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In the cluster randomized crossover trial, a sequence of treatment conditions, rather than just one treatment condition, is assigned to each cluster. This contribution studies the optimal number of time periods in studies with a treatment switch at the end of each time period, and the optimal number of treatment switches in a trial with a fixed number of time periods. This is done for trials with a fixed number of clusters, and for trials in which the costs per cluster, subject, and treatment switch are taken into account using a budgetary constraint. The focus is on trials with a cross-sectional design where a continuous outcome variable is measured at the end of each time period. An exponential decay correlation structure is used to model dependencies among subjects within the same cluster. A linear multilevel mixed model is used to estimate the treatment effect and its associated variance. The optimal design minimizes this variance. Matrix algebra is used to identify the optimal design and other highly efficient designs. For a fixed number of clusters, a design with the maximum number of time periods is optimal and treatment switches should occur at each time period. However, when a budgetary constraint is taken into account, the optimal design may have fewer time periods and fewer treatment switches. The Shiny app was developed to facilitate the use of the methodology in this contribution.

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BACKGROUND: Subjective cognitive decline (SCD) is prevalent in community-dwelling (pre)frail older adults. This study aimed to investigate whether baseline subjective cognitive decline (SCD) and mild cognitive impairment (MCI) impacted the effectiveness of an exercise intervention among (pre)frail older adults. METHODS: This is a post hoc analysis of a stepped-wedge cluster randomized trial among (pre)frail older adults across six communities. The intervention effectiveness was examined among (pre)frail older people among subgroups with normal cognition (n = 44), SCD (n = 58), or MCI (n = 30). RESULTS: The normal cognition group had both immediate and persistent treatment responses to most outcomes. The SCD group showed positive responses to frailty (0-, 12-, 24 week), ambulation and dynamic balance (0-week), and depressive symptoms (12-week). The MCI group exhibited immediate improvement in frailty, cognition, depressive symptoms, social support and QoL, which persisted only in frailty status, social support and mental QoL at follow-ups. The MCI group showed superior immediate responses to cognitive function and depressive symptoms compared to another two subgroups. No differences were found between the normal cognition and SCD groups except for cognitive status (12-week). CONCLUSIONS: (Pre)frail people with SCD or MCI had fewer improved outcomes compared to those with normal cognition regardless of immediate or persistent improvements. The incorporation of cognitive strategies with exercise interventions are recommended among (pre)frail older adults with SCD or MCI.

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The FICUS trial is a cluster-randomized superiority trial to determine the effectiveness of a nurse-led, interprofessional family support intervention (FSI) on the quality of care, family management and individual mental health of family members of critically ill patients, compared to usual care. This paper describes the statistical analysis plan of the FICUS trial. The primary outcome is quality of family care, assessed by the Family Satisfaction in ICU Questionnaire (FS-ICU-24R) at patient discharge from the ICU. Several secondary outcomes are additionally assessed 3, 6, and 12 months thereafter. Sixteen clusters (ICUs) were randomly assigned 1:1 to FSI or usual care using minimization (8 per treatment). The target sample size is 56 patients per cluster (896 in total). Recruitment has been completed in January 2024. The follow-up of the last participant will be completed in early 2025. The primary and secondary outcomes will be analyzed by linear mixed-effects models (LMM). The main model for the primary outcome will include a random intercept per cluster with treatment (FSI vs. usual care) as the only explanatory variable due to the relatively small number of clusters. In addition, covariate-adjusted analyses will be conducted, including two cluster-level characteristics used in the minimization as well as participant-level characteristics. Moreover, a number of subgroup analyses by cluster- and participant-level characteristics are pre-specified.Trial registration ClinicalTrials.gov NCT05280691 . Registered on February 20, 2022.

