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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 (β = −.23) but increased for sexual minority participants (β =.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. [ABSTRACT FROM AUTHOR]

PURPOSE: The aim of this study is to expand the current knowledge on the relationship between poverty, family functioning, and the mental health of adolescent girls in families affected by poverty and HIV/AIDS in southern Uganda. The study investigates the association between family functioning and mental health and examines whether family functioning moderates the intervention effect on adolescent mental health. METHODS: Longitudinal data were collected over the course of 24 months in a cluster randomized controlled trial conducted among N=1,260 girls aged 14-17 years in Uganda. Participants were randomized into control group (n=408 girls from n=16 schools), matched youth development accounts treatment, YDA (n=471 girls from n=16 schools), and integrated intervention combining YDA with multiple family group component (n=381 girls from n=15 schools). RESULTS: We found a significant positive association between family functioning and mental health of adolescent girls in our sample. Moderator analyses suggests that effect of the intervention on Beck Hopelessness Scale was significantly moderated by family cohesion (χ2 (4) =21.43; p = .000), frequency of family communication (χ2 (4) =9.65; p = .047), and quality of child-caregiver relationship (χ2 (4) =11.12; p = .025). Additionally, the intervention effect on depression was moderated by the comfort of family communication (χ2 (4) =10.2; p = .037). DISCUSSION: The study findings highlight the importance of family functioning when examining the link from poverty to adolescent mental health. The study contributes to the scarce evidence suggesting that asset-accumulation opportunities combined with a family strengthening component may improve parenting practices and adolescent mental health in poor households.

OBJECTIVE: This study evaluated the effectiveness of the promotion of postural shift intervention using a dynamic seat cushion on the 6-month incidence of neck and low-back pain among high-risk office workers. METHODS: In a cluster-randomized controlled trial (RCT), 133 office workers were randomly assigned, at cluster level, to intervention (N=67) and control (N=66) groups. The intervention group received a dynamic seat cushion to encourage postural shifts during sitting, while the control group received a placebo seat pad. Primary outcomes were 6-month incidence of neck and low-back pain. Secondary outcomes included sitting discomfort, pain intensity, disability, and trunk muscle performance. Analyses utilized Cox proportional hazard models. RESULTS: During the 6-month period, 15% of participants in the intervention group developed neck pain and 10% developed low-back pain. For the control group, this was 65% and 59%, respectively. Hazard rate (HR) ratios, after adjusting for biopsychosocial factors, indicated a protective effect of the intervention for neck pain [HR_adj 0.19, 95% confidence interval (CI) 0.09–0.39, P

BACKGROUND: Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD. METHODS: The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. DISCUSSION: Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population. TRIAL REGISTRATION: Clinicaltrials.gov, identifier NCT04218201, January 6, 2020.

Reviews that synthesize global evidence on the impact of poverty reduction interventions on child and adolescent mental health (CAMH) report inconclusive results and highlight the need to unpack the mechanisms that connect poverty-reduction to CAMH. To address this gap, we examine the proposition that family relations is an important relational factor transmitting effect of poverty on CAMH, and test whether family relations mediate the effect of poverty-reduction intervention on depression, hopelessness, and self-concept among AIDS orphans in Uganda. We use longitudinal data collected over the course of 48 months in a cluster-randomized controlled trial conducted among N = 1410 AIDS orphans from n = 48 schools in Uganda. To examine the relationship between intervention, latent mediator (family relations and support) and CAMH outcomes (Beck Hopelessness Scale (BHS), Tennessee Self-Concept Scale (TSCS), and Depression), we ran structural equation models adjusting for clustering of individuals within schools. Relative to the control group, participants in both treatment arms reported lower levels of hopelessness and depression, and significantly higher levels of self-concept. They also report significantly higher levels of latent family relationship in all three models. In both treatment arms, the direct effect of the intervention on all three outcomes is still significant when the latent family relations mediator is included in the analyses. This suggests partial mediation. In other words, in both treatment arms, the significant positive effect of the intervention on childrens depression, hopelessness, and self-concept is partially mediated by their family relationship quality. Our findings support the argument put forward by the Family Stress Model showing that the poverty-reduction program improves childrens mental health functioning by improving family relationships. The implications of our study extend beyond the narrow focus of poverty reduction, suggesting that asset-building interventions have broader impacts on family dynamics and child mental health.

Abstract 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

Background: Violence against children at home and at school is particularly prevalent in Africa and is associated with adverse and persistent health effects on children. The violence prevention intervention Interaction Competencies with Children - for Teachers (ICC-T) is an effective tool to reduce violence against children by fostering teachers' non-violent communication and interaction skills. To enhance these effects, in the present study, ICC-T will be extended to parents (ICC-P) aiming to increase children's experience of consistent behavior and application of non-violent discipline strategies between teachers and parents. Methods: To investigate the effectiveness of the school-based combined implementation of ICC-T and ICC-P, a cluster-randomized controlled trial with 16 primary schools in the urban district of Morogoro in Eastern Tanzania will be conducted. Both quantitative (structured interviews) and qualitative (focus group discussions, in-depth interviews, evaluation forms) methods will be used to investigate the effects on teachers' and parents' violence against children in home and school settings. The intervention implementation will be accompanied by a comprehensive process evaluation to assess the implementation quality of and participants' engagement with ICC-T and ICC-P. Potential downstream effects of violence reduction will be investigated by assessing the children's mental health and well-being. Discussion: The present study aims to provide evidence for the feasibility, acceptability, and effectiveness of the school-based combined implementation of ICC-T and ICC-P to reduce teacher and parental violence against children and contribute to children's well-being in home and school settings. Trail registration: The clinical trial was registered at ClinicalTrials.gov (ClinicalTrials.gov, 2024) under the identifier NCT06369025 (Hecker, Preventing Physical and Emotional Violence by Parents and Teachers in Public Schools in Tanzania (ICC-T/ICC-P_Tanz) (PreVio), 2024) on April 17, 2024. [ABSTRACT FROM AUTHOR]

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 [ABSTRACT FROM AUTHOR]

BackgroundSpatial repellents (SRs) have been widely used for prevention of mosquito bites, but their efficacy in reducing Aedes-borne viruses (ABV) has not been tested rigorously at large scale in Asia. To address this knowledge gap, a trial to evaluate the efficacy of Mosquito Shield™, a transfluthrin SR, was developed in Gampaha District of Sri Lanka across three Medical Officer of Health areas; i.e., Negombo, Wattala, and Kelaniya.MethodsThis trial is a cluster-randomized, placebo-controlled, double-blinded clinical trial. A total of ~14,430 subjects aged ≥ 6 months in 30 clusters (15 intervention, 15 placebo) from ~3900 households (HH) will be randomly selected for enrolment into a "febrile surveillance cohort." A subset of the surveillance cohort, ~3570 subjects aged ≥4-16 years that test seronegative (naïve) or are serologically positive for a previous single dengue virus (DENV) infection (monotypic) at baseline sampling, will be enrolled into a "longitudinal cohort" for measuring DENV infection based on laboratory-confirmed seroconversion during the trial. Persons identified positive for antibodies against multiple DENV serotypes (multitypic) at baseline will be monitored for secondary analyses. Active ABV disease will be assessed using an enhanced passive surveillance system with case ascertainment performed in designated healthcare facilities. Serum samples will be taken from longitudinal cohort subjects within 1-2 weeks of when intervention is first deployed (T0) with additional samples taken ~12 (T1) and ~24 months (T2) from baseline sampling. DENV seroconversion and ABV active disease rates from baseline (pre-intervention) and follow-up (post-intervention) samples will be compared between intervention and placebo clusters. Participating houses will be monitored entomologically (indoor adult Aedes aegypti population densities and adult female blood fed status) within 3 months before intervention deployment and monthly during the intervention phase. Entomological surveys will monitor indoor adult Ae. aegypti population densities and blood fed status. Dengue incidence in each cohort will be estimated and compared to determine the public health benefit of using an SR. Entomological parameters will be measured to determine if there are entomological correlates of SR efficacy that may be useful for the evaluation of new SR products.DiscussionThe trial will serve as an efficacy assessment of SR products in South Asia. Results will be submitted to the World Health Organization Vector Control Advisory Group for assessment of public health value towards an endorsement to recommend inclusion of SRs in ABV control programs.Trial registrationSri Lanka Clinical Trial Registry SLCTR /2022/018. Registered on July 1, 2022.Clinicaltrialsgov NCT05452447 . Registered on July 11, 2022. The Universal Trial Number is U1111-1275-3055.

