PHOENIx is rising!

The A5300B/I2003B/PHOENIx, Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB), protocol is an international, multisite clinical trial comparing Delamanid with the current prophylactic regime of isoniazid, for the prevention of household contacts of adults with MDR, developing MDR.  With a total of 3452 high-risk household contacts of an adult with MDR-TB expected to be enrolled from 1726 households by 25 international sites, this is a trial with one of the largest enrolment numbers in an ACTG Network and IMPAACT study.

There are multiple objectives outlined in the protocol looking at efficacy, safety and adherence – of the most important ones. For this trial to be successfully executed, the team is relying on recruiting adequate numbers of participants and receiving accurate data from the sites. To ensure a protocol with such complexity is successful, it is important that adequate and intensive training are provided.

The PHOENIx protocol development is moving forward rapidly with the version 1.0 of the protocol expected to be released to sites during quarter one or two of 2018. 

One of the vulnerable populations included in this protocol is children under the age of five years. As many of the sites are ACTG Network sites, a lot of focus has been put on these sites to ensure that they have staff experienced in pediatrics and invest in having their staff trained in pediatric TB aspects. The Desmond Tutu site, an IMPAACT site under the lead of Professor Anneke Hesseling has presented a week-long training in pediatric TB in Cape Town in September 2017.This training was presented by leading experts in the field of pediatric TB. ACTG Network sites were invited to attend this training and participation from these attendees were excellent.  

In anticipation for sites to be well prepared for this protocol, three regional trainings were scheduled. These training were to be held in Johannesburg (Johannesburg), Bangkok (Thailand) and Lima (Peru). It was understood that some of the sites may not have the full complement of staff on board for the initial regional training. However, the ACTG Network and IMPAACT leadership, along with the PHOENIx Protocol Team, thought that was important to initiate the training process so that gaps identified in the site implementation plan (SIP) are addressed and critical steps within clinical operations are reviewed. Site staff who will be involved with the PHOENIx data management, pharmacy, lab, adherence, community outreach, and general clinic operations were invited to attend one of the three regional trainings. To date, the trainings in Johannesburg and Bangkok were successfully completed.

Johannesburg, South Africa -  6 and 7 November 2017

This training was co-hosted by the Aurum Institute (Johannesburg) and held at the Sunnyside Hotel in Parktown, Johannesburg. The training was well attended with 178 attendees and delegates from 15 sites from 8 countries. The training was held over two days – the first day being more focused on the detail of the protocol and the second day focusing more on practical issues. The different topics were presented by presenters being experts in the fields. All presentations were recorded and are posted on the PHOENIx protocol specific web page (PSWP) to be used as a training resource for sites and the protocol team.

Bangkok, Thailand – 28 and 29 November 2017

This training was co-hosted by the Siriraj Hospital Mahidol University and held at the Renaissance Bangkok Ratchaprasong Hotel in Bangkok, Thailand.The training was well attended with 83 participants by delegates from six sites from Thailand, India, and the Philippines. Where possible, presenters from the region, who have knowledge of local clinical needs and issues presented. Where local presenters were not necessary or available, PHOENIx team members and in one case a video recording with PHOENIx Team member facilitation were used.

Lima, Peru – 4 and 5 April 2018

The third meeting has been confirmed to be held in Lima, Peru at the JW Marriott Hotel.  The Barranco site will be the local site host. We expect about 100 participants to be at this training from seven sites located in Peru, Brazil, and Haiti.

Participants were given the opportunity to rate the presentations, give comments and make suggestions via evaluation forms they completed after each session. The feedback was very positive and suggestions made by the attendees have been used to continue supporting sites as they prepare for this study by providing additional information and training on monthly site/team calls, site specific calls, site visits, etc. 

Overall the trainings were very well attended by sites and attendees engaged in a positive manner. There were adequate opportunity and time for the attendees to engage in discussion with the presenters and protocol team, which was a good platform for attendees to meet the team and discuss any concerns.

Pictures from PHEONIx Trainings: