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Table 1 Key features of the two community based case studies

From: When they see us, it’s like they have seen the benefits!”: experiences of study benefits negotiations in community-based studies on the Kenyan Coast

Feature The RSV-study The Malaria-study
Study question/objective Define and quantify who acquires infection from whom in relation to transmission of respiratory syncytial virus (RSV) in households. Evaluate the efficacy of a ‘promising’ malaria candidate vaccine against malaria disease in infants and children, and across diverse malaria transmission settings in Africa; aimed to address key safety and efficacy information required for vaccine licensure.
Study design Basic science descriptive study. Double blind (observer blind), randomized, controlled, multi-centre study.
Study period Oct 2009 – June 2010; participant involvement for 6 months. 2008 – 2013 (later extended to 2015); participant involvement for 34 months.
Number of study sites One site in KEMRI-WT, Kilifi. Eleven sites in seven African countries.
Study area in Kilifi One location, 15 kms from the Kilifi County Hospital (KCH), within KHDSS. Three administrative divisions, 30 kms from KCH, 5 locations, in Kilifi County.
Composition of study team A total of 16 team members; Minimum of 47 staff;
• 10 FWs, 2 data entry clerks, one each SFW, clinician, coordinator, PI and senior researcher, • 36 FWs, 3 SFWs, 3 clinicians, 2 Medical officers, and one each of study coordinator, PI and senior researcher;
• Team also included shared staff (lab technicians, drivers) with other projects. • Team also included shared staff (data entry clerks, lab technicians, and drivers) with other projects.
Participants Entire household in a defined geographic locality; household - where members living in the same compound and with a common eating arrangement e.g. share meals made from the same kitchen. HH selected if had an infant born after previous RSV epidemic; and at least one elder sibling. Children aged 6-12 weeks and 5-17 months at first vaccination; 16,000 children across the 11 sites, a minimum of 6,000 in each of the age category;
For Kilifi site, allocated total of 900 children, 600 and 300 in the 5-17 months 6-12 weeks group respectively.