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BACKGROUND: Maternity waiting home (MWH) has been advocated as an approach to improve women's access to obstetric services in low-resource settings; however, its use remains low. This study investigated the effectiveness of couple-based health education on maternal knowledge, attitudes, and use of MWHs in rural Ethiopia. METHODS: A total of 320 couples from 16 clusters were allocated to the intervention and control groups using restricted randomization. Participants in the intervention group received group health education, home visits, and information flyers along with usual care, whereas those in the control group received usual care. Statistical differences were estimated using the chi-squared test. The impact of the intervention was evaluated using generalized linear regression and difference-in-differences models. RESULTS: Baseline and endline data were collected from the 320 couples. The intervention increased knowledge by 37.5 % (95 % CI: 32.2 % - 42.8 %), attitude by 33.8 % (95 % CI: 28.8 %-39.2 %), and utilization of MWH by 32.9 % (95 % CI: 27.9 %-38.2 %) among women. In addition, compared to those in the control group, women in the intervention group were almost six times more likely to have increased knowledge of MWH (AOR 5.74, 95 % CI: 3.51-9.38), four times more likely to have improved attitudes of MWH (AOR 4.45, 95 % CI: 2.78 -7.13), and four times more likely to stay at MWH (AOR 4.45, 95 % CI: 2.78 -7.12). CONCLUSION: Providing health education to couples can improve maternal knowledge, attitudes, and the use of MWHs. Policymakers and healthcare cadres can use the current intervention strategy to enhance maternal health services, particularly MWHs, in rural Ethiopia.

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INTRODUCTION: The "Migrants' Approached Self-Learning Intervention in HIV/AIDS for Tajiks" (MASLIHAT) recruits and trains Tajik labour migrants who inject drugs as peer educators (PEs) in delivering HIV prevention information and encouragement to adopt risk-reduction norms and practices within their diaspora social networks while reducing their own HIV risk. METHODS: The MASLIHAT intervention was tested in Moscow in a cluster-randomized controlled trial with 12 recruitment sites assigned to either the MASLIHAT intervention or an equal-time peer-educator training focused on other health conditions (TANSIHAT). From October 2021 to April 2022, 140 male Tajik migrants who inject drugs were recruited as PEs to attend the 5-session MASLIHAT training or the TANSIHAT non-HIV comparison condition. Each participant in both groups recruited two network members (NMs) who inject drugs with the intent to share with them the information and positive strategies for change they had learned (n = 280). All PEs and NMs (n = 420) participated in baseline and follow-up interviews at 3-month intervals for 1 year. All received HIV counselling and testing. Modified mixed effects Poisson regressions tested for group differences in injection practices, sexual risk behaviours and heavy alcohol use over time. RESULTS: At baseline, across both groups, 75% of participants reported receptive syringe sharing (RSS), 42% reported condomless sex and 20% reported binge drinking at least once a month. In contrast to TANSIHAT where HIV risk behaviours remained the same, significant intervention effects that were sustained over the 12 months were observed for receptive syringe and ancillary equipment sharing among both MASLIHAT PEs and NMs (p < 0.0001). Significant declines in the prevalence of sexual risk behaviours were also associated with the MASLIHAT intervention (p < 0.01), but not the comparison condition. Binge alcohol use was not affected in either condition; the MASLIHAT intervention had a transitory effect on drinking frequency that dissipated after 9 months. CONCLUSIONS: The MASLIHAT peer-education intervention proved highly effective in reducing HIV-related injection risk behaviour, and moderately effective in reducing sexual risk behaviour among both PEs and NMs. Network-based peer education is an important tool for HIV prevention among people who inject drugs, especially in environments that are not amenable to community-based harm reduction.

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In the individual stepped-wedge randomized trial (ISW-RT), subjects are allocated to sequences, each sequence being defined by a control period followed by an experimental period. The total follow-up time is the same for all sequences, but the duration of the control and experimental periods varies among sequences. To our knowledge, there is no validated sample size calculation formula for ISW-RTs unlike stepped-wedge cluster randomized trials (SW-CRTs). The objective of this study was to adapt the formula used for SW-CRTs to the case of individual randomization and to validate this adaptation using a Monte Carlo simulation study. The proposed sample size calculation formula for an ISW-RT design yielded satisfactory empirical power for most scenarios except scenarios with operating characteristic values near the boundary (i.e., smallest possible number of periods, very high or very low autocorrelation coefficient). Overall, the results provide useful insights into the sample size calculation for ISW-RTs.

