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Going through all the lessons and assignments made completion of the Blueprint a lot easier since so much of it was discussed or developed in the earlier modules. Not being at a site, however, made many of the assignments and the Blueprint more challenging. While, I have been involved with GPP for a long time in one form or another, the course helped to reinforce much of my knowledge and think about some aspects in a more focused way.
I think it is likely that additional implementation studies and demonstration projects would play an important role in the scale-up of an effective microbicide or ring. For scale-up to be successful there would need to be information about real world use and a strong foundation of awareness and understanding among those who would need it most. As we have seen with PrEP, issues of stigma and discrimination would need to be addressed through ongoing educational efforts so that they are acceptable and widely adapted for use.
While I’m not involved in working with stakeholders at a specific trial site or even within a network, at the Division of AIDS level we do reach out to stakeholders when a trial is ending to help ensure that messages are consistent, accurate, and timely. We’ve done this with varying degrees of success for different studies. Though we try to be well prepared with our plans in place, there are definitely times we are caught off guard, for example for unexpected trial termination as a result of a DSMB recommendation. In general we have a list of relevant stakeholders for each study that we review and we develop a tiered communication approach and a timeframe within which we communicate results and messages. The same information is shared within a given network and with the sites, so that they in turn can communicate with their stakeholders and through their channels of communication.
With regard to future access of a trial product, I know there access plans are put in place prior to trial initiation and they are developed with key stakeholders (e.g., in country regulatory bodies, ministries of health etc.). One challenge is that issues of access beyond a certain point in time post-trial may be left to the responsibility of the site, working with their institution, Ministries of Health, the specific industry partner and perhaps other donors. As a result, longer term access goes beyond the agreements made when developing/conducting the trial and are not necessarily in our control.
I thought the modules were very well designed. I liked the varied, real world examples and the interactive nature of them as well. They were really very well done. I also enjoyed the discussion forum and liked hearing about what others have experienced and how they deal with specific situations. I thought have questions to prompt the discussion and course instructors chime in with additional questions and thoughts really helped to keep the discussion moving along and meaningful. Since I’m not at a research site or research network, the work assignments were somewhat challenging for me and I approached them differently each time. I’m not sure how I would modify them for folks who are not at a site, but am certainly willing to brainstorm with you on the possibilities.
Thanks for putting this together and for the thought you put into reviewing each and every assignment and post. I found the review comments very helpful.
Jauhara said it so well.. CAPRISA did have extensive relationships in the community and they were able to build on those relationships and partnerships as they planned and conducted the study. They had a large network of stakeholders that helped them with their educational and outreach plans and those stakeholders could also help them in furthering awareness, understanding and support for the trial and participants
With CAPRISA as a perfect example, I think engagement efforts can help participants feel more comfortable making the decision to participate, and actually participating in a trial. If the people feel there is a relationship between themselves and the research team and if the researchers garner support from others in the community (e.g., providers, service organizations, community leaders etc) participants y can feel more trusting of the information they receive about the research and proposed trial and feel support rather than stigma as a result of participation. Engagement can lead staff to be more understanding of local and cultural practices, as well as participants’ general needs/concerns, particularly with regard to research, and can address them. Ideally, this underlying knowledge and foundation, will translate to greater sensitivity on the staff’s part and will enable participants to feel they can approach staff with any questions or needs that they have. The clinic setting itself may reflect this understanding and/or sensitivity with appropriate visual images and language on materials, such as posters, flyers and brochures. Ultimately, as Jauhara noted, with effective engagement, participants can become more vested in the research and take pride in their contribution toward the outcome.
I have heard other stories like the one Pongpun describes, where family members or friends believe someone is infected because they are on PrEP or as I described earlier because they test positive because of VISP. It sounds like in her case, not only did the site staff effectively address the specific situation but worked with the CAB to plan for this sort of reaction in the future.
I have to imagine and hope that with increased awareness and knowledge in the broader community (as a result of continued stakeholder engagement and other efforts) we can garner more support for trial participants overall and reduce social harms such as these.
The issue of Vaccine Induced Seropositivity or VISP is very real for our vaccine participants. About 10 to 20% of people who join our HIV vaccine studies report personal problems or discrimination because of joining an HIV vaccine study. Family or friends may worry, get upset or angry, or assume that you are infected with HIV or at high risk and treat you unfairly as a result. It’s more rare for a person to lose a job because the study took too much time away from work, or because their employer thought they had HIV. But there are issues with foreign travel, insurance, and US military service.
