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Study setting

Item 9: Description of study settings (e.g., community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained.

Example

“Selection of Countries

. . . To detect an intervention-related difference in HIV incidences with the desired power, the baseline incidences at the sites must be sufficiently high. We chose the participating sites so that the average baseline annual incidence across all communities in the study is likely to reach at least 3%. The various sites in sub-Saharan Africa met this criterion, but we also wanted sites in Asia to extend the generalizability of the intervention. The only location in Asia with sufficient incidence at the community level is in ethnic minority communities in Northern Thailand, where HIV incidence is currently in excess of 7%;[Reference X] thus they were invited to participate as well. Our final selection of sites combines rural (Tanzania, Zimbabwe, Thailand, and KwaZulu-Natal) and an urban (Soweto) location. The cultural circumstances between the sub-Saharan African sites vary widely . . .

Definition of Community

Each of the three southern African sites (Harare, Zimbabwe; and Soweto and Vulindlela, South Africa) selected eight communities, the East African (Tanzanian) site selected 10 communities, and Thailand selected 14 communities . . . They are of a population size of approximately 10,000 . . . which fosters social familiarity and connectedness, and they are geographically distinct. Communities are defined primarily geographically for operational purposes for the study, taking into account these dimensions of social communality. The communities chosen within each country and site are selected to be sufficiently distant from each other so that there would be little cross-contamination or little possibility that individuals from a control community would benefit from the activities in the intervention community.” 113

Explanation

A description of the environment in which a trial will be conducted provides important context in terms of the applicability of the study results; the existence and type of applicable local regulation and ethics oversight; and the type of healthcare and research infrastructure available. These considerations can vary substantially within and between countries.

At a minimum, the countries, type of setting (e.g., urban versus rural), and the likely number of study sites should be reported in the protocol. These factors have been associated with recruitment success and degree of attrition for some trials,68;91;92;114-117 but not for others.118;119 Trial location has also been associated with trial outcome,120 aspects of trial quality (e.g., authenticity of randomisation121), and generalisability.122

8: Trial design 10: Eligibility criteria
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