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First of all I would like to move a vote of thanks to our able facilitators Anne, Jessica and team for a job well done. You facilitated in a way that made the training very interesting. One issue I would like to find out is whether there is a way in which research community teams can get to know the amount of money provided in every protocol for stakeholder/community engagement, because if you have no idea of the resources available to do your job planning becomes very challenging. I wish there was a way research organizations would be required to have minimum stakeholder engagement package as a condition of conducting research. We could be able to prepare stakeholders and communities to support and own research process.
I learned during this training that stakeholder engagement is critical and was surprised that the only stakeholder CAB that we have been engaging is not adequate. I have learned through issues management that it is prudent to be proactive in anticipating issues in consultation with stakeholders instead of our practice of reacting to issues with no Communication and issues management plan. This course has given me the necessary tools to plan and execute my work. I wish this course would continue… I am sure the network we have established will come in handy in ensured we lean on each other, Apart from Alice the only other person I knew was Erica who comes from our sister site in Southern Tanzania, our network has really expanded. I am a CoP member and look forward to continued collaboration. I am already missing this GPP training!
Nokolunga raised an interesting scenario of a community that reject research despite stakeholder engagement. If indeed that occurred it would mean that site selection was not done well because research ought to be attempting to answer a question that is relevant to the local community. a community can be in denial but will eventually open up when you engage broader stakeholders and come forward to participate in the search for a lasting solution to their health problems through technologies researchers are trying to develop through the planned study/ies.
I think CAPRISA succeeded because they were well resourced being able to address community needs obviously endeared them to the community. Did they include non HIV activities like building school, teachers houses, and feeding program in their initial stakeholder engagement budget or it came up as an emerging issue and they requested a supplementary budget?
In our site sustaining support groups after a study is difficult because travel reimbursements for members stop when the protocol follow up ends, usually because budgets are limited to a study lifespan. However stakeholder engagement especially the CAB goes on because ongoing studies support their monthly meetings.
Broader stakeholders are engaged during our HIV vaccine awareness days on May 18th usually attended by former study participants among other community members and and WAD days on 01 December
I have now learned that innovative ways exist of leveraging on other stakeholder events to sustain relationships in the light of limited budgets so that one can keep broader stakeholders engaged.
It is critical that once participants are enrolled in a study every effort should be employed to ensure they complete their study visits. Going forward it would be helpful to implement GPP during protocol development for these anticipated events with stakeholders by developing a communication and issues management plan.
We had a similar incident where participants who seroconverted during the study blamed the site for infecting them and attempted to sue. We engaged the CAB and reached out to participants to allay the fear that their participation in the study will result in HIV infection. This GPP course has now taught us that issues that are anticipated should be planned for in communication and issues management plan.
When community members protest against poor or lack of services by their local authorities, causing disruption of traffic, attendance of research scheduled events may be disrupted. This type of unanticipated events are difficult to predict and mitigation planned. sometimes it may require the site to plan for additional provision of funds for transport reimbursement since it may force study participant to use longer routes to the site, or participants may need to be rescheduled.
Jessica I appreciate your input that stakeholder engagement is not limited to time but an ongoing, “live” process. Now the final protocol is with you it has gone through you regulatory process and ready for recruitment. The challenge this poses is that the mother brings this participant to study ques for the process. The mother then goes to another health care provider for her medical attention.
Now because the protocol only provided a budget for treatment of participants for study related harms/injuries and minor ailments, upon consultation can stakeholders require that mothers too should be treated and ask the sponsor to review the budget? How can this be enforced to comply with GPP?
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
Oops! i just noted I did not participate in this discussion.
Stakeholder engagement in terms of CAB happen monthly and has become part of the site routine. During the monthly meetings CAB members are give research updates and protocols undergoing regulatory review presented to them, and their input to Informed Consent sought. This then become recruitment focused and conversation around ongoing and upcoming protocols. The site believe they represent all stakeholders which is not true because they are broader than the CAB and when you have 13 members they can not represent all stakeholders
Stakeholder engagement as anticipated by GPP requires a new approach and that this course will help us understand and plan to reach out to all stakeholders continuously.
