scholarly journals Disinvestment in the presence of uncertainty: Description of a novel, multi-group, disinvestment trial design and protocol for an application to reduce or cease use of mobilisation alarms for preventing falls in hospitals

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0261793
Author(s):  
Terry P. Haines ◽  
Mari Botti ◽  
Natasha Brusco ◽  
Lisa O’Brien ◽  
Bernice Redley ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Research Approach ◽  
Process Safety ◽  
Stepped Wedge ◽  
Clinical Process ◽  
Patient Falls ◽  
Project Governance ◽  
Cluster Randomised ◽  
Uncertain Evidence ◽  
Hospital Wards

Disinvestment is the removal or reduction of previously provided practices or services, and has typically been undertaken where a practice or service has been clearly shown to be ineffective, inefficient and/or harmful. However, practices and services that have uncertain evidence of effectiveness, efficiency and safety can also be considered as candidates for disinvestment. Disinvestment from these practices and services is risky as they may yet prove to be beneficial if further evidence becomes available. A novel research approach has previously been described for this situation, allowing disinvestment to take place while simultaneously generating evidence previously missing from consideration. In this paper, we describe how this approach can be expanded to situations where three or more conditions are of relevance, and describe the protocol for a trial examining the reduction and elimination of use of mobilisation alarms on hospital wards to prevent patient falls. Our approach utilises a 3-group, concurrent, non-inferiority, stepped wedge, randomised design with an embedded parallel, cluster randomised design. Eighteen hospital wards with high rates of alarm use (≥3%) will be paired within their health service and randomly allocated to a calendar month when they will transition to a “Reduced” (<3%) or “Eliminated” (0%) mobilisation alarm condition. Dynamic randomisation will be used to determine which ward in each pair will be allocated to either the reduced or eliminated condition to promote equivalence between wards for the embedded parallel, cluster randomised component of the design. A project governance committee will set non-inferiority margins. The primary outcome will be rates of falls. Secondary clinical, process, safety, and economic outcomes will be collected and a concurrent economic evaluation undertaken.

scholarly journals PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e023562 ◽  
Author(s):  
Deirdre Hayes-Ryan ◽  
Karla Hemming ◽  
Fionnaula Breathnach ◽  
Amanda Cotter ◽  
Declan Devane ◽  
...  
Keyword(s):  
Growth Factor ◽  
Maternal Morbidity ◽  
Primary Outcome ◽  
Mode Of Delivery ◽  
Randomised Trial ◽  
Placental Growth Factor ◽  
Randomised Control Trial ◽  
Stepped Wedge ◽  
Cluster Randomised ◽  
Maternity Hospitals

IntroductionWomen presenting with suspected pre-eclampsia are currently triaged on the basis of hypertension and dipstick proteinuria. This may result in significant false positive and negative diagnoses resulting in increased morbidity or unnecessary intervention. Recent data suggest that placental growth factor testing may be a useful adjunct in the management of women presenting with preterm pre-eclampsia. The primary objective of this trial is to determine if the addition of placental growth factor testing to the current clinical assessment of women with suspected preterm pre-eclampsia, is beneficial for both mothers and babies.Methods and analysisThis is a multicentre, stepped wedge cluster, randomised trial aiming to recruit 4000 women presenting with symptoms suggestive of preterm pre-eclampsia between 20 and 36+6 weeks’ gestation. The intervention of an unblinded point of care test, performed at enrolment, will quantify maternal levels of circulating plasma placental growth factor. The intervention will be rolled out sequentially, based on randomisation, in the seven largest maternity units on the island of Ireland. Primary outcome is a composite outcome of maternal morbidity (derived from the modified fullPIERS model). To ensure we are not reducing maternal morbidity at the expense of earlier delivery and worse neonatal outcomes, we have established a co-primary outcome which will examine the effect of the intervention on neonatal morbidity, assessed using a composite neonatal score. Secondary analyses will examine further clinical outcomes (such as mode of delivery, antenatal detection of growth restriction and use of antihypertensive agents) as well as a health economic analysis, of incorporation of placental growth factor testing into routine care.Ethics and disseminationEthical approval has been granted from each of the seven maternity hospitals involved in the trial. The results of the trial will be presented both nationally and internationally at conference and published in an international peer-reviewed journal.Trial registration numberNCT02881073.

