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My knowledge of GPP was almost non-existent, although I knew that it existed, thoroughly understood the 6 guiding principles, and had quite a bit of real world experience seeing and participating in their implementation. Learning GPP through this course dramatically expanded my understanding of how the principles could be applied in practice. Although I understood the need for and the concept of community engagement that extends beyond traditional CABs or CAGs, I now have a much better and deeper understanding. I feel much more knowledgeable about the different kinds and levels of stakeholders and how that term refers to a group of people that extends way beyond the target population for a study or its participants. I also have a new appreciation for how an inclusive, multi-disciplinary team of dedicated and knowledgable people can come to the table and develop this kind of process, learning from past misfortune and going on to get into a very deep level of detail and develop very specific and useful tools. I found this, the history, and the case studies in the course both helpful and inspiring.
It sounds like using GPP principles could help in these ways:
Participant education materials, presentations, activities, and messaging based on valid community stakeholder engagement would improve understanding about the trial’s purpose and the importance of adherence. As you say, in your situations seeking to establish an understanding and appreciation of health seeking in general may be important too.
GPP also calls for early planning including contingency considerations which might be re-visited. If it is known that visit attendance is low, there are a number of avenues that could be pursued. “Other priorities” sounds a bit vague and so it may be important, with stakeholder guidance, to delve deeper into what this really represents. Could it be stigma? Fear of partners or family members finding out? Is it related to work and the use of the product? Is it a problem of nutrition, safety, hunger, or other needs that are priorities? Is transportation or anonymity a problem?
Like CAPRISA, Vanderbilt has the advantage of having been involved in HIV research at various levels for a long time. It has a broad portfolio of related research that includes laboratory, treatment, prevention, and public health study. Much of its work involves collaborations, and this broad base and longevity means it has established and reasonably good quality relationships with many stakeholders, although I’d like to see the depth of these improve.
In terms of treatment trials, research and clinic operations are so closely integrated that there is not much perceived need to proactively facilitate or challenges to sustaining an ongoing relationship with the community; these relationships tends to be somewhat less visible and public.
By contrast, in terms of prevention trials, there are some challenges. Between large trials, the amount of resources and personnel dedicated to community engagement is markedly reduced. The site attempts to maintain a level of community awareness in those times, especially since earlier stage trials continue. The CAB continues to meet on an ongoing basis at all times. Still, with fewer personnel and dollars, the ability to actively conduct outreach and engagement beyond the CAB is hampered. On the other hand, during a large trial, having a focus on a specific study and the associated messaging actually makes it easier and more productive to engage community in a number of ways including outreach.
Our site increasingly depends on personal relationships, and networking based on those and using social media to promote its existence and specific prevention trials. It also benefits from the reality that the Nashville and Middle Tennessee USA community is being served by numerous competent agencies that effectively and fairly broadly deliver treatment and prevention services and information to the communities most at risk.
I want to thank everyone for the very original and insightful responses to this exercise. Since I personally always post my response before reading others, I wanted to make a few more comments after enjoying yours.
1) I did not ready the exercise to specify that this was a club catering to MSM. It may be, it may be a club who *tolerates* MSM even if it is not a “gay” club, or it may simply be a mainstream club that operates without any conscious consideration of MSM. Given that homosexuality is stigmatized and illegal, however, one can imagine a scenario where MSM attempt to blend in at clubs that do not cater to them.
2) In light of the above, I believe one should be very careful about assuming that the club owners or staff would be interested in helping a study that intends to recruit MSM, or for that matter any study related to sexual health or HIV. Likewise, if the club does not cater ro MSM, I question whether they would have interest in protecting MSM – even if they did they may be concerned about this becoming known.
In my experience, even in metropolitan cities in the US, clubs and owners are a mixed bag. Clubs that openly cater to an MSM clientele often are altruistic, but there are certainly some who are more concerned with image and profit than helping the community. Some who do want to help the community are very careful to keep those efforts separate from the club’s operation or are highly concerned and very controlling about how their participation is communicated. I wonder if the club in this hypothetical scenario would want to be associated with any aspect of any study that engages persons persons who are MSM. I would think withholding the study’s purpose or details about who is being recruited could be ethically questionable.
