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.

Using Intervention Mapping to Develop a Novel Pain Self-Management Intervention for People with Cirrhosis.

BACKGROUND: Chronic pain is common among patients with cirrhosis and is challenging to treat. While promising, pain self-management (PSM) interventions have not been tailored to this population's needs. AIMS: To design a PSM intervention for patients with cirrhosis. METHODS: Semi-structured interviews with 17 patients with cirrhosis, 12 hepatologists, and 6 administrators from two medical centers were conducted to inform a rigorous, structured intervention mapping (IM) process. Qualitative content analysis was guided by social cognitive theory (SCT) and the Consolidated Framework for Implementation Research (CFIR) and incorporated into intervention development. A planning group met regularly throughout the intervention, to reach consensus about how to use data and theory to develop the intervention through IM. RESULTS: Participants described barriers to PSM behaviors, including the absence of simple, evidence-based interventions for pain for patients with cirrhosis, inadequate provider knowledge, time, and training, and lack of champions, funding, and communication. Patients described high motivation to treat pain using behavioral methods including meditation, prayer, and exercise. The intervention was designed to address barriers to PSM behaviors for patients with cirrhosis, using behavior change methods that address knowledge, self-efficacy, and outcome expectations. The LEAP (Liver Education About Pain) intervention is a 12-week, modular intervention delivered by phone via individual and group sessions with a health coach. CONCLUSIONS: People with cirrhosis, hepatologists, and administrators informed this theory-driven, tailored PSM intervention, which was designed to be implementable in the real world.

Intervention Mapping to develop a Social Cognitive Theory-based intervention for chronic pain tailored to individuals with HIV.

Chronic pain is an important comorbidity among individuals with HIV. Behavioral interventions are widely regarded as evidence-based, efficacious non-pharmacologic interventions for chronic pain in the general population. An accepted principle in behavioral science is that theory-based, systematically-developed behavioral interventions tailored to the unique needs of a target population are most likely to be efficacious. Our aim was to use Intervention Mapping to systematically develop a Social Cognitive Theory (SCT)-based intervention for chronic pain tailored to individuals with HIV that will improve pain intensity and pain-related functional impairment. Our Intervention Mapping process was informed by qualitative inquiry of 24 patients and seven providers in an HIV primary care clinic. The resulting intervention includes group and one-on-one sessions and peer and staff interventionists. We also developed a conceptual framework that integrates our qualitative findings with SCT-based theoretical constructs. Using this conceptual framework as a guide, our future work will investigate the intervention's impact on chronic pain outcomes, as well as our hypothesized proximal mediators of the intervention's effect.

Literacy-Adapted Cognitive Behavioral Therapy Versus Education for Chronic Pain at Low-Income Clinics: A Randomized Controlled Trial.

Background: Chronic pain is common and challenging to treat. Although cognitive behavioral therapy (CBT) is efficacious, its benefit in disadvantaged populations is largely unknown. Objective: To evaluate the efficacy of literacy-adapted and simplified group CBT versus group pain education (EDU) versus usual care. Design: Randomized controlled trial. (ClinicalTrials.gov: NCT01967342). Setting: Community health centers serving low-income patients in Alabama. Patients: Adults (aged 19 to 71 years) with mixed chronic pain. Interventions: CBT and EDU delivered in 10 weekly 90-minute group sessions. Measurements: Self-reported, postintervention pain intensity (primary outcome) and physical function and depression (secondary outcomes). Results: 290 participants were enrolled (70.7% of whom were women, 66.9% minority group members, 72.4% at or below the poverty level, and 35.8% reading below the fifth grade level); 241 (83.1%) participated in posttreatment assessments. Linear mixed models included all randomly assigned participants. Members of the CBT and EDU groups had larger decreases in pain intensity scores between baseline and posttreatment than participants receiving usual care (estimated differences in change scores-CBT: -0.80 [95% CI -1.48 to -0.11]; P = 0.022; EDU: -0.57 [CI, -1.04 to -0.10]; P = 0.018). At 6-month follow-up, treatment gains were not maintained in the CBT group but were still present in the EDU group. With regard to physical function, participants in the CBT and EDU interventions had greater posttreatment improvement than those receiving usual care, and this progress was maintained at 6-month follow-up. Changes in depression (secondary outcome) did not differ between either the CBT or EDU group and the usual care group. Limitations: Participants represented a single health care system. Self-selection bias may have been present. Conclusion: Simplified group CBT and EDU interventions delivered at low-income clinics significantly improved pain and physical function compared with usual care. Primary Funding Source: Patient-Centered Outcomes Research Institute.

