Pharmacokinetics and Safety of Remdesivir in Pregnant and Non-Pregnant Women with COVID-19: Results from IMPAACT 2032.

BACKGROUND: Pregnant people with COVID-19 experience higher risk for severe disease and adverse pregnancy outcomes, but no pharmacokinetic (PK) data exist to support dosing of COVID-19 therapeutics during pregnancy. We report PK and safety data for intravenous remdesivir in pregnancy. METHODS: IMPAACT 2032 was a phase IV prospective, open-label, non-randomized opportunistic study of hospitalized pregnant and non-pregnant women receiving intravenous remdesivir as part of clinical care. Intensive PK sampling was performed on infusion days 3, 4, or 5 with collection of plasma and peripheral blood mononuclear cells (PBMCs). Safety data were recorded from first infusion through 4 weeks post-last infusion and at delivery. Geometric mean ratios (GMR) (90% confidence intervals [CI]) of PK parameters between pregnant and non-pregnant women were calculated. RESULTS: Fifty-three participants initiated remdesivir (25 pregnant; median (IQR) gestational age 27.6 (24.9, 31.0) weeks). Plasma exposures of remdesivir, its two major metabolites (GS-704277 and GS-441524), and the free remdesivir fraction were similar between pregnant and non-pregnant participants. Concentrations of the active triphosphate (GS-443902) in PBMCs increased 2.04-fold (90% CI 1.35, 3.03) with each additional infusion in non-pregnant versus pregnant participants. Three adverse events in non-pregnant participants were related to treatment (one Grade 3; two Grade 2 resulting in treatment discontinuation). There were no treatment-related adverse pregnancy outcomes or congenital anomalies detected. CONCLUSIONS: Plasma remdesivir PK parameters were comparable between pregnant and non-pregnant women, and no safety concerns were identified based on our limited data. These findings suggest no dose adjustments are indicated for intravenous remdesivir during pregnancy.

Lamivudine dosing for preterm infants exposed to HIV: a population pharmacokinetic modelling and simulation study.

OBJECTIVES: To develop a pragmatic twice daily lamivudine dosing strategy for preterm infants from 24 to 37 completed weeks of gestation. METHODS: Data were combined from eight pharmacokinetic studies in neonates and infants receiving lamivudine oral solution. A population pharmacokinetic model was developed using non-linear mixed effects regression. Different lamivudine dosing strategies, stratified by gestational age at birth (GA) bands, were simulated in a virtual population of preterm infants, aimed at maintaining lamivudine drug exposures (AUC0-12) within a reference target range of 2.95 to 13.25 µg·h/mL, prior to switching to WHO-weight band doses when ≥4 weeks of age and weighing ≥3 kg. RESULTS: A total of 154 infants (59% female) contributed 858 lamivudine plasma concentrations. Median (range) GA at birth was 38 (27-41) weeks. At the time of first pharmacokinetic sampling infants were older with median postnatal age (PNA) of 6.3 (0.52-26.6) weeks. Lamivudine concentrations were described by a one-compartment model, with CL/F and V/F allometrically scaled to weight. Maturation of CL/F was described using an Emax model based on PNA. CL/F was also adjusted on GA to allow extrapolation for extreme prematurity. Simulations predicted an optimal lamivudine dosing for infants GA ≥24 to <30 weeks of 2 mg/kg twice daily from birth until weighing 3 kg; and for GA ≥30 to <37 weeks, 2 mg/kg twice daily for the first 4 weeks of life, followed by 4 mg/kg twice daily until weighing 3 kg. CONCLUSIONS: Model-based predictions support twice daily pragmatic GA band dosing of lamivudine for preterm infants, but clinical validation is warranted.

Psychiatrists' Comfort Using Computers and Other Electronic Devices in Clinical Practice.