The protocol consents for our HIV vaccine trials address the potential social impact risks of study participation and all our CAB members participate in reviewing protocols, consents, and communications materials, including VISP-related materials. The protocols and other materials detail the potential risks including being denied medical or dental care, employment, insurance, a visa, or entry into the [US] military. Participants are told that if they do have a positive HIV antibody test caused by the study vaccine, they will not be able to donate blood or organs.
DAIDS has had procedures in place to help our study participants with VISP since before the first extramural HIV vaccine volunteer was ever vaccinated, and they continue to be in place today. We provide our study participants free HIV testing for as long they need it. (Some patients have tested positive for more than 20 years, and continue to obtain free confirmatory testing as needed.)
DAIDS also helps with immigration and visa issues as many countries ban travel of those who are HIV infected. Each country has its own policy and some are more reasonable than others. One issue that we have been unable to address successful is entry into the US military. We also work to make sure our participants can get insurance. Agreements were reached with insurers years ago and we have had to remind them of those agreements and provide documentation related to study participation/VISP. For all of these staff at DAIDS and at the HVTN have worked with a range of stakeholders, clinicians, labs, CABs, and global experts among others.
We also have a protocol (participation is voluntary) that follows folks with VISP to determine the duration of VISP and any changes over time and there is a VISP registry so that if a site should close there is a record of trial participation. Participants are aslso offered ID cards to authenticate their participation and there is a toll free number for them to call if any issues arise. This is all voluntary as some people may not want physical evidence that they were in the trial. NIAID/DAIDS also has several funded projects underway for rapid tests that would not be reliant on antibodies.
DAIDS, and the Global Vaccine Enterprise also organized a workshop with global stakeholders in 2013 to address these issues and figure out how they could best support study volunteers in the short and long-term.
I appreciate Mathias’ and Laura’s comments about confusion and misconception. I was at a meeting with community stakeholders from all over the world this weekend, and so many of the stories I heard made me think of this module – stories of stigma, denial,and lack of awareness/knowledge among IRB members, among others. It so clearly emphasized the importance of broad stakeholder engagement from the earliest stages of trial development and on!
The lack of clean needles in the prevention package severed or at least significantly strained the relationship between advocates and researchers and created a lack of trust of both the researchers and the research process. It led to the study being viewed as unethical and, because the certainly of the data was called into question, it ultimately undermined the results of the trial and the future support of PrEP. The discussion with stakeholders needs to occur early and often in the trial development process. In this case, there was clearly a heated debate between the researchers and advocates but I’m not clear as to the extent to which there was respectful discussion during which potential options were ever discussed prior to the study initiation. It may be that there would never have been agreement, but again, it’s unclear whether or not drug users who attend the clinics, advocates, ethicists, and health ministry officials were all approached together and whether various options and the impact of the different options were discussed. In this case, while government laws may not have permitted the provision of clean needles, increased engagement from the beginning may have led to the identification of other options, and/or a coming to terms from key stakeholders about the trial design and an acceptance as to the value of the research and/or need for it. Again, I think the inclusion of a broad range of key stakeholders – potential participants to government officials, advocates to ethicists, regulators to providers – could help in identifying and weighing the impact of various options.
I really appreciated Jahura’s and Laura’s examples of how community input changed or is hoping to change the protocol. They both illustrate so clearly how stakeholder’s knowledge of the community – cultural and social context, research interests, practices etc. are so important to take into consideration when designing a study. Not addressing the issues raised by community in both instances could greatly impact trial success (recruitment/retention, acceptance of study etc).
Each of the NIH funded HIV/AIDS clinical trials networks has a different approach but they all gather stakeholder input during protocol development, especially on the informed consent process. They rely on CAB input but often create other mechanisms for input (other advisory groups or consultations etc.). Some examples of how our networks obtain input during protocol development are provided below:
In the HIV Vaccine Trials Network 2 global CAB members and one Community Educator participate on every protocol team. They provide input into all aspects of the protocol and the CAB members are asked to pay particular attention to the sample informed consent form and the parts of it that are specific to protocol. They are also asked to pay attention to whether or not the protocol makes sense overall, in terms of participation – is what is being asked of a participant reasonable. The CAB members participating on the team are permitted to share the protocol with their local CAB as well. Site CABs also have a chance to review the protocol and informed consent form once the protocol has been developed. At that point, the informed consent can be altered so that it makes more sense for their specific community.