Abstract 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

OBJECTIVE: Poor cardiorespiratory fitness and health is common among childcare workers. We designed the `Goldilocks-games` according to the Goldilocks Work principle to provide high-intensity physical activity for childcare workers. We investigated the effectiveness of this Goldilocks Work intervention in increasing occupational high-intensity physical activity and improving work-related health. METHODS: In a two-arm cluster randomized trial, 16 childcare institutions with 142 workers were randomly allocated to either an 8-week Goldilocks Work intervention or a control group. The primary outcome was occupational time in high-intensity physical activity. Secondary outcomes were occupational time in active physical behaviors, heart rate during sleep, pain, physical exhaustion, energy at work, work productivity, and need for recovery. RESULTS: The intervention was successfully delivered and received. Both groups had a low amount of occupational high-intensity physical activity at baseline, and the intervention group reported playing the games 3.1 [standard deviation (SD) 1.5] times/week for a duration of 112.2 (SD 175.0) min/week. However, the intervention did not increase high-intensity physical activity or the secondary outcomes, except for energy at work, measured on a scale from 0–10, increasing 0.65 [95% confidence interval (CI) 0.08–1.21], and need for recovery, measured on a scale from 1–5, decreasing -0.32 (95% CI, -0.54– -0.09). CONCLUSION: The intervention was successfully delivered and received, but did not increase high-intensity physical activity. The intervention group increased their energy at work and decreased their need for recovery, but not the other health-related outcomes. Further research on how to design and implement health-promoting work environment interventions in childcare is needed.

Abstract 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.

BackgroundGiven persistent gaps in coordination of care for medically complex primary care patients, efficient strategies are needed to promote better care coordination.ObjectiveThe Coordination Toolkit and Coaching project compared two toolkit-based strategies of differing intensity to improve care coordination at VA primary care clinics.DesignMulti-site, cluster-randomized QI initiative.ParticipantsTwelve VA primary care clinics matched in 6 pairs.InterventionsWe used a computer-generated allocation sequence to randomize clinics within each pair to two implementation strategies. Active control clinics received an online toolkit with evidence-based tools and QI coaching manual. Intervention clinics received the online toolkit plus weekly assistance from a distance coach for 12 months.Main measuresWe quantified patient experience of general care coordination using the Health Care System Hassles Scale (primary outcome) mailed at baseline and 12-month follow-up to serial cross-sectional patient samples. We measured the difference-in-difference (DiD) in clinic-level-predicted mean counts of hassles between coached and non-coached clinics, adjusting for clustering and patient characteristics using zero-inflated negative binomial regression and bootstrapping to obtain 95% confidence intervals. Other measures included care coordination QI projects attempted, tools adopted, and patient-reported exposure to projects.Key resultsN = 2,484 (49%) patients completed baseline surveys and 2,481 (48%) completed follow-ups. Six coached clinics versus five non-coached clinics attempted QI projects. All coached clinics versus two non-coached clinics attempted more than one project or projects that were multifaceted (i.e., involving multiple components addressing a common goal). Five coached versus three non-coached clinics used 1-2 toolkit tools. Both the coached and non-coached clinics experienced pre-post reductions in hassle counts over the study period (- 0.42 (- 0.76, - 0.08) non-coached; - 0.40 (- 0.75, - 0.06) coached). However, the DiD (0.02 (- 0.47, 0.50)) was not statistically significant; coaching did not improve patient experience of care coordination relative to the toolkit alone.ConclusionAlthough coached clinics attempted more or more complex QI projects and used more tools than non-coached clinics, coaching provided no additional benefit versus the online toolkit alone in patient-reported outcomes.Trial registrationClinicalTrials.gov identifier: NCT03063294.

Abstract Background Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD. Methods The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. Discussion Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population. Trial Registration: Clinicaltrials.gov, identifier NCT04218201, January 6, 2020.

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. [ABSTRACT FROM AUTHOR]

Reports on the effects of salt substitution among individuals with normal blood pressure are scarce and controversial. 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. 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. 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. 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) [Display omitted] [ABSTRACT FROM AUTHOR]

The aim of this study is to expand the current knowledge on the relationship between poverty, family functioning, and the mental health of adolescent girls in families affected by poverty and HIV/AIDS in southern Uganda. The study investigates the association between family functioning and mental health and examines whether family functioning moderates the intervention effect on adolescent mental health. Longitudinal data were collected over the course of 24 months in a cluster randomized controlled trial conducted among N=1,260 girls aged 14–17 years in Uganda. Participants were randomized into control group (n=408 girls from n=16 schools), matched youth development accounts treatment, YDA (n=471 girls from n=16 schools), and integrated intervention combining YDA with multiple family group component (n=381 girls from n=15 schools). We found a significant positive association between family functioning and mental health of adolescent girls in our sample. Moderator analyses suggests that effect of the intervention on Beck Hopelessness Scale was significantly moderated by family cohesion (χ2 (4) =21.43; p =.000), frequency of family communication (χ2 (4) =9.65; p =.047), and quality of child-caregiver relationship (χ2 (4) =11.12; p =.025). Additionally, the intervention effect on depression was moderated by the comfort of family communication (χ2 (4) =10.2; p =.037). The study findings highlight the importance of family functioning when examining the link from poverty to adolescent mental health. The study contributes to the scarce evidence suggesting that asset-accumulation opportunities combined with a family strengthening component may improve parenting practices and adolescent mental health in poor households. [ABSTRACT FROM AUTHOR]

OBJECTIVES: This study aimed to compare the effectiveness of the multifaceted implementation strategy (multifaceted group) versus a discrete implementation strategy (discrete group) for implementing the Swedish Guideline for the Prevention of Mental Ill-health Problems at the Workplace on the primary intervention outcome – exhaustion – and secondary outcomes of stress, health, recovery, psychosocial safety climate, and social and organizational risk factors. Another aim was to examine whether the primary and secondary outcomes differed on the basis of guideline adherence levels, irrespective of the group. METHODS: A cluster-randomized waiting-list controlled trial with 6- and 12-months follow-up was conducted among 19 Swedish public schools. Primary and secondary outcomes as well as guideline adherence were assessed by self-reported questionnaire. Linear mixed modeling was used to compare differences in outcomes between the groups from baseline to 6 and 12 months, and in relation to different adherence levels. RESULTS: The trial comprised 698 employees (83.1%) participated. There were no differences between groups in the primary and secondary outcomes at 6 months, while at 12 months differences were observed for some outcomes to the advantage of the discrete group. Better guideline adherence was associated with improvements in exhaustion at 12 months and the secondary outcomes of psychosocial safety climate, work organization and job content, interpersonal relations and leadership, and recovery over 6 and 12 months. CONCLUSION: The multifaceted implementation strategy was no more effective than the discrete strategy in improving health outcomes or organizational and social work environment. However, higher adherence to the guideline was associated with larger improvements in health outcomes and organizational and social work environment, irrespective of the implementation strategy used.

Abstract Background Tuberculosis (TB) remains a major cause of morbidity and mortality in the world, despite being a preventable and curable disease. The World Health Organization (WHO) End-TB Strategy, aligned with the Sustainable Development Goals (SDGs), sets a target of reducing the TB mortality rate by 95%, TB incidence rate by 90%, and catastrophic costs due to TB by 2035, compared with a 2015 level. To achieve these ambitious targets, several interventions have been implemented in the last few years, resulting in major progress toward reducing the burden of TB. However, over one-third of the global TB cases remained undetected and never received treatment. Most of those undetected cases were found in low- and middle-income countries such as Ethiopia. Though several interventions were implemented to increase TB case detection and mitigate catastrophic costs associated with TB, sustaining these interventions in resource-constrained settings remains challenging. Consequently, an alternative method is needed to increase TB case detection while decreasing diagnosis delays and catastrophic costs. Therefore, this study aimed to integrate traditional TB care into modern TB care to improve TB control programs, including early TB case detection, and reduce catastrophic costs in high TB burden settings such as Ethiopia. Methods A cluster randomized controlled trial will be conducted in northwest Ethiopia to determine the effectiveness of integrating traditional care with modern TB care. The intervention will be conducted in randomly selected districts in the South Gondar Zone. The control group will be an equal number of districts with usual care. The intervention comprised three key components, which include referral linkage from traditional to modern health care; training of health professionals and traditional care providers in three different rounds to increase their knowledge, attitude, and skills toward the referral systems; and TB screening at traditional health care sites. The primary outcomes of interest will be an increase in case detection rate, and the secondary outcomes of interest will be decreased diagnosis delays and catastrophic costs for TB patients. Data will be collected in both the intervention and control groups on the main outcome of interest and a wide range of independent variables. Generalized linear mixed models will be used to compare the outcome of interest between the trial arms, with adjustment for baseline differences. Discussion This cluster-randomized controlled trial study will assess the effectiveness of a strategy that integrates traditional healthcare into the modern healthcare system for the control and prevention of TB in northwest Ethiopia, where nearly 90% of the population seeks care from traditional care systems. This trial will provide information on the effectiveness of traditional and modern healthcare integration to improve TB case detection, early diagnosis, and treatment, as well as reduce the catastrophic costs of TB. Trial registration ClinicalTrials.gov NCT05236452. Registered on July 22, 2022.

