EDCTP EACCR 4th year report

Transcription

DMS # 72347-V1
EDCTP Report for the Regional Networks of Excellence
Submission of individual reports per site will no longer be accepted by EDCTP. Project Coordinators are requested to submit
ONE consolidated report per Network
Call Scheme
Report type
Report
Reporting period
Capacity-building
Annual
fourth
From [16th May 2012] To [15th May 2013] (Year 4)
SECTION A: PROJECT PROFILE
This information is used in the Project Profile published on the EDCTP website
Project Coordinator
Please provide a recent photograph for your profile
Annex 1
Name: Prof. Pontiano Kaleebu
EDCTP grant code
CB.07.41700.001
Name of Network
EACCR
Grant title
The East African Consortium for Clinical Research: A capacity-building network of excellence,
training and mentorship in the conduct of clinical trials in Africa
Coordinating Institution
Email Address: pontiano.kaleebu@mrcuganda.org
Uganda Virus Research Institute (UVRI)
P.O Box 49
Entebbe (Uganda)
51-59 Nakiwogo Road
Phone: +256 417704103
Country
Uganda
Total number of sites/institutions*
35 institutions
Number of active sites contributing to this report
17 regional leading & 18 sister institutions continue to be active members
Grant start and end date
From
Value of EDCTP grant
3.46 million euros
16th May 2009
To
31st December 2013
*only applies to sites with legal entity status
EDCTP Reporting Template for the Regional Networks of Excellence
Page 1 of 44
DMS # 72347-V1
1.1
List of collaborators
Please provide details of the work package leaders and other collaborators on the grant, indicating their role in the project (for example, project coordinator,
PhD and MSc supervisor, site PI, work package leader, etc). Where collaborators have more than one role, please provide details.
Site/Institution
Country
1. Uganda Virus
Research institute
Uganda
2. MRC/UVRI
Research Unit
Uganda
3. Kilimanjaro
Christian Medical
Centre (KCMC)
Tanzania
Active
(Y/N)*
Y
Name of collaborator
Prof. Pontiano Kaleebu
Y
Prof. Heiner Grosskurth
Y
Prof. Gibson Kibiki
Y
4. MRC/UVRI
Research Unit
5.
Kenya Medical
Research InstituteKilifi
Uganda
Prof. Alison Elliott
Y
Kenya
Prof. Kevin Marsh
Y
6. Uganda Virus
Research Institute
Uganda
7. Kenya Medical
Reserach Institute
Kenya
Dr. Edward Katongole
Mbidde
Y
Dr. Nobert peshu
Y
8. University of
Oxford
9. Ifakara Health
Research InstituteIHI
10. Armauer Hansen
Reserach Institute
(AHRI)
UK
Dr. Trudie Lang
Y
Tanzania
Dr. Abdulla Salim
Y
Ethiopia
Dr. Abraham Aseffa
Role in Network
Area of
expertise
Gender
Current email
Overall Project
Coordinator
Former Director
MRC/UVRI Unit &
co-applicant
Deputy Overall
Project
Coordinator
Facilitator of
capacity-building
activities & coapplicant
Co-applicant &
Head of institution
HIV
Male
Pontiano.Kaleebu@mrcug
anda.org
heiner.grosskurth@gmail.
com
HIV
Male
TB
Male
kibiki@kcri.ac.tz/
kcmcadmin@kcmc.ac.tz
Immunology
& Infectious
Diseases
Female
Alison.tom@infocom.co.ug
Malaria
Male
KMarsh@kemriwellcome.org
Chairman EACCR
Steering
committee &
Director, UVRI
Malaria node
coordinator
HIV, Bioethics,
oncology
Male
Directoruvri@uvri.go.ug
Malaria
Male
NPeshu@kemriwellcome.org
Member, EACCR
Steering
committee &
training
Member, EACCR
Steering
committee &
Head of IHI
Member, EACCR
Steering
committee &
Head of site
Malaria,
clinical trials,
Training (elearning)
Malaria
Female
Trudie.lang@ondm.ox.ac.
