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As many others have noted — it was extremely useful to have the detailed guidance through the content of the GPP Guidelines, to have interactions with others who are engaged in the same work, and to have the facilitation of skilled moderators. We can all sit in our offices and read the GPP Guidelines (and I am sure many of us have!) but this course was much more useful than that as it forced us to think through the principles, apply them concretely to our own research programs, and to hear from others about their experiences. I also hope that this learning community can be extended and that we can continue to draw on each other and the facilitators as we move our work forward.
Thank you very much Anne and Jessica for helping us all build a foundation on which to grow our programs.
We have not yet arrived to “after” or “between” any studies but this was very helpful in giving us some ideas about activities and approaches to take when we get there. We are currently planning a lead-up / preparatory observational study to lead into the efficacy study with the idea that participants in this study will be eligible for screening for the efficacy study. It will be key to think about the types of engagement during this study that can lead to the efficacy study, including research literacy events, ‘appreciation events’, and creative ways to build trust within the community.
How might your team handle this situation?
A lot of important suggestions have already been made by my fellow learners. Here are a few other thoughts.
After such an attack it would be important for the research team to convene a meeting with their local CAB and other stakeholders to properly debrief the incident and to develop strategies that are appropriate to that local context to prevent such attacks in the future. They may also wish to develop clear communication about the attack and future strategies to share with trial participants and potential participants so that the research team is in charge of the communication about what happened and can also communicate their response, to minimize potential additional rumours. In addition the research team should discuss what their responsibilities are towards the participants who were harmed. Finally, the research team should discuss with the CAB what kind of communication approaches could be useful to dispel the rumours that the trial is “training men to be gay.”
In response to Anne’s comments — I think this case study is incredibly relevant to trials being planned now. Some trials of next generation prep products, like long acting injectable PrEP or monoclonal antibodies, are being designed with a standard of care comparator in settings where oral daily PrEP is not available. I think it is important to engage local stakeholders in conversations about this to assess their understanding of tenofovir-based PrEP and the gaps in their knowledge, and whether they understand that a product that does protect against HIV exists already but is just not available in their national context yet. In the Thai example, it seems like clean needles were not available inside or outside the trial – so no injecting drug users were able to access them, even though it seems like ethically wrong to not provide clean needles . Likewise, if a new PrEP study is implemented in a place where TDF-based prep is not available, then is the study unethical for not providing TDF to participants? The issue of standard of care in the local settings is very difficult to navigate. However engaging with community stakeholders, discussing these issues ahead of time, and having a discussion about what the trial will commit to if PrEP does become available in the country, are all important topics for community consultation. Trials have to operate within national contexts with national laws and policies — but communication and transparent discussion with the community would hopefully increase trust and transparency.
I feel it is important to come to local sites with draft protocols that are intended to receive feedback from local stakeholders.
We have just gotten through the process of getting agreement to the basic outlines of a trial protocol for our planned study among the various partners at the global level and are getting ready to have a first conversation with regulatory bodies to get their feedback. Once we get that feedback we will be moving on to sharing the general idea of the study design with other national stakeholders, potential site investigators, and communities. The lesson provided useful examples for how we could structure getting feedback — for discussions with potential site investigators we may be able to use the clinical study proposal that has already been translated; however for discussions with the community stakeholders, we will need to create lay summaries in local languages. I expect that this process will take several months.
Mark’s post is really very insightful and highlights the potential benefits and pitfalls of social media. In China, where the government has very tight control over traditional media and the messages and stories that are reported on, there is a greater measure of openness on social media platforms like WeChat. However, as many have said, there is also a great opportunity for misinformation and rumours to be spread quickly and widely. In thinking through our trial’s communication strategy we will want to invest staff time in participating in relevant WeChat groups and monitoring discussions related to the trial. If misinformation arises there, it will be critical to have the appropriate “key messages” and have a person identified to respond to issues in online forums.
Haoyu accurately describes what we have done to date in terms of community engagement — which is engage with the “obvious” community groups who have experience engaging with the clinical research sites already. A stakeholder mapping exercise will be a critical first step and mapping would be useful to conduct both at the national level and at each of the sites. I think it will be useful to think of typologies of stakeholders (local CDC, local CBOs, academic centers, hospitals) and their theoretical importance; then working with local contacts in each site, figure out which actual organization are in operation in that geographic location and figure out how to engage them. One of the stakeholder types whom we engaged early on and would now like to re-engage are social networking sites in China, particularly those focused on MSM, whether they are hook up sites or cultural information exchange type sites. I would be interested whether others have experience engaging these type of websites and whether these types of entities have been useful to engage as stakeholders.
Thank you Phumeza, that is very helpful. As we only have one trial coming down the development pipeline for now, it may be hard to advocate for such a robust team. On the flip side, given how little work has been done to date, we arguably need to devote more efforts to this. It is very helpful for me to have your example, and others (keep them coming!) to use as concrete talking points for my discussions and negotiations with the sponsor. Thank you.
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.
As Haoyu mentioned, at trial sites that we are considering for the China PrEP trial currently being planned, there has been little / no meaningful community engagement. Our team has conducted some early formative research at two of the potential trial sites in the form of surveys and focus groups. We have also visited the potential sites to understand baseline clinical capacity and to begin to understand relationships between trial site and community. However after going through Lesson 2 it strikes me that 1) we have not done a good enough job following up with individuals and groups whom we engaged to maintain the engagement and grow the mutual respect, understanding and importantly, trust. And 2) we have not done a good enough job documenting these interactions. This matters for our own institutional recording to ensure that when staffing changes occur, we have a record of what has been done to date. Such reports / notes could also be shared back with community members who participated in these activities as a record of what we have done together and to ensure that they agree with our perception of what has taken place. Both of these are things I think we can make sure we put more emphasis on in the future.
The trial in which I am involved is still in its very early stages of planning and will take place in a country and at sites that have not previously had any multinational HIV prevention trials. From my perspective there is extremely limited knowledge about GPP across the whole research team, including the sponsor, the protocol development team, sites investigators being vetted for participation, regulatory bodies, not to speak of community stakeholders. One very concrete learning from Lesson 1 is the idea that the sponsor should adopt the GPP guidelines as a requirement — this will be a goal which should be achievable with sufficient explanation about GPP and the ways in which they function to strengthen the overall trial design and implementation. It is very encouraging to read that in other sites the whole research team is knowledgeable about and invested in GPP and gives me hope that we will get there as well.
Hello everyone,
My name is Kathrine Meyers. I am a social scientist working at the Aaron Diamond AIDS Research Center, based in NY but with frequent travel to China where our HIV prevention projects are located. My work has been mostly in HIV prevention program implementation and policy advocacy. More recently I have been pulled into clinical trials of HIV prevention products, here in the US and in China. I am eager to learn all I can from this fantastic group of advocates and to become an articulate advocate for the need for GPP within clinical trials being planned in China on a general level and more specifically, how to engage community participation in a context that is hostile to civil society and stigmatizing of men who have sex with men. I look forward to our journey together!
Kathrine
