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The growing number of people living with dementia will result in increased costs of dementia worldwide. The e-Health intervention 'Exergaming' may improve health and quality of life of people with dementia, but the cost-effectiveness is unknown. We assessed the cost-effectiveness of exergaming compared to regular activities from a societal perspective in day-care centres (DCC) for people with dementia and their informal caregivers (IC) alongside a cluster randomised controlled trial. We included 112 dyads (person with dementia and IC) from 20 psychogeriatric DCCs (11 exergaming, 9 control) across the Netherlands. Exergaming consisted of interactive cycling at least twice a week for 6 months. Measurements were conducted at baseline (T0), after 3 (T1) and 6 (T2) months. Primary outcomes were minutes of physical activity, mobility of the participants with dementia (Short Physical Performances Battery, SPPB), and Quality-Adjusted Life-Years (QALYs) of participants with dementia and ICs. ICs filled out cost diaries to measure healthcare and informal care utilisation during the study. There were no statistically significant differences in outcomes or costs between the groups at the level of participants with dementia, the ICs or the dyad. With regard to QALYs and SPPB, the probability that exergaming is cost-effective compared to control was low for all possible willingness-to-pay (WTP) thresholds. However, for physical activity at WTP thresholds of 0, 50 and 250 Euros per additional minute of physical activity, the probability of cost-effectiveness is 0.46, 0.84 and 0.87, respectively. Exergaming in DCC was not cost-effective compared to usual activities. However, considering the small sample size and the large number of missing observations, findings should be interpreted with caution. Future studies with larger samples are recommended to obtain definitive answers on the cost-effectiveness of exergaming. This trial was registered in the Netherlands Trial Register (NTR5537/NL5420).

Background Little is known whether patients with lower health literacy could retain the practice and knowledge of home blood pressure monitoring (HBPM) after an educational programme. Methods A cluster randomised controlled trial in five primary care clinics recruited participants with uncontrolled hypertension. Clinics were randomised either to a HBPM group education (Risk Assessment and Management Programme (RAMP-group), or individual counselling of self-management (RAMP-individual). Health literacy was assessed by the Chinese Health Literacy Scale for Chronic Care. Practice and knowledge of HBPM were surveyed by a 10-item HBPM knowledge checklist and patient record review 6 months after interventions. Predictors for regular HBPM and good HBPM knowledge were assessed by multivariate logistic regression models. Results 287 participants (RAMP-group: 151; RAMP-individual: 136) were follow-up for 6 months. 272 participants completed the knowledge questionnaires (response rate 94.8%). 67.8% of the participants performed HBPM regularly, and there was no statistical difference between both interventions. Age more than 65 (adjusted odds ratios (aOR) 2.58, 95% CI 1.37 to 4.86, p=0.003), not working (aOR 2.34, 95% CI 1.10 to 4.97, p=0.027)and adequate health literacy (aOR 2.25, 95% CI 1.28 to 3.95, p=0.005) predicted regular HBPM. Participants in RAMP-group demonstrated a significant lower body weight than those in RAMP-individual (−0.3±2.0 kg vs +0.7 ±1.7 kg, p Conclusion Patients could retain HBPM knowledge better after RAMP-group than RAMP-individual. Older, retired and patients with adequate health literacy were more likely to continue weekly HBPM 6 months after education. Trial registration number NCT02551393.

Background In the context of the Coronavirus Disease (COVID-19) pandemic, adherence to suggested precautionary measures has been highlighted to be extremely important in preventing and curtailing the spread of COVID-19. However, strict adherence to precautionary measures could be very demanding. Materials and Method This cluster randomized controlled trial done among 1517 undergraduate dental students tested the effectiveness of ‘Dissonance Induction’(DI) and ‘Assessment Reactivity’(AR) in improving adherence to WHO suggested COVID-19 precautionary measures as compared to a control group. At baseline, participants in the DI group were tested for their knowledge on COVID-19 precautionary measures, immediately followed by assessment of their adherence to these precautionary measures. This methodology was adapted so as to systematically reveal to the participants the poor adherence to their self-held cognitions, should there be any. The magnitude of dissonance was measured as the proportion of such dissonant cognitions held by an individual. In the AR group, at baseline, participants were inquired about their attitudes alone towards COVID-19 precautionary measures. The control group was neither assessed for knowledge and adherence nor for attitudes towards the precautionary measures at baseline. Two weeks after the administration of the aforementioned interventions in the DI and AR groups, the three study groups were assessed for adherence to COVID-19 precautionary measures. Results The follow-up adherence scores in the DI group were found to be significantly higher (15.11±4.1) compared to the AR (13.13±2.01) and control (12.87±2.97) groups as analyzed by Kruskal-Wallis ANOVA (H=243.5; P

Background The rising number of nursing home (NH) residents and their increasingly complex treatment needs pose a challenge to the German health care system. In Germany, there is no specialized geriatric medical care for NH residents. Nursing staff and general practitioners (GPs) in particular have to compensate for the additional demand, which is compounded by organizational and structural hurdles. As a result, avoidable emergency calls and hospital admissions occur. In the SaarPHIR project (Saarländische PflegeHeimversorgung Integriert Regelhaft), a complex intervention focusing on a medical care concept was developed in a participatory practice-based approach involving NH representatives and GPs. The complex intervention addresses the collaboration between nurses and GPs and aims to help restructure and optimize the existing daily care routine. It is expected to improve the medical care of geriatric patients in NHs and reduce stressful, costly hospital admissions. The intervention was pilot-tested during the first 12 months of the project. In the present study, its effectiveness, cost-effectiveness, and safety will be evaluated. Methods The study is a cluster-randomized controlled trial, comparing an intervention group with a control group. The intervention includes a concept of interprofessional collaboration, in which GPs group into regional cooperating teams. Teams are encouraged to cooperate more closely with NH staff and to provide on-call schedules, pre-weekend visits, joint team meetings, joint documentation, and improved medication safety. At least 32 NHs in Saarland, Germany (with at least 50 residents each) will be included and monitored for 12 months. The primary endpoint is hospitalization. Secondary endpoints are quality of life, quality of care, and medication safety. The control group receives treatment as usual. Process evaluation and health economic evaluation accompany the study. The data set contains claims data from German statutory health insurance companies as well as primary data. Analysis will be conducted using a generalized linear mixed model. Conclusion A reduction in hospital admissions of NH residents and relevant changes in secondary endpoints are expected. In turn, these will have a positive impact on the economic assessment. Trial registration German Clinical Trials Register: DRKS00017129. Registered on 23 April 2019. https://www.drks.de/drks_web/setLocale_EN.do.

Highlights • Iron folic acid consumption can reduce anemia, but compliance remains low. • Interventions can promote interpersonal communication for behavior change. • Topic-specific and general interpersonal communication modalities appear effective. • Interpersonal communication mediated the intervention effect on iron supplement use., Objective More than half of Indian women of reproductive age are anemic. Regular iron folic acid uptake can prevent and treat anemia. This study investigated the effect of interpersonal communication on improving IFA use among women of reproductive age. Methods The Reduction in Anemia through Normative Innovations (RANI) Project is a cluster randomized trial that collected longitudinal data from control (n = 1896) and intervention (n = 1898) communities in Odisha, India at Time 1 and six months later at Time 2. Structural equation models assessed the effect of the intervention on iron folic acid use via multiple interpersonal communication pathways. Results Compared to the control arm, iron folic acid use significantly increased in the intervention arm. Both, general health interpersonal communication and anemia-specific interpersonal communication were augmented in the intervention communities. The impact of the intervention on iron folic acid use was mediated through anemia-specific interpersonal communication. Conclusion The RANI Project increased interpersonal communication among participants, resulting in increased iron folic acid use for anemia reduction. Practice implications Strategic use of targeted interpersonal communication to promote behavior change appears to be a viable strategy to increase iron folic acid use to reduce anemia.

Background The quality of the home learning environment has a significant influence on children’s language and communication skills during the early years with children from disadvantaged families disproportionately affected. This paper describes the protocol and participant baseline characteristics of a community-based effectiveness study. It evaluates the effects of ‘smalltalk’, a brief group parenting intervention (with or without home coaching) on the quality of the early childhood home learning environment. Methods/design The study comprises two cluster randomised controlled superiority trials (one for infants and one for toddlers) designed and conducted in parallel. In 20 local government areas (LGAs) in Victoria, Australia, six locations (clusters) were randomised to one of three conditions: standard care (control); smalltalk group-only program; or smalltalk plus (group program plus home coaching). Programs were delivered to parents experiencing socioeconomic disadvantage through two existing age-based services, the maternal and child health service (infant program, ages 6–12 months), and facilitated playgroups (toddler program, ages 12–36 months). Outcomes were assessed by parent report and direct observation at baseline (0 weeks), post-intervention (12 weeks) and follow-up (32 weeks). Primary outcomes were parent verbal responsivity and home activities with child at 32 weeks. Secondary outcomes included parenting confidence, parent wellbeing and children’s communication, socio-emotional and general development skills. Analyses will use intention-to-treat random effects (“multilevel”) models to account for clustering. Recruitment and baseline data Across the 20 LGAs, 986 parents of infants and 1200 parents of toddlers enrolled and completed baseline measures. Eighty four percent of families demonstrated one or more of the targeted risk factors for poor child development (low income; receives government benefits; single, socially isolated or young parent; culturally or linguistically diverse background). Discussion This study will provide unique data on the effectiveness of a brief group parenting intervention for enhancing the early home learning environment of young children from disadvantaged families. It will also provide evidence of the extent to which additional one-on-one support is required to achieve change and whether there are greater benefits when delivered in the 1st year of life or later. The program has been designed for scale-up across existing early childhood services if proven effective. Trial registration 8 September 2011; ACTRN12611000965909.

