Bangladesh (Chittagong) study

Community information and permission Community awareness meeting © TDR/WHO It was necessary to obtain permission from the communities to conduct the trial; this could only occur after the village leaders and the key community members had full knowledge of what the trial would involve. The first step involved discussion of the proposed study with the community leaders to obtain their understanding of the study, approval and cooperation during the study implementation. The study started first in Ukhiya and then sequentially in the other upazillas. A total of 31 awareness meetings were held with leaders of Ukhiya upazilla by the time of study initiation. The meetings carefully explained the practical details of the study to the community, defined the expected community roles and also the role of the research team. If community leaders gave their permission, then individuals or groups (especially women and mothers of young children who would be at particular risk) were given more detail about the trial and its conduct, information about the medication, placebo and the randomisation process, and they were offered the opportunity to review and discuss the informed consent form, the meaning and reason for using a placebo, the confidentiality of study participant information, the eligibility of a patient for treatment - symptoms, age, location - the right to withdraw and the need for adherence to referral advice through a referral slip that would given them advantages of improved hospital management of their condition. Posters and leaflets were distributed and loudspeaker announcements (miking) began to be sure that community members knew about the study. House-to-house visits by the fieldworkers continued during the study. The preparatory phase took two years and by the end of this extensive and intensive period, everyone in the community became aware of the nature of the trial and knew what to expect in relation to its conduct. Before initiation of the study, the study monitor visited a number of schools, health clinics, and met with community members, especially women, so as to assess the level of community awareness and knowledge of the general principles of the clinical trial (the concept of blinding of treatment, use of placebo, informed consent, need for referral and continued management at the thana health centre). Awareness meetings were also held before study initiation at different administrative levels: sub district, district, division, and centres to make the administration, elected representative, press etc. aware of the study. Identification of village recruiters Village recruiters, Chittagong © TDR/WHO In Bangladesh, communities were informed that village members would be employed if they had at least 8 years of schooling, and that existing health workers could also apply to participate in the trial as village recruiters. The recruiters had to stay in the locality during night time. In all countries, the village recruiters were part of the project team and reported to supervisors of the study. Supervision Review of Case Record Forms by Co-PI © TDR/WHO One hundred and sixty-nine recruiters reported to 34 field supervisors who reported to 6 field investigators (medical doctors) and the core team. The supervisors were responsible for collecting informed consent forms, enrolment forms, blood slides and follow-up forms from each recruiter. The supervisor was also responsible for supplying enrolment forms, lancets, blood slides, checking and replenishing drug cartons, and following up to ensure completion of all forms and that the number of enrolments matched the number of drugs and blood slides used and empty drug boxes returned. There were monthly review meetings of the core investigators and the entire team in the field (recruiters, supervisors, hospital staff) to discuss all issues that affected patient enrolment and welfare - completion of CRFs, follow up of cases, replenishment of drugs, patients following referral advice to go to hospital. Investigators visited the community, referral hospitals, and field stations from time to time to ensure the adherence to the Standard Operating Procedures. Yearly, a coordination meeting was held involving all the investigators, field staff and policy planners to report and review the progress of the study.