Background: Tuberculosis (TB) remains a major cause of morbidity and mortality in the world, despite being a preventable and curable disease. The World Health Organization (WHO) End-TB Strategy, aligned with the Sustainable Development Goals (SDGs), sets a target of reducing the TB mortality rate by 95%, TB incidence rate by 90%, and catastrophic costs due to TB by 2035, compared with a 2015 level. To achieve these ambitious targets, several interventions have been implemented in the last few years, resulting in major progress toward reducing the burden of TB. However, over one-third of the global TB cases remained undetected and never received treatment. Most of those undetected cases were found in low- and middle-income countries such as Ethiopia. Though several interventions were implemented to increase TB case detection and mitigate catastrophic costs associated with TB, sustaining these interventions in resource-constrained settings remains challenging. Consequently, an alternative method is needed to increase TB case detection while decreasing diagnosis delays and catastrophic costs. Therefore, this study aimed to integrate traditional TB care into modern TB care to improve TB control programs, including early TB case detection, and reduce catastrophic costs in high TB burden settings such as Ethiopia. Methods: A cluster randomized controlled trial will be conducted in northwest Ethiopia to determine the effectiveness of integrating traditional care with modern TB care. The intervention will be conducted in randomly selected districts in the South Gondar Zone. The control group will be an equal number of districts with usual care. The intervention comprised three key components, which include referral linkage from traditional to modern health care; training of health professionals and traditional care providers in three different rounds to increase their knowledge, attitude, and skills toward the referral systems; and TB screening at traditional health care sites. The primary outcomes of interest will be an increase in case detection rate, and the secondary outcomes of interest will be decreased diagnosis delays and catastrophic costs for TB patients. Data will be collected in both the intervention and control groups on the main outcome of interest and a wide range of independent variables. Generalized linear mixed models will be used to compare the outcome of interest between the trial arms, with adjustment for baseline differences. Discussion: This cluster-randomized controlled trial study will assess the effectiveness of a strategy that integrates traditional healthcare into the modern healthcare system for the control and prevention of TB in northwest Ethiopia, where nearly 90% of the population seeks care from traditional care systems. This trial will provide information on the effectiveness of traditional and modern healthcare integration to improve TB case detection, early diagnosis, and treatment, as well as reduce the catastrophic costs of TB. Trial registration: ClinicalTrials.gov NCT05236452. Registered on July 22, 2022. [ABSTRACT FROM AUTHOR]

Abstract Background Spatial repellents (SRs) have been widely used for prevention of mosquito bites, but their efficacy in reducing Aedes-borne viruses (ABV) has not been tested rigorously at large scale in Asia. To address this knowledge gap, a trial to evaluate the efficacy of Mosquito Shield™, a transfluthrin SR, was developed in Gampaha District of Sri Lanka across three Medical Officer of Health areas; i.e., Negombo, Wattala, and Kelaniya. Methods This trial is a cluster-randomized, placebo-controlled, double-blinded clinical trial. A total of ~14,430 subjects aged ≥ 6 months in 30 clusters (15 intervention, 15 placebo) from ~3900 households (HH) will be randomly selected for enrolment into a “febrile surveillance cohort.” A subset of the surveillance cohort, ~3570 subjects aged ≥4–16 years that test seronegative (naïve) or are serologically positive for a previous single dengue virus (DENV) infection (monotypic) at baseline sampling, will be enrolled into a “longitudinal cohort” for measuring DENV infection based on laboratory-confirmed seroconversion during the trial. Persons identified positive for antibodies against multiple DENV serotypes (multitypic) at baseline will be monitored for secondary analyses. Active ABV disease will be assessed using an enhanced passive surveillance system with case ascertainment performed in designated healthcare facilities. Serum samples will be taken from longitudinal cohort subjects within 1–2 weeks of when intervention is first deployed (T0) with additional samples taken ~12 (T1) and ~24 months (T2) from baseline sampling. DENV seroconversion and ABV active disease rates from baseline (pre-intervention) and follow-up (post-intervention) samples will be compared between intervention and placebo clusters. Participating houses will be monitored entomologically (indoor adult Aedes aegypti population densities and adult female blood fed status) within 3 months before intervention deployment and monthly during the intervention phase. Entomological surveys will monitor indoor adult Ae. aegypti population densities and blood fed status. Dengue incidence in each cohort will be estimated and compared to determine the public health benefit of using an SR. Entomological parameters will be measured to determine if there are entomological correlates of SR efficacy that may be useful for the evaluation of new SR products. Discussion The trial will serve as an efficacy assessment of SR products in South Asia. Results will be submitted to the World Health Organization Vector Control Advisory Group for assessment of public health value towards an endorsement to recommend inclusion of SRs in ABV control programs. Trial registration Sri Lanka Clinical Trial Registry SLCTR /2022/018. Registered on July 1, 2022. ClinicalTrials.gov NCT05452447 . Registered on July 11, 2022. The Universal Trial Number is U1111-1275-3055.

PurposeScant research has investigated whether health promotion interventions have sustained effects in increasing physical activity and healthful diet among adolescents in sub-Saharan Africa, which is experiencing an epidemiological transition from infectious diseases to noncommunicable diseases as leading causes of mortality. We examined whether an intervention increased adherence to 5-a-day diet and physical activity guidelines during a 54-month postintervention period among South African adolescents and whether its effects weakened at long-term (42 and 54 months postintervention) compared with short-term (3, 6, and 12 months postintervention) follow-up.MethodsWe randomized 18 randomly selected schools serving grade 6 learners (mean age = 12.6) in a township and a semirural area in Eastern Cape Province, South Africa, to one of the two 12-hour interventions: health promotion, targeting healthful diet and physical activity; attention-matched control, targeting sexual risk behaviors. We tested the intervention's effects on adherence to 5-a-day diet and physical activity guidelines using generalized estimating equations logistic regression models adjusting for baseline behavior and clustering within schools.ResultsHealth promotion intervention participants had higher odds of meeting 5-a-day diet and physical activity guidelines than control participants. The effect on 5-a-day diet did not weaken at long-term compared with short-term follow-up, but the effect on physical activity guidelines was weaker at long-term follow-up, mainly because of a reduced effect on muscle-strengthening physical activity. The intervention also increased health promotion attitude and intention and health knowledge and reduced binge drinking compared with the control group.ConclusionsA 12-hour intervention in grade 6 shows promise in increasing self-reported adherence to healthful diet and physical activity guidelines during a 4.5-year postintervention period among South African adolescents.

Background: In the Lake Victoria Basin of western Kenya, malaria remains highly endemic despite high coverage of interventions such as insecticide-impregnated long-lasting insecticidal nets (LLIN). The malaria-protective effect of LLINs is hampered by insecticide resistance in Anopheles vectors and its repurposing by the community. Ceiling nets and LLIN with synergist piperonyl butoxide (PBO-LLIN) are novel tools that can overcome the problems of behavioral variation of net use and metabolic resistance to insecticide, respectively. The two have been shown to reduce malaria prevalence when used independently. Integration of these two tools (i.e., ceiling nets made with PBO-LLIN or Olyset®Plus ceiling nets) appears promising in further reducing the malaria burden. Methods: A cluster-randomized controlled trial is designed to assess the effect of Olyset®Plus ceiling nets on reducing malaria prevalence in children on Mfangano Island in Homa Bay County, where malaria transmission is moderate. Olyset®Plus ceiling nets will be installed in 1315 residential structures. Malaria parasitological, entomological, and serological indicators will be measured for 12 months to compare the effectiveness of this new intervention against conventional LLIN in the control arm. Discussion: Wider adoption of Olyset®Plus ceiling nets to complement existing interventions may benefit other malaria-endemic counties and be incorporated as part of Kenya’s national malaria elimination strategy. Trial registration: UMIN Clinical Trials Registry UMIN000045079. Registered on 4 August 2021. [ABSTRACT FROM AUTHOR]

Abstract Background According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents. Methods This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications. Discussion This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly. Trial registration ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.