uk
Male
Salim.abdulla@gmail.com/
sabdulla@ihi.or.tz
TB
Male
aseffaa@gmail.com
Page 2 of 44
DMS # 72347-V1
Site/Institution
11. National Institute
for Medical
Research – Mwanza
for Medical
Research – Mwanza
13. Armauer Hansen
Reserach Institute
(AHRI)
14. Muhimbili
University of Health
and Allied Sciences
(MUHAS)
15. Institute of
Endemic Diseases
(IEND)
16. Muhimbili
and Allied Sciences
(MUHAS)
for Medical
Research Dar es
Salaam
for Medical
Research –
Muhimbili
for Medical
Research –
Muhimbili
20. Muhimbili
and Allied
Sciences(MUHAS)
Country
Active
(Y/N)*
Y
Tanzania
Dr. John Changalucha
Y
Tanzania
Mr. Mark Urassa
Y
Canadian
Prof. Engers Howard
Y
Tanzania
Dr. Muhammed Bakari
Y
Sudan
Prof. Maowia Mukhtar
Y
Dr. Patricia Jane
Munseri
Tanzania
Y
Dr. Mwele Ntuli
Malecela
Tanzania
Y
Dr. Sayoki Godfrey
Mfinanga
Tanzania
Y
Tanzania
Dr. Beatrice K Mutayoba
Y
Tanzania
Role in Network
Area of
expertise
Gender
Current email
Member, EACCR
Steering
committee &
Head of site
Facilitator, HIV
activities
Medical
microbiology
Male
jchangalucha@yahoo.com
HIV
Male
malloomark@yahoo.com
Supervisor
Training & coapplicant
Mentoring & coapplicant
Training
Male
engersh@ahriatlert.org/en
gers_h@yahoo.com
HIV, Training
Male
drbakari@yahoo.com/mba
kari@muchs.ac.tz
Facilitator of
EACCR capacitybuilding activities
Facilitator of
EACCR capacitybuilding activities
Malaria,
Training
Male
mmukhtar@tropmedicine.
org
Training
Female
pmunsereri@yahoo.com
Vice chair,
Steering
Committee &
Director General –
NIMR
TB node
coordinator
Neglected
infectious
diseases
Female
mmalecela@hotmail.com/
mmalecela@nimr.or.tz
TB, HIV and
NCDs
Male
gsmfinanga@yahoo.com
Facilitator of
activities in the
TB Node
Scientist-TB
Female
bmutayoba@nimr.or.tz/be
atricemutayoba@yahoo.co
m
Trainer
Training
Male
jkillewo@muhas.ac.tz
Prof. Japhet Killewo
Page 3 of 44
DMS # 72347-V1
Site/Institution
21. Muhimbili
and Allied
Sciences(MUHAS)
Country
Active
(Y/N)*
Y
Tanzania
Prof. Eligius Lyamuya
Y
22. Uganda Virus
Research Institute
Uganda
Dr. Jonathan Kayondo
Y
23. KEMRI/CDCKisumu
24 Walter Reed
Project/KEMRI
Kisumu
25. University of
Nairobi/Kenya
AIDS Vaccine
Initiative (KAVI)
26. Maseno University
Kenya
Mr. Steve Wandiga
Y
Kenya
Dr. Berhards Ogutu
Y
Dr. Walter Godfrey
Jaoko
Kenya
Kenya
Y
Prof.Ofulla Ayub V.O
Y
27. Ugandan Ministry
of Health
Uganda
Dr. Asuman Lukwago
Y
28. St Rapheal
Nsambya Hospital
Uganda
Dr. Martin Nsubuga
N
29. NIMR-Tabora
Tanzania
Dr. stafford Kibona
Role in Network
Area of
expertise
Member, steering
committee &
Trainer
HIV,
microbiology,
immunology
Male
elyamuya@muhas.ac.tz
Member,
implementation
committee
HIV, malaria,
molecular
biology, bioinformatics
TB
Male
jkayondo@gmail.com
Male
swandiga@kemricdc.org
Malaria
Male
b6ogutu@gmail.com
HIV,
microbiology,
training
Male
wjaoko@kaviuon.org
Malaria,
training
Internal
medicine,
policy
Male
ofullavo@yahoo.com
Male
lukwagoman@yahoo.com
Internal
medicine
Male
Martin_nsubuga@yahoo.c
o.uk/
martin.nsubuga.dr@gmail.