This report highlights findings from the Study of Psychiatrists' Use of Informational Resources in Clinical Practice, a cross-sectional Web- and paper-based survey that examined psychiatrists' comfort using computers and other electronic devices in clinical practice. One-thousand psychiatrists were randomly selected from the American Medical Association Physician Masterfile and asked to complete the survey between May and August, 2012. A total of 152 eligible psychiatrists completed the questionnaire (response rate 22.2 %). The majority of psychiatrists reported comfort using computers for educational and personal purposes. However, 26 % of psychiatrists reported not using or not being comfortable using computers for clinical functions. Psychiatrists under age 50 were more likely to report comfort using computers for all purposes than their older counterparts. Clinical tasks for which computers were reportedly used comfortably, specifically by psychiatrists younger than 50, included documenting clinical encounters, prescribing, ordering laboratory tests, accessing read-only patient information (e.g., test results), conducting internet searches for general clinical information, accessing online patient educational materials, and communicating with patients or other clinicians. Psychiatrists generally reported comfort using computers for personal and educational purposes. However, use of computers in clinical care was less common, particularly among psychiatrists 50 and older. Information and educational resources need to be available in a variety of accessible, user-friendly, computer and non-computer-based formats, to support use across all ages. Moreover, ongoing training and technical assistance with use of electronic and mobile device technologies in clinical practice is needed. Research on barriers to clinical use of computers is warranted.

Parent-child relational problem: field trial results, changes in DSM-5, and proposed changes for ICD-11.

Caregiving relationships are significant factors in the development, mediation, or moderation of childhood mental health problems. However, epidemiological and clinical research has been limited by lack of reliable, succinct, and standardized methods of assessing parent-child relationship constructs. The Relational Processes Workgroup (ad hoc to the DSM-5 process) proposed more specific criteria to define a parent-child relational problem (PCRP). These criteria were field tested in one of the DSM-5 Field trial sites, utilizing a similar research design as DSM-5. Participants included 133 symptomatic children (5-17 years) in active treatment for a mental health problem and their primary caregiver (86% mothers). Two separate clinicians, each blinded to the assessment of the other clinician as well as the DSM-5 diagnoses, interviewed the dyads within a 2-week period, utilizing the proposed PCRP criteria. Prior to each interview, parents were asked to write about their relationship with their child, and children (over the age of 10 years) filled out the Parental Bonding Instrument, Brief Current, and the Perceived Criticism Measure. Clinicians were able to read the narratives and see results of the child report measures before assessing the dyad. The weighted prevalence of a PCRP in this sample was 34%. The interclass kappa for overall agreement between clinicians was 0.58 (0.40, 0.72), which indicates good interrater reliability. Further, clinicians found the PCRP diagnostic criteria clinically useful and an improvement over the brief description of PCRP that was presented in DSM-IV. Relationships between children and their primary caregiver can be assessed in a reliable manner, based on clinical interview with the child-caregiver dyad and several self-report measures.

ED Triage Decision-Making With Mental Health Presentations: A "Think Aloud" Study.

INTRODUCTION: Triage is the process whereby persons presenting to the emergency department are quickly assessed by a nurse and their need for care and service is prioritized. Research examining the care of persons presenting to emergency departments with psychiatric and mental health problems has shown that triage has often been cited as the most problematic aspect of the encounter. Three questions guided this investigation: Where do the decisions that triage nurses make fall on the intuitive versus analytic dimensions of decision making for mental health presentations in the emergency department, and does this differ according to comfort or familiarity with the type of mental health/illness presentation? How do "decision aids" (i.e., structured triage scales) help in the decision-making process? To what extent do other factors, such as attitudes, influence triage nurses' decision making? METHODS: Eleven triage nurses participating in this study were asked to talk out loud about the reasoning process they would engage in while triaging patients in 5 scenarios based on mental health presentations to the emergency department. RESULTS: Themes emerging from the data were tweaking the results (including the use of intuition and early judgments) to arrive at the desired triage score; consideration of the current ED environment; managing uncertainty and risk (including the consideration of physical reasons for presentation); and confidence in communicating with patients in distress and managing their own emotive reactions to the scenario. DISCUSSION: Findings support the preference for using the intuitive mode of decision making with only tacit reliance on the decision aid.