scholarly journals Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare trial): study protocol for a stepped-wedge cluster randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Carina King ◽  
Malini Pires ◽  
Naveed Ahmed ◽  
Kohenour Akter ◽  
Abdul Kuddus ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Stepped Wedge ◽  
Community Based ◽  
Participatory Learning ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
And Control

Abstract Background An estimated 463 million people globally have diabetes, with the prevalence growing in low-and middle-income settings, such as Bangladesh. Given the need for context-appropriate interventions to prevent type 2 diabetes mellitus (T2DM), the ‘Diabetes: Community-led Awareness, Response and Evaluation’ (D:Clare) trial will rigorously evaluate the replication and scale-up of a participatory learning and action (PLA) cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control. Methods This is a stepped-wedge cluster randomised controlled trial, with integrated process and economic evaluations, conducted from March 2020 to September 2022. The trial will evaluate a community-based four-phase PLA cycle intervention focused on prevention and control of T2DM implemented over 18 months, against a control of usual care. Twelve clusters will be randomly allocated (1:1) to implement the intervention at project month 1 or 12. The intervention will be evaluated through three cross-sectional surveys at months 1, 12 and 24. The trial will be conducted in Alfadanga Upazila, Faridpur district, with an estimated population of 120,000. Clusters are defined as administrative geographical areas, with approximately equal populations. Each of the six unions in Alfadanga will be divided into two clusters, forming 12 clusters in total. Given the risk of inter-cluster contamination, evaluation surveys will exclude villages in border areas. Participants will be randomly sampled, independently for each survey, from a population census conducted in January 2020. The primary outcome is the combined prevalence of intermediate hyperglycaemia and T2DM, measured through fasting and 2-h post-glucose load blood tests. A total of 4680 participants provide 84% power to detect a 30% reduction in the primary outcome, assuming a baseline of 30% and an ICC of 0.07. The analysis will be by intention-to-treat, comparing intervention and control periods across all clusters, adjusting for geographical clustering. Discussion This study will provide further evidence of effectiveness for community-based PLA to prevent T2DM at scale in a rural Bangladesh setting. However, we encountered several challenges in applying the stepped-wedge design to our research context, with particular consideration given to balancing seasonality, timing and number of steps and estimation of partial versus full effect. Trial registration ISRCTN: ISRCTN42219712. Registered on 31 October 2019

scholarly journals Peer reviewed evaluation of registered end-points of randomised trials (the PRE-REPORT study): protocol for a stepped-wedge, cluster-randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028694
Author(s):  
Christopher W Jones ◽  
Amanda Adams ◽  
Mark A Weaver ◽  
Sara Schroter ◽  
Benjamin S Misemer ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Peer Review ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Selective Outcome Reporting ◽  
Outcome Reporting ◽  
Cluster Randomised ◽  
Peer Reviewers

IntroductionClinical trials are critical to the advancement of medical knowledge. However, the reliability of trial conclusions depends in part on consistency between pre-planned and reported study outcomes. Unfortunately, selective outcome reporting, in which outcomes reported in published manuscripts differ from pre-specified study outcomes, is common. Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts. However, the persistently high rate of selective outcome reporting among published clinical trials indicates that the current peer review process at most journals does not effectively address the problem of selective outcome reporting.Methods and analysisPRE-REPORT is a stepped-wedge cluster-randomised trial that will test whether providing peer reviewers with a summary of registered, pre-specified primary trial outcomes decreases inconsistencies between prospectively registered and published primary outcomes. Peer reviewed manuscripts describing clinical trial results will be included. Eligible manuscripts submitted to each participating journal during the study period will comprise each cluster. After an initial control phase, journals will transition to the intervention phase in random order, after which peer reviewers will be emailed registry information consisting of the date of registration and any prospectively defined primary outcomes. Blinded outcome assessors will compare registered and published primary outcomes for all included trials. The primary PRE-REPORT outcome is the presence of a published primary outcome that is consistent with a prospectively defined primary outcome in the study’s trial registry. The primary outcome will be analysed using a mixed effect logistical regression model to compare results between the intervention and control phases.Ethics and disseminationThe Cooper Health System Institutional Review Board determined that this study does not meet criteria for human subject research. Findings will be published in peer-reviewed journals.Trial registration numberISRCTN41225307; Pre-results.

