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As community actors we have implemented the Community Advisory Committee (CAC) but their participation is not dynamic in the formative research in the community. We submitted the studies for their review but they can not make any changes in the protocol.
To improve this context we proposed to increase skills and knowledge of CAC members thus they will be part of the investigations and representatives of the community. Also is necessary that institutions involved in research must learn about the importance of GPP as part of the investigations.
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Approaches do differ from site to site. Formative research buy in will therefore also vary from site to site or area to area. The approach that we use is to have what we call ‘ indabas” with community stake holders to inform them about the research but the main purpose of this dialogue would be to assess what the needs of the community is to be able to see if the methodology of the study fits that’s of the needs. And this is not a once off process. Sometimes we have to keep going back and forth until most of the concerns are ruled out-especially ones that need immediate attention or that can be a stumbling block to the research process. Even if the trial is delayed for whatever reasons, that dialogue must always be there because these are the vey people who will act as a link between the community and the site staff. In this type of scenario, we find that engaging with communities first should take preference over engagement with other stakeholders.
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How have you involved community stakeholders in formative research activities in your context? If you haven’t, how could you potentially involve them more meaningfully in the future?
Our Pevention CAB is a great resource and we involved them in formative research activities. They reviewed the study protocol, recruitment materials and helped structure our messaging for the study. The CAB members were very instrumental in identifying and refering us to key stakeholders in the community such as Ward Counselors, members of NGOs and CBOs and community gate keepers from formal and informal settlements. The CAB also suggested upcoming events that presented opportunities for icnreasing awareness of study and the different contraceptive methods that would be available. They met and still meet monthly to provide updates from the community eg myths and misconceptions arising from the community, and we provide them with updates on the study progress.
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The study i’m invoved in is the first one of its kind in the area so the study team thought it was crucial to do a formative research before hand. As such we carried out a vast community education program targeting all the stake holders and managed to reach out some NGOs, CBOs, FBOs, community leaders, health personel and potential participants. These stakeholders were involved way back and now it has been a year before the study start up. But to maintain the momentum, we do provide them with quarterly reports on the study update so as to keep them informed. Cab have been helpful in the formulation of study tools and providing information of which stakeholders were critical for such a trial.
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We have had some few instances that we have conducted formative research to improve on the study protocol.To me this has had huge impact on the involvement of the various stakeholders.Formative research provided an opportunity for engagement and inputs to the study protocol.It also an opportunity for mutual understanding between the researchers and the various stakeholders including future study participants.Research tools have been modified to reflect respect and autonomy.
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Our involvement focuses on inter-CAB dialogues with CABs from other sites and not necessarily ones that clinical research studies and collaborate to ensure joint out reach programmes within the same community so that person in the community do not perceive us to be in competition with one another. We also look at ways of maintaining the balance when it comes to recruiting same participants. So communication is essential. Dialogue between standard of health care centre workers in the surrounding drainage are should be such that we are able to keep them updated of participants progress on the study. PI open door policy is one of the main factors that enhance effective community engagement in this regard. Without this, the whole process would be meaningless because as we all know- its a two way channel.
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As I told previously we have not done any work related to clinical trial and community stakeholder involvement in formative research but, In future we want to conduct HIV prevention clinical trials. So for Formative research we will first find active community stakeholder who are having interest in research by doing survey at different areas, by conducting interview (telephonic/personal). With these community stakeholders we will organize meeting on topics, we want to conduct HIV prevention clinical trials, we want to do this kinds of research, How it will be beneficial for community, and tries to collect, understand, How much target population are there in community, what are the local norms, cultural and social issues, what are their expectations from research team, and How they are looking towards research. If all things going positive in favors of research and research team, then community advisory groups (CAG) will be formed, and knowledge about research will be deliver to CAG members. Then these trained/ Knowledgeable CAG members collect all information related formative research by visiting school, colleges, temples, mosques, churches, NGOs, different places, and help researcher to produce a community map. I think this will be the potential and meaningful involvement of community stakeholder in formative research activities.
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Hi, I know that we as a sponsor did not reach out (pro)actively to community stakeholders but we know that our sites have indeed reached out to community groups at time of recruitment period (was part of their recruitment plan). Some of the sites also have a site set up that provide the opportunity for the subjects to interact and come together at certain time points, not linked to the protocol, but linked to the clinic itself. I have not yet looked into the fact to see if indeed these sites do have a better retention percentage (as retention is becoming our next hurdle as it seems).
The sponsor did reach out to the study staff to take their input into account with regards to INC/EXCL criteria, trial procedures, … and adapted the protocol set up if needed.
