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Though I’ve always known the importance of practicing GPP, I learned that GPP is more than just obtaining informed consent and filling out a work plan each year. This course has broken down all of the principles utilized to build the GPP program and has allowed me to discover the importance of each one in stakeholder engagement and trial planning. My colleagues taking this course have also provided great insight and some creative ideas in terms of reaching out to potential stakeholders as well as current CAB members. I feel that the information I’ve learned here is truly invaluable and will help boost our site’s stakeholder engagement–it will certainly help in creating a better engagement plan!
Lucky, your site is blessed to have the resources available to do mobile HIV testing and additional services such as family planning. To be honest, that is where I’ve envisioned the direction of our clinic heading in the future so, hopefully, I’ll have the support and resources necessary to do so. How are you able to offer/fund the additional services?
Our site has maintained relationships within all demographics in our community by continuing to support their causes, both in-person and financially when able. We attend community health fairs, PRIDE events, clinic open houses, and support our community members business as patrons as well as by setting up information tables and inviting community members to come out and enjoy food/drinks while learning more about our clinic, vaccine research, and HIV prevention.
Katherine, you made a good point when you stated that the trial team should discuss what happened with future trial participants. That is something that I did not immediately think about when forming my response. Indeed, anyone interested in participating in a trial will have heard about it and likely be expecting an explanation so that they will feel that it will be safe to join a study.
This, in my opinion, is a bit of a tricky situation. As many others have already noted, it would have likely been best to invite local club and hangout owners and workers to a stakeholder meeting to discuss the premise of the study and potential implications that may arise. Being that the trial is taking place in a community where homosexuality is both outlawed and highly stigmatized, however, even taking this step could lead to discrimination and fights if the owners and workers still have the community mindset; they may take the information learned at the meeting and choose to gossip or incite violence instead of help.
I feel that beforehand, the trial team should have conducted a focus group (away from the clinic) consisting of local bar and hangout owners and employees to gain insight on the tolerance levels of people working in the individual venues. That way, perhaps the team could inform and recommend that participants refrain from going to certain places that would be unwelcoming. The team would then also be able to identify people who could be the stakeholders that would learn more details about the trial such as the type of people who will be participating. This way, the likelihood of a violent situation could be reduced.
Considering that the attack has already happened, the team’s first priority is the safety and well-being of the participants involved. Our team would contact the participant to check on his health and see how he feels about the situation. He would be offered a referral to counseling services. At this point, a list of “no-go” places would be created and the focus groups consisting of club and hangout owners held to determine tolerance. The community education team could then focus on informing those who are less tolerant about our trial site and what our actual mission is so that, hopefully, incidents like this do not happen again. It would also be a good opportunity to create a media campaign to proactively inform the community and combat “hate-crimes”.
Hi Ella,
I think that researchers probably did plan for the study and likely even consulted with their CABs but, they did fail in researching Thailand’s drug laws and the implications that it could have on their research plan and with their stakeholders. In this case, there was a lack of effective communication (the importance of which I stress at my site all the time) between researchers/coordinators, stakeholders, and possibly even participants themselves which had the potential to derail all of the work that was done to launch BTS. It seems that stakeholders did not trust the legitimacy of the results because they were skeptical of the research team’s ethics as opposed to the results themselves being false. Either way, there is definitely room for improvement in this case!
Despite the political barriers surrounding the controversy, the decision to not provide clean needles made it seem as though researchers did not care about reducing the risk of contracting HIV in participants who were receiving the placebo. To add insult to injury, the stakeholders concerns were not even addressed during the dissemination of the trial results. This, in turn, led to stakeholders’ mistrust of the trial team and question the legitimacy of the results.
Although the results of the trial ended up being promising, it may have been better to delay starting the trial until a larger discussion about the concerns of drug user advocates and the importance of providing clean needles to injection drug users was had. Lead PIs and coordinators could have also mentioned that they took note of stakeholders’ concerns, why they were unable to make changes, and that they planned to address them in future studies.
Researchers can engage stakeholders better by not only listening to their concerns but also taking them into strong consideration and mapping out the different possible outcomes of including or not including a suggestion. When politics and laws are involved, it is best to begin engagement early, provide statistical data to relevant lawmakers/strategists, and how changing a policy or allowing an exception for a study will help both the study population and the community at large.
The advent of various social media platforms has, for the most part, been beneficial to our site in regards to engagement. We have been able to reach people who would have been reluctant to approach us or engage in conversation when approached during outreach or community events and we are also able to share information with a broad audience. Many of the participants who are currently enrolled in our clinical trials were reached through a social media platform.
In the future, we would like to start a social media campaign that will get people talking more about our clinic and our research. So far, we have not used social media for actual trial planning; however, as our GPP plan falls into place, I do think that this can be incorporated.
I think that Richard makes a good point about ruling out some stakeholders simply because they may not hold the characteristics that are needed at a given moment. Something that I left out in my post is that we do try to think about how to maintain a presence in communities/populations that are not the focus of a current study. While it’s important to maintain a presence and allow stakeholder involvement from these groups during down-time due to politics, we also want to remain ethical and don’t want already vulnerable populations to feel used.
