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This study evaluated the effectiveness of a seven-session, bystander-focused, classroom-delivered curriculum (i.e., Bringing in the Bystander—High School Curriculum [BITB-HSC]) in reducing rates of interpersonal violence among high school students. High schools (N = 26) were randomly assigned to the treatment or control condition. In classrooms in treatment schools, students (n = 1081) completed a baseline survey, participated in the BITB-HSC, and completed an immediate post-test, a short-term post-test (approx. 2 months after intervention), and a long-term post-test (approx. 1 year after intervention). Youth in control schools (n = 1322) completed surveys at similar time points but did not participate in the BITB-HSC. Participants were 15.8 years old on average and largely White (85.1%) and heterosexual (84.5%). Students exposed to the BITB-HSC demonstrated significant short-term changes in victim empathy and bystander barriers/facilitators, and long-term changes in rape myths, media literacy, bystander readiness, and knowledge relative to youth in the control condition. Although the BITB-HSC had little long-term impact on actual bystander behavior, there were reductions in some forms of violence among students in the BITB-HSC condition relative to the control condition. Future research is needed to determine if, for whom, why, and in what contexts (e.g., classroom-based versus school-wide initiatives) bystander-focused violence prevention initiatives reduce violence.

Background Immigrant women’s challenges in realizing sexual and reproductive health and rights (SRHR) are exacerbated by the lack of knowledge regarding how to tailor post-partum contraceptive services to their needs. Therefore, the overall aim of the IMPROVE-it project is to promote equity in SRHR through improvement of contraceptive services with and for immigrant women, and, thus, to strengthen women’s possibility to choose and initiate effective contraceptive methods post-partum. Methods This Quality Improvement Collaborative (QIC) on contraceptive services and use will combine a cluster randomized controlled trial (cRCT) with a process evaluation. The cRCT will be conducted at 28 maternal health clinics (MHCs) in Sweden, that are the clusters and unit of randomization, and include women attending regular post-partum visits within 16 weeks post birth. Utilizing the Breakthrough Series Collaborative model, the study’s intervention strategies include learning sessions, action periods, and workshops informed by joint learning, co-design, and evidence-based practices. The primary outcome, women’s choice of an effective contraceptive method within 16 weeks after giving birth, will be measured using the Swedish Pregnancy Register (SPR). Secondary outcomes regarding women’s experiences of contraceptive counselling, use and satisfaction of chosen contraceptive method will be evaluated using questionnaires completed by participating women at enrolment, 6 and 12 months post enrolment. The outcomes including readiness, motivation, competence and confidence will be measured through project documentation and questionnaires. The project’s primary outcome involving women’s choice of contraceptive method will be estimated by using a logistic regression analysis. A multivariate analysis will be performed to control for age, sociodemographic characteristics, and reproductive history. The process evaluation will be conducted using recordings from learning sessions, questionnaires aimed at participating midwives, intervention checklists and project documents. Discussion The intervention’s co-design activities will meaningfully include immigrants in implementation research and allow midwives to have a direct, immediate impact on improving patient care. This study will also provide evidence as to what extent, how and why the QIC was effective in post-partum contraceptive services. Trial registration NCT05521646, August 30, 2022.

This manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate the efficacy of attractive targeted sugar baits (ATSB) described in an already published protocol. The master SAP contains an overarching plan for all three trials, which can be adapted to trial-specific circumstances. The primary objective of the trials is to evaluate the efficacy of ATSB in the presence of universal vector control coverage with insecticide-treated nets (ITN) or indoor residual spraying (IRS) after two transmission seasons on clinical malaria incidence as compared with universal vector control coverage with ITN or IRS alone. The primary outcome measure is the incidence rate of clinical malaria, assessed in cohorts aged 12 months to less than 15 years (≥ 5 years to 15 years in Mali) during monthly follow-up visits. The primary unadjusted analysis will be conducted on the intention-to-treat analysis population without adjustment for any anticipated confounding variables. The primary outcome will be analyzed using a multi-level model constructed on a generalized linear model framework with a Poisson likelihood and a log link function. Random intercepts will be included for each study cluster and a fixed effect for study-arm. The analyst will be blinded to study arm assignment. Several secondary outcomes will be analyzed, as well as a pooled analysis (individual patient data meta-analysis) across the three trial sites. Additionally, a standard meta-analysis is expected to be conducted using combined data from all sites.