3) I wonder if the fact that the site has become known as a ‘place where people train men to become gay’ isn’t a bit of a distraction. In this story, were the participants attacked because they were associated with such a place, or were they attacked because they were believed to be gay themselves? In the latter case, will improving understanding about this myth or educating the community about research or even homosexuality be productive?
4) If one of the solutions pursued was a list of “no-go” places, careful consideration would have to ask if having been provided such a list would actually be a study-related benefit or if having a need to follow such a list would constitute a study-related harm.
I’ll answer the questions in reverse.
What could have been done in advance to potentially prevent this from happening?
If we’ve followed GPP, we’ve anticipated this sort of problem. This may or may not mean we could have prevented it, but it definitely calls into question our success in implementing some aspects of the principles and guidelines of GPP. While we could not have solve the problem of stigmatization or criminalization directly or completely, we have consulted with community stakeholders. Such consultations should have helped us to anticipate this potential problem, identify ways to mitigate its likelihood, and develop plans ways to handle it if occurs. For instance, our efforts to identify a site where a) participation could occur discretely and without “branding” participants and b) which is in a locale where prosecution and persecution of MSM occurs at reduced levels may not have been successful. Our study site should be housed within a clinic that serves multiple populations with multiple types of services that mask its operation and reduces the risk of “outing” participants. We should have taken care that MSM appointments are not “concentrated” in a narrow time window in terms of the day or week. We should have tried to identify an urban area which is more tolerant of MSM than other urban or rural areas.
[One slightly positive aspect in this narrative is that our hypothetical research site has obtained the information that this incident has occurred and that it is believed related to trial participation. This may indicate that in terms of GPP we have created an environment where participants are comfortable enough to report the incident, and/or we have established a trusted / collaborative relationship with third parties and we have procedures for investigating reports from these third parties and dealing with the reported events.]
How might your team handle this situation?
This needs to be addressed on two levels:
In the immediate, assuming my team has done its work in terms of community engagement, we are prepared to refer the affected trial participants for medical, psychological, and social services to deal with the impact of the attack. We assess the harm to the participants and we report it to the trial sponsors, ethics committee or IRB, and or other regulatory bodies according to established procedures and regulations. We have enough understanding of the local / regional culture to know whether pursuing legal options (reporting the attack and seeking prosecution of the attackers) is wise or will increase harm to those victimized, and if such pursuit is prudent we have access to the expertise and resources needed. We help those involved decide whether they should continue study participation in a way that empowers them and doesn’t make them feel excessively obligated – and if possible we attempt to do so in a way that obtains and preserves as much study data as possible and minimizes risk to the study overall.
Once the participants’ needs have been addressed, we deal with the larger issues. We consult with stakeholders, including the recruited population, to help us determine definitively if the incident was study related. We ask ourselves, the participants, and stakeholders if there are practical ways to further mitigate the risk of harm from this kind of incident; and if there are we create and implement a mitigation plan. Our collaborators also help us determine whether this incident was more likely random and isolated or something that we can expect to happen on an ongoing basis. We can then determine if study participation is indeed increasing the risk of participant harm. Even if we do not make this determination, we revisit and refresh all of the work we’ve done under this section of GPP to make sure we are mitigating potential risks and prepared to deal with future incidents.
If there don’t seem to be ways to mitigate what has been determined to be a study-associated risk of harm, we must according to the severity of harm and urgency of the risk consider relocating our site and/or taking steps to stop enrollment and participation at our site.
* What implications did the lack of inclusion of clean needles in the prevention package have on trial results?
The dictionary provides a number of definitions of “implications” and I’ll address the question based on two of them:
If one reads “implications” as “something that is suggested without being said directly: something that is implied,” I’d say that one very obvious implication from the community’s point of view is that achieving the number of endpoints (HIV seroconversions) required to power the statistical analysis and evaluate efficacy of PrEP in this trial was deemed more important by the researchers than providing the best possible HIV prevention standard in the trial (and the community’s ethical and moral concerns.)