Experience Starting an Addiction Medicine Practice-Based Research Network.

OBJECTIVES: This paper outlines the experience developing Addiction Medicine Practice-Based Research Network (AMNet), which promotes the adoption of patient-reported outcome measures (PROMs) and measurement-based care in outpatient addiction treatment practices and creates a platform for quality improvement and research. METHODS: From August 2019 to July 2023, the AMNet team selected patient-reported outcome measures for implementation in the American Psychiatric Association's clinical data registry (PsychPRO), recruited addiction medicine providers, and collected PROMs data. RESULTS: AMNet selected 12 PROMs for implementation in PsychPRO. Through July 2023, 1565 providers expressed interest, of whom 216 of the 929 eligible providers (23%) attended an onboarding call/webinar. Two hundred six providers (95%) from 54 practices returned Participation Agreements. Subsequently, 65 providers (32%) from 39 practices withdrew, resulting in 141 (68%) providers from 15 practices. From November 2020 to July 2023, 38 providers submitted PROMs data using 1 of 3 PsychPRO patient portals. Sixteen of the 53 providers (30%) who signed up for the initial portal collected data from 468 patients. As of July 2023, 83 of the 141 providers (59%) opted to submit PROMs data from their own portal or electronic health record. CONCLUSIONS: Next steps will include continued recruitment of providers, addressing barriers to data transfer and integrating data from providers' portals into the registry to create a platform for future research.

Patient Engagement in and Adaptations to Delivery of Outpatient Care for Opioid Use Disorder During the COVID-19 Pandemic.

OBJECTIVE: The authors investigated adaptations to outpatient care delivery and changes in treatment demand and engagement among patients receiving medications for opioid use disorder (MOUD) in the months after the declaration of the COVID-19 public health emergency in 2020. METHODS: Data were collected through an online survey (June-November 2020) of outpatient MOUD prescribers. The survey obtained information on outpatient practices' adaptations to MOUD treatment and urine drug screening (UDS) and elicited provider views on the effects of the COVID-19 pandemic on patient demand for, and engagement in, treatment. Multivariable regression analyses were used to examine associations among practice characteristics, patient engagement, and service adaptations. RESULTS: Of 516 respondents, 74% reported adaptations to MOUD delivery during the pandemic. Most respondents implemented virtual visits for initial (67%) and follow-up (77%) contacts. Prescribers of buprenorphine were more likely than those who did not prescribe the medication to report MOUD adaptations. Among respondents reporting any MOUD adaptation, 77% made adaptations to their UDS practices. Among 513 respondents who answered COVID-19-related questions, 89% reported that the pandemic had affected the treatment and engagement of their patients. Of these respondents, 30% reported increased difficulty with patient engagement, and 45% reported that their patients preferred virtual visits during this period, whereas 18% endorsed patient preference for in-person visits. CONCLUSIONS: Telehealth and federal regulatory easements in response to the COVID-19 pandemic enabled providers to continue treating patients for opioid use disorder in 2020. The results suggest that care adaptations and changes in patient demand and engagement were common in the practices surveyed.

Engaging undergraduate nursing students in research: the students' experience of a summer internship program pilot project.

Educators continue to struggle with ways to foster an interest in and a passion for nursing research among undergraduate students. The purpose of this article is to describe the introduction of undergraduate student internships at the Manitoba Centre for Nursing and Health Research, Faculty of Nursing, University of Manitoba, as an innovation in education that allowed students to be employed while engaging them in student learning, scientific inquiry, and scholarship through one-to-one faculty-student research mentorships. In this article, the key components of the summer internship program are described, along with five nursing students' experiences of their participation in the program.

DSM-5-TR: Rationale, Process, and Overview of Changes.