Introduction The increased use of long-acting reversible contraceptives (LARCs), such as intrauterine devices and hormonal implants, has the potential to reduce unintended pregnancy and abortion rates. However, use of LARCs in Australia is very low, despite clinical practice guidance and statements by national and international peak bodies advocating their increased use. This protocol paper describes the Australian Contraceptive ChOice pRojet (ACCORd), a cluster randomised control trial that aims to test whether an educational intervention targeting general practitioners (GPs) and establishing a rapid referral service are a cost-effective means of increasing LARC uptake. Methods and analysis The ACCORd intervention is adapted from the successful US Contraceptive CHOICE study and involves training GPs to provide ‘LARC First’ structured contraceptive counselling to women seeking contraception, and implementing rapid referral pathways for LARC insertion. Letters of invitation will be sent to 600 GPs in South-Eastern Melbourne. Using randomisation stratified by whether the GP inserts LARCs or not, a total of 54 groups will be allocated to the intervention (online ‘LARC First’ training and rapid referral pathways) or control arm (usual care). We aim to recruit 729 women from each arm. The primary outcome will be the number of LARCs inserted; secondary outcomes include the women's choice of contraceptive method and quality of life (Short Form Health Survey, SF-36). The costs and outcomes of the intervention and control will be compared in a cost-effectiveness analysis. Ethics and dissemination The ACCORd study has been approved by the Monash University Human Research Ethics Committee: CF14/3990-2014002066 and CF16/188-2016000080. Any protocol modifications will be communicated to Ethics Committee and Trial Registration registry. The authors plan to disseminate trial outcomes through formal academic pathways comprising journal articles, nation and international conferences and reports, as well as using more ‘popular’ strategies including seminars, workshops and media engagements. Trial registration number ACTRN12615001346561.

Objectives Interventions to prevent postpartum common mental disorders (PCMD) among unselected populations of women have had limited success. The aim was to determine whether What Were We Thinking (WWWT) a gender-informed, psychoeducational programme for couples and babies can prevent PCMD among primiparous women 6 months postpartum. Design Cluster-randomised controlled trial. Setting 48 Maternal and Child Health Centres (MCHCs) from 6 Local Government Areas in Melbourne, Australia were allocated randomly to usual care (24) or usual care plus WWWT (24). Participants English-speaking primiparous women receiving primary care at trial MCHCs were recruited to the intervention (204) and control (196) conditions. Of these, 187 (91.7%) and 177 (90.3%) provided complete data. Intervention WWWT is a manualised programme comprising primary care from a trained nurse, print materials and a face-to-face seminar. Main outcome measures Data sources were standardised and study-specific measures collected in blinded computer-assisted telephone interviews at 6 and 26 weeks postpartum. The primary outcome was PCMD assessed by Composite International Diagnostic Interviews and Patient Health Questionnaire (PHQ) Depression and Generalised Anxiety Disorder modules. Results In intention-to-treat analyses the adjusted OR (AOR) of PCMD in the intervention compared to the usual care group was 0.78 (95% CI 0.38 to 1.63, ns), but mild to moderate anxiety symptoms (AOR 0.58, 95% CI 0.35 to 0.97) and poor self-rated health (AOR 0.46, 95% CI 0.22 to 0.97) were significantly lower. In a per protocol analysis, comparing the full (three component) intervention and usual care groups, the AOR of PCMD was 0.36, (95% CI 0.14 to 0.95). The WWWT seminar was appraised as salient, comprehensible and useful by >85% participants. No harms were detected. Conclusions WWWT is readily integrated into primary care, enables inclusion of fathers and addresses modifiable risks for PCMD directly. The full intervention appears a promising programme for preventing PCMD, optimising family functioning, and as the first component of a stepped approach to mental healthcare. Trial registration number ACTRN12613000506796; Results.

Background Valid and reliable measures such as London Measure of Unplanned Pregnancy (LMUP) are imperative for understanding fertility-related behaviors and estimating unintended pregnancy. The aim of this study was to validate the LMUP in the Hindi language for a wider reach in India. Methods An interviewer administered version of the LMUP was translated and pretested in Hindi. The LMUP was field tested with married women in the reproductive age group across forty informal settlements in Mumbai in the post intervention census of a cluster randomized control trial to improve the health of women and children. Analyses involved the full sample and sub-groups according to time-from-conception. Reliability (internal consistency) was assessed using Cronbach’s alpha, inter-item correlations, and item-rest correlations. Construct validity was assessed by hypothesis testing and confirmatory factor analysis. Results 4991 women were included in the study (1180 were pregnant, 2126 in their first- and 1685 in their second postnatal year). LMUP item completion rates were 100 % and the full range of LMUP scores was captured. Reliability: the scale was internally consistent (Cronbach’s α = 0.84), inter-item correlations were positive, and item-rest correlations were above 0.2 for all items except item six (0.07). Construct validity: hypotheses were met, and confirmatory factor analysis showed that a one-factor model was a good fit for the data, confirming unidimensional measurement. The sub-group analysis (by pregnant, first-, and second postnatal year) showed that the psychometric properties of the LMUP were similar across the groups. In terms of LMUP scores, the women in the postnatal groups were very slightly, but significantly, more likely to have an LMUP score of 10 + compared to pregnant women; the difference between the first and second postnatal year was not significant. Conclusions The Hindi LMUP is valid and reliable measure of pregnancy intention that may be used in India. Trial Registration This study is registered with ISRCTN, number ISRCTN56183183, and Clinical Trials Registry of India, number CTRI/2012/09/003004.

AIMS We assessed the effect of transitional care on patient-reported outcomes (PROs) in women and men hospitalized for heart failure. METHODS AND RESULTS In this sex-specific analysis of a stepped wedge cluster randomized trial in Canada, the effect of a patient-centered transitional care model was tested on pre-specified PROs of discharge preparedness (B-PREPARED score, range 0-22), quality of transition [Care Transitions Measure-3 (CTM-3) score, range 0-100], and health-related quality of life (HRQOL) (EQ-5D-5L, range 0-1). Among 986 patients (47.4% women), B-PREPARED at 6 weeks was greater with the intervention than usual care [mean difference (MD) 4.01 (95% confidence interval-CI 2.90-5.12); P

Randomized clinical trials are the gold standard for the development of new drugs. Clinical trials have become increasingly complex, in particular in the field of inflammatory bowel diseases. For this reason, a new study design called ‘cluster randomized trial’ has been introduced. Cluster randomized trials randomly assign groups of individuals within a population of interest, such as people in a particular research site, clinic or hospital, and measure the effects of an intervention at the individual level. In contrast to individual randomization, cluster randomization permits the evaluation of a cluster-level intervention, may be logistically simpler and less expensive than a conventional randomized trial, and can help reduce the effect of treatment contamination. An important aspect requiring particular attention in cluster randomized trials is the risk for imbalance of covariates at baseline which decreases the statistical power and precision of the results, and reduces face validity and credibility of the trial results. A variety of restricted randomization methods have been proposed to minimize risk of imbalance. Our aim here is to clarify the advantages and drawbacks of cluster randomized trials in order to properly interpret study results and to identify their role in upcoming inflammatory bowel disease trials.

Background Diabetes has become a major public health challenge worldwide, especially in low- and middle-income countries (LMICs). Uncontrolled hyperglycemia, hypertension, and dyslipidemia major risk factors for all-cause mortality and cardiovascular disease (CVD) are common in patients with diabetes in China. We propose to compare the effectiveness of team-based care plus a clinical decision support system (CDSS) with team-based care alone on glycemic, blood pressure (BP), and lipid control, and clinical CVD reduction among patients with type-2 diabetes and at high risk for CVD. Methods The Diabetes Complication Control in Community Clinics (D4C) study is a cluster-randomized trial conducted among 38 community health centers in Xiamen City, China. Nineteen clinics have been randomly assigned to team-based care plus CDSS and 19 to team-based care alone. Team-based care includes primary care providers, health coaches, and diabetes specialists working collaboratively with patients to achieve shared treatment goals for CVD risk factor reduction. The CDSS integrates guideline-based treatment algorithms for glycemic, BP, and lipid control, along with a patient's medical history and insurance policy, to recommend treatment and follow-up plans. In phase 1, the co-primary outcomes are mean reduction in glycated hemoglobin (HbA1c), systolic BP (SBP), and low-density lipoprotein (LDL)-cholesterol over 18 months, and the proportion of patients with controlled HbA1c, SBP, and LDL-cholesterol at 18 months’ between the 2 comparison groups. In phase 2, the primary outcome is the difference in major CVD incidence (non–fatal stroke, non–fatal myocardial infarction, hospitalized heart failure, and CVD mortality) between the 2 comparison groups. Mean reduction in HbA1c, SBP, and LDL-cholesterol levels will be simultaneously modeled for a single overall treatment effect. Conclusion The D4C trial will generate evidence on whether a CDSS will further reduce the CVD burden among patients with diabetes beyond team-based care at community clinics. If proven effective, this implementation strategy could be scaled up within primary care settings in China and other LMICs to reduce CVD incidence and mortality among patients with diabetes.

