Improving Parental Health Literacy in Primary Caregivers of 0- to 3-Year-Old Children Through a WeChat Official Account: Cluster Randomized Controlled Trial.

Background: Parental health literacy is important to children's health and development, especially in the first 3 years. However, few studies have explored effective intervention strategies to improve parental literacy. Objective: This study aimed to determine the effects of a WeChat official account (WOA)-based intervention on parental health literacy of primary caregivers of children aged 0-3 years. Methods: This cluster randomized controlled trial enrolled 1332 caregiver-child dyads from all 13 community health centers (CHCs) in Minhang District, Shanghai, China, between April 2020 and April 2021. Participants in intervention CHCs received purposefully designed videos via a WOA, which automatically recorded the times of watching for each participant, supplemented with reading materials from other trusted web-based sources. The contents of the videos were constructed in accordance with the comprehensive parental health literacy model of WHO (World Health Organization)/Europe (WHO/Europe). Participants in control CHCs received printed materials similar to the intervention group. All the participants were followed up for 9 months. Both groups could access routine child health services as usual during follow-up. The primary outcome was parental health literacy measured by a validated instrument, the Chinese Parental Health Literacy Questionnaire (CPHLQ) of children aged 0-3 years. Secondary outcomes included parenting behaviors and children's health outcomes. We used the generalized linear mixed model (GLMM) for data analyses and performed different subgroup analyses. The ß coefficient, risk ratio (RR), and their 95% CI were used to assess the intervention's effect. Results: After the 9-month intervention, 69.4% (518/746) of caregivers had watched at least 1 video. Participants in the intervention group had higher CPHLQ total scores (ß=2.51, 95% CI 0.12-4.91) and higher psychological scores (ß=1.63, 95% CI 0.16-3.10) than those in the control group. The intervention group also reported a higher rate of exclusive breastfeeding (EBF) at 6 months (38.9% vs 23.44%; RR 1.90, 95% CI 1.07-3.38) and a higher awareness rate of vitamin D supplementation for infants younger than 6 months (76.7% vs 70.5%; RR 1.39, 95% CI 1.06-1.82). No significant effects were detected for the physical score on the CPHLQ, breastfeeding rate, routine checkup rate, and children's health outcomes. Furthermore, despite slight subgroup differences in the intervention's effects on the total CPHLQ score and EBF rate, no interaction effect was observed between these subgroup factors and intervention factors. Conclusions: Using a WHO literacy model-based health intervention through a WOA has the potential of improving parental health literacy and EBF rates at 6 months. However, innovative strategies and evidence-based content are required to engage more participants and achieve better intervention outcomes.

Longer-term Effect of Physical Activity Intervention on Sleep Quality: A Secondary Analysis of Cluster Randomized Controlled Trial.

STUDY OBJECTIVES: To examine the longer-term effect of physical activity (PA) intervention on sleep quality and whether the effect was heterogeneous between daytime nappers and non-nappers. METHODS: This study was a secondary analysis of a cluster randomized controlled trial in China. Eight villages were randomized 1:1 to intervention or control group. The intervention group received an 8-week PA intervention, while the control group did not. The primary outcome of this study was the change in the Pittsburgh Sleep Quality Index (PSQI) global score at 24 months. RESULTS: The 511 participants had a mean age of 70.94 years (SD 5.73) and 55.6% were female. The intervention showed improvements in the PSQI global score at 8 weeks (adjusted mean difference -1.05; P=0.002), and the effect diminished at 24 months (-0.64; P=0.06). There were statistically significant improvements in the PSQI global score for daytime nappers, but not for non-nappers at 8 weeks (adjusted mean difference -0.98; P=0.01 vs -1.27; P=0.05), 12 months (-0.86; P=0.03 vs -0.84; P=0.21), and 24 months (-0.80; P=0.04 vs -0.14; P=0.84), although these improvements were below the minimum detectible level of the PSQI which is 1 point. CONCLUSION: The 8-week PA intervention was effective in improving sleep quality, while the effect was diminished and below the minimum detectible level of the PSQI which is 1 point after 24 months. The effect of PA intervention on sleep quality was more pronounced in daytime nappers. Additional interventions (e.g., focusing on multiple behavioral interventions such as PA and healthy diet) are needed to maintain the beneficial effect of PA on sleep quality in the general older populations. Further research is required to confirm the mechanisms of the effect of napping and develop tailored interventions.

