pain self-management in PWH and rigorous intervention mapping. The STOMP intervention has three major components: group sessions, one-on-one pain self-management sessions, and peer leaders.
STOMP is a 2-arm randomized trial conducted with PWH with chronic pain. The trial compares STOMP, a theory-based intervention tailored to improving chronic pain in PWH, with a comparison group receiving enhanced usual care effectiveness on pain and HIV proximal outcome measures. The proposed sample size is 280 PWH recruited from two high-volume Center for AIDS Research Network of Integrated Clinical Systems clinical sites.
Study procedures are ongoing, and results will be recorded in future manuscripts.
The study will generate evidence on the effectiveness of STOMP with the potential to dramatically change chronic pain treatment for PWH.
clinicialtrials.gov, Clinical Trials Registration # NCT03692611https://clinicaltrials.gov/ct2/show/NCT03692611?term=STOMP&cond=Hiv&draw=2&rank=1.
针对 HIV 感染者（PWH）慢性疼痛的行为干预措施研究较少，但具有改善疼痛和功能的巨大潜力。慢性疼痛是一种重要的合并症，影响着 30%至 85%的 PWH，与功能障碍的几率增加、急诊室利用率增加、HIV 护理保留不足以及未能实现病毒学抑制有关。然而，迄今为止，针对 PWH 慢性疼痛的有效且可扩展的干预措施很少。
本文概述了一项针对新型基于理论的疼痛自我管理干预措施“Skills TO Manage Pain”（STOMP）的随机对照试验方案，该干预措施针对 PWH 开发并量身定制，与增强的常规护理对照组进行比较。STOMP 是一项为期 12 周的干预措施，源自之前针对 PWH 疼痛自我管理的工作和严格的干预映射。STOMP 干预措施有三个主要组成部分：小组会议、一对一疼痛自我管理会议和同伴领导。
STOMP 是一项针对慢性疼痛 PWH 的 2 臂随机试验。该试验比较了 STOMP，一种针对改善 PWH 慢性疼痛的基于理论的干预措施，与接受增强常规护理的对照组在疼痛和 HIV 近端结果测量方面的效果。拟招募 280 名来自两个高容量艾滋病研究中心综合临床系统临床站点的 PWH。
研究程序正在进行中，结果将在以后的论文中记录。
该研究将为 STOMP 的有效性提供证据，有可能彻底改变 PWH 的慢性疼痛治疗方法。
ClinicalTrials.gov，临床试验注册号 NCT03692611 https://clinicaltrials.gov/ct2/show/NCT03692611？term=STOMP&cond=Hiv&draw=2&rank=1.