Abstract Background Despite high acceptance rates in the field, the implementation of the 2019 published German evidence and consensus-based S3 guideline is unsatisfactory. This study aims to assess the superiority of an adaptive online version with a better visualization of the recommendations in terms of guideline conformity, application of shared decision making, and digital health expertise compared to the classic pdf print version of the guideline. Methods The study is a multicenter, controlled, cluster-randomized trial with two arms: one arm investigating the implementation of the German schizophrenia guideline in form of a digital format (intervention group using the evidence ecosystem MAGICapp), the other arm in form of the classic print pdf version (control group). Physicians and psychologists working in specialized hospitals will be included in the study. The guideline-knowledge before and after the intervention is defined as primary outcome measure. Secondary endpoints include digital health expertise and application of shared decision making. Discussion This is the first study evaluating if an adaptive-digital version of the schizophrenia guideline is superior to the classic pdf print version. Therefore, the guideline is digitally prepared in the evidence-ecosystem MAGICapp, which covers the whole process of the development of a living guideline. We intend to use the results of the cluster-randomized trial for developing the German S3 guideline for schizophrenia in form of a living guideline in future. Trial registration The study is registered (10 May 2022) in the German Clinical Trials Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00028895 .

Abstract Background Long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) target night-time indoor biting mosquitoes and effectively reduce malaria transmission in rural settings across Africa, but additional vector control tools are needed to interrupt transmission. Attractive targeted sugar baits (ATSBs) attract and kill mosquitoes, including those biting outdoors. Deployment of ATSBs incorporating the insecticide dinotefuran was associated with major reductions in mosquito density and longevity in Mali. The impact of this promising intervention on malaria transmission and morbidity now needs to be determined in a range of transmission settings. Methods/design We will conduct three similar stand-alone, open-label, two-arm, cluster-randomized, controlled trials (cRCTs) in Mali, Kenya, and Zambia to determine the impact of ATSB + universal vector control versus universal vector control alone on clinical malaria. The trials will use a “fried-egg” design, with primary outcomes measured in the core area of each cluster to reduce spill-over effects. All household structures in the ATSB clusters will receive two ATSBs, but the impact will be measured in the core of clusters. Restricted randomization will be used. The primary outcome is clinical malaria incidence among children aged 5–14 years in Mali and 1–14 years in Kenya and Zambia. A key secondary outcome is malaria parasite prevalence across all ages. The trials will include 76 clusters (38 per arm) in Mali and 70 (35 per arm) in each of Kenya and Zambia. The trials are powered to detect a 30% reduction in clinical malaria, requiring a total of 3850 person-years of follow-up in Mali, 1260 person-years in Kenya, and 1610 person-years in Zambia. These sample sizes will be ascertained using two seasonal 8-month cohorts in Mali and two 6-month seasonal cohorts in Zambia. In Kenya, which has year-round transmission, four 6-month cohorts will be used (total 24 months of follow-up). The design allows for one interim analysis in Mali and Zambia and two in Kenya. Discussion Strengths of the design include the use of multiple study sites with different transmission patterns and a range of vectors to improve external validity, a large number of clusters within each trial site, restricted randomization, between-cluster separation to minimize contamination between study arms, and an adaptive trial design. Noted threats to internal validity include open-label design, risk of contamination between study arms, risk of imbalance of covariates across study arms, variation in durability of ATSB stations, and potential disruption resulting from the COVID-19 pandemic. Trial registration Zambia: ClinicalTrials.gov NCT04800055 . Registered on March 15, 2021 Mali: ClinicalTrials.gov NCT04149119 . Registered on November 4, 2019 Kenya: ClinicalTrials.gov NCT05219565 . Registered on February 2, 2022

Abstract Background Systematic reviews suggest that preschool environmental/organizational changes may be effective in increasing physical activity (PA) levels of preschool children, but evidence is scarce regarding feasible, effective, and equitable interventions that can be scaled up. Specifically, it is essential to understand whether introducing a multicomponent organizational change in terms of policy in the preschool context may be beneficial for children’s PA levels and concomitant health outcomes. To bridge this knowledge gap, our main aim is to examine the feasibility and effectiveness of a policy package in increasing PA levels in preschool children, using a large-scale pragmatic cluster-randomized controlled trial. Methods This proposed study is a pragmatic cluster-randomized controlled trial with two conditions (intervention and control with a 1:1 ratio) with preschools as clusters and the unit of randomization. We aim to recruit approximately 4000 3–5-year-old children from 90 preschools and retain more than 2800 children from 85 preschools to provide adequate statistical power for the analyses. The intervention to implement is a co-created, multicomponent policy package running for 6 months in preschools randomized to intervention. Change in accelerometer measured PA levels in children between intervention and control from pre- and post-intervention will be the primary outcome of the study, while secondary outcomes include health outcomes such as musculoskeletal fitness, psychosocial functioning, and absence due to illness in children among others. Implementation will be studied carefully using both quantitative (dose, fidelity) and qualitative (interview) methodologies. The change in primary and secondary outcomes, from pre- to post-intervention, will be analyzed with linear mixed-effect models (to allow both fixed and random effects) nested on a preschool level. Discussion This is a large-scale co-creation project involving the City of Stockholm, childcare stakeholders, preschool staff, and the research group with the potential to influence more than 30,000 preschool children within the Stockholm area. The study will add reliable evidence for the implementation of PA policies at the organizational level of preschools and clarify its potential effect on objectively measured PA and health markers in children. Trial registration ClinicalTrials.gov NCT04569578 . Prospectively registered on September 20, 2020.

Many children would benefit from a diet richer in vegetables and fruit. Reluctance to taste new foods is widely recognized as a barrier to healthy dietary variety in children. 'Flavour School' is a programme of ' sensory food education ', aiming to increase children's confidence and curiosity in exploring foods and flavours, especially vegetables and fruit. We report a pre-registered, cluster-randomised controlled trial to assess the outcomes of the Flavour School programme, in n = 160 children aged 4–7 years from 5 UK schools in London and Leeds. Children either received the Flavour School programme (experimental group n = 84) or no intervention (control group n = 76), in a two-level design with children clustered within school classes. Data collection consisted of video recorded behavioural observation during a tasting activity designed to resemble a Flavour School activity, conducted before and after the intervention. Linear regression models were used to fit relationships between independent variables and outcomes; Willingness-to-taste , Enjoyment (positive/negative facial expression), and Expressiveness (change in facial expression). Most children engaged readily in the tasting activity at baseline. At follow-up children engaged with the tasting activity even more readily (on average biting one more food sample), with no significant effect of the intervention. We interpret these findings to indicate that intra-individual tasting behavior in children is context-dependent. Our results suggest that the context of sensory food education activities facilitates openness to tasting across the normal range of individual traits. However, we find no evidence that receiving sensory food education makes a reluctant taster into a less reluctant taster; no 'curative' effect of the intervention was observed. Rather, even usually fussy/reluctant children were often willing to have a go at tasting in the conducive context of an exploratory activity. ISRCTN: 40249947 Date assigned 17/03/2020 Last edited 24/10/2022 Version 1.2 Trial Acronym OASES (Outcomes Assessment of Sensory Education in Schools) [Display omitted] [ABSTRACT FROM AUTHOR]