The impact of a digital guideline version on schizophrenia guideline knowledge: results from a multicenter cluster-randomized controlled trial.

BACKGROUND: Clinical practice guidelines are crucial for enhancing healthcare quality and patient outcomes. Yet, their implementation remains inconsistent across various professions and disciplines. Previous findings on the implementation of the German guideline for schizophrenia (2019) revealed low adherence rates among healthcare professionals. Barriers to guideline adherence are multifaceted, influenced by individual, contextual, and guideline-related factors. This study aims to investigate the effectiveness of a digital guideline version compared to print/PDF formats in enhancing guideline adherence. METHODS: A multicenter, cluster-randomized controlled trial was conducted in South Bavaria, Germany, involving psychologists and physicians. Participants were divided into two groups: implementation of the guideline using a digital online version via the MAGICapp platform and the other using the traditional print/PDF version. The study included a baseline assessment and a post-intervention assessment following a 6-month intervention phase. The primary outcome was guideline knowledge, which was assessed using a guideline knowledge questionnaire. RESULTS: The study included 217 participants at baseline and 120 at post-intervention. Both groups showed significant improvements in guideline knowledge; however, no notable difference was found between both study groups regarding guideline knowledge at either time points. At baseline, 43.6% in the control group (CG) and 52.5% of the interventional group (IG) met the criterion. There was no significant difference in the primary outcome between the two groups at either time point (T0: Chi2(1) = 1.65, p = 0.199, T1: Chi2(1) = 0.34, p = 0.561). At post-intervention, both groups improved, with 58.2% in the CG and 63.5% in the IG meeting this criterion. CONCLUSIONS: While the study did not include a control group without any implementation strategy, the overall improvement in guideline knowledge following an implementation strategy, independent of the format, was confirmed. The digital guideline version, while not superior in enhancing knowledge, showed potential benefits in shared decision-making skills. However, familiarity with traditional formats and various barriers to digital application may have influenced these results. The study highlights the importance of tailored implementation strategies, especially for younger healthcare providers. TRIAL REGISTRATION: https://drks.de/search/de/trial/DRKS00028895.

The impacts of task shifting on the management and treatment of malnourished children in Northern Kenya: a cluster-randomized controlled trial.

Treating children with acute malnutrition can be challenging, particularly regarding access to healthcare facilities during treatment. Task shifting, a strategy of transferring specific tasks to health workers with shorter training and fewer qualifications, is being considered as an effective approach to enhancing health outcomes in primary healthcare. This study aimed to assess the effectiveness of integrating the treatment of acute malnutrition by community health volunteers into integrated community case management in two sub-counties in northern Kenya (Loima and Isiolo). We conducted a two-arm non-inferiority cluster-randomized controlled trial across 20 community health units. Participants were children aged 6-59 months with uncomplicated acute malnutrition. In the intervention group, community health volunteers used simplified tools and protocols to identify and treat eligible children at home and provided the usual integrated community case management package. In the control group, community health volunteers provided the usual integrated community case management package only (screening and referral of the malnourished children to the health facilities). The primary outcome was recovery (MUAC ≥12.5 cm for 2 consecutive weeks). Results show that children in the intervention group were more likely to recover than those in the control group [73 vs 50; risk difference (RD) = 26% (95% CI 12 to 40) and risk ratio (RR) = 2 (95% CI 1.2 to 1.9)]. The probability of defaulting was lower in the intervention group than in the control group: RD = -21% (95% CI -31 to -10) and RR = 0.3 (95% CI 0.2 to 0.5). The intervention reduced the length of stay by about 13 days, although this was not statistically significant and varied substantially by sub-county. Integrating the treatment of acute malnutrition by community health volunteers into the integrated community case management programme led to better malnutrition treatment outcomes. There is a need to integrate acute malnutrition treatment into integrated community case management and review policies to allow community health volunteers to treat uncomplicated acute malnutrition.

Effects of gamification in advanced life support training for clinical nurses: A cluster randomized controlled trial.

