4.10: Implementation

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7.1 Community acceptance

Critical to the conduct of a successful trial is that the trial population co-operates during the conduct of the trial and takes up the intervention offered. They must feel a part of the trial and perceive it to be for the benefit of their community. To ensure these aspects will require careful planning and investigation before the trial starts, including appropriate discussion with, and explanation to, community leaders and potential participants. Feedback and interaction should be continued throughout the course of the trial. These aspects are discussed in several chapters, and especially in Chapters 6 and 9 and part of Chapter 15.

7.2 Feasibility studies and pilot testing

Unless the acceptability and feasibility of implementing the intervention and the evaluation procedures that will be used in the trial have already been tested locally, it is usually wise to conduct a smaller feasibility study in advance of the main trial. The feasibility study may only include some aspects of the trial, such as the acceptability and feasibility of delivering the intervention, or the feasibility of enrolling trial participants or of administering a questionnaire or collection and testing of laboratory specimens. Whether or not such a feasibility study has been conducted, it is essential that all the trial procedures are tested together in a pilot study, exactly as they will be applied in the actual large-scale field trial. However, the pilot study should be conducted on a much smaller number of participants and with enough time for the trial procedures to be modified in the light of the findings. Feasibility studies and pilot studies are discussed in detail in Chapter 13.

7.3 Staff recruitment, training, and retention

The dedication and commitment of the staff employed to conduct a field research project are essential. This will involve their careful selection, training, and then support. They must understand the importance of their role in the trial and how it relates to that of others. The importance of high-quality work must be emphasized, and this must be monitored throughout the trial (see Section 9 and Chapter 16). Trials of long duration present the additional challenge of keeping staff motivated and performing at adequate levels of quality and avoiding excessive turnover. Open and frank discussions with staff are essential, and benefits, such as regular increases in salaries over time, may help motivation and retention.

7.4 Field organization

All aspects of field procedures should be planned in advance, and potential problems and solutions anticipated (for example, in case of staff sickness or vehicle, computer, or laboratory equipment failure). The trial design must reflect not only what is ideal, but also what can be done, given the constraints under which the trial must be conducted. These aspects are considered in detail in Chapters 16 and 17. Issues relating to mapping and conducting a census of the trial area are covered in Chapter 10.