First round training for research staff from PREGART trial sites in Ethiopia
PREGART Project has conducted the first round training on Good clinical Practice (GCP), Good clinical Laboratory Practice (GCLP) and Protocol familiarization for research staff from different PREGART trial sites in Ethiopia from February 28 to March 02, 2020 at Bishoftu, 45 kilometres south of Addis Ababa. Thirty-five trainees including obstetricians/gynecologists, pediatrician, clinical nurses, laboratory technologists, pharmacists, adherence supporters, project coordinators and data manager participated in this training. At the end of the training, selected trainees with different responsibilities in the clinical trial demonstrated the clinical flow of the trial as a role-play. Trained HIV positive adherence support mothers were involved as trial participants in this role-play. The activity plan and other issues relevant for the successful implementation of the project has also been discussed.
PREGART presentation in Uganda
After the official launch in Ethiopia in September, the PREGART clinical trial was also officially presented in Uganda on 23 January 2020 at the Protea Hotel Marriot in Kampala.
The launch was preceded by an investigators' meeting and was followed by a site visit at one of the facilities where the trial will be implemented, the Mildmay Hospital Uganda.
Read and download programs and speakers' presentations:
- PREGART Clinical trial launch and investigator’s meeting schedule
- PREGART Clinical trial launch
- Overview by Eleni Aklillu - Karolinska Institutet
- Capacity building by Birkneh T. Tadesse - Hawassa University
- Communication and Dissemination by Marco Simonelli - Istituto Superiore di Sanità
- Anticipated Challenges and Mitigation Strategies by Jackson k. Mukonzo - Makerere University
Kick-off meeting
PREGART project kick-off and investigators meeting in Addis Abeba on 14-16 September 2019.
Read and download the Report:
Watch the videos of the speeches:
PREGART kick off meeting – Part 1
Speakers Part 1: – Dr. Eng Fiseha Getachew, Vice president for academic affairs of Hawassa University and Delegate of Hawassa University president – Mr. Girma Eshetu, State minister advisor and delegate, Ethiopian Ministry of Health – Prof. Josephat Byamugisha, SAC representative, Makerere University
PREGART Kick off meeting part 2
Speakers Part 2: – Dr. Shingai Machingaidze EDCTP project head South Africa – Prof. Eleni Aklillu Karolniska institute (Sweden) Principal investigator – Dr. Birkneh Tadesse, Project coordinator Hawassa University – Dr. Jackson Mukonzo, Principal investigator, Makerere University – Dr. Mekdes Daba, Secretary – Ethiopian Society of Obstetrician and Gynecologist (ESOG) – Dr. Eba Mijena, Director General for research and academic Ministry of Science and Higher Education of Ethiopia
Speakers’ presentations:
- PREGART Clinical trial: investigators meeting schedule
- PREGART Kick off meeting schedule
- PREGART Ethiopia trial site hospitals representatives and Hawassa University investigators meeting
- Overview by Eleni Aklillu – Karolinska Institutet
- Overview II by Birkneh T. Tadesse – Hawassa University
- Communication and Dissemination by Marco Simonelli – Istituto Superiore di Sanità
- Anticipated Challenges and Mitigation Strategies by Jackson k. Mukonzo – Makerere University
- EDCTP Overview by Shingai Machingaidze
See the media gallery and know the members of the project. Watch the video presentation of the project.
PHOTOGALLERY
PREGART video presentation
PREGART partners
The trial will be implemented in Ethiopia and Uganda by research teams based at Karolinska Institute (KI), Stockholm, Sweden; Istituto Superiore di Sanità (ISS), Rome, Italy; Hawassa University (HU), Hawassa, Ethiopia and Makerere University (MU), Kampala, Uganda – PREGART Consortium will be established by the four Universities. Know PREGART partners.
PREGART starts!
Safety and efficacy of Dolutegravir and EFV400 for pregnant and breastfeeding women: a randomized non-inferiority clinical trial. Expected outcomes include generating scientific evidence to support the use of EFV400 and DTG for pregnant and breastfeeding women, generating evidence on the safety of EFV400 and DTG for pregnant and breastfeeding women. PK/PD/PGx data will also be generated to further support the dosing of EFV and DTG during pregnancy and breastfeeding. Read project presentation and work packages.