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In first time when I saw Blueprint, I feel it hard to understand. I need to read again and again. I try to search example in website but not found. Around module 3-4 that I feel fine and engage in GPP blueprint. I think this tool useful for everyone who work in clinical field not only prevention trial. It should expand to treatment trial because community engagement important for study. I like everyone who have discussed in forum and great idea for me. Thank you for feedback from my lesson from Anne and team. I will bring your good comment to my work in future.
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
For my experience of iPrEx and MTN study, PrEP in Thailand not well known in general population. I think only people who work in this area that understanding about PrEP, especially in MSM/TG. If anyone interest to use PrEP, they need to pay by themselves. However, government have interested about PrEP. Hope they have policy to support PrEP soon.
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?
We had been dissemination iPrEx result to all stakeholders. No problem for us to provide information. iPrEx team have great preparation plan and share to each site. We have communication plan for this step. We set time point to share result in step by step and set target for releasing news. I think that only media that difficult. We prepare news release to media but in real situation we found that many website copy and developing some content that error and miss some information. This is good experience for our team about awareness to providing information to media.
Dear GPP working staff,
Thank you for your team that hard work and done excellent job. For me, I like the visual and method to explain in each module. The practice is excellent but it hard to understand some questions for me. I need to use more time for understanding about questions in each module. I think that is my problem about language in English. However, thank you for you all that improve my experience about GPP. I hope that I will use this practice for create GPP plan in next project.
Cheers,
Pongpun
I agree with Jessica and Laura about should conversation out of HIV in community forum. In my experiences that work with Transgender woman group, they have interesting about hormone or medicine that beauty supplement. This topic is hot topic for them and they have more attention. We can add topic about side effect of them and instruction for safety.
Sometime we should survey interesting of community that what topic they concern or interest? This is great for them that should known story that more than HIV from staff. We can add or link knowledge of HIV from this activity such as sharing needle for injection hormone can cause of HIV transmission.
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. In accrual period, out reach staff have meeting with stakeholder in several groups and receive information/opinion about study that useful for study. Staff can use this opportunity to create and share plan such as recruitment and retention plan, safety plan, plan for management in case stigma etc. Staff will have awareness about anything that community and stakeholder concerns. From my experiences for PrEP 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 concern about side effect of study product, fear rectal exam, concern brand of condom that provide to participant and confuse about process in protocol. We have plan for every process of study as community concern such as what are concern in recruitment process, what is message that use for participants, how to manage risk management.
2) How did CAPRISA’s comprehensive approach contribute to their success and network of relationships?
CAPRISA’ team have excellent process to engage community. They have deep interesting and more power for manage plan. I think they have great preparing participant to deep understand protocol. Because this is important thing for success of protocol. Participant can comply with protocol and no problem of retention or adherence. Staff analyze in each steps and have community consultation. The important is staff maintain relationship in whole study with community. Because they can build relationship and known any concern during the trial.
3) What are some examples of how you have sustained relationships with communities after and between trials?
Between trial, we have CAB meeting in quarterly. We have meeting regularly with stakeholder and join activities that they have. After study close out, we still have meeting with CAB. We will report them about close out plan, progression of study result, participant found social harm or not. Additional, we have website that use for report result of study. If community have forum or activity, staff will participate for updating and evaluate about impact of study after close.
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)?
I have been found that participant have social harm from family because his mother found Truvada in his bedroom. She understand that her son has HIV infection because she search internet and found that this drug is ARV.
2) How has your team dealt with these situations? Which stakeholders provided input, and how did they help?
Clinic staff investigate with participant about this situation and evaluate seriousness with him. We prefer option to resolve with him such as invite his mother to clinic and explain study to her. Finally, participant can explain to his mom with himself and this event resolved. At that time we no have stakeholder engagement clearly. However, we did consult with CAB after this situation resolved and they had suggestions about management plan for social harm.
I have been found same situation with Rona and Jauhara about vaccine trial induced to false positive. Participant call to clinic and consult about this situation because she has rejected from blood donation. This trial had finished around 2 years and this participant has follow up in final visit as protocol already. I need to clarify with this organization and she disclose by herself that she was vaccine trial participant. Everyone understand and this event resolved.