Community delivery of Antiretroviral therapy (ART) is a novel innovation to increase sustainable ART coverage for People living with HIV (PLHIV) in resource limited settings. Within a nested cluster-randomised sub-study in two urban communities that participated in the HPTN 071 (PopART) trial in Zambia we investigated individual acceptability and preferences for ART delivery models. Stable PLHIV were enrolled in a cluster-randomized trial of three different models of ART: Facility-based delivery (SoC), Home-based delivery (HBD) and Adherence clubs (AC). Consenting individuals were asked to express their stated preference for ART delivery options. Those assigned to the community models of ART delivery arms could choose (“revealed preference”) between the assigned arm and facility-based delivery. In total 2489 (99.6%) eligible individuals consented to the study and 95.6% chose community models of ART delivery rather than facility-based delivery when offered a choice. When asked to state their preference of model of ART delivery, 67.6% did not state a preference of one model over another, 22.8% stated a preference for HBD, 5.0% and 4.6% stated a preference for AC and SoC, respectively. Offering PLHIV choices of community models of ART delivery is feasible and acceptable with majority expressing HBD as their stated preferred option.

Background The prevalence of gestational diabetes mellitus (GDM) is rising rapidly in many low- and middle-income countries (LMICs). Most women with GDM in LMICs are undiagnosed and/or inadequately managed due to a lack of knowledge and skills about GDM on the part of both providers and patients. Following contextual analysis, we developed an educational/behavioural intervention for GDM delivered through a package of culturally tailored films. This trial aims to evaluate whether the intervention can improve the timely detection and management of GDM in two LMIC settings. Methods Two independent cluster randomised controlled trials, one each to be conducted in Uganda and India. Thirty maternity facilities in each country have been recruited to the study and randomised in a 1:1 ratio to the intervention and control arms. The intervention comprises of three interconnected sets of films with the following aims: to improve knowledge of GDM guidelines and skills of health providers, to raise awareness of GDM screening among pregnant women and their families, and to improve confidence and skills in self-management among those diagnosed with GDM. In facilities randomised to the intervention arm, a GDM awareness-raising film will be shown in antenatal care waiting rooms, and four films for pregnant women with GDM will be shown in group settings and made available for viewing on mobile devices. Short films for doctors and nurses will be presented at professional development meetings. Data will be collected on approximately 10,000 pregnant women receiving care at participating facilities, with follow-up at 32 weeks gestational age and 6 weeks postnatally. Women who self-report a GDM diagnosis will be invited for a clinic visit at 34 weeks. Primary outcomes are (a) the proportion of women who report a GDM diagnosis by 32 weeks of pregnancy and (b) glycaemic control (fasting glucose and HbA1C) in women with GDM at ~34 weeks of pregnancy. The secondary outcome is a composite measure of GDM-related adverse perinatal-neonatal outcome. Discussion Screening and management of GDM are suboptimal in most LMICs. We hypothesise that a scalable film-based intervention has the potential to improve the timely detection and management of GDM in varied LMIC settings. Trial registration ClinicalTrials.gov NCT03937050, registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605, registered on 26 February 2020.

Objective Using a nested, cluster-randomized trial, we tested the hypothesis that a shared decision-making intervention, as part of consent, would improve study-related knowledge. Methods We developed a shared decision-makingintervention then randomized sites in a clinical trial to intervention or control (standard consent). We collected participants’ knowledge (primary outcome) and decisional support data. Other data came from a clinical registry and research coordinator surveys. We compared outcomes between study arms using generalized estimating equation models, accounting for clustering. We used qualitative description to understand variation in intervention use. Results 265 individuals, from 34 sites, enrolled in the parent trial during our study period. Of those, 241 participants completed our survey. There was no knowledge difference between arms (mean difference = 0.56 (95 %CI: -3.8, 4.9)). Both groups had a considerable number of participants with misunderstandings. We also found no difference for decisional support (mean difference = 1.5 (95 %CI: -1.8, 4.8)) or enrollment rate between arms. Clinician use of the intervention varied between sites. Conclusions We found no differences in outcomes but demonstrated the feasibility and acceptability of incorporating a shared decision-making intervention into consent. Practice implications Future work should consider adapting our intervention to other trials and more robust measurement strategies.

Purpose To assess whether routine fundus photography (RFP) to screen for posterior segment disease at community eye clinics (vision centers [VCs]) in India increases referral to centralized ophthalmolic care. Design Stepped-wedge, cluster-randomized trial. Participants Patients aged 40 to 75 years and those aged 20 to 40 years with a known history of hypertension or diabetes mellitus presenting to 4 technician-run VCs associated with the Aravind Eye Care System in India. Methods VCs (clusters) were randomized to standard care or RFP across five 2-week study periods (steps). Patients in each cluster received standard care initially. At the start of each subsequent step, a randomly chosen cluster crossed over to providing RFP to eligible patients. All clusters took part in RFP during the last step. Standard care involved technician eye exams, optional fundus photography, and teleconsultation with an ophthalmologist. RFP involved eye exams, dilation and 40-degree fundus photography, and teleconsultation with an ophthalmologist. Main Outcome Measures Standard care and RFP clusters were compared by the proportion of patients referred for in-person evaluation by an ophthalmologist because of fundus photography findings and urgency of referral (urgently in ≤ 2 weeks vs. nonurgently in > 2 weeks). Generalized linear mixed models adjusting for cluster and step were used to estimate the odds of referral due to fundus photography findings compared with standard care. Results A total of 1447 patients were enrolled across the VCs, including 737 in the standard care group and 710 in the RFP group. Compared with standard care, the RFP group had a higher proportion of referrals due to fundus photography findings (11.3% vs. 4.4%), nonurgent referrals due to fundus photography (9.3% vs. 3.3%), and urgent referrals due to fundus photography (1.8% vs. 1.1%). The RFP intervention was associated with a 2-fold increased odds of being referred because of photography findings compared with standard care (odds ratio, 2.07; 95% confidence interval, 0.98–4.40; P = 0.058). Conclusions Adding RFP to community eye clinics was associated with an increased odds of referral compared with standard care. This increase in referral was mostly due to nonurgent posterior segment disease.

Summary: Background: Secondary distribution of HIV self-testing (HIVST) kits by patients attending clinic services to their partners could improve the rate of HIV diagnosis. We aimed to investigate whether secondary administration of HIVST kits, with or without an additional financial incentive, via women receiving antenatal care (ANC) or via people newly diagnosed with HIV (ie, index patients) could improve the proportion of male partners tested or the number of people newly diagnosed with HIV. Methods: We did a three-arm, open-label, pragmatic, cluster-randomised trial of 27 health centres (clusters), eligible if they were a government primary health centre providing ANC, HIV testing, and ART services, across four districts of Malawi. We recruited women (aged ≥18 years) attending their first ANC visit and whose male partner was available, not already taking ART, and not already tested for HIV during this pregnancy (ANC cohort), and people (aged ≥18 years) with newly diagnosed HIV during routine clinic HIV testing who had at least one sexual contact not already known to be HIV-positive (index cohort). Centres were randomly assigned (1:1:1), using a public selection of computer-generated random allocations, to enhanced standard of care (including an invitation for partners to attend HIV testing services), HIVST only, or HIVST plus a US$10 financial incentive for retesting. The primary outcome for the ANC cohort was the proportion of male partners reportedly tested, as ascertained by interview with women in this cohort at day 28. The primary outcome for the index cohort was the geometric mean number of new HIV-positive people identified per facility within 28 days of enrolment, as measured by observed HIV test results. Cluster-level summaries compared intervention with standard of care by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03705611. Findings: Between Sept 8, 2018, and May 2, 2019, nine clusters were assigned to each trial arm, resulting in 4544 eligible women in the ANC cohort (1447 [31·8%] in the standard care group, 1465 [32·2%] in the HIVST only group, and 1632 [35·9%] in HIVST plus financial incentive group) and 708 eligible patients in the index cohort (234 [33·1%] in the standard care group, 169 [23·9%] in the HIVST only group, and 305 [42·9%] in the HIVST plus financial incentive group). 4461 (98·2%) of 4544 eligible women in the ANC cohort and 645 (91·1%) of 708 eligible patients in the index cohort were recruited, of whom 3378 (75·7%) in the ANC cohort and 439 (68·1%) in the index cohort were interviewed after 28 days. In the ANC cohort, the mean proportion of reported partner testing per cluster was 35·0% (SD 10·0) in the standard care group, 73·0% in HIVST only group (13·1, adjusted risk ratio [RR] 1·71, 95% CI 1·48–1·98; p

Background We implemented an opt-out clinic-based intervention pairing syphilis tests with routine human immunodeficiency virus (HIV) viral load testing. The primary objective was to determine the degree to which this intervention increased the detection of early syphilis. Methods The Enhanced Syphilis Screening Among HIV-Positive Men (ESSAHM) Trial was a stepped wedge cluster-randomized controlled trial involving 4 urban HIV clinics in Ontario, Canada, from 2015 to 2017. The population was HIV-positive adult males. The intervention was standing orders for syphilis serological testing with viral loads, and control was usual practice. We obtained test results via linkage with the centralized provincial laboratory and defined cases using a standardized clinical worksheet and medical record review. We employed a generalized linear mixed model with a logit link to estimate odds ratios (ORs) and 95% confidence intervals (CIs) of the intervention. Results A total of 3895 men were followed over 7471 person-years. The mean number of syphilis tests increased from 0.53 to 2.02 tests per person per year. There were 217 new diagnoses of syphilis (control, 81; intervention, 136), for which 147 (68%) were cases of early syphilis (control, 61 [75%]; intervention, 86 [63%]). The annualized proportion with newly detected early syphilis increased from 0.009 to 0.032 with implementation of the intervention; the corresponding time-adjusted OR was 1.25 (95% CI, .71–2.20). Conclusions The implementation of standing orders for syphilis testing with HIV viral loads was feasible and increased testing, yet produced less-than-expected increases in case detection compared to past uncontrolled pre–post trials. Clinical Trials Registration NCT02019043.