com
Parasitology,
Human
African
Trypanosomia
sis
Male
kibonastbr@yahoo.com
Trainer/facilitator
of capacitybuilding activities
& member
steering
committee
Steering
committee
member
Co-applicant &
trainer
Co-applicant,
trainer
Steering
committee
member, coapplicant
Director of sister
site, co-applicant,
source of
potential
participants
Director of sister
site, co-applicant,
source of
potential
participants
Gender
Current email
Page 4 of 44
DMS # 72347-V1
Site/Institution
for Medical
Research -Tanga
Country
Active
(Y/N)*
Role in Network
Director of sister
site, co-applicant
Malaria
Female
Dr. Martha Lemnge
marthalemnge@yahoo.co
m
Site Director,
Steering
committee
member
Steering
committee
member
Steering
committee
member
Director of sister
site, source of
potential
participants
CollaboratorNorthern partner,
co-applicant
Advisor TB
research
HIV
Male
lmaboko@mmrp.org
TB
Male
hoelsche@lrz.uinmuenchen.de
HIV
Male
Eric.sandstrom@karolinsk
a.se
Paediatrics,
epidemiology
Female
tugu2000flo@gmail.com
TB
Male
Odd.morkve@cih.uib.no
TB
Male
vanlethf@kncvtbc.nl
Training
Training
Male
Michael.ashton@gu.se
Facilitator of
capacity-building
HIV
Male
akambugu@idi.co.org
CollaboratorNorthern partner,
co-applicant
Networking
Male
a.vanderven@aig.umcn.nl
Facilitation of TB
node activities,
Member, TB node
secretariat
TB
Male
B_ngowi@yahoo.co.uk
Y
Tanzania
Y
31. NIMR-Mbeya
Tanzania
32.
University of
Munich
Germany
33. . Karolinska
Institute
Sweden
Dr. Leonard Maboko
N
Dr. Michael Hoelscher
Y
Prof. Eric Sandstrom
Y
34.Masaka Hospital
35. Centre for
International Health,
University of Bergen
36. KNCV Tuberculosis
Foundation
37. Goteborg
University
38. Infectious Disease
Institute- Mulago
39. Radbourd
University Medical
center Nijmmegen
(RUMCN)
40.
National
Institute for Medical
Research – Muhimbili
Dr. Florence
Tugumisirize
Uganda
N
Norway
Netherlands
Sweden
Uganda
Netherlands
Prof. Odd Morkve
N
N
Y
N
Dr. Van der Leth
Prof. Ashton Michael
Dr. Andrew Kambugu
Prof. Van der Ven
Y
Tanzania
Area of
expertise
Dr. Bernard Ngowi
Gender
Current email
*Active: Sites involved with EDCTP-funded project activities during the current reporting period
Please submit copies of CV’s of any new collaborators as supporting annexes
Page 5 of 44
DMS # 72347-V1
1.2
Abstract (max 850 characters)
Give a summary of the project and what was achieved, including the aims and objectives, research questions being addressed, study methods, results, findings
and achievements of the project.
Introduction: Since May 2009, an expandable East African Consortium for Clinical Research (EACCR) went into action with 35 regional institutions and 7
northern partners to promote health product innovation (drugs, devices and other solutions), capacity development and networking. It addresses challenges of
fragmented/uncoordinated efforts, diminishing indigenous scientists, insufficient funds and inadequate infrastructure in Eastern Africa in partnership with the
industry (both pharmaceutical and business) and policy makers. EACCR integrates scientists, health practitioners, academicians and policy makers from the
region (including Ethiopia and Sudan) and Europe. It has networked actively with other research consortia and development partners in Africa and beyond.
Methods: We conducted participatory appraisal (documented/reported observations, content analysis, teleconferencing and record abstraction) between May
2012-May 2013 on EACCR’s work packages categorized into: governance, training, infrastructure, research and networking. Governance was structured regionally
into 4 coordinating centers: Malaria (Kenya), TB (Tanzania), HIV (Uganda) and Training (Tanzania).
Results and achievements: We maintained a consensus-governed and networked consortium also supporting other linked projects/activities of other funding
streams. We secured 2 additional reports from Kenya and Tanzania for a regional social science study. We also registered 2 additional MSc research fellows from
Ethiopia and Tanzania; recorded 11 graduated MSc fellows; completed 4 EDCTP senior fellowships and reached at least 100 scientists through 4 short-courses in
GCLP, GCP, TB laboratory techniques, clinical monitoring and trial conduct. Five more laboratories of sister sites in Kenya, Sudan and Uganda were upgraded.