Menstrual cycle characteristics are largely considered unmodifiable reproductive factors, a framing that prevents exploration of the ways structural factors interfere with menstrual health. Given the role of structural factors like healthy food and healthcare access on reproductive health and the grave need for structural interventions to known reproductive health disparities that disproportionately target cisgender women racialized as Black, it is imperative that science begin to examine how structural factors influence menstrual health. To explore such research, we employ critical race theory and intersectionality to illustrate what a structural intervention to improve menstrual cycle health could look like. Centering those with the greatest need, persons racialized as Black and/or LatinX living in food and healthcare deserts in Northern Manhattan, our illustrative sample includes four groups of persons who menstruate (e.g., cisgender girls and women) that are pre-menarche, pre-parous, postpartum, or perimenopausal. We describe a hypothetical, multilevel clustered-randomized control trial (cRCT) that provides psychoeducation on racism-related trauma and free delivered groceries to both treatment and control groups, while randomizing 30 clusters of housing associations to receive either sexual health clinics at their housing association or free vouchers for healthcare. We embed mixed methods (diaries, interviews, surveys, mobile apps, observation) into the design to evaluate the effectiveness of the 1-year intervention, in addition to determining the impact on participants through their perspectives. Through this illustration, we provide a novel example of how structural interventions can apply mixed methods to evaluate effectiveness while delivering services to populations impacted by multiple structural factors. We demonstrate how qualitative and quantitative approaches can be paired in clustered RCTs and how a living logic model can empirically incorporate the population perspective into more effective interventions. Lastly, we reveal how sensitive menstrual health is to structural factors and how upstream improvements will trickle down to potentially reduce health disparities in reproductive health.

INTRODUCTION Few evidence‐based psychosocial interventions target people with advanced dementia. METHODS Namaste Care Family is a daily multi‐dimensional care program to improve quality of life (QoL) of people with dementia and their family caregivers. In this cluster‐randomized controlled trial, adjusted linear mixed models were used to analyze effects at 1, 3, 6, and 12 months follow‐up. Ten nursing homes implemented the program (n = 116) while nine nursing homes provided care as usual (n = 115). RESULTS The intervention group showed less discomfort (−1.06; 95% confidence interval [CI] = −1.88 to −0.23) and fewer sentinel events (‐0.40; 95% CI = −0.64 to −0.16), specifically pneumonia (−0.08; 95% CI = −0.14, −0.02). There were no differences in residents’ QoL, challenging behavior, and medication use. There was no effect on positive caregiving experiences, caregiver burden or guilt, whereas conflict with staff was lower at 12 months (−2.04; 95% CI = −4.07 to −0.01). DISCUSSION Namaste Care Family has some beneficial effects on residents with dementia and family caregivers. Clinical Trial Registration: This trial was registered with the CCMO Research with human participants (old ID 5692/new ID 5570). Highlights Namaste Care Family involves family in a daily program for residents with dementia. Residents’ quality of life did not improve (primary outcome) due to the program. Also, family's positive caregiving experiences did not improve (primary outcome). Namaste Care Family reduced discomfort and sentinel events in people with dementia. Family caregivers’ conflict with staff over caregiving decreased due to the program.