BACKGROUND: Cardiopulmonary resuscitation training is a mandatory competency, especially for healthcare professionals. However, the spread of COVID-19 caused a sharp decline in the number of participants on advanced life support training, thereby accelerating the diversification of educational methods. Gamification is an increasingly popular method of diversifying instruction, but its effectiveness remains controversial. AIM: To evaluate the effectiveness of gamification learning in advanced life support training. DESIGN: A cluster randomized controlled trial. SETTING: A single advanced life support training center. PARTICIPANTS: Clinical nurses who are currently practicing in a hospital. METHODS: A part of the existing advanced life support course was gamified using Kahoot! platform. Conventional learning and gamified learning were each conducted 11 times, and the level of knowledge after training was assessed. The assessment questions were categorized into advanced life support algorithms, teamwork, and cardiac arrest rhythms. RESULTS: A total of 267 were enrolled in the study, and 148 and 139 learners were assigned to CL and GL, respectively. There was no difference in post-training knowledge related to teamwork, and cardiac arrest rhythms between the conventional learning and gamified learning groups, but knowledge related to the advanced life support algorithm was low in the gamified learning group. CONCLUSIONS: Even if the learners are the same, advanced life support gamification training can lead to negative outcomes depending on the simplicity or goal of the training content. To improve the effectiveness of the training, various methods of gamification training should be applied depending on the goal and content of the training.

Universal Sexual Violence Intervention Effects in a Cluster-Randomized Trial: Moderation by Sexual Orientation.

Sexual minority (e.g., gay/lesbian, bisexual, and queer) students are more likely than their heterosexual peers to experience sexual violence (SV) during college. Interventions that prevent SV and improve SV care-seeking behaviors for sexual minority students are lacking. Giving Information for Trauma Support and Safety (GIFTSS) is an evidence-based universal SV intervention implemented by providers during college health and counseling visits. Compared to controls, GIFTSS participants reported greater self-efficacy to use SV harm reduction strategies and SV disclosure during clinical visits. However, GIFTSS' effectiveness for sexual minority participants is unknown. The current study examines whether sexual orientation moderates GIFTSS' effects on numerous SV-related outcomes (i.e., to test whether intervention effects at 4 and 12 months differed based on sexual orientation). Across 28 college campuses in Pennsylvania and West Virginia, 2,291 students participated in a two-arm cluster-randomized controlled trial. We used mixed models with two- and three-way interaction terms to test whether sexual orientation modified GIFTSS' effects at 4- and 12-month follow-up on participants': SV recognition; knowledge of and self-efficacy to enact SV harm reduction strategies; intentions to intervene; knowledge of and self-efficacy to use SV-related services; SV disclosure during visits; and recent SV exposure. Overall, 22.1% of participants were sexual minorities (n = 507). Sexual orientation moderated GIFTSS effectiveness as indicated by significant three-way interaction (p = .01) at 12-month follow-up, and knowledge of SV services decreased for heterosexual participants (ß = -.23) but increased for sexual minority participants (ß = .23). Our study indicates that universal provider-based education may promote greater knowledge of SV services among sexual minority than heterosexual participants, and population-specific interventions are needed that reduce sexual minority students' SV exposure, service utilization, and other critical aspects of SV prevention on university campuses.Clinical Trial Registration: Registry name: College Health Center-based Alcohol and Sexual Violence Intervention (GIFTSS), Registration number: NCT02355470, Web link: https://clinicaltrials.gov/ct2/show/NCT02355470, Deidentified individual participant data will not be made available.

Considerations for first field trials of low-threshold gene drive for malaria vector control.

Sustainable reductions in African malaria transmission require innovative tools for mosquito control. One proposal involves the use of low-threshold gene drive in Anopheles vector species, where a 'causal pathway' would be initiated by (i) the release of a gene drive system in target mosquito vector species, leading to (ii) its transmission to subsequent generations, (iii) its increase in frequency and spread in target mosquito populations, (iv) its simultaneous propagation of a linked genetic trait aimed at reducing vectorial capacity for Plasmodium, and (v) reduced vectorial capacity for parasites in target mosquito populations as the gene drive system reaches fixation in target mosquito populations, causing (vi) decreased malaria incidence and prevalence. Here the scope, objectives, trial design elements, and approaches to monitoring for initial field releases of such gene dive systems are considered, informed by the successful implementation of field trials of biological control agents, as well as other vector control tools, including insecticides, Wolbachia, larvicides, and attractive-toxic sugar bait systems. Specific research questions to be addressed in initial gene drive field trials are identified, and adaptive trial design is explored as a potentially constructive and flexible approach to facilitate testing of the causal pathway. A fundamental question for decision-makers for the first field trials will be whether there should be a selective focus on earlier points of the pathway, such as genetic efficacy via measurement of the increase in frequency and spread of the gene drive system in target populations, or on wider interrogation of the entire pathway including entomological and epidemiological efficacy. How and when epidemiological efficacy will eventually be assessed will be an essential consideration before decisions on any field trial protocols are finalized and implemented, regardless of whether initial field trials focus exclusively on the measurement of genetic efficacy, or on broader aspects of the causal pathway. Statistical and modelling tools are currently under active development and will inform such decisions on initial trial design, locations, and endpoints. Collectively, the considerations here advance the realization of developer ambitions for the first field trials of low-threshold gene drive for malaria vector control within the next 5 years.