Upon receiving the report of this incident of social harm related to study participation, my first line of action is to notify the PI and study team. Next I will call CAB members and other relevant stakeholders so that we can consult and come up with a communication and issues management plan to address and mitigate the issue and explore of preventing recurrence of the same.
What could have done earlier.
GPP was not implemented before the trial commenced, apparently the team had not done proper mapping to understand the sociocultural landscape, because what mattered and cause concern to the community could have been found out. When a research study seem to challenge community norms, a back lash should be anticipated, and a communication and issues management plan developed in consultation with relevant stake holders to prevent the crisis.
Implication of lack of clean needles;
Obviously lack of clean needles impacted negatively on participants on the placebo arm of the blinded controlled trial because sharing contaminated needles is one of the surest ways of contracting HIV. This could also paint the trial team negatively as the old concerns of participants being guinea pigs is likely to result. The research team had the difficult task of balancing the odds; the need to develop an effective HIV prevention tool and the need to comply with the law they chose to do both. The research team ended up being perceived as uncaring since they knew for a fact that sharing contaminated needles exposed users to HIV infection yet they watched it happen which is unethical. On the other hand if they covertly offered clean needles they would have been breaking the law. This whole scenario resulted from inadequate time for stakeholder engagement and exclusion of critical stakeholders in law enforcement in compliance with GPP requirements.
How can researchers engage stakeholders to better negotiate prevention packages that combine various arrays of options tailored to meet their needs?
Like provided in the GPP there is need to devote adequate time for stakeholder mapping and engagement long before the study. Obviously nobody seem to have reached out to law enforcement stakeholders or law makers to advocate for the need to accord HIV prevention the same seriousness accorded to fighting drug use since both impact negatively on health of the nationals while one drives the other.
This reminds me of a scenario we had while I served in the Technical Working group developing tools for HIV programming for Key population mainly male and female sex workers in Kenya . So various stakeholders stakeholders were invited which included representatives of the key populations and a representative form Police AIDS control unit a senior Police officer. When introductions were made the policeman protested that there was no way he could sit with people in sex work while it remains illegal in the country. He threatened to work away unless the Sex workers were expelled from the meeting. It took the intervention of the then head of National AIDS Control program ( now the Director of medical services in Kenya) who convinced the Police officer that it will take the effort of all stakeholders to fight the pandemic without apportioning blame if the country was to switch of the taps of HIV spread
With strong advocacy groups law enforcement agencies can be convinced that to fight HIV we need “to take the bull by the horns” and involve all possible stakeholders.
Should participants enrolled in Biomedical HIV prevention trials have access to higher standards of prevention/care than other members of the local community?
Yes ideally they should because volunteering to participate in a IND study where there might risks that have not been understood are involved makes one a hero and heroes participating due to altruism should be given the best care possible as advocated for by GPP as part of stakeholder negotiation before studies begin. There is of course need to balance that in such a manner that it does not become coercive especially in our resource limited settings.
A draft protocol that was to be implemented in the site was send to the CAB as is common they were expected to fill a questionnaire that asks whether the protocol answers a scientific that is relevant to the site, and whether if they qualified they would participate in the study. the CAB noted that Phase I IND protocol planned to enroll 18 subjects. They disliked the use of world subject because it make people like object that can not exercise any right. They insisted this be substituted with either volunteers or participants. This was changed to participants,
When a protocol is send to the site in the final form, to comply with the stakeholder engagement guidelines the protocol will be presented to the CAB to review informed Consent document this has been our practice. We have now learned that other stakeholders targeted likely to be affected by research ought to be reached, and their research literacy build so that they can be able to make informed opinion about planned research. It will be easy to have their buy in and help in addressing misconceptions.
We missed this discussion questions in the forum last week and are now contributing belatedly.
Social media has had no impact on trials in our site so far, basically because of the literacy level of our participants and that the majority of them do not own smart phones.