The DSM-5 text revision (DSM-5-TR) is the first published revision of the DSM-5 since its publication in 2013. Like the previous text revision (DSM-IV-TR), the main goal of the DSM-5-TR is to comprehensively update the descriptive text accompanying each DSM disorder on the basis of reviews of the literature over the past 10 years. In contrast to the DSM-IV-TR, in which updates were confined almost exclusively to the text, the DSM-5-TR includes many other changes and enhancements of interest to practicing clinicians, such as the addition of diagnostic categories (prolonged grief disorder, stimulant-induced mild neurocognitive disorder, unspecified mood disorder, and a category to indicate the absence of a diagnosis); the provision of ICD-10-CM symptom codes for reporting suicidal and nonsuicidal self-injurious behavior; modifications, mostly for clarity, of the diagnostic criteria for more than 70 disorders; and updates in terminology (e.g., replacing "neuroleptic medications" with "antipsychotic medications or other dopamine receptor blocking agents" throughout the text and replacing "desired gender" with "experienced gender" in the text for gender dysphoria). Finally, the entire text was reviewed by an Ethnoracial Equity and Inclusion Work Group to ensure appropriate attention to risk factors such as the experience of racism and discrimination, as well as the use of nonstigmatizing language.

Physiologically-based pharmacokinetic modeling of remdesivir and its metabolites in pregnant women with COVID-19.

Pregnant individuals are at high risk for severe illness from COVID-19, and there is an urgent need to identify safe and effective therapeutics for this population. Remdesivir (RDV) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor. Limited RDV pharmacokinetic (PK) and safety data are available for pregnant women receiving RDV. The aims of this study were to translate a previously published nonpregnant adult physiologically based PK (PBPK) model for RDV to pregnancy and evaluate model performance with emerging clinical PK data in pregnant women with COVID-19. The pregnancy model was built in the Open Systems Pharmacology software suite (Version 10) including PK-Sim® and MoBi® with pregnancy-related changes of relevant enzymes applied. PK were predicted in a virtual population of 1000 pregnant subjects, and prediction results were compared with in vivo PK data from the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Network  2032 study. The developed PBPK model successfully captured RDV and its metabolites' plasma concentrations during pregnancy. The ratios of prediction versus observation for RDV area under the curve from time 0 to infinity (AUC0-∞ ) and maximum concentration (Cmax ) were 1.61 and 1.17, respectively. For GS-704277, the ratios of predicted versus observed were 0.94 for AUC0-∞ and 1.20 for Cmax . For GS-441524, the ratios of predicted versus observed were 1.03 for AUC0-24 , 1.05 for Cmax , and 1.07 for concentrations at 24 h. All predictions of AUC and Cmax for RDV and its metabolites were within a twofold error range, and about 60% of predictions were within a 10% error range. These findings demonstrate the feasibility of translating PBPK models to pregnant women to potentially guide trial design, clinical decision making, and drug development.

Achieving the 'perfect handoff' in patient transfers: building teamwork and trust.

AIMS: To use the philosophy and methodology of Appreciative Inquiry (AI) in the investigation of unit to unit transfers to determine aspects which are working well and should be incorporated into standard practice. BACKGROUND: Handoffs can result in threats to patient safety and an atmosphere of distrust and blaming among staff can be engendered. As the majority of handoffs go well, an alternative is to build on successful handoffs. EVALUATION: The AI methodology was used to discover what was currently working well in unit to unit transfers. The data from semi-structured interviews that were conducted with staff, patients, and family informed structural process improvements. KEY ISSUES: Themes extracted from the interviews focused on the situational variables necessary for the perfect transfer, the mode and content of transfer-related communication, and important factors in communication with the patient and family. CONCLUSIONS: This project was successful in demonstrating the usefulness of AI as both a quality improvement methodology and a strategy to build trust among key stakeholders. IMPLICATIONS FOR NURSING MANAGEMENT: Giving staff members the opportunity to contribute positively to process improvements and share their ideas for innovation has the potential to highlight expertise and everyday accomplishments enhancing morale and reducing conflict.

A Crosswalk Study of DSM-IV and DSM-5 Criteria for PTSD from the DSM-5 Field Trials.

