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1) In completing your stakeholder engagement plan or action plan, did any questions come up that you would like feedback on from the group? For instance, would you like ideas for how to engage particular stakeholders on a specific topic? Feel free to post questions here.
How does one engage the community when protocols are completed and we engage them at implementation phase which is often the case with most research? We have engaged the community when the protocols are in draft and we have had no concerns or issues from the community. The other challenge is to engage communities on HIV when it is not their priority as certain communities do not have access to meet their basic needs, Also we explain the incidence and prevalence of HIV, communities often need help with unemployment, nutrition and poverty and managing an abusive partner. We have started to post job adverts in the site waiting room but this is not always consistent.
2) Lastly, how has your understanding of GPP changed since you first enrolled in the course? What did you learn that surprised you?
I have enhanced my thinking on community engagement and have been able to see areas of improvement in my own processes and systems with community engagement even though we have been implementing the GPP principles for over a decade in research. The GPP section on prioritisation and assessing the stakeholders using the four quadrants has been most useful. The one aspect that requires more dialogue is the process of applying GPP in research projects and settings where there is limited or minimum engagement of investigators with the community. GPP or community engagement needs to equate to GCP and this is an area that we need to work towards collectively.
I am grateful to the team for being part of the 2015 GPP course. THANK YOU
Think about the CAPRISA case study highlighted in the online training module for Lesson 9. How did their comprehensive approach contribute to their success and network of relationships created over time? What are some examples of how you have sustained relationships with communities after and between trials?
CAPRISA approach to the community was engaging stakeholders on trial and non trial related issues and they made the efforts to learn the cultural and social factors that impact on research outcomes. They developed trust and had mutual respect for the community and this helped them achieve good outcomes in the CAP 004 trial. They worked within the ethical framework on research implementation and had meetings with the CAB and the relevant stakeholders. They supported the community in non trial related work and discussed issues linked to community needs and not only what the researchers. They also engaged with the department of health and education.
At our research centre, we have sustained relationships by providing training to the community on HIV and non HIV related issues. We have also developed peer educators and they have become the voice of promoting prevention and treatment messages. Post trials, we have continued with community education and provided other study results so that the community may be kept informed about the research field. We have worked in several communities for over a decade as we have build trust and relationships at the ward level. Several of our community staff have roles in the OSS (Operations Sukuma Sake) group which helps meet the needs of the community in the various wards.
The team will need to assess the safety of all trial participants and ensure that everyone is aware of the rumour and potential impact on their safety. The team must then develop an issues management plan to address the rumour with support and input from the key stakeholders and community by discussing the study, explain the concept of being gay and that it is not to be denied among the community members. Researchers may engage with advocates and alert the local police of potential violence linked to the research population group.
The researchers should have developed a better understanding of the community and their views and responses to the research among the gay or MSM population. Sensitization and education efforts on MSM should have been implemented and assessed so that the researchers appreciate the cultural and social factors impacting on the project goals. The security and safety of the participants in context of stigma should have been discussed and the team needed to develop a plan prior to study start up.
Let’s talk about a PrEP efficacy trial in Bangkok, Thailand that enrolled HIV-negative injecting drug users (IDUs) and sparked a debate about standards of HIV prevention, care, and treatment in trials. Take some time to read over the case study (attached in the field below) and think about the following questions:
1) What implications did the lack of inclusion of clean needles in the prevention package have for trial results?
There were more participants who seroconverted as the prevention package did not include clean needles which would have come with harm reduction counselling messages and behaviour change even if it was during the trial. But the results was also not acceptable to the stakeholders as the HIV prevention package was limited with not clean needles being provided to the participants. Thus, while the results was good for the HIV prevention field, it was not good for the advocates and community members advocating for the provision of clean needles. But I am hoping that even though the clean needles was not provided, the study team did discuss access via other methods including maybe purchasing these if feasible. If needles were provided than the sustainability would also raise ethical issues for long term impact on HIV prevention.
2) How can researchers engage stakeholders to better negotiate prevention packages that combine various arrays of options tailored to the needs of diverse subgroups?
