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BackgroundTo estimate the effects on pain of two medications (low-dose naltrexone and gabapentin) compared to placebo among people with HIV (PWH) with heavy alcohol use and chronic pain.MethodsWe conducted a pilot, randomized, double-blinded, 3-arm study of PWH with chronic pain and past-year heavy alcohol use in 2021. Participants were recruited in St. Petersburg, Russia, and randomized to receive daily low-dose naltrexone (4.5mg), gabapentin (up to 1800mg), or placebo. The two primary outcomes were change in self-reported pain severity and pain interference measured with the Brief Pain Inventory from baseline to 8 weeks.ResultsParticipants (N = 45, 15 in each arm) had the following baseline characteristics: 64% male; age 41 years (SD±7); mean 2 (SD±4) heavy drinking days in the past month and mean pain severity and interference were 3.2 (SD±1) and 3.0 (SD±2), respectively. Pain severity decreased for all three arms. Mean differences in change in pain severity for gabapentin vs. placebo, and naltrexone vs. placebo were -0.27 (95% confidence interval [CI] -1.76, 1.23; p = 0.73) and 0.88 (95% CI -0.7, 2.46; p = 0.55), respectively. Pain interference decreased for all three arms. Mean differences in change in pain interference for gabapentin vs. placebo, and naltrexone vs. placebo was 0.16 (95% CI -1.38, 1.71; p = 0.83) and 0.40 (95% CI -1.18, 1.99; p = 0.83), respectively.ConclusionNeither gabapentin nor low-dose naltrexone appeared to improve pain more than placebo among PWH with chronic pain and past-year heavy alcohol use.Clinical trial registrationClinicalTrials.gov (NCT4052139).

Abstract Background People who use drugs (PWUD) in rural communities increasingly use stimulants, such as methamphetamine and cocaine, with opioids. We examined differences in hepatitis C virus (HCV) testing and treatment history among rural PWUD with opioids, stimulants, and other substance use combinations. Methods PWUD were enrolled from ten rural U.S. communities from 2018 to 2020. Participants self-reporting a positive HCV result were asked about their HCV treatment history and drug use history. Drug use was categorized as opioids alone, stimulants alone, both, or other drug(s) within the past 30 days. Prevalence ratios (PR) were yielded using adjusted multivariable log-binomial regression with generalized linear mixed models. Results Of the 2,705 PWUD, most reported both opioid and stimulant use (74%); while stimulant-only (12%), opioid-only (11%), and other drug use (2%) were less common. Most (76%) reported receiving HCV testing. Compared to other drug use, those who reported opioid use alone had a lower prevalence of HCV testing (aPR = 0.80; 95% CI: 0.63, 1.02). Among participants (n = 944) who self-reported an HCV diagnosis in their lifetime, 111 (12%) ever took anti-HCV medication; those who used both opioids and stimulants were less likely to have taken anti-HCV medication compared with other drug(s) (aPR = 0.41; 95% CI: 0.19, 0.91). Conclusions In this pre-COVID study of U.S. rural PWUD, those who reported opioid use alone had a lower prevalence of reported HCV testing. Those diagnosed with HCV and reported both opioid and stimulant use were less likely to report ever taking anti-HCV medication.

Background. People living with HIV (PWH) frequently have co-morbid substance use disorders that may have been impacted by the COVID-19 pandemic. This study examined associations between COVID-related stress and increased substance use among PWH in Washington State. Methods. Between August 2020 and March 2021, we conducted an online survey of 397 PWH in western Washington. Logistic regression was used to analyze associations between a COVID-19 stress score and four self-reported outcomes: increased alcohol use, increased cigarette smoking, increased marijuana use, and increased use of illicit substances. Results. Thirty-five (38.0%) of 92 participants who smoked, 61 (23.4%) of 261 participants who used alcohol, 15 (14.6%) of 103 participants who used marijuana, and 35 (33.0%) of 102 participants who used illicit substances reported increased use of these substances. Higher COVID-19 stress scores were associated with higher odds of increased cigarette smoking (adjusted odds ratio [aOR] = 1.15, 95% confidence interval [CI]: 1.04–1.27), even after adjustment for anxiety and depressive symptoms (aOR 1.14, 95%CI: 1.03–1.27). COVID-19 stress was not associated with an increased use of alcohol, marijuana, or illicit substances. Conclusions. COVID-19-related stress was associated with self-reported increased cigarette smoking among PWH in western Washington during the pandemic.