EACCR contributed to 1 published peer-review article, at least 5 oral presentations at international meetings and to other several scientific presentations through
other funding mechanisms. It has a regional reciprocal monitoring scheme of at least 10 experienced monitors, who have cumulatively conducted 27 site visits to
11 clinical trials and mentored at least 10 new monitors, including 2 from our new partner institution in Rwanda.
1.3
Description of the project
The project description should cover background, objectives, results and outcomes, capacity building and networking (max: 5000 characters).
Background
EACCR is an Eastern African-led, EDCTP-enabled network established in May 2009 to contribute to: health research coordination; increased active mass of African
scientists and research administrators; upgraded infrastructure; stronger networking and advocacy for conducting clinical trials or other research on HIV, Malaria,
TB and other diseases of public health importance under best practices. It has 35 regional institutions from Kenya, Uganda, Tanzania, Ethiopia and Sudan in
partnership with 7 northern partners. It coordinates & promotes health product innovation, capacity development and networking in Eastern Africa for improved
health and social advancement of its population.
Objectives






To
To
To
To
To
To
strengthen regional research coordination and infrastructure for multi-centre clinical trials plus other health research
enable less developed sites within EACCR to improve their capacity to participate in multi-centre clinical trials through mentorship and collaboration
plan and support training/mentoring of promising regional scientists and administrators through both short and long term courses
contribute to improved strategic quality management of research through an affordable reciprocal monitoring scheme
apply an interactive website for better communication, enhanced networking, advocacy, common databases and training
promote advocacy for: regionally-owned research and health agenda; research use in policy and programming and resource mobilization
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DMS # 72347-V1
Results and outcomes
We secured 2 additional reports from Kenya and Tanzania for a regional social science study (annexes 1 and 2). EACCR contributed to 1 published peer-review
article (annex 3) and to at least 5 oral presentations at international meetings (annexes 4-6). Other network-linked scientific presentations/publications through
other funding streams are not included here.
Capacity building
We maintained a consensus-governed and networked consortium. We also registered 2 additional MSc research fellows from Ethiopia and Tanzania; recorded 11
graduated MSc fellows; completed 4 EDCTP senior fellowships and reached at least 100 scientists through 4 short-courses in GCLP, GCP, TB laboratory
techniques, clinical monitoring and trial conduct. Five more laboratories of sister sites in Kenya, Sudan and Uganda were upgraded. It has a regional reciprocal
monitoring scheme of at least 10 experienced monitors, who have cumulatively conducted 27 site visits to 11 clinical trials and mentored at least 10 new
monitors, including 2 from our new partner institution in Rwanda.
Networking

Prepared a proposal to EDCTP for a joint planning meeting of stakeholders from EACCR and TESA (On-going by date of reporting)

Submitted a research capacity building proposal to WHO/TDR (10th May 2013)

Distributed over 400 EACCR brochures during national & international meetings (On-going by date of reporting)

Two EACCR members gave oral presentations at the 4 th annual East African Health and Science conference following successful peer-review of the
submitted abstracts (annexes 7 & 8). This conference took place at Serena Hotel in Kigali, Rwanda. See report in annex 9. (26th – 29th Mar 2013)

Worked with the East Central & Southern Africa Health Community on an EDCTP capacity needs assessment for ethics committees of selected institutions
in Uganda (Feb – Mar 2013). Refer to annex 10.

EACCR Scientific Liaison Officer attended a scientific meeting in Les Diablerets, Switzerland at the invitation of the TB Vaccine Initiative (TBVI) and the
consortium on TB Vaccine Trials in Europe and Africa (TB-TEA), 26th Jan – 1st Feb 2013. Refer to annex 11.

Made Advocacy for EACCR in the Afrique one consortium meeting held in NDjamena (29 th Sep – 6th Oct 2012). Refer to annex 12.

