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The GPP training has raised my personal awareness about the different stakeholders and the need to proactively communicate with them. The many real life case studies were very helpful in understanding the challenges around HIV prevention research.
A question – I hope people are still reading this discussion forum 🙂 – apart from the ebola example provided above, are you aware of any other disease indications were GPP is being applied?
Many thanks to Anne and Jessica, you are not only great GPP experts, but at the same time enthusiastic and encouraging teachers!
The Caprisa site invested over time in building capacity within the communities, which proved to be a great basis to build trust, and to truly connect with the local community before a clinical trial starts.
Referring to chapter 3.5 of GPP, a study sponsor could e.g. build a connect with the local Community by providing clinical trial information, long before the study starts, during the trial upon study closure, and ultimately about the study results. Currently we do provide newsletters to study participants with an update about the study progress. The same newsletters could be distributed by the site staff to the CAB members.
What implications did the lack of inclusion of clean needles in the prevention package have for trial results?
Although there is a controversial element in this case, evidence of PrEP efficacy among injection drug users could probably be demonstrated earlier, as the number of new HIV infections, needed to draw a conclusion on efficiency, would have been reached sooner. In the end, less study participants may need to be exposed to an experimental method. The sooner the effectiveness can be confirmed, the sooner the new method of prevention can be rolled out at a national/ global scale. It would be interesting to make a statistical analysis of this scenario: How many people would be exposed to an experimental method without additional intervention (in this case clean needles), and how many study participants would need to be exposed with additional intervention?
Give an example of successful stakeholder engagement in protocol and/or IC development. What changes were made as a result of the input gathered?
We are in the process of developing an electronic ICF (not just for HIV prevention trials, but for all types of clinical studies). I intend to involve stakeholders at a local level, to test the concept for HIV prevention trials: is the information presented in an understandable and user-friendly way? How to deal with the concept in poor resource settings? ie the eICF can be accessed at the study clinic (eg via iPAD), however how can the study participant consult the ICF when going home?
Hi Charles, good to know about your local policy: this seems to be a useful approach! How much does such review usually take?
Also interested to learn how other sites deal with this: all input welcome!!
In preparation of an international HIV prevention study, we have to map which stakeholders should review the protocol. With this have to take into account relationships between different groups, as well as ensuring that country-specific feedbacks are incorporated. I learned today that priority setting can be helpful in reaching out to protocol reviewers.
In my research team, there is awareness about the different stakeholders, from a local to an international level. There is still a lot to do in terms of stakeholder engagement, and priorities will need to be set seen the limited resources we’re (all) dealing with
Hi everyone:
your feedbacks and examples are extremely valuable to me (working at a global level): your examples and experience enhance my understanding of the many local challenges you are facing.
I also have a question for you: per GCP guidelines, subjects should not be coerced to participate to a study. In this light, have you ever faced concerns (eg raised by Ethics Committees) around offering HIV preventive methods by a study sponsor? If so, how have you handled this situation, any suggestions around framing/ communicating this topic to ECs?
Look forward hearing from you!