• What is the primary question addressed by this study? We investigated the effects of a 9-month community-based multidomain intervention of mindfulness meditation, cognitive training, exercise, and nutrition counseling on improving cognition compared to controls for Chinese older adults having risks of cognitive decline. • What is the main finding of this study? Multidomain intervention had immediate benefits on improving cognitive performance measured by objective assessments and subjective cognitive abilities relative to the control, and the benefits on subjective cognitive abilities were retained for 1 year after the completion of the intervention. • What is the meaning of the finding? Multidomain intervention that targeted multiple predictors of cognitive decline can have immediate benefits on improving cognitive performance for older adults at risk of cognitive decline. Long-term effects on cognition and individual differences in response to the intervention deserve further investigation. We sought to assess cognitive benefits of a community-based multidomain intervention for improving cognition among older adults at risk of cognitive decline (COMBAT). A two-armed cluster-randomized controlled trial. Community-dwelling older adults aged 60 years or older and were at risk of cognitive decline (n = 209). In this 9-month intervention study, 10 community hospitals in Beijing, China, were randomized (1:1) to receive either a multidomain intervention of meditation, cognitive training, exercise, and nutrition counseling or usual care. The intervention was delivered with weekly 1-hour group training sessions and weekly home homework. Primary outcome was change in cognition as measured by a composite Z score of seven cognitive tests. Secondary outcomes included subjective cognitive abilities, positive and negative affective experiences, physical activity, and dietary habits. Assessments were administered at baseline, end of the intervention, and 1 year after completing the intervention (1-year follow-up). Immediately after the intervention, the intervention group showed significant enhancement in cognitive performance (p = 0.026). The between-group difference in the Z score of change of cognition was 0.20 (95% CI: 0.053, 0.35), with a Hedges' g of 0.40 (95% CI: 0.29, 0.50). However, this cognitive benefit was not significant at 1-year follow-up. This multidomain intervention was effective to improve cognition for at-risk individuals. Long-term effects on cognitive function and individual differences in response to the intervention deserve further investigation. [ABSTRACT FROM AUTHOR]

Abstract Background Adolescents and youth living with HIV (AYAHIV) have worse HIV outcomes than other age groups, particularly in sub-Saharan Africa (SSA). AYAHIV in SSA face formidable health system, interpersonal- and individual-level barriers to retention in HIV care, uptake of ART, and achievement of viral suppression (VS), underscoring an urgent need for multi-component interventions to address these challenges. This cluster-randomized control trial (cRCT) aims to evaluate the effectiveness and monitor implementation of a community-informed multi-component intervention (“CombinADO strategy”) addressing individual-, facility-, and community-level factors to improve health outcomes for AYAHIV. Methods This trial will be conducted in 12 clinics in Nampula Province, Northern Mozambique. All clinics will implement an optimized standard of care (control) including (1) billboards/posters and radio shows, (2) healthcare worker (HCW) training, (3) one-stop adolescent and youth-friendly services, (4) information/motivation walls, (5) pill containers, and (6) tools to be used by HCW during clinical visits. The CombinADO strategy (intervention) will be superadded to control conditions at 6 randomly selected clinics. It will include five additional components: (1) peer support, (2) informational/motivational video, (3) support groups for AYAHIV caregivers, (4) AYAHIV support groups, and (5) mental health screening and linkage to adolescent-focused mental health support. The study conditions will be in place for 12 months; all AYAHIV (ages 10–24 years, on ART) seeking care in the participating sites will be exposed to either the control or intervention condition based on the clinic they attend. The primary outcome is VS (viral load

Background: Culturally-appropriate family models of diabetes self-management education and support (DSMES) using community health workers (CHWs) have been shown to help address barriers to improving type 2 diabetes mellitus (T2DM) self-management for racial/ethnic minority communities; however, there is limited DSMES research among Marshallese and other Pacific Islanders. Using a community-based participatory research approach, we engaged community stakeholders to co-design a study to implement a culturally adapted family model DSMES (F-DSMES) intervention in faith-based organizations (FBOs) (i.e., churches). Methods: Using a cluster-randomized controlled trial design, we will assess the effectiveness of the F-DSMES intervention for Marshallese patients with T2DM in Arkansas and Oklahoma. Twenty-four FBOs (with 12 primary participants per FBO) will be randomized to one of two study arms: the intervention arm or the wait-list control arm. Primary participants must have at least one family member willing to attend education sessions and data collection events. The F-DSMES intervention consists of ten h of diabetes education delivered by CHWs over eight to ten weeks. Data will be collected from the intervention arm at pre-intervention (baseline), immediate post-intervention (12 weeks), and three months post-intervention. The wait-list control arm will complete a second pre-intervention data collection before receiving the intervention. The primary study outcome will be glycemic control, as measured by HbA1c. Secondary measures include glucose, weight, body mass index, blood pressure, diabetes self-management behaviors, and diabetes management self-efficacy. Conclusion: The knowledge gained from this research will inform future DSMES and other health promotion interventions conducted with Marshallese and other Pacific Islander communities.

Abstract Background Common mental disorders are highly prevalent in the working population, affecting about 1 in 5 persons in the Organisation for Economic Co-operation and Development countries. About 30% of those affected have a first period of sick leave. Despite several attempts to reduce the risk of sick leave among employees with common mental disorders, there is a lack of knowledge about effective, preventive interventions which aim to reduce such risks. This protocol describes the design of a study to evaluate the effectiveness of a problem-solving intervention delivered by first-line managers to employees with common mental disorders on the prevention of sick leave during the 12-month follow-up. Methods/design The study applies a two-armed cluster-randomized trial design of a problem-solving intervention conducted in private-sector companies. First-line managers are randomized into intervention- or control groups by computer-generated random numbers, allocation ratio 1:1. Employees are eligible if at risk for future sick leave due to common mental disorders. These are identified by self-reported psychological health measured by the General Health Questionnaire 12-item, cut-off ≥3, or a positive answer to risk of sick leave. The intervention is based on problem-solving principles. It involves the training of the first-line managers who then deliver the intervention to employees identified at risk of sick leave. First-line managers in the control group receives a lecture. Primary outcome is number of registered days of sick leave due to common mental disorders during the 12-month follow-up. Secondary outcomes are general health, psychological symptoms, work performance, work ability and psychosocial work environment. A process evaluation will examine the intervention’s reach, fidelity, dose delivered, dose received, satisfaction and context. Research assistants managing the screening procedure, outcome assessors and employees are blinded to randomization and allocation. Discussion The study includes analyses of the intervention’s effectiveness and an alongside process evaluation. Methodological strengths and limitations, for example the risk of selection bias, attrition and risk of contamination are discussed. Trial registration Clinicaltrials.gov NCT04975750 Date of registration: 08/16/2021.

Abstract Background A large proportion of non-communicable diseases (NCDs) are treatable within primary health care (PHC) settings in a cost-effective manner. However, the utilization of PHCs for NCD care is comparatively low in India. The Access-to-Medicines (ATM) study examined whether (and how) interventions aimed at health service optimization alone or combined with community platform strengthening improve access to medicines at the primary health care level within the context of a local health system. Method A quasi-randomized cluster trial was used to assess the effectiveness of the intervention (18 months) implemented across 39 rural PHCs (clusters) of three sub-districts of Tumkur in southern India. The intervention was allocated randomly in a 1:1:1 sequence across PHCs and consisted of three arms: Arm A with a package of interventions aimed at health service delivery optimization; B for strengthening community platforms in addition to A; and the control arm. Group allocation was not blinded to providers and those who assessed outcomes. A household survey was used to understand health-seeking behaviour, access and out-of-pocket expenditure (OOP) on key anti-diabetic and anti-hypertension medicines among patients; facility surveys were used to assess the availability of medicines at PHCs. Primary outcomes of the study are the mean number of days of availability of antidiabetic and antihypertensive medicines at PHCs, the mean number of patients obtaining medicines from PHC and OOP expenses. Result The difference-in-difference estimate shows a statistically insignificant increase of 31.5 and 11.9 in mean days for diabetes and hypertension medicines availability respectively in the study arm A PHCs beyond the increase in the control arm. We further found that there was a statistically insignificant increase of 2.2 and 3.8 percentage points in the mean proportion of patients obtaining medicines from PHC in arm A and arm B respectively, beyond the increase in the control arm. Conclusion There were improvements in NCD medicine availability across PHCs, the number of patients accessing PHCs and reduction in OOP expenditure among patients, across the study arms as compared to the control arm; however, these differences were not statistically significant. Trial registration Trial registration number CTRI/2015/03/005640 . This trial was registered on 17/03/2015 in the Clinical Trial Registry of India (CTRI) after PHCs were enrolled in the study (retrospectively registered). The CTRI is the nodal agency of the Indian Council of Medical Research for registration of all clinical, experimental, field intervention and observation studies.