scholarly journals Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e033640 ◽  
Author(s):  
R I Helou ◽  
Gaud Catho ◽  
Annabel Peyravi Latif ◽  
Johan Mouton ◽  
M Hulscher ◽  
...  
Keyword(s):  
Antimicrobial Stewardship ◽  
Professional Training ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Great Promise ◽  
Antimicrobial Use ◽  
Stepped Wedge ◽  
Cluster Randomised ◽  
The Impact

IntroductionWith the widespread use of electronic health records and handheld electronic devices in hospitals, informatics-based antimicrobial stewardship interventions hold great promise as tools to promote appropriate antimicrobial drug prescribing. However, more research is needed to evaluate their optimal design and impact on quantity and quality of antimicrobial prescribing.Methods and analysisUse of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland. Secondary outcomes will include antimicrobial use metrics, clinical and process outcomes. A multicentre stepped-wedge cluster randomised trial will randomise entities defined as wards or specialty regarding time of introduction of the intervention. We will include 36 hospital entities with seven measurement periods in which the primary outcome will be measured in 15 participating patients per time period per cluster. At participating wards, patients of at least 18 years of age using antimicrobials will be included. After a baseline period of 2-week measurements, six periods of 4 weeks will follow in which the intervention is introduced in 6 wards (in three hospitals) until all 36 wards have implemented the intervention. Thereafter, we allow use of the app by everyone, and evaluate the sustainability of the app use 6 months later.Ethics and disseminationThis protocol has been approved by the institutional review board of each participating centre. Results will be disseminated via media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.Trial registration numberClinicalTrials.gov registry (NCT03793946). Stage; pre-results.

scholarly journals Community Participatory Learning and Action Cycle Groups to Reduce Type 2 Diabetes in Bangladesh (DClare): Study Protocol for a Stepped-Wedge Cluster Randomised Controlled Trial

2021 ◽  
Author(s):  
Carina King ◽  
Malini Pires ◽  
Naveed Ahmed ◽  
Kohenour Akter ◽  
Abdul Kuddus ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Stepped Wedge ◽  
Community Based ◽  
Participatory Learning ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
And Control

Abstract BackgroundAn estimated 463 million people globally have diabetes, with the prevalence growing in low-and middle-income settings, such as Bangladesh. Given the need for context appropriate interventions to prevent type 2 diabetes mellitus (T2DM), the “Diabetes: Community-led Awareness, Response and Evaluation” (D:Clare) trial will rigorously evaluate the replication and scale-up of a participatory learning and action (PLA) cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control. MethodsThis is a stepped-wedge cluster randomised controlled trial, with integrated process and economic evaluations, conducted from March 2020 – September 2022. The trial will evaluate a community-based four-phase PLA cycle intervention focused on prevention and control of T2DM implemented over 18-months, against a control of usual care. Twelve clusters will be randomly allocated (1:1) to implement the intervention at project month 1 or 12. The intervention will be evaluated through three cross-sectional surveys at months 1, 12 and 24. The trial will be conducted in Alfadanga upazila, Faridpur district, with an estimated population of 120,000. Clusters are defined as administrative geographical areas, with approximately equal populations. Each of the six unions in Alfadanga will be divided into two clusters, forming 12 clusters in total. Given the risk of inter-cluster contamination, evaluation surveys will exclude villages in border areas. Participants will be randomly sampled, independently for each survey, from a population census conducted in January 2020. The primary outcome is the combined prevalence of intermediate hyperglycaemia and T2DM, measured through fasting and 2-hour post glucose load blood tests. A total of 4680 participants provides 84% power to detect a 30% reduction in the primary outcome, assuming a baseline of 30% and ICC of 0.07. Analysis will be by intention-to-treat, comparing intervention and control periods across all clusters, adjusting for geographical clustering. DiscussionThis study will provide further evidence of effectiveness for community-based PLA to prevent T2DM at scale in a rural Bangladesh setting. However, we encountered several challenges in applying the step-wedged design to our research context, with particular consideration given to balancing seasonality, timing and number of steps and estimation of partial versus full effect. Trial registrationISRCTN42219712 (https://doi.org/10.1186/ISRCTN42219712). Registration date: 31/10/2019.