OBJECTIVE To evaluate the effect of structured contraceptive counselling on the uptake of long-acting reversible contraceptives (LARCs) and pregnancy rates. DESIGN Cluster randomised trial. SETTING Abortion, youth and maternal health clinics in Stockholm, Sweden. POPULATION Sexually active women aged ≥18 years without a wish for pregnancy seeking abortion and/or contraceptive counselling. METHODS For participants in clinics randomised to intervention, trained healthcare providers implemented a study-specific intervention package designed for structured contraceptive counselling. Participants in the control clinics received routine counselling. MAIN OUTCOME MEASURES The primary outcome was choice of LARCs at first visit. Secondary outcomes were LARC initiation at 3 months and pregnancy rates at 3 and 12 months. We used logistic mixed-effects models with random intercept for clinic to account for clustering. RESULTS From September 2017 to May 2019, 28 randomised clinics enrolled 1364 participants. Analyses including 1338 subjects showed that more participants in the intervention group compared with the control group chose LARCs: 267/658 (40.6%) versus 206/680 (30.3%) (OR 2.77, 95% CI 1.99-3.86). LARC initiation was higher in the intervention group compared with the control group: 213/528 (40.3%) versus 153/531 (28.8%) (OR 1.74, 95% CI 1.22-2.49). At the abortion clinics, the pregnancy rate was significantly lower at 12 months in the intervention group compared with the control group: 13/101 (12.9%) versus 28/103 (27.2%) (OR 0.39, 95% CI 0.18-0.88). CONCLUSIONS Structured contraceptive counselling increased LARC uptake in all clinics and significantly reduced unintended pregnancy rates in abortion clinics at the 12 months follow-up. TWEETABLE ABSTRACT Structured contraceptive counselling increased LARC uptake and reduced pregnancy rates at 12 months.

OBJECTIVE To develop and assess an alternative care model using community-based groups for people living with HIV and facilitate by lay personnel. METHODS Geographic locations in the Academic Model Providing Access to Healthcare Kitale clinic catchment were randomized to standard of care versus a community-based care group (ART Co-op). Adults stable on antiretroviral therapy and virally suppressed were eligible. Research Assistant-led ART Co-ops met in the community every 3 months. Participants were seen in the HIV clinic only if referred. CD4 count and viral load were measured in clinic at enrollment and after 12 months. Retention, viral suppression, and clinic utilization were compared between groups using χ2, Fisher exact, and Wilcoxon rank sum tests. RESULTS At 12 months, there were no significant differences in mean CD4 count or viral load suppression. There was a significant difference in patient retention in assigned study group between the intervention and control group (81.6% vs 98.6%; P < 0.001), with a number of intervention patients withdrawing because of stigma, relocation, pregnancy, and work conflicts. All participants, however, were retained in an HIV care program for the study duration. The median number of clinic visits was lower for the intervention group than that for the control group (0 vs 3; P < 0.001). CONCLUSIONS Individuals retained in a community-based HIV care model had clinical outcomes equivalent to those receiving clinic-based care. This innovative model of HIV care addresses the problems of insufficient health care personnel and patient retention barriers, including time, distance, and cost to attend clinic, and has the potential for wider implementation.

Background Acute aortic syndrome (AAS) is an uncommon, life-threatening emergency that is frequently misdiagnosed. The 2020 Canadian clinical practice guidelines for the diagnosis of AAS incorporate all available evidence into four key recommendations. In order to facilitate the implementation of these recommendations, a clinical decision aid was created. The objective of this study was to identify barriers and facilitators among physicians prior to implementation of the guideline recommendations in a multicentre step wedge cluster randomized control trial. Methods We conducted semi-structured interviews with nine emergency room physicians working at five sites distributed between urban academic and rural settings. We used purposive sampling, contacting physicians until data saturation was reached. Interview questions were designed to understand potential barriers and facilitators to guideline recommendation uptake and use. Responses were analysed according to the Theoretical Domains Framework, and overarching themes describing these barriers and facilitators were identified. Results Two themes and six subthemes encompassing 13 theoretical domains were identified. These included clinical decision-making support, awareness of the evidence, social factors, expected consequences, ability of physicians to acquire the necessary data and ease of use. A majority of interviewees anticipated that the guideline recommendations would support clinical decision making and more effectively risk-stratify patients. Other facilitators included endorsement of the guidelines by professional organizations and peers. Barriers to implementation include the fact that laboratory testing and knowledge of the rationale for its use in the investigation of AAS were not widespread. The complexity of the clinical decision aid and concerns about test specificity were also identified as potential barriers to use. Conclusion Physicians were amenable to using the AAS guideline recommendations to support clinical decision-making and to reduce resource use. A structured intervention should be developed to address the identified barriers and leverage the facilitators in order to ensure successful implementation. Our findings may have implications for the implementation of other guidelines used in emergency departments.

International audience; Objectives: To estimate the prevalence of time-to-event (TTE) outcomes in cluster randomized trials (CRTs) and to examine their statistical management. Study design and setting: We searched PubMed to identify primary reports of CRTs published in six major general medical journals (2013-2018). Nature of outcomes and, for TTE outcomes, statistical methods for sample size, analysis, and measures of intracluster correlation were extracted.Results: A TTE analysis was used in 17% of the CRTs (32/184) either as a primary or secondary outcome analysis, or in a sensitivity analysis. Among the five CRTs with a TTE primary outcome, two accounted for both intracluster correlation and the TTE nature of the outcome in sample size calculation; one reported a measure of intracluster correlation in the analysis. Among the 32 CRTs with a least one TTE analysis, 44% (14/32) accounted for clustering in all TTE analyses. We identified 12 additional CRTs in which there was at least one outcome not analyzed as TTE for which a TTE analysis might have been preferred.Conclusion: TTE outcomes are not uncommon in CRTs but appropriate statistical methods are infrequently used. Our results suggest that further methodological development and explicit recommendations for TTE outcomes in CRTs are needed.

Objective To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p p p Conclusions There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464.

BACKGROUND To determine if a school-based physical activity (PA) intervention that supported primary school teachers to schedule PA during school hours impacted their own PA. METHODS A 2x2 factorial group cluster-randomised controlled trial was undertaken in 12 Australian primary schools. The nine-month intervention supported classroom teachers to increase scheduled weekly PA for their class via physical education, sport, Energisers and integrated lessons. Teachers' PA (n = 76) was measured at follow-up only using accelerometers (Actigraph GT3X or GT9X). Linear mixed models were used to estimate between-group differences in teachers' mean minutes of sedentary, light, moderate-to-vigorous-intensity physical activity (MVPA) across the school day and during class-time. RESULTS At follow-up, there were non-significant between-group differences favouring intervention teachers, compared to controls, for light PA (4.9 minutes, 95% CI: -6.3, 16.0; P = .33) and MVPA (0.4 minutes, 95% CI: -10.9, 11.6; P = .94) across the school day; although not favouring the intervention for sedentary behaviour (5.1 minutes, 95% CI: -11.4, 21.7; P = .48). Similar patterns were seen during class-time for light PA and sedentary time, but not for MVPA. CONCLUSIONS Supporting teachers with the scheduling of PA for their class may impact on their own PA. Fully powered studies are needed to better understand the impact of the intervention on teachers' PA. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12616001228471 (http://www.anzctr.org.au/).

Purpose. To determine the percentage of parents who report quitting spontaneously and examine the factors associated with these quits. Methods. As part of a cluster randomized control trial addressing parental smoking in a pediatric outpatient setting, 12-month follow-up survey data were collected from parents who had self-identified as smokers when exiting from 10 control practices. Parents were considered to have made a spontaneous quit if they reported not smoking a cigarette, even a puff, in the last 7 days and chose the statement “I did not plan the quit in advance; I just did it” when describing how their quit attempt started. Results. Of the 981 smoking parents enrolled at baseline, 710 (72%) completed the 12-month follow-up. Of these, 123 (17%) reported quitting, of whom 50 (41%) reported quitting spontaneously. In multivariable analysis, parents who reported smoking on some days vs. every day (OR 3.06 (95% CI 1.42, 6.62)) and that nobody had smoked in their home/car vs. someone had smoked in these settings in the past 3 months (OR 2.19 (95% CI 1.06, 4.54)) were more likely to quit spontaneously. Conclusions. This study shows that, of parents who quit smoking, a substantial percentage report quitting spontaneously and that intermittent smoking and smoke-free home/car policies are associated with reports of quitting spontaneously. Promoting smoke-free home/car policies, especially when parents are not willing to make a plan to quit smoking, might increase the likelihood that parents decide to quit without advance planning. Pediatric healthcare providers are uniquely positioned to use the child’s visit to motivate parents to quit smoking and eliminate their child’s exposure to tobacco smoke, regardless of the frequency of smoking or a readiness to plan a quit attempt. Clinical Trial Registration. This trial is registered with NCT01882348.

Background Finding effective, accessible treatment options such as professional-delivered cognitive behavioral therapy (CBT) for medically complex individuals is challenging in rural communities. Purpose We examined whether a CBT-based program intended to increase physical activity despite chronic pain in patients with diabetes delivered by community members trained as peer coaches also improved depressive symptoms and perceived stress. Methods Participants in a cluster-randomized controlled trial received a 3-month telephonic lifestyle modification program with integrated CBT elements. Peer coaches assisted participants in developing skills related to adaptive coping, diabetes self-management goal-setting, stress reduction, and cognitive restructuring. Attention controls received general health advice with an equal number of contacts but no CBT elements. Depressive symptoms and stress were assessed using the Centers for Epidemiologic Studies Depression and Perceived Stress scales. Assessments occurred at baseline, 3 months, and 1 year. Results Of 177 participants with follow-up data, 96% were African Americans, 79% women, and 74% reported annual income Conclusions This peer-delivered CBT-based program improved depressive symptoms and stress in individuals with diabetes and chronic pain. Training community members may be a feasible strategy for offering CBT-based interventions in rural and under-resourced communities. Clinical Trial Registration NCT02538055.

