EARTH study team site visits in South Africa and Mozambique
by Alfredo Tagarro
Between the 1st and 16th February 2018, a team of researchers from the EPIICAL platform carried out site visits for the EARTH study. The team was composed of Dr. Eleni Nastuoli, leader of the EPIICAL Virology platform, myself, the clinical co-chair of the EARTH protocol and Dr. Sarah Watters, responsible for Laboratory Coordination. The EARTH project, nested within the EPIICAL, is focused on participants in five sites across South Africa and Mozambique: Africa Health and Research Institute (AHRI) in Durban, the Chris Hani Baragwanath Hospital in Soweto, the Tygerberg Hospital in Stellenbosch, the Ariel Glaser Foundation in Maputo and Centro de Investigaçao de Saude de Manhica (CISM) in Manhica. The study recruits newly infected infants treated within 90 days of life. The enrolled children will be followed-up for up to 2 years of age with close clinical and laboratory monitoring in order to establish a well-characterized cohort of early treated HIV infected children. The immunogical and virological characterization of this population will lead us to gain significant information on the establishment and the dynamics of viral reservoir, in order to identify potential targets for NDMTs. The EARTH site visit had four clear and simple objectives:1. Discover2. Define3. Coordinate 4. Unify Objective 1 is related to understanding and seeing first hand how the study will operate within each site. Objectives 2-4 are related to specific issues of the EARTH protocol.
The first site on the packed agenda was AHRI in Durban. The team were in the expert hands of Dr. Siva Danaviah from the laboratory side and Prof. Nigel Klein from the clinic. Dr. Watters spent time visiting the laboratory facilities and going through the laboratory protocols in detail with the enthusiastic and well prepared team. Meanwhile, Drs. Nastouli and Tagarro were in Somkhele, a three hour drive from Durban, to see the clincal sites, including Hlabissa Hospital. The three day visit culminated with a debrief held at the impressive K-RITH Tower and a chance to catch up with the data managers. Next, the team moved to Johannesburg. There, at the Chris Hani Baragwanath Hospital in Soweto, they visited the Perinatal HIV Research Unit, where an excellent and fruitful meeting with Dr. Avy Violari’s entire clinical and data management team took place. The suggestions of the clinical team were incorporated into the EARTH visit schedule. The team spent an interesting day at Clincal Laboratory Services (CLS), led by Fiona Shahim. Fiona Shahim provided an excellent tour of the laboratory, which has years of experience processing clinical trial samples. H3A samples are housed within the CLS Bio Repository. Dr. Watters spent the afternoon with the PBMC processing team going through SOPs, ironing out queries and taking on useful comments. The final stop in South Africa was Cape Town, where the team visited the Tygerberg Hospital in Stellenbosch. The team, led by Prof. Mark Cotton, with Dr. Shaun Barnabas as project manager, coordinated the clinical aspects of EARTH. The team then visited the hospital Research Laboratory, where a meeting with Dr. Gert Van Zyl and Dr. Richard Glashoff promised a fruitful collaboration. Later in the day, in the good company of Dr. Barnabas, the team met with the centralised Laboratory, where some of the study samples will be processed. At this point Dr. Nastouli returned to the UK, whilst Drs. Tagarro and Watters moved on to Mozambique. In Maputo, Dr. María Laín of the Ariel Glaser Foundation showed Dr. Tagarro the ART clinic within the Matola Hospital, where the EARTH study will take place. Whilst here Dr. Tagarro had the opportunity to meet with the Clinical Research team, who demonstrated how the clinic works for ongoing paediatric studies and what has been put in place in preparation for recruitment to EARTH. Meanwhile, Dr. Watters met with Dr. Dulce Bila, the Ariel Glaser Foundation Research coordinator, and the Laboratory team of the National Institute for Health of the Ministry of Health to fine-tune the aspects concerning the samples. Finally, the EARTH team and members of the Ariel Glaser Foundation team traveled to Centro de Investigação em Saúde de Manhiça (CISM) in the Manhiça district. There, the enthusiastic team led by the Drs. Tacilta Mampossa and Elisa López Varela took Dr. Tagarro on a tour of the Manhiça Hospital and the Research Center, which will function as a whole for the EARTH study. Dr. Innocenia Cuamba and Dr. Watters worked side by side in the Laboratory. The entire Mozambican team had the opportunity to meet and finalize the details regarding the Ethics Committee, the recruitment, the samples and the data. The objectives of the visit were fulfilled extensively, as the subsequent enrolments have demonstrated. Currently, one hundred children have been enrolled in the cohort. We expect that some of these children will benefit in the future with new therapies targeted against HIV. We are excited and optimistic about the future of EARTH and EPIICAL. We want to thank all the members of the EARTH collaborating research centres for their attention, commitment and their hospitality.
Alfredo Tagarro (PhD, MD) is a Paediatrician at Hospital Infanta Sofía and Clinical Researcher in Hospital 12 de Octubre, with experience in infectious diseases, rheumatology, and respiratory diseases. He is currently involved in Penta and EU funded projects on HIV and childhood pneumonia. He is also an Associate Professor of Paediatrics at the European University of Madrid.