Background Outside of sub-Saharan Africa, Plasmodium vivax has become the dominant species of malaria. Focal mass drug administration (fMDA) is a potential strategy to support elimination efforts, but controlled studies are lacking. Methods The FocaL mass drug Administration for Plasmodium vivax Malaria Elimination (FLAME) study is a 3-year cluster randomized controlled trial to determine the impact and safety of fMDA to reduce P. vivax transmission. The study will be conducted in Loreto, Peru, where standard interventions have reduced P. vivax cases, but transmission persists due to a high proportion of subclinical infections. Thirty low transmission communities (API < 250 cases/1000 population) will be randomized 1:1 to fMDA versus control using a restricted randomization. All communities will receive Peruvian national standard malaria control measures. In the intervention arm, high-risk individuals (living within 200 m of a P. vivax case reported in the prior 2 years) without contraindication to study medications, including G6PD deficiency, will receive three cycles of fMDA over a 2-year period. Each cycle will include two rounds of directly observed therapy delivered 2 months apart. The fMDA regimen will include 25 mg/kg chloroquine (CQ) plus a single 300 mg dose of tafenoquine (TQ) for individuals age ≥ 16 years, and 25 mg/kg of CQ plus 7 days of 0.5 mg/kg/day of primaquine (PQ) if younger. The primary outcome is the cumulative incidence of symptomatic P. vivax malaria. The sample size provides 80% power to detect at least a 68% relative reduction in cumulative P. vivax incidence, based on alpha of 0.05 and a coefficient of variation ( k ) of 0.87. Secondary outcomes include safety, cost-effectiveness, and infection prevalence and seroprevalence which will be assessed in annual cross-sectional surveys. Safety will be assessed in passive and active pharmacovigilance, including post-treatment screening for G6PD-associated hemolysis by assessing for anemia and hematuria in a sample. Discussion The trial will generate evidence regarding fMDA for P. vivax and inform malaria elimination efforts in Peru and similarly endemic settings. Findings will be disseminated in peer-reviewed publications and through stakeholder meetings in Peruvian and international research forums. Trial registration Clinicaltrials.gov NCT05690841. This trial was registered on 09 January 2023. Peruvian Clinical Trial Registry (REPEC) 020–23. This trial was registered on 21 February 2024.

Background Behavioural risk factors may often present during adolescence and account for 70% of premature deaths during adulthood. Excessive sedentary behaviour and screen time have become significant concerns, especially among adolescents, due to their potential negative impact on physical and mental health. Adolescents with a high screen-based sedentary time are more likely to be physically inactive, have unhealthy body structure and poor academic performance. The objective of our study is to assess the effect of multi-component modular educational intervention on screen-based sedentary time (SST) and non-screen-based Sedentary time (NSST) among adolescents. Methods Ethical approval for the study has been obtained from the institutional Ethics Committee of Kasturba Medical College in Mangalore, India. This cluster randomized control trial will be carried out in schools located in the urban area of Mangalore. Using simple randomization, the eligible schools will be randomized into intervention and control arms, each consisting of 10 clusters. A multi-component modular educational intervention will be administered to participants in the intervention group at baseline, second and fourth month. The control group will receive the standard curriculum. Both the groups will be assessed at baseline and at second month, fourth month and sixth month of follow up for SST, NSST and level of physical activity. Anthropometric measurements like height, weight, waist circumference and hip circumference will be taken at baseline and sixth month of follow up. Results A comprehensive school-based modular educational intervention can have cumulative advantages by reducing screen- and non-screen-based sedentary time, and encouraging physical activity. Similar modular teaching can be incorporated into the curriculum, which will promote healthy life-style among the adolescents.

Background Each year, 2.2 million intrapartum-related deaths (intrapartum stillbirths and first day neonatal deaths) occur worldwide with 99% of them taking place in low- and middle-income countries. Despite the accelerated increase in the proportion of deliveries taking place in health facilities in these settings, the stillborn and neonatal mortality rates have not reduced proportionately. Poor quality of care in health facilities is attributed to two-thirds of these deaths. Improving quality of care during the intrapartum period needs investments in evidence-based interventions. We aim to evaluate the quality improvement package—Scaling Up Safer Bundle Through Quality Improvement in Nepal (SUSTAIN)—on intrapartum care and intrapartum-related mortality in public hospitals of Nepal. Methods We will conduct a stepped wedge cluster randomized controlled trial in eight public hospitals with each having least 3000 deliveries a year. Each hospital will represent a cluster with an intervention transition period of 2 months in each. With a level of significance of 95%, the statistical power of 90% and an intra-cluster correlation of 0.00015, a study period of 19 months should detect at least a 15% change in intrapartum-related mortality. Quality improvement training, mentoring, systematic feedback, and a continuous improvement cycle will be instituted based on bottleneck analyses in each hospital. All concerned health workers will be trained on standard basic neonatal resuscitation and essential newborn care. Portable fetal heart monitors (Moyo®) and neonatal heart rate monitors (Neobeat®) will be introduced in the hospitals to identify fetal distress during labor and to improve neonatal resuscitation. Independent research teams will collect data in each hospital on intervention inputs, processes, and outcomes by reviewing records and carrying out observations and interviews. The dose-response effect will be evaluated through process evaluations. Discussion With the global momentum to improve quality of intrapartum care, better understanding of QI package within a health facility context is important. The proposed package is based on experiences from a similar previous scale-up trial carried out in Nepal. The proposed evaluation will provide evidence on QI package and technology for implementation and scale up in similar settings. Trial registration number ISRCTN16741720 . Registered on 2 March 2019.