I think I can conclude that the formative research was done on “theoretical protocol content level” but not really on the “practical trial implementation” level. For the latest point, we completely relied on site level. -
For me back here in lagos Nigeria, every formative research carried involves community key opinion leaders in the design , administering of research activities, the only challenge that comes on along is the dissemination of formative research results through the community stakeholders approval. This is one challenge I do forsee in my context. But all there is some level to great extent of involving community stakeholders especially when it comes with research with MSMs or PWIDs or FSWs. there is a level of stakeholder consultation activities
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How have you involved community stakeholders in formative research activities in your context? If you haven’t, how could you potentially involve them more meaningfully in the future?
In my previous employment, we involvement stakeholders in various ways which it was to put different categories such formal stakeholders that are registered, CBO , ordinary members of community, clinics, transport association, Africa diaspora community. As you may known that after South Africa democracy, South Africa saw an increase of people coming all over and mostly depending who is their contact, they arrive in an area called Hillbrow in Johannesburg. In doing formative research, we conducted focus group discussion with various groups and stakeholders who are already in CAG/, In depth interview (IDI) as part reinforcing generalised information gathered , also did the ethnography of mapping the area and this was done by temporarily employing community members from the area as recommended by stakeholders, and also trained youth and older people on photography to take pictures of their community and interpret it in their own understanding. Involving Africa diaspora association to understand issues affecting political, economic refuges and how we incorporate them in trials and development in general. This was helpful because in the process of employing more CLOs we had to look at French speaking, Shona , Ndebele etc. The desktop analysis done using the municipality facilities and this was helpful to get literature review and confirmation of statistics according to demography of the area etc.
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Unlike Kathrine’s experience of too early formative research activities. Our own was too late formative research activities because the seed fund from my institute came very late. We had to adjust the timeline set for our drug therapeutic efficacy trial (DTET), which was eventually stressful to both the clinical research staff and some of the trial participants who were also pre-engaged during the formative research activities. So I agree that timing is very crucial in what we do prior to clinical trial.
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Sherri had the same question for Phumeza that I had–I find it insightful that Phumeza’s community engagement began before there was even a protocol. This is something that I’ve toyed with for a couple of studies at our site; however, I found it difficult to convey anything more than the concept of the study to community members and potential stakeholders because the protocol was not yet official or was incomplete and the details frequently changed. Also, often times, the base materials for some of our studies have already been created by the core network which leaves little to no room for edits that are recommended by community members and stakeholders. In studies that we do have a little more leeway for creating our own materials for, we are often stifled by a lack of funding to produce them. Situations such as these only highlight the importance of identifying key stakeholders to educate and learn from, though.
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For the most-part, our site typically relies on the community stakeholders in our CAB for any type of formative research. The extent of our formative research with the CAB has been identifying possible stakeholders and, still, that is mostly done by the community education team at our CRS. The inexperience in formative research isn’t due to a lack of trying, however. Our current CAB members have been nurtured in an attempt to get them to understand the importance of community and stakeholder engagement and to build excitement and initiative around some of the examples that were provided in our module.
I think that stakeholder engagement and utilization of formative research methods will take shape and improve with the diversification and expansion of our current CAB. Until then, I think that it would serve us well to identify stakeholders outside of our current CAB and begin building the foundation for a relationship built on trust and mutual understanding. At that point, more in-depth formative research such as community forums and interviews can be used.
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In a previous study, we – together with the site, who identified and had the contacts from/with the local communities, organized an informal meeting with some CAB members. Looking back, this meeting was very useful, informative but quite late in the project. Moving on, for future studies, we could involve community stakeholders much earlier in the process so that
- their FB and input can be used to form or shape the trial
- more and very efficient outreach activities can be organized – again in close partnership with the clinical sites who have the most valuable contacts and knowledge about the community stakeholders.
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My colleagues and I have been involved in research where our focus is on describing and evaluating current community engagement practice at a research centre in the Cape Town, South Africa. This was also the focus of my doctoral research. Across the two settings in which I have been conducting this research I/we utilised formative activities such as focus groups and key informant interviews to develop an understanding of and document stakeholder’s descriptions, understandings and perceptions of community engagement and their role in this process at these sites. I/we, also examined the community engagement plan developed by the research centre staff to guide their community engagement activities and reviewed the literature on community engagement in HIV vaccine research. The stakeholders involved in our formative data collection have been clinical research participants, community outreach staff and CAB members. The data collected has provided us with an understanding of how community engagement is currently being practiced, understood and experienced by stakeholders involved in this process. The next step in our formative research is to develop a survey to assess community members’ levels of knowledge of HIV vaccine research and their confidence in making decisions about HIV vaccine trial participation.
