WP3 : CLINICAL TRIAL TEAM

The Clinical Trial Team are conducting the first in human trials to assess the performance of the GIFT-Africa device in women from South Africa, Zimbabwe and Madagascar. The primary endpoint of the clinical study is to measure the performance (sensitivity, specificity, positive and negative predictive values) of the GIFT device compared to gold standard nucleic acid amplification tests for STIs and Nugent scoring for BV. Secondary outcomes will include (1) testing the performance of the GIFT device against clinical signs and symptoms and laboratory-confirmed vaginal cytokine concentrations and (2) exploring the proportion of cases of genital inflammation explained by other bacteria (from 16S rRNA gene sequencing) not identified using laboratory STI and BV testing, as well as other potential confounders.

TANIA CRUCITTI – (IPM; TEAM LEAD)
tcrucitti@pasteur.mg

Tania is a clinical biologist and infectious disease researcher with work experience in conducting clinical trials, laboratory diagnostics and biomedical research. The focus of her research has been prevention, diagnosis and treatment of STIs, including HIV. I collaborated in clinical trials focused on HIV and STI prevention, conducted evaluations of novel diagnostic assays for STIs and HIV, performed research on STI pathogens, on the genital microbiome, and on inter- and intra-microbial and host-microbial interaction. She worked at the Institute of Tropical Medicine in Antwerp, Belgium and joined the Institut Pasteur Network in 2018. Currently, I’m based Madagascar, heading the unit of experimental bacteriology.

RINDRA RANDREMANANA – (IPM)
rrandrem@pasteur.mg

Dr Rindra Vatosoa RANDREMANANA is a medical epidemiologist, and the head of the Epidemiology and Clinical Research Unit at Institut Pasteur de Madagascar. She has many years of experience in  clinical research. Her research topics are childhood malnutrition and infectious diseases such as plague, tuberculosis, diarrhoea and COVID-19.

KATHARINA KRANZER – (LSHTM)
katharina@lshtm.ac.uk

Professor Kranzer is a medical doctor, microbiologist and epidemiologist based in Zimbabwe. She holds a dual appointment at LSHTM and the Ludwig-Maximillian-University Munich. Her research is mainly focused on improving diagnostics, linkage to care and treatment for tuberculosis, sepsis and STIs. From 2015-2018 she headed the National Tuberculosis Reference Laboratory in Germany, which also serves as a WHO Supranational Reference Laboratory for several countries in Central Asia and West Africa.

CHIDO DZIVA CHIKWARI – (OPHID)
chido.dzivachikwari@lshtm.ac.uk

Chido is an epidemiologist with experience developing, coordinating and evaluating implementation research studies with particular focus on projects evaluating the provision of sexual and reproductive health services for adolescents and young people in facility and community-based settings, HIV testing interventions as well as community based psychosocial support for children and adolescents living with HIV and their caregivers. This work has also involved validation of oral HIV tests for children and evaluating the use of assisted HIV testing for children by their caregivers. She holds a PhD in Infectious and Topical Diseases from LSHTM.

KATHERINE GILL – (DTHF)
katherine.gill@hiv-research.org.za

Dr Katherine Gill is a medical doctor and senior researcher at DTHF in Cape Town specializing in HIV Prevention Clinical Trials and COVID-19 research. She has been a medical doctor for 20 years and has more than 10 years experience running a clinical Trial site in Masiphumelele. She is part of the Clinicians society working group for PrEP and STI guidelines.  She is currently completing a degree in master of Public Health.

LINDA-GAIL BEKKER – (DTHF)
linda-gail.bekker@hiv-research.org.za

Prof Linda-Gail Bekker is the Director of the Desmond Tutu HIV Centre at IDM, UCT and Chief Operations Officer of DTHF. She is a physician scientist and infectious disease specialist. Her research interests include programmatic and action research around antiretroviral roll out and TB integration, prevention of HIV in women, youth and MSM. Prof Bekker has also recently been involved in a number of COVID19 vaccine trials and co-leads the Sisonke Phase 3B study which has seen the vaccination of 500 000 health care workers in South Africa. She has led numerous investigator-driven studies in HIV treatment, prevention and tuberculosis. She is a past president of the International AIDS Society and served as the International Co-Chair of the 9th IAS Conference and 22nd International AIDS Conference and Co-Chaired the Research 4 Prevention Conference that was held in January 2021.

JANNEKE VAN DE WIJGERT – (UMC)
j.h.h.vandewijgert@umcutrecht.nl

Janneke van de Wijgert, MD PhD MPH, is Professor of Infectious and Immune-mediated Disease Epidemiology at the Julius Center for Health Science and Primary Care, UMC in Utrecht, the Netherlands. Her main areas of research are the role of the cervicovaginal microbiome in reproductive and neonatal health and disease, the role of the human microbiome in health and disease more broadly, and evaluation of diagnostics, treatments, and prevention interventions for infectious and immune-mediated diseases. She has been employed by research institutions in the Netherlands, UK and USA with collaborations worldwide.

MICAELA LURIE – (UCT)
micaela.lurie@gmail.com

Micaela Lurie has been a member of the Passmore-lab (https://passmore-lab.org.za/) at UCT since 2018. She completed her Honours and Masters Degrees in Medical Virology with her work focusing on Chlamydia trachomatis research. She will begin her PhD studies in 2022 where she will evaluate inflammatory cytokines in the GIFT cohort.