Background Over 80% of the morbidity and mortality related to non-communicable diseases (NCDs) occurs in low-income and middle-income countries (LMICs). Community health workers (CHWs) may improve disease control and medication adherence among patients with NCDs in LMICs, particularly in sub-Saharan African settings. In Uganda, and the majority of LMICs, management of uncontrolled hypertension remains limited in constrained health systems. Intervening at the primary care level, using CHWs to improve medical treatment outcomes has not been well studied. We aim to determine the effectiveness of a CHW-led intervention in blood pressure control among confirmed hypertensive patients and patient-related factors associated with uncontrolled hypertension. Methods We will conduct a stepped-wedge cluster randomized controlled trial study of 869 adult patients with hypertension attending two NCD clinics to test the effectiveness, acceptability, and fidelity of a CHW-led intervention. The multi-component intervention will be centered on monthly household visits by trained CHWs for a period of 1 year, consisting of the following: (1) blood pressure and sugar monitoring, (2) BMI monitoring, (3) cardiovascular disease risk assessment, (4) using checklists to guide monitoring and referral to clinics, and (5) healthy lifestyle counseling and education. During home visits, CHWs will remind patients of follow-up visits. We will measure blood pressure at baseline and 3-monthly for the entire cohort. We will conduct individual-level mixed effects analyses of study data, adjusting for time and clustering by patient and community. Conclusion The results of this study will inform community delivered HTN management across a range of LMIC settings. Trial registration ClinicalTrials.gov NCT05068505 . Registered on October 6, 2021.

To evaluate the effectiveness of the CARES-MFW (Clinical Augmented Reality Education Simulation for Malignant Fungating Wounds) app in enhancing nurses’ knowledge and clinical reasoning in the care of MFWs. Malignant fungating wounds (MFWs) affect many patients with advanced cancer, with nearly 50 % dying within six months of diagnosis. These wounds often present with heavy exudate, pain, malodor and bleeding, leading to profound physical and psychosocial distress. Traditional MFW education lacks clinical realism and limits knowledge transfer. Augmented reality simulation offers an immersive, interactive and context-rich approach that may improve nurses’ MFW knowledge and clinical reasoning. A cluster-randomized controlled trial. This study was conducted at a teaching hospital in Taiwan, involving 188 oncology nurses from 12 units. The units were randomly assigned to either an intervention group (CARES-MFW app group; n = 94, 6 units) or a control group (traditional education group; n = 94, 6 units). Participants completed the Malignant Fungating Wounds Knowledge Inventory and Clinical Reasoning Scale at baseline (T0), immediately post-intervention (T1) and at 8-week follow-up (T2). Baseline scores showed no significant differences between groups. The intervention group demonstrated significantly higher MFWs knowledge scores than the control group at T1 and T2. While clinical reasoning scores improved in the intervention group at T2, the between-group difference was not statistically significant. The CARES-MFW app effectively and sustainably enhanced nurses’ knowledge and clinical reasoning in MFWs care. By providing interactive 3D simulations and real-time feedback, the app offers an accessible solution that addresses gaps in traditional education. •CARES-MFW app uses 3D simulation to enhance nurses’ knowledge in MFW care.•CARES-MFW app delivers effective AR-enhanced standardized training for oncology nurses.•CARES-MFW app effectively boosts nurses’ clinical reasoning via AR and case-based learning.