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BackgroundBased on high-quality evidence, guidelines recommend the long-term use of secondary prevention medications post-myocardial infarction (MI) to avoid recurrent cardiovascular events and death. Unfortunately, discontinuation of recommended medications post-MI is common. Observational evidence suggests that prescriptions covering a longer duration at discharge from hospital are associated with greater long-term medication adherence. The following is a proposal for the first interventional study to evaluate the impact of longer prescription duration at discharge post-MI on long-term medication adherence. ObjectiveThe overarching goal of this study is to reduce morbidity and mortality among post-MI patients through improved long-term cardiac medication adherence. The specific objectives include the following. First, we will assess whether long-term cardiac medication adherence improves among elderly, post-MI patients following the implementation of (1) standardized discharge prescription forms with 90-day prescriptions and 3 repeats for recommended cardiac medication classes, in combination with education and (2) education alone compared to (3) usual care. Second, we will assess the cost implications of prolonged initial discharge prescriptions compared with usual care. Third, we will compare clinical outcomes between longer (>60 days) versus shorter prescription durations. Fourth, we will collect baseline information to inform a multicenter interventional study. MethodsWe will conduct a quasiexperimental, interrupted time series design to evaluate the impact of a multifaceted intervention to implement longer duration prescriptions versus usual care on long-term cardiac medication adherence among post-MI patients. Intervention groups and their corresponding settings include: (1) intervention group 1: 1 cardiac center and 1 noncardiac hospital allocated to receive standardized discharge prescription forms supporting the dispensation of 90 days’ worth of cardiac medications with 3 repeats, coupled with education; (2) intervention group 2: 4 sites (including 1 cardiac center) allocated to receive education only; and (3) control group: all remaining hospitals within the province that did not receive an intervention (ie, usual care). Administrative databases will be used to measure all outcomes. Adherence to 4 classes of cardiac medications — statins, beta blockers, angiotensin system inhibitors, and secondary antiplatelets (ie, prasugrel, clopidogrel, or ticagrelor) — will be assessed. ResultsEnrollment began in September 2017, and results are expected to be analyzed in late 2020. ConclusionsThe results have the potential to redefine best practices regarding discharge prescribing policies for patients post-MI. A policy of standardized maximum-duration prescriptions at the time of discharge post-MI is a simple intervention that has the potential to significantly improve long-term medication adherence, thus decreasing cardiac morbidity and mortality. If effective, this low-cost intervention to implement longer duration prescriptions post-MI could be easily scaled. Trial RegistrationClinicalTrials.gov NCT03257579; https://clinicaltrials.gov/ct2/show/NCT03257579 International Registered Report Identifier (IRRID)DERR1-10.2196/18981

BackgroundPhysical inactivity is associated with increased health risks. Primary care providers (PCPs) are well positioned to support increased physical activity (PA) levels through screening and provision of PA prescriptions. However, PCP counseling on PA is not common. ObjectiveThis study aimed to assess the feasibility of implementing an electronic health (eHealth) tool to support PA counseling by PCPs and estimate intervention effectiveness on patients’ PA levels. MethodsA pragmatic pilot study was conducted using a stepped wedge cluster randomized trial design. The study was conducted at a single primary care clinic, with 4 pre-existing PCP teams. Adult patients who had a periodic health review (PHR) scheduled during the study period were invited to participate. The eHealth tool involved an electronic survey sent to participants before their PHR via an email or a tablet; data were used to automatically produce tailored resources and a PA prescription in the electronic medical record of participants in the intervention arm. Participants assigned to the control arm received usual care from their PCP. Feasibility was assessed by the proportion of completed surveys and patient-reported acceptability and fidelity measures. The primary effectiveness outcome was patient-reported PA at 4 months post-PHR, measured as metabolic equivalent of task (MET) minutes per week. Secondary outcomes assessed determinants of PA, including self-efficacy and intention to change based on the Health Action Process Approach behavior change theory. ResultsA total of 1028 patients receiving care from 34 PCPs were invited to participate and 530 (51.55%) consented (intervention [n=296] and control [n=234]). Of the participants who completed a process evaluation, almost half (88/178, 49.4%) stated they received a PA prescription, with only 42 receiving the full intervention including tailored resources from their PCP. A cluster-level linear regression analysis yielded a non–statistically significant positive difference in MET-minutes reported per week at follow-up between intervention and control conditions (mean difference 1027; 95% CI −155 to 2209; P=.09). No statistically significant differences were observed for secondary outcomes. ConclusionsOur results suggest that it is feasible to build an eHealth tool that screens and provides tailored resources for PA in a primary care setting but suboptimal intervention fidelity suggests greater work must be done to address PCP barriers to resource distribution. Participant responses to the primary effectiveness outcome (MET-minutes) were highly variable, reflecting a need for more robust measures of PA in future trials to address limitations in patient-reported data. Trial RegistrationClinicalTrials.gov NCT03181295; https://clinicaltrials.gov/ct2/show/NCT03181295