Submitted research & capacity building proposal to the Tropical Health & Education Trust, UK in partnership with University of Oxford (Sep 2012)

Submitted a proposal for a Youth Community HIV/AIDS (YoCHA) program to funders in Netherlands in collaboration with a South African partner (Aug
2012)

Submitted a proposal on a point-of-care diagnostic for Malaria in collaboration with a Canadian industrial partner from Alberta to Grand ChallengesCanada (Jul 2012)
1.4
Relevance to EDCTP’s objectives and mission
Public health relevance to developing countries and alignment with the priorities of the EDCTP Joint Programme
In line with EDCTP’s principle of supporting networks of research centres involved in clinical trials, EACCR facilitates collaboration in Eastern Africa by uniting 35
diverse regional instutions with their distinctive strengths into a network for synergy and complementarity. Its members are learning and developing ‘by doing’
Page 7 of 44
DMS # 72347-V1
how to plan jointly (instead of ‘silo’ planning), manage this initiative by consensus, share and pool limited resources equitably and jointly increase capacity to
raise the quality of health research and practice for accelerating development of new or improved tools (vaccines, diagnostics, drugs, microbicides and
interventions). This resonates well with the set mission of EDCTP. These expected outcomes are meant to improve the health and social advancement of the
Eastern African population. The knock-on impact of EACCR will be feasible once adequate and sustainable capacity (of people, infrastructure, governance, finance,
science and technology) has been built to conduct multi-centre clinical trials and other health research under best practices with adequate sample size
requirements and networking. By networking in EACCR, meaningful partnerships (south-south, south-north and north-north) are created and strengthened in line
with this ideal principle of EDCTP. This creates the enabling environment for handling many more multi-disease clinical trials, which are the heart of EDCTP’s
business. The objectives of EACCR mentioned above address the regional challenges of inadequate research infrastructure, limited critical mass of researchers
and administrators, fragmentation and duplication of effort, competition for limited unshared resources and poor use of research evidence in policy formulation
and programming. EACCR strives to collaborate with similar initiatives e.g through Wellcome Trust (THRiVE consortium, Makerere-UVRI Infection and Immunity
program and Afriqueone) at institutional, country and regional level to avoid duplication of efforts, promote synergy and ensure sustainability. In addition, EACCR
seeks partnership with national disease control programs, political goodwill and financial support regional governments and the East African Community to
address mutual concerns collectively and jointly use research evidence for further interventions and higher-level advocacy. The onus is also upon the EACCR and
its stakeholders to channel successful health products developed and evaluated through policy to large-scale implementation supported by strengthened health
systems.
SECTION B: PROJECT MANAGEMENT
Overall summary of progress on the grant during this reporting period (max 300 words)
17 regional leading and 18 sister institutions continue to be active members. Some improvement in communication has been noted from Nsambya
hospital, Sudan and Ethiopia. Several active research and capacity building calls were circulated regularly to node coordinators. We handled work
plan and budget for revised contract to finalize pending activities after May 2012. Members held regular teleconferences and e-mail discussions of
the EACCR implementation committee and node committees to discuss pertinent issues to the Network. EACCR’s coordinator is now a member of
the regional steering committee of the East African Community for the annual East African Health, Science & International Exhibition conference.
In this conference, EACCR contributed to the review of scientific abstracts, developing the scientific program and to mobilizing conference
participants and co-funders.

Has there been any change to the management structure since submission of the last report to EDCTP? Yes -Malaria Node Assistant (Ms. Peninna Soipei
Menza) from KEMRI-Kilifi in the organogram below, moved to new job. She was replaced by Ms. Esther Kivaya.
Page 8 of 44
(12 members) &
Secretariat
UVRI, EBB, UG
Committee
(9 members)
KCRI, Kilimanjaro, TZ
(6 members)
KEMRI-Kilifi, Kenya
TB Node Committee
(6 members)
NIMR-Muhimbili, TZ
DMS # 72347-V1
4
EACCR Governance Structure
EACCR Steering
Committee
(13 members)
Project Implementation
Committee
(12 members)
Chair: PC or DPC
HIV Node Committee
(12 members) &
Secretariat
UVRI, EBB, UG
Training Node
Committee
(9 members)
KCRI, Kilimanjaro, TZ
Malaria Node Committee
(6 members)
KEMRI-Kilifi, Kenya
TB Node Committee
(6 members)
NIMR-Muhimbili, TZ
4
Page 9 of 44
DMS # 72347-V1
SECTION C: RESEARCH ACTIVITIES
Provide an update on the research activities that are supported by this grant. Copy and paste the table below should you wish to add additional trials, studies
or sub-studies undertaken by the Network
Research activity
Includes all laboratory-based,
epidemiology/proof-ofconcept/demographic/observational,
non-interventional studies and clinical
trials
Social science study on Health Seeking Behaviour of People on Anti-Retroviral Therapy for at least 3 years in Kenya,
Tanzania and Uganda. 2 reports were received from Kenya and Tanzania during this reporting period. Investigators will
now write a publication combining the findings from these 3 countries
Disease area
Start and end dates
Study design
Phase of Trial (if applicable)
Principal Investigator
Co-Investigator 1
Co-Investigator 2
Co-investigator 3
HIV
June 2010 and May 2013
Qualitative case study household evaluation
Not applicable
Prof. Janet Seeley (UVRI, Entebbe, Uganda)
Mr. Ondeng’e Ken (KEMRI-CDC, Kisumu, Kenya)
Mr. Mark Urassa (NIMR, Mwanza, Tanzania
Ms. Mary Nyikuri (KEMRI-CDC, Kisumu, Kenya)
Sponsor (if applicable)
Aim of study
To investigate and document the health seeking behavior, for all conditions, of people who have been accessing ART for
at least three years to understand more about their adjustment to life with HIV as a chronic condition. This was to
compare and contrast findings across the 3 countries with the view of informing the planning in the future.
