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I agree that the trial results dissemination needs to happen in language that all stakeholders can understand, regardless of their background in science and, specifically, the science behind the trial product. Thanks for advocating for that, Jauhara! But I also believe that it is critical that, in the effort to describe the results in language people can understand, there is no important information left out. That would be my only concern, but of course it is very important that people can make sense of the results that are shared with them. I think overall, communications should be simple, but thorough. 🙂
I think our setting would be very conducive to the introduction and scale-up of an efficacious microbicidal prevention product, especially if this product had the potential to be turned into an MPT, or multipurpose prevention technology, like a combination birth control + HIV prevention gel or ring. The financial, human, and other resources are all here in San Francisco, and so is the precedent for HIV prevention as a cause worthy of financial and other resource investment. I agree with Rona that the demonstration projects that were seen for PrEP would certainly need to be repeated for any additional microbicide products that are being rolled out, and I think the power of combination technologies would really make waves, not to mention reduce stigma and pushback associated with PrEP-like HIV prevention tools that has been seen with Truvada so far, since birth control is a relatively more acceptable form of prevention technology.
I have not personally been involved in results dissemination for a trial, although I have explained past trial results to potential study participants over the phone or while networking or recruiting at outreach events. This is always an exciting moment for education and interesting conversations about people’s perceptions of research, science, and HIV prevention as portrayed in the media, religious organizations, or their friends and families, vs. what the science and research suggests. Even better is when one of these conversations ends with someone saying, “Wow, I can’t believe PrEP exists. I am definitely going to tell my friends about it!” because I know that our conversation has not only had an impact on this one individual, but that the information is going to seep into other communities of which that individual is a part and which Bridge HIV has not yet reached.
Challenges are how to correct people’s misinformed notions without discrediting the sources where people heard this misinformation. Also, being wary of assuming that someone has a base knowledge of science, research, HIV prevention, or whatever we are talking about, since lots of people actually may not have this assumed background and foundation from which to build the rest of our conversation. This certainly applies to trial results dissemination, since oftentimes laypeople have difficulty understanding scientific language or ideas. At the same time, the media’s often oversimplified messages can reduce or exaggerate the scientific results of a study, which is then downplayed or oversensationalized, to the detriment of the actual scientific impact of those results. The answer is, certainly, to meet people where they’re at with the correct, accurate information in terms and language that they can easily understand. And I feel that this would be best delivered in multiple, overlapping formats – written published articles, advertisements on public transportation or billboards perhaps, live presentations, social media, local news TV channel interviews with a representative of the study, digital media like podcasts and videos on YouTube and other popular platforms online, etc. – so that the information can really sink in.
I loved the interactive nature and design of the modules, and I especially enjoyed discussion forum conversations with all of you because they made this online course far more engaging than others I have experienced in the past. I’ve learned so much and gained additional perspectives on all the issues we discussed from all of you!
I think the work assignments could be improved if we were given the chance to give peer review/feedback on them, just like we were able to interact in the discussion forum! Of course, I would like feedback from the course instructors, as well, but the comments from other classmates would also be really beneficial, I think.
Thanks to all of you for designing and participating in such a great learning opportunity!
While I agree that limited resources and staffing can be a challenge, it’s very helpful to sustain creative engagement by collaborating with other local advocacy and stakeholder groups, both research-oriented and otherwise, in the planning and executing of engagement activities or events. This way, you are further engaging with communities and networking to develop/strengthen the stakeholder base, not only in the communities you reach through the activity/event, but also in the planning processes — and you have the added resources and staff power of these other organizations and individuals in combination with your own! Many hands make light work. 🙂
1. I think engagement efforts are of utmost importance, long before someone becomes a participant or even identifies as a stakeholder. Just familiarizing people with clinical research and building trust/providing education and awareness to communities and populations that are traditionally harder to reach or somehow marginalized from research and medical arenas — these efforts can have a huge impact on how a trial site is perceived. Word of mouth is especially important in some of these marginalized and hard-to-reach pockets of the population, so one person’s good or bad experience with us can be the deciding factor in whether we garner support from a large stakeholder group, or not. As for a concrete example, I have been in the room for in-service presentations or conference events targeted towards some of these populations, such as people of color or trans* people, where I overheard either supportive/approving comments among audience members, or I saw reactions and overheard negative comments citing distrust of certain things that were being said or the people who were saying them. I have also heard from several people over the phone while I screen them for our studies that they are very glad we include so many gender and race options for them to identify themselves, including a write-in option as well as a “decline to state” choice. This sort of wording on the phone questionnaire arises only from consulting with and engaging with these same communities and stakeholders whose representation in clinical research is historically low due to distrust of researchers, in part due to researchers’ lack of competency/humility. If someone feels right at the onset of the screening process for one of our studies that they will be respected and recognized for exactly who they are, then they are likely to enjoy their experience in the trial significantly more, not to mention that they will also be more likely to let friends who are also in their communities know about their positive experience.