If one reads “implications” as “a possible future effect or result,” I’d say on the information provided here in the case history, the implications were a number of general harms to this, other ongoing, and future research in the area:
1) Since the standard of HIV prevention provided within the trial did not meet what a substantial contingent in the community felt should be provided, a smoldering distrust co-existed with the conduct of the trial and persisted afterwards.
2) The potential for successfully conducting similar clinical trials in the future with participants from this population may have been reduced; successfully conducting such future trials so may require more effort and expense. Interestingly and importantly, advocacy and activist did not reach a level that stopped or prevented completion of the trial. This leaves me pondering the overall attractiveness of participation in the trial, which was placebo controlled, and whether efforts to counter therapeutic misconception via education, outreach, and informed consent were sufficient. In any case, however, although the level of activism that developed wasn’t sufficient to stop the trial, the level of activism (distrust) that remains could well be enoough to prevent a new trial from being started – particularly if there are not radical differences in both the protocol and the engagement process.
3) Moreover, while the trial results appear to have been generally accepted by the scientific / research community, they may not be deemed legitimate or may be distrusted by the very population originally intended to be served by the trial’s conduct. In other words, the conduct of the trial may have harmed the usefulness of what was learned in the participant population.
4) Because there were differences (sometimes stark) between the requests made in stakeholder meetings and any actions taken as a result of those meetings, any post-trial distrust may include cynicism about the engagement process and questions about the sincerity of those who conducted those efforts.
* How can researchers engage stakeholders to better negotiate comprehensive prevention packages tailored to the needs of diverse subgroups?
The short answer is more effectively implementing GPP. It would appear in this case that efforts to engage stakeholders were, simply put, “too little, too late.” While it may be true that there was no possible way to integrate syringe exchange in this trial, it may also be true that the trial should not have been conducted in this country. This might have been an outcome of early GPP / engagement regarding site selection. Regardless of whether the location was deemed appropriate, the engagement processes as implemented in this case appear to have failed to acheive mutual understanding of what could and could not be done, and failed to acheive sufficient compromises or alternate solutions on other issues to maximize trust and confidence.]
An opportunity for the researchers to demonstrate their own “advocacy” was missed when they failed to explicitly address the ethical / moral issues of being prohibited from including clean needles and the ensuing controversy by means of publication.
This is an interesting question. The primary method is to adapt the informed consent to local regulatory needs and based on historical wisdom, then circulate it to the community advisory board with a solicitation for feedback. This is done with a real commitment to hearing that feedback and making changes whenever appropriate and possible.
In addition, it is hoped that the community stakeholders understand that no protocol is ever *really* in final form in the sense that ancillary documents, memos, and even protocol revisions can and do occur when circumstance warrant and dictate the need. This could happen for any of the reasons related to community and contextual realities such as feasibility, relevance, and acceptability as discussed in the lesson but it could also occur in the face of study enrollment that is poorer (or in rare cases better) than anticipated.
On the other hand, the real work of stakeholder involvement occurs prior to the stage via the solicitation of experienced community stakeholders to serve on the protocol team and on working groups, via the conduct of forums and stakeholder meetings at the regional, national, and global level, etc.
I have a unique point of view since I am affiliated with the research site where events that were presented in the current module’s 505 case study occured. While what occurred was not to my knowledge part of any planning or strategy, we were fortunate that it turned out to be something we and the network were able to leverage positively.
My experiences over time as usage of the internet and web has evolved have taught me that as each new mode of communication emerges, it adds to and does not replace what we’ve already been using. So these new modes don’t replace but add to the larger communication scenario. This sometimes means more, not less work, more, not less planning, and consideration of more, not less contingencies.