A cluster randomization trial is one in which clusters of individuals are randomly allocated to different intervention arms. This design has become the standard for the evaluation of health care and educational strategies. To assess treatment effect, many cluster randomization trials involve outcomes that are lack meaningful units, making interpretation difficult. This difficulty may be dealt with by estimating the Mann-Whitney probability, which quantifies the probability that a typical response from one treatment arm is larger (or smaller) than a typical response from the other arm. In this work, we propose procedures for estimating this probability in cluster randomization trials. Primary emphasis is given to confidence interval estimation in trials with a small number of large clusters. The essence of the procedures is to obtain placement values based on overall ranks and arm-specific ranks prior to application of the ratio estimator, cluster-size-weighted means and mixed models for adjusting clustering effects. Nine confidence intervals were developed by applying three interval methods each based on the three variance estimators. The proposed methods can be applied to studies with binary, ordinal or continuous outcomes without making parametric assumptions. Simulation results demonstrated that the three variance estimators performed equally well, with the confidence interval procedures based on logit and inverse hyperbolic sine transformations performing better in terms of coverage and average interval width, even when the numbers of clusters are as small as 3 to 5 clusters per arm. The methods are illustrated using data from three published cluster randomization trials with SAS code provided.

Background Methods to enhance the accuracy of the depression diagnosis continues to be of relevance to clinicians. The primary aim of this study was to compare the diagnostic precision of two different diagnostic strategies using the Mini International Neuropsychiatric Interview (MINI) as a reference standard. A secondary aim was to evaluate accordance between depression severity found via MINI and mean Major Depression Inventory (MDI) sum-scores presented at referral. Methods This study was a two-armed, cluster-randomized superiority trial embedded in the Collabri trials investigating collaborative care in Danish general practices. GPs performing case-finding were instructed always to use MDI when suspecting depression. GPs performing usual clinical assessment were instructed to detect depression as they would normally do. According to guidelines, GPs would use MDI if they had a clinical suspicion, and patients responded positively to two or three core symptoms of depression. We compared the positive predictive value (PPV) in the two groups. Results Fifty-one GP clusters were randomized. In total, 244 participants were recruited in the case-finding group from a total of 19 GP clusters, and 256 participants were recruited in the usual clinical assessment group from a total of 19 GP clusters. The PPV of the GP diagnosis, when based on case-finding, was 0.83 (95% CI 0.78–0.88) and 0.93 (95% CI 0.89–0.96) when based on usual clinical assessment. The mean MDI sum-scores for each depression severity group indicated higher scores than suggested cut-offs. Conclusions In this trial, systematic use of MDI on clinical suspicion of depression did not improve the diagnostic precision compared with the usual clinical assessment of depression. Trial registration The trial was retrospectively registered on 07/02/2016 at ClinicalTrials.gov. No. NCT02678845.

Summary: Background: Almost a quarter of the world's undernourished people live in India. We tested the effects of three nutrition-sensitive agriculture (NSA) interventions on maternal and child nutrition in India. Methods: We did a parallel, four-arm, observer-blind, cluster-randomised trial in Keonjhar district, Odisha, India. A cluster was one or more villages with a combined minimum population of 800 residents. The clusters were allocated 1:1:1:1 to a control group or an intervention group of fortnightly women's groups meetings and household visits over 32 months using: NSA videos (AGRI group); NSA and nutrition-specific videos (AGRI-NUT group); or NSA videos and a nutrition-specific participatory learning and action (PLA) cycle meetings and videos (AGRI-NUT+PLA group). Primary outcomes were the proportion of children aged 6–23 months consuming at least four of seven food groups the previous day and mean maternal body-mass index (BMI). Secondary outcomes were proportion of mothers consuming at least five of ten food groups and child wasting (proportion of children with weight-for-height Z score SD

Background Syphilis is a common sexually transmitted infection (STI) among men who have sex with men (MSM). Increasing syphilis testing is important to syphilis control. However, in low- and middle-income countries like China, syphilis testing rates remain low among MSM. We describe a randomized controlled trial protocol to examine the effectiveness of social network distribution approaches of syphilis self-testing among MSM in China. Methods We will recruit index and alter MSM. Indexes will be eligible if they: are born biologically male; aged 18 years or above; ever had sex with another man; are willing to distribute syphilis testing packages or referral links to their alters; and willing to provide personal contact information for future follow-up. Three hundred MSM will be recruited and randomly assigned in a 1:1:1 ratio into three arms: standard of care (control arm); standard syphilis self-testing (SST) delivery arm; and referral link SST delivery arm. Indexes will distribute SST packages or referral links to encourage alters to receive syphilis testing. All indexes will complete a baseline survey and a 3-month follow-up survey. Syphilis self-test results will be determined by photo verification via a digital platform. The primary outcome is the mean number of alters who returned verified syphilis testing results per index in each arm. Discussion The trial findings will provide practical implications in strengthening syphilis self-testing distribution and increasing syphilis testing uptake among MSM in China. This study also empowers MSM community in expanding syphilis testing by using their own social network. Trial registration Chinese Clinical Trial Registry, ChiCTR2000036988. Registered 26 August 2020 - Retrospectively registered.

Abstract Undertaking recruitment for research in schools is an effective way to recruit young people for research participation but it is not without its challenges. Gaining access and coordinating many levels of different organisations and stakeholders whose cooperation and approval are crucial all add time and sometimes logistical challenges for the research team. In addition, recruiting around sensitive research topics can elicit additional barriers to successful research. The research team aimed to conduct a pragmatic cluster randomised controlled trial involving schools in a local government region in Victoria, Australia, to assess the effect of a vaccination-based educational card game called “Vaxcards” on vaccine consent returns. Schools were contacted via phone and email to determine which staff member would best be a contact point for a face-to-face meeting to discuss the methods and purpose of the study. Email follow-ups were scheduled to follow up non-responsive schools and consent forms. The minimum required sample size was 13. Of 31 eligible schools, 13 were recruited. The research team encountered several unanticipated challenges before achieving the recruitment target. The most common reasons for non-participation were being too busy with other commitments, concerns regarding the topic of vaccination being too sensitive, and concerns that key stakeholders in the school would not approve of the research topic of vaccination. One school required a review by a private research ethics board that rejected the study. Significant hesitancy and misinformation about vaccine science was observed that affected engagement with a small number of schools. This paper highlights the challenges of recruiting schools in the context of public anxieties about vaccines and has several important learning lessons for successful recruitment about sensitive topics. This includes navigating approval processes for research in schools, the importance of local champions, dealing with misinformation and the importance of strong relationships and organisational trust. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001753246. Prospectively registered on 25 October 2018 8:24:21 AM

Objective This study aimed to test the effectiveness of the Whole of Systems Trial of Prevention Strategies for Childhood Obesity (WHO STOPS Childhood Obesity) for behavioral, health-related quality of life (HRQoL), and BMI outcomes. Methods This was a cluster randomized trial of 10 communities randomly allocated (1:1) to start intervention in 2015 (step 1) or in 2019 (after 4 years) in South West Victoria, Australia. Data were collected from participating primary schools in April to June of 2015 (73% school participation rate), 2017 (69%), and 2019 (63%). Student participation rates were 80% in 2015 (1,792/2,516 invited), 81% in 2017 (2,411/2,963), and 79% in 2019 (2,177/2,720). Repeat cross-sectional analyses of measured height and weight (grades two, four, and six [aged approximately 7 to 12 years]), self-reported behavior, and HRQoL (grades four and six) were conducted. Results There was an intervention by time interaction in BMI z scores (P = 0.031) and obesity/overweight prevalence (P = 0.006). BMI z score and overweight/obesity prevalence decreased between 2015 and 2017 and increased between 2017 and 2019 in intervention communities. The intervention significantly reduced takeaway food consumption (P = 0.034) and improved physical (P = 0.019), psychosocial (P = 0.026), and global (P = 0.012) HRQoL. Water consumption increased among girls (P = 0.033) in the intervention communities, as did energy-dense, nutrient-poor snack consumption among boys (P = 0.006). Conclusions WHO STOPS had a positive impact on takeaway food intake and HRQoL.

Objective:To evaluate the effectiveness of a multicomponent intervention (MCI) on children’s dietary diversity and its impact pathway components of children’s food knowledge and healthy food preferences.Design:A 6-week cluster randomised controlled trial with a MCI consisting of child nutrition education plus family engagement through parental nutrition education, meal preparation and tasting was compared with two groups: single component intervention (SCI) of child nutrition education, and control, conducted during February to July 2018. Preschool centres were randomly assigned to one of the three arms. Children’s food knowledge, healthy food preferences and dietary diversity scores were collected. Intervention effects were analysed using a pre-post analysis and a difference-in-difference model.Setting:Fourteen preschool centres in an urban area of Kurunegala, Sri Lanka.Participants:Child–parent dyads of children aged 4–6 years. Final analyses included 306 (for food knowledge and preferences) and 258 (for dietary diversity) dyads.Results:MCI significantly influenced the impact pathways to children’s dietary diversity by increasing children’s food knowledge and healthy food preferences scores by 3·76 and 2·79 (P < 0·001), respectively, but not the dietary diversity score (P = 0·603), compared with the control arm. Relative to SCI, MCI significantly improved children’s food knowledge score by 1·10 (P < 0·001), but no significant effects were noted for other outcome variables.Conclusions:Improved food knowledge and preferences require a positive food environment and time to develop into healthy eating behaviours. Research into dietary diversity should broaden to incorporate the contextual roles of the home and general food environments to more completely understand food choices of children.

