Micky Hingorani
Forum Replies Created
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1) Social media has not affected the conduct of the trial at my site. We are considering using it in future to see how people will respond to it.
2) During results dissemination the participants thought that the number of participants that tested positive for HIV during the trial was the percentage of participants who got infected at the site. E.g. 66 women became HIV positive during the trial and they thought 66% of the women at our site got infected with HIV. When we became aware of this, an emergency meeting was held and the misunderstanding was clarified with the participants. Also, this was communicated with our local CAB and stakeholders. We also decided that every time a participant comes in to get the results, we will clarify this misunderstanding so that they were able to communicate it with their peers on the study.
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In my community, it is on the rise and police are battling to control it because drug dealers have become intelligent with their packaging of the drugs. It’s not your typical white powder or newspaper rolled marijuana. Drugs now look like sweets and are named accordingly. I figure most youth are using drugs as a form of escape and there’s also the added strain of peer pressure.
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Hi Heidi,
The example from Thailand may give you an idea about reviewers for international study. For HIV vaccine research, every study has to get approval from the national sub-committee for HIV vaccine research. The sub-committee have regular reviewers to review all the protocol – most of them are MD/researchers, and only one is representative of NGOs. It isn’t an ideal approach but at least there is one non-scientist reviewer who provide community perspectives. So far, the comments and suggestions by the NGO representative were responded to accordingly in writing and in revision of the original protocol. I think that IRB that includes community member can do the same.
This still doesn’t answer your question about how to select the reviewers. Based on my experience, reviewing protocol and related document is time-consuming and very challenging for non-scientist. I also feel that even the researchers themselves find it is time-consuming and they often read only the parts that interested them. Therefore finding the reviewers have to based on the person’s experience (and knowledge) and willingness.
For Jessica’s question on how to overcome the top to bottom approach, I think capacity building for CAB is very important specifically about GPP. Another one is to provide protocol document or detailed summary of the study to CAB in advance before the meeting so that they can study or discuss with other people before the meeting. Another example from one CAB in Thailand is to allocate tine for a closed CAB session in each meeting. This will be the opportunity for CAB members to discuss candidly without the presence of researchers and the team. The decision or discussion can then be presented to the researchers anonymously.
Udom
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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.
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social media has never had effect on the trails at our site due to the coverage and access to platforms by the general community.
We have been fortunate not to experience any unexpected issues at the site but have in place an issues management plan for some anticipated issues that may occur in different protocols
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Yes, engagement can indirectly result in better recruitment — but engagement is much broader and not just aimed at trial conduct. Ultimately, GPP is about ensuring that the larger research agenda is acceptable and responsive to community needs, as well as increasing the likelihood of generating meaningful and sustainable results. And stakeholders can provide input on all of the GPP topics areas and all stages of the research. The HVTN 505 case study that appears in Lesson 7 even illustrates how a research team incorporated significant inputs from stakeholders that impacted design and conduct of the research during the actual trial!
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I do agree of recruitment and outcomes being the key objective of a trial process. How ever Community engagement is wider than participant recruitment, though Participant recruitment is the focus of all the engagement activities.
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I believe there are reviewers of community protocols social scientists who have capacity and can be able to do a good job.
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Hi all, Charles has summarized on what happens in our local setting. In addition, a mechanism should be put in place to ensure CAB members of participating site get an opportunity during protocol development to give their input so that they do not appear to be rubber stamping what scientist have already deliberated on.
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The biggest problem that I see is that in most cases the engagement is top bottom. The researchers tend to dominate the whole process thereby giving little attention to the inputs from the CAB members. The CAB members are in most cases at the receiving end.
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At our site we realised that it is not possible for the CAB to represent all the stakeholders in the community, which is why we have identified other stakeholders that we have partnered with. eg We have the District Aids Council and the Local Aids Council. These comprises of all government departments, NGO’s and other stakeholders. We usually engage with these stakeholders quarterly and we meet with the CAB monthly. We then contact individual stakeholders when there is a need to do so. We motivate our stakeholders by attending their meetings and giving presentations to them so that they can be updated about the progress of the study. We also partner with them when having community events. We also distribute educational material to the community. We maintain our relationship with them throughout the trials.
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At our site we realised that it is not possible for the CAB to represent all the stakeholders in the community, which is why we have identified other stakeholders that we have partnered with. eg We have the District Aids Council and the Local Aids Council. These comprises of all government departments, NGO’s and other stakeholders. We usually engage with these stakeholders quarterly and we meet with the CAB monthly. We then contact individual stakeholders when there is a need to do so.
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I think that the most important thing before recruitment should be community assessment, which includes identifying stakeholders in the community. Once this has been done, then stakeholder engagement and community sensitization can be done before recruitment.
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Hi everyone, I find this a bit challenging because we usually receive the protocol when it has been approve and then we review it with the CAB. So, even if the CAB has got some ideas nothing can be done about it.
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In the Ugandan context, social media has minimal effects on the trial because of its low coverage and values attached to it by the population.
At our site we have had rumors about the IPM 027 IP causing cancer. We have invited participants to share their feelings about the subject, generate solutions as well as give them the right information.
<span style=”line-height: 1.5em;”> The CAB is consulted for information and recommendations applicable to affected communities. </span>
Community sensitization is done following the approved brochures from; Ministry of Health about cancer facts and other approved messages.
This issue has however been anticipated following the earlier stakeholder meetings. It results into non adherence by trial participants but with the rightful information and reference to the Participant Information Sheet (PIS) or consent and protocol the issue is resolved. It is important to exhibit transparency among the study participants by always referring to the PIS and protocol, it has been beneficial in managing these issues as they lay out the action plans in case any anticipated issues emerged.