2. I think CAPRISA must have done an excellent, truly thorough job of formative research to identify all of the non-research-related or health-related needs at the trial site, because by focusing on providing other services and education to key groups at the site, the researchers were able to build trust and the foundation for lasting partnerships long after the completion of the trial, not to mention how these efforts benefited their protocol development and study design, and later, their study recruitment and retention. Additionally, there was extensive effort put into education and awareness before the trial began, which accomplished the goal of engaging people in the goals and purpose of the research and invited them to become more actively involved and invested in the project, rather than remaining passive or becoming despondent and disinterested in the study.
3. To sustain relationships with communities after and between trials, we continually make an effort to schedule in-service presentations for staff and clients at our partner organizations and at various stakeholder organizations and groups. We also engage previous participants and other folks with whom we have made relationships before and during a trial as members of our CAG whenever possible, or if their schedules do not permit this commitment, we host community forum events every few months, as well as inviting the public to panels with guest speakers and representatives from the global network as well as local stakeholders and researchers to keep the communities we engage with informed about the current developments and issues going on in HIV prevention and vaccine research, policies, and news. Sometimes the subject of our in-service presentations or forums strays from the sole focus on HIV and includes broader themes, such as health equity more generally, in order to address additional concerns of the communities we have these relationships with.
I would echo much of what’s been said already in the forum on the subject of false-positivity as a result of trial participation (whether that be for an experimental HIV vaccine that gives someone VISP, or a PrEP study where antiretrovirals and other experimental products are being tested/dispensed to participants) or as a result of being prescribed Truvada for PrEP by one’s physician. I think that social media and the internet in general are wonderful places where these social harms can be mitigated successfully much of time. One such place on social media is the “PrEP Facts: Rethinking HIV Prevention and Sex” Facebook page, where incredibly informed and fascinating discussions about the problems and joys of accessing and taking Truvada take place between community members who support/themselves take PrEP, sometimes providers (though usually this is a space set aside for nonprofessionals to discuss these issues), and the curious. I think places like these on social media, in combination with other websites and YouTube videos that share personal experiences and opinions, could be a really great direction to take the social harm concerns that are specific to HIV clinical trials. Bridge HIV has actually made some videos starring interviewed trial participants from vaccine studies, obviously with their explicit consent, and shared these videos to spread the word about what it’s really like to be in an HIV vaccine study, and these videos were really well received. I hope that we can do more of these kinds of projects moving forward, to humanize the clinical research process some more, dispel myths about HIV research, and address the legitimate concerns that do exist about social trial-related harms (including stigma, discrimination, VISP, etc.).
1. As many others have mentioned, VISP has been an issue for vaccine trial participants in the past. I don’t believe we have had anyone attempt to donate blood or organs, likely because of effective education during the informed consent process that this will no longer be an available option for them. However, people may test outside of the approved sites in the national registry, and then the consequences may be problematic and stigmatizing if this results in folks believing they are HIV-positive based on a false positive antibody reading of a rapid test.
