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Dear colleagues, I do not believe that we are on lesson 9 and therefore, we are in the end. I think that the part of sharing our experience would not stop. I really enjoy that part and it is really learn from you.
Yes, that is true research team’s approaches and engagement activities are opportunities for mutual exchange and it enhance proactive communication with the local community. Some of rumors are reported to the Counselor or Doctors during the study visit, and they call me and seat down with Principal Investigator to discuss about how to resolve that issue. If necessary, CAB and local authorities are consulted to seek advice. It is always great to work in team, it reserve you more time, and you do not use a lot of energy.
Anne, like you mentioned, normally sustained engagement can be very challenging, but when the communication between research team, community team and stakeholders is well done, it is true, the cost is not high, as trainers are most of the time from the Research team, we use location from community for free. This reduces definitely costs.
Jessica, I agree with you, it is important to share examples of things that didn’t work. What mechanisms used to sustain engagement those just were not successful.
On my site, as I said from beginning, being in country that were clinical naïve when we started doing clinical research, we got a great opportunity to learn a lot from different countries. Before we start the study, my colleagues and I in community departments have been to Uganda and to Nairobi (Mombassa) to gain their experiences. From the global level, we have been interacting a lot with Global Campaign for Microbicide, they are the ones who come and train us. So all mentioned earlier, shared with us many things including the potential problems that usually clinical trials face and how to avoid them. It is not easy for me to share with things that not went well, I have been privileged to have great stakeholders (National and International) always willing to provide advice before anything negative happens. Then later we started working with IPM, and really learned a lot from them, in terms of engaging community, avoiding social harms from the community etc. But I would encourage anyone who have things that did not went well, to share what mechanisms used, because it is a great contribution, we all learn from history.
1) How can engagement efforts impact a participant’s experience in a trial? Do you have a concrete example from your own work?
Colleagues, I am happy to say that engagement efforts impact positively the participants experience in a trial, I am briefly giving some examples that we, as Research Centre experienced when we were doing incidence study in 2006-2008. The study population were high risk of getting HIV. So, we recruited sex workers and we were recruiting in areas known as areas having high level of sex workers. But that time, Government were doing all to discourage people being sex workers, as it was indication of increasing HIV. Different strategies have been used to help sex workers to quit that job, but it was not working. The participants(sex workers) who were enrolled in the study, were also known as impossible people who were always drunk during nights and cause problems, in neighborhood, because they had a lot of noise when they fight with some of their clients. that was their life and security people had to work at night to stop those sex workers to disturb people around. In middle of study, some local authorities came to thank a lot Research Centre because the majority of sex workers who were in the study, due to having continuously counseling on change behavior, were progressively start changing their behavior, they had stopped to go in street during nights, but continue to receive clients from hope, that was the first step, then later their reduced the number of clients.
from the reimbursement fees they get from Research Center, some were proactive and started doing a small business, like selling fruits, etc. few of them got married, it was very impressive
In the end, Research Center got a lot of credibility, but when you think about it, we managed to get there because we were in collaboration with stakeholders, the information we were sharing contributed to the participants change behavior positively.
In addition they got to know their rights in terms of health care in general, they have been encouraged to know the importance of doing medical check up, most of people have health insurance, but they believe that they use it when they are sick, and some are free like HIV testing, antenatal care for those who are found pregnant, etc.
2) How did CAPRISA’s comprehensive approach contribute to their success and network of relationships?
The success and network of relationships with CAPRISA’s approach is definitely positive. There is no way that the trial get problems during study or after study when the all community stakeholders( from large community such as global and national level are engaged or consulted.) this is to enhance and empower community engagement level. So when we plan to engage community, we have to think and plan well in order to a success trial results.
3) What are some examples of how you have sustained relationships with communities after and between trials?
Sustainability of relationship with communities is to simply keep in touch by:
Responding to their invitations, they usually invite Research Centre to either make presentation or to come to just participate in their meetings
There is contribution each year of being a member of Rwanda Nation NGO forum, we always contribute
Every December, we are among organization that have been selected to do public awareness in community about HIV/AIDs,
Each year, Research Centre provide to all stakeholders a happy Christmas and happy new card. Sometimes, depending on the budget, we also provide some gifts, such T-Shirts, pens, bags etc. Written on a message that we want to pass on.
We make sure that when the study finish, we do a dissemination of results (which stakeholders like a lot); by organizing a symposium and invite stakeholders.
To give a response an clear communication as soon as possible to any concern about study in the community or in Ministry of Health.(that is also appreciated by stakeholders)
CAB continue to be updates.
After study, we also organize a get together with former participants.
