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Topic
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- Discuss the link between formative research and community engagement for a trial. How are they alike? What are some differences between the two?
- 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?
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Replies
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1. Formative research is actually like the foundation of Community engagement, makes you understand the community its structure, challenges, beliefs,it is after this mapping, is when you can be able to have logical engagement.
2. Community Engagement therefore is the building of a trusting relationship with community members that creates a supportive environment for research
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Formative research assesses the community any potential study will be implemented. This information is important as it will determine if a study will be accepted by the community and will enrollment be successful. It is my position that every CAB should be study specific. For instance if a study is recruiting black MSM and transgender women it is important to have the same representation on the CAB.
It is important to engage the community of various research approaches. Community engagement should be implemented even when a study is not currently active or enrolling.
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<span style=”line-height: 1.5em;”>Formative research and community engagement for a trial are intrinsically linked. Formative research helps to lay the groundwork for effective communication with community stakeholders. Formative research is a critical step that includes identifying key stakeholders and thinking through the role that different stakeholders can/will play in supporting trial work. Stakeholder mapping work done in the formative research stage can greatly facilitate implementation of a stakeholder communication plan during the trial.</span>
With my organization, stakeholder identification is a key formative research step. Stakeholder mapping exercises are crucial to overcoming this initial challenge. Without this, it would be easy to start down the road of getting feedback and input from stakeholders and stakeholder groups we are already familiar with. However, often, some of the most valuable insight is gained from stakeholders outside of the “usual suspects” that we know, or have already worked with in the past.
Other formative research activities we have utilized includes stakeholder surveys (e.g., needs assessments) and stakeholder meetings. Both of these help us to bring diverse stakeholder perspectives (e.g., patients/advocates, industry, academia, government) to the table so we can work to align the needs of all as we develop a new work initiative/project. This formative research step is a critical component to the work because it helps to ensure that all stakeholder views/voices are reflected in the project we develop.
In the past, community stakeholders have been asked to provide input on survey questions before finalizing and disseminating more broadly. In the future, I see the role and opportunity for input of community stakeholders growing, especially as we develop project with more of a focus on patient engagement. For example, we are developing a new patient and advocate training program, and we expect community stakeholder input received during stakeholder meetings to directly inform the topics and format for the program.
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Several of you mentioned community mapping as a key element of formative research. It is important to identify who the key stakeholders and community gate keepers are, however it is also important to think about formative research as more than a fact finding assessment. It is also a first opportunity to reestablish trust or strengthen a relationship with community.
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In our context we have done community mapping in trying to get to understand sex workers from their Hot spots. We get to understand their way of living and the challenges they face that can interfere with our trial study. The GPP Course is adding value to us on how to strategies the community engagement.
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Formative research is the baseline, community mapping, aims to establish community stakeholders, the myths and misconceptions so as to develop appropriate tools to engage the community. Community engagement is the process of reaching out to the community after establishing gate keepers for their buy in.
formative research is also a form of or a step in community engagement.
In preparation for our first vaccine study we mapped the community in an effort to establish critical stakeholders, we eventually reached. we then engaged them to in preparation for the study and addressed all their fears and concerns. Political leaders initially had concerns but eventually came out strongly in support of our study. we also have a CAB that meets regularly to get updated on our research activities while giving us community concerns.
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I believe that Formative research is a component of community engagement. It a process that which draws a road map for community engagement. In the absence of formative research, it will be very difficult for research to have a meaningful community engagement. Therefore, I feel that formative research is foundation for a meaningful community engagement.
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Hi everyone! What about engaging community members in formative research activities to help with message development and communications planning? Has anyone had experience with linking formative activities to those aspects of GPP ?
I love Neetha’s comment about engaging stakeholders in a situational analysis– this was probably useful to assess potential risks or identify groups to engage that might spread inaccurate information as well?
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Formative research provides a firm ground for effective community engagement. It is through formative research that the research team understands its community, learns and develops strategies on how to engage them in the research activities.
Our sit has managed to Map community leaders and Conduct Focus Group Discussions with different Stakeholders in different study communities.
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- 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.
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Thanks Nokulanga and Jessica,
other important links i may think in formative research at my area is having discussion forum or meetings with local government authorities (LGA), area counselors and community chiefs (famously known as MWENE). These are people who are very respected, trusted and influential in the community, if the research team has all the support from these people entry and recruitment in that community will be smooth. Furthermore these are the people who understand very well the culture, beliefs and norms of the particular area they always give advise or guidance on what or how to approach some of the sensitive matters or issues that might be of the concern in the area. on the other hand if something goes wrong with regards to study or there is misconception or concern we want to manage we always use the same stakeholders to seat together and discuss how to talk the matter
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formative research is what we do to ensure we have the basics rights about the population we what to engage with. community engagement is plan design to ensure that our community is well informed about our research and how we will address potential problems.
the difference between the two is that formative research is what you found out about a particular community and community engagement blue print of how you speak with these community.
we were looking for low risk areas and the CAB assisted in doing community mapping and identify areas were the low risk participants.
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As it is described, Formative research activities enables research teams to gain an informed understanding of local population, its socio- culture norms and practices,local perceptions, etc, this can only be achieved by identifying relevant stakeholders. Eg; CAB members and having meetings with them. It is in such arrangements that the above information could be obtained.
The formative research and community engagement seem to be alike in that the objectives are the same. getting informed.
Research teams and PIs and CAB members have had meetings before and during the trials, and CAB members have arranged meetings with identified community stakeholders and research teams. In such arrangements most conerns from both ends are addressed.