2. These and other trial participants, as well as some local providers, HIV/AIDS organizations, and members of our Community Advisory Group, have spoken up about concerns regarding VISP, and we have attempted to weave significant education into the informed consent for all HIV vaccine studies. Sometimes we post articles to our HIV vaccine studies Facebook page (called SFisReady) that have to do with VISP and other side effects or social stigmas associated with experimental HIV vaccines, which includes not just study participants but also other stakeholders and community members in its audience for increased reach of this education and awareness. Increasingly, health providers who would run HIV tests and discover these cases of VISP are becoming more aware of the existence of VISP from being in an HIV vaccine trial, which is also helpful; there could definitely be more presentations done on this topic, especially in health clinics and other health provision locations to spread knowledge of VISP further in the community.
I really liked the point Patchara brought up, about stakeholders perhaps being confused or having misconceptions of what is expected of participants being in the trial, especially based on other associations people may have with a given trial site or specific study visit location. For example, because injection drug users were the study population, the researchers decided to conduct the study at a clinic where methadone was distributed. There is stigma associated with such clinics in the United States, and I imagine the same might be true in Thailand, so that is one concern with using that clinic as the location. Another issue is that stakeholders might conflate methadone and PrEP distribution or misunderstand what exactly the trial entailed based on what else was known about the trial site. And as Patchara said, stakeholders might think it was a condition to make volunteers participate in the trial, that they had to also take methadone. There are a lot of subtleties that go into location and choosing where to place a trial site, and these choices can definitely have a huge impact on how the study is perceived by stakeholders, participants, and the greater community alike. Even more broadly than an HIV prevention package, there should be formative research that addresses questions about what should make up the broader research package to make sure all stakeholders have given their input into and have gathered a comprehensive understanding of the goals of the research and how best to go about it, down to the last detail of where the participants will go for dosing/appointments.
The implications of not including clean needles in the participants’ prevention package could have skewed the trial results to dampen or falsely increase the perceived efficacy of PrEP compared to its actual efficacy, depending on how lack of access to clean needles may or may not have affected the behaviors of the participants enrolled. In addition to this logistical effect on trial results, the other implications were that the study was perceived as unethical and therefore the results were not to be trusted. Even worse, the outcome of this lack of trust from one particular study likely could be later associated with future studies run by the same (or even different) biomedical research institutions attempting to learn more about other possible interventions for HIV prevention. However, to play devil’s advocate, not including the needles in the trial did likely maintain good relations between the local government and the researchers, since the researchers did not push any illegal agenda by including these clean needles against the wishes of the government. Obviously that relationship benefit does not outweigh the costs of not providing the needles, but it is important to recognize all stakeholders when considering the situation.
As for how researchers could engage stakeholders to better negotiate these prevention packages, I think that soliciting input from diverse kinds of stakeholders is critical: everyone from local government officials to previous trial participants to advocacy groups for people who may be represented in the study population, to community members living at the trial site, and even to the media, both local and global. If we want to tailor these packages and the options within to the particular needs of diverse subgroups, then we will need to consult with stakeholders and members of each of those subgroups in forums like focus groups, online or in-person surveys, inviting these folks to come on board community advisory groups and assist in protocol development, and other formative research opportunities as well. Only by asking and listening can we be sure to integrate all of the necessary and appropriate tools into a given trial site’s prevention package. The package should also be something that is able to evolve on an ongoing basis during the trial, by encouraging stakeholders to continue to provide their feedback and opinions about its effectiveness and comprehensiveness during the trial.
Jauhara, I completely agree that it is a challenge and a discredit to the research that the protocols are typically not written by those who reside and work at the sites where a trial ultimately proceeds. While it is so critical to get local feedback from stakeholders to make sure the protocol and the trial are the best possible fit for that location and the norms and dynamics going on in that context, it is unfortunate that all this is is “feedback.” I wish there were more research protocols that were, truly, community-based rather than mostly just participatory, because if research was “developed from within,” as you say, I think it would be all the more effective and powerful because there would not need to be any “justification” for why the community/stakeholders at the trial site have to “buy into” the research, as you say. I am especially wary of efforts to “translate” the protocol into laypeople’s terms in order for stakeholders with less research experience to understand, because there is a tendency in such processes to “dumb down” the actual research somewhat; to a certain extent, the intensely rigorous science behind a study design or protocol may require some dumbing down in order to explain effectively to people without years of experience in that scientific field, but it still has the potential for misinformation or selective communication about what exactly is involved in a trial. Of course, such manipulation would not be within best participatory practices, but the challenge and threat of unconsciously, accidentally leaving out information or losing important aspects in translation into “lay language” do still persist, and the main way to avoid this is really to make sure that protocols are being developed and drafted at the trial site more often than they are now. Lots to think about, thanks for bringing this issue up!