Objective: Posttraumatic stress disorder (PTSD) is prevalent and sometimes severely disabling. Providing effective treatment for PTSD and addressing its social consequences require accurate diagnosis. PTSD criteria have changed in all editions of the American Diagnostic Criteria since introduction of the diagnosis in DSM-III in 1980. The DSM-5 Field Trials demonstrated very good inter-rater reliability for PTSD, but a crosswalk study comparing DSM-IV and DSM-5 criteria has potential to identify diagnostic differences generated by changed criteria. Methods: A DSM-IV to DSM-5 PTSD crosswalk study was conducted in real-world adult clinical treatment settings in two DSM-5 Field Trials sites, the Dallas (N = 93) and Houston (N = 48) Veterans Affairs medical centers. The crosswalk assessment was conducted by trained clinicians who interviewed the patients and rated both sets of criteria on a combined checklist. Results: PTSD prevalence differed insubstantially between criteria sets (42% vs. 45% and 55% vs. 52% in the Dallas and Houston sites, respectively), with moderate to excellent diagnostic agreement (reliability indicated, respectively, by κ = .53 and .93); however, substantial proportions of individuals diagnosed in one criteria set did not meet criteria in the other. Differences in cross-criteria diagnostic reliability were largely a function of differing definitions of criterion A trauma. Conclusions: Reliability across the two criteria sets was generally good to excellent, and diagnostic discrepancy predominantly reflected the elimination of criterion A2 in DSM-5 with a smaller contribution from changes to the avoidance and numbing criteria.

Optimizing Dolutegravir Initiation in Neonates Using Population Pharmacokinetic Modeling and Simulation.

BACKGROUND: A knowledge gap exists for dolutegravir (DTG) pharmacokinetics and safety during the first 4 weeks of life, preventing safe and effective DTG use in neonates. SETTING: Population pharmacokinetic modeling and simulation were used to assess newborn DTG dosing requirements during the first few days of life as a function of maternal DTG dosing history before delivery. METHODS: DTG PK data were obtained from pregnant women and infants enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1026S study. Maternal and neonate population pharmacokinetic models were separately developed. Monte Carlo simulations were performed to simulate neonatal concentrations after 2 doses of DTG after birth for infants born to mothers either receiving or not receiving DTG before delivery. RESULTS: In DTG-naïve infants, a 5-mg DTG dose at birth with a second dose after 48 hours maintained median concentrations above the lower bound of the target range (0.77 µg/mL) and below the upper bound of the target range (7.34 µg/mL representing 2-fold above the adult Cmax value). In DTG-exposed infants, a 5-mg DTG dose at 24 hours after birth with a second dose after 48 hours maintained median concentrations within or nearly within the target range, even if the last maternal DTG dose was taken as soon as 6 hours or as long as 24 hours before delivery. CONCLUSIONS: Newborn DTG dosing requirements during the first few days of life depend on maternal DTG dosing history before delivery. These results may help the design of future clinical studies of DTG in the neonatal population.

Climate Change and Mental Health: Implications for the Psychiatric Workforce.

Climate change is a major global public mental health crisis that is expected to increase the need for mental health services. Psychiatrists and other mental health care providers must address workforce needs through recruitment, training and education, prevention and intervention, public policy and advocacy, and direct efforts to reduce climate change. This column discusses concrete steps for the psychiatric workforce to take to prepare for growing mental health needs associated with climate change.

Climate change and mental health research methods, gaps, and priorities: a scoping review.

Research on climate change and mental health is a new but rapidly growing field. To summarise key advances and gaps in the current state of climate change and mental health studies, we conducted a scoping review that comprehensively examined research methodologies using large-scale datasets. We identified 56 eligible articles published in Embase, PubMed, PsycInfo, and Web of Science between Jan 1, 2000, and Aug 9, 2020. The primary data collection method used was surveys, which focused on self-reported mental health effects due to acute and subacute climate events. Other approaches used administrative health records to study the effect of environmental temperature on hospital admissions for mental health conditions, and national vital statistics to assess the relationship between environmental temperature and suicide rates with regression analyses. Our work highlights the need to link population-based mental health outcome databases to weather data for causal inference. Collaborations between mental health providers and data scientists can guide the formation of clinically relevant research questions on climate change.