BackgroundAs the increasing prevalence of type 2 diabetes mellitus has put pressure on health systems to appropriately manage these patients, there have been a growing number of mobile apps designed to improve the self-management of diabetes. One such app, BlueStar, has been shown to significantly reduce hemoglobin A1c (HbA1c) levels in small studies and is the first app in the United States to receive Food and Drug Administration approval as a mobile prescription therapy. However, the impact of the app across real-world population among different clinical sites and health systems remains unclear. ObjectiveThe primary objective of this study was to conduct a pragmatic randomized controlled trial of the BlueStar mobile app to determine if app usage leads to improved HbA1c levels among diverse participants in real-life clinical contexts. We hypothesized that this mobile app would improve self-management and HbA1c levels compared with controls. MethodsThe study consisted of a multicenter pragmatic randomized controlled trial. Overall, 110 participants randomized to the immediate treatment group (ITG) received the intervention for 6 months, and 113 participants randomized to the wait-list control (WLC) group received usual care for the first 3 months and then received the intervention for 3 months. The primary outcome was glucose control measured by HbA1c levels at 3 months. Secondary outcomes assessed intervention impact on patient self-management, experience of care, and self-reported health utilization using validated scales, including the Problem Areas in Diabetes, the Summary of Diabetes Self-Care Activities, and the EuroQol-5D. Intervention usage data were collected directly from the app. ResultsThe results of an analysis of covariance controlling for baseline HbA1c levels did not show evidence of intervention impact on HbA1c levels at 3 months (mean difference [ITG−WLC] −0.42, 95% CI −1.05 to 0.21; P=.19). Similarly, there was no intervention effect on secondary outcomes measuring diabetes self-efficacy, quality of life, and health care utilization behaviors. An exploratory analysis of 57 ITG participants investigating the impact of app usage on HbA1c levels showed that each additional day of app use corresponded with a 0.016-point decrease in participants’ 3-month HbA1c levels (95% CI −0.03 to −0.003). App usage varied significantly by site, as participants from 1 site logged in to the app a median of 36 days over 14 weeks (interquartile range [IQR] 10.5-124); those at another site used the app significantly less (median 9; IQR 6-51). ConclusionsThe results showed no difference between intervention and control arms for the primary clinical outcome of glycemic control measured by HbA1c levels. Although there was low usage of the app among participants, results indicate contextual factors, particularly site, had a significant impact on overall usage. Future research into the patient and site-specific factors that increase app utilization are needed. Trial RegistrationClinicaltrials.gov NCT02813343; https://clinicaltrials.gov/ct2/show/NCT02813343 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02813343)

: Introduction: Despite the increasing availability of new psychoactive substances (hereafter referred to as “salts”) in Eastern Europe and Central Asia, there is a dearth of epidemiological data on the relationship between injecting “salts” and HIV risk behaviours. This is particularly relevant in settings where injection drug use accounts for a substantial proportion of the HIV burden, such as in Kyrgyzstan, a former Soviet Republic. This study assessed whether injecting “salts” is associated with sexual and injection‐related HIV risk behaviours among people who inject drugs in Kyrgyzstan. Methods: The Kyrgyzstan InterSectional Stigma Study is a cohort of people who inject drugs in Kyrgyzstan's capital of Bishkek and the surrounding rural administrative division of Chuy Oblast. We conducted a cross‐sectional analysis using survey data collected from cohort participants between July and November 2021, which included information on injection drug use (including “salts”) and HIV risk behaviours. To minimize confounding by measured covariates, we used inverse‐probability‐weighted logistic and Poisson regression models to estimate associations between recent “salt” injection and HIV risk behaviours. Results: Of 181 participants included in the analysis (80.7% men, 19.3% women), the mean age was 40.1 years (standard deviation [SD] = 8.8), and 22% (n = 39) reported that they had injected “salts” in the past 6 months. Among people who injected “salts,” 72% (n = 28) were men, and most were ethnically Russian 59% (n = 23), with a mean age of 34.6 (SD = 9.6). Injecting “salts” was significantly associated with a greater number of injections per day (adjusted relative risk [aRR] = 1.59, 95% confidence interval [CI] = 1.30−1.95) but lower odds of using syringe service programmes in the past 6 months (adjusted odds ratio [aOR] = 0.20, 95% CI = 0.12−0.32). Injecting “salts” was also significantly associated with lower odds of condomless sex in the past 6 months (aOR = 0.42, 95% CI = 0.24−0.76) and greater odds of having ever heard of pre‐exposure prophylaxis (aOR = 4.80, 95% CI = 2.61−8.83). Conclusions: (PWID) people who inject drugs who inject “salts” are a potentially emergent group with increased HIV acquisition risk in Kyrgyzstan. Targeted outreach bundled with comprehensive harm reduction and pre‐exposure prophylaxis services are needed to prevent transmission of HIV and other blood‐borne viruses., INTRODUCTION For more than three decades, injection drug use has fuelled the HIV epidemic in Eastern Europe and Central Asia (EECA) [1, 2]. Kyrgyzstan's HIV epidemic, like most EECA countries, [...]