When the subject of stakeholder involvement comes up at our clinic, it is typically in the form of a suggestion–i.e. “Let’s contact so-and-so to tell them about this study…” Because we do not have many stakeholders outside of our CAB (in terms of number and diversity), as a team, we have not typically discussed involving one stakeholder over another. Personally, I look for mutual beneficence and the involvement/impact that the stakeholder(s) have in the communities of our target population as well as the general community as a whole. I am hoping that once our initial stakeholder engagement plan is created that these types of conversations will be prevalent and prove to be fruitful in successful engagement.
Sherri had the same question for Phumeza that I had–I find it insightful that Phumeza’s community engagement began before there was even a protocol. This is something that I’ve toyed with for a couple of studies at our site; however, I found it difficult to convey anything more than the concept of the study to community members and potential stakeholders because the protocol was not yet official or was incomplete and the details frequently changed. Also, often times, the base materials for some of our studies have already been created by the core network which leaves little to no room for edits that are recommended by community members and stakeholders. In studies that we do have a little more leeway for creating our own materials for, we are often stifled by a lack of funding to produce them. Situations such as these only highlight the importance of identifying key stakeholders to educate and learn from, though.
For the most-part, our site typically relies on the community stakeholders in our CAB for any type of formative research. The extent of our formative research with the CAB has been identifying possible stakeholders and, still, that is mostly done by the community education team at our CRS. The inexperience in formative research isn’t due to a lack of trying, however. Our current CAB members have been nurtured in an attempt to get them to understand the importance of community and stakeholder engagement and to build excitement and initiative around some of the examples that were provided in our module.
I think that stakeholder engagement and utilization of formative research methods will take shape and improve with the diversification and expansion of our current CAB. Until then, I think that it would serve us well to identify stakeholders outside of our current CAB and begin building the foundation for a relationship built on trust and mutual understanding. At that point, more in-depth formative research such as community forums and interviews can be used.
Bernice: I have to admit that my jaw dropped a little bit when I read that there are times when certain people cannot be seen in public. That definitely has the potential to create issues with visit windows or emergency situations like serious SAEs. I’m interested in discovering whether or not these festival periods were taken into consideration before the start of the trial and what your team did differently for subsequent trials to ensure that they were prepared next time.
Mark: I’m extremely impressed by the involvement and initiative of your CAB. Do you happen to be able to share an example of one of your brochures? I’m just curious to see the work that they’ve done. I’m also glad you mentioned that your clinic moved at some point. There are talks about our clinic moving to a new building as well, and I don’t think that our PIs and other decision makers have even considered consulting members of the community in regards to the type of environment that they’d feel comfortable in. I’m thinking a survey about what they do and don’t like about our current location and service is probably long overdue.
In terms of having a negative impact on a particular protocol, our site has not had many issues when it comes to a stakeholder being less than fully or minimally involved. The closest occurrence that I can think of would be when we invited a city council member to one of our UCAB (United Community Advisory Board) meetings–both because she had not been present at a meeting in some time and because results of the HIV/AIDS 2020 summit and the protocol for the AMP (Antibody Mediated Prevention) Study were going to be discussed. This particular council member is very active in her district and takes pride in looking out for the best interest of those living there; especially since residents in some areas within her district are considered as marginalized or having a low socioeconomic status. Although she agreed to come to the meeting, she showed up late and missed a great deal of the background information about the AMP Study and missed the HIV 2020 discussion entirely. She did, however, hear one of our PIs speak briefly about funding the study. She then began asking questions about how much participants who decided to join would get paid and, she didn’t like the answer. When our PI asked how much she thought we should pay participants per visit, she stated something to the effect of $200 to $300 citing that $75-$100 per visit was too low for people in her community to get for joining an “HIV study”, especially when [our university] has billions of dollars. Although we understood her sentiment, she assumed that because we were affiliated with a university, that that meant we had plenty of money to compensate participants. She forgot about the cost of study materials, the study drug, and other costs associated with developing and implementing a clinical trial (and that we’re not funded by the university itself). An open dialogue about compensation and ethics during a clinical trial began after that, which is great; however, in the end, the councilwoman told us that she couldn’t, in good faith, recommend such a low-paying trial to people in her community. I am not really sure if she ended up expressing her point of view to her constituents because she has not been to another meeting and, as I mentioned, there has not been a negative impact on any particular protocol thus far in terms of recruitment. I do think, however, that not having a mutual understanding with such an important stakeholder could eventually lead to repercussions.
I’m surpised that some sites have not had any GPP training and, considering its importance, I agree that GPP should be a requirement.
Jorge, I think it’s pretty awesome that, even though you guys haven’t been trained on GPP, that your PI still takes the time to try and secure funding for your team’s assessments. Was that something that you had to convince your PI to do, or did he already understand the importance due to his experience and GCP?
