[Micky Hingorani]

1. Protocol describes the rationale, objectives, design, methodology, statistical considerations, ethical considerations and organisation of trial. CAB members give their input during protocol discussion but we use draft protocol because that when we are able to make changes and CAB members sometimes come up with words used in the community that we as a site were not aware of, those are one of the important stakeholders in the community and their involvement in the trial is important. It is very important to be transparent with our stakeholders and give a clear understanding protocol development process.
2. When Protocol is sent, we as a trial staff sit and discuss the protocol, we look at the language used and we translate to language used in our community so that it will be understood by everyone. We then identify relevant stakeholders who usually are the CAB members therefore Study Coordinator and or Principal Investigator conduct a meeting with the CAB members to inform them about the protocol and they give their input.

[Micky Hingorani]

Thanks Nokulanga for a good advice, This scenario happened to our site several years ago, actually it was the CAB member of that are who come to notify the clinic that  this was the reason people were  reluctant to come for their schedule visit. The man was screened out due to his HIV status and it seems he did not expect that result as he had tested somewhere about two months earlier  and he was free from infection (probably he was in window period). So he was telling people that our test give false results.  we sort of managed the situation by inviting all participant  enrolled and those on screening for a long discussion and  we conducted a community meeting  but like you have said we did not reach everyone and due to this we lost some potential participants who believed his story.

[Micky Hingorani]

Although at the end BTS yield good results, I think there was problem is stakeholder engagement at different levels (the onion diagram) in the beginning of the trial. It seems there was no common understanding among advocates, organization and different network, the Ministry of Public Health and the sponsors on the details of the trial design and procedures.  On the other hand the reaction of advocates showed the research team that the community is not asleep, thus it was a call for the researchers to do better stakeholder engagement in future.

For better negotiation of HIV prevention package,  the research team was supposed to engage (may be at the stage of trial design) with the Bangkok Metropolitan Administration, the Thailand Ministry of Public Health, Thailand’s narcotics law officials and the sponsors (CDC). These stakeholders would have understood importance of provision of clean needles to study participants for the success of research.

[Micky Hingorani]

1. In our site during the stakeholder engagement meeting, the stakeholders brought up the issues of exclusion of people who were sick with HIV, Hepatitis and diabetes. The result of stakeholders being involved was in the inclusion of people who had well managed form of HIV, hepatitis and diabetes. During informed consent process the protocol states that the men taking part in the study should be asked if their female partners were get pregnant. That was amended and that was excluded.

2. The relevant stakeholders should be given time to make inputs in the study and also there should be transparency and communication during the study. Technical parts should be explained to the stakeholder.

[Micky Hingorani]

Give an example of successful stakeholder engagement in protocol and/or IC development. What changes were made as a result of the input gathered?

At our site a few years ago, the members from DAIDS visited our unit and discussed the length of ICs in microbicide trials with peer educators and members from the community (CWG members). This was a useful exercise as the members explained that the length of the ICs in English was long and when translated in the local language it is even longer making it difficult for participants to internalise all the information. After a day of discussions and consultations with the community members, it was agreed that a short form of the IC will be a way forward. However, the process of implementing a short IC with key information is ongoing and we continue to have lengthy ICs in biomedical clinical trials. Fortunately. the use of graphic tools and various material to explain the study to participants and community members has contributed to better understanding of the research procedures.  There is discussion on ensuring that ICs have relevant information for decision making among participants and their family members and relatives.  This engagement also helped community members understand the purpose of providing the key information to participants thus achieving mutual understanding of the IC information and length of the forms.

2)    If a protocol gets sent to your trial site in final form, how would you address the GPP recommendation for stakeholder involvement in protocol development?

This is a common practice within projects where it is not always feasible to engage the community at the trial site but there was community engagement at national or network level. Thus, we explain that although the site community may not have been engaged on the protocol, there was community input by a national or international CAB member. We also invite the site community members to share their feedback and concerns which may not always in changes but it is possible to amend protocol. To be honest and transparent with the community about the process helps with understanding that it is not always feasible to engage the community when the protocol is being drafted as this is dependent on sponsors, resources and logistics.  The GPP and other community guidelines must be explained and shared with the stakeholders so that they know their roles in the research process.

[Micky Hingorani]

I think the most important thing is to find out what might have been the reason for her ineligibility and from there, involve CAB where the participant is coming from because CAB members know the community and they understand everything happening in the community. Community events can also be a great step to address all the myths and misconceptions because by community events you not only targeting a certain number of people but community as a whole.

[Micky Hingorani]

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?

 

[Micky Hingorani]

I guess GPP would say that better relationships and transparency on these issues between research teams and stakeholders naturally lead to more ethical and participatory trials. But you’re right— how do we involve and consult community members, advocates, sponsors, investigators, national policymakers, treatment and prevention programs, etc etc when there are such great ethical and political complexities? There have been some global consultations among stakeholders to discuss the standard of prevention in biomedical HIV clinical trials and it’s critical for that conversation to continue! Decision making about the changing prevention landscape and how to react to emerging trial results will vary from country to country– there is no one-size-all or formulaic approach. But– bottom line– achieving consensus on these controversial issues requires investment and commitment from a very broad range stakeholders. Everyone has to ask and discuss the difficult questions, in absence of clear cut answers and sometimes with minimal information.

[Micky Hingorani]

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?

[Micky Hingorani]

The issue of law and ethical procedures is indeed a very exciting scenario. In most cases this is the situation where most of the researchers and community engagers find themselves. We are caught in the conflict of law with ethical procedures. In most cases, any research is supposed to respect the law of the land. In the Thai situation, the issue of needle exchange is perceived to be illegal. And that’s it. There is need for advocates to push for legislation of laws that are not in conflict with certain practices in society. In Zambia, we have been facing this same problem is terms of conducting research on MSM. Any mention of statistics on MSM is perceived to be illegal. How then do we reconcile law and ethical standards?

[Micky Hingorani]

My colleagues remarks are very informative.  It seems that it can often be a challenge to get input from the stakeholders in a timely way to incorporate into a near final/final protocol.  I wonder if it is possible to have some common elements of protocols routinely reviewed so that when trial-specific elelments come along, the focus can be on what is unique to that protocol and it impact on the stakeholder.

[Micky Hingorani]

Hi this is a challenging situation to our site, we also receive most of the protocols in final stage, although ocassionally we have an optoni of having a site specific addendum if there some areas, where the site can not comply or study on that particular area (for example, recruiting transgenders as is a rare or even unknown to our societies). At least the site is able to modify few areas, otherwise the CAB are most of the time engaged in review of the Informed consent and other recruitment materials.

[Micky Hingorani]

And here is the BTS case study for your review!

[Micky Hingorani]

1) How has social media and online communication affected your trial communication planning and engagement strategies with stakeholders?

2) Have you ever experienced unexpected issues at your trial site or in your research context? How were they handled? What lessons were learned?

Social media and online communication have not affected our communication with stakeholders. however social media is used a lot in our community.

The was rumor at one stage in a certain part of the community were somebody said we are giving people HIV. the information was brought to our attention by a CAG member and CAG members together with the community engagement team organised a meeting with community for an information session. the meeting went very well. we learned that community education is a shared responsibility between site and the CAG.

[Micky Hingorani]

Hi Alice, great work, what happened to the parents of the participant? where they part of the meeting were community education took place?