Efficacy of a Pain Self-Management Intervention Tailored to People With HIV: A Randomized Clinical Trial.

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.

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

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.

Recent Stressful Life Events, Lifetime Traumatic Events, Missed Visits, and Antiretroviral Adherence Among Black Women With HIV in the Southeastern United States: A Cross-sectional Study.

ABSTRACT: Lifetime traumatic events are prevalent among people with HIV and consistently associated with deleterious HIV outcomes. Yet, little is known about the impact of recent stressful events on health outcomes among Black women with HIV (WWH). This cross-sectional study assessed the prevalence of recent stressful events and lifetime traumatic events and their association with HIV outcomes in Black WWH ( n = 200) in the Southeastern United States. We evaluated the association between stressful events and HIV outcomes using chi-square tests and unadjusted and adjusted logistic regression analyses. In the unadjusted analyses, missed visits were associated with higher odds of recent stressful events (odds ratio [OR] 1.10, 95% confidence interval [CI] 1.04-1.16) and lifetime traumatic events (OR 1.15, 95% CI 1.05-1.26). In the adjusted analysis, exposure to recent stressful events was independently associated with missed visits (adjusted OR 1.08, 95% CI 1.01-1.15). Interventions addressing recent stressful events are warranted.

The Mediating Role of Social Support and Resilience Between HIV-Related Stigmas and Patient Activation Among Young Black Women Living With HIV in the Southern United States: A Cross-sectional Study.

ABSTRACT: Little is known about the construct of patient activation for engaging in favorable self-management behaviors in people with HIV. We conducted a cross-sectional study among young Black women with HIV (n = 84) to examine the association between stigma and patient activation and the mediating role of social support and resilience. Social support mediated the relationship between the following dimensions of stigma and patient activation: internalized (ß = -0.20, SE = 0.08, CI [-0.369 to -0.071]) and anticipated in health care settings (ß = -0.06, SE = 0.04, CI [-0.177 to -0.001]). Resilience mediated the relationship between the following dimensions of stigma and patient activation: anticipated in health care (ß = -0.20, SE = 0.08, CI [-0.387 to -0.057]) and community settings (ß = -0.15, SE = 0.08, CI [-0.318 to -0.017]), and enacted in community settings (ß = -0.14, SE = 0.09, CI [-0.332 to -0.001]). Our findings suggest intrapersonal and interpersonal mechanisms by which various dimensions of stigma contribute to patient activation, thus identifying social support, resilience, and patient activation as potential intervention targets.