Background: Despite high acceptance rates in the field, the implementation of the 2019 published German evidence and consensus-based S3 guideline is unsatisfactory. This study aims to assess the superiority of an adaptive online version with a better visualization of the recommendations in terms of guideline conformity, application of shared decision making, and digital health expertise compared to the classic pdf print version of the guideline.Methods: The study is a multicenter, controlled, cluster-randomized trial with two arms: one arm investigating the implementation of the German schizophrenia guideline in form of a digital format (intervention group using the evidence ecosystem MAGICapp), the other arm in form of the classic print pdf version (control group). Physicians and psychologists working in specialized hospitals will be included in the study. The guideline-knowledge before and after the intervention is defined as primary outcome measure. Secondary endpoints include digital health expertise and application of shared decision making.Discussion: This is the first study evaluating if an adaptive-digital version of the schizophrenia guideline is superior to the classic pdf print version. Therefore, the guideline is digitally prepared in the evidence-ecosystem MAGICapp, which covers the whole process of the development of a living guideline. We intend to use the results of the cluster-randomized trial for developing the German S3 guideline for schizophrenia in form of a living guideline in future.Trial Registration: The study is registered (10 May 2022) in the German Clinical Trials Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00028895 . [ABSTRACT FROM AUTHOR]

Background: According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents.Methods: This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications.Discussion: This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly.Trial Registration: ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020. [ABSTRACT FROM AUTHOR]

Introduction: This cluster-randomized controlled trial aimed to assess the effect of the "Which test is best?" tool on risk-appropriate screening (RAS) and colorectal cancer (CRC) screening uptake. Methods: General practices in Sydney and Melbourne, Australia, and a random sub-sample of 460 patients (aged 25–74 years) per practice were invited by post. Clusters were computer randomized independently of the researchers to an online CRC risk calculator with risk-based recommendations versus usual care. Primary and secondary outcomes were RAS and screening uptake via self-reported 5-year screening behaviour after 12 months follow-up. The usual care group (UCG) also self-reported 5-year CRC screening behaviour at 12 month post-randomization. Results: Fifty-six practices were randomized (27 to the intervention and 29 to the control, 55 practices participated) with 818 intervention and 677 controls completing the primary outcome measure. The intervention significantly increased RAS in high-risk participants compared with UCG (80.0% vs. 64.0%, respectively; OR = 3.14, 95% CI: 1.25–7.96) but not in average-risk (44.9% vs. 49.5%, respectively; OR = 0.97, 95% CI: 0.99–1.12) or moderate-risk individuals (67.9% vs. 81.1%, respectively; OR = 0.40, 95% CI: 0.12–1.33). Faecal occult blood testing uptake over 12 months was increased compared with the UCG (24.9% vs. 15.1%; adjusted OR = 1.66, 95% CI: 1.24–2.22), and there was a non-significant increase in colonoscopies during the same period (16.6% vs. 12.2%; adjusted OR = 1.42, 95% CI: 0.97–2.08). Conclusion: An online CRC risk calculator with risk-based screening recommendations increased RAS in high-risk participants and improved screening uptake overall within a 12-month follow-up period. Such tools may be useful for facilitating the uptake of risk-based screening guidelines. [ABSTRACT FROM AUTHOR]

Background: Evidence-based interventions that optimize physical function for disabled and older adults living in the community who have difficulty with daily living tasks are available. However, uptake has been limited, particularly in resource-constrained (Medicaid) settings. Facilitation may be an effective implementation strategy. This study's aim was to compare internal facilitation (IF) versus IF and external facilitation (EF) on adoption and sustainability of an intervention in a Medicaid home and community-based waiver.Methods: In a hybrid type 3 trial, waiver sites (N = 18) were randomly assigned to implement the intervention using a bundle of strategies with either IF or IF and EF. Adoption and sustainability were assessed via Stages of Implementation Completion (SIC) for each site. Clinician attitudes toward evidence-based practice and self-efficacy were evaluated among 539 registered nurses, social workers, and occupational therapists. Medicaid beneficiary outcomes of activities of daily living, depression, pain, falls, emergency department visits, and hospitalizations were evaluated in a sample of N = 7030 as reflected by electronic health records data of the Medicaid waiver program. Linear mixed-effects models were used to compare outcomes between trial arms while accounting for cluster-randomized design.Results: The mean SIC scores were 72.22 (standard deviation [SD] = 16.98) in the IF arm (9 sites) and 61.33 (SD = 19.29) in the IF + EF arm (9 sites). The difference was not statistically significant but corresponded to the medium clinically important effect size Cohen's d = 0.60. Clinician implementation outcomes of attitudes and self-efficacy did not differ by trial arm. Beneficiary depression was reduced significantly in the IF + EF arm compared to the IF arm (p = .04, 95% confidence interval for the difference [0.01, 0.24]). No differences between trial arms were found for other beneficiary outcomes.Conclusions: Level of facilitation did not enhance capacity for adoption and sustainability of an evidence-based intervention in a Medicaid setting that cares for disabled and older adults. Improved beneficiary depression favored use of IF and EF compared to IF alone, and no differences were found for other outcomes. These findings also suggest level of facilitation may not have impacted beneficiary outcomes.Trial Registration: ClinicalTrials.gov , NCT03634033 ; date registered August 16, 2018. [ABSTRACT FROM AUTHOR]

Background: Systematic reviews suggest that preschool environmental/organizational changes may be effective in increasing physical activity (PA) levels of preschool children, but evidence is scarce regarding feasible, effective, and equitable interventions that can be scaled up. Specifically, it is essential to understand whether introducing a multicomponent organizational change in terms of policy in the preschool context may be beneficial for children's PA levels and concomitant health outcomes. To bridge this knowledge gap, our main aim is to examine the feasibility and effectiveness of a policy package in increasing PA levels in preschool children, using a large-scale pragmatic cluster-randomized controlled trial.Methods: This proposed study is a pragmatic cluster-randomized controlled trial with two conditions (intervention and control with a 1:1 ratio) with preschools as clusters and the unit of randomization. We aim to recruit approximately 4000 3-5-year-old children from 90 preschools and retain more than 2800 children from 85 preschools to provide adequate statistical power for the analyses. The intervention to implement is a co-created, multicomponent policy package running for 6 months in preschools randomized to intervention. Change in accelerometer measured PA levels in children between intervention and control from pre- and post-intervention will be the primary outcome of the study, while secondary outcomes include health outcomes such as musculoskeletal fitness, psychosocial functioning, and absence due to illness in children among others. Implementation will be studied carefully using both quantitative (dose, fidelity) and qualitative (interview) methodologies. The change in primary and secondary outcomes, from pre- to post-intervention, will be analyzed with linear mixed-effect models (to allow both fixed and random effects) nested on a preschool level.Discussion: This is a large-scale co-creation project involving the City of Stockholm, childcare stakeholders, preschool staff, and the research group with the potential to influence more than 30,000 preschool children within the Stockholm area. The study will add reliable evidence for the implementation of PA policies at the organizational level of preschools and clarify its potential effect on objectively measured PA and health markers in children.Trial Registration: ClinicalTrials.gov NCT04569578 . Prospectively registered on September 20, 2020. [ABSTRACT FROM AUTHOR]

BackgroundThe massive scale-up of insecticide-treated nets (ITNs) and indoor residual spraying (IRS) has led to a substantial increase in malaria vector insecticide resistance as well as in increased outdoor transmission, both of which hamper the effectiveness and efficiency of ITN and IRS. Long-lasting microbial larvicide can be a cost-effective new supplemental intervention tool for malaria control.Methods/designWe will implement the long-lasting microbial larvicide intervention in 28 clusters in two counties in western Kenya. We will test FourStar controlled release larvicide (6 % by weight Bacillus thuringiensis israelensis and 1 % Bacillus sphaerius) by applying FourStar controlled release granule formulation, 90-day briquettes, and 180-day briquettes in different habitat types. The primary endpoint is clinical malaria incidence rate and the secondary endpoint is malaria vector abundance and transmission intensity. The intervention will be conducted as a two-step approach. First, we will conduct a four-cluster trial (two clusters per county, with one of the two clusters randomly assigned to the intervention arm) to optimize the larvicide application scheme. Second, we will conduct an open-label, cluster-randomized trial to evaluate the effectiveness and cost-effectiveness of the larvicide. Fourteen clusters in each county will be assigned to intervention (treatment) or no intervention (control) by a block randomization on the basis of clinical malaria incidence, vector density, and human population size per site. We will treat each treatment cluster with larvicide for three rounds at 4-month intervals, followed by no treatment for the following 8 months. Next, we will switch the control and treatment sites. The former control sites will receive three rounds of larvicide treatment at appropriate time intervals, and former treatment sites will receive no larvicide. We will monitor indoor and outdoor vector abundance using CO2-baited CDC light traps equipped with collection bottle rotators. Clinical malaria data will be aggregated from government-run malaria treatment centers.DiscussionSince current first-line vector intervention methods do not target outdoor transmission and will select for higher insecticide resistance, new methods beyond bed nets and IRS should be considered. Long-lasting microbial larviciding represents a promising new tool that can target both indoor and outdoor transmission and alleviate the problem of pyrethroid resistance. It also has the potential to diminish costs by reducing larvicide reapplications. If successful, it could revolutionize malaria vector control in Africa, just as long-lasting bed nets have done.Trial registrationU.S. National Institute of Health, study ID NCT02392832 . Registered on 3 February 2015.