Background Moderate to severe pain has been frequently reported in hospitalized older adults. Pain in hospitalized persons with dementia within the context of other common symptoms, functional decline, delirium, and behavioral and psychological symptoms of dementia (BPSD), has received little attention. Aims Describe the incidence of pain, the pharmacologic management of pain, and the association of pain with physical function, delirium, and BPSD in hospitalized persons with dementia. Design Descriptive, cross-sectional study. Setting Six medical units in three hospitals. Participants Baseline data from 299 hospitalized persons with dementia enrolled in the Family-centered Function-focused Care (Fam-FFC) cluster randomized trial. Methods Descriptive analyses of pain used the Pain Assessment in Advanced Dementia (PAINAD) scale and the use of medication for pain management. Linear regression analyses tested relationships between pain and:1) physical function (Barthel Index), 2) delirium severity (Confusion Assessment Method Severity Short Form) and 3) BPSD severity (Neuropsychiatric Inventory- Questionnaire). Results The majority of the sample was female (61.9%), non-Hispanic (98%), and Black (53.2%), with a mean age of 81.58 (SD=8.54).Of the 299 patients, 166 (56%) received pain medication. Of the 108 individuals who demonstrated pain, 40% (n=43) did not receive pain medication. When controlling for age, gender, cognition, and comorbidities, pain was significantly associated with function, delirium severity, and BPSD severity. Conclusions Results suggest that pain may be undertreated in hospitalized persons with dementia, and should be considered upon admission to optimize function, decrease delirium, and prevent or decrease BPSD.

Background Incorporating social determinants of health into care delivery for chronic diseases is a priority. Objectives The goal of this study was to evaluate the impact of group medical visits and/or microfinance on blood pressure reduction. Methods The authors conducted a cluster randomized trial with 4 arms and 24 clusters: 1) usual care (UC); 2) usual care plus microfinance (MF); 3) group medical visits (GMVs); and 4) GMV integrated into MF (GMV-MF). The primary outcome was 1-year change in systolic blood pressure (SBP). Mixed-effects intention-to-treat models were used to evaluate the outcomes. Results A total of 2,890 individuals (69.9% women) were enrolled (708 UC, 709 MF, 740 GMV, and 733 GMV-MF). Average baseline SBP was 157.5 mm Hg. Mean SBP declined −11.4, −14.8, −14.7, and −16.4 mm Hg in UC, MF, GMV, and GMV-MF, respectively. Adjusted estimates and multiplicity-adjusted 98.3% confidence intervals showed that, relative to UC, SBP reduction was 3.9 mm Hg (−8.5 to 0.7), 3.3 mm Hg (−7.8 to 1.2), and 2.3 mm Hg (−7.0 to 2.4) greater in GMV-MF, GMV, and MF, respectively. GMV and GMV-MF tended to benefit women, and MF and GMV-MF tended to benefit poorer individuals. Active participation in GMV-MF was associated with greater benefit. Conclusions A strategy combining GMV and MF for individuals with diabetes or hypertension in Kenya led to clinically meaningful SBP reductions associated with cardiovascular benefit. Although the significance threshold was not met in pairwise comparison hypothesis testing, confidence intervals for GMV-MF were consistent with impacts ranging from substantive benefit to neutral effect relative to UC. Incorporating social determinants of health into care delivery for chronic diseases has potential to improve outcomes. (Bridging Income Generation With Group Integrated Care [BIGPIC]; NCT02501746 )

Objectives: The authors aimed to develop a moral intervention and to determine whether it was more effective in preventing doping than an educational (i.e., knowledge-based) intervention; their primary outcome was doping likelihood, and the secondary outcomes were moral identity, moral disengagement, moral atmosphere, and anticipated guilt. Methods: Eligible athletes (N = 303) in the United Kingdom and Greece took part in the study. The authors randomly assigned 33 clubs to either the moral or the educational intervention. They measured outcomes pre- and postintervention and at 3- and 6-month follow-up. Results: Athletes in both interventions in both countries reported lower doping likelihood and moral disengagement and higher guilt from pre- to postintervention. These effects were maintained at the 3- and 6-month follow-ups. There were no effects on moral identity or moral atmosphere. Conclusions: In addition to disseminating information about doping, doping prevention programs should include content that focuses on moral variables.

Background Biannual distribution of azithromycin to children 1–59 months old reduced mortality by 14% in a cluster-randomized trial. The World Health Organization has proposed targeting this intervention to the subgroup of children 1–11 months old to reduce selection for antimicrobial resistance. Here, we describe a trial designed to determine the impact of age-based targeting of biannual azithromycin on mortality and antimicrobial resistance. Methods AVENIR is a cluster-randomized, placebo-controlled, double-masked, response-adaptive large simple trial in Niger. During the 2.5-year study period, 3350 communities are targeted for enrollment. In the first year, communities in the Dosso region will be randomized 1:1:1 to 1) azithromycin 1–11: biannual azithromycin to children 1–11 months old with placebo to children 12–59 months old, 2) azithromycin 1–59: biannual azithromycin to children 1–59 months old, or 3) placebo: biannual placebo to children 1–59 months old. Regions enrolled after the first year will be randomized with an updated allocation based on the probability of mortality in children 1–59 months in each arm during the preceding study period. A biannual door-to-door census will be conducted to enumerate the population, distribute azithromycin and placebo, and monitor vital status. Primary mortality outcomes are defined as all-cause mortality rate (deaths per 1000 person-years) after 2.5 years from the first enrollment in 1) children 1–59 months old comparing the azithromycin 1–59 and placebo arms, 2) children 1–11 months old comparing the azithromycin 1–11 and placebo arm, and 3) children 12–59 months in the azithromycin 1–11 and azithromycin 1–59 arms. In the Dosso region, 50 communities from each arm will be followed to monitor antimicrobial resistance. Primary resistance outcomes will be assessed after 2 years of distributions and include 1) prevalence of genetic determinants of macrolide resistance in nasopharyngeal samples from children 1–59 months old, and 2) load of genetic determinants of macrolide resistance in rectal samples from children 1–59 months old. Discussion As high-mortality settings consider this intervention, the results of this trial will provide evidence to support programmatic and policy decision-making on age-based strategies for azithromycin distribution to promote child survival. Trial registration This trial was registered on January 13, 2020 (clinicaltrials.gov: NCT04224987).

Background Central line-associated bloodstream infections (CLABSIs) result in approximately 28,000 deaths and approximately $2.3 billion in added costs to the U.S. healthcare system each year, and yet, many of these infections are preventable. At two large health systems in the southeast United States, CLABSIs continue to be an area of opportunity. Despite strong evidence for interventions to prevent CLABSI and reduce associated patient harm, such as use of chlorhexidine gluconate (CHG) bathing, the adoption of these interventions in practice is poor. The primary objective of this study was to assess the effect of a tailored, multifaceted implementation program on nursing staff’s compliance with the CHG bathing process and electronic health record (EHR) documentation in critically ill patients. The secondary objectives were to examine the (1) moderating effect of unit characteristics and cultural context, (2) intervention effect on nursing staff’s knowledge and perceptions of CHG bathing, and (3) intervention effect on CLABSI rates. Methods A stepped wedged cluster-randomized design was used with units clustered into 4 sequences; each sequence consecutively began the intervention over the course of 4 months. The Grol and Wensing Model of Implementation helped guide selection of the implementation strategies, which included educational outreach visits and audit and feedback. Compliance with the appropriate CHG bathing process and daily CHG bathing documentation were assessed. Outcomes were assessed 12 months after the intervention to assess for sustainability. Results Among the 14 clinical units participating, 8 were in a university hospital setting and 6 were in community hospital settings. CHG bathing process compliance and nursing staff’s knowledge and perceptions of CHG bathing significantly improved after the intervention (p = .009, p = .002, and p = .01, respectively). CHG bathing documentation compliance and CLABSI rates did not significantly improve; however, there was a clinically significant 27.4% decrease in CLABSI rates. Conclusions Using educational outreach visits and audit and feedback implementation strategies can improve adoption of evidence-based CHG bathing practices. Trial registration ClinicalTrials.gov, NCT03898115, Registered 28 March 2019.

Background In a cross-sectional stepped-wedge cluster randomized trial comparing usual care to a new intervention, treatment allocation and time are correlated by design because participants enrolled early in the trial predominantly receive usual care while those enrolled late in the trial predominantly receive the new intervention. Current guidelines recommend adjustment for time effects when analyzing stepped-wedge cluster randomized trials to remove the confounding bias induced by this correlation. However, adjustment for time effects impacts study power. Within the Frequentist framework, adopting a sample size calculation that includes time effects would ensure the trial having adequate power regardless of the magnitude of the effect of time on the outcome. But if in fact time effects were negligible, this would overestimate the required sample size and could lead to the trial being deemed infeasible due to cost or unavailability of the required numbers of clusters or participants. In this study, we explore the use of prior information on time effects to potentially reduce the required sample size of the trial. Methods We applied a Bayesian approach to incorporate the prior information on the time effects into cluster-level statistical models (for continuous, binary, or count outcomes) for the stepped-wedge cluster randomized trial. We conducted simulations to illustrate how the bias in the intervention effect estimate and the trial power vary as a function of the prior precision and the mis-specification of the prior means of the time effects in an example scenario. Results When a nearly flat prior for the time effects was used, the power or sample size calculated using the Bayesian approach matched the result obtained using the Frequentist approach with time effects included. When a highly precise prior for the time effects (with accurately specified prior means) was used, the Bayesian result matched the Frequentist result obtained with time effects excluded. When the prior means of the time effects were nearly correctly specified, including this information improved the efficiency of the trial with little bias introduced into the intervention effect estimate. When the prior means of the time effects were greatly mis-specified and a precise prior was used, this bias was substantial. Conclusion Including prior information on time effects using a Bayesian approach may substantially reduce the required sample size. When the prior can be justified, results from applying this approach could support the conduct of a trial, which would be deemed infeasible if based on the larger sample size obtained using a Frequentist calculation. Caution is warranted as biased intervention effect estimates may arise when the prior distribution for the time effects is concentrated far from their true values.

