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After the formation CAG in our trial site, we usually call a community meeting and begin the engagement of CAG members and Baale as facilitators at these meetings. Most times we often end our formative research activities with FGDs, addressing stigmatisation, access to and quality of care and what to do during the trial to ensure participants retention.
We always review the recent engagement activities at our clinical site to identify the key stakeholders involved, their roles and the type of research done. Most times these stakeholders include, community leaders (Baale, local chiefs, clerics and politicians), caregivers, household heads, CBOs and NGOs. By prioritizing their relevance, we then engage them. Most often we form CAG among them to bring unity and our CAG composition is not permanent. It varies from one research to another. However, we always involve the Baales for the constitution of these CAGs in our trial sites and we have found their input highly useful.
Unlike Kathrine’s experience of too early formative research activities. Our own was too late formative research activities because the seed fund from my institute came very late. We had to adjust the timeline set for our drug therapeutic efficacy trial (DTET), which was eventually stressful to both the clinical research staff and some of the trial participants who were also pre-engaged during the formative research activities. So I agree that timing is very crucial in what we do prior to clinical trial.
For our about to commence zinc trial in Makoko, a slum community in Lagos where diarrhea and HIV screening is currently ongoing, we first consulted the PI of the recently concluded diabetes and hypertension surveillance and perception study. the PI shared her community engagement and research experience with us. Though she worked on adults, she let us know that the community is not used to longitudinal studies and dwellers always have high expectations from engaging them for health programs. She also advised us of the appropriate logistics and advocacy visits we need to do. We also interacted with a member of malaria society of Nigeria to get useful information regarding the malaria screening exercise carried out by the society to mark the World Malaria Day of 2014. This trial community lacked a CAB. So we began by getting approval from Lagos Primary Health Care Board, followed by approval from Local government authority controlling the community after paying advocacy visit to the chairman of the LGA in the company of the Medical Officer for Health of the district PHC who had earlier been briefed and included as a co-PI. Following these activities, we have been having the full support of the community from Baale of Makoko, to chiefs, elders, heads of households and mothers/caregivers of children below five years, our eventual trial participants. So evidence of government and district authority/health involvement in this research really helped our community engagement. So far we have conducted two town hall meetings to discuss the zinc trial and issues of time-point collection of stool samples to understand the transmission dynamics of viral and bacterial diarrhea in the community. Some of the suggestions of the caregivers such as free distribution of ORS instead of training on ORS preparation alone has been noted and used to revise the study protocol. Feedback of this to the community has also strengthened the cordial relationship we are having the community members.
I am of the opinion that we repeat majority of the GPP topic areas used to ensure engagement of the trial participants in the first place and this means extra budget. This is where the contribution of the host institution is also very important
In the middle of a clinical trial, occassion may warrant modifying some parts of the study protocol. How do we communicate this to our trial participants without compromising their retention or optimal engament?.
BamideleGonzalo. Thanks. I quite agree with your submission. Now that I have GPP exposure, our previous error of under budgetting for advocacy/site preparation will not longer exist. As issues regarding participants retention in a trial require extra funding for activities that will avert barriers to their engagement and retention like our MSM which we recruit by snowballing. Ela, Lucky and Marks. Thanks. Your submission are also very useful.
I have been fortunate to have a satisfactory involvement of our stakeholders in protocol development and implementation at three clinical trial sites I have worked. Except for one of the sites where timing schedule of IRB visit to the site for project implementation monitoring became an issue between the community leaders and trial participants. The IRB members were to visit the trial site to ascertain some monitoring indicators based on the study protocol and milestones. During these visits they were to meet all the community leaders around the trial site and trial participants. Although resolution was made regarding timing of visits but the low level of trial participants involvement was obvious for trading and other socio-economic commitment reasons. Although this challenge did not affect our trial outcome, we felt that repeated occurrence of similar issues could compromise the ethical standard set for our future trials at this site.
Since different categories of stakeholders are involve in clinical trials, it is important to have appropriate engagement plan for each category to be involved in a trial based on the goal and objectives set for GPP. All issues pertaining to each stakeholder group must be addressed before GPP implementation. Funding level is crucial for determining the stakeholder prioritization
Thanks Phumeza, your point was very true. We experienced how important timing and local translation of informed could be in a setting where the literacy level among women in our recent malaria clinical trial in north-Central Nigeria. Although this slowed our enrollment drive, the retention was satisfactory. (though not 100%)
Actually, one of the things that just came to my mind regarding participants’ retention is the need to also have a flexible mode of same communication so as to address the different literacy levels of the study participants. One communication mode can’t fit all.
we also organize workshop training and also invite our participants we we mark some of the world health days (e.g world TB day),
Anthonia, you actually spoke my mind on GCP versus GPP. Most proposals in my country are currently being reviewed on the basis of GCP and GLP as far as ethics is concerned. This GPP course is very timely for me.
Jessica, I really gained from your perspective of identifying issues that could come up in the course of engaging study participants in a clinical trial and being able to address them satisfactorily. thanks Kenneth for bringing up the importance of information, communication and meeting expectations of trial participants. Lucky and Mahesh, your points are also noted. I quite agree with the need to have a mechanism of operation (like an SOP), but a flexible one, when engaging trial participants.
Based on lesson 1 that I received this morning, I am of the opinion that my research team as a whole has an average understanding of GPP. But at individual level, this understanding varies. This is because we take so much cognizance of good clinical practice (GCP) rather than GPP when engaging the stakeholders at trial participant and community level. We provide information about why the trial, how it will be conducted, logisitics, risks, confidentiality, compensation/reimbursement, autonomy etc. We allay their fears regarding the potential risks (e.g stigmatisation, discrimination, marginalisation where possible). Although individual opinion varies, as a whole,I think we don’t give much time for understanding the perception and expectations of the community, which is very important as I know GPP now. We are too conscious of the budget and are somehow resistant to unplanned request of the community.