Study need to develop plan for protect participant and for safety. Staff have been emphasize all participant about urgent contact to staff anytime if they found problem form study. Stakeholder can help researcher to know about all concern or any effect that may be occurred with participants of trial.
I think that this period time for prevention study will proof this concept about prevention packaged. Truvada has approved for PrEP and next study have to use Truvada for prevention package or not? This question should be asked from stakeholder. Some country, no policy provide PrEP within health coverage and people do not know about this. This is challenge for next study that will conduct there.
However, this situation not same as provide clean needle to IDUs. It is legal and challenge for researcher who need to comply with local policy in country, comply with protocol and comply with stakeholder view.
1) What implications did the lack of inclusion of clean needles in the prevention package have for trial results?
Clean needle is one of prevention method for HIV prevention package. Clinical trial phase 3 for efficacy should control any factors that may effect with study. This study did not provide clean needle which the ways of HIV infection for IDU are sharing needle and sex. I think that lack of clean needles induce to trust of trial result. We do not know that control have sharing needle more than case or not? If we provide clean needle in 2 groups, it will fair for conclusion that this factor not effect the result. It is same as condom use that is provided by study, using condom depend on participant chose. If researcher able to provide complete of prevention package for participant, it 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?
Researcher should have formative research and stakeholder mapping for survey opinion of them. Researcher should offer many ways and possibility that will do in study and receive comment and suggestion from stakeholder. If researcher have imperative that can not operate, they can consult with community or stakeholder about it. Researcher should have consultation meeting and have conclusion for meeting. I think that stakeholder accept study if researcher try to tailor study in the best way. It not need to do all things that stakeholder prefer but should try to do and adjust as the way that they prefer.
Hi All,
I agree to you all and indeed to promote about consultation community in process develop of protocol. That is safety and useful for study and community. Science, culture and social have to good cooperate and concern about participant and community that may affected directly from study.
1. From my experienced, I have been join to community consultation for MTN017 at my site. After protocol team visit all sites and they can revise the protocol in some item such as eligibility criteria. In previous version, this protocol not include transgender woman but after this meeting they revise criteria and site can enroll TG to join this study. This meeting, we invite many people to join which should be called stakeholder engagement. We have CAB, MSM NGOs, students, HIV positive NGOs, teacher and previous PrEP participant who join this meeting. This meeting is accepted by all people and proof that community consultation prior study start has useful and respect to community view.
2. Even if final protocol approved, I think that community or stakeholder can discussion and provide any information to protocol team for consider. Many protocol were revised or have amendment from community concern. Mostly of protocol agree to revise or accept any comments that may be affected to study progress. I think that normally community will not change the objective or hypothesis of study but they always concern about safety and participation of participant in study. Sometime related with Inform consent and procedure in protocol. However, if we found suggestion from community that affect to major of change protocol. I think that it would be useful if this suggestion send to protocol team.
1) I think that social media and online communication affected to study and stakeholder engagement. We need to do plan for communication and risk communication which social media and online communication need to list in plan. We should also listed this media as one of stakeholder.
In the past, I have been inform study result in clinic website after that many NGOs have downloaded and use for meeting or forum discussion. However, at that time we provide study result in many way such as newspaper, radio, television and some website. We found that some website show wrong message and some message not same as original. However, after we posted anything about study in media online or share anything in media, we have to monitoring any post or feedback after that. If we found some information wrong and misunderstand, we have to explain what is fact.
2) Same as situation above, we need to monitor any response after share anything to media. I have lessons learned from this situation from PrEP trial , I should draft information, news or any information prior to provide the media. We can scope detail and use clearly language for accurate information. Including picture that related to information, we should provide them to media because some media use wrong picture that induce to wrong information. We have meeting with CAB before provide result. Some information need to submit IRBs.
I agree with you all and I have been found issues same as Patchara about participant’s colleague gossiped him that he has HIV infection so he joined in study. That is not correct because we done PrEP trial which enroll only negative HIV persons. We offer him for resolve this social harm reduction such as explain to his friend and colleague. In finally, he can resolve it by himself. He can explain about study information and his boss support him and understand.
Hi Anne, I think that media could stated as key stakeholder. In my opinion, they have power for build good or bad news about study. We should listed them in stakeholder engagement plan and build relationship. We need to provide study information to them clearly. If we found rumor, we need to do communication plan and clearly to response.