In the HIV Prevention Trials Network, there are study specific community working groups that provide community technical assistance to protocol teams. These groups are formed for each protocol being developed and made up of one Community Educator and one CAB representative from each of the sites that will be participating in the study.
In the AIDS Clinical Trials Group, protocols in development are forwarded to CAB members at each site (unit and site investigators and coordinators are copied) regardless of whether or not the site will be participating in the study. The thought behind this is that some of those CAB members may have knowledge/experience that would still be important to consider as the study is being developed. There is a lay version of the protocol that is sent out and it also helps all CAB members to become familiar with the research being conducted throughout the network and with research principles and terminology. The CAB draft version of the protocol is provided by the network staff and includes the hypothesis, background material, rationale and schema, inclusion/exclusion criteria, study objectives, and schedule of events. (at this stage of the protocol development the Informed Consent has not been written).
With regard to a protocol being sent in final form, I think I would first want to know if any other stakeholders had input (even if my specific site didn’t, e.g, at a network or regional level, with other stakeholders vs. the site). While it may be difficult to alter the protocol at this point in the process, knowing whether there was any engagement, what questions were raised, if and how they were resolved, would be important to know. In addition, I would ensure that relevant stakeholders were informed of the protocol, still given an opportunity to review it and raise questions, and in particular review the informed consent and/or participate in its development. My understanding is that even once a protocol is finalized, the informed consent can still be modified based on to address the specific needs, language, culture etc. that is appropriate to the site. Stakeholder engagement at this point would still be valuable to help shape communication/messaging about the study, recruitment materials and in developing strategies on how best to share the information with other key stakeholders.
From the R4P guide, I have the following information on some posters that may be of interest:
Community Engagement, GPP and Advocacy
Poster Session 01 (Poster Themes 1-26), Wednesday Oct. 29 10:00-11:00 and 17:00-18:30, Level 0, Hall 2
Morar N. Seven Steps to Strengthen Community Engagement in HIV Preventions Trials in Durban. [P02.03]
Broder G, Maynard J, Karuna S, Anude C, Sobieszczyk M, Hammer S. Implementing Good Participatory Practice (GPP) in HVTN505 – the HIV Vaccine Trials Network (HVTN) Experience. [P07.02]
Siskind R, Morar N, Campbell R, Schouten J. Implementing Community Involvement in National Institutes of Health (NIH) HIV/AIDS Clinical Trials Networks. [P07.05]
Research Participants Skills Development as Peer Educators in Their Communities – Morar S., Ramjee G. [P07.06]
Managing Communication and Facilitating the Exchange of Ideas in a Large, Multi-Site Clinical Trial: Experiences from the ASPIRE Study – Scheckter R., Schwartz K., Mayo A., Baeten J., Palanee T., Soto-Torres L., Torjesen K. [P02.01]
A Rectal Revolution Takes a Village: Developing an Educational Video about Rectal Microbicides – Collins, C. Friedland, B., Pickett, J. [P02.02]
How Community Education Tools Facilitated Understanding of the ASPIRE vaginal ring Study: Kampala Experience – Kemigisha D., Ndawula P., Nanyonga S., Nakyanzi T., Etima T., Akello C., Kabwigu S., Nanziri S., Matovu F., Cokley C., White R., Nakabiito C. [P02.04]
Bridging the Gap: Uniting Participants and Staff for Improved ASPIRE Study Metrics at Wits Reproductive Health and HIV Institute in Hillbrow – Reddy K., Rees H., Palanee T. [P02.06]
Retention and Adherence in Trials:
Maximizing Participant Retention in a Phase2B HIV Prevention Trial in Kampala, Uganda: The MTN-003 (VOICE Study) – Muwawu R., Matovu F., Kapaata F., Kikonyogo F., Bukenya R., Musisi J., Kaggwa M., Saava M., Kabwigu S., Nakabiito C. [P23.09]
Recruitment for Retention in Biomedical HIV Prevention Studies: Strategies, Challenges, Lessons Learned from MTN-020 (ASPIRE) Study, at Kampala Site – Nanziri S., Gati B., Nakyanzi T., Matovu F., Etima J., Kabwigu S., Kemigisha D., Nanyonga S., Ndawula P., Nakabiito C. [P23.10]
The Research Registry: A Valuable Strategy for Longitudinal Success in HIV Prevention Research Recruitment – Weinman R., Baker J., Labbett R., Karas S., Riddle S., McGowan I. [P23.18]
Some oral presentations that may be of interest include:
Tuesday October 28th, Presentation OA07.01:
Characteristics of Young Black Men who have sex with Men enrolled in HPTN 061
1:30 PM ‐3:00 PM Location: Level 1, Meeting Room 1.60
Oral Abstract Session 07
Presenters: C. Watson, J. Lucas, S. Fields and D. Wheeler on behalf of the HPTN Black Caucus
Wednesday, October 29th
Presentation OA19.04, The Utilization of Good Participatory Practice (GPP) during the Planning and Implemenation of a PrEP Study among Black MSM
1:30pm -5:00pm, Location: Level 2, Meeting Room 2.40
Oral Abstract Session 19
Presenters: J. Lucas, G. King, P. Watkins, C. Watson, C. Hutchinson, C. Rogers, S. Wakefield, and S. Fields
Thursday, October 30th
Presentation OA28.03: Facing the Realities of HIV Universal Test and Treat: Early Lessons
Learnt from the Delivery of the HPTN 071/PopART Study Intervention
1:30 PM ‐3:00 PM Location: Level 1, Auditorium 2
Oral Abstract Session 28
Presenters: K. Shanaube, S. Griffith, M.Simwinga, C. Ngulube, E. Sakala, S. Simbeza, M. Mutonyi, S. Fidler, R. Hayes, H. Ayles
Thanks so much, Rona.
I agree with so many of the comments that have already been stated. I too love that the negative publicity generated by AHF actually had the opposite effect of what was intended by inspiring folks to learn more about PrEP for themselves. How fabulous that they didn’t just take what they heard and leave it at that. It’s such an interesting contrast to the impact that rumors and misinformation had in the scenarios Patchara described. But it sounds like her site did all the right things in garnering support from local NGOs to provide accurate information in a way that was respectful of participants and didn’t jeopardize confidentiality.
Hi all,
I won’t be at the R4P conference but I did co-author an abstract that was accepted for a poster presentation. My colleagues, Russell Campbell and Neetha Morar will be presenting it. Its called Implementing Community Involvement in National Institutes of Health (NIH) HIV/AIDS Clinical Trials Networks and discusses a guidance document that we developed for community engagement. It is very complementary to GPP and the poster notes the value of GPP and other guidance tools for community engagement. Our other network colleagues will be presenting in other sessions on the use of GPP in the NIH-funded HIV/AIDS research networks.
I hope those of you attending enjoy the conference.
Social media can definitely affect communication and we saw that particularly with HVTN 505. In that study, vaccinations were halted early following the recommendations made after a DSMB interim analysis. Participants were notified as per communication plans and notification as well as follow-up materials (slide sets among others) were prepared for CABs and stakeholders by the HVTN to help them better understand the results and implications. But the participant notification was made public almost immediately via social media, and well before NIAID had issued a press release. After two (or three) social media postings and a posting on Wikipedia, NIAID was prompted to issue its press release earlier than anticipated. Luckily, the postings were not inaccurate. Many of the immediate postings thereafter tended to be positive in tone despite the disappointing results, but it still necessitated some fast planning and action.
The news for HVTN 505, while certainly possible, was in many ways unexpected at the time of the DSMB and caught us a bit off guard. We were able to quickly mobilize a call with scientists and key stakeholders to discuss communications strategies and timelines but the news really did take on a life of its own in many ways. While media and stakeholder lists can be developed early on in the life of a trial, this really emphasizes the importance of regularly reviewing them, and of having all pertinent staff – from NIAID, the network, protocol chairs and sites, up to date and ready to implement the plans should they need to. The study did get a lot of attention following the initial announcement, and although the results were disappointing, the messages were consistent and focused on the fact that we really do learn something from every study. Also, many of the messages were focused that although the results were not what we wanted, the trial did what it set out to do, which was answer the scientific question as to whether or not the vaccine regimen was effective. There were also those asking whether we really did need a vaccine given that there were other prevention strategies. This provided an opportunity to emphasize the critical need for continued HIV vaccine research and to reiterate that while other prevention modalities are very important and can have an important impact, a vaccine remains our best hope for truly ending the epidemic.