Community-Based Health Education Led by Women's Groups Significantly Improved Maternal Health Service Utilization in Southern Ethiopia: A Cluster Randomized Controlled Trial.

OBJECTIVE: This study aimed to evaluate the effect of health education intervention (HEI) on maternal health service utilization (MHSU) in southern Ethiopia. METHODS: From 10 January to 1 August 2023, a community-based, two-arm, parallel-group cluster randomized controlled trial (cRCT) was conducted among pregnant mothers in the Northern Zone of Sidama National Regional State, Ethiopia. We utilized multilevel mixed-effects modified Poisson regression with robust variance to control for the effects of clustering and potential confounders. The level of significance was adjusted for multiple comparisons. RESULTS: The overall utilization of at least one antenatal care (ANC) visit was 90.2% in the treatment group and 59.5% in the comparator group (χ2 = 89.22, p < 0.001). Health facility delivery (HFD) utilization was considerably different between the treatment group (74.3%) and the comparator group (50.8%) (χ2 = 70.50, p < 0.001). HEI significantly increased ANC utilization (adjusted risk ratio [ARR]: 1.32; 99% CI: 1.12-1.56) and HFD utilization (ARR: 1.24; 99% CI: 1.06-1.46). The utilization of at least one postnatal care (PNC) service was 65.4% in the treatment group and 52.1% in the comparator group (χ2 = 19.51, p = 0.01). However, after controlling for the effects of confounders and clustering, the impact of HEI on PNC utilization was insignificant between the two groups (ARR: 1.15; 99% CI: 0.89-1.48). CONCLUSION: A community-based HEI significantly increased ANC and HFD utilization but did not increase PNC utilization. Expanding the HEI with certain modifications will have a superior effect on improving MHSU. TRIAL REGISTRATION NUMBER: NCT05865873.

The Multi-domain Lifestyle Intervention for Cognitive Impairment in Community-Dwelling Older Adults in Hangzhou (The Heritage Study): Study Design and Protocol.

BACKGROUND: The globe has been working to promote a multi-domain lifestyle intervention for dementia prevention in older adults, referring to the Worldwide-FINGERS (Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) initiative. In China, the multi-domain lifestyle intervention has been implemented in rural communities (MIND-China), yet the adaptability of such intervention based on the urban communities in China has not been verified. OBJECTIVE: To examine the effectiveness and feasibility of the multi-domain lifestyle intervention on dementia prevention in at-risk community-dwelling older adults in China. DESIGN, SETTING, PARTICIPANTS: The multi-domain lifestyle intervention study is a community-based 2-year cluster randomized controlled trial (RCT). A total of 1200 participants aged 60-80 years old will be recruited from twelve communities in Hangzhou, Zhejiang. Inclusion criteria were the Montreal Cognitive Assessment 5 minutes protocol (5 min MoCA) score of 6-9 or the Ascertain Dementia 8 (AD 8) score of ≥2, and having modifiable lifestyle factors. INTERVENTION, MEASUREMENTS, RESULTS: Participating communities will be randomized into either the structured multi-domain intervention (SMI) arm or the self-guided intervention (SGI, general health education) arm. The SMI consists of cognitive training, physical exercise, and nutritional and dietary instruction for the first 12 months; and vascular risks monitoring and control for 24 months. The primary outcome is the global cognitive performance, measured by the comprehensive Neuropsychological Test Battery (NTB). The secondary outcomes include domain-specific cognitive performances, physical function, mental health, physiological and biochemical indices, adherence to healthy lifestyles, and neuroimaging metrics. The feasibility of intervention will be evaluated around the five dimensions of the RE-AIM framework and in conjunction with quantitative data, operational data and results of focus group discussions. CONCLUSIONS: Following the Worldwide-FINGERS, this cluster RCT will verify the adaptability of the multi-domain lifestyle intervention in the urban community settings in China. This study will add evidence for global dementia prevention and management among older adults.

