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Thank you for sharing such important and useful information. Our site has only mantained stakeholders relationship just before, during the study at study closure and result disemmination. engaging them in all the activites that yo have mentioned. But after that there is no sustainability and I feel this is a major weakness in our stakeholder engagement and mostly the reason has been funding, the argument has been that “the study is closed and so is the budget:”. But I think community engagement must be continous though the level of engagement will depend on the life cycle of the project, without stakholder sustainability, stakeholders feel used then damped after the required data has been collected.
Thank you Leader Ngoyi for discussing funding and education for the stakeholders. Stakeholders are supposed to have adequate knowledge about the actual study in order to make negotiations for the preventon packges accordingly.
Jaura and Laura thank you for your great contributions I agree with you both, the results must be disemminated in the language that the participant understands and it is important that the study comes up with key messages which are translated and adhered to accordingly so that the same information is given in any prefered languages to all stakeholders.
In the same maner that we give study informtion to the stakeholders, for us from the developing worle setting we translate all docuemns that we share with participants and stakeholders including brochures so that they also read in their own lanmguage that way they develop confidence that the study is not hiding anything that it is transparent ans so they compare what information they have in Engilsh and in the local language.
sustainability of research community relationship is very important. Though the resources can be challenging as Anne has indicated, we try to work within the available resources because good community relationship does not only contribute to successful acrrual but also to retention and even when you come to the result dissemination, negative or positive study outcome, challenges are minimal because the communities are kept upto speed with the progress of the study and they feel part of it and so will be part of the outcome.
I recall in the previous clinical trial we did at our site, we used similar activites that Marie’s site used. We held mid study parties with communites and participants this was not to entice them but to give then an opportunity to mingle with other participants share adherence challenges learn from one onother, and we felt this events improved retention and adherence.
We disseminated results and unblinded to them the study arm individuals belonged to individually with no difficulties at all. And this is because different scenarios were shared to them during the study. And so they looked forward to receiving the results. this was a study that enrlled 625 HIV negative women, HSV 2 positive. withng which we even had a group that seroconverted, from this I have learnt that communication in critical in clinical trials.
Thanks Anne for sharing the websites on VISP, this is going to help us very much.
You have mentioned inappropriate treatment for HIV as one of the potential harms from VISP I envision this scenario happening in PMTCT because the current practise is that, upon obtaining rapid HIV results expectant mothers are commenced on ART , the CD4 count level is not considered. The team must plan for adequeate stakeholder engagement involving health workers especially the MCH staff.
1. What implications did the luck of inclusion of clean needles in the prevention packge have for trial participants.
luck of provision of clean needles to the drug user was enethical. Human research protection guidelines were not taken it to consideration at all.
2.How can reseachers engage stakeholders to better negotiate packages that combine various arrays of option tailored to the need of diverse groups.
I agree with all engaging stakeholders early in the protocol development stage is critical and most import take stakeholder input into considerations.
How can engagement efforts impact participant experience in a trial. Engagement has a positive impact on a participant it creates trust and a sense of belonging. continuous involvement during the study is crucial because well informed participants are easily retained. The study can only achieve its objectives if participants are retained. From the experience Mathias had we can appreciate that research literate community is an important factor to study success.
2. Caprisa’s comprehensive approach, indeed contributed to their success story, because participants felt cared for as complete individuals not as study objects to be commended to adhere to the study product.
3.examples of how we have sustained relationships with communities during and in between we routinely communicate the progress of the research and we consult and sought for feedback from the communities.
Our site has not been involved in PrEP, however thinking of what might be similar or different to the introduction and possible scale up of the efficacius microbicide is mainly lack of political will. It is one important factor that could affect the introduction and roll out of the efficacius microbicide. Zambia is a young democratic country with a lot of several political parties in the policy making insitution, which results in anachy in policy delivery. While the health system is conducive with adequate manpower, the Ministry can not do much even of the regulatory authourites granted approval timely.
I was involved in a trial where we disemminated results to all stake holders. It has been the most joyous period of my life as a research personnel. I came to appreciate the importance of stakeholder engagement in the disemination of research results. Lesson learned was that every stakeholder at all levels must be involved and their expected role and contribution to be considered.
I wish to thank the team for sharing the reality about VISP. Being a new HVTN site, we have just been imagining how we will be handling such situations. Rona you have given us great information which we are going to put into use I wish I could be allowed to print your experience and share with the team.
Our site has not experienced much social harms due to partipation in the trial, but one occurence was so serious that we had to engage the women’s lobby group and the victim support unit. When the partner found out that the wife was taking part in the HPTN trial which tested acyclovir suppressive therapy for HIV prevention in HSV2 positive women, the husband who was HIV positive started abusing the woman sexually, he could clean upthe vagina with the cloth to have dry sex with her with the intention of infecting her, he could rape her on several occasions, she was an orphan, uneducated she depended on him unfortunately. We ralised that she started loosing weight, she was miserable all the time she came for the study visits, we probed she explained the situation and we had to interven.
In response to question 2 from Erica. It can be challenging to give feedback to a final document as but I agree with Patchara, even if the protocol is finalized stakeholder input can still be given. To my understanding even when the study has already started changes can be instituted through protocol amendments. I believe that stakeholder input is applicable at any stage of the the life of the protocol as long as the stakeholder input informs amendment to the protocol.
one example of of a successful engagement in protocol and ICF development is the most recent qualitative quantitative research study we recently completed this was HPTN O63, despite the CWG members having given their feedback, the protocol team went ahead and sent the protocol and the ICF including the ACASI questionnaire and other questionnaires to the community for stakeholder input. It was found that the language which was used in the protocol and in the questionnaires was not culturally acceptable. For example; in our local languages, we do not use names for genitals as they are, we use words like, female private parts, CAB recommended the culturally acceptable words and they were changed.
the community was not comfortable with the use of ACASI and recommended that we have a staff administered questionnaire to avoid speculations, as you may b aware our country is one of the developing countries , however, after extensive community consultation it was agreed that the protocol team send the a practice ACASI to the community and so some of the CAB members and community members from the study population were picked at random to take part in the exercise and they recommended that ACASI was good for our people . The study collected quality data through ACASI because of stakeholder involvement in the protocol development.
In response to Anne’s question on mechanisms used to engage some stakeholder and not all. We have used the formal mechanism where we have worked with CAB and the already established community groups like traditional healer groups, the Neighborhood health committee boards, the zonal group leaders of the research site are, holding meetings and in the most recent resent research we used focus group discussion which proved to be very effective. However form the knowledge which is being gathered form the AVAC team we have planned to use both mechanisms which is the formal and the informal in the upcoming HIV vaccine trial, keeping in mind that stakeholders will be engaged at different levels according to the stakeholder mapping results.
Hello Ericcan,
We are in the same situation with Juala social media is a new concept in our setting so we do not include it in our our strategic planing with the stakeholders because very few individuals use it.
It is most recently that we experienced negative reporting in research and so our organisation decided to come up with communication department after the MTN MDP 301 trial experience, where the social media caused damage!!! as leader Ngoyi has expressed above. In this kind of a situation even if the site had a plan in place damage had already been caused.
I appreciate the strategy leader Ngoyi used in the SA experience of using the same platform to respond to the allegations promptly, other than using the different platform so that the concerned social media can get the truth from the horse,s mouth and clear the air.