1. One example of successful stakeholder engagement in protocol development was our consultation with our CAG regarding our targeted populations and outreach for an upcoming vaginal ring PrEP study. Our CAG members, as well as members of our own Community Programs team at Bridge HIV, cited some issues with the current draft of the protocol at the time, which stated that the trial would be open to all those who identified as natal women and still had the requisite anatomy to allow for insertion of the study product. This suggested that transgender men would most likely be candidates for inclusion in the study, depending of course on their surgical history; as such, our Community Programs team was becoming excited with the potential for additional education/outreach to this community, as well as recruitment of transmen for this study. However, the protocol also stipulated that any potential participants who used any form of hormone therapy would not be eligible. Given our own and our CAG members’ knowledge of the local trans male community, we know this combination of criteria would make the vast majority of transmen who were interested in participating ineligible right off the bat, and we were of course concerned, therefore, about promoting the study within a community we might largely have to turn away at the point of screening. The changes that were made as a result of this input included resubmission of the protocol with these issues highlighted; the Microbicides Trials Network is still reviewing this most recent round of feedback, and we and our CAG look forward to hearing back from them soon.
2. If a protocol was sent to our trial site in final form, we would address the GPP recommendation for stakeholder involvement in protocol development by presenting the finalized protocol to our CAG and requesting any feedback they had, since there are often opportunities to submit protocol revisions and updates throughout the trial process. If there were any egregious issues with the protocol as informed by the CAG, we would present this feedback to the larger trials network and attempt to delay trial enrollment at our site until the issues were appropriately resolved, however necessary. If none of this were possible (and I sincerely hope this would never be the case), we would convene another meeting of the CAG to explain the reasons why the suggested revisions to the protocol were unable to be applied or accepted, and we would attempt to find other ways (outside of the technicalities, logistics and bureaucracies of the protocol itself) to address the outstanding protocol issues to the satisfaction of our stakeholders.
I agree with Jessica — Patchara’s description of the way that situation was handled is really an excellent example of best practices in circumstances where participants need our support but confidentiality remains key. Stakeholder support of other stakeholders, especially when we cannot directly provide the support needed, is another superb reason why stakeholder engagement is so critical, particularly because once the research team does complete a trial and, in some cases, contact with those stakeholders is decreased due to less direct engagement, these stakeholders will still have the networks they have forged, through you, with one another, and they can fall back on these as needed to support one another.
1) Social media and online communication has been a major part of Bridge HIV’s engagement with stakeholders, especially in recent years. We developed two websites, one centered on HIV vaccines research and the other on PrEP research, to engage folks online with regards to new and opportunities in the Bay Area when it comes to our studies and HIV prevention in general; interested individuals can fill out inquiry forms on these websites to be entered onto our recruitment lists for our studies, or they can simply learn about HIV prevention research and how to become more involved even if they are not participants, as advocates or informed community members. We also interact with our stakeholders through our two twin Facebook pages that are linked to these aforementioned websites; I am tasked with posting a minimum of twice weekly on each page, usually with news or op-ed articles regarding these subjects. We rarely perform explicit recruitment on Facebook, or Twitter (where we also have a presence) for that matter; these platforms are almost purely used to help educate, spark discussion and critical thought, and promote awareness of our mission and brand among community stakeholders. When we do use these platforms for recruitment, we involve other stakeholders, such as past vaccine study participants who consented and volunteered to having their pictures professionally taken for a vaccine study ad campaign, which we have since used to distribute as both hard-copy and digital media. Often, these individuals featured in the ads will self-promote, posting the ads featuring themselves on their own Facebook pages, which is very exciting for us because of how actively engaged and positive our past participants can be about being involved in our studies.