Implementation and dissemination of physical activity-related health competence in vocational nursing training: study protocol for a cluster-randomized controlled intervention trial.

BACKGROUND: Although the nursing sector gains growing importance in an aging society, students representing the future workforce often show insufficient health. Acknowledging the health-enhancing effects of adequate physical activity, the educational system in Bavaria, Germany, has recently integrated the promotion of physical activity-related health competence (PAHCO) into the nursing curriculum. However, it cannot be assumed that PAHCO has sufficiently permeated the educational practices and routines of the nursing schools. Therefore, the goal of the present study is to examine and compare the effectiveness as well as implementation of different intervention approaches to address PAHCO in the Bavarian nursing school system. METHODS: We randomly assign 16 nursing schools (cluster-based) to four study arms (bottom-up, top-down led by teachers, top down led by external physical activity experts, control group). Schools in intervention group 1 (IG-1) develop multicomponent inventions to target PAHCO via cooperative planning (preparation, planning, and implementation phase). Intervention groups 2 and 3 (IG-2, IG-3) receive both an expert-based intervention (developed through intervention mapping) via trained mediators to address PAHCO. External physical activity experts deliver the structured PAHCO intervention in IG-2, while teachers from the nursing schools themselves conduct the PAHCO intervention in IG-3. In line with a hybrid effectiveness implementation trial, we apply questionnaire-based pre-post measurements across all conditions (sample size calculation: nfinal = 636) to examine the effectiveness of the intervention approaches and, simultaneously, draw on questionnaires, interview, and protocol data to examine their implementation. We analyze quantitative effectiveness data via linear models (times-group interaction), and implementation data using descriptive distributions and content analyses. CONCLUSION: The study enables evidence-based decisions about the suitability of three intervention approaches to promote competencies for healthy, physically active lifestyles among nursing students. The findings inform dissemination activities to effectively reach all 185 schools of the Bavarian nursing system. TRIAL REGISTRATION: Clinical trials NCT05817396. Registered on April 18, 2023.

Clinical effectiveness and cost-effectiveness of a multicomponent frailty management program "Say No To Frailty" in Singapore: A cluster-randomized controlled trial protocol.

BACKGROUND: A 12-week multicomponent frailty management program - Say No To Frailty (SNTF) consisting of interactive talks and fitness exercises led by a trained program leader has shown feasibility and positive health outcomes in community-living older adults with frailty and pre-frailty in Singapore. This study aims to evaluate the clinical- and cost-effectiveness of SNTF on physical functions, self-confidence, community participation, quality of life and fall reduction in the local community setting. METHODS: This study will use the cluster-randomization method to randomly allocate 12 participating centres into three arms. Centres under two intervention arms will conduct the same SNTF program but led by a program leader with different training backgrounds (an Allied Health Professional (AHP) v.s. a non-AHP), whereas centres under the control arm will continue their usual care without an additional intervention. Eligible participants at each participating centre will be recruited via the convenience sampling method in the community setting. Primary outcome measure (frailty level) and secondary outcome measures (e.g., physical functions, self-confidence, community participation, quality of life) will be conducted by the blinded assessors at baseline, immediate, 3 months and 9 months post-intervention. Fall data will be collected during the one-year study period. Outcomes between and within groups will be compared and analysed using STATA to evaluate the clinical effectiveness. Program costs and relevant healthcare costs during the follow-up phase will be recorded for cost-effectiveness analysis. CONCLUSION: This study will provide significant insights into conducting SNTF for Singapore community-living older adults with frailty and pre-frailty on clinical- and cost-effectiveness. Australia New Zealand Clinical Trials Registry: ACTRN12621001673831.

Effectiveness of a needs-tailored nurse-led recovery program for community-dwelling people with schizophrenia: a cluster-randomized controlled trial.