Abstract Background Virtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers. Methods Using Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms. Discussion This study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices. Trial registration Clinicaltrials.gov . NCT04062552; Pre-results. Registered: August 20, 2019. https://clinicaltrials.gov/ct2/show/NCT04062552?term=NCT04062552&draw=2&rank=1

Abstract Background Sleep problems are highly prevalent in people with dementia. Nevertheless, there is no “gold standard” intervention to prevent or reduce sleep problems in people with dementia. Existing interventions are characterized by a pronounced heterogeneity as well as insufficient knowledge about the possibilities and challenges of implementation. The aim of this study is to pilot and evaluate the effectiveness of a newly developed complex intervention to prevent and reduce sleep problems in people with dementia living in nursing homes. Methods This study is a parallel group cluster-randomized controlled trial. The intervention consists of six components: (1) the assessment of established sleep-promoting interventions and an appropriate environment in the participating nursing homes, (2) the implementation of two “sleep nurses” as change agents per nursing home, (3) a basic education course for nursing staff: “Sleep problems in dementia”, (4) an advanced education course for nursing staff: “Tailored problem-solving” (two workshops), (5) workshops: “Development of an institutional sleep-promoting concept” (two workshops with nursing management and sleep nurses) and (6) written information and education material (e.g. brochure and “One Minute Wonder” poster). The intervention will be performed over a period of 16 weeks and compared with usual care in the control group. Overall, 24 nursing homes in North, East and West Germany will be included and randomized in a 1:1 ratio. The primary outcome is the prevalence of sleep problems in people with dementia living in nursing homes. Secondary outcomes are quality of life, quality of sleep, daytime sleepiness and agitated behavior of people with dementia, as well as safety parameters like psychotropic medication, falls and physical restraints. The outcomes will be assessed using a mix of instruments based on self- and proxy-rating. A cost analysis and a process evaluation will be performed in conjunction with the study. Conclusions It is expected that the intervention will reduce the prevalence of sleep problems in people with dementia, thus not only improving the quality of life for people with dementia, but also relieving the burden on nursing staff caused by sleep problems. Trial registration Current controlled trials: ISRCTN36015309 . Date of registration: 06/11/2020.

Background: Inequality in health can have profound effects on a child's opportunities later in life. To prevent these downstream effects in families at increased risk of adversity, programs are needed to provide support and improve well-being across several domains. The present trial is aimed at assessing the effectiveness of the Minding the Baby® (MTB) home visiting intervention in improving the mother-child relationship, parental reflective functioning, well-being, and mental health, as well as child development and well-being in families at known risk of adverse health, relational, and developmental outcomes.Methods: The study is a pragmatic, prospective, quasi-cluster-randomized controlled trial in which seven Danish municipalities were randomized to MTB training in either 2018 or 2019. A total of 250 pregnant women at increased risk of adversity will be recruited (75 care as usual families and 175 intervention families). Care as usual families will be recruited before and after the MTB training. The MTB intervention is an attachment-based, interdisciplinary home visiting intervention offered from the third trimester of pregnancy until the child is 2 years old. The participants are assessed at baseline, and when the infant is 3, 12, and 24 months old. The primary outcome is maternal sensitivity measured by the Coding Interactive Behavior scale applied to video recordings of mother-infant interactions. Secondary outcomes include parent-child interaction, parental reflective functioning, parental mental health, maternal satisfaction, parental stress, and child development and well-being. The treatment effect is estimated as a fixed effect using a binary indicator of MTB treatment, and cluster-robust standard errors based on wild bootstrap are used for inference.Discussion: This is the first trial of MTB in a Scandinavian context and will include the largest sample yet in a trial of MTB. The trial is expected to contribute to knowledge about the effect of early support for pregnant women, their infants, and their families at increased risk of adversity.Trial Registration: ClinicalTrials.gov NCT03495895 . The study was registered on April 12, 2018. [ABSTRACT FROM AUTHOR]

Introduction  There is some evidence that homeopathic treatment has been used successfully in previous epidemics, and currently some countries are testing homeoprophylaxis for the coronavirus disease 2019 (COVID-19) pandemic. There is a strong tradition of homeopathic treatment in India: therefore, we decided to compare three different homeopathic medicines against placebo in prevention of COVID-19 infections. Methods  In this double-blind, cluster-randomized, placebo-controlled, four parallel arms, community-based, clinical trial, a 20,000-person sample of the population residing in Ward Number 57 of the Tangra area, Kolkata, was randomized in a 1:1:1:1 ratio of clusters to receive one of three homeopathic medicines (Bryonia alba 30cH, Gelsemium sempervirens 30cH, Phosphorus 30cH) or identical-looking placebo, for 3 (children) or 6 (adults) days. All the participants, who were aged 5 to 75 years, received ascorbic acid (vitamin C) tablets of 500 mg, once per day for 6 days. In addition, instructions on healthy diet and general hygienic measures, including hand washing, social distancing and proper use of mask and gloves, were given to all the participants. Results  No new confirmed COVID-19 cases were diagnosed in the target population during the follow-up timeframe of 1 month—December 20, 2020 to January 19, 2021—thus making the trial inconclusive. The Phosphorus group had the least exposure to COVID-19 compared with the other groups. In comparison with placebo, the occurrence of unconfirmed COVID-19 cases was significantly less in the Phosphorus group (week 1: odds ratio [OR], 0.1; 95% confidence interval [CI], 0.06 to 0.16; week 2: OR, 0.004; 95% CI, 0.0002 to 0.06; week 3: OR, 0.007; 95% CI, 0.0004 to 0.11; week 4: OR, 0.009; 95% CI, 0.0006 to 0.14), but not in the Bryonia or Gelsemium groups. Conclusion  Overall, the trial was inconclusive. The possible effect exerted by Phosphorus necessitates further investigation. Trial registration:  CTRI/2020/11/029265. [ABSTRACT FROM AUTHOR]

Background: Digital health interventions have been shown to improve data quality and health services in low- and middle-income countries (LMICs). Nonetheless, in LMICs, systematic assessments of time saved with the use of digital tools are rare. We ran a set of cluster-randomized controlled trials as part of the implementation of a digital maternal and child health registry (eRegistry) in the West Bank, Palestine. Objective: In the eRegTime study, we compared time spent on health information management in clinics that use the eRegistry versus the existing paper-based documentation system. Methods: Intervention (eRegistry) and control (paper documentation) arms were defined by a stratified random subsample of primary health care clinics from the concurrent eRegQual trial. We used time-motion methodology to collect data on antenatal care service provision. Four observers used handheld tablets to record time-use data during one working day per clinic. We estimated relative time spent on health information management for booking and follow-up visits and on client care using mixed-effects linear regression. Results: In total, 22 of the 24 included clinics (12 intervention, 10 control) contributed data; no antenatal care visits occurred in the other two clinics during the study period. A total of 123 and 118 consultations of new pregnancy registrations and follow-up antenatal care visits were observed in the intervention and control groups, respectively. Average time spent on health information management for follow-up antenatal care visits in eRegistry clinics was 5.72 minutes versus 8.10 minutes in control clinics (adjusted relative time 0.69, 95% CI 0.60-0.79; P<.001), and 15.26 minutes versus 18.91 minutes (adjusted relative time 0.96, 95% CI 0.61-1.50; P=.85) for booking visits. The average time spent on documentation, a subcategory of health information management, was 5.50 minutes in eRegistry clinics versus 8.48 minutes in control clinics (adjusted relative time 0.68, 95% CI 0.56-0.83; P<.001). While the average time spent on client care was 5.01 minutes in eRegistry clinics versus 4.91 minutes in control clinics, some uncertainty remains, and the CI was consistent with eRegistry clinics using less, the same, or more time on client care compared to those that use paper (adjusted relative time 0.85, 95% CI 0.64-1.13; P=.27). Conclusions: The eRegistry captures digital data at point of care during client consultations and generates automated routine reports based on the clinical data entered. Markedly less time (plausibly a saving of at least 18%) was spent on health information management in eRegistry clinics compared to those that use paper-based documentation. This is likely explained by the fact that the eRegistry requires lesser repetitive documentation work than paper-based systems. Adoption of eRegistry-like systems in comparable settings may save valuable and scarce health care resources. [ABSTRACT FROM AUTHOR]

