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Another way in which stakeholders can be engaged is through the establishment of sustainable relationships with the media house such as print and radio media. This will help to prevent negative reporting by the media or ensure that the site has full control on media reporting
1) The PrEP example in Module 10 highlighted how product introduction and scale-up can differ according to factors such as the country’s health systems, regulatory approval processes, and the availability of financial, human and other resources. Reflect on your setting and think about the potential process for introduction and possible scale-up of an efficacious microbicide (e.g., tenofovir gel or dapivarine ring). Describe what might be similar or different to the PrEP timeline.
The starting point will be to conduct Community Dialogues and Focus Group Discussions (FGD) with groups of Community Stakeholders, Broader Stakeholders, District, Provincial and National Stakeholders. The objective will be to assess stakeholder’s reaction to various results scenarios. The following three results scenarios; Positive, Flat or Negative results and people should be asked on how they will react to these various scenarios. The communication plan aimed at addressing concerns identified during the assessment exercise should be developed. Such plan should aim to develop targeted messages that aim to address real issues
2) Describe ways you have engaged stakeholders (or been engaged as a stakeholder) in results dissemination for a trial and/or possible future access of a trial product. What were some of the challenges? Are there lessons learned you might share:
Consultation meetings with CAG and other stakeholders through out various phases of a trial. Possible challenges include a situation in which their are no enough resources to sustain product access in a community. Other challenges include lack of stakeholder support to a new product. Lessons learned is that stakeholder consultation should be an on-going process that should happen through out various phases of a trial in which potential trial threats are identified and addressed
In our site we have experienced a lot of personal stigma associated with the use of Investigational Product. Participants complained about the discomfort associated with the product usage. The use of 1% Tenofovir gel had its own challenges. Most participants reported personal discomfort associated with gel usage. Some have reported that their partners were complaining that they are “wet” and some have been accused of cheating
Intervention
The site consulted with CAB to get their input on the above mentioned harms. Some of the advices offered was the provision of pads and petty liners. Participants were also advised to insert their gels early enough before sexual intercourse in order to avoid problems associated with the product use. Motivational talks were issued to participants on the gel usage.
1) What are some examples of trial-related harms that participants have experienced, or might experience, at your site or the site you are affiliated with (e.g. loss of housing, social stigma, vaccine induced seropositivity)?
The trial related harms can be classified into the following categories:
Product Related Harm: An example of product related harm include Vaccine Induced Seropositivity (VISP) a serious concern to people participating in HIV vaccine trials. People have reported discrimination and stigma associated with VISP. Another challenge is that VISP it is an unknown concept in our communities. The community understanding of HIV results is that you are either HIV Positive or Negative. We need more education around VISP
Community Related Harm: People participating in HIV prevention trials are perceived as promiscuous and having multiple sexual partners. Some are perceived to be HIV positive despite their participation in HIV prevention trial.
Family related Harm: Some participants have reported physical abuse by either family members or partners due to their lack of disclosure regarding their participation in an HIV prevention trial.
How has your team dealt with these situations? Which stakeholders provided input, and how did they help
Our site has introduced the participant’s support groups to help participants with issues that will disturb their participation in the HIV prevention trials. Groups consisting of cohort groups of participants was introduced during the implementation of FACTS 001 trial. These FACTS clubs also included a sub-group consisting of partners and family members. This intervention has been very useful since it provided a different perspective to stakeholder engagement.
Trial participants were exposed to the risk of acquiring HIV and the study did not take safety measures into consideration when designing and implementing this trial . The role that advocacy groups can play in trial designing and implementation was not taken into account and as such there was a lack of consultation when it comes to advocacy groups
Firstly, I must congratulate the team for putting together the GPP blueprint that provided us with the framework on how the GPP guidelines can be implemented. The blueprint provided us with the guidance on how the program Goals, Objectives, Activities including Deliverables and Indicators can be link during the program designing and implementation. It provided us with the guidance on how to develop “SMART” objectives. I have also learned about the importance of using the previously developed stakeholder data-base to prepare for the future stakeholder data-base. It was key to learn about the different levels and types of stakeholders including those with positive interest into the trial as well as those with conflicting interest. The stakeholder engagement template for use in the development of community engagement plan was very useful. The use of stakeholder Priority Grid to prioritise stakeholders according to the following four categories: Quadrant 1-Partener, Quadrant 2-Involve, Quadrant 3-Inform and Quadrant 4-Consider was important and very useful. Lastly it was important to learn about the develop of issues management plan and how to identify potential threats early in a trial and plan for such threats well in advance.
The lack of provision of clean needles as part of the prevention package compromised the relationship between the researchers and the advocacy groups. This did not only affect the relationship between researchers and advocacy groups but also the questioned the credibility of using Tenofovir as part of the prevention package. The study was viewed as being unethically and there were many questions relating recruitment activities related to the BTS. The ethical aspect of conducting this study was questioned considering the fact that half of the participants were receiving placebo. The issue here was that such participants were exposed to HIV by not providing them with clean needles. There were also questions relating to post-trial access for participants who took part in this study.