I think we need to take care not to romanticize social media and/or online communication or treat them as a panacea. In reality in my experience, the pitfalls of social media are very much like those of traditional mass media – outside of planted stories that stick to press release language and/or coverage by very specialized and invested writers (like those at aidsmap, for instance), the potential for distortion, misinterpretation, and scientific errors is generally high. The only consolation is that most of these problems don’t end the in yield major problems.
Here’s a concrete example regarding the 505 case study cited: What was not reported is that I happened to be sitting at the computer monitoring email when the story broke locally. Although I believe the case study discussed the story being published in our local mainstream daily newspaper, Tennessean, it was actually our local lgbt community newspaper which was the news outlet which first broke the story. I happened to have a good working relationship with the editor and contacted him immediately (as a community activist) about a quote attributed to the local PI that referred to the DSMB halting of injections as a “failure” and some other minor linguistic fine points. Fortunately he agreed to amend the story (which at that point had only been published online.)
We’ve come a long way since 505, and now what you will see at our site with regard to the AMP study is that social media is being leveraged very heavily. I would say this is both beneficial and risk-laden. Social media is highly beneficial when accurate messaging is sourced from the site or network and when best practices are used it attracts a lot of interest in participation. Social media (I’m thinking primarily of facebook, but also others like snapchat and twitter) offers the additional advantage of serving as a primary communication platform for relationship building and post-enrollment contact for may of those who are in the demographic age range that AMP targets in our community.
I think there are risks when participants become very public and there is always the risk that someone from within our outside of the study will begin to use social media to attack or spread misinformation about the study. Our site is encouraged to follow network policy in terms of handling social media, but the bottom line is that it is impossible to control. Just like individuals who have been participants who choose to become public and speak out are impossible to control. Just like mainstream media is impossible to control (but I concede relationship-building can help mediate risk more easily in this instance.) In the end social media is just another communications reality with which we must deal.
I would say the measures that need to be taken include making sure that key talking points are pushed heavily and regularly from the site and network itself so that they carry the most weight and have the most visibility. I think it is very important that relationships with media players be strong so that those resources can be called on for help if an individual goes rogue via social media or the web. It is important that when the site works with participants to promote trial participation via social media, that a kind of consent and counseling process takes place (and even legal releases signed) before that collaboration and promotion occurs.
Like Marie, I don’t believe we’ve ever taken a comparative approach.
I’d also say that because in terms of biomedical prevention (vaccine research) we are a very old site with a strong legacy of involvement and (mostly) goodwill there is a lot of existing network infrastructure.
To my knowledge the process has been informal, organic, and we’ve probably never been as systematic or analytic as the processes described in GPP would prescribe.
So to date I would say this:
-> Our process has been organic, informal, and experimental – largely a product of good common-sense relationship building along with a generous amount of trial and error.
-> While this may not have been the most efficient method, it has yielded strong positive results over time.
-> This being the case, subsequent iterations of the process have probably been almost exclusively need driven. By this I mean if there was any structured formal process for seeking new or different stakeholders, it was the result of an identified need or gap.
-> The CAB would most likely be seen only as a source of ideas and suggestions when needs or gaps were identified, but the CAB didn’t engage in a formal prioritization process.
-> Staff might have done work on this outside of the CAB structure informally through conversations and presence / participation in other kinds of community activities
-> Our approach might also be characterized as a “shotgun” approach, meaning that we tried anything and everything to see what might work.In the end, some level of prioritization has inevitably occurred on perceptions of productivity and limitations in terms of time and resources. I doubt any of this has been formally analyzed, mapped, or otherwise documented.
I do think our good fortune could be leading to a kind of inertia that is a barrier to maximizing results.
We have not involved stakeholders in formative research. We have been very successful with enrollment, so perhaps it is because we are a long-established site with a good reputation that this is the case. I noted in the assignment that although we excel at meeting overall recruitment, we sometimes do not have participants that accurately represent the populations in our community most affected. This is less critical for the majority of trials which are early phase – and may even be a result of those trials seeking lower risk individuals. We currently have a large phase 3 trial enrolling, and doing some formative research might help us to accrue those individuals who have been historically under-represented, i.e. black msm and trans men and women who have sex with men. I like the UNITY study’s example of forming a council(s) separate from the CAB and using that resource to guide efforts in their specific communities.
