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I would like to say congratulate the team for putting together the GPP online training course. Thank you for feedback from my lesson from Anne and team. I will bring your good comment to our clinical trial working in near future.
For the GPP Blueprint, I think it useful for my work because the tool is quite clear on how to practice in order to following GPP via steps by steps.
For more understanding in this tools, I think. You should be added an example of study trial that using the Blueprint tool. (An example of competition on the Blueprint will help us to more understanding in the shot time period).
Thank you very much.Siriporn
I agreed with Mathias Wambuzi that CABs are engaged in drawing a dissemination plan, preparing key messages and their translation into local languages. And also all stakeholders should involve. And also greed that challenges are how to correct people’s misinformed notions without discrediting the sources where people heard this misinformation.
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
Refer to The World Health Organisation in 2012, published guidance on the use of PrEP for serodiscordant couples, and men and transgender women who have sex with men. Specifically the HIV-negative partner of a serodiscordant. .
It has been argued that pre-exposure prophylaxis could have an enormous impact on the worldwide HIV epidemic. Mathematical models estimate that if tenofovir PrEP was used by 90 percent of high-risk people and was effective 90 percent of the time, potentially the spread of HIV infection could be reduced by more than 80 percent in a few years. However in THAILAND, If anyone interest to use PrEP, they need to pay by themselves. In the Future, hope policy could be prevented HIV infection by using PrEP and preventing high-risk behaviours among the most sexually active population groups.
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?
I never involved in PrEP trial but I think it is importance to sharing large trial results, in language that all stakeholders can understand, regardless of their background in science and, specifically, the science behind the trial product.I agreed with Patchara that engagement efforts can help researcher develop Information Education material in lay language, smooth recruitment, researcher understand well on norms&culture& their life style etc. It helps participant easy to understand information, trust, believe process of study and researcher etc.
1) How can engagement efforts impact a participant’s experience in a trial? Do you have a concrete example from your own work?
Engagement effort can help participant more understanding study and also make positively the participants experience in a trial, I believe that engagement efforts in the community have positive impact on participants experience in the trial. These efforts provide a sense in the minds of the community people that the outcome of the trial is their direct contribution that they have worked towards and their fore share the benefits/achievement with the researchers.
From my experiences for Test and Treat study in MSM/TG, prior start recruitment staff have forum with activist, CAB and key persons. These meeting we receive more information about any concerns of group such as side effect of early ARV initiation, concern and confuse about process in protocol. We have plan for every process of study as community concern .
2) How did CAPRISA’s comprehensive approach contribute to their success and network of relationships?
CAPRISA’ team has good process to engage community and comprehensive approach contributed to their success and network of relationships in such a way that it conducted targeted outreaches to educated about the trial, learn about cultural factors that might affect the trial.
3) What are some examples of how you have sustained 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. We have CAB meeting in every 3 months also. After study close out, we still have meeting with CAB. We will report them about close out plan, progression of study result.1.) For our study, we have experience on stigma on the enrollment process and follow up process with ARV clinic (Anti-retroviral clinic). Subject who interest to enroll in the study should go to ARV Clinic for screening and enrollment and will follow up at ARV clinic in every 3 months. Therefore the study indicates that subject who is HIV negative and HIV positive can enroll in the study. The fact that when we recruit HIV negative participants in to the ARV clinic, they come from same areas with HIV positive and subject who on ARV treatment,
Subject who have HIV negative status; they concern uncomfortable and start grapping and subject stigma when they go to the ARV clinic for conduct the study (they said they HIV negative). We refer them to the trained counselors and study team for discuss and give suggestion and find appropriate solution.2.) Study team setup the meeting with ARV clinic staffs, counselor, and participants for find solution.