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Haoyu’s comments accurately capture the formative research activities we have conducted and also the issues with them. I was also interested in Sherri’s question to Phumeza — how far in advance are these formative research activities useful — what are the pros and cons of doing it too early? I feel we did this early, and created an expectation that the trial was coming soon, even though we were clear it would be 1+ year away (and now it has been 2-3 years). As a result I feel concerned about ensuring that we don’t move too early. For that reason, I feel like more general education around research literacy would be good as an interim step.
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Yes, we have engaged community stakeholders in conducting surveys, one on one interviews and focus groups. These formative research activities help us to better understand community members views on PrEP, HIV prevention, and participation in trials. However, the weaknesses I see in our formative research efforts are 1. we mostly worked with community groups that worked closely with the site research facilities already, so our information source is a bit narrow. 2. we haven’t fully utilized these research findings to help us further our engagement activities and to inform next steps due to uncertainties and delays in the trial itself.
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For our about to commence zinc trial in Makoko, a slum community in Lagos where diarrhea and HIV screening is currently ongoing, we first consulted the PI of the recently concluded diabetes and hypertension surveillance and perception study. the PI shared her community engagement and research experience with us. Though she worked on adults, she let us know that the community is not used to longitudinal studies and dwellers always have high expectations from engaging them for health programs. She also advised us of the appropriate logistics and advocacy visits we need to do. We also interacted with a member of malaria society of Nigeria to get useful information regarding the malaria screening exercise carried out by the society to mark the World Malaria Day of 2014. This trial community lacked a CAB. So we began by getting approval from Lagos Primary Health Care Board, followed by approval from Local government authority controlling the community after paying advocacy visit to the chairman of the LGA in the company of the Medical Officer for Health of the district PHC who had earlier been briefed and included as a co-PI. Following these activities, we have been having the full support of the community from Baale of Makoko, to chiefs, elders, heads of households and mothers/caregivers of children below five years, our eventual trial participants. So evidence of government and district authority/health involvement in this research really helped our community engagement. So far we have conducted two town hall meetings to discuss the zinc trial and issues of time-point collection of stool samples to understand the transmission dynamics of viral and bacterial diarrhea in the community. Some of the suggestions of the caregivers such as free distribution of ORS instead of training on ORS preparation alone has been noted and used to revise the study protocol. Feedback of this to the community has also strengthened the cordial relationship we are having the community members.
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We do what we call ‘ Advocacy ‘ . We have appointment with the Baale ( Chief) of the Land and his council members. During this meeting, the research process is explained in details to them to speak to the community members on our behalf before we commence. most times the Chief and his council members are included in the research if they are eligible to rule out fear on the part of community members.
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In our previous research on HIV related issues we had different stakeholders because we covered all the geo-political zones in Nigeria but when we started clinical trials we selected the stakeholders within Abuja and environ since the clinical trials are taking place in Abuja and we involved them in the formative rsearch
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May be this can be differ from site to site but for my site although we have built a good relationship with our study communities and various stakeholders i still feel it would be a surprise to our stakeholders not to involve them at formative research.
I strongly feel that it is extremely important to involve stakeholders no matter how much you are known in the community. You may not involve all stakeholders but select some who may be vital at this stage.
I feel it is wrong to exclude stakeholders just because you feel that you are now known in the community, and you have known the community as this may make stakeholders to react or you may miss important issues and make your work difficult.
It is very important to involve stakeholders at any stage of the study for mutual understanding and easy follow on trial issues.
Thank you
Isaac
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We are a long standing research site with longstanding relationships with our stakeholders. Whilst we have a CAB which acts as a good communication channel with our stakeholders in the formative research stage (and all other stages), this channel is not always effectively used. It has been very effective, especially when engaging with the youth CAB for our projects focusing on adolescent girls and young women, a hard target population.
We have done stakeholder mapping for each of our research projects but making this from a paper document, into a reality is hard work. More effort could be made among the team implementing to identify effective strategies of engagement and communication for identified stakeholders, and all seeking to engage stakeholders intentionally.
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We have always involved stakeholders in our formative research however, we select which stakeholders to involve at this stage. We have usually worked with the Community Advisory Board (CAB), Neighborhood Heath Committee (NHC) and Health Facility Staff if in that setting. I personally feel it is very important to involve stakeholders at this stage so as to have a smooth flow during implementation. It helps the stakeholders and the research team to have mutual understanding.
You do not need all stakeholders at this stage but select those you think can be instrumental at this stage and keep on building on the same until the implementation stage.