BackgroundIndividuals who initiate injection drug use often receive assistance from an injection-knowledgeable peer. Persons who assist peers in injection initiation events often inject frequently, which heightens overdose risk. As such, overdose and injection initiation events may be correlated. To explore a potential relationship, we assessed temporal associations between experiencing a non-fatal overdose and assisting others in initiating injection drug use among persons who inject drugs in two North American cities - Vancouver, Canada and Tijuana, Mexico.MethodsFrom 2014 to 2018, this retrospective cohort study included people who inject drugs from Vancouver (n=1332) and Tijuana (n=666) who completed a baseline and six-month follow-up interview. Within each site, we assessed bidirectional temporal associations using two separate multivariable logistic regression models: for model 1, recent provision of injection initiation assistance (at six months) was the outcome and recent overdose (at baseline) was the exposure; for model 2, recent overdose (at six months) was the outcome and recent provision of injection initiation assistance (at baseline) was the exposure. Both models adjusted for potential confounders.ResultsVancouver-based participants reporting overdose at baseline had 163% greater odds of reporting provision of injection initiation assistance at follow-up (adjusted Odds Ratio [aOR] 2.63; 95% Confidence Interval [CI] 1.41-4.90); while participants reporting provision of injection initiation assistance at baseline had 89% greater odds of reporting a non-fatal overdose at follow-up (aOR 1.89; 95% CI 1.00-3.57). Among Tijuana-based participants, we did not observe a statistically significant association in either direction.ConclusionFindings in Vancouver suggest that injection initiation assistance and overdose are bidirectionally-associated phenomena. The present findings highlight the need for interventions that ensure that persons who provide injection initiation assistance are given overdose prevention support, both for themselves and for those they assist to initiate injection drug use. While our Tijuana-based results did not suggest a bidirectional relationship, preventative approaches should nonetheless be undertaken.

ObjectiveTo assess the relationship between experiencing homelessness and assisting injection drug use (IDU) initiation among people who inject drugs (PWID) in Tijuana, Mexico and Vancouver, Canada.MethodsWe used self-reported questionnaire data collected semi-annually on PWID from Tijuana (n = 703) and Vancouver (n = 1551) between 2014 and 2017. Within each setting, the effect of recent (i.e., past six months) homelessness on recent provision of injection initiation assistance (i.e., helping anybody inject for the first time in the past six months) was estimated using inverse-probability-of-treatment (IPT)-weighted estimation of a marginal structural model.ResultsAcross follow-up, the prevalence of recent homelessness at a given visit ranged from 11.6%-16.5% among Tijuana-based participants and 9.4%-18.9% among Vancouver-based participants; the prevalence of recent provision of injection initiation at a given follow-up visit was lower, ranging from 3.3%-5.4% in Tijuana and 2.5%-4.1% in Vancouver. Based on the IPT-weighted estimates, recent homelessness was associated with 66% greater odds among Tijuana-based PWID (Adjusted Odds Ratio [AOR] = 1.66; 95% CI: 1.01-2.73) and 47% greater odds among Vancouver-based PWID (AOR = 1.47, 95% CI: 1.02-2.13) of providing injection initiation assistance over the same six-month period.ConclusionWe found that recently experiencing homelessness was associated with an increased likelihood of PWID reporting IDU initiation assistance over time in both Tijuana and Vancouver. Addressing homelessness may decrease the initiation of IDU via multiple pathways.