All of that, increase relationship with stakeholders.
Dear all, this is definitely an inspiration discussion, it is amazing to see how we all have some how same concerns and questions in our mind. My comments are on minimizing social harm before the trial start, yes Research team and community team may try to reduce potential social harm by educating potential participants, and stakeholders, gettogether and think potential social harm that may occur during study and propose solutions, but still social harm in clinical trials are there. The experience from our site, we have been trying to do our best to minimize rumors in the community before study start, by collaborating and educating all stakeholders that we think are relevant for the trial, but we still have social harm, not many but they still exist. While for us, we are confident that we did our best to make people understand well the trial before it start.
For that reasons, we have been trying to assess why. We have that found, those participants who are excluded in the study are mostly the ones who cause social harms in the community due their rumors; we tried to discuss with some of participants, here is what we got as responses: participants who are excluded try to hide that they had been excluded, because they do not want partner, family or neighbors to know why they did not continue to participate in the trial. So they have to create such stories, others do that because they are jealousy etc. To me avoiding social harm, I think it is not easy. What we do is to make sure that we do our best, and we have stakeholders who are active enough to keep their eye open and share with us any information including social harm so that we intervene as soon as possible.
1) What are some examples of trial-related harms that participants have experienced, or might experience, at your site or the site you are affiliated with (e.g. loss of housing, social stigma, vaccine induced seropositivity)?
For our site, we did not face a serious harm, it was more about social stigma. HIV testing is one of the test done before the participants be enrolled in the study. The fact that when we recruit participants, they come from same areas, and they know that HIV is one of exclusion criteria; so if other participants found out that they neighbors are not coming to the Research Centre, they will started gasping, maybe she is HIV positive, while they know that there are many reasons of exclusions criteria, but they always think about HIV in first place. This cause stigma those who are found HIV, that why even though they are excluded, we refer them to the trained counselors, ,(we give her a list of clinics that we walk together and they chose them selves which one they prefer) but still and we also make a follow up by calling them and find out how they are doing.
and some rumors caused social harm as well. E.g. women especially those who are excluded, tried to find away of explaining why they are not coming to the Research Centre and said, they stopped because RC remove uterus, or they inject things that would harm participants, those kind of things. So some participants get problems with their partners or families who hear those stories, and some times we have to intervene
2) How has your team dealt with these situations? Which stakeholders provided input, and how did they help?
Most of the time, Principal Investigator and Study Physician come with me in the community to give correct information, it depends on what kind of information we have, if it is serious then we go there as team, or we invite participants with their partners to come to Research Centre and we explain more. Most of the time study participants are the ones reporting social harm, or community mobilizers or local authorities. And they are the ones who suggest that we could go in the community or we invite people at Research Centre. It depend on situation.
What implications did the lack of inclusion of clean needles in the prevention package have for trial results?
For Researchers, not including clean needles in the prevention package was not right thing to do. And that shows that the consultations with stakeholders were not properly done. I am sure that somebody from stakeholders would have mentioned that clean needles was would be in prevention package. To avoid any misunderstanding and confusion about that study from stakeholders, Researchers need to know that consultations with different stakeholders from the community, should be done in beginning of protocol development to make sure that the trial will be conducted smoothly and the results will come out successfully. If the community is not involved from beginning, addressing issues that come later during the study, it is very difficult, that may affect not only bad trial results, but also credibility of researchers, and more energy. So later on they may have trouble to conduct other studies in future. It is time to all of us to think a head, and work together, increase collaboration, and consult each other in all stage of protocol development.
2) How can researchers engage stakeholders to better negotiate prevention packages that combine various arrays of options tailored to the needs of diverse subgroups?
First of all, researcher need to make a clear message to every stake holders. What I mean here, researcher team would select all stakeholders who will be involved in the study. Share with them the protocol and seek for inputs, sometimes researchers need to keep their protocol confidential, totally agree, that why we have to sign a confidential agreements, we would ask every one who will be selected to provide input to sign that. that is more reasonable that ending with troubles that may occur after, or getting bad results of the trial.
Dear colleagues,
I am back on line. I was not in Rwanda, and it was not easy for me to be connected. I am happy to reading again your interesting discussions, I was missing that. I totally agree with you all, engaging community in early stage, is the best way to avoid confusion and misunderstandings, eventually, it increase more trust between Researchers and Community, it provide freedom to communicate effectively and do move out any concerns that one of them may have during the study. as every one get time to raise he/her questions before hand and have clear image or situation earlier. So let support that idea of involving earlier stage, because we all benefit from it. Working in harmony, we always get a positive result .