This is were it is important to engage your stakeholders early during your trial design. If this study was discussed with a group of advocates during the early stages of the trial design, the challenges could have been identified early and options made available. The early inclusion of broad range of stakeholders including government officials and Advocacy groups could have ensured proper provision of clean needles to BTS participants
Another good example of successful stakeholder engagement on protocol and ICF development includes the recruitment of CAB members to serve in the protocol development committee in order to ensure that that the community perspective is represented. Another example could be that of having a community member serving in the Local Ethics Committee. Having a rep serving in the local ethics committee will ensure that all approved protocols take into account the needs of the community. Consultation with CAB though structured dialogues and Focus Group Discussion can be helpful. Community voice can also be heard during the development of recruitment and educational material, especially in situations where the protocol has been finalised. All comments and suggestions made can be measured to assess the impact.
Stakeholders can provide a very impactful input into the protocol and ICF development. Some of the word(s) used during the designing of the protocol might not be culturally and legally sensitive to the targeted social context e.g. protocols developed in Europe and intended for implementation in Africa. Another example include a situation in which protocol developers and sponsors use words that are not appropriate to the targeted audience. For example, the use of words such as “Men who have sex with other Men” (MSM) or “Female Sex Workers”. Stakeholders might advice that such words be altered for socially acceptable words like “high risk population”. Good stakeholder engagement can provide us with the words that are both legally and culturally sensitive to the intended social context. Indicators for a successful stakeholder input can be measured by the proportion or the number of inputs/words made by the stakeholders into the protocol or Informed Consent Development (ICF) process
Hi, Marie
Thank you kindly for a very useful insight on how we can use our networks to effectively engage with our stakeholders. I also like the idea of involving CAB during the protocol development stage. But this approach became very difficult in situations where the sponsor comes with a ready to implement complete protocol. The use of pre-screening questionnaire/protocol is a useful one. Our site is in a process of adopting a generic screening protocol as this can assist in eliminating non-qualifying participants early in the trial.
Hi, All
How social media and on-line communication affected our trial communication and engagement strategies:
The use of social media such as “Facebook and “What’s up” had a huge impact on the site’s communication plan and strategy with trial participants and stakeholders. During the implementation of one of the trial at our site, a page was established in which study participants and community members were able to communicate with the site. This also provided a useful platform for the community members to post questions about the trial and investigational product under research.
Experience of unexpected issues at our trial site
The sudden announcement of VOICE trial that the 1% Tenofovir gel does did not show efficacy in the VOICE trail. This presented a huge challenge to us in terms of how does one explain the difference between the gel used in CAPRISA, VOICE and FACTS. This also made us aware of the facts that it does not mater how advance can you plan, there is always bound to be an unexpected occurrences in a trial. This also taught about the importance of regularly revisiting the plan to ensure that they it address the needs of your stakeholders
Anne and others
You are raising a very important question on the barriers to create a long-term relationship with your stakeholders. I think lack of proper planning can be a barrier on its own. My experience is that community engagement activities take priority before and during the trial implementation. What I mean here is that after meeting your recruitment accruals, there is a shift in focus. Usually this is where most of us are loosing it. When you need some of your stakeholders later in the trial, you will have lost some of your key stakeholders. Proper planning will ensure on-going and continuous stakeholder engagement. This also require aligning your stakeholder engagement plan with various phases of a clinical trial
Hi, Erikan
Module design was excellent. I was also fascinated by its interactive nature, it was well organised and exciting to follow. What I found very interesting was link between the module content, GPP guidelines and the operationalization of these guidelines into the GPP blue print. Work assignment were excellent because they allowed us to extend our thinking beyond the guidelines itself. I must also confess that the comments from the marked work assignments were excellent. In-terms of the discussion forums they have allowed us to keep contact with our fellow colleagues and establish networks with people common interest to us.
Aspects of the program that need to be improved:
- I feel that the time allocated to this course was not enough and I therefore would like to suggest that we increase the course duration to at least 6 months with each module given 2 weeks.
- We have submitted work assignment and we were given feedback which was good to read and follow. My feeling is that these feedback were not quantifiable enough for me to know where I need to improve. What I mean here is that it would have been good if we could be allocate a percentage to each assignment and work on the average percentage to determine the final mark.
- Since this is a web-based portal, can I suggest that we improve on internet connectivity. I agree with Jauhara, it was a mission to upload some of the assignments
Regards
John
Dear Siripon
In your comments you mentioned that during the conduct of formative research, Focus Group Discussions were used as a tool to assess different perceptions in you community. What I would like to find out from you is” was there a specific tool used to implement these focus group discussions? Was the information collected analysed and formed part of your formative research final report? if yes, will it be possible to share some of the information gathered with the rest of the team?
Discuss the link between formative research and community engagement for a trial. How are they alike? What are some differences between the two?
By Formative research we refer to the activities that enable the research staff to gain a better and informed understanding of the local population, socio-cultural norms and practices, local power dynamics, local perceptions, channels of communication and decision making as well as the local history of research. Formative research also assist the research staff to understand the needs and priorities of people who are locally affected by and are able to influence the trial. Community Engagement on the other hand allows the research team especially the community engagement team to establish sustainable relationships with the community stakeholders in which the research in been implemented. The difference between formative research and community engagement is that formative research happens during the plenary stages of the trial and community engagement needs to happen during various phases of the trial’s life cycle.
Yes, Tembisa Clinical Research Site (TCRS) was involved in the formative research exercise. The exercise allowed the site to develop a community stakeholder data base, assess the community perceptions and power dynamics to mention the few. The formative research was followed by the development of the community engagement plan. A draft copy of the plan was shared with the site’s Community Advisory Board (CAB) for input and comments. All comments made by CAB were incorporated into the final copy of the Stakeholder Engagement Plan. In this way the community stakeholder’s voice was heard.
