Infectious Diseases - Research Publications

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Author: Biggs, Beverley-Ann × Author: Hipgrave, David × Author: Tran, Thach × Type: Journal Article ×

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    Protocol for an economic evaluation alongside a cluster randomised controlled trial: cost-effectiveness of Learning Clubs, a multicomponent intervention to improve women's health and infant's health and development in Vietnam
    Nguyen, T ; Sweeny, K ; Tran, T ; Luchters, S ; Hipgrave, DB ; Hanieh, S ; Tran, T ; Tran, H ; Biggs, B-A ; Fisher, J (BMJ PUBLISHING GROUP, 2019-12)
    INTRODUCTION: Economic evaluations of complex interventions in early child development are required to guide policy and programme development, but a few are yet available. METHODS AND ANALYSIS: Although significant gains have been made in maternal and child health in resource-constrained environments, this has mainly been concentrated on improving physical health. The Learning Clubs programme addresses both physical and mental child and maternal health. This study is an economic evaluation of a cluster randomised controlled trial of the impact of the Learning Clubs programme in Vietnam. It will be conducted from a societal perspective and aims to identify the cost-effectiveness and the economic and social returns of the intervention. A total of 1008 pregnant women recruited from 84 communes in a rural province in Vietnam will be included in the evaluation. Health and cost data will be gathered at three stages of the trial and used to calculate incremental cost-effectiveness ratios per percentage point improvement of infant's development, infant's health and maternal common mental disorders expressed in quality-adjusted life years gained. The return on investment will be calculated based on improvements in productivity, the results being expressed as benefit-cost ratios. ETHICS AND DISSEMINATION: The trial was approved by Monash University Human Research Ethics Committee (Certificate Number 2016-0683), Australia, and approval was extended to include the economic evaluation (Amendment Review Number 2018-0683-23806); and the Institutional Review Board of the Hanoi School of Public Health (Certificate Number 017-377IDD- YTCC), Vietnam. Results will be disseminated through academic journals and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12617000442303.
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    Protocol for a process evaluation of a cluster randomized controlled trial of the Learning Club intervention for women's health, and infant's health and development in rural Vietnam
    Fisher, J ; Trang, N ; Thach, DT ; Ha, T ; Tuan, T ; Luchters, S ; Hipgrave, D ; Hanieh, S ; Biggs, B-A (BMC, 2019-07-23)
    BACKGROUND: Learning Clubs is a multi-component intervention to address the eight common risk factors for women's health, and infant's health and development in resource-constrained settings. We are testing in a cluster randomized controlled trial in rural Vietnam whether this intervention improves cognitive development in children when they are aged two. There are few comprehensive process evaluations of complex interventions to optimise early childhood development. The aim is to conduct a planned process evaluation of the Learning Clubs intervention in Vietnam. METHODS: The evaluation will be conducted alongside the Learning Clubs trial using both qualitative and quantitative methods. Four domains will be included in the evaluation: [1] Context - how contextual factors affect the implementation and outcomes; [2] Implementation - what aspects of the Learning Clubs intervention are actually delivered and how well the intervention is delivered; [3] Mechanism of impact - how the intervention produces changes in the primary and secondary outcomes; and [4] National integration - how the intervention can be scaled up for application nationally. Purposive sampling will be used to recruit project stakeholders from commune, provincial and national levels. Results of the process evaluation will be integrated with those of the outcome and economic evaluations to provide a comprehensive picture of the effectiveness of the Learning Clubs intervention for early childhood development in rural Vietnam. DISCUSSION: Results of the evaluation will provide evidence about the implementation of the intervention and explanations for any differences in the outcomes between participants in intervention and control conditions. The evaluation will be integrated into each stage of the outcome assessments, but will be implemented by a bilingual team independent of the team implementing the intervention. It will therefore provide evidence which will not be influenced by or influence the intervention and will inform both generalisation to other settings and scalability in Vietnam. TRIAL REGISTRATION: Trial registration number ACTRN12617000442303 on the Australian New Zealand Clinical Trials Registry. Registered 27/03/2017. Prospectively registered.