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  • Sylvia Kusemererwa

    Member
    August 10, 2020 at 7:29 pm

    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.

  • Sylvia Kusemererwa

    Member
    August 5, 2020 at 8:24 pm

    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.

  • Sylvia Kusemererwa

    Member
    July 31, 2020 at 5:04 pm

    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.

  • Sylvia Kusemererwa

    Member
    July 28, 2020 at 5:21 pm

    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.

  • Sylvia Kusemererwa

    Member
    August 13, 2020 at 10:42 am

    Agree, that should be helpful. Luckily now all engagement plans are being reviewed and approved by ethics committees.

  • Sylvia Kusemererwa

    Member
    August 13, 2020 at 10:41 am

    Very true. Thanks

  • Sylvia Kusemererwa

    Member
    August 13, 2020 at 10:40 am

    That’s helpful. It is really a challenge especially with social media.

  • Sylvia Kusemererwa

    Member
    August 10, 2020 at 7:24 pm

    I guess that’s where advocates come in to create an environment that ensures free vaccines for communities.

  • Sylvia Kusemererwa

    Member
    August 10, 2020 at 7:22 pm

    I agree, pretesting would clear the dilemma between stakeholders

  • Sylvia Kusemererwa

    Member
    August 7, 2020 at 8:55 am

    Oh yes indeed! we look forward to WHO’s input in September 2020.

  • Sylvia Kusemererwa

    Member
    August 5, 2020 at 8:16 pm

    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.

  • Sylvia Kusemererwa

    Member
    August 5, 2020 at 8:09 pm

    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.

  • Sylvia Kusemererwa

    Member
    August 5, 2020 at 8:04 pm

    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.

  • Sylvia Kusemererwa

    Member
    August 4, 2020 at 9:49 am

    WHO will be releasing their pre-qualification of the ring and probably guidelines in September 2020.

    There guidance will be very important on that.

  • Sylvia Kusemererwa

    Member
    August 4, 2020 at 9:07 am

    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.

Viewing 1 - 15 of 20 posts