Sylvia Kusemererwa
Forum Replies Created
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That would be interesting to observe! However, if provided as part of the study design, women would choose between taking a pill and using a ring. Similar to what is being done under the REACH trial, 6 months on pills and 6 months on the ring followed by a crossover.
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One of the times would be at the point of results dissemination. At that point you would have information that may fall on the positive or negative shared. However, you could always remind participants that each one of them signed a consent form accepting to participate and that they are free to continue or withdraw from a study at their own will at any time.
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I think monitoring community engagement may be a bit of a challenge. You would have to track the numbers and responses. I guess one would need both quantitative and qualitative skills to do this which is not usually the case. The data teams never participate in data collected under community engagement. So the teams would have to do this by them selves.
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That was the most exciting news in the history of HIV prevention for women!!!
Finally something that women could use to prevent themselves from acquiring HIV without consulting anyone.
We look forward to the applications to FDA and national regulatory bodies in Africa.
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Agree, that should be helpful. Luckily now all engagement plans are being reviewed and approved by ethics committees.
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Very true. Thanks
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That’s helpful. It is really a challenge especially with social media.
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I guess that’s where advocates come in to create an environment that ensures free vaccines for communities.
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I agree, pretesting would clear the dilemma between stakeholders
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Oh yes indeed! we look forward to WHO’s input in September 2020.
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One way to closely work with them is have them as members of the CAB. In this way, they will understand research conduct and become advocates in communities.
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I agree with you Patricia, stakeholder involvement at all levels of protocol development is key. Yes, IRBs may also outsource for experts in a filed to review and provide input to protocols.
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They usually need more than one efficacy trial to licence a drug.
However considering the different populations, CAB LA could be licensed for MSM and trans women, then the label updated to include cis women when the results become available.
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WHO will be releasing their pre-qualification of the ring and probably guidelines in September 2020.
There guidance will be very important on that.
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Now that would be a tricky scenario. However, the CAB lead would have to provide feedback to the PI. We had this happen before during the Partner’s PrEP trial. We did get feedback about participant concerns and addressed them there after.