Browsing by Author "Clay, Olivio J."

Now showing 1 - 5 of 5
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    Cost-effectiveness of a chronic pain intervention for people living with HIV (PLWH)
    (Taylor & Francis, 2018) Merlin, Jessica S.; Westfall, Andrew O.; Johnson, Mallory O.; Kerns, Robert D.; Bair, Matthew J.; Kertesz, Stefan; Turan, Janet M.; Clay, Olivio J.; Starrels, Joanna L.; Kilgore, Meredith; Medicine, School of Medicine
    Background: Chronic pain is a common, disabling, and costly comorbidity, particularly in people living with HIV (PLWH). This study developed and pilot tested a pain self-management intervention for chronic pain tailored to PLWH called Skills TO Manage Pain (STOMP). Objectives: Given the additional resources needed to deliver STOMP in HIV clinical settings, an important objective of the pilot study was to assess not only STOMP’s preliminary efficacy, but also its cost-effectiveness. Research design and subjects: The present study draws from a 44-participant, 2-arm randomized pilot trial of the STOMP intervention vs usual care among PLWH and at least moderate chronic pain (Clinicaltrials.gov: NCT02824562). Cost-effectiveness is presented as the incremental cost-effectiveness ratio (ICER). Costs were considered from the clinic perspective over a 1-year time horizon using real costs from the pilot trial. It was conservatively assumed there would be no costs savings. The Standard Gamble (SG) method was used to directly measure utilities. Results: Thirty-six participants met inclusion criteria for the present analyses. Mean age was 52 years; 61% were female and 86% were black. The total cost of STOMP was $483.83 per person. Using the SG method, the change in QALYs was 0.15, corresponding to an ICER of $3,225. Conclusions: STOMP’s cost/QALY is substantially lower than the $50,000 to $100,000/QALY benchmark often used to indicate cost-effectiveness. Although based on a pilot trial and, therefore, preliminary, these findings are promising, and suggest the importance of cost analyses in future STOMP trials.
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    Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people with HIV: The STOMP protocol
    (Elsevier, 2023-06) Fitzgerald Jones, Katie; Bair, Matthew J.; Orris, Sarah Margaret; Johnson, Mallory; Liebschutz, Jane M.; Demonte, William; Clay, Olivio J.; Durr, Amy L.; Farel, Claire E.; Agil, Deana; Burkholder, Greer; Johnson, Bernadette; Conder, Kendall; Leone, Mireille; Napravnik, Sonia; Thomas, Tammi; Browne, Lindsay; King, Kiko; Mullen, LaToya; Merlin, Jessica; Demonte, William S.; Medicine, School of Medicine
    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.
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    Intervention Mapping to develop a Social Cognitive Theory-based intervention for chronic pain tailored to individuals with HIV
    (Elsevier, 2018-02-19) Merlin, Jessica S.; Young, Sarah R.; Johnson, Mallory O.; Saag, Michael; Demonte, William; Kerns, Robert; Bair, Matthew J.; Kertesz, Stefan; Turan, Janet M.; Kilgore, Meredith; Clay, Olivio J.; Pekmezi, Dorothy; Davies, Susan; Medicine, School of Medicine
    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.
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    A Randomized Pilot Trial of a Novel Behavioral Intervention for Chronic Pain Tailored to Individuals with HIV
    (Springer Nature, 2018-08) Merlin, Jessica S.; Westfall, Andrew O.; Long, Dustin; Davies, Susan; Saag, Michael; Demonte, William; Young, Sarah; Kerns, Robert D.; Bair, Matthew J.; Kertesz, Stefan; Turan, Janet M.; Kilgore, Meredith; Clay, Olivio J.; Starrels, Joanna; Pekmezi, Dorothy; Johnson, Mallory O.; Medicine, School of Medicine
    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.
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    The relationship of cognitive change over time to the self-reported Ascertain Dementia 8-item Questionnaire in a general population
    (Oxford University Press, 2021) Passler, Jesse S.; Kennedy, Richard E.; Crowe, Michael; Clay, Olivio J.; Howard, Virginia J.; Cushman, Mary; Unverzagt, Frederick W.; Wadley, Virginia G.; Psychiatry, School of Medicine
    Objective: The aim of the study was to examine the relationship between longitudinally assessed cognitive functioning and self-reported dementia status using the Ascertain Dementia 8-item questionnaire (AD8) in a national population-based sample. Methods: The analysis included 14,453 participants from the REasons for Geographic and Racial Differences in Stroke study. A validated cutoff of ≥2 symptoms endorsed on the AD8 (administered 10 years after enrollment) represented positive AD8 status. Incident cognitive impairment was defined as change from intact to impaired status in the Six-Item Screener score, and cognitive decline was defined by trajectories of Letter "F" Fluency from the Montreal Cognitive Assessment, and Animal Fluency, Word List Learning, and Word List Delayed recall, all from the Consortium to Establish a Registry for Alzheimer's Disease battery. Logistic regression models controlled for demographics, health variables, and depressive symptoms. Results: Sensitivity and specificity of the AD8 to detect incident cognitive impairment were 45.2% and 78.4%, respectively. Incident cognitive impairment and a one-word decline in WLL increased the odds of self-reported positive AD8 by 96% (95% CI: 1.68-2.28) and 27% (95% CI: 1.17-1.37), respectively. There was a strong association between high depression risk and self-reported positive AD8 in sensitivity analyses. Conclusions: Incident cognitive impairment and high depression risk were the strongest predictors of self-reported positive AD8 in this population-based sample. Our results inform the utility of the AD8 as a self-report measure in a large, national sample that avoids selection biases inherent in clinic-based studies. The AD8 is screening measure and should not be used to diagnose dementia clinically.