We set up the appropriate comfortable area clinic for participant in this study. We did consult with CAB after this situation resolved and they had suggestions about management plan for subject harm.For our study, we have experience on stigma on the enrollment process and follow up process with ARV clinic (Anti-retrovirus clinic). Subject who interest to enroll in the study should go to ARV Clinic for screening and enrollment and will follow up at ARV clinic in every 3 months. Therefore the study indicates that subject who is HIV negative and HIV positive can enroll in the study. The fact that when we recruit HIV negative participants in to the ARV clinic, they come from same areas with HIV positive and subject who on ARV treatment,
Subject who have HIV negative status; they concern uncomfortable and start grepping and subject stigma when they go to the ARV clinic for conduct the study (they said they HIV negative). We refer them to the trained counselors and study team for discuss and give suggestion and find appropriate solution.Dear all,
I really liked the point team brought up; about engage all stakeholders early during trial design. The point of proper provision of clean needles to BTS participants should be discussed at the beginning during study design. I totally agree with you all, engaging community in early stage, is the best way to avoid confusion and misunderstandings, eventually also, and do move out any concerns that one of them may have during the study.1) What implications did the lack of inclusion of clean needles in the prevention package have for trial results?
The study did not provide the clean needles to the study participants yet it is a known standard of prevention among in IDU. I think clean needle is a one factor that effect the results of the study (provide the clean needle may be effect the research question and objective if this study), therefore the wellbeing of subject should be concerned. And ff researcher able to provide complete of prevention package for participant, it the can prove efficacy of study.2) How can researchers engage stakeholders to better negotiate prevention packages that combine various arrays of options tailored to the needs of diverse subgroups?
Formative research such as CAB meeting can help researchers engage stakeholder in better negotiate prevention package. Researcher should offer many ways and possibility that will do in study and receive comment and suggestion from stakeholder.1) Give an example of successful stakeholder engagement in protocol and/or IC development. What changes were made as a result of the input gathered?
I have been joining to community consultation for Test and Treat study at my site. We discussed about IC development. In IC, the langue is not clear when we call Transgender women in Thai Langue. This meeting, we invite TG stakeholder to join and give comments on IC, so, the details on subject information sheet in term of TG in Thai Langue will be changed after discussed.2) If a protocol gets sent to your trial site in final form, how would you address the GPP recommendation for stakeholder involvement in protocol development?
I think, we should address the GPP recommendation for stakeholder involvement in protocol development by presenting the finalized protocol to CAB and stakeholders requesting any feedback. And also, involve and review subject information sheet and IC and study materials, which is acceptable in the community. However, if we found suggestion from community that affect to major of change protocol. The study team will discuss after receive any comments.Thank you very much for recommend the FHI Communications Handbook for Clinical Trials. I am interesting the components of communication and issues management planning before, during, and after a clinical trial and how to incorporate online media in overall communications strategy.
Also, I think unexpected issues may be occurred in any steps. Clear communication with all stakeholders is important.
1. In my experience, social media and online communication affected to study and stakeholder engagement. We developed one websites. We use advertisement for recruitment, we involve MSM stakeholders who volunteered to having their pictures professionally taken for a study an campaign, which we have since used to distribute as both hard-copy and electronic media. We meeting and discussed with local CAB before and during create the online advertisement are including in the engagement strategy.
2. Unexpected issues for my experience is animation cartoon with showing how to take ARV medication, the NGOs (Patient living with HIV) concert the picture is sensitive for patient living with HIV because the steps to take ARV may be make patient uncomfortable. We plan have a meeting with CAB before and during create information in the future time.
1) We discussed with local NGOs and CAB for created map. Some time we used Mapping from local NGOs. We determine who constitutes in the MSM/TG group by who is interested and available to commit also. The primary method that we use is meeting with clinic staff, community educator, PI, physician, local NGOs) and list stakeholder that may be effected conducting study. Another method is list from CAB meeting.
2). For sustainability of stakeholders. We have a meeting with CAB members in every 3 month, but sometimes we may need them for urgent reasons before their schedule time.
We contact a member of MSM/TG community who organize, facilitate, and connect with various communities and organizations arranging for us to attend local events, forums and other engagement opportunities, and working at certain venues around our trial site to engage via street outreach/recruitment.
