Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people living with HIV: Skills To Manage Pain (STOMP)

PI: Jessica Merlin, MD, PhD, MBA

Co-Is: Michael S. Saag, MD; Mallory O. Johnson, PhD; Olivio J. Clay, PhD; Michael J. Mugavero, MD, MHSC; Dustin M. Long, PhD; Meredith L. Kilgore, PhD; Edward Cachay, MD

Grant Number: NIH 1R01MH115754-01A1

Project Summary: Behavioral interventions for chronic pain among people living with HIV (PLWH) are an understudied area, with great potential to improve pain and function. Chronic pain is an important comorbidity that affects between 30% and 85% of PLWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve virologic suppression. What is not known is how to optimally address chronic pain in this population. Opioids are a commonly used treatment for chronic pain, particularly in PLWH. Opioid prescribing for chronic pain often does not result in substantial improvement in outcomes and contributes to the growing epidemic of opioid addiction and overdose.

In contrast, behavioral interventions are among the most effective and safest treatments for chronic pain in the general population. Pain Self-Management (PSM) is a Social Cognitive Theory (SCT)-based behavioral approach that involves pain-related skill acquisition and goal setting. PSM interventions have been promoted by the 2016 Department of Health and Human Services National Pain Strategy (DHHS NPS) as an effective, scalable approach to chronic pain management. Especially given the current opioid crisis, the DHHS NPS underscored the urgent need to develop and test PSM interventions tailored to the unique needs of vulnerable populations, particularly PLWH, that can be implemented and disseminated nationwide. Until an effective and scalable PSM intervention for chronic pain in PLWH is developed, reducing the burden of chronic pain safely and effectively in this population will not be possible.

The overall objective of this proposal is to evaluate a novel theory-based PSM intervention,“Skills TO Manage Pain” (STOMP), developed for and tailored to PLWH. We will accomplish our overall objective with the following primary specific aim: 1) Evaluate the efficacy of STOMP, a theory-based intervention tailored to improving chronic pain in PLWH. Given our rigorous intervention development process and promising pilot trial results, our working hypothesis is that STOMP will decrease pain and improve function in PLWH. We also propose the following secondary aims: 2) Conduct exploratory analyses of the impact of STOMP on HIV outcomes associated with chronic pain (i.e. retention in care, virologic suppression), and 3) Investigate proximal outcomes as potential mediators of STOMP's impact on chronic pain. This approach is innovative because it incorporates novel peer co-led group sessions that were created based on our formative intervention development work, includes patients with comorbidities (e.g., depressive symptoms, addiction history) common among PLWH but typically excluded from chronic pain studies, and investigates the impact of a chronic pain intervention on disease-specific HIV outcomes in addition to pain and function. The proposed research will be significant because if successful, it will pave the way for future dissemination and implementation studies that have the potential to dramatically change chronic pain treatment for PLWH.

Other Sites:
University of Alabama at Birmingham, Birmingham, AL
University of California San Diego, La Jolla, CA
University of California San Francisco, San Francisco, CA

Merlin JS, Samet JH, Cheng DM, Lira MC, Tsui JI, Forman LS, Colasanti J, Walley AY, Del Rio C, Liebschutz JM. Marijuana Use and Its Associations With Pain, Opioid Dose, and HIV Viral Suppression Among Persons Living With HIV on Chronic Opioid TherapyJ Acquir Immune Defic Syndr. 2019 Oct 1;82(2):195-201. doi: 10.1097/QAI.0000000000002119. PubMed PMID: 31513554; PubMed Central PMCID: PMC6746234.

Merlin JS, Long D, Becker WC, Cachay ER, Christopoulos KA, Claborn K, Crane HM, Edelman EJ, Harding R, Kertesz SG, Liebschutz JM, Mathews WC, Mugavero MJ, Napravnik S, C OʼCleirigh C, Saag MS, Starrels JL, Gross R. Brief Report: The Association of Chronic Pain and Long-Term Opioid Therapy With HIV Treatment Outcomes. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):77-82. doi: 10.1097/QAI.0000000000001741. PubMed PMID: 29771793; PubMed Central PMCID: PMC6092197.

Merlin JS, Westfall AO, Long D, Davies S, Saag M, Demonte W, Young S, Kerns RD, Bair MJ, Kertesz S, Turan JM, Kilgore M, Clay OJ, Starrels J, Pekmezi D, Johnson MO. A Randomized Pilot Trial of a Novel Behavioral Intervention for Chronic Pain Tailored to Individuals with HIVAIDS Behav. 2018 Aug;22(8):2733-2742. doi: 10.1007/s10461-018-2028-2. PubMed PMID: 29340913; PubMed Central PMCID: PMC6047927.

Merlin JS, Young SR, Johnson MO, Saag M, Demonte W, Kerns R, Bair MJ, Kertesz S, Turan JM, Kilgore M, Clay OJ, Pekmezi D, Davies S. Intervention Mapping to develop a Social Cognitive Theory-based intervention for chronic pain tailored to individuals with HIV. Contemp Clin Trials Commun. 2018 Jun;10:9-16. doi: 10.1016/j.conctc.2018.02.004. eCollection 2018 Jun. PubMed PMID: 29696153; PubMed Central PMCID: PMC5898474.