BACKGROUND: Meeting people's needs is positively correlated with their recovery. However, recovery services rarely include nurse-led programs tailored to the needs of these people. This study aimed to evaluate the effectiveness of a new needs-tailored recovery program by using a cluster-randomized controlled trial design. METHODS: We conducted a parallel randomized controlled trial in two community psychiatric departments, employing nurse-level clustering for intervention delivery and selecting participants through convenience sampling. The participants were people diagnosed with schizophrenia that were receiving homecare services. The experimental group (n = 82) received needs-tailored recovery program for six months. The control group (n = 82) received traditional homecare. Data were collected at baseline, post-intervention, and the three-month follow-up (the study ran from February to December 2021). The outcomes were recovery, needs, hope, empowerment, psychotic symptoms, and medication adherence. We used repeated measures ANOVA tests to examine the effect of the group × time interaction. RESULTS: The participants in the experimental group demonstrated statistically significant improvements in recovery, hope, and medication adherence compared to the control group, both immediately post-intervention and at the three-month follow-up. Moreover, they exhibited statistically significant reductions in needs compared to the control group at the three-month follow-up (p < .05). While the interaction effect for psychotic symptoms was not significant, the time effect was significant (p < .05). No significant interaction or time effect was observed for empowerment. CONCLUSION: The findings increase our understanding of recovery-oriented care that prioritizes therapeutic alliance, integrated needs assessment, individual goals, hope, and empowerment. TRIAL REGISTRATION: The Clinicaltrials.gov identifier NCT05304780 retrospectively registered on 03/31/2022.

The TELEhealth Shared decision-making Coaching and Navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators.

Background: Lung cancer screening (LCS) can reduce lung cancer mortality but has potential harms for patients. A shared decision-making (SDM) conversation about LCS is required by the Centers for Medicare & Medicaid Services (CMS) for LCS reimbursement. To overcome barriers to SDM in primary care, this protocol describes a telehealth decision coaching intervention for LCS in primary care clinics delivered by patient navigators. The objective of the study is to evaluate the effectiveness of the intervention and its implementation potential, compared with an enhanced usual care (EUC) arm. Methods: Patients (n = 420) of primary care clinicians (n = 120) are being recruited to a cluster randomized controlled trial. Clinicians are randomly assigned to 1) TELESCOPE intervention: prior to an upcoming non-acute clinic visit, patients participate in a telehealth decision coaching session about LCS delivered by trained patient navigators and nurse navigators place a low-dose CT scan (LDCT) order for each TELESCOPE patient wanting LCS, or 2) EUC: patients receive enhanced usual care from a clinician. Usual care is enhanced by providing clinicians in both arms with access to a Continuing Medical Education (CME) webinar about LCS and an LCS discussion guide. Patients complete surveys at baseline and 1-week after the scheduled clinic visit to assess quality of the SDM process. Re-navigation is attempted with TELESCOPE patients who have not completed the LDCT within 3 months. One month before being due for an annual screening, TELESCOPE patients whose initial LCS showed low-risk findings are randomly assigned to receive a telehealth decision coaching booster session with a navigator or no booster. Electronic health records are abstracted at 6, 12 and 18 months after the initial decision coaching session (TELESCOPE) or clinic visit (EUC) to assess initial and annual LCS uptake, imaging results, follow-up testing for abnormal findings, cancer diagnoses, treatment, and tobacco treatment referrals. This study will evaluate factors that facilitate or interfere with program implementation using mixed methods. Discussion: We will assess whether a decision coaching and patient navigation intervention can feasibly support high-quality SDM for LCS and guideline-concordant LCS uptake for patients in busy primary care practices serving diverse patient populations. Trial Registration: This study was registered at ClinicalTrials.gov (NCT05491213) on August 4, 2022.

The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms.

Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0-59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. Study approval has been granted by all relevant institutional review boards, national and WHO ethical review committees. Findings will be shared with communities, healthcare providers, Ministries of Health and other local, national and international stakeholders to facilitate evidence-based decision-making on scale-up.Study registration: NCT04910750 and NCT05065320.

Pulse oximetry and clinical decision support algorithms show potential for supporting healthcare providers to identify and manage severe illness among children under-five attending primary care in resource-constrained settings, whilst promoting resource stewardship but scale-up has been hampered by evidence gaps.This study design article describes the largest scale evaluation of these interventions to date, the results of which will inform country- and global-level policy and planning .

Alerta Cannabis: A Tailored-Computer Web-Based Program for the Prevention of Cannabis Use in Adolescents: A Cluster-Randomized Controlled Trial Protocol.

