[Neetha Shagan Morar]

Hi Vincent, at HPRU, SAMRC, we had the CONRAD gel trial stop over a decade ago. Several issues in the media that caused fear and stakeholders and participants raised concerns. Gita Ramjee wrote a paper on the experiences. More recently, the HVTN 702 HIV vaccine trial was stopped as it showed safety data but DSMB found that there was no signs of efficacy. This was disappointing but glad that there was no harm to participants. We are still follow up participants before the study ends which gives the team an opportunity to hear feedback from participants. Dealing with disappointment from participants and CABs has been important. Not easy with COVID-19 lockdown limitations. We ensure with new studies that we continue to remind our participants and stakeholders that studies may stop anytime for a range of reasons but this does not stop the hope and beliefs of people. What strategies have other sites used that we may learn when introducing new studies including COVD-19 studies?

[Neetha Shagan Morar]

The WHO document will be most useful. We may need to assist the process of access. We may need to review our role at the local country level to promote and advocate for the ring to be considered by regulators by making the voices of our participants and stakeholders be heard, captured and shared.

[Neetha Shagan Morar]

This new experiences and outcomes are so great to learn from as we all try new methods to engage and communicate with our stakeholders and staff. It seems that we may want to write our experiences for newsletters and if feasible for relevant journals as these insights are novice especially in settings where there is limited access to technologies (smart phones, laptops etc) and platforms (zoom, microsoft team etc). The GPP training has helped to improve and revise current systems and practices and develop ways to monitor and evaluate outcomes.

[Neetha Shagan Morar]

Great to have this discussion on inducement and community engagement. The input from the stakeholders on how they perceive the activity or event is valuable so that we all learn the views on how inducement is perceived by the stakeholders and researchers. It may also be helpful to have trainings on ethics and research with our stakeholders. Currently, social media has resulted in several mis understanding of public health research in terms of financial gains, pharma roles in profits and harm to participants, vaccines are not needed etc. All this against a backdrop on discussions around corruption, abuse of power, COVID-19 is not real but man made etc. We all need to have a collective voice on inducement and local responses to such issues.

[Neetha Shagan Morar]

Dear Edith

Recently I realized that we need to actively non supporters to hear their side and not always ask them to support what we want. May I suggest that you invite the rep from the religious sector to address the researchers and the CAB on their methods used to promote prevention of COVID-19, TB and HIV so that we open ourselves to learn from them. As per GPP, mutual understanding is key in this process and may help with collaboration and support. We may learn to agree to disagree.

[Neetha Shagan Morar]

Thanks all for the great ideas, questions and responses. As part of the HVTN network community calls, we having a discussion on social media engagement plans, SOPs, guidelines. We now encouraging all principal investigators to add the use of social media in community engagement, recruitment, retention etc as part of the regulatory submissions to the local IRB.

[Neetha Shagan Morar]

Dear Rachel

From my experience, there is always overlap in community engagement activities. I have earnt that it is good practice to have a community plan based on the understanding of the community before education. This may help getting the community involved in the education programme as speakers and facilitators and have topics relevant to the community and not only on the research related topics.

[Neetha Shagan Morar]

Hi Breanne

Thanks for the great discussion. Prior to the COVID-19 pandemic, we engaged the stakeholders when concepts were being developed and there was time, resources and face to face meetings to get feedback and discuss issues. Thus, the stakeholders always appreciated the transparency and respect researchers showed to ensure there was mutual understanding of the research proposals. With COVID-19 the speed is to such an extent that community engagement is not able to catch up. Fortunately, HPRU community teams have maintained contact and explain the speed and urgency for the COVID-19 related studies. the suggestion for SA National CAB and Stakeholder Forum webinars is critical and there are conversations on this issue.

[Neetha Shagan Morar]

Dear Sylvia. Thanks for the great discussion topic. We at SAMRC are excited as we were part of ASPIRE and HOPE. We are preparing to explain the EMA opinion to participants once our local IRB approve the material. I agree with the comment that we have to promote all effective methods and advocate for our local. Africa and other regulatory groups to consider the results. Communities and advocates need to be encouraged to discuss issues of access as the vaginal ring is a women initiated option for HIV Prevention. AVAC is hosting a webinar on this EMA opinion this week.

[Neetha Shagan Morar]

Great. Thanks for sharing

[Neetha Shagan Morar]

Thanks for this guidance. I think I have the same experience and will send an email

[Neetha Shagan Morar]

In community work, change takes time and often one has to listen to the silence and hear what is not being said to understand ourselves and the community. Quote that helps me is ” Be amazing. Things do not change; we change” Henry David Thoreau

[Neetha Shagan Morar]

At HPRU, SAMRC, it has been mainly telephone contacts. The site teams will be trained on use of Zoom and other platforms to engage the CWG/CAB. Also exploring data access for the community stakeholders.

[Neetha Shagan Morar]

Hi Jessica and Sylvia. Great to meet you virtually.

My name is Neetha Shagan Morar. I am based in Durban, South Africa. I manage research within a clinical trial environment and have experience of being part of the local ethics committee at SAMRC.