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BACKGROUND: Patients with opioid use disorder (OUD) have increased emergency and hospital utilization. The PROUD trial showed that implementation of office-based addiction treatment (OBAT) increased OUD medication treatment compared to usual care, but did not decrease acute care utilization in patients with OUD documented pre-randomization (clinicaltrials.gov/study/NCT03407638). This paper reports secondary emergency and hospital utilization outcomes in patients with documented OUD in the PROUD trial. METHODS: This cluster-randomized implementation trial was conducted in 12 clinics from 6 diverse health systems (March 2015-February 2020). Patients who visited trial clinics and had an OUD diagnosis within 3 years pre-randomization were included in primary analyses; secondary analyses added patients with OUD who were new to the clinic or with newly-documented OUD post-randomization. Outcomes included days of emergency care and hospital utilization over 2 years post-randomization. Explanatory outcomes included measures of OUD treatment. Patient-level analyses used mixed-effect regression with clinic-specific random intercepts. RESULTS: Among 1988 patients with documented OUD seen pre-randomization (mean age 49, 53 % female), days of emergency care or hospitalization did not differ between intervention and usual care; OUD treatment also did not differ. In secondary analyses among 1347 patients with OUD post-randomization, there remained no difference in emergency or hospital utilization despite intervention patients receiving 32.2 (95 % CI 4.7, 59.7) more days of OUD treatment relative to usual care. CONCLUSIONS: Implementation of OBAT did not reduce emergency or hospital utilization among patients with OUD, even in the sample with OUD first documented post-randomization in whom the intervention increased treatment.

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AIM: To evaluate the effectiveness of utilizing the integrated pulmonary index for capnography implementation during sedation administered by nurses. DESIGN: Cluster-randomized trial. METHODS: Participants were enrolled from the interventional radiology department at an academic hospital in Canada. Nurses were randomized to either enable or disable the Integrated Pulmonary Index feature of the capnography monitor. Procedures were observed by a research assistant to collect information about alarm performance characteristics. The primary outcome was the number of seconds in an alert condition state without an intervention being applied. RESULTS: The number of seconds in an alarm state without intervention was higher in the group that enabled the integrated pulmonary index compared to the group that disabled this feature, but this difference did not reach statistical significance. Likewise, the difference between groups for the total alarm duration, total number of alarms and the total number of appropriate alarms was not statistically significant. The number of inappropriate alarms was higher in the group that enabled the Integrated Pulmonary Index, but this estimate was highly imprecise. There was no difference in the odds of an adverse event (measured by the Tracking and Reporting Outcomes of Procedural Sedation tool) occurring between groups. Desaturation events were uncommon and brief in both groups but the area under the SpO2 90% desaturation curve scores were lower for the group that enabled the integrated pulmonary index. CONCLUSION: Enabling the integrated pulmonary index during nurse-administered procedural sedation did not reduce nurses' response times to alarms. Therefore, integrating multiple physiological parameters related to respiratory assessment into a single index did not lower the threshold for intervention by nurses. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The time it takes to respond to capnography monitor alarms will not be reduced if the integrated pulmonary Iindex feature of capnography monitors is enabled during nurse-administered procedural sedation. IMPACT: Results do not support the routine enabling of the integrated pulmonary index when nurses use capnography to monitor patients during procedural sedation as a strategy to reduce the time it takes to initiate responses to alarms. REPORTING METHOD: CONSORT. PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public contribution. TRIAL REGISTRATION: This study was prospectively registered at ClinicalTrials.gov (ID: NCT05068700).