scholarly journals Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India

2021 ◽  
Vol 6 (6) ◽  
pp. e003902
Author(s):  
Rachana Parikh ◽  
Adriaan Hoogendoorn ◽  
Daniel Michelson ◽  
Jeroen Ruwaard ◽  
Rhea Sharma ◽  
...  
Keyword(s):  
Mental Health ◽  
Low Income ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
New Delhi ◽  
Stepped Wedge ◽  
Whole School ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionWe evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems.MethodsWe conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents.ResultsBetween 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001).ConclusionA single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India.Trial registration numberNCT03633916.

scholarly journals Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

2021 ◽  
Author(s):  
Sharon A. Simpson ◽  
Elinor Coulman ◽  
Dunla Gallagher ◽  
Karen Jewell ◽  
David Cohen ◽  
...  
Keyword(s):  
Weight Management ◽  
Healthy Eating ◽  
Primary Outcome ◽  
Intervention Group ◽  
Control Group ◽  
Risky Drinking ◽  
Management Intervention ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Weight Management Intervention

Abstract 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 < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. 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.

scholarly journals 141. Implementation of Veterans Affairs Outpatient Antimicrobial Stewardship Interventions for Asymptomatic Bacteriuria and Acute Respiratory Infections, a Stepped Wedge Randomized Study

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S81-S82
Author(s):  
Grace Mortrude ◽  
Mary Rehs ◽  
Katherine Sherman ◽  
Nathan Gundacker ◽  
Claire Dysart
Keyword(s):  
Patient Satisfaction ◽  
Primary Outcome ◽  
Respiratory Infections ◽  
Asymptomatic Bacteriuria ◽  
Educational Interventions ◽  
Antibiotic Prescribing ◽  
Acute Respiratory Infections ◽  
Stepped Wedge ◽  
Post Intervention ◽  
The Impact

Abstract Background Outpatient antimicrobial prescribing is an important target for antimicrobial stewardship (AMS) interventions to decrease antimicrobial resistance in the United States. The objective of this study was to design, implement and evaluate the impact of AMS interventions focused on asymptomatic bacteriuria (ASB) and acute respiratory infections (ARIs) in the outpatient setting. Methods This randomized, stepped-wedge trial evaluated the impact of educational interventions to providers on adult patients presenting to primary care (PC) clinics for ARIs and ASB from 10/1/19 to 1/31/20. Data was collected by retrospective chart review. An antibiotic prescribing report card was provided to PC providers, then an educational session was delivered at each PC clinic. Patient education materials were distributed to PC clinics. Interventions were made in a step-wise (figure 1) fashion. The primary outcome was percentage of overall antibiotic prescriptions as a composite of prescriptions for ASB, acute bronchitis, upper-respiratory infection otherwise unspecified, uncomplicated sinusitis, and uncomplicated pharyngitis. Secondary outcomes included individual components of the primary outcome, a composite safety endpoint of related hospital, emergency department or primary care visit within 4 weeks, antibiotic appropriateness, and patient satisfaction surveys. Figure 1 Results There were 887 patients included for analysis (405 pre-intervention, 482 post-intervention). Baseline characteristics are summarized in table 1. After controlling for type 1 error using a Bonferroni correction the primary outcome was not significantly different between groups (56% vs 49%). There was a statistically significant decrease in prescriptions for bronchitis (20.99% vs 12.66%; p=0.0003). Appropriateness of prescriptions for sinusitis (OR 4.96; CI 1.79–13.75; p=0.0021) and pharyngitis (OR 5.36; CI 1.93 – 14.90; p=0.0013) was improved in the post-intervention group. The composite safety outcome and patient satisfaction survey ratings did not differ between groups. Table 1 Conclusion Multifaceted educational interventions targeting providers can improve antibiotic prescribing for indications rarely requiring antimicrobials without increasing re-visit or patient satisfaction surveys. Disclosures All Authors: No reported disclosures

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

Sign in / Sign up

Export Citation Format

Share Document