BACKGROUND: The growing use of cannabis in adolescence is a public health problem that must be addressed through prevention. In Spain, the average age of initiation of cannabis use in the adolescent population is 14.8 years. At 14 years, the lifetime prevalence of cannabis use is 11.7%, which increases to 51.,5% at the age of 18; the prevalence of cannabis use in the population aged 14 to 18 years is 28.6%, a figure that must be tried to reduce, that is why this school prevention program is proposed: Alerta Cannabis. METHODS: The Alerta Cannabis research project consists of design, implementation, and evaluation. In the first phase, a computer-tailored eHealth program (Alerta Cannabis) is developed based on the I-Change Model, an integrated model based on three main behavioral change processes: awareness, motivation, and action. This program consists of four 30-minute sessions that will provide culturally adapted and personalized advice to motivate students not to use cannabis through text feedback, animations, and gamification techniques. This phase will also include usability testing. In the implementation phase, secondary school students from Western Andalusia, Spain (Seville, Cádiz, Huelva, and Córdoba) and Eastern Andalusia (Jaén, Málaga, and Granada) will be randomized to an experimental condition (EC) or a control condition (CC) for a cluster randomized clinical trial (CRCT). Each condition will have 35 classes within 8 schools. GI will receive the online intervention Alerta Cannabis. EC and CC will have to fill out a questionnaire at baseline, six months, and twelve months of follow-up. In the last phase, the effect of Alerta Cannabis is evaluated. The primary outcomes are the lifetime prevalence of cannabis use and its use in the last 30 days and at 6 months. At 12 months of follow-up, the prevalence in the last 12 months will also be assessed. The secondary outcome is the intention to use cannabis. DISCUSSION: The study tests the effect of the innovative program specifically aimed to reduce the use of cannabis in the adolescent population through eHealth in Spain. The findings aim to develop and implement evidence-based cannabis prevention interventions, which could support school prevention, for instance, the assistance of school nurses. If the program proves to be effective, it could be useful to prevent cannabis use on a national and international scale. TRIAL REGISTRATION: NCT05849636. Date of registration: March 16, 2023.

Providing Lesbian, Gay, Bisexual, Transgender, Nonbinary, and Queer Adolescents With Nurturance, Trustworthiness, and Safety: Protocol for Pilot Cluster Randomized Controlled Trial Design.

BACKGROUND: Sexual and gender minority youths (lesbian, gay, bisexual, transgender, nonbinary, and queer individuals) face elevated risks of substance use (eg, alcohol and tobacco) and mental health issues (eg, depressive symptoms and suicidality) compared to their cisgender heterosexual peers. These inequities are hypothesized to be reduced by building supportive high school environments via the training of school staff. An intervention that trains school staff to better understand and support sexual and gender minority youths and engage in positive bystander behaviors that protect them from bullying exposure may reduce disparities in drug and alcohol use among them. Experts, school staff, and sexual and gender minority youths developed Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety (PLANTS), a web-based intervention to train school staff on how to support, affirm, and protect sexual and gender minority youths. OBJECTIVE: This paper describes the design of the PLANTS pilot trial primarily aimed at assessing its acceptability, usability, appropriateness, and feasibility. We hypothesize PLANTS will have high acceptability, usability, appropriateness, and feasibility as rated by the school staff. Secondary objectives focus on implementation, safety, and pre-post changes in high school staff outcomes, including self-efficacy and skills (eg, active-empathic listening and bullying intervention). Exploratory objectives focus on the impact of PLANTS on student health outcomes. METHODS: In a 2-arm cluster randomized controlled trial, high schools in Massachusetts are allocated to PLANTS or an active comparator group (publicly available sexual and gender minority youths resources or training). High school staff complete pretest and posttest surveys containing validated scales. Primary outcomes are validated measures of acceptability, usability, appropriateness, and feasibility of the intervention completed by staff during posttest surveys. To test our primary hypotheses for each outcome, we will calculate means and 95% CIs and P values using 1-sample 2-sided t tests against a priori thresholds or benchmarks of success. Secondary outcomes include staff's active-empathetic listening skills, self-efficacy for working with sexual and gender minority youths, bystander intervention behaviors for bullying and cyberbullying, and self-efficacy for PLANTS' change objectives completed during pretest and posttest staff surveys. Staff can also complete a posttest interview guided by the Information-Motivation-Behavior model and Consolidated Framework for Implementation Research. Exploratory outcomes include student-level data collected via the 2021 and 2023 MetroWest Adolescent Health Surveys, a health behavior surveillance system in 30 Massachusetts schools. RESULTS: School enrollment began in May 2023 and participant enrollment began in June 2023. Data collection is expected to be completed by February 2024. CONCLUSIONS: This pilot trial will yield important information about the PLANTS intervention and provide necessary information to conduct a fully powered trial of the efficacy of PLANTS for reducing the deleterious health inequities experienced by sexual and gender minority youths. TRIAL REGISTRATION: ClinicalTrials.gov NCT05897827; https://clinicaltrials.gov/study/NCT05897827. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55210.