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Background: A significant number of women die from pregnancy and childbirth complications globally, particularly in low- and middle-income countries (LMICs). Receiving at least four antenatal care (ANC) visits may be important in reducing maternal and perinatal deaths. This study investigates factors associated with attending ≥ 4 ANC visits in Sarlahi district of southern Nepal. Methods: A secondary analysis was conducted on data from the Nepal Oil Massage Study (NOMS), a cluster-randomized, community-based longitudinal pregnancy cohort study encompassing 34 Village Development Committees. We quantified the association between receipt/attendance of ≥ 4 ANC visits and socioeconomic, demographic, morbidity, and pregnancy history factors using logistic regression; Generalized Estimating Equations were used to account for multiple pregnancies per woman. Results: All pregnancies resulting in a live birth (n=31,867) were included in the model and 31.4% of those pregnancies received 4+ ANC visits. Significant positive associations include socioeconomic factors such as participation in non-farming occupations for women (OR=1.52, 95% CI: 1.19, 1.93), higher education (OR=1.79, 95% CI: 1.66, 1.93) and wealth quintile OR=1.44, 95% CI: 1.31, 1.59), nutritional status such as non-short stature (OR=1.17, 95% CI: 1.07, 1.27), obstetric history such as adequate interpregnancy interval (OR=1.31, 95% CI: 1.19, 1.45) and prior pregnancy but no live birth (OR=2.14, 95% CI: 1.57, 2.92), symptoms such as vaginal bleeding (OR=1.35, 95% CI:1.11, 1.65) and awareness of the government's conditional cash transfer ANC program (OR=2.26, 95% CI: 2.01, 2.54). Conversely, belonging to the lower Shudra caste (OR=0.56, 95% CI: 0.47, 0.67), maternal age below 18 or above 35 (OR=0.81, 95% CI:0.74, 0.88; OR=0.77, 95% CI: 0.62, 0.96)), preterm birth (OR=0.41, 95% CI: 0.35, 0.49), parity ≥ 1 (OR=0.66, 95% CI: 0.61, 0.72), and the presence of hypertension during pregnancy (OR=0.79, 95% CI: 0.69, 0.90) were associated with decreased likelihood of attending ≥ 4 ANC visits. Conclusions: These findings underscore the importance of continuing and promoting the government's program and increasing awareness among women. Moreover, understanding these factors can guide interventions aimed at encouraging ANC uptake in the most vulnerable groups, subsequently reducing maternal-related adverse outcomes in LMICs. Trial registration: The clinicaltrial.gov trial registration number for NOMS was #NCT01177111. Registration date was August 6th, 2010.

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INTRODUCTION: The goal of this study was to evaluate changes in knowledge, attitudes, and other key suicide prevention issues for substance use disorder (SUD) counselors trained to administer the Preventing Addiction Related Suicide (PARS) module as part of a large-scale clinical trial. PARS is a 3-hour, PowerPoint based intervention designed with and for community SUD agencies for their Intensive Outpatient (IOP) group therapy programs. A previous randomized study of 906 patients from 15 community SUD sites showed positive changes in patients' suicide prevention knowledge, attitudes, and help seeking. METHODS: Counselor participants completed measures of knowledge and attitudes about suicide and their confidence treating suicidal patients at each step of a large, stepped wedge cluster randomized trial of PARS, including after the final step. Data analysis compared scores in steps prior to counselors' training in PARS with scores in the steps following counselors' PARS training. RESULTS: A total of 126 counselors participated in the study (89 % of those approached; 89-92 % retention across follow-up). Evaluation of both PARS efficacy and the PARS training by SUD counselors was highly rated. Counselor scores after receiving PARS training (vs. scores prior to PARS training) showed greater suicide knowledge, less maladaptive attitudes about suicide, and greater confidence in working with suicidal patients. CONCLUSIONS: Based on this rigorous test of PARS training for SUD counselors working in community SUD intensive outpatient programs, PARS training, as well as doing the PARS intervention, was rated as highly effective and acceptable. PARS offers an integrated, brief, engaging, and effective training method to improve suicide care for both SUD counselors and SUD clients.