Dear all,
I am reflecting on these discussions, and Mathias mentioned something that reminded me that most of our CAB members are mainly from community area, they have capacity/skills to contribute on the socio-cultural part in the protocol, they are also able to contribute on socio-science component of the protocol; as we have qualified nurses and social scientist in the group
My question is, as we all see the importance of involving stakeholders early in the protocol development; and depending on protocol, we also have a clinical research part, should we have to extend our stakeholders and recruit scientist who would also contribute to the clinical part? or Study Physicians are enough, as they usually do this part?
1) Give an example of successful stakeholder engagement in protocol and/or IC development. What changes were made as a result of the input gathered?
I am supporting my colleagues who mentioned the importance of stakeholders engagement in protocol and/or IC development. It is very crucial in term of building trust between research team and stakeholders, and it also facilitate the recruitment and retention of participants, as you start recruitment with confidence because everything have been thought of before hands.
I share with you one of examples that resulted positively while engaging our stakeholders in providing inputs on the protocol.
IPM (International Partnership for Microbicide) was our main sponsor. When our Research Centre gets a draft of the protocol from them, we invite our CAB to provide their inputs on ICF, Recruitment process, the target population, etc.
In 2006, we did a study on HIV incidence, where we needed 400 high risk participants, which mean that we had to prescreen a lot to get this number. when we were locating the recruitment sites, in collaboration with stakeholders, we had realized that the majority of Sex workers( who were targeted population) are young Girls.
In Rwanda the age of adults who can consent for themselves, is 21 years old; not 18 (as it is required in most of protocols). CAB suggested Research Centre to request the permission of recruiting young Sex workers between 18-20 years.
The Research Centre wrote an official letter attached with another support letter from CAB members to the National Ethics Committee, and we got permission. We got to know that the arguments from CAB letter, influenced the positive response. So from 2006 our Research Centre we are allowed to recruit participants from 18 years and above, but those who are between 18 to 20, they have to come with guardians, with an official letter from the local administration stating that the person is her/his guardian.
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?
Because GPP, these days in clinical research would have to be followed, the amendments are done even after the protocol is finalized; which I think should be avoided before hand by involving the community in the beginning of protocol development. Most of the time, we get a draft of protocol seeking community inputs, on last minutes, if the changes requested to be change in protocol need to take time, an example above, we got response of recruiting young women, when the protocol had already finalized, it would not wait for response. But any way we had to recruit them as we had got Government permission through the Rwandan ethics committee.
So I think we should be the ones who would make a step to negotiates , how we would be included in a team who is involved in protocol development from the beginning.
Myself, I already negotiated with my Research Director to notify our sponsors that I would like to be part of a team who develops protocol, and I hope that will happen.
I would encourage you all to do the same, because I am sure, we might useful to change or ameliorate some things from beginning , following GPP guidelines.
Hello Nanyondo,
Let me share with you what we always do when we have a new study, to avoid those kind of rumors from the study or potential participants as the most of the come up with such stories, we first make sure that CAB have been involved in protocol inputs before it finalized. Before we start recruitment in the recruitments sites that are chosen, we train the local authorities from the recruitment areas, the we do general education where men and women are invited, then we go back for the recruitment of potential participants. Those who are invited for the recruitment sessions, most of them are from those who had come for the general education on the research. During our recruitment session, we do power point presentation with the information about the studies we are going to do, after presentation and answering the questions, you invite one by one to meet individually for prescreening using prescreening check list. This is to minimize the number of participants who would come at the site and be excluded from the sites. We have found this very important in term of finance and less time that would be used by research team.
Rumors will still exist, but with approach is very easy to handle them, as you will be having support from all those people who you trained. Sometimes rumours may occur in the community, and they resolve between them selves and you get to know later what happened. who resolved it and she/he did, or if they do not manage, they call you.
Regarding media, make sure that you have in you CAB, 1 or 2 members from different media, it is so important. There is time that we got a problem of a study that was discontinued, as the news were in international radio, it affected us. To use social media, we had to pay, almost 6 .000$ and we ended up not paying even 1$.
Make sure to have a good relationship with your line Ministry, even if we do have members from media, it was not enough, because our line Ministry had to write a letter asking media to assist us. That all I would share with you.
1) How has social media and online communication affected your trial communication planning and engagement strategies with stakeholders? <b><i></i></b>
The social media and online communication affected our trial communication planning, as social media reaches a good number of people from the entire country and in short time, its consequence maybe be positive or negative.