Primary
Not Applicable
Secondary
Not Applicable
Main Objectives
Target population
Sample size
Adults on ART for at least 3 years
and at least 2 household
Target
Equal number
members they live with and have
gender:
of males and
disclosed their HIV status
females for
(comparison group)
ART patients
20 ART patients per country and 40 household members per country
Age
range:
18 years and above
Page 10 of 44
DMS # 72347-V1
Participating sites
Site 1: UVRI, Entebbe, Uganda
Site 2: KEMRI-CDC, Kisumu, Kenya
Site 3: NIMR, Mwanza, Tanzania
Ethics and Regulatory Approval
Name of committee approving the protocol: Uganda National Council for Science and Technology (Uganda), Kenya Medical
Research Institute (Kenya) and National Institute for Medical Research (Tanzania)
Protocol
Version
Site 4
Site 5
Site 6
Informed consent
(Local language)
[insert number here]
Amendments to protocol
Informed Consent
(English)
[insert date here]
[insert date here]
[insert date here]
[insert date here]
Date of approval
[DD/MM/YYYY]
Trial Insurance Certificates
Submit the latest version as supporting documents (if applicable) Not applicable
Trial Master File Index
Submit a copy of the checklist as supporting documents (if applicable) Not applicable
Clinical Trial Registration
Name of Registry
Trial Registration number
Date of registration
Investigational Product
Controls
Product type
(drugs/microbicides/etc)
Product Name
Pharmaceutical
Manufacturer/Supplier
GMP certificate
Investigational Brochure
on record
Acquision of product
Product Name
Manufacturer/Supplier
GMP certificate
Investigational Brochure
on record
Acquision of product
(i.e Pan African Clinical Trials Registry/ Clinical Trials.Gov)
[insert date here]
Product 1
Not applicable
Not applicable
Not applicable
Product 2
Not applicable
Not applicable
Not applicable
Not applicable
[insert date here]
[insert date and version here]
[insert date here]
[procured/drug donation]
Not applicable
Not applicable
[insert date here]
Page 11 of 44
DMS # 72347-V1
Trial status
Summary of progress made during
the reporting period. Give details of
changes in objectives, timelines,
setbacks and challenges that have
occurred and how these are being
addressed
Progress updates
of clinical trial activities
Monitoring plan
Data Management Strategy
Data sharing
Completed field study activities. Data analysis and interpretation of country reports/data is on-going. Refer to annexes 1
and 2.
Recruitment status
Number of participants screened
Number of participants enrolled
Number of participants lost to follow up
Number of study withdrawals
Number of adverse events reported
Number of serious adverse events
Provide a brief summary of the
serious adverse events reported
Name of clinical trial monitor
Contact details of monitor
Internal/External
Type of Visits
Monitoring format
Number of visits
Date of last monitoring visit
Report available (Yes/No)
As per annexed reports 1 and 2.
Site 1
Site 2
Site 3
Site 4
(i.e types)
Not applicable
(i.e pre-trial, mid-trial, termination)
i.e Number of CRF’s assessed [10%, 50%, 100%]
[submit report as a supporting annex]
As per annexed reports 1 and 2.