A Randomized Pilot Trial of a Novel Behavioral Intervention for Chronic Pain Tailored to Individuals with HIV.

Chronic pain is an important and understudied comorbidity in people living with HIV (PLWH). We conducted a pilot trial of Skills TO Manage Pain (STOMP), an innovative social cognitive theory-based pain self-management intervention tailored to PLWH, to assess feasibility, acceptability, and preliminary efficacy. Eligibility criteria included being HIV+, ≥ moderate pain for ≥ 3 months and a score of ≥ 4 on the three-item PEG pain severity and interference scale. Participants were randomized in a 1:1 fashion to STOMP or a usual care comparison. Among 22 participants randomized to STOMP, median session attendance was 9/12 (75%). Of 19 STOMP participants surveyed, 13 reported being "much better" overall since beginning treatment. Brief pain inventory-total scores decreased by 2 points in the intervention group and 0.9 in the control group (p = 0.11). STOMP is feasible, acceptable, and shows preliminary evidence of efficacy and promise for a full-scale trial.

Using Patient Perspectives to Inform the Development of a Behavioral Intervention for Chronic Pain in Patients with HIV: A Qualitative Study.

Background: Chronic pain is a common and disabling comorbidity in individuals living with HIV. Behavioral interventions are among the most effective and safe nonpharmacologic treatments for chronic pain. However, the success of a behavioral intervention is influenced by how well it is tailored to the target population's biological, psychological, and social context. Given well-documented psychosocial vulnerabilities among persons with HIV, it is critical to develop a behavioral intervention for chronic pain tailored to this population. Objective: To use qualitative methods to investigate patient preferences for the structure and delivery of a behavioral intervention for chronic pain in individuals with HIV. Methods: Interviews and focus groups were used to elicit participant preferences. A thematic analysis approach, with an initial round of open coding, was used to develop the codebook and analyze the data. Results: Qualitative data from 12 interviews and 3 focus groups with patients living with HIV and chronic pain (total N = 24) were analyzed. Emergent themes fell into four major categories: perceived value of group sessions, incorporating peer leadership, and two key elements of how the intervention should be delivered: the HIV status of group participants and views on phone-delivered intervention content. Discussion: This study provides a framework for the structure and delivery of a behavioral intervention for chronic pain in individuals with HIV based on patient preferences. We will use these results to design our intervention, and hope that our approach informs the work of investigators in other disciplines who seek to incorporate patient preferences during intervention development.

Future implications of eHealth interventions for chronic pain management in underserved populations.

Many underserved communities, especially those in rural settings, face unique challenges that make high quality healthcare less accessible. The implementation of eHealth technologies has become a potentially valuable option to disseminate interventions. The authors' work in rural Alabama Federally Qualified Health Centers provide insights into the access to technology as well as the likelihood of utilizing eHealth technology in underserved communities. This paper will review current challenges related to digital dissemination of behavioral health interventions for chronic pain. Two major concerns are the lack of technological resources and the lack of appropriate materials for patients who may have low levels of reading, health and/or digital literacy. We will propose some recommendations to address common barriers faced by those providing care.

Colorectal cancer knowledge, attitudes, screening, and intergenerational communication among Japanese American families: an exploratory, community-based participatory study.

Adults of Japanese descent (Nikkei) in the United States have higher risk for colorectal cancer (CRC) than their white counterparts. Family norms toward CRC screening may influence screening behaviors of Nikkei adults. This community-based participatory research study explores if mailing educational pamphlets to Nikkei families can influence CRC knowledge, attitudes, and screening adherence; and trigger intergenerational communication about CRC. Among 56 parent-offspring dyads contacted, 24 were eligible (e.g., no prior CRC screening/diagnosis) and were randomized into 3 cohorts defined by the "target recipient(s)" of study pamphlets about CRC screening: parent only, offspring only, and both parent and offspring. Among the 19 completed dyads (79.2 % = 19/24), results showed that CRC knowledge of most pamphlet recipients increased in all cohorts; however, some misinformation and attitudinal barriers persisted. Although some parent-offspring communication about CRC increased after mailing pamphlets to offspring, only spousal communication occurred after mailing pamphlets to parents. Additional benefits were not observed in increasing parental screening intent/behavior after mailing pamphlets to both parent and offspring. At the end, among the 10 parents who reported developing CRC screening intent or having scheduled a CRC screening, 8 attributed to study pamphlets and 2 to communication with their offspring. Self-reported barriers preventing screening and parent-offspring communication about CRC were identified. This exploratory study describes preliminary findings that will inform future research aimed to promote CRC screening and reduce racial/ethnic disparities at the community level by enhancing intergenerational communication among Nikkei families.