Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people with HIV: The STOMP protocol

Katie Fitzgerald Jones; Matthew J Bair; Sarah Margaret Orris; Mallory Johnson; Jane M Liebschutz; William Demonte; Olivio J Clay; Amy L Durr; Claire E Farel; Deana Agil; Greer Burkholder; Bernadette Johnson; Kendall Conder; Mireille Leone; Sonia Napravnik; Tammi Thomas; Lindsay Browne; Kiko King; LaToya Mullen; Jessica Merlin

doi:10.1016/j.cct.2023.107163

Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people with HIV: The STOMP protocol

Contemp Clin Trials. 2023 Jun:129:107163. doi: 10.1016/j.cct.2023.107163. Epub 2023 Mar 21.

Authors

Katie Fitzgerald Jones¹, Matthew J Bair², Sarah Margaret Orris³, Mallory Johnson⁴, Jane M Liebschutz³, William Demonte⁵, Olivio J Clay⁶, Amy L Durr⁷, Claire E Farel⁷, Deana Agil⁷, Greer Burkholder⁸, Bernadette Johnson⁸, Kendall Conder⁷, Mireille Leone⁷, Sonia Napravnik⁷, Tammi Thomas⁸, Lindsay Browne⁷, Kiko King⁸, LaToya Mullen⁹, Jessica Merlin³

Affiliations

¹ Center for Aging and Serious Illness, Division of Geriatrics and Palliative Care, Massachusetts General Hospital, Boston, MA, USA. Electronic address: kfjones@mgh.harvard.edu.
² VA HSR&D Center for Health Information and Communication, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
³ Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
⁴ Center for AIDS Prevention Studies, University of San Francisco, San Francisco, CA, USA.
⁵ Virginia Mason Franciscan Health, Bonney Lake, WA, USA.
⁶ Department of Psychology, College of Arts and Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.
⁷ Division of Infectious Diseases, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁸ Division of Infectious Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
⁹ Division of Infectious Diseases, Department of Medicine, Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

PMID: 36958702
DOI: 10.1016/j.cct.2023.107163

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.

Keywords: HIV; Pain; Self-management; Social cognitive theory.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural

MeSH terms

Chronic Pain* / epidemiology
Chronic Pain* / therapy
Comorbidity
HIV Infections* / complications
HIV Infections* / epidemiology
Humans
Pain Management / methods
Randomized Controlled Trials as Topic
Self-Management*

Associated data

ClinicalTrials.gov/NCT03692611

Grants and funding

R01 MH115754/MH/NIMH NIH HHS/United States