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INTRODUCTION: Women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a significantly increased risk of breast cancer, which can be substantially reduced with antiestrogen therapy for chemoprevention. However, antiestrogen therapy for breast cancer risk reduction remains underutilized. Improving knowledge about breast cancer risk and chemoprevention among high-risk patients and their healthcare providers may enhance informed decision-making about this critical breast cancer risk reduction strategy. METHODS/DESIGN: We are conducting a cluster randomized controlled trial to evaluate the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. We have cluster randomized 26 sites across the U.S. through the SWOG Cancer Research Network. A total of 415 patients and 200 healthcare providers are being recruited. They are assigned to standard educational materials alone or combined with the web-based decision support tools. Patient-reported and clinical outcomes are assessed at baseline, after a follow-up visit at 6 months, and yearly for 5 years. The primary outcome is chemoprevention informed choice after the follow-up visit. Secondary endpoints include other patient-reported outcomes, such as chemoprevention knowledge, decision conflict and regret, and self-reported chemoprevention usage. Barriers and facilitators to implementing decision support into clinic workflow are assessed through patient and provider interviews at baseline and mid-implementation. RESULTS/DISCUSSION: With this hybrid effectiveness/implementation study, we seek to evaluate if a multi-level intervention effectively promotes informed decision-making about chemoprevention and provide valuable insights on how the intervention is implemented in U.S. TRIAL REGISTRATION: NCT04496739.

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BACKGROUND: This protocol paper describes the overall design for HPV MISTICS, a multilevel intervention to increase human papillomavirus (HPV) vaccination initiation and completion rates among adolescents aged 11-17. METHODS: We will conduct a hybrid type 1 implementation-effectiveness trial using a stepped-wedge cluster randomized trial in eight federally qualified health centers (FQHCs) in Florida. Intervention components target three levels: system, providers, and parents. Outcomes will be assessed using quantitative (e.g., vaccination data, survey data) and qualitative methods (e.g., staff and parent interviews). We expect to quantify changes in HPV vaccine series initiation and completion rates for adolescents ages 11-17 in the eight FQHCs. We have hypothesized a 20-percentage point increase in HPV vaccine series initiation and a 10-percentage point increase in series completion. We also anticipate being able to explore factors at the system, provider, and patient levels as potential covariates. Implementation outcomes, barriers, and facilitators identified in the study will help characterize the implementation process and inform potential future intervention scale-up. RESULTS: The project is ongoing; effectiveness and implementation outcomes will be determined following project completion. CONCLUSIONS: Findings will provide evidence of an equity-informed research design and implementation procedures that could help improve HPV vaccination rates in similar health systems. CLINICAL TRIALS IDENTIFIER: NCT05677360 (date registered: 2022-12-22); https://clinicaltrials.gov/study/NCT05677360?lead=Moffitt%20Cancer%20Center%20&aggFilters=status:rec&page=2&rank=17.