As for the ways in which social media and other online communication has affected our communication planning, we definitely do monitor our online presence on Facebook, Twitter, and other platforms constantly in order to maintain healthy debate that does not become very offensive, as well as to counter misinformation, which often spreads virally online, with correct facts and myth-busting.
2) Since I came onboard with Bridge HIV, the main issue in our PrEP research context that has arisen is the criticism of Truvada by the AIDS Healthcare Foundation (AHF), who launched an ad campaign in August this year that described government promotion of this prevention strategy as a public health disaster and misconstrued research results to incite doubts in people’s minds about Truvada’s effectiveness. However, far from restricting people’s education and interest regarding PrEP (either Truvada or other experimental PrEP products such as those we are studying at Bridge HIV), the AHF’s controversial ad campaign and associated news about its stance on PrEP has generated a surge in advocacy, self-education, curiosity, and awareness about PrEP in many LGBTQ and other communities, at least in the Bay Area. In fact, I can even attest that some potential participants I have screened for our studies were inspired to learn more about and possibly join our research efforts in part because of all the hype about Truvada that AHF inspired. Many blogs, websites and Facebook pages have also sprung up or increased in popularity/clout in response to AHF’s negative press and the controversy they created. As for Bridge HIV’s specific response to the AHF and their public opinion on PrEP, we responded as we always do in the face of controversy and misinformation: we provided accurate and layperson-accessible information and education via our online channels in order to assure that our followers and stakeholders, as well as anyone else who Googled “PrEP” in response to AHF’s campaign, could come to an informed understanding of whether/how well Truvada actually works.
I like Mathias’s comment about networking of “previous” and “current”/”future” stakeholders, especially with the added note that those words in quotations really don’t mean anything because once a stakeholder, always a stakeholder — even for a new study that is looking to involve, engage, and ultimately recruit a totally different population! Stakeholders involved in previous trials and newly identified stakeholders for upcoming trials can both benefit from meeting one another and networking, not to mention the benefits this could bring to the research site and trial as a whole as well. Great point!
1) In our strategic community programs meetings, our team tends to make charts more than maps to determine our educational, outreach, and recruitment efforts throughout the trial site area. Other opportunities to engage in community mapping have arisen when members of our team have the chance to attend local or national conferences where mapping is a group activity, which have been very productive in the past but usually much broader than just what would apply to our specific trial site. We determine who constitutes our CAG mostly by who is interested and available to commit to the group, with no one ever having been turned away from participating. As for active recruitment of new CAG members, we ask current members and sometimes, past trial participants whom we believe could engage other organizations, individuals and communities to participate that we haven’t yet drawn into our group yet. Most of our CAG members are actually involved in HIV/AIDS organizations, other research, or activism/advocacy work of some kind; it has been harder to retain those who do not have other connections to our field, so we have overall kept up with only the more involved CAG members. This is a work in progress. However, we do feel that the CAG membership mostly represents the key populations and communities we are working with in our research, so there is stakeholder representation but it stands to be improved.
2) Our CAG is one major way for us to engage with stakeholders and their representatives on an organized ongoing basis, since we meet monthly. As for other modes of investment in stakeholder engagement, we have one member of our community programs team whose major task is to organize, facilitate, and connect with various communities and organizations — scheduling in-service educational or outreach presentations, arranging for us to attend local events/festivals/forums and other engagement opportunities, and working at certain venues around our trial site to engage via street outreach/recruitment. We also have two members of our team dedicated to social media outreach and engagement, with a minimum of 2 posts per page/account per week. We are often lucky at our trial site that we are assigned to enroll for consecutive trials that are related to and build off of one another, so that it is quite easy for us to engage stakeholders in a long-term capacity because of the continuity of the research we are engaged in ourselves. Stakeholders tend to want to stick around for the long haul to see whether the future of this research will take us, them, and their communities; likewise, we are thrilled to have their continued engagement as each study answers more and more research questions and moves the Networks closer to reaching the research goals.
