TB Proof responses to specific questions from Bhekisisa:

• Can you respond to allegations put forth in the statement that TASK told TB
Proof not to further engage with broader civil society about the trial?

This question misrepresents the wider context of the engagement. TASK requested TB
Proof not to engage on behalf of the Trial Consortium at the civil society consultation that
took place on 11 June and to limit answers directly related to TB Proof’s contributions and
community engagement. We communicated this clearly in writing before the meeting and at
the start of the meeting, and reiterated this towards the end of the meeting. The latter
statement was taken out of context to imply that TASK was preventing TB Proof from
engaging with civil society, which is not the case. TASK asked that questions relating to
information that is not in public domain be referred to the Consortium lead due to ethical
obligations to ensure patient confidentiality and compliance with good clinical practice
guidelines. This corresponded with the guidance that TB Proof received from an
independent ethicist.

• Advocacy organisations allege that TB Proof was unable to answer key

questions on issues related to ethics as well as the composition of an
oversight community advisory board

It is important to note that TB Proof is a voluntary civil society partner to the trial consortium.
TB Proof is in a position to provide information about its role as civil society partner in
community engagement. Many of the questions posed in this letter addressed to TASK, but
also sent to TB Proof, concerned trial processes and procedures and information about
enrolled participants. These questions should be directed to the Trial Consortium and
relevant ethics committees. This point was raised at the meeting.

• During the public call which took place on Thursday, SANAC members said
they were unaware the task team meeting on 13 May was considered a
consultation on the trial.

There appears to be disagreement among organisations regarding what constitutes

‘engagement’ (the word ‘consultation’ was not mentioned anywhere in the questions sent to
TB Proof), e.g. the SANAC Civil Society Forum (CSF) TB Task Team was informed about
the trial during a call on 13 May, by TB Proof, which is a longstanding member. Further
information, with an express invitation to participate, was shared via email to all invitees to
the call (also on 13 May), including the SANAC CSF Chairperson and the currently Acting
CEO of SANAC, who also presided over the discussion about the trial. The latter responded
to the email positively (on 16 May) with the undertaking to reach out to others for possible
support. Some signatories of the above letter now allege that information sharing did not
constitute ‘engagement’.

Please note that this contested SANAC meeting is only one of several steps TB Proof
undertook to engage other organisations and health workers in this trial. It is important to
acknowledge that this engagement process took place amidst a national state of crisis,
where the country was in Level 5 lockdown, and engagement primarily used a digital
platform.

END