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Community-based intervention trials in low- and middle-income countries 

Community-based intervention trials in low- and middle-income countries
Chapter:
Community-based intervention trials in low- and middle-income countries
Author(s):

Zunyou Wu

and Sheena G. Sullivan

DOI:
10.1093/med/9780199218707.003.0035
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date: 19 June 2019

Community intervention trials began to be used in low- and middle-income countries about 20 years ago. Since then, they have been increasingly employed to test interventions that address urgent and preventable public health issues, particularly infectious disease control, neonatal mortality, malnutrition, and unhealthy behaviours. Various methodological considerations need to be considered in the planning, conduct, and analysis of community trials, especially when conducted in low- and middle-income countries. Selection of the study site needs to consider the baseline prevalence of the health problem of interest, the representativeness of the community chosen for the study, and the available resources. Background information is often absent before the trial and can be collected through qualitative research and community consultation. Engagement of the community at all stages of the trial is crucial for success and scale-up. Published trials have typically used pre/post or intervention/control comparisons to measure effectiveness. Where control groups are used and several communities are included in the study, the methodology should consider issues associated with conducting cluster-randomized trials which affect the sample size, statistical power, randomization, and statistical analyses. There are various ethical issues associated with conducting community trials, particularly with regard to obtaining informed consent from individuals versus community leaders, the use of control groups, and the distribution of incentives for participation. The type, intensity, and quality of the intervention must be considered acceptable and culturally sensitive to the communities. Simplicity, affordability, and sustainability of intervention strategies should always be emphasized. Success is often measured by morbidity and mortality rates associated with the disease of interest, but behavioural, psychosocial, environmental, and other indirect measures may also be used. Similarly cohort, cross-sectional or population-level data can be used for evaluation. Because they are often needs-driven, community-based intervention trials conducted in low- and middle-income countries have an enormous potential for scale-up. Scientific robustness of a trial should be maintained as much as possible while taking into account the limitations of working in low- or middle-income settings, including human resource and infrastructure limitations. Most of all, trials should prioritize the development of simple, cheap, effective, and sustainable solutions to health problems to facilitate uptake and use in routine public health work.

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