Micky Hingorani
Forum Replies Created
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This is exactly what happened after our site was selected as one of the three sites for the Nigeria PrEP demonstration project. Our site replaced another site that had initially been chosen for the project. Because of this, our local site team and community stakeholders had not been involved in all the consultations and formative research activities that had gone into development of the protocol. A wide variety of stakeholders from the three initial sites including community stakeholders such as serodiscordant couples, local health care providers, representatives of civil society organisations, key populations namely MSM and male and female sex workers and so on had participated in FGDs and consultative workshops aimed at exploring public opinion, community interest, and perceptions about the use and access to PrEP in Nigeria as well as obtaining their suggestions for the design and implementation of the PrEP demonstration project. However for reasons unknown to me, our site was selected and we received the protocol in final form.
As the study coordinator, I had to read the protocol and understand it thoroughly in order to explain it very well to other members of our research team. I also made sure that everyone had a copy of the protocol. For our community stakeholders, we organised a training workshop that included the research team, CAB members, representatives of CSOs and the media to enhance their research literacy and knowledge of research ethics and how to review research protocols. We also summarized the protocol in powerpoint format, in layman’s terms. All these helped the stakeholders easily grasp and understand the technical information and terminology like informed consent, inclusion/exclusion criteria, and adverse drug reactions and so on. In a subsequent meeting with the CAB, the Principal Investigator and I did a point by point review of the protocol with which further enhanced their understanding of the protocol and enabled them to ask questions.
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When we receive the protocol, we invite the CAB and do some presentations about the protocol to make them under stand it better. we also circulate it to all the study staff. We translate the consent form (information leaflet) in the local languages in the simple way possible.
We draw plans how to recruit within the speculated time lines. -
Advising research staff to be cautious of timing will also be an important step to avoid implementing community stakeholder engagement at a later stage.
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The stakeholders need to be targeted with training on the protocol so that they have an understanding of the terms and procedures related to the trial. Inviting representatives from multi-sector community structures will be a best example.
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If I receive the final protocol form, I would hope that it is not the first time I would be reviewing this document. If a multi-site trail is being implemented hopefully our CAB would have the opportunity to provide input before the final version is released.
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Currently we do not have a final form of protocol, so we have not met this situation before and are not able to provide an example. But I would imagine once we get the final form of the protocol, we would first hold a community workshop to educate community stakeholders about the protocol, answer their questions, address their concerns to ensure they have a well understanding of the protocol. We would also collect questions, advice and suggestions from community stakeholders from the workshop and bring them back to the research team through various communication mechanisms (including CAB) to see what kind of community engagement activities we could do in order to address their comments and incorporate their suggestions.
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In my case, as a CAB member, I try to provide as much feedback as possible when consulted about the protocol; in turn, the research team fowards those feedbacks to the network level. For instance, our CAB has already identified a procotol flaw in HPTN 083 which may hamper the participation of transgender women – here in Brazil, a lot of them make use of gluteal prosthesis; but the protocol establishes that the injections have to be applied in that region, which of course will make a lot of them ineligible.
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Hi Piero,
Thanks for your interesting response.I must commend your CAB. By identifying the flaw in the HPTN 083 protocol, your CAB has demonstrated that it has a high level of research literacy to be able to read and understand the technical information in the protocol. Also it has demonstrated that it is knowledgeable of the local norms and practices of transgender women in Brazil. I think these are two very important characteristics that enable a CAB successfully engage with a research site. How long has your CAB been involved in research and what were the strategies used to develop their research literacy? Also, is the study already being implemented or is the protocol still being drafted? Hopefully this is still the early stage. But if ethical approval has already been obtained, protocol amendment may involve another lengthy ethical review except if the ethics committee decides to give expedited approval.
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Philister
Once the protocol has been sent to our site we invite the site Community Advisory Board and make a protocol presentation to them, develop summaries of the protocol in a simplified form ans share with them to review and provide their input on what they think about the study design, the target population, the benefits and risks, recruitment and retention, blood collection and shipment. We collect their views and make changes according to their suggestions and recommendations. -
We haven´t a communication planning and engagement strategies, yet. But, I believe that social media (facebook, tweeter) is a cheap and quick communication, easy to use and it reaches many people. Through these tools we may disclose the study, recruitment and results.
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The GPP recommendations are new to me. I am learning so much from this course. Therefore, I can present a hypothetical response given that I have not physically engaged in this type of research. In the final form, stakeholder engagement is necessary – CABs, other national and local stakeholder groups, participants, and the media all play a pivotal role in ensuring the research lives through its entire life cycle. Cultural and ethical issues are to be considered in this final protocol. But one wonders, is a protocol ever “final” in so much that it cannot cater to deal with issues that may arise and are pertinent to the trial success. If a protocol is so “final” that it does not leave room for the unforeseen, then that in itself is a tragedy waiting to happen.
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The social media has been used as an important tool for communication with the community, about recruitment, follow up and updates about the different researches as any important news.
We make sure the message is clear, simple and sufficient in order to clarify the community and avoid misconceptions. should be approved by the CAB and the ethical committee, -
While we use online communication extensively in our PrEP study when communicating and engaging with stakeholders, we have not really explored the use of social media in our context. The role of social media is covered in the manual of operating procedures for our study and we acknowledge that social media such as Facebook, YouTube and Twitter are good avenues for disseminating messages and can even help in recruiting participants into the study. But we have not yet started making use of social media. We however use listservs such as the Nigeria eforum which is moderated by the Journalists Against AIDS (JAAIDS) Nigeria, the NHVMAS (New HIV Vaccine And Microbicides Society) listserv, International Rectal Microbicide Advocacy listserv, Project Africa for Rectal Microbicide listserv. Through these and others like them information can be shared quickly and easily. There are also discussions among the members where stakeholders can also raise their concerns. We also used listservs during our formative research to distribute online surveys. Because listservs are moderated, discussions are monitored and handled in such a way to prevent negative and inaccurate information undermining the research.
I think the use of social media is very good but they have to be subject to IRB ethical approval and I think if it’s to be used for participants, they have to give informed consent even if it’s for a platform as common and simple as WhatsApp. In creating a social media group for WhatApp for participants in a HIV research study, the participants may not even want their fellow participants to know they are in the study because stigma is still an issue in Nigeria. WhatsApp and Facebook have several identifying markers like display pictures, phone numbers, e.t.c. that may make our participants reluctant to join. However, this discussion has definitely piqued my interest and I’ll raise it with the rest of our research team to see how we can explore using social media in our stakeholder communication and engagement. -
Social media is a very powerful tool to use ,is effective, cheap and very quick.We use it as a platform where we are able to reach out to the community stakeholders and inform them about the upcoming studies and what is expected from them. We spread the word through facebook and with all the advanced technology we have we are sure that all our stakeholders wil get the massage. We also encourage the community stakeholders to express their views which sometimesbthey cant in the community meetings/forums due to time so they are able to use our web page and facebook page to do so.But we make sure that our pages are monitored so that we dont share confidential information and everything is related to the studies or clinic.
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Nice article Samantha, thanks for sharing!