Positive when the social media are publishing good information about the research; Negative when it publishing unpleased trial results. That is why the research Centre has to make sure to recruit a good and an effective stakeholders, who would be handy, when social media has published information that would disturb Research Centre.
Even though social media publishes interesting information about the Research studies, the audience (especially audience from Research naïve population) may interpret the information negatively, due to their level of understand the purpose of clinical research.
That why I would encourage Research Centres to engage stakeholders as early as possible and who are able to intervene when it is necessary, e.g. when there are social harm caused by media etc.
Social media would affect communication planning and engagement strategies for stakeholders, e.g. that CAB prepare their action plan for year, if social media has given information that contract with what they have been educating to the population, It is normal that their activities are affected and to correct them takes more energy.
2) Have you ever experienced unexpected issues at your trial site or in your research context? How were they handled? What lessons were learned?
Yes, our Research Centre has been experience unexpected problem, during the stop of CAPRISA study.
As we were doing research on microbicide studies, at the same time, we have been doing a lot of awareness, so then people who have been following us doing advocacy of microbicide got news that CAPRISA has been discontinued because it is not effective.
We got a lot of calls from different people, and some were sounding unhappy, accusing us being using people.
Action taken:
We called our CAB and Mobilizers for an immediate meeting, the conclusion from the meeting was to invite immediately our participants for a meeting to ensure them that there was no problem, as the products were different.
We invited different media(national and private), we used them to answer questions to from population.
Principal investigator and myself had 2 hours on radio that we had chosen, which is popular in Rwanda to discuss that issue with population.
The Deputy Director from of Rwanda Biomedical Centre from Ministry of Health, the Chairperson from Rwanda National Ethics committee, the participant who was willing to contribute and support Research Centre, were all interviewed with different radio regarding our Research activities.
As a Communication and Community Outreach person, I wrote an article showing the difference between microbicide studies, to show people and calm them that the product that Rwandans were using were different from CAPRISA study, and the article passed in 3 different newspapers and it was in all languages(Kinyarwanda, French, and English).
It was hard, but I was really happy how much we are supported by our stakeholders, and all things mentioned above regarding how we handled the problem, have been done in 3 days. It was really amazing.
The other thing we did, we recorded all questions asked and the answers from me and our Principal Investigator, and we did transcript of all of that recordings.
1) 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?
Even thought I had said something on that topic yesterday, I think I forgot to mention that type or nature of the studies are also considered while you are recruiting CAB members or any other stakeholders, like for examples, if you do studies on family planning, you will need to include all health facilities in charge of family planning from grass root administration to the high level, which is Ministry of health. In Rwanda, all activities are decentralized, like for example, health facilities in charge of family planning are from Sector level to the Ministry level, and they work closely, as researcher you need stakeholders from each level, those from sector level, to help you in recruitment and retention of participants, those from Ministry level are to help you to make sure that study end with success, and they are also policy makers, which are an important part for research especially during dissemination of the study results.
As regards of stakeholder mapping: let take an example of High HIV incidence community mapping:
Sorry, I tried to use a table here which would be more visible on what I would like to share but it is not working. During community mapping, I think there are some important things to consider: With the example below community components, we may think of questions to direct or to prepare us on best way to chose community. From each example of community component and its created questions, we may obtain anticipated outcomes.
1. Community component: 2. Questions 3* Outcomes/discoveries/ observations/ problem areas.etc
*People: * …………………… *………………………………………………………………….
*Opportunities: *……………………. *……………………………………………………………
*Group: * ……………………. *…………………………………………………………….
*Community services: *………………………… *…………………………………………………………….
*Source of information: *……………………….. *…………………………………………………………….
*Employment and Industries: * …………………….. *…………………………………………………………….
*Cultural identity: *……………………… *…………………………………………………………….
Hello to all of you again,
Anne, of course by reading more and more from the materials and colleague’s experiences, personally I do see where the gap is already in term of building a better stakeholders engagement. Which I think it is not difficult to implement in the future, due to the existing experiences we do have already in collaboration with our stakeholders. I will say that we need to polish what we were doing in term of collaboration, communication etc. That why, I am really happy to be a part of this course even thought I am missing time to do my assignments on time due to another responsibilities, But I am enjoying a lot, as I am evaluating myself through to the discussions and documentations; and looking forward to make some improvement. The only thing that we do to engage another stakeholders, not CAB, is to share with them the new studies coming, like local authorities, we train them before starting any study, we invite them in meetings, we participate in their meetings where thy sometimes ask us to updates community where we are with research, we invite them to talk to the media if needed, etc. That how basically I will say that we engage them.
