ABSTRACT
Importance: Chronic pain is a common condition for which efficacious interventions tailored to highly affected populations are urgently needed. People with HIV have a high prevalence of chronic pain and share phenotypic similarities with other highly affected populations. Objective: To evaluate the efficacy of a behavioral pain self-management intervention called Skills to Manage Pain (STOMP) compared to enhanced usual care (EUC). Design, Setting, and Participants: This randomized clinical trial included adults with HIV who experienced at least moderate chronic pain for 3 months or more. The study was set at the University of Alabama at Birmingham and the University of North Carolina-Chapel Hill large medical centers from August 2019 to September 2022. Intervention: STOMP combined 1-on-1 skill-building sessions delivered by staff interventionists with group sessions co-led by peer interventionists. The EUC control group received the STOMP manual without any 1-on-1 or group instructional sessions. Main Outcomes and Measures: The primary outcome was pain severity and the impact of pain on function, measured by the Brief Pain Inventory (BPI) summary score. The primary a priori hypothesis was that STOMP would be associated with a decreased BPI in people with HIV compared to EUC. Results: Among 407 individuals screened, 278 were randomized to STOMP intervention (n = 139) or EUC control group (n = 139). Among the 278 people with HIV who were randomized, the mean (SD) age was 53.5 (10.0) years; 126 (45.0%) identified as female, 146 (53.0%) identified as male, 6 (2.0%) identified as transgender female. Of the 6 possible 1-on-1 sessions, participants attended a mean (SD) of 2.9 (2.5) sessions. Of the 6 possible group sessions, participants attended a mean (SD) of 2.4 (2.1) sessions. Immediately after the intervention compared to EUC, STOMP was associated with a statistically significant mean difference for the primary outcome, BPI total score: -1.25 points (95% CI, -1.71 to -0.78 points; P < .001). Three months after the intervention, the mean difference in BPI total score remained statistically significant, favoring the STOMP intervention -0.62 points (95% CI, -1.09 to -0.14 points; P = .01). Conclusion and Relevance: The findings of this randomized clinical trial support the efficaciousness of STOMP as an intervention for chronic pain in people with HIV. Future research will include implementation studies and work to understand the optimal delivery of the intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT03692611.
ABSTRACT
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: Study procedures are ongoing, and results will be recorded in future manuscripts. CONCLUSION: The study will generate evidence on the effectiveness of STOMP with the potential to dramatically change chronic pain treatment for PWH. TRIAL REGISTRATION: clinicialtrials.gov, Clinical Trials Registration # NCT03692611https://clinicaltrials.gov/ct2/show/NCT03692611?term=STOMP&cond=Hiv&draw=2&rank=1.
