[Sylvia I. Davila]

Hi Edith: At the community meetings the local scientific (PI and sub investigators) provide to the community the information and clarify any questions the community may have. During the community activities the staff go with the CAB/stakeholders and they identify any incorrect information. Also we can have meeting to practice the message and provide the community a fact sheet with the information to ensure the correct message is delivery. In the next meeting or in a follow up call/conversation we can ask about the experience a identify any misconception and new information regarding the community needs.

[Sylvia I. Davila]

Hi Daisy: The study open on May 1 and close to F/up on July 7, 2020. https://clinicaltrials.gov/ct2/show/NCT04358068

Thanks!

[Sylvia I. Davila]

For HIV studies, we continue receiving the study’s CAB draft, site early draft to be discussed, reviewed and provide stakeholder’s recommendations. When the protocol is implemented the study team meets in a monthly basis if needed with the site staff.

With the COVID-19 studies is totally different. We are receiving the final version, without the site stakeholder recommendations requested. Once the study final version is provided to the site, we are having weekly TEAM Study meetings to clarify doubts, and be informed in real time of the issues in each site to find real time solution for them. Sharing ideas and alternative from everybody to resolved the situation in the best way possible…learning during in the process…learning doing thinks at the same time.

All the ideas are welcome and considered in the weekly meetings. The stakeholder issues and concerns are brought to the team by each site and solutions are provided. , as possible.

Example: The site staff brought to the Study TEAM attentions (in the weekly meetings) the community lack of enthusiasm for the study drugs used for COVID-19 Treatment.

The media, WHO, FDA actions and information release confuse the stakeholder and NIH were not openly supporting our study or clarifying the misunderstanding of the study drug use in the study and the importance of the study.

The stakeholder were asking for the NIH to openly support the study and talk to the press, in order to provide the strategy for each local site,and be able to delivery the message to the community and recruit participants, but this was not possible. Given these, and low enrollment and lack of community enthusiasm for the study drugs, the protocol leadership felt it best to stop the study. The study was close prematurely.

[Sylvia I. Davila]

Regarding our local CAB and participants activities, we use a document to get their authorization to the use of the photos OR interview or video. The example below is for the publication of an interview and photo in the study newsletter:

I, ______________________ hereby authorize the Leadership and Operations Center, the AIDS Clinical Trials Network (ACTG) and REPRIEVE team to use my words ( below in blue), photographs (enclosed) of me on the Web site, newsletter and social media channels including, but not limited to, Facebook, Twitter, Google Plus and YouTube. I understand that I will not receive compensation of any sort for my participation. I understand that my likeness may continue to be used after my term with the ACTG and or REPRIEVE study ends. I also understand and agree that ACTG and REPRIEVE team shall have no liability for third party use of such photographs and words.

Hope this help to answer part of your question…..

[Sylvia I. Davila]

Regarding our local CAB and participants activities, we use a document to get their authorization to<font color=”#4d5c6d” face=”inherit”> the use of the </font><font color=”#4d5c6d”>photos OR interview or video. The example below is for the publication of an interview and photo in the study newsletter:</font>

The <b style=”font-family: inherit; font-size: inherit; color: rgb(77, 92, 109);”>_______________________ hereby
authorize the Leadership and Operations Center, the AIDS Clinical Trials Network (ACTG)
and REPRIEVE team to use my words ( below in blue), photographs (enclosed)
of me on the Web site, newsletter and social media channels including, but not
limited to, Facebook, Twitter, Google Plus and YouTube. I understand that I
will not receive compensation of any sort for my participation. I understand
that my likeness may continue to be used after my term with the ACTG and or
REPRIEVE study ends. I also understand and agree that ACTG and REPRIEVE team
shall have no liability for third party use of such photographs and
words.

Hope this help to answer part of your question…..

[Sylvia I. Davila]

Hi! I’m Sylvia Davila from Puerto Rico. I have been working in the Medical Sciences Campus Clinical Trials Unit for more than 25 years with the AIDS Clinical Trials Unit. We have also have HPTN studies and INSIGHT Network studies. We have a CAB that we are now sharing with the AIDS Malignancy Consortium (AMC). @Daniel_Casiano and me work together.

[Sylvia I. Davila]

During the COVID-19 Pandemic at Puerto Rico, I met with the Community Advisory Board (CAB)using zoom app for virtual meetings. Challenges: Teach CAB members how to use zoom. Positive results: More community participation. At the next day, each one of them came to received the intensive in compliance with all the distance, face mask, hand sanitizer and temperature check.

[Sylvia I. Davila]

Using ZOOM for virtual meetings have help me to engage with the CAB!

[Sylvia I. Davila]

In Puerto Rico we continue training and meetings with the stakeholder using zoom platform. Also the PI record educational COVID-19 video with local collaborators, and is post in the social media (facebook). We gave to the CAB members and Participants a prevention kit for COVID-19, which include: face shield, one cloth mask, 3 surgical mask, sanitizer and soap sheets.

[Sylvia I. Davila]

so true Daisy…I think about a piece of art, each person helping and sharing ideas (with patience) and listening each other, are the many small things, that will result in a great masterpiece…. Thanks!!!

[Sylvia I. Davila]

Wow! Thanks Neetha! I totally agree… we change and then all around us change, as a result of the new way of seen things… yes, yes, yes, great ideas happen when we hear the silent…

[Sylvia I. Davila]

Love it! Thanks so much fo shear your quote and you story.