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BACKGROUND: Hypertension (HT) is an orchestrator of atherosclerotic cardiovascular disease (ASCVD) in people living with type 2 diabetes (T2D). Control of systolic blood pressure (SBP) and HT as a whole is suboptimal in diabetes, partly due to the scarcity of doctors. While nurse-led interventions are pragmatic and cost-effective in the control of HT in primary health care, their effectiveness on SBP control among patients with T2D in Uganda is scantly known. AIM: We evaluated the effectiveness of a nurse-led management intervention on SBP among T2D patients with a high ASCVD risk in Uganda. METHODS: A two-armed cluster randomized controlled trial compared the nurse-led management intervention with usual doctor-led care. The intervention involved training nurses to provide structured health education, protocol-based HT/CVD management, 24-h phone calls, and 2-monthly text messages for 6 months. The primary outcome was the mean difference in SBP change among patients with T2D with a high ASCVD risk in the intervention and control groups after 6 months. The secondary outcome was the absolute difference in the number of patients at target for SBP, total cholesterol (TC), fasting blood glucose (FBG), glycated hemoglobin (HbA1C), low-density lipoprotein (LDL), triglycerides (TG), and body mass index (BMI) after the intervention. The study was analyzed according to the intention-to-treat principle. Generalized estimating equations were used to assess intra-cluster effect modifiers. Statistical significance was set at 0.05 for all analyses. RESULTS: Eight clinics (n = 388 patients) were included (intervention 4 clinics; n = 192; control 4 clinics; n = 196). A nurse-led intervention reduced SBP by -11.21 ± 16.02 mmHg with a mean difference between the groups of -13.75 mmHg (95% CI -16.48 to -11.02, p < 0.001). An increase in SBP of 2.54 ± 10.95 mmHg was observed in the control group. Diastolic blood pressure was reduced by -6.80 ± 9.48 mmHg with a mean difference between groups of -7.20 mmHg (95% C1 -8.87 to -5.48, p < 0.001). The mean differences in the change in ASCVD score and glycated hemoglobin were -4.73% (95% CI -5.95 to -3.51, p = 0.006) and -0.82% (95% CI -1.30 to -0.35, p = 0.001), respectively. There were significant absolute differences in the number of patients at target in SBP (p = 0.001), DBP (p = 0.003), and TC (p = 0.008). CONCLUSION: A nurse-led management intervention reduces SBP and ASCVD risk among patients with T2D. Such an intervention may be pragmatic in the screening and management of HT/ASCVD in Uganda. TRIAL REGISTRATION: Pan African Clinical Trial Registry, PACTR202001916873358, registered on 6th October 2019.

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Cluster randomized crossover and stepped wedge cluster randomized trials are two types of longitudinal cluster randomized trials that leverage both the within- and between-cluster comparisons to estimate the treatment effect and are increasingly used in healthcare delivery and implementation science research. While the variance expressions of estimated treatment effect have been previously developed from the method of generalized estimating equations for analyzing cluster randomized crossover trials and stepped wedge cluster randomized trials, little guidance has been provided for optimal designs to ensure maximum efficiency. Here, an optimal design refers to the combination of optimal cluster-period size and optimal number of clusters that provide the smallest variance of the treatment effect estimator or maximum efficiency under a fixed total budget. In this work, we develop optimal designs for multiple-period cluster randomized crossover trials and stepped wedge cluster randomized trials with continuous outcomes, including both closed-cohort and repeated cross-sectional sampling schemes. Local optimal design algorithms are proposed when the correlation parameters in the working correlation structure are known. MaxiMin optimal design algorithms are proposed when the exact values are unavailable, but investigators may specify a range of correlation values. The closed-form formulae of local optimal design and MaxiMin optimal design are derived for multiple-period cluster randomized crossover trials, where the cluster-period size and number of clusters are decimal. The decimal estimates from closed-form formulae can then be used to investigate the performances of integer estimates from local optimal design and MaxiMin optimal design algorithms. One unique contribution from this work, compared to the previous optimal design research, is that we adopt constrained optimization techniques to obtain integer estimates under the MaxiMin optimal design. To assist practical implementation, we also develop four SAS macros to find local optimal designs and MaxiMin optimal designs.