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Stakeholder engagement is defined in the GPP document as, “…processes through which trial funders, sponsors, and implementers build transparent, meaningful, collaborative, and mutually beneficial relationships with interested or affected individuals, groups of individuals, or organizations, with the ultimate goal of shaping research collectively.” Formative research can be regarded as one form of community engagement (a subset). Of note, formative research would be one of the first steps in community engagement and lay the foundation for engagement and open and trusting relationships.
I cannot directly answer this question as I am not currently a staff member executing clinical trials. However, from a Sponsor perspective, one of the most important things to do is make sure those involved with trial development are aware of the importance of formative research and encourage and help facilitate this work.
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Formative research to some extend could be said to be a feasibility study and involve in several ways the element of community engagement especially the qualitative approach. Focus group discuss (FGD), In depth interviews, Key Information Interviews (KII-Interviewing people who are in position to know) and community mapping are formative research (qualitative) methods and at the same time community engagement strategies that yield quality information about study feasibility. Both are similar in so many ways and what differentiate both is the intention of the research team.
Our current effort (Ebola) was very sensitive in nature so community engagement and consultation was done as an informal formative research. Key informant interviews, stakeholders consultative meetings and focus group discussions yielded quality information for planning.
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Formative research is like community mapping. You get as much information about the community, population number of people, needs analysis of the community based on the research you want to conduct within the community.
Community engagement is when you do certain activities to engage with the community. We have Public holiday events around the theme of the holiday and sometimes we team up with other organisations around the community to have great impact.
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1. Formative research is a means of understanding the community within which the research will take place. we can use this platform to find out how knowledgeable the community is about HIV and HIV prevention research. Once this has been ascertained, we can go back into the community with the correct tools and activities to inform them about HIV and HIV preventions research thereby engaging them and getting them to be familiar and comfortable with the research.
2. In May this year we hosted a HIV Vaccines Awareness Day to inform the community of Soweto about HIV Vaccine trials. Local stakeholders were involved, like the LGBTI and local NGOs that perform HIV testing and counselling. Instead of having a general information session, we played games with the community and gave away prizes to those who participated in the games. This was a great way to educate and involve the community. At the end, there was an information and answer session where they were free to ask questions. They were also encouraged to go to the stalls in the venue to find out more information.
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Formative research is the first activity done to deepen the level of research knowledge, experience and preparedness amongst site team and populations that will be involved in, affected by, or have influence over the trial, which will in turn, help plan community engagement activities accordingly.
This process also assist research team to gain an understanding of attitude, beliefs and socio behavioural factors among the potential trial population that could interfere with recruitment, retention or trial conduct. Once all this information has been gathered, it is then site can be plan well tailored community engagement activities.
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- Formative research in my understanding helps to gain an understanding of the communities that the trail will be conducted in and helps understand all the communication chanells that are used by the population at hand , this is a fundemental step for good community engagement as it sets a good understanding of the communities that you will set out to reach
- We have worked with the District Councils to up date the list of leadership hirachy as a way of keeping track how information and communitation moves from the Traditional Authorities right down to the block leaders and to the house holds in our catchment area. We also work with other stake holders to see how best the national events can best be layed out to be able to reach out to communities.
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Erica- I think you’re right that formative research is a step. Are there other ways to think about the potential link between formative research and community engagement? For instance, formative research is an important time to assess the potential for social harm to a specific population. Formative research can help members of the research team assess parts of the protocol or even site configuration that could potential increase the amount of stigma or discrimination potential participants might face.
Can you think of any links?
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Dear Erica,
I believe that involving community is very much important, that also help with identifying stakeholders that might have a negative impact in the trial process. by the look of things you are targeting stakeholders in different levels that a brilliant idea. Understanding channels of communication is very important as one of the formative research activities.
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1. I think formative research is part or step of community engagement that assists the research team to understand the study population and trying to set the right foot in the community for the success of the trial
2. For our upcoming Vaccine trial at this stage we have involved the CAB members about the trial in general ( tTarget population, numbero f participants to be enrolled, objectives, duration, number of visits and general procedures). Also together we reviewed the participant informed consent to be used for the trial . we have discussed recruitment plans/strategies. We are still waiting for ethical clearance from the IRBs, once we receive approval we are planing to conduct a meeting or community forum with community leaders and other stakeholders like street leaders,area government leaders, health officers, religious leader, previous vaccine trial participants and other influential people in the target area, there after we plan to hold a press conference with local media personnel and from there we will continue with information seminars, community meeting and radio talk shows
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1. As we know Formative Research enables Research team to gain understanding of the local populations, it social, cultural, norms and practices that helps a lot in engaging with the community, because understanding the community you working with assist a lot in the trial process. Understanding the channels of communication is also very important because for example in rural areas we still have Chiefs and we use certain way to address any issues to them that includes trials that we might be conducting, importance of dress code, language used but all that happens only if there is an engagement with community because some of research team members are coming from different areas which are unique from where the trial is conducted therefore engaging with the community helps in overcoming all possible situations that may cause delays and study to be unsuccessful. The difference between the two is that, when the study is conducted protocol is developed and the protocol need to be followed and there are situations whereby the community might have different views when it comes to the how the protocol is drafted and it is impossible to put everything according to what some of community members prefer that is why its important to involve community in different levels.
2. We conducted community events in rural areas where the community is still naïve when it comes to research and we involved community members who are very influential in those communities, we also involved CAB members whom we consider as our community stakeholders. We also had a Soccer Tournament that was attended by all municipalities that are under UThukela District Municipality and the main purpose of that tournament was Male involvement. It all started with a march that was lead by the Mayor of UThukela District and the March was all about “No woman will be abused in my name” “No woman will be infected in my name” and Brothers for life was part of that March and the whole event. We believe that if male partners are involved in research trial it will be much easier for women to participate and adhere to trials that are conducted.
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