Background: Substance-related and addictive disorders are among the most common mental disorders in adolescence and young adulthood. Vocational school students are a risk group for problematic substance use and addictive behavior. However, the availability of evidence-based prevention concepts and programs is underdeveloped in the vocational school setting.Methods/design: A two-arm cluster randomized waitlist-controlled trial will be conducted to evaluate the effectiveness of an app-based intervention to decrease substance use, gambling, and digital media use in vocational school students in Germany. Vocational students will participate in an app-based intervention that is designed to support voluntary commitment to abstain from or reduce substance or digital media use over a period of 2 weeks. The "education-as-usual" control arm will have access to the intervention after data collection is completed. One of the primary outcome measures will be the use of alcohol, nicotine, and digital media 30 days after the intervention. Several secondary outcome measures will also be included, such as cannabis consumption, gambling, symptoms of stress, physical activity, mindfulness, well-being, impulsivity and sensation seeking, and readiness to change. A total of 4500 vocational students from 225 classes will be recruited and randomized across three German federal states.Discussion: This study protocol describes the design of an RCT testing the effectiveness of an app-based intervention to reduce addictive behaviors in vocational school students. It is expected that this approach will be feasible for and effective in the vocational school setting and that the study provides comprehensive information on the key factors involved in temporary abstaining or reducing substance or digital media use.Trial Registration: German Clinical Trials Register DRKS00023788 . Registered on 20 January 2021. [ABSTRACT FROM AUTHOR]

The effectiveness of physical activity interventions can be improved through examining the aspects related to their implementation. However, little such evidence has been collected, particularly in low- and middle-income countries. This study aimed to evaluate the implementation of a school-based physical activity intervention with qualitative and quantitative data from different actors (students, teachers and parents) involved in developing the program. The program was conducted in 2017 with three main components: (i) teacher training, (ii) environmental changes and (iii) educational actions. Mixed-method evaluation was performed by an independent evaluation team using a validated indicator matrix for the implementation process, including the self-reported information of students, teachers and parents, as well as interviews with teachers. In the 3 eligible schools, 350 adolescents (51% girls) answered the implementation questionnaire, as did 45 parents (84% mothers), and 47 teachers (70% female). In the qualitative analysis, 18 teachers participated. Categorical analysis found that the intervention was considered feasible by teachers. In general, teachers had a more positive perception of the implementation than did students. The lack of engagement from the school community and parents and the busy schedule of teachers were indicated to be the main difficulties. In conclusion, despite the teachers' motivation, some barriers prevented the successful implementation of the program. [ABSTRACT FROM AUTHOR]

Abstract Background Men who have sex with men (MSM) are an important HIV key population in China. However, HIV testing rates among MSM remain suboptimal. Digital crowdsourced media interventions may be a useful tool to reach this marginalized population. We define digital crowdsourced media as using social media, mobile phone applications, Internet, or other digital approaches to disseminate messages developed from crowdsourcing contests. The proposed cluster randomized controlled trial (RCT) study aims to assess the effectiveness of a digital crowdsourced intervention to increase HIV testing uptake and decrease risky sexual behaviors among Chinese MSM. Methods A two-arm, cluster-randomized controlled trial will be implemented in eleven cities (ten clusters) in Shandong Province, China. Targeted study participants will be 250 MSM per arm and 50 participants per cluster. MSM who are 18 years old or above, live in the study city, have not been tested for HIV in the past 3 months, are not living with HIV or have never been tested for HIV, and are willing to provide informed consent will be enrolled. Participants will be recruited through banner advertisements on Blued, the largest gay dating app in China, and in-person at community-based organizations (CBOs). The intervention includes a series of crowdsourced intervention materials (24 images and four short videos about HIV testing and safe sexual behaviors) and HIV self-test services provided by the study team. The intervention was developed through a series of participatory crowdsourcing contests before this study. The self-test kits will be sent to the participants in the intervention group at the 2nd and 3rd follow-ups. Participants will be followed up quarterly during the 12-month period. The primary outcome will be self-reported HIV testing uptake at 12 months. Secondary outcomes will include changes in condomless sex, self-test efficacy, social network engagement, HIV testing social norms, and testing stigma. Discussion Innovative approaches to HIV testing among marginalized population are urgently needed. Through this cluster randomized controlled trial, we will evaluate the effectiveness of a digital crowdsourced intervention, improving HIV testing uptake among MSM and providing a resource in related public health fields. Trial registration ChiCTR1900024350 . Registered on 6 July 2019.

Abstract Background Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities, are being used to tackle physical barriers to access. However, their effectiveness has not been rigorously assessed. The objective of this cluster randomized trial was to evaluate the effectiveness of functional MWHs combined with community mobilization by trained local leaders in improving institutional births in Jimma Zone, Ethiopia. Methods A pragmatic, parallel arm cluster-randomized trial was conducted in three districts. Twenty-four primary health care units (PHCUs) were randomly assigned to either (i) upgraded MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care. Data were collected using repeat cross-sectional surveys at baseline and 21 months after intervention to assess the effect of intervention on the primary outcome, defined as institutional births, at the individual level. Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12 months prior to being surveyed were eligible for interview. Random effects logistic regression was used to evaluate the effect of the interventions. Results Data from 24 PHCUs and 7593 women were analysed using intention-to-treat. The proportion of institutional births was comparable at baseline between the three arms. At endline, institutional births were slightly higher in the MWH + training (54% [n = 671/1239]) and training only arms (65% [n = 821/1263]) compared to usual care (51% [n = 646/1271]). MWH use at baseline was 6.7% (n = 256/3784) and 5.8% at endline (n = 219/3809). Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH+ & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22). Conclusions Both the combined MWH+ & leader training and the leader training alone intervention led to a small but non-significant increase in institutional births when compared to usual care. Implementation challenges and short intervention duration may have hindered intervention effectiveness. Nevertheless, the observed increases suggest the interventions have potential to improve women’s use of maternal healthcare services. Optimal distances at which MWHs are most beneficial to women need to be investigated. Trial registration The trial was retrospectively registered on the Clinical Trials website ( https://clinicaltrials.gov ) on 3rd October 2017. The trial identifier is NCT03299491 .

OBJECTIVE: Many employees have high physical exertion at work and suffer from musculoskeletal pain (MSP) leading to sickness absence with large costs. Participatory ergonomics is a potentially effective intervention for reducing physical exertion, MSP and sickness absence. The main aim of this study was to investigate the effectiveness of a 20-week workplace participatory ergonomic intervention among childcare workers on physical exertion and MSP. METHODS: In a two-arm cluster-randomized trial, 190 workers were recruited from 16 childcare institutions and randomly assigned to either a 20-week participatory ergonomics intervention consisting of three training workshops or a control group receiving usual care. Primary outcomes were physical exertion during work, maximal pain intensity, number of pain regions, and pain-related work interference. Secondary outcomes were MSP-related sickness absence, need for recovery (NFR), employee involvement, and self-efficacy. We followed the intention-to-treat principle and adhered to the registered study protocol (ISRCTN10928313). RESULTS: After 20 weeks, half the workers noticed some positive changes in their work. However, there were no statistically discernible effects in physical exertion, maximum pain intensity, pain-related work interference, or number of pain regions. We found a significant reduction of MSP-related sickness absence in the intervention compared to the control group [-0.48 days per month (95% confidence interval (CI), -0.8– -0.1]. We found no significant effects in NRF or involvement of employees, but self-efficacy was reduced in the intervention compared to the control group [-0.2 (95% CI, -0.3– -0.0)]. CONCLUSION: This 20-week training for a participatory ergonomic intervention in childcare workers did not show effects on physical exertion and MSP, but was both feasible and effective in reducing MSP-related sickness absence.