I guess I am blessed that I have been involved in a lot of success. Part of that is because the institutions where I am have a long history of being dedicated to engagement, and that in the US funding for treatment and prevention is tied to various requirements for engagement. I can’t think of many bad examples but here are two \:
At one point, when the site was enrolling individuals for treatment trials that offered full treatment to HIV+ folks who had not been on medication before, a rumor that there were upcoming difficulties obtaining treatment drugs in the community found its way into staff recruitment conversations. This came to the attention of CAB members and we immediately approached the staff complaining that not only was this untrue, but that it was unethical to so blatantly make a connection between trial participation and access to treatment. We honestly believed that had this continued, serious ethical concerns might have threatened enrollment or even institutional support of the site.
In another case, our treatment clinic was sold and moved. The community was not consulted at all regarding the structural, regulatory, operational, and environmental changes that were to be made. As a result patients were very unhappy with things like service and the environment, and perceived that cultural incompetency, homophobia, and other forms of negative judgements were being played out in a contrastingly cold, austere clinical environment. A pop-up advocacy group was formed to voice these concerns at the highest level in order to bring pressure to bear. One of the things we did was make the case that the institution was demonstrating discrimination against the same communities to which it reached for research participants. The IRB was contacted, and for a brief moment research staff (who had not caused these changes) had concerns that successful enrollment might be threatened. When concessions were made, things cooled down, but ufortunately, while these tactics yielded results, they also left enduring hard feelings and damaged relationships on both sides.
I’d also like to give a positive example. The research site needed a new non-study-specific recruitment brochure. The CAB leadership offered to develop this at the grassroots level. The basic layout and content was developed using community process in a series of CAB meetings. We decided to only use non-professional, passionate advocates as models. We were able to get the design work done at low cost. We published multiple versions featuring different photos that might appeal to different potential participants. The CAB oversaw all of this work and the brochure is considered a big success and is still being used.
Here are some questions you may sometimes hear:
“What’s in it for me (us)?”
“What have you done for me lately?”
These are not unreasonable.In other words, be a collaborator and a supporter and that will be returned to you.
Another point is what I call “the spoonful of sugar” principle. This is from a song in a Walt Disney movie “Mary Poppins” that references a saying “a spoonful of sugar helps the medicine go down.” In other words, we are asking volunteers to contribute in real, meaningful, and sometimes difficult ways – and that means we are asking them to work. Volunteers often have their own feelings, ideas, and agendas about what is important in HIV. If we want folks to come back, they need to feel that CAB is fun and rewarding.
So, while we must have some level of structure and focus, I recommend making allowances for folks to do what they like, what is fun, etc. One meeting may feature a training that is technical, but the next might be on something interesting going on in the community that isn’t directly related to the research at hand (a new outreach program or service, for example.) While CAB members may man an outreach booth in order to raise awareness of available studies, what they may love is handing out condoms. Why not let them do both?
I also take care to try to choose educators who can connect and hold the interest of the audience, and have a varied agenda that always ends on a high note (something positive to take home.)
I think this is always a challenge. Most often in my setting, these efforts are covered by a partial allocation of a person’s time. They are often underfunded. Strategically, I think we must advocate that grants allocate specific and sufficient resources for these efforts and that those resources manifest themselves at the point of implementation in actual effort / outcomes.
Lots of good points here. I do think that retention is a function of research site operation. Those I trust say the key word is relationships. This comes down to valuing people as people, not just as research “subjects” (I prefer the term participant.) This can look different in different places but comes down to a lot of common sense things like making participation easy and stress free, being as flexible as possible, demonstrating genuine concern for participants, and thanking them repeatedly. One thing I think our site has found successful is not having a hard line between recruiting staff and study staff. An effort is made to allow participants to maintain a personal relationship with the recruiters, even though they are not performing study functions.
