September 2014 | AIMS

AIMS Newsletter Issue 4 September 2014

Inside this issue:

Message from CI 1

AIMS New Team Members 2

Sites Status Quo 2

Randomisation Rankings 2

News Flash 3

AIMS in the Spotlight 4

AIMS Stars 5

AIMS in Birmingham 6

FAQ’s 7

Dear Friends

Welcome to the fourth issue of the AIMS newsletter.

In this month’s issue hear all about our exciting new recruitment and randomisation in Uganda.

We took The Aims Trial to the street of Birmingham to tell people about our research in a community engagement day....see what the children of Birmingham thought of research....We were surprised by the responses!

UGANDA NOW RANDOMISING

PATIENTS

See the Snaps on page 3

SEPTEMBER ISSUE 2014

Page 1

AIMS Trial

The AIMS Team Welcome New Members

Randomisation Rankings

Sites Status Quo

Malawi are soaring with an

amazing 176 randomisations

Uganda are closing in on them

with a wonderful 21

randomisations

Tanzania: St Francis Hospital and Bagamoyo District Hospital are ready to recruit, everything is in place! Pakistan: AKU Hospital, Hyderabad Hospital and Karimabad Hospital have received written approval from the DRAP. We are dispatching the drugs to Pakistan this week.

Page 2

Sanyu Research Institute Acam Janefrances

Ifakara Health Institute Dr Jerome Chibwana Dr Ulimwengu

AIMS STARTS

RECRUITING IN UGANDA

Page 3

NEWS FLASH

21 Randomised

Dr Tom Otim & James Ditai fully kitted out in the

AIMS trial kit for the launch

Prof Julius Wandabwa

launching the AIMS trial in Mbale

Dr Benon Wanume, hospital director in

Mbale, officially opening the AIMS

trial

Acam Janefrances in

the AIMS office in Mbalw

James Ditai showing us the great follow up system at Mbale

Dr. Tom Otim

Mr. James Ditai

Andrew Weeks (University of Liverpool) is a Professor of International Maternal Health and director of theSanyu Research Unit. He trained in Sheffield and Leeds, and spent 2 years as a visiting lecturer at Makerere University in Uganda before going to Liverpool in 2003. He was awarded a personal chair in 2011, and is honorary consultant obstetrician at Liverpool Women’s Hospital. His primary interest is in the translation of maternity care from high to low resource settings. He has a particular interest in misoprostol (he runs the www.misoprostol.org website), postpartum haemorrhage and the management of labour. He is currently running the INFORM study in India comparing the Foley catheter and misoprostol for induction of labour (funded by the MRC/Wellcome/DFID), the BabyGel study in Uganda (an MRC funded cluster RCT assessing the benefits of providing alcoholic hand gel to postnatal mothers in homes without running water), and the PPH Shelf study (an NIHR funded project developing a new treatment for PPH in which an intravaginal device diagnoses the source of postpartum bleeding as well as providing a platform against which to compress the uterus).

Page 4 AIMS IN THE SPOT LIGHT - UGANDA

Principal Investigator

Research Nurse & Prescriber Mrs. Acam Janefrances

Professor Andrew Weeks

Trial Manager

Uganda UK Support

Dr Otim Tom Charles is a Senior Consultant Obstetrician and Gynaecologist and head of department Obs & Gynae in Mbale Regional Referral hospital in Eastern Uganda. Formerly worked in Gulu Regional Referral Hospital in Northern Uganda as a specialist Obs &Gynae and rose to consultant and Senior Consultant. He was also director of Gulu Regional Referral Hospital for 4 years. While in Gulu he actively participated in the management of Ebola outbreak in late 2000. He also worked as a medical officer for 2 years in West Nile region in Northwest Uganda. He trained from Makerere university where he graduated with Bachelor of Medicine and bachelor of surgery (MBchB) and later Masters of Medicine (M.Med Obs&gynae). His main areas of expertise are feto-maternal medicine in developing countries. He is also interested in urogynaecology where currently he performs fistulae repairs in many hospitals in Northern and Eastern Uganda. He is also interested in football and the teams he supports are Uganda cranes and Manchester United. He was previously involved in medical interventional studies of effect of war on women in Uganda, Liberia and South Sudan. Aims trial is going to be of great impact in developing countries as the result is going to clarify on antibiotic use before miscarriage surgery.