Thank you
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We have not involved stakeholders in formative research. We have been very successful with enrollment, so perhaps it is because we are a long-established site with a good reputation that this is the case. I noted in the assignment that although we excel at meeting overall recruitment, we sometimes do not have participants that accurately represent the populations in our community most affected. This is less critical for the majority of trials which are early phase – and may even be a result of those trials seeking lower risk individuals. We currently have a large phase 3 trial enrolling, and doing some formative research might help us to accrue those individuals who have been historically under-represented, i.e. black msm and trans men and women who have sex with men. I like the UNITY study’s example of forming a council(s) separate from the CAB and using that resource to guide efforts in their specific communities.
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Phumeza- in regards to your adolescent vaccine study- how far in advance of recruitment for the study did you engage the community? Months before the study? Years? Also, had you worked with adolescents before or were you building new relationships in the community? We are trying to be more adolescent friendly and I feel like we should start these activities now (even though we don’t have an immediate protocol coming our way for adolescents at our site).
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Hi Sherri
We had been engaging with the community for months before we had the protocol and yes before the study we already had a Youth Friendly Clinic that had been runnin for over 3years. We were providing youth friendly services e.g. family planning, HIV testing and treatment, pregnancy test and psychosocial counseling, so we had already established the relationship with the community. My opinion will be even though you dont have a protocol that include adolescents yet just do the ground work as we are shifting the focus now to include young people in clinical trials. This will help you when that protocol finaly comes your way.
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the main way I work with stakeholders in formative research activities is with our CAB when we do protocol reviews for the ACTG. Our site leader goes over the CAB protocol summary in detail and we discuss rationale, recruitment and procedures. We mainly select studies to review that we are planning (or hoping) to do in Pittsburgh. Our CAB has an active HIV positive voice and they offer good insight into what limitations they see in the protocol. While we openly discuss the protocol, everyone completes the questionnaire on their own and we submit it independently (so there is privacy for people opinions).
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Currently, we have a community advisory board who is gradually grasping the concept of formative research , but have not being involved meaningfully. For me to do this, am planning a HIV Research ;Literacy workshop for community stakeholders. That is one i want to start the process in our site.
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I have little experience in involving community stakeholders in formative research, but if I would start formative research I would certainly involve them. Start with some internet and literature searching and than find community stakeholders, and start talking to them and from there learn and expand the list of community stakeholders who are relevant for my research. ask them about local issues, how to best approach potential study volunteers, how to reimburse them within the legal framework, other expectations, the list is endless. Formative research is were it start and cannot be done without community stakeholders.
In our HIV clinical vaccine trials most of the time we use well experienced sites, who have already done the formative research and have mapped out everything, at least that is what I expect from them. I don’t see myself going to an area and set up a get together with local stakeholders, not that I don’t want to. So please let me know what sites and other stakeholders expect from the sponsor (except budget).
Now we go to a site or network and ask them if the study is feasible and how many subjects the site can recruit and in how many months. Everything else is done by the site. I really would like to be involved more but don’t know how (not yet).
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The site was planning an Adolescent Vaccine study. We invited everyone that works with young people e.g. teachers, nurses, community health care workers, Parents and Adolescents. We held a lot of focus groups, dialogues and one on one interviews to get their opinion, understanding and preparing them for the study. The response we got on those was overwhelming and so positive. It was a lessoned learned that consultation with the relevant groups is vital before the commence of the project.
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A map of the community was put on the table and we drew lines to indicate which part of the community would be involved in the research, as our community is quite big.
Before the trial started, the research team looked for active community organizations and visited local clinics, NGO’s, churches, schools and the Chief of the community. The research that we have conducted, was one of the first researches in our community. As we experienced that we’re working in a research-naïve setting, we first had to focus on research itself, before we could explain the planned trial. Within the community we held community discussions/meetings, whereby research was explained and during these meetings we looked for support and created an understanding among community members.
From key stakeholders in the community, who were very interested in the study, we created a Community Advisory Group (CAG), who helped us further in identifying stakeholders and community organizations and set up more activities within the community, where we could explain research and the planned trial. From other key stakeholders that showed great interest we also created a male involvement group, a key stakeholder group (who helps organizing events in the community) and other partner groups (who host events, whereby the research team is invited to present about the research).
These initial steps helped us a lot in starting the trial, recruiting participants and now by disseminating the results. It’s good to have support from the community!
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I totally agree with the views of Phumeza,that consultation with the relevant stakeholders is important.It also provides an opportunity for the stakeholders to inform the study.The researchers have an opportunity to suit the study to the needs of the community.
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