Screening chimeric GAA variants in preclinical study results in hematopoietic stem cell gene therapy candidate vectors for Pompe disease.

Pompe disease is a rare genetic neuromuscular disorder caused by acid α-glucosidase (GAA) deficiency resulting in lysosomal glycogen accumulation and progressive myopathy. Enzyme replacement therapy, the current standard of care, penetrates poorly into the skeletal muscles and the peripheral and central nervous system (CNS), risks recombinant enzyme immunogenicity, and requires high doses and frequent infusions. Lentiviral vector-mediated hematopoietic stem and progenitor cell (HSPC) gene therapy was investigated in a Pompe mouse model using a clinically relevant promoter driving nine engineered GAA coding sequences incorporating distinct peptide tags and codon optimizations. Vectors solely including glycosylation-independent lysosomal targeting tags enhanced secretion and improved reduction of glycogen, myofiber, and CNS vacuolation in key tissues, although GAA enzyme activity and protein was consistently lower compared with native GAA. Genetically modified microglial cells in brains were detected at low levels but provided robust phenotypic correction. Furthermore, an amino acid substitution introduced in the tag reduced insulin receptor-mediated signaling with no evidence of an effect on blood glucose levels in Pompe mice. This study demonstrated the therapeutic potential of lentiviral HSPC gene therapy exploiting optimized GAA tagged coding sequences to reverse Pompe disease pathology in a preclinical mouse model, providing promising vector candidates for further investigation.

The Wellness Planner: empowerment, quality of life, and continuity of care in mental illness.

Coordination of mental health services has often been a challenge from the user's point of view. Resulting gaps in care can lead to increased use of crisis services, more frequent hospitalization, and impaired quality of life. This study examined an innovative approach to building an individual's self-care capacities by testing the use of a wellness intervention: an adaptation of a client-held medical record/crisis plan in booklet form. Fifty individuals using community mental health services were recruited. Using a pretest-posttest design, participants completed measures of empowerment, continuity of care, quality of life, and satisfaction with services at the start of and again following 3 months of using the booklet. The booklet, referred to as the Wellness Planner, included components that have been empirically demonstrated as effective, such as crisis planning, goal setting, and resource planning. For the 42 individuals who completed the study, statistically significant increases were seen in empowerment, continuity of care, and satisfaction with services after 3 months of using the Wellness Planner. Qualitative data further demonstrated positive acceptance of the booklet by the users. Findings of the study suggest that the use of such a booklet could not only have a positive impact on the recovery of individuals but could also have utility within the mental health system. Since the completion of this study, the Winnipeg Regional Health Authority has adopted the booklet for use within all its adult mental health programs. Future research will focus on the impact of the booklet on system-wide indicators such as service utilization and readmission rates.

Addiction Medicine Practice-Based Research Network (AMNet): Building Partnerships.

This column describes the collaboration among the American Psychiatric Association (APA), American Society of Addiction Medicine, Friends Research Institute, and the National Institute on Drug Abuse to create the Addiction Medicine Practice-Based Research Network (AMNet). The collaboration, which aims to address the opioid overdose epidemic in the United States, leverages the APA's clinical data registry (PsychPRO) and is recruiting office-based addiction medicine and addiction psychiatry practices for AMNet. AMNet aims to address knowledge gaps regarding patient care in such practices, facilitate performance improvement efforts, and serve as a research platform.

An Ecological Study of a Universal Employee Depression Awareness and Stigma Reduction Intervention: "Right Direction".