Background Measures that better describe “healthy” and sustainable recovery during nutritional treatment of children with moderate acute malnutrition (MAM) are needed. Objectives We compared changes to body composition among children receiving 1 of 4 specialized nutritious food (SNFs) during treatment of MAM and by recovery and relapse outcomes. Methods The study was nested within a prospective, cluster-randomized, community-based, cost-effectiveness trial assessing 4 SNFs to treat children aged 6–59 mo with MAM [midupper arm circumference (MUAC) ≥11.5 cm and

Background: Falls are a significant health problem and the most common cause of injuries in older people. Different types of exercise have been recommended to prevent falls, including balance exercise and range of motion. However, there is a lack of evidence to compare the effect of the two exercises.Purpose: This study aimed to compare the effect of Balance Strategy Exercise (BSE) and Lower Limb-Range of Motion (ROM) exercise on reducing the risk of falls among older people living in long-term care facilities. Methods: This was a quasi-experimental study using a pre-post design without a control group. A total of 30 older adults from two nursing homes who met the inclusion and exclusion criteria participated in the study. A cluster randomization technique was used to assign the older people into either BSE or Lower-Limb ROM groups evenly. Treatment was given for 30 minutes per session, three sessions per week for three weeks. The risk of falls was measured using the Timed Up and Go (TUG) test. The paired t-test, Wilcoxon and Mann-Whitney U-test were used to analyze the data. Results: Results showed significant differences in the TUG scores before and after the intervention within both the BSE (p=0.001) and the Lower Limb-ROM group (p=0.001). However, the Lower Limb-ROM group demonstrated a significantly higher reduction in TUG score than the BSE group after the intervention (p=0.008).Conclusion: Lower Limb-ROM exercise is better to reduce the risk of falls among older people living in institutional care than BSE. This exercise can be applied as part of a fall prevention program in nursing homes.

To determine the effects of Chinese medicine (CM) involving triple rehabilitation therapy (中医三联康复疗法) on the progression of knee osteoarthritis (KOA). A total of 722 patients recruited from 38 community health service centers located in China from March 2013 to March 2017 were randomly divided into treatment and control groups equally, using a cluster randomization design. Health education combined with CM involving triple rehabilitation therapy for KOA (electro-acupuncture, Chinese medicinal herb fumigating-washing, and traditional exercises) was administered in the treatment group while conventional rehabilitation therapy (physical factor therapy, joint movement training, and muscle strength training) was administered in the control group. Patients with a visual analog scale (VAS) scores ≽4 were treated with dispersible meloxicam tablets (7.5 mg, once daily). The Lequesne index scores, VAS scores, range of motion (ROM), lower limb muscle strength, knee joint circumference, quantitative scores of KOA symptoms, and the short-form 36 item health survey questionnaire (SF-36) scores were measured for each patient at 5 checkpoints (before treatment, at the 2nd week and the 4th week during the 4-week treatment period, at 1 month and 3 months after end of treatment), and adverse reactions were observed also. A total of 696 patients completed the entire process, with 351 in the treatment group and 345 in the control group. At all treatment checkpoints, the treatment group demonstrated better outcomes than the control group with regard to the total Lequesne index scores, effective rate and improvement rate of the total Lequesne index scores, VAS scores, lower limb muscle strength, knee circumference, quantitative scores of KOA symptoms, and SF-36 scores as well (P

Justice-involved youth are at a higher risk of negative outcomes from sexual activity and alcohol use relative to their non-justice involved peers. In the current study, we tested the extent to which variability in neurocognitive response (i.e., activation in the right superior parietal lobule; rSPL) during a risky decision-making task moderated the success of a sexual risk reduction intervention. In a cluster randomized trial blocked by gender, justice-involved adolescents (N = 269) first completed a risky decision-making task during a magnetic resonance imaging (MRI) session, then were assigned to an information-only control (GINFO) or sexual risk reduction intervention incorporating alcohol risk reduction content (GPI + GMET) and then re-contacted every three months for one year. Youth in the GPI + GMET intervention reported less sexual risk behavior 12 months after intervention than those in the control. Although neurocognitive activation was associated with sexual risk behavior, it did not moderate intervention outcomes. This risk-reduction intervention appears to work equally well across a range of neurocognitive responses.

BACKGROUND: This study assessed the measurement properties of two commonly used self-report physical activity (PA) measures: the International Physical Activity Questionnaire-Short Form (IPAQ-SF) and the Physical Activity Scale for the elderly (PASE) in adults with osteoarthritis. METHODS: Secondary analysis of the MOSAICS cluster randomised controlled trial baseline and 3-month follow-up questionnaires, total scores and subdomains of the IPAQ-SF and PASE were compared. Intra-class correlations (ICC) were used to assess test-retest reliability, measurement error was assessed using standard error of measurement (SEM), smallest detectable change (SDC) and 95% limits of agreement (LoA). Responsiveness was assessed using effect size (ES), standard responsive measurement (SRM) and response ratio (RR). RESULTS: There was moderate correlation (r = 0.56) between the total IPAQ-SF scores (score ranges 0-16,398) and the total PASE scores (score ranges 0-400). Subdomain correlations were also moderate (ranges 0.39-0.57). The PASE showed greater reliability compared to the IPAQ-SF (ICC = 0.68; 0.61-0.74 95% CI and ICC = 0.64; 0.55-0.72, respectively). Measurement errors in both measures were large: PASE SEM = 46.7, SDC = 129.6 and 95% LoA ranges = -117 to 136, the IPAQ-SF SEM = 3532.2 METS-1 min-1 week , SDC = 9790.8 and 95% LoA ranges = -5222 to 5597. Responsiveness was poor: ES -0.14 and -0.16, SRM -0.21 and -0.21, and RR 0.12 and 0.09 for the IPAQ-SF and PASE, respectively. DISCUSSION: The IPAQ-SF and PASE appear limited in reliability, measurement error and responsiveness. Researchers and clinicians should be aware of these limitations, particularly when comparing different levels of PA and monitoring PA levels changes over time in those with osteoarthritis.

Background/Aim In clinical trials, there is potential for bias from unblinded observers that may influence ascertainment of outcomes. This issue arose in the Strategies to Reduce Injuries and Develop Confidence in Elders trial, a cluster randomized trial to test a multicomponent intervention versus enhanced usual care (control) to prevent serious fall injuries, originally defined as a fall injury leading to medical attention. An unblinded nurse falls care manager administered the intervention, while the usual care arm did not involve contact with a falls care manager. Thus, there was an opportunity for falls care managers to refer participants reporting falls to seek medical attention. Since this type of observer bias could not occur in the usual care arm, there was potential for additional falls to be reported in the intervention arm, leading to dilution of the intervention effect and a reduction in study power. We describe the clinical basis for ascertainment bias, the statistical approach used to assess it, and its effect on study power. Methods The prespecified interim monitoring plan included a decision algorithm for assessing ascertainment bias and adapting (revising) the primary outcome definition, if necessary. The original definition categorized serious fall injuries requiring medical attention into Type 1 (fracture other than thoracic/lumbar vertebral, joint dislocation, cut requiring closure) and Type 2 (head injury, sprain or strain, bruising or swelling, other). The revised definition, proposed by the monitoring plan, excluded Type 2 injuries that did not necessarily require an overnight hospitalization since these would be most subject to bias. These injuries were categorized into those with (Type 2b) and without (Type 2c) medical attention. The remaining Type 2a injuries required medical attention and an overnight hospitalization. We used the ratio of 2b/(2b + 2c) in intervention versus control as a measure of ascertainment bias; ratios > 1 indicated the likelihood of falls care manager bias. We determined the effect of ascertainment bias on study power for the revised (Types 1 and 2a) versus original definition (Types 1, 2a, and 2b). Results The estimate of ascertainment bias was 1.14 (95% confidence interval: 0.98, 1.30), providing evidence of the likelihood of falls care manager bias. We estimated that this bias diluted the hazard ratio from the hypothesized 0.80 to 0.86 and reduced power to under 80% for the original primary outcome definition. In contrast, adapting the revised definition maintained study power at nearly 90%. Conclusion There was evidence of ascertainment bias in the Strategies to Reduce Injuries and Develop Confidence in Elders trial. The decision to adapt the primary outcome definition reduced the likelihood of this bias while preserving the intervention effect and study power.