Researchers may start the process of having mutual understanding of the reasons for countries not including certain interventions in HIV prevention programmes and assess the cultural, social and economical factors contributing to these decisions. Then the researchers should engage the government and policy makers and share options without judging the in country decisions. Researchers may engage with the advocates locally and nationally to assess the feasibility of convincing government to include options for HIV prevention as a long term goal and discuss impact on policies. Eventually, most countries and public health decision makers want the best for the population in terms of reducing HIV prevention but lack of political will is often a limitation. Researchers also need to be patient with the community and allocate resources to work with advocates and stakeholders including government to assist with changes in policies linked to access to HIV prevention methods. Research on acceptability and need of the population for HIV prevention options being conducted with support from government and stakeholders may help with their decision making. This is an issue that needs to be discussed widely as HIV prevention research trials needs to make all options available to participants while at the same time be transparent with participants about the reasons for lack of availability in the population.
Give an example of successful stakeholder engagement in protocol and/or IC development. What changes were made as a result of the input gathered?
At our site a few years ago, the members from DAIDS visited our unit and discussed the length of ICs in microbicide trials with peer educators and members from the community (CWG members). This was a useful exercise as the members explained that the length of the ICs in English was long and when translated in the local language it is even longer making it difficult for participants to internalise all the information. After a day of discussions and consultations with the community members, it was agreed that a short form of the IC will be a way forward. However, the process of implementing a short IC with key information is ongoing and we continue to have lengthy ICs in biomedical clinical trials. Fortunately. the use of graphic tools and various material to explain the study to participants and community members has contributed to better understanding of the research procedures. There is discussion on ensuring that ICs have relevant information for decision making among participants and their family members and relatives. This engagement also helped community members understand the purpose of providing the key information to participants thus achieving mutual understanding of the IC information and length of the forms.
2) If a protocol gets sent to your trial site in final form, how would you address the GPP recommendation for stakeholder involvement in protocol development?
This is a common practice within projects where it is not always feasible to engage the community at the trial site but there was community engagement at national or network level. Thus, we explain that although the site community may not have been engaged on the protocol, there was community input by a national or international CAB member. We also invite the site community members to share their feedback and concerns which may not always in changes but it is possible to amend protocol. To be honest and transparent with the community about the process helps with understanding that it is not always feasible to engage the community when the protocol is being drafted as this is dependent on sponsors, resources and logistics. The GPP and other community guidelines must be explained and shared with the stakeholders so that they know their roles in the research process.
What is the difference between involvement and engagement. This is now an issue that I am debating as I learn about the priority roles using the guide in the four quadrants.) What is your experience with stakeholder mapping? How do you use stakeholder maps at your site? Discuss how you (and your colleagues) determine the importance of involving one stakeholder versus another. For example, how do you determine who constitutes your CAB?
I have minimum experience with mapping and have used the techniques of conducting a situational analysis and community profile to understand the community. We have used information from various resources to understand the community and develop our referral structures and network contacts. We ensure that all health and social development members are part of the stakeholders and that the CAB is made up of volunteers from our recruitment areas, health services, traditional leaders and social development services. I like the idea of critical thinking of developing CABs and using the mapping techniques explained in this module. We have used a system of asking members to complete biosketches and we assessed their eligibility to be CAB members using a few criteria indicators such as willingness to be part of HIV prevention, experience in an organisation, ability to participate and contribute to discussions, have had health education and outreach exposure. This has helped to a limited extent.
2) Stakeholder engagement is not easy and multiple partnerships can be hard to manage. How can you partner with stakeholders to create a community of sustained engagement? How can you get members of your research team to “buy-in” to sustained or longer-term stakeholder partnerships?