Page 12 of 44
DMS # 72347-V1
SECTION D: CAPACITY DEVELOPMENT
Indicate how infrastructure upgrades and purchasing of capital equipment** has improved the capacity (under each section below), to
conduct future research for each collaborating site. Annex 2 provides explanation on how levels are classed.
Laboratories
Malaria laboratory equipment procured, installed and in use
Clinical laboratory equipment procured, installed and in use
Clinical trial facilities
Renovated building of health facility for a malaria node sister site
Information technology and information sharing facilities
Purchased an ICT server for the malaria node sister site
*Level at
baseline
Name of site
*Current level
Siaya district
hospital, Kenya
BNNICD, El Gazera,
Sudan
UVRI clinic, Uganda
2
2
2
2
2
2
Maseno University,
Kenya
2
2
*Level at
baseline
Name of site
Taveta district
hospital, Kenya
Name of site
NIMR-Kilosa,
Tanzania
2
*Current level
2
*Level at
baseline
*Current level
2
2
Page 13 of 44
DMS # 72347-V1
Long-term training
Please report on the progress made towards the training targets of all long-term trainees within this Network
Type of training
Target number of trainees
Postdoctoral
2
Doctoral
2
Masters
26
*Others
Not applicable
*Others may include candidates completing Honors, Bachelors degrees or National Diplomas
Candidate
Name
Surname
Gender
Nationality
Project Title
Institution
where registered
Date
Registered
Envisaged
Date of
completion
Vikram
Already
communicat
ed
Already
communic
ated
P Kaleebu, D
Pillay, JL
Mbisa
March 2010
March
2012
Prof (s)
Yuka
Manabe;R.C
olebunders;
Luc Kestens
Already
communicat
ed
Already
communic
ated
Supervisor
Post-Doctoral
Student 1
Eugene
Kinyanda
M
Ugandan
Student 2
Jonathan
Kayondo
M
Ugandan
Clinical trials in HIV/AIDS in
Africa: Should they routinely
control for mental health
factors?’ (Uganda, 20112103)
Evolution of HIV-1 ARV drug
resistance mutations in the
ART naïve during therapy;
threshold frequency levels
and linkage context
associated with treatment
failure in Uganda’ (Uganda,
2010-2012)
London School of
Hygiene and
Tropical Medicine
Health Protection
Agency-UK and
UVRI/MRC
Doctoral
Student 1
William
Worodria
M
Ugandan
Short and long term clinical
and immunological outcomes
of patients with HIV/TB coinfections on ART’ (Uganda,
2011-2013).
University of
Antwerp, Belgium
and Makerere
University
Page 14 of 44
DMS # 72347-V1
Student 2
Pauline
Byakika
F
Ugandan
Comparison of efficacy,
safety and pharmacokinetics
of intravenous artesunate
and intravenous quinine
followed by oral artemisinin
combination therapy for
severe malaria treatment in
Uganda and evaluation of
pharmacokinetic drug
interactions of artesunate,
quinine, lumefantrine and
piperaquine with
antiretroviral drugs’ (Uganda,
2011-2013)
University of
Liverpool
M Kamya, E
Katabira, D
Black, C
Merry, S
Khoo
Student 1
Thomas
Mwinyiheri
M
Tanzanian
Modelling TB transmissions in
zoonotic areas of Arusha and
Manyara regions.
University of Dar
es Salaam
Dr
N.Shaban,
Bsc, PhD &
Dr S. G.
Mfinanga,
MD, PhD &
Dr. S. D.
HoreMusekwa,
BSc, PhD
Student 2
Charles E.
Makasi
M
Tanzanian
To be communicated
University of
London
International
Programmes/Lond
on Shool of
Hygiene and
Tropical
Medicine/Stewart
March 2011
March
2013
Masters
Oct-10
Oct-12
Oct-10
Oct-13
Page 15 of 44
DMS # 72347-V1
Others
Student 3
Stella
Zawedde
Muyanja
F
Ugandan
Student 4
Seith
Chekata
Inzaule
M
Tanzanian
Student 5
Charles
Kabugo
M
Ugandan
Student 6
Patrick
Kazooba
M
Ugandan
Student 7
Juma
Magambo
M
Tanzanian
Student 8
Shimma
Ahmed
M
Sudanese
Student 9
Aman
Elbadawi
M
Sudanese
Assessing the impact of
Integration of HIV and TB
services on TB Case finding
and Treatment in rural health
centers in Uganda
Combined antiretroviral
treatment switch and
discontinuation among HIV
infected patients in new
Nyanza general provincial
hospital, western Kenya
Incidence and factors
associated with TB iris is
patients attending the HIV
clinic in Masaka hospital.