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Background: Nearly 100 million people are pushed into poverty every year due to catastrophic health expenditures (CHE). We evaluated the impact of cash support programs on healthcare utilization and CHE among households participating in a cluster-randomized controlled trial focusing on adolescent childbearing in rural Zambia. Methods and findings: The trial recruited adolescent girls from 157 rural schools in 12 districts enrolled in grade 7 in 2016 and consisted of control, economic support, and economic support plus community dialogue arms. Economic support included 3 USD/month for the girls, 35 USD/year for their guardians, and up to 150 USD/year for school fees. Interviews were conducted with 3,870 guardians representing 4,110 girls, 1.5-2 years after the intervention period started. Utilization was defined as visits to formal health facilities, and CHE was health payments exceeding 10% of total household expenditures. The degree of inequality was measured using the Concentration Index. In the control arm, 26.1% of the households utilized inpatient care in the previous year compared to 26.7% in the economic arm (RR = 1.0; 95% CI: 0.9-1.2, p = 0.815) and 27.7% in the combined arm (RR = 1.1; 95% CI: 0.9-1.3, p = 0.586). Utilization of outpatient care in the previous 4 weeks was 40.7% in the control arm, 41.3% in the economic support (RR = 1.0; 95% CI: 0.8-1.3, p = 0.805), and 42.9% in the combined arm (RR = 1.1; 95% CI: 0.8-1.3, p = 0.378). About 10.4% of the households in the control arm experienced CHE compared to 11.6% in the economic (RR = 1.1; 95% CI: 0.8-1.5, p = 0.468) and 12.1% in the combined arm (RR = 1.1; 95% CI: 0.8-1.5, p = 0.468). Utilization of outpatient care and the risk of CHE was relatively higher among the least poor than the poorest households, however, the degree of inequality was relatively smaller in the intervention arms than in the control arm. Conclusions: Economic support alone and in combination with community dialogue aiming to reduce early childbearing did not appear to have a substantial impact on healthcare utilization and CHE in rural Zambia. However, although cash transfer did not significantly improve healthcare utilization, it reduced the degree of inequality in outpatient healthcare utilization and CHE across wealth groups. Trial Registration: https://classic.clinicaltrials.gov/ct2/show/NCT02709967, ClinicalTrials.gov, identifier (NCT02709967).

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BACKGROUND: We evaluated the impact of the CHORUS™ app on adherence to the cabotegravir and rilpivirine long-acting injectable (CAB + RPV LAI) monthly injections schedule. METHODS: Healthcare centers (HCCs) were randomized to access CHORUS™ CAB + RPV LAI features (intervention) or not (control) from 01OCT2021-31JAN2022. Target window adherence (maintenance injections ≤7 days before/after target day) was assessed with multivariate logistic regression (generalized estimating equations). RESULTS: CAB + RPV LAI was administered to 188 and 79 individuals at intervention and control HCCs, respectively. Intervention was not associated with improved target window adherence (adjusted odds ratio: 0.61 [95% CI: 0.30-1.25]). However, app use was associated with increased odds of adherence compared to no app use among all intervention HCCs (2.98 [1.26-7.06]) and at smaller HCCs (3.58 [1.31-9.80]). CONCLUSIONS: While access to CHORUS™ CAB + RPV LAI features did not improve target window adherence, app use did, especially at smaller HCCs which may not have established LAI management procedures. TRIAL REGISTRATION: https://clinicaltrials.gov/show/NCT04863261.

Evaluation of a mobile app and web portal to help with the timely injections of cabotegravir + rilpivirine long-acting injectionsCabotegravir + rilpivirine long-acting injectable (CAB+RPV LAI) is the first long-acting regimen for HIV treatment, which was approved in the US in 2021. CAB+RPV LAI should be administered ≤7 days before/after the target date. We conducted a trial to evaluate the impact of the CHORUS™ app and web portal on the timing of monthly CAB+RPV injections. The intervention clinics had access to features designed to help with CAB+RPV LAI management, including flagging delayed/missed injections and appointment scheduling status. Control clinics did not have access to these features and managed CAB+RPV LAI administration on their own. Access to the app and web portal features for intervention clinics had no impact on timing of injections compared to control clinics. However, intervention clinics who actively used the app were close to three times more likely to give injections on-time than intervention clinics who did not use the app. The effect of app use was seen specifically among smaller clinics caring for <1000 people with HIV: smaller clinics that actively used the app were 3.58 times more likely to give injections on-time than those who did not use the app. In conclusion, while access to CHORUS™ CAB+RPV LAI features in the app and the web portal did not improve the likelihood of on time injections, actively using the app did make a difference, especially at smaller clinics which may not have established injection management procedures.