James Ditai is the AIMS trial manager in Mbale, Uganda, and Executive Director of Sanyu Africa Research Institute (SAfRI). He started working for the University of Liverpool in September 2011 as the International Research Coordinator following an open competitive selection from an international field. After his appointment, he worked with Prof Andrew Weeks to set up SAfRI, an international research unit that seeks to develop the University’s key priority of improving research performance and positioning as a global university. The unit’s stated aim is to improve Maternal, Newborn and Child Health, especially among the poor through high quality, collaborative clinical research particularly using low cost, innovative technologies. With grants from Bill and Melinda Gates Foundation, Wellcome Trust, UKAid, and MRC, James is building the research capacity within Mbale hospital, surrounding lower health facilities and communities. James has a strong health, research and policy background, having passed his Masters of Public Health (MPH) from The University of Manchester with an Equity and Merit scholarship. He has also been a commonwealth professional fellow and CDC Fellow.

Acam Janefrances is a Nurse Midwife qualified with Diploma in Nursing attained from Soroti school of Registered comprehensive Nursing, Diploma in Registered Midwifery from Mulago school of Nursing and midwifery, and a certificate in Enrolled midwifery from Ngora School of nursing and midwifery in Uganda. Her main areas of expertise include Data collection, Completing the CRFs, Follow up of participants, Home visit, Taking care of mothers in labour, Cooking. Her main interests include Adventuring and touring, watching television, playing netball, Delivering Mothers, She has been involved in researches previously namely, MamaMiso trial, Mama baby life care extension, causes of dysentery in the community, and Early sexual activities among adolescents in the community. AIMS trial is a very good study because it may reduce the use of Antibiotics among the women presenting with miscarriages, hence the hospital will save the money for purchasing other things. The unit will have an organized way of managing patients with miscarriage with the installation of the ultra sound scan machine with the department of obstetrics and gynaecology specifically.

Team Tanzania….please send us some information about your team…We would like you to feature next!

James Ditai is the AIMS trial manager in Mbale, Uganda, and Executive Director of Sanyu Africa Research Institute (SAfRI). He started working for the University of Liverpool in September 2011 as the International Research Coordinator following an open competitive selection from an international field. After his appointment, he worked with Prof Andrew Weeks to set up SAfRI, an international research unit that seeks to develop the University’s key priority of improving research performance and positioning as a global university. The unit’s stated aim is to improve Maternal, Newborn and Child Health, especially among the poor through high quality, collaborative clinical research particularly using low cost, innovative technologies. With grants from Bill and Melinda Gates Foundation, Wellcome Trust, UKAid, and MRC, James is building the research capacity within Mbale hospital, surrounding lower health facilities and communities. James has a strong health, research and policy background, having passed his Masters of Public Health (MPH) from The University of Manchester with an Equity and Merit scholarship. He has also been a commonwealth professional fellow and CDC Fellow.