Abstract Background Patients with chronic pain on opioids frequently experience loneliness, which is associated with poorer health outcomes and higher risk for opioid misuse and opioid use disorder. Given that almost half of opioids are prescribed in primary care, a critical need exists for the development and testing of interventions to reduce loneliness in primary care patients at risk for opioid misuse. Cognitive behavioral therapy and social prescribing have been shown to be efficacious in reducing loneliness and improving outcomes in other populations but have not been tested in patients at risk for substance use disorder. The overall objective of our study is to reduce opioid misuse and opioid use disorder by addressing loneliness in patients on long-term opioid therapy in real-world primary care settings. Methods We will conduct a 3-arm pragmatic, randomized controlled trial to compare the effectiveness of two group-based, telehealth-delivered interventions with treatment as usual: (1) cognitive behavioral therapy to address maladaptive thought patterns and behaviors around social connection and (2) a social prescribing intervention to connect participants with social opportunities and develop supportive social networks. Our primary outcome is loneliness as measured by the UCLA Loneliness Scale and our dependent secondary outcome is opioid misuse as measured by the Common Opioid Misuse Measure. We will recruit 102 patients on long-term opioid therapy who screen positive for loneliness from 2 health care systems in Washington State. Implementation outcomes will be assessed using the RE-AIM framework. Discussion Our study is innovative because we are targeting loneliness, an under-addressed but critical social risk factor that may prevent opioid misuse and use disorder in the setting where most patients are receiving their opioid prescriptions for chronic pain. If successful, the project will have a positive impact in reducing loneliness, reducing opioid misuse, improving function and preventing substance use disorder. Trial Registration NCT06285032, issue date: February 28, 2024, original.

Abstract Background Accurate prevalence estimates of drug use and its harms are important to characterize burden and develop interventions to reduce negative health outcomes and disparities. Lack of a sampling frame for marginalized/stigmatized populations, including persons who use drugs (PWUD) in rural settings, makes this challenging. Respondent-driven sampling (RDS) is frequently used to recruit PWUD. However, the validity of RDS-generated population-level prevalence estimates relies on assumptions that should be evaluated. Methods RDS was used to recruit PWUD across seven Rural Opioid Initiative studies between 2018-2020. To evaluate RDS assumptions, we computed recruitment homophily and design effects, generated convergence and bottleneck plots, and tested for recruitment and degree differences. We compared sample proportions with three RDS-adjusted estimators (two variations of RDS-I and RDS-II) for five variables of interest (past 30-day use of heroin, fentanyl, and methamphetamine; past 6-month homelessness; and being positive for hepatitis C virus (HCV) antibody) using linear regression with robust confidence intervals. We compared regression estimates for the associations between HCV positive antibody status and (a) heroin use, (b) fentanyl use, and (c) age using RDS-1 and RDS-II probability weights and no weights using logistic and modified Poisson regression and random-effects meta-analyses. Results Among 2,842 PWUD, median age was 34 years and 43% were female. Most participants (54%) reported opioids as their drug of choice, however regional differences were present (e.g., methamphetamine range: 4-52%). Many recruitment chains were not long enough to achieve sample equilibrium. Recruitment homophily was present for some variables. Differences with respect to recruitment and degree varied across studies. Prevalence estimates varied only slightly with different RDS weighting approaches, most confidence intervals overlapped. Variations in measures of association varied little based on weighting approach. Conclusions RDS was a useful recruitment tool for PWUD in rural settings. However, several violations of key RDS assumptions were observed which slightly impacts estimation of proportion although not associations.

Abstract Background Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold. Methods This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold. Results The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs.