Background It is reported that the longer-term outcomes for stroke survivors are poor, with a range of unmet needs identified. Objectives The aims were to develop and test a longer-term stroke care strategy focused on improving the quality of life of stroke survivors and their carers by addressing unmet needs, and maintenance and enhancement of participation (i.e. involvement in life situations). Design Five overlapping workstreams were undertaken – (1) refinement of content by semistructured interviews with stroke survivors and their carers and by a review of the literature to inform content and delivery of the care strategy; (2) exploration of service models by national survey and focus groups with purposely selected services; (3) intervention development by interaction with a reference group of stroke survivors, carers, and health and social care professionals; (4) refinement and pilot implementation of the developed intervention in three stroke services (case studies); and (5) a cluster randomised controlled feasibility trial in 10 stroke services across England and Wales. Setting The intervention development work and feasibility trial were in stroke services (inclusive of primary, secondary, community and social care provision) across England and Wales. Participants Participants were stroke survivors resident in the community and their carers, and health and social care professionals in the included stroke services. Data sources Interviews with 28 stroke survivors and their carers at least 9 months post stroke ascertained their needs and the barriers to and facilitators of addressing those needs. Additional literature reviews identified 23 needs. No evidence-based interventions to address these needs were reported; self-management was highlighted as a possible delivery mechanism. In workstream 2, a national survey revealed that the most common model of stroke service provision was care up to 12 months post stroke, reported by 46 (40%) services. Thirty-five (30%) services provided care up to 6 months post stroke and 35 (30%) provided care beyond 12 months, thus identifying 6 months post stroke as an appropriate delivery point for a new intervention. Through focus groups in a range of services, stroke survivors’ perceived unmet needs and the barriers to and enablers of service provision were identified. Intervention Using information obtained in workstreams 1 and 2 and working closely with a stakeholder reference group, we developed an intervention based on the unmet needs prioritised by stroke survivors and their carers (workstream 3). In workstream 4, action groups (clinicians, stroke survivors and researchers) were established in three stroke services that led implementation in their service and contributed to the iterative refinement of the intervention, associated training programme and implementation materials. The intervention (called New Start) was delivered at 6 months post stroke. Key components were problem-solving self-management with survivors and carers, help with obtaining usable information, and helping survivors and their carers build sustainable, flexible support networks. Results A cluster randomised feasibility trial (workstream 5) was successfully implemented in 10 stroke services across England and Wales, with associated process and health economic evaluations. Five services were randomised to provide New Start, while five continued with usual care; 269 participants were recruited. Progression criteria – in terms of our pre-determined (red, amber, green) criteria for progress to a full trial: target stroke survivor recruitment rates were achieved, on average, across sites (24.1 per site over 6 months, green); 216 (80.3%) registered stroke survivors returned follow-up questionnaires at 9 months (84.1% in the intervention arm and 75.8% in the usual care arm, green); according to data reported by sites, overall, 95.2% of registered stroke survivors were offered at least one session of the intervention (green); all five intervention sites had at least two facilitators deemed competent, delivered the New Start intervention and provided it to stroke survivors (green). However, at some sites, there were concerns regarding the number of stroke survivors being offered, accepting and receiving the intervention. Only small differences in outcomes and costs were observed between the New Start and usual care groups, and considerable uncertainty around the cost-effectiveness remains. Conclusions We report a complex programme of work that has described the longer-term needs of stroke survivors and highlighted evidence and service gaps. Working closely with stroke survivors, an intervention was developed that has been refined in three services and feasibility tested in a cluster randomised controlled trial. Further refinement of the target population and optimisation of the intervention materials is required prior to a full randomised controlled trial evaluation. Future work Optimisation of the intervention, and clearer specification of recipients, are required prior to a full trial evaluation. Trial registration Current Controlled Trials ISRCTN38920246. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 3. See the NIHR Journals Library website for further project information.

Background The first step in improving interprofessional teamwork entails training health professionals (HP) to acknowledge the role and value the contribution of each member of the team. The International Classification of Functioning, Disability and Health (ICF) has been developed by WHO to provide a common language to facilitate communication between HPs. Objective To determine whether ICF training programme would result in improved knowledge and attitudes regarding interprofessional practice within Rwandan district hospitals. Design, setting and participants A cluster randomised, single blinded, control trial design was used to select four district hospitals. Participants included physicians, social workers, physiotherapists, nutritionists, clinical psychologists/mental health nurses. Intervention Health professionals either received one day’s training in interprofessional practice (IPP) based on the ICF (experimental group) as a collaborative framework or a short talk on the topic (control group). Outcome measures Validated questionnaires were used to explore changes in knowledge and attitudes. Ethical approval was obtained from the relevant authorities. Results There were 103 participants in the experimental and 100 in the control group. There was no significant difference between Knowledge and Attitude scales at baseline. Post-intervention the experimental group (mean = 41.3, SD = 9.5) scored significantly higher on the knowledge scale than the control group (mean = 17.7, SD = 4.7 (t = 22.5; p Conclusion The ICF proved to be a useful framework for structuring the training of all HPs in IPP and the training resulted in a significant improvement in knowledge and attitudes regarding IPP. As suggested by the HPs, more training and refresher courses were needed for sustainability and the training should be extended to other hospitals in Rwanda. It is thus recommended that the framework can be used in interprofessional education and practice in Rwanda and possibly in other similar countries. Trial registration Name of the registry: Pan African Clinical Trial Registry. Trial registration number:PACTR201604001185358. Date of registration: 22/04/2016. URL of trial registry record:www.pactr.org

Background Sexual problems of intellectually disabled adolescents are associated with their inability to understand sexuality. Given the important role of parents in forming the attitude of their adolescents towards sexuality, the present study aimed to compare the effect of two educational interventions on mothers’ awareness, attitude and self-efficacy regarding sexual health care of intellectually disabled adolescent girls. Materials and methods This cluster randomized control trial was conducted in six intellectually disabled adolescent education centers in Isfahan, Iran in 2018. The centers were randomly assigned to intervention groups (group training and training through booklet) and control group. Mothers of educable intellectually disabled adolescent girls (n = 81) were entered into the three groups using convenience sampling and their awareness, attitude and self-efficacy regarding sexual health care of adolescent girls were assessed using questionnaires before and after the educational intervention. Data were analyzed using descriptive and inferential statistical methods. Results The mean score of mothers’ awareness, attitude and self-efficacy in each of the “group training”, “training through booklet group” and “control group” was significantly different after the intervention compared to before the intervention (p 0.05). Conclusion Implementation of the group training intervention for mothers of intellectually disabled adolescent girls in comparison with training through booklet was associated with a greater increase in their awareness, attitude and self-efficacy regarding sexual health care of adolescent girls. Therefore, group training is suggested as a suitable way to educate mothers about sexual health care of intellectually disabled adolescent girls. Trial registration IRCT, IRCT20160224026756N5. Registered 22 June 2018, https://en.irct.ir/user/trial/31704/view.

Background: Depression is common in nursing homes, particularly among newly admitted residents. This cluster randomised controlled trial evaluated the effectiveness of the Program to Enhance Adjustment to Residential Living (PEARL) in reducing depression in this group. Methods: Participants were 219 newly-admitted residents (mean of 4.4 weeks since admission) in 42 nursing homes in Melbourne, Australia, with a mean age of 85.5 years (SD = 7.3). Nursing homes were randomly allocated to the intervention or standard care condition. Level of depressive symptoms was evaluated at baseline (T1), one week post- intervention (T2), 2 months post-intervention (T3, primary end point), and 6 months post-intervention (T4). Changes in depressive symptoms in the intervention and control groups over time were compared using a multilevel model, with nursing homes modelled as random intercept. Results: In intention to treat analyses, depressive symptoms reduced from T1 to T3 to a greater degree in the intervention condition (Mchange=2.56, SDchange=5.71) than in the control (Mchange=0.63, SDchange=5.25), with a significant, small-medium treatment effect size (p=.035; Cohen's d=0.36). The reduction in depressive symptoms from T1 to T4 was not significant (p=.369; Cohen's d=0.32). Limitations: The findings require replication, particularly comparing PEARL with an active control condition. Conclusions: PEARL is a simple, brief program that was effective in reducing symptoms of depression in newly admitted nursing home residents.

Background Around 1 in 7 people in India are impacted by mental illness. The treatment gap for people with mental disorders is as high as 75–95%. Health care systems, especially in rural regions in India, face substantial challenges to address these gaps in care, and innovative strategies are needed. Methods We hypothesise that an intervention involving an anti-stigma campaign and a mobile-technology-based electronic decision support system will result in reduced stigma and improved mental health for adults at high risk of common mental disorders. It will be implemented as a parallel-group cluster randomised, controlled trial in 44 primary health centre clusters servicing 133 villages in rural Andhra Pradesh and Haryana. Adults aged ≥ 18 years will be screened for depression, anxiety and suicide based on Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorders (GAD-7) scores. Two evaluation cohorts will be derived—a high-risk cohort with elevated PHQ-9, GAD-7 or suicide risk and a non-high-risk cohort comprising an equal number of people not at elevated risk based on these scores. Outcome analyses will be conducted blinded to intervention allocation. Expected outcomes The primary study outcome is the difference in mean behaviour scores at 12 months in the combined ‘high-risk’ and ‘non-high-risk’ cohort and the mean difference in PHQ-9 scores at 12 months in the ‘high-risk’ cohort. Secondary outcomes include depression and anxiety remission rates in the high-risk cohort at 6 and 12 months, the proportion of high-risk individuals who have visited a doctor at least once in the previous 12 months, and change from baseline in mean stigma, mental health knowledge and attitude scores in the combined non-high-risk and high-risk cohort. Trial outcomes will be accompanied by detailed economic and process evaluations. Significance The findings are likely to inform policy on a low-cost scalable solution to destigmatise common mental disorders and reduce the treatment gap for under-served populations in low-and middle-income country settings. Trial registration Clinical Trial Registry India CTRI/2018/08/015355. Registered on 16 August 2018.