Evaluation of a financial incentive intervention on malaria prevalence among the residents in Lake Victoria basin, Kenya: study protocol for a cluster-randomized controlled trial.

BACKGROUND: In the Lake Victoria basin of western Kenya, malaria remains highly endemic despite high coverage of interventions such as mass distribution of long-lasting insecticidal nets (LLIN), indoor residual spraying (IRS) programs, and improvement of availability and accessibility of rapid diagnostic tests (RDT) and artemisinin-based combination therapy (ACT) at community healthcare facilities. We hypothesize that one major cause of the residual transmission is the lack of motivation among residents for malaria prevention and early treatment. METHODS: This study will aim to develop a demand-side policy tool to encourage local residents' active malaria prevention and early treatment-seeking behaviors. We examine the causal impact of a financial incentive intervention complemented with malaria education to residents in malaria-prone areas. A cluster-randomized controlled trial is designed to assess the effect of the financial incentive intervention on reducing malaria prevalence in residents of Suba South in Homa Bay County, Kenya. The intervention includes two components. The first component is the introduction of a financial incentive scheme tied to negative RDT results for malaria infection among the target population. This study is an attempt to promote behavioral changes in the residents by providing them with monetary incentives. The project has two different forms of incentive schemes. One is a conditional cash transfer (CCT) that offers a small reward (200 Ksh) for non-infected subjects during the follow-up survey, and the other is a lottery incentive scheme (LIS) that gives a lottery with a 10% chance of winning a large reward (2000 Ksh) instead of the small reward. The second component is a knowledge enhancement with animated tablet-based malaria educational material (EDU) developed by the research team. It complements the incentive scheme by providing the appropriate knowledge to the residents for malaria elimination. We evaluate the intervention's impact on the residents' malaria prevalence using a cluster-randomized control trial. DISCUSSION: A policy tool to encourage active malaria prevention and early treatment to residents in Suba South, examined in this trial, may benefit other malaria-endemic counties and be incorporated as part of Kenya's national malaria elimination strategy. TRIAL REGISTRATION: UMIN000047728. Registered on 29th July 2022.

Effect of a Salt Substitute on Incidence of Hypertension and Hypotension Among Normotensive Adults.

BACKGROUND: Reports on the effects of salt substitution among individuals with normal blood pressure are scarce and controversial. OBJECTIVES: This study sought to assess the effects of a salt substitute (62.5% NaCl, 25% KCl, and 12.5% flavorings) on incidence of hypertension and hypotension among older adults with normal blood pressure. METHOD: A post hoc analysis was conducted among older adults with normal blood pressure participating in DECIDE-Salt, a large, multicenter, cluster-randomized trial in 48 elderly care facilities for 2 years. We used the frailty survival model to compare risk of incident hypertension and the generalized linear mixed model to compare risk of hypotension episodes. RESULTS: Compared with usual salt group (n = 298), the salt substitute group (n = 313) had a lower hypertension incidence (11.7 vs 24.3 per 100 person-years; adjusted HR: 0.60; 95% CI: 0.39 to 0.92; P = 0.02) but did not increase incidence of hypotension episodes (9.0 vs 9.7 per 100 person-years; P = 0.76). Mean systolic/diastolic blood pressure did not increase from the baseline to the end of intervention in the salt substitute group (mean changes: -0.3 ± 11.9/0.2 ± 7.1 mm Hg) but increased in the usual salt group (7.0 ± 14.3/2.1 ± 7.5 mm Hg), resulting in a net reduction of -8.0 mm Hg (95% CI: -12.4 to -3.7 mm Hg) in systolic and -2.0 mm Hg (95% CI: -4.1 to 0.1 mm Hg) in diastolic blood pressure between intervention groups. CONCLUSIONS: In Chinese older adults with normal blood pressure, replacing usual salt with a salt substitute may reduce the incidence of hypertension without increasing hypotension episodes. This suggests a desirable strategy for population-wide prevention and control of hypertension and cardiovascular disease, deserving further consideration in future studies. (Diet Exercise and Cardiovascular Health [DECIDE]-Salt Reduction Strategies for the Elderly in Nursing Homes in China [DECIDE-Salt]; NCT03290716).