Abstract Background Unhealthy alcohol use (UAU) is particularly dangerous for people with chronic liver disease. Liver clinics may be an important setting in which to provide effective alcohol-related care by integrating evidence-based strategies, such as brief intervention and medications for alcohol use disorder. We conducted qualitative interviews with clinical stakeholders and patients at liver clinics in four Veterans Health Administration (VA) medical centers to understand barriers and facilitators of integrating alcohol-related care and to support tailoring of a practice facilitation implementation intervention. Methods Data collection and analysis were guided by the Consolidated Framework for Implementation Research (CFIR). Interviews were transcribed and qualitatively analyzed using a Rapid Assessment Process (RAP) guided by the CFIR. Results We interviewed 46 clinical stakeholders and 41 patient participants and analyzed findings based on the CFIR. Clinical stakeholders described barriers and facilitators that ranged from operations/clinic resource-based (e.g., time and capacity, desire for additional provider types, referral processes) to individual perspective and preference-based (e.g., supportiveness of leadership, individual experiences/beliefs). Patient participants shared barriers and facilitators that ranged from relationship-based (e.g., trusting the provider and feeling judged) to resource and education-based (e.g., connection to a range of treatment options, education about impact of alcohol). Many barriers and facilitators to integrating alcohol-related care in liver clinics were similar to those identified in other clinical settings (e.g., time, resources, role clarity, stigmatizing beliefs). However, some barriers (e.g., fellow-led care and lack of integration of liver clinics with addictions specialists) and facilitators (e.g., presence of quality improvement staff in clinics and integrated pharmacists and behavioral health specialists) were more unique to liver clinics. Conclusions These findings support the possibility of integrating alcohol-related care into liver clinics but highlight the importance of tailoring efforts to account for variation in provider beliefs and experiences and clinic resources. The barriers and facilitators identified in these interviews were used to tailor a practice facilitation implementation intervention in each clinic setting.

Heterogeneity of outcomes across different clinical trial study sites is often inevitable. Understanding how outcomes differ by site is important for planning future programs and studies. We examined the extent of heterogeneity of hepatitis C virus (HCV) treatment cascade outcomes among persons who inject drugs (PWIDs) across sixteen clinical sites utilized in the HERO Study—a pragmatic randomized trial of HCV treatment support. Treatment cascade outcomes included averages of overall treatment adherence and proportions of treatment initiation, treatment completion, sustained virologic response (SVR) test completion, and SVR achievement. The HERO study utilized 16 clinical sites across the United States (US): eight opioid treatment programs (OTPs) and eight community health centers (CHCs). Variability of the outcomes across the 16 clinical sites was assessed using ranges and intraclass correlation coefficients (ICC) estimated from mixed-effects linear or logistic regression models. Treatment initiation was analyzed in the intention-to-treat (ITT) sample (N = 755); treatment completion, adherence, and SVR test completion in the modified ITT (mITT) sample, which is the sample that initiated treatment (N = 623); and SVR achievement in the mITT and per-protocol (PP, N = 501) samples. Across the 16 clinical sites, the range observed in the averages of overall treatment adherence was from 68% to 81% [ICC = 0.026 (0.005, 0.054)], and the ranges of proportions observed were from 68% to 96% for treatment initiation [ICC (95% CI) = 0.086 (0.051, 0.155)], 60% to 100% for treatment completion [ICC = 0.049 (0.008, 0.215)], 54% to 95% for SVR test completion [ICC = 0.096 (0.006, 0.177)], 46% to 90% for SVR achievement in the mITT sample [ICC = 0.070 (0.014, 0.122)], and 76% to 100% for SVR achievement in the PP sample [ICC = 0.143 (0.021, 0.422)]. The variability of the outcomes across 16 US sites treating HCV among PWIDs appears to be substantial in view of the ranges and ICC values of the outcomes. It is imperative to develop tailored interventions to target the sources of variability and reduce barriers at the patient, provider, clinic, and state policy levels to facilitate more equitable access to HCV treatment and reduce heterogeneity in treatment outcomes.