Hello colleagues,
1) First of all, CAB members are from the different institutions/ Organizations/former research participants that are in the position with capacity of helping ongoing clinical research. It is a group which sometimes changes depending on situations. This is concern of other stakeholders as well. You may need to add on some CAB or other stakeholders depending on research level, some sites start with a small group of CAB/stakeholders, because that all needed at that moments, but as the research site grow, you may need to support your CAB/stakeholders by adding more members, most of the time is better if you choose the new ones in collaboration with existing CAB members. Selecting stakeholders, you have to be objective while recruiting, because you need members who are capable and available to positively contribute to the clinical research.
2)For sustainability of stakeholders. CAB members meet every month, but sometimes we may need them for urgent reasons before their schedule time. During trainings of stakeholders, depending on what is on the training agenda, sometimes we invite CAB, research team and other stakeholders, with aim of allowing them to meet and socialize; which later we have find that is very important, seeing how they exchange and discuss about the clinical trials, and the perceptions from the communities, and suggest solutions to the research. Each group(CAB, Research team, other stakeholders) prepare also a presentation to be given in that training. We usually have 3 days of the training in the end of years. In order to motivate our stakeholders, we reimburse their transport fees, so no one would not miss because of the lack of transport.
All our stakeholders, are invited in symposium organized by Research site, especially during a launch of new study or dissemination of the study results, where sometimes our CAB member are also presents.
Dear Ann and all,
I hope you had a nice weekend. It is true that we seems to engage CAB other than other stakeholders, but beside engaging a site specific CAB, we also try to engage other stakeholders, e.g, we engage our Ministry of Health as our line Ministry; we engage Ministry of Gender and Family Promotion, women Parliamentarians, National Women Council, women associations, selected NGOs, families of participants, etc (because studies we have doing are for women).
How to engage them?
1)We use presentations, meetings, organize trainings, updates them for the previous and upcoming studies; the objective of this to provide Knowledge and skills about Clinical trials.
2) We engage them by inviting them in our official events, some are invited as our guest honors( especially those coming from high level, e.g Ministries), others are coming to support the research sites.
When media want to talk to our stakeholders, they do it willingly. When Research need official documents, they get them without problem, because they are aware of what we are doing, as we share with them reports,
If any one from community have any question, they have number and contact person, they call any time they want during working hours.
Research nominated a representative who would be available to participate in any meeting organized with our Stakeholders, which increase a good collaboration.
We have been invited with different stakeholders to make a presentation on our research. But as mentioned in beginning, most of the time, Our CAG are the ones to be engaged.
Engaging other stakeholders, it is the best way to do smoothly the trial, but some times it is also limited by budgets.
Dear Ann,
I do not know if I understand well what you mean by community leaders, we commonly use local authorities who are leaders from District level to the village level, I would even include on that level, Directors of division from our line Ministry which is Ministry of Health. Then, we have central level which composed with Director of Units, Director Generals, Ministers, etc.
When we do initial formative research activities, we work with the local authorities, because in Rwanda, there is any messages or activities done in the community without approval from community leaders, some do, but even if you trial to do that without approval, the sustainability of your activities is not guaranty. There is a group in the community who is in charge of reviewing all materials(brochures, presentations etc). They do that because they want to minimize the duplication of activities in the community, or to see if the messages are appropriates according to Rwandan context. So they are involved because they even review materials and give inputs or suggestions if necessary.
Regarding the design and conduct of initial formative research activities, I would say that Research team together with community team from sponsors draft design research activities, CAG would be invited to provide their inputs. Then, local authorities who is in charge of Research on District level, will be given documents regarding the research activities for review, which in most cases they do not change contents, but at list they know what is being done, or they provides suggestions that would help in better achievement of the activities planned.
A part of having documents reviewed by the local authorities, they contribute in getting the right potential participants, and choosing the best recruitment sites, they also available when media needs to talk to them about research trial done in their community.
Totally agree to add on what we have been doing with local authorities, we would definitely think how to incorporate local expertise and input by doing Focus Group Discussions, interviews or surveys. I have never think that before and it is really interesting and feasible.
As now we are doing research on the family planning with Ring Plus, looking the safety and accessibility of product; we have been doing many FGD and individual interviews for participants and partners. The participants showed that they actually like the ring for diverse reason, we are planning to have meetings and do surveys with leaders who make policies, to see what they think about providing the ring to the Rwandan population in the future. so I think, instead of doing a surveys, we would do Focus Group Discussion, or individual interviews, it would give more information, because at that point you will be able to probe for more information.
So, based on what we are learning, I think we need to improve, and get more information by organizing FGDs and individual interviews to our Local authorities (community leaders)
MMU
