Appropriate communication strategies and content should be designed and developed for different community audiences, depending on the nature of the information to be conveyed in the trial (also see Chapter 23). Depending on the specific requirements of the trial, these strategies may need to operate at several levels of the trial commu- nity, including communication with individuals, specific target groups, or the wider public. For example, community engagement can feed into, and overlap with, consent processes, which are discussed in Chapter 6 and are a clearly key activity in any trial (Participants in the Community Engagement Consent Workshop, 2013). All commu- nication activities must use culturally appropriate methods and take into consideration the target audience’s beliefs and norms, numeracy and literacy skills, power structures, gender issues, and other community dynamics that may differ from those of the trial team. Special issues may arise related to the collection of blood, urine, or stool speci- mens (see Chapter 17, Section 2).
Participatory methods, using visual aids, can be used to illustrate and simplify sci- entific concepts related to the trial. Community health workers, traditional birth at- tendants, and other community health care providers with established credibility may sometimes be appropriate people to communicate with community members at vari- ous levels throughout the trial. But their motivation, training, other activities, and sustained engagement will need to be managed in collaboration with other commu- nity representatives (Angwenyi et al., 2013). Forms of participatory theatre, song, and dance can be effective in introducing new studies in contexts where these are estab- lished and valued means of communication. In some settings, radio, roadshows, and mobile phone messaging have been used to communicate with communities about research (Ndebele et al., 2012).
While much of the content of the information to be conveyed will depend on the de- tails of the trial, it will be important in all cases to emphasize general information on the nature of research, including the voluntary nature of participation and the confidenti- ality of any information provided by the participants. Given common public concerns about safety in intervention trials, it may also be helpful to give a basic explanation of international and national research review processes for all studies and, for trials of drugs and vaccines, the trial phases, so that the current study is widely seen in this context. CABs and front-line staff can provide good support in assessing the appropri- ateness and comprehensibility of information included in messages and materials to support communication about the trial.
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5 Sustaining community engagement
The initial discussions with the community leaders will provide insights for developing good strategies for sustained community engagement. Intervention studies evaluating medical products or vaccines will require close monitoring, and therefore continuous surveillance and frequent engagement with a CAB and other community members. AEs, often unpredictable, may worry local communities, harm the reputation of the trial and its parent research institutions, and damage the credibility of the researchers. Such events need to be appropriately managed. Effective management and reporting mechanisms, with clearly defined protocols, should be established as part of wider community engagement strategies. Informal meetings and fora can be held period- ically to engage community members about their perspectives of the trial and to ad- dress any concerns in a timely manner. Frequent two-way information flow between the investigators, front-line staff, CAGs, other representative groups, and individual community members can foster trust, ensure sustainability, and enhance management oversight.
In long-term field trials, even if excellent procedures have been established to in- corporate the ideas of community members and to respond to concerns at the outset, new expectations may evolve over time, and perceptions may change. Good sustained community engagement mechanisms should ensure that the trial team is aware of these issues, and it will be necessary to work with the front-line staff and representative groups to decide how best to address them.
Some trials may involve community members in substantial inconvenience. If pro- cedures are time-consuming, participants may become fatigued and their initial enthu- siasm may wane. Generally, it is important to discuss what time of day, or what time of year, is most convenient for the community members. Sometimes, compensating indi- viduals, in the form of money or food, for time lost from work or other activities may be warranted, and, in some cultures, it may be considered appropriate to compensate the participant if a blood sample is taken. However, this could be a disastrous practice in some settings, as it may fuel commonly held rumours that blood is being bought and sold by researchers. Various strategies have been adopted by researchers to ensure culturally appropriate compensation for trial participation such as through the provi- sion of health care services. These strategies need careful thinking through for each trial, ideally with community input. Mechanisms for referral to appropriate health care and compensation if harm does occur are key elements of trial protocols and could be informed by community representatives. All benefits must be viewed carefully from an ethical standpoint, with the aim of ensuring that people are compensated appropriately, but intra-family and community conflicts are minimized, and individuals are not ‘co- erced’ to participate in the study against their will (Molyneux et al., 2012). See Chapter 6 for further discussion of these issues.
Consideration of the frequency and nature of feedback of results is important in all trials and must be considered from the outset. It is important to distinguish between feedback of individual and of overall (aggregate) trial results.
For individual test results, a common reason for a participant to refuse to provide a
5: SUSTAINING COMMUNITY ENGAGEMENT 157 on the first sample. Sometimes, this problem may be avoided by conducting some la- boratory tests on site. For example, haemoglobin, rapid tests for malaria, and tests for a large number of other conditions can be performed in the field. Rapid diagnostic tests for malaria, for example, can be done on the spot, and immediate treatment can then be provided, if indicated. Where this is not possible, individual results can be fed back to participants, and the practical and health implications of doing so for individuals and the research team may need careful deliberation and clear communication with both trial participants and the wider trial community.
For overall trial results, it is important to keep local health workers and the
DHMT informed of the progress of the trial and of the results, as they accumulate and at the end of the trial. Newsletters or district and provincial meetings can be used to communicate the results to them. At the completion of the trial, the final re- sults of the study should be communicated to, and discussed with, the participants and the trial community as a whole. The implications for the community should be discussed with them, as well as with all the authorities involved. Such feedback is essential, not only from an ethical point of view, but it may also pave the way for co-operation in future research activities and for sustained health-seeking behav- iour on the part of the community members. For example, research on the feedback of findings from a malaria vaccine trial in Kenya showed that sharing of aggregate findings was very much appreciated and that the inclusion of individual results in feedback sessions reassured participants of trial safety and helped ensure that posi- tive results of the trial were not over-interpreted. Feedback sessions also offered an opportunity to explain key information and respond to emerging community questions and ultimately re-evaluate and re-negotiate trial relationships and bene- fits (Gikonyo et al., 2013).
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