We have on one occasion experienced sensational adverse coverage by the media. A couple was informed that their two daughters were in our site to “sell blood”. They live 12km away from the site they quickly came and created a scene at our gate attracting a huge crowd including the press. They proceeded to the local police station and reported that their under age daughters were bled to death in our site.
The police accompanied them and established that the daughters had come to inquire whether the could participate in one of our trials, that they were aged 20 and 22years were well and had not even consented to participate and that they both had children. The following day press ran sensational report POLICE STORM A US MILITARY RESEARCH FACILITY subsequent to this we called an urgent CAB meeting where we gave them the true and clear picture of the situation. They then convened a meeting with all local community leaders, and all national and local media houses represented. The correct information was given and time was given to answer questions.
As a result of this training we have now learned that there is need to give communication training to the CAB and site staff so that together we can all develop the site’s Communication plan.
We do not engage with media as general practice though we work with them to in Planing the World AIDS Vaccines awareness Day and World AIDS Day, where we use the international Athletic star who come from the region to participate in competitive races to mobilize the community. We also use the WAVD as our site open day when the public including the media can tour our facilities
For the additional question of sustaining stakeholders interest; Every May 18th the The World AIDS Vaccines Awareness Day (WAVD) we work with star athletes to stage competitive race and fun run. This being a region where most of the international athletic champions come from it attracts community interest. We also host talent shows and body building events as build up activities for WAD every December and involve stakeholders in these plans.
I start by admitting that in our site we have not engage in stakeholder mapping as described in this course, though I have some experience to share, that makes the case for the need for stakeholder engagement before trials.
1. Our first study was a HIV vaccine cohort targeting mainly Tea plantation workers and their adult dependents to establish HIV prevalence, incidence and viral diversity in this community which fairly represented the general population in the region. The tea plantation was chosen because it had a stable population of migrant workers residing in the plantation who would be easy to follow up. Scientists went population and explained to the workers that they aimed to recruit participants who would be tested for HIV and the results would be confidential, among the information to be used would be their employment numbers. Plantation workers declined because they thought their employer was working with the research to find out people who were infected so that they could be fired. During that time care and treatment was not available and knowing one was infected was like a death sentence. All attempts by management to convince workers to attend information sessions failed, since workers and their adult dependents had been assured that participation was voluntary.
Scientist took a back seat and engaged community outreach team to establish what the issues that generated hostile reception of the study were. This when it was decided after learning from sites that had done similar work, that it was important to form a community advisory group. A scientist, plantation executive and some plantation union representatives were picked and the scientist became the group chair. When meeting were called, participation was very poor. To improve community dynamics, the scientist, and Tea plantation executive stepped down, and in their place a local teacher, health care worker, and grass root government administrator were picked and information on community fears and concerns started flowing in, which were gradually addressed
The local administrator, Pastors and teachers had received all manner of myths from the community indicating that they trusted them and hence their membership. Workers were being represented by their union and they had to be included. Members were therefore picked based on the trust the target community had on them.
To engage various stakeholders of diverse backgrounds was initially a challenge, however they were informed in capacity building forums that HIV was wrecking havoc in the community and has leaders they have to lead the fight from the front and that research was critical in knowing the extend of the problem, so that a solution the search for a vaccine could begin. They were eventually brought together in support of research by the common threat they all faced.
I do not consider recruitment as the as the core theme and objective of stakeholder engagement but I can understand where most of us are coming from; In most sites or at least in our site community engagement has always been not been given the priority it deserves. What usually happens is that when a protocol is being developed scientists who have the say in protocol management will be preoccupied with the science and budgets. By the time version 1.0 of the protocol is released priority becomes the regulatory review process. The next thing will be to ask the community engagement team to develop a recruitment SOP and the pressure move to the community and get potential study participants for screening. It is therefore understandable why people confuse the two. This training has described Community Engagement as the process of identifying, educating and involving critical stakeholders ( which includes potential study participants) before, during and after the trial.