Sustainability is not easy in an environment with high unemployment and high expectations for monetary rewards or compensation. But we have now been working with our communities for over a decade and built trust as we have always been open and honest to our stakeholders of the research process, outcomes and study closures. We have also provided support for capacity development of community members who have attended conferences and scientific events sharing their voice about final results. Long term partnerships may be achieved using the GPP principles and applying this in partnership with the community. Developing capacity of the community members to access employment and improve technical skills like using a computer, chairing sessions, presenting at meetings, writing minutes has helped with sustainability to a limited extent. This is work in progress for me personally but very important to strengthen my skills in sustaining CABS.
- Discuss the link between formative research and community engagement for a trial. How are they alike? What are some differences between the two?
The link between the two is that formative research provides a systematic documented understanding of the community and helps with engaging the relevant community structures as one is able to assess the research responses. Not all trials have formative research and sites conduct community engagement by developing a community profile and situational analysis based on available information within the organisations in the community. The difference is also that with formative research one needs to get local IRB approvals as data is collected and interviews are held often for the purpose of publication in peer reviewed journals. Community teams who engage the community do not always document all responses in a systematic manner but currently documentation for all community work is now a requirement. Formative research also has focused objectives and data collection methods to achieve the objectives. Recent PrEP trials have had formative research to provide researchers with a better understanding of the socio-cultural context of the community.
- What types of formative research activities have you conducted in your context? How have you involved community stakeholders in these formative research activities? If not, how could you potentially involve them?
We have not conducted formative research in the setting but we have developed a community profile and situational analysis of the community with assistance of stakeholders. They have worked with us to help us understand the dynamics of the community. In a previous trial, the community members where interviewed by researchers as part of a social science sub study within the clinical trial. This provided valuable information about the stakeholders and their acceptability of the trial and product.
Lesson 2, module 2 assignment was challenging as it required analytical skills and time to complete it. I may need to read the sections again to improve my understanding of the principles and scope of GPP. I look forward to the webinars where we may discuss the principles and section three. Thanks for the great module explanations.
The benefit I have experienced from stakeholder engagement in a rural community where the organization conducted clinical trials and other HIV related research was that of trust, integrity and mutual understanding which are the principles of GPP.
The rural site was to be closed after a decade of research with the community resulting in developing partnerships with traditional leaders. The community stakeholders and members of the community working group (CWG) which is equivalent of the CAB were informed of the closure which was linked to end of trial, funding and staffing logistics. The study results were given to the stakeholders and CWG members by the PI while results were embargoed and the traditional leader said that if anyone disclosed the information, they will appear in the tribal court. This was a true reflection of the community and researchers understanding norms and the research processes by both groups. There was trust and integrity displayed by the community as they maintained confidentiality until the results were released to the public two days later. I share this story at all community events to highlight the impact and benefits of community engagement. There were no negative rumours after the results were released and a CWG member and participant volunteered to speak to the media about their experiences in the trial. These measurable outcomes of maintaining trust and having an understanding of the processes contributed to the success of sharing trial results with the community while these results were embargoed This event took place about 8 years ago.
Stakeholder engagement is appreciated and recognized by our research team as it emphasized by the Clinical Trials Unit principal investigator who ensures that all team members appreciate community engagement. We have and continue to address the differences between stakeholder engagement and meeting protocol requirements such as recruitment, retention and adherence. Research team members have also joined the community team to educate stakeholders on clinical procedures such as blood draws, Pap smears (test to assess risk of cervical cancer), medical examination and composition the product. The efforts needs to continue and be strengthened by community guidelines.
The research team has a good understanding of the importance of stakeholder engagement in research as we have a dedicated director and principal investigator who has made community engagement part of all team members role and responsibility (direct and indirect). Stakeholder engagement activities are discussed at weekly management meetings and at monthly research project meetings which includes the entire unit employees (over 100 employees). Documentation of stakeholder engagement follows the similar guidelines of Good Clinical Practice where logs and reports are written for community events and outcomes. our nurses, doctors, counsellors and investigators have been in the community to explain complex clinical issues such as Pap Smear (tests to assess cervical cancer), what the blood is used for in the laboratory and safety tests in trials. But it would be valuable if the research team members consistently maintain the relationships with stakeholders. Thus, monitoring and measuring the impact and role of research team members may be valuable.
