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Table 2 Study procedures and FW roles in the two 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

  The RSV-study The Malaria-study
Study procedures Follow-up visits at home every 3-4 days; data from each HH member collected at each visit included: Randomisation to one of three groups
• Temperature, • Experimental malaria vaccine and its booster at 1.5 years
• Nasopharyngeal flocked swab (NFS), • Experimental malaria vaccine and a different
• Respiratory illness signs and symptoms, • Booster dose of either Meningitis and
• Respiratory rate taken for all children under 5 years, • Septicaemia vacci;ne; and
• Three doses of rabies vaccine plus a different booster doses of Meningitis and septicaemia;
• Oral swab (taken at alternate visits (once-a-week). • Initial physical examination, medical history, anthropometric tests, temperature.
• Three vaccine doses each a month apart, and
A demographic and risk assessment questionnaire administered at beginning and end of the study. • booster dose at 34 months.
• 5 scheduled blood samples over 3 years; each 2.5mls.
• Monitoring of minor and serious adverse events; immediate post-vaccination and over time.
• 6 consecutive follow-up visits post-vaccination at home. Monitoring of minor and serious adverse events.
• Referral to nearest health facility for common illnesses, and to KCH for serious illnesses as advised by attending clinician.
Fieldworkers roles FWs Carried out all the study procedures at the households. FWs Undertook the following roles:
• Home follow-up visits to monitor minor and serious adverse events.
• Where necessary, made referrals to the health facilities.
• Organised for transport and food for all those attending the health facility
• On rota at the local healthy facilitate to assist with anthropometric measures, temperature, and keeping of research data records
• Followed-up research defaulters.