BackgroundGiven the prevalence and harms of incarceration among persons who inject drugs (PWID) and their role in injection drug use initiation, we aimed to investigate whether recent incarceration influences the likelihood PWID assist others in their first-ever injection.MethodsProspective cohort study of PWID in Vancouver, Canada who had their PReventing Injecting by Modifying Existing Responses (PRIMER) baseline visit between December 2014 and May 2017, reported never providing injection initiation assistance previously, and had ≥1 follow-up visit. The primary outcome, provision of injection initiation assistance, was defined via self-report as helping anybody inject for the first time in the past six months. The primary exposure was recent incarceration, i.e., self-report of being jailed, imprisoned or detained in the past six months. Participants were assessed biannually until November 2017, drop-out, or their first report of the primary outcome.Results1,199 PWID (62.1% male; mean (SD) age, 44.4 (12.3) years) were included in our study. Across 4,171 follow-up visits, 67 participants (5.6%) reported providing injection initiation assistance. The proportion of participants reporting recent incarceration varied between 2.4% to 5.1% per follow-up visit. Based on a multivariable discrete-time proportional hazards regression analysis, recent incarceration was associated with an increased risk of providing injection initiation assistance during the same six-month period (adjusted hazard ratio, 2.64; 95% CI, 1.19 to 5.86).ConclusionsThe observed association between recent incarceration and risk of providing injection initiation assistance suggests that incarceration could be contributing to the expansion of injection drug use practices within vulnerable populations over time.

Investigating the mechanisms of behavior change interventions provides a more fulsome understanding of how and why interventions work (or don't work). We assessed mechanisms of two interventions (mailouts alone, and mailouts plus telephone support, informed by the Health Action Process Approach (HAPA) and Habit Theory), designed to increase medication adherence after myocardial infarction. We conducted a process evaluation alongside a pragmatic trial. Medication adherence was assessed via self-report at 12-months in the trial, and participants in all trial groups were invited to contemporaneously complete an additional questionnaire assessing targeted mechanisms (HAPA constructs and automaticity). We used multiple regression-based mediation models to investigate indirect effects. Of 589 respondents, 497 were analyzed (92 excluded due to missing data). Mailouts plus telephone support had statistically significant but small effects on intention, social support, action planning, coping planning, and automaticity. There were no indirect effects of interventions on medication adherence via these constructs. Therefore, while this intervention led to changes in proposed mechanisms, these changes were not great enough to lead to behavior change. Refinements (and subsequent evaluation) of the interventions are warranted, and our findings indicate that this could involve offering more intensive support to form plans and identify cues for taking medications, in addition to providing physical supports to encourage self-monitoring, feedback, and habit formation. Trial registration: ClinicalTrials.gov: NCT02382731., Author(s): Nicola McCleary [sup.1] [sup.2] , Noah M. Ivers [sup.3] [sup.4] [sup.5] [sup.6] [sup.7] [sup.8] , J-D Schwalm [sup.9] [sup.10] , Holly O. Witteman [sup.1] [sup.11] , Monica Taljaard [sup.1] [...]

Despite the availability of publicly funded hepatitis C (HCV) treatment in Canada, treatment gaps persist, particularly among people who inject drugs. We estimate correlates of HCV care cascade engagement (testing, diagnosis, and treatment) among people who inject drugs in Toronto, Canada and examine the effect of accessing differing supervised consumption service (SCS) models on self‐reported HCV testing and treatment. This is a cross‐sectional baseline analysis of 701 people who inject drugs surveyed in the Toronto, Ontario integrated Supervised Injection Services (OiSIS‐Toronto) study between November 2018 and March 2020. We examine correlates of self‐reported HCV care cascade outcomes including SCS model, demographic, socio‐structural, drug use, and harm reduction characteristics. Overall, 647 participants (92%) reported ever receiving HCV testing, of whom 336 (52%) had been diagnosed with HCV. Among participants who reported ever being diagnosed with HCV, 281 (84%) reported chronic HCV, of whom 130 (46%) reported HCV treatment uptake and 151 (54%) remained untreated. Compared to those with no SCS use, participants who had ever injected at an integrated SCS model with co‐located HCV care had greater prevalence of both ever receiving HCV testing (adjusted prevalence ratio [aPR]: 1.12, 95% confidence interval [CI]: 1.02–1.24) and ever receiving HCV treatment (aPR: 1.67, 95% CI: 1.04–2.69). Over half of participants diagnosed with chronic HCV reported remaining untreated. Our findings suggest that integrated SCS models with co‐located HCV care represent key strategies for linkage to HCV care, but that more is needed to support scale‐up. [ABSTRACT FROM AUTHOR]