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Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

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Study Objectives: Insufficient sleep is common among children and adolescents, and can contribute to poor health. School-based interventions potentially could improve sleep behavior due to their broad reach, but their effectiveness is unclear. This systematic review focused on the effects of school-based interventions on sleep behavior among children and adolescents aged 5 to 18 years. Methods: Five electronic databases were searched for randomized controlled trials of sleep health interventions initiated or conducted in school settings and in which behavioral sleep outcomes were measured. Cochrane risk of bias tools were used to assess study quality. Results: From the 5303 database records and two papers from other sources, 21 studies (22 papers) met the inclusion criteria for this review. These studies involved 10 867 children and adolescents at baseline from 13 countries. Most studies (n = 15) were conducted in secondary schools. Sleep education was the most common intervention, either alone (n = 13 studies) or combined with other initiatives (stress management training, n = 2; bright light therapy, n = 1; health education, n = 1). Interventions were typically brief in terms of both the intervention period (median = 4 weeks) and exposure (median = 200 minutes). Behavioral outcomes included actigraphy-measured and self-reported sleep patterns, and sleep hygiene. All outcomes had high risk of bias or some concerns with bias. Sleep education interventions were typically ineffective. Later school start times promoted longer sleep duration over 1 week (1 study, high risk of bias). Conclusions: Current evidence does not provide school-based solutions for improving sleep health, perhaps highlighting a need for complex, multi-component interventions (e.g. whole-of-school approaches) to be trialed.

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BACKGROUND/AIMS: When designing a cluster randomized trial, advantages and disadvantages of tentative designs must be weighed. The stepped wedge design is popular for multiple reasons, including its potential to increase power via improved efficiency relative to a parallel-group design. In many realistic settings, it will take time for clusters to fully implement the intervention. When designing the HEALing (Helping to End Addiction Long-termSM) Communities Study, implementation time was a major consideration, and we examined the efficiency and practicality of three designs. Specifically, a three-sequence stepped wedge design with implementation periods, a corresponding two-sequence modified design that is created by removing the middle sequence, and a parallel-group design with baseline and implementation periods. In this article, we study the relative efficiencies of these specific designs. More generally, we study the relative efficiencies of modified designs when the stepped wedge design with implementation periods has three or more sequences. We also consider different correlation structures. METHODS: We compare efficiencies of stepped wedge designs with implementation periods consisting of three to nine sequences with a variety of corresponding designs. The three-sequence design is compared to the two-sequence modified design and to the parallel-group design with baseline and implementation periods analysed via analysis of covariance. Stepped wedge designs with implementation periods consisting of four or more sequences are compared to modified designs that remove all or a subset of 'middle' sequences. Efficiencies are based on the use of linear mixed effects models. RESULTS: In the studied settings, the modified design is more efficient than the three-sequence stepped wedge design with implementation periods. The parallel-group design with baseline and implementation periods with analysis of covariance-based analysis is often more efficient than the three-sequence design. With respect to stepped wedge designs with implementation periods that are comprised of more sequences, there are often corresponding modified designs that improve efficiency. However, use of only the first and last sequences has the potential to be either relatively efficient or inefficient. Relative efficiency is impacted by the strength of the statistical correlation among outcomes from the same cluster; for example, the relative efficiencies of modified designs tend to be greater for smaller cluster auto-correlation values. CONCLUSION: If a three-sequence stepped wedge design with implementation periods is being considered for a future cluster randomized trial, then a corresponding modified design using only the first and last sequences should be considered if sole focus is on efficiency. However, a parallel-group design with baseline and implementation periods and analysis of covariance-based analysis can be a practical, efficient alternative. For stepped wedge designs with implementation periods and a larger number of sequences, modified versions that remove 'middle' sequences should be considered. Due to the potential sensitivity of design efficiencies, statistical correlation should be carefully considered.

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