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We are a multi network site so we don’t have a period when there are no studies taking place. There are a lot of things that we do as cooperate social responsibility. We support Dzama school project where we have built school blocks and teacher houses. We also support with the school feeding program. This school is within our catchment area and it is in a village where we recruit more participants for various studies.
As a site we also take part in national events like World Aids day commemorations and candlelight memorial. We give financial and material support towards these events.
Before the start of the study the research team was supposed to work closely with relevant stakeholders to identify and plan for such risks and come up with a solution. This is why there is a need to have an Issues management plan. By developing this plan prior to trial implementation,the research team will be better equipped to deal with such issues.
If you receive a protocol, i feel there is still a need to call for a stakeholders review so that they give their thoughts about the protocol. Feedback should be sent to the protocol team so that they know what the stakeholders think about the protocol. The stakeholders will also help to come up with ways on how to better communicate with the communities and also how to deal with issues when they arise during the conduct of the study.
This was a very good study but things did not go well from the beginning. As it is, it seems the stakeholders were not involved from the protocol development stage. Prevention of study participants is very important in any research. Not providing clean needles was not a good thing even though the researchers had to abide by the laws of the state. It would have been better if this was shared and discussed by various stakeholders before the study started enrolling.
HIV prevention package is very important was supposed to be looked into very critically by the research team, the sponsors and the stakeholders as it is an important part of the research.
During the IC review for HVTN study the CAB members noticed that there were some pictures which looked scaring. There was a picture of somebody being given the vaccine with a very big needle on each arm. To the CAB members this was scaring and they thought it may put off some people who want to participate. They asked for it to be removed from the IC and it was removed.
Even if the protocol is sent in the final form,the stakeholders meet and review the protocol and make sure that the protocol meets the requirement of the stakeholders. If there are issues that need to be addressed a report should be sent to the protocol team and relevant bodies so that amendments should be made.
Due to lack of access and minimal coverage, social media didn’t have any effect on trial communication planning and engagement strategies with stakeholders? Our communication is done through community sensitization,stakeholder debriefing and using IEC materials and many others.
As a site we have not experienced any unexpected issues so far.
There is a lot of sensitization in the community regarding sexual gender based violence. There has been establishment of Village victim support units which are supported by different non governmental organisations where the victims report the cases. All the cases end up in the hands of the police and perpetrators are put to justice.
The only problem in Malawi is under reporting of such cases. Most of the people think these are just family issues and should be dealt with indoors as a family issue. This is why most organisations are coming in to sensitize the communities.
It is very important that the community stakeholders are involved in the development of messages because they are the best people who can advise on the best language to be used. This can only be very helpful if the stakeholders are involved from the beginning.
Steve
I think they have a good understanding of the value of the stakeholders but the problem is the understanding of who are the stakeholders. Most of the times they think stakeholders are only those organisations who are dealing with HIV. They don’t include community people and family members of study participants and many others as stakeholders. But these are very important stakeholders as far as research is concerned.