At his birth in Mbale Regional Hospital in Uganda, James was said to have delivered by the breech in a ‘knee-first’ position. The observers in the labour ward stated that he had “knelt” from the Mother’s womb, and said “Obote azalidwa”, meaning that the then president of Uganda had been reborn. Everyone wanted to witness the child who knelt during childbirth! Like any other traditional Ugandan child, James’s career journey began in March 1989, when he went to the nearby primary school, joining primary one, which took place under the largest mango tree in the school. He joined Teso College Aloet for his advanced level secondary education where he emerged the Sciences Best student in the 2001 Uganda Advanced Certificate of Education (UACE) Examinations and joined Makerere University in 2002 for his undergraduate training. In 2005, with a zealous interest in research, James approached Dr Kalyesubula Robert, a Senior House Officer in Medicine then, with whom he had worked on the HAART Nevirapine Hepatotoxicity study and in 2006-7, James actively collected data within Mulago hospital and Infectious Diseases Institute in Kampala, Uganda. In 2008, he joined the Joint Clinical Research Centre (JCRC) (an HIV/AIDS care, treatment and research centre) to set up and coordinate a prospective cohort study in Western Uganda. Within three years, he was responsible for seven studies and had progressed from a study coordinator to a Regional Research and Projects Manager for the whole Midwest Uganda. While at JCRC, his passion was and has always been in designing and implementing interventions targeted at mothers. JCRC provided him with access to mothers and a strong research background, but the interventions were dominantly HIV/AIDS related. So he was always on the search for researchers in maternal and newborn child health. Like the dream of any bachelor, little did James know that he was yet to get married to his passion when there came up a job opportunity of an international research coordinator to work with mothers directly, and the University of Liverpool! That job opportunity was the beginning to end the life of being a bachelor and become married to his passion. Even before applying for the job, he informed his employer, the executive director of JCRC, Professor Peter Mugyenyi, that he had found researchers (Prof Andrew Weeks and Prof Zarko Alfirevic) who were leaders in his field of interest, maternal health. The Director without hesitation wrote him an excellent recommendation for the job and to James’s excitement; he was offered the job with the University of Liverpool. Since then he has been inspired him too much by Prof Weeks, who continues to mentor him and I find him an exceptional line manager that everyone should dream to work with. He has been profoundly involved in meticulous managing of numerous clinical trials/ researches (both international and national) and functioning of community health interventions in rural areas in the previous seven (07) years in Uganda and East Africa. He too has provided monitoring of clinical trials for over 6 years in Uganda and for 3 years in East Africa. James recently completed the MamaMiso community trial in Mbale district and has developed a network of health workers whose research capacity has been built in these rural communities. Even local village health workers can now capture data according to GCP principles. James’s ambition is to become an expert in clinical trials methodology in developing countries, especially in rural communities and build up his capacity as a key investigator to allow him run clinical trials independently. James expects to enrol into a PhD upon availability and ward of a scholarship. Research has an imperative role to play and as an early career researcher James expects to expand on the SAfRI’s skills’ capacity through education and Research in the Mbale region critical for improved outcomes of mothers, newborns, and children within these communities.

Page 5AIMS STARS

Mr. James Ditai - Uganda

Who Will Be The Next AIMS Star?

Page 5

AIMS Online

Contact us:

Amie a.wilson.5@bham.ac.uk

David d.m.lissauer@bham.ac.uk

Phone

UK +44 (0) 1216236835 Mobile +44 (0) 7816174170

AIMS hits Birmingham We asked the Children of Birmingham what they

thought of research….See their responses below! AIMS is on TWITTER

Please FOLLOW us.

www.twitter.com/aimstrial

AIMS is on FACEBOOK Please LIKE ‘AIMS Trial’

www.facebook.com/aimstrial

AIMS is on the Web. Check out the website for current form versions and all other useful documents. www.aimstrial.org

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AIMS ONLINE

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Look out for the next AIMS Newsletter …Coming Soon!

Q: ‘I have randomized a patient but no pack numbered has been given on the database’ A: Contact the trial coordinator. All of the remaining packs may have been allocated to the other arm of the trial. This usually occurs when only a few packs are remaining at the clinic store for randomization. More packs need to be added to the store and added on the database under the ‘transfer IMP’ tab, as available for randomization. Please inform Amie if this issue. See Flowchart 4a ‘IMP unavailable’ for guidance. Q: ‘The patient does not have a phone or a personal phone number that I can call her on’ A: Is the patient able to provide a phone number of a relative or friend that she is in close communication with e.g. Sister or Neighbor Q: ‘I want to practice using the database. Is this possible?’ A: Yes AIMS has a test database. You can enter as many pretend patients as you wish. http://www.medscinet.net/AIMSTest/ The log in details are: User name: aimstest Password: aims Q: ‘A patient wants to take part in the trial but cannot return for the follow up appointment. Can she be included?’ A: No. It is essential that patients return for follow up. This is the only true way of assessing the primary outcome. Patients that do not return are classed as lost to follow up.’ Q: ‘When should I perform a white cell count?’ A: When one or more of the following symptoms is reported: UTERINE TENDERNESS, PURULENT VAGINAL DISCHARGE or if the patient has a temperature above 38.0 oC Q: ‘If a white cell count has already been taken at a previous appointment and the patient has one or more symptom again should I repeat the white cell count?’ A: Yes. A white cell count should be taken at every appointment when the patient has one or more symptom. If the patient is an inpatient and has one or more symptoms daily, this will require daily white cell counts. A white cell count should be taken every day that the patient has one or more of the specified symptoms.

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Got a Question?

Email Amie