Objective: Right Direction (RD) was a component of a universal employee wellness program implemented in 2014 at Kent State University (KSU) to increase employees' awareness of depression, reduce mental health stigma, and encourage help-seeking behaviors to promote mental health. We explored changes in mental health care utilization before and after implementation of RD. Methods: KSU Human Resources census and service use data were used to identify the study cohort and examine the study objectives. A pre-post design was used to explore changes in mental health utilization among KSU employees before and after RD. Three post-intervention periods were examined. A generalized linear mixed model approach was used for logistic regression analysis between each outcome of interest and intervention period, adjusted by age and sex. Logit differences were calculated for post-intervention periods compared to the pre-intervention period. Results: Compared to the pre-intervention period, the predicted proportion of employees seeking treatment for depression and anxiety increased in the first post-intervention period (OR = 2.14, 95% Confidence Interval [CI] = 1.37-3.34), then declined. Outpatient psychiatric treatment utilization increased significantly in the first two post-intervention periods (OR =1.89, 95% CI = 1.23-2.89; OR = 1.75, 95% CI = 1.11-2.76). No difference was noted in inpatient psychiatric treatment utilization across post-intervention periods. Unlike prescription for anxiolytic prescriptions, receipt of antidepressant prescriptions increased in the second (OR = 2.25, 95% CI = 1.56-3.27) and third (OR = 2.16, 95% CI = 1.46-3.20) post-intervention periods. Conclusions: Effects of RD may be realized over the long-term with follow-up enhancements such as workshops/informational sessions on mindfulness, stress management, resiliency training, and self-acceptance.

Strategies to aid self-isolation and quarantine for individuals with severe and persistent mental illness during the COVID-19 pandemic: A systematic review.

BACKGROUND: Individuals with severe and persistent mental illness (SPMI) have a higher risk of contracting COVID-19 than individuals without SPMI. In combination with physical distancing, hygiene protocols, and vaccines, quarantine and self-isolation are primary means of viral containment. However, individuals with SPMI may experience more difficulties with mandated quarantine or self-isolation because of their illness(es), stigma, and marginalization. To date, there is a lack of consensus on strategies that could aid such individuals in completing isolation. AIM: This review aimed to synthesize evidence for interventions to support self-isolation and mandated quarantine for COVID-19 among individuals with SPMIs. METHODS: We followed the PRISMA guidelines, searching 19 electronic databases (9 published literature registries and 10 gray literature sources). We looked for relevant randomized controlled trials, quasi-experimental studies, and program evaluations of the effectiveness of relevant psychosocial, pharmacological, harm reduction, and addiction management strategies to support isolation settings or quarantine requirements for individuals with any SPMI (e.g., any mental disorder, substance use disorder, or their combination). FINDINGS: Of 10,298 total records that were located, 5582 were duplicate citations. Upon screening the remaining 4716 unique records by title and abstract, we excluded a further 3562 records. Only one original article met our inclusion criteria after reviewing the full texts of the remaining 1154 citations. To support individuals experiencing homelessness during the COVID-19 pandemic, San Francisco developed an isolation hotel that reduced COVID-19 hospital strain for 1009 participants (25% had a mental health disorder and 26% had a substance use disorder). While 81% completed their hotel stay, 48 patients had behavioral health needs that exceeded the hotel's capabilities. No other studies met our review's eligibility criteria. Most articles located by the search simply proposed solutions or discussed the challenges brought by COVID-19 for people with SPMIs. While some documents went a step further (e.g., shelter guidance documents to support individuals experiencing homelessness), these rarely addressed individuals with SPMIs directly. CONCLUSIONS: This systematic review evaluated evidence from published and gray literature on interventions to support self-isolation and mandated COVID-19 quarantine for individuals with SPMIs. Only one study met our inclusion criteria. This study found a beneficial effect of a dedicated isolation hotel for individuals experiencing homelessness and COVID-19-where approximately 25%-50% of the study sample had a mental or substance use disorder. While there has been an abundance of COVID-19 protocols in general, information for SPMIs is lacking. As the pandemic continues and we better prepare for future pandemics, developing protocols for supporting SPMIs in this context is imperative.