Predictors of virological
failure among HIV-infected
patients on first-line
antiretroviral therapy in a
rural cohort of South Western
Uganda
Envelope Sequence Diversity
and the Development of
broadly neutralizing
Antibodies in Chronically
Human Immunodeficiency
Virus Type 1 Infected
Individuals from Rural
Uganda
Evaluation of new cloned
MTB antigens and
identification of
immunodiagnostic markers of
pulmonary TB
Molecular mapping of drug
Makerere College
of Health Sciences
Ass Prof.
David
Guwatude
Makerere College
of Health Sciences
Dr.Archilles
Katamba
Makerere College
of Health Sciences
Dr.Archilles
Katamba
LSHTM, UK and
MRC Research Unit
Anne
Tholen,
Jonathan
Levin
Makerere
University
Aug 2010
Aug 2013
Aug-10
Aug-12
Aug-10
Sep 2011
Aug-12
To be
communic
ated
Aug-10
Aug-12
Oct-10
Oct-12
Oct-10
Oct-12
Prof. George
W. Lubega
University of
Khartoum
Prof.
Mukhtar
Maowia
University of
Dr. Osama
Page 16 of 44
DMS # 72347-V1
Student
10
Student
11
Daveline
Pauline
Nyakundi
Akoo
M
Kenyan
F
Kenyan
Student
12
Philemon
Tenu
M
Tanzanian
Magogo
M
Tanzanian
Student
13
Frank
Student
14
Rajabu
Rija
M
Tanzanian
Student
15
Tolbert
Sonda
M
Tanzanian
Student
16
Jane
Rogathi
F
Tanzanian
M
Tanzanian
Student
17
Richard
Kinyaha
resistance pattern of
Mycobacterium TB 1 Gadaref
state, eastern Sudan
To be communicated
Immunization among
Immunocompromised groups
Mathematical modeling of
age-specific mortality rates
to estimate HIV prevalence in
adults using demographic
surveillance data in Kisesa,
Mwanza
Evaluation of cheap and
locally available attractants
as baits in outdoor adult
mosquito control devices.
Factors associated with
Anamia analysis of data on
three different measurement
tools in pregnant women and
children under 5yrs.
Morbidity and mortality
trends in people living with
HIV/AIDs attending
Kilimanjaro Christian medical
centre from 2005-2010
Association between nutrition
and childhood epilepsy in Hai
District, Kilimanjaro Region,
Tanzania.
Retrospective cohort study
on drug susceptibility test on
second line anti tuberculosis
Khartoum
sharief
LSHTM, UK
To be
communicat
ed
To be
communicat
ed
Walden University
Kilimanjaro
Christian Medical
University College
(KCMU Co)
Kilimanjaro
Christian Medical
University College
(KCMU Co)
Kilimanjaro
Christian Medical
University College
(KCMU Co)
Kilimanjaro
Christian Medical
University College
(KCMU Co)
Kilimanjaro
Christian Medical
University College
(KCMU Co)
Kilimanjaro
Christian Medical
University College
Oct-10
Aug-10
Oct-13
Aug 13
Jim Todd,
MSc, PhD
Oct-10
Oct-12
Dr. Robert
Malima
Oct-10
Oct-12
Oct-10
Oct-12
Oct-10
Oct-12
Oct-10
Oct-12
Oct-10
Oct-12
Jim Todd,
MSc, PhD
Jim Todd,
MSc, PhD &
Charles
Mtabho, MD,
MPH
Jim Todd,
MSc, PhD &
Kathryn
Burton, MD,
MMED
Prof. G.
Kibiki, MD,
MMED, PhD
Page 17 of 44
DMS # 72347-V1
Student
18
Elizabeth
Kussaga
F
Tanzanian
Lydia
Nabacwa
F
Ugandan
drugs for multi drug
resistance tuberculosis
patients treated cases.
Assessment of factors
influencing individuals’
participation in field based
research.
Student
19
Sariko
F
Tanzanian
To be communicated
Molecular assessment of
Pfmdr 1 gene mutation after
the introduction of
Artemesin-based combination
therapy in Tanzania
To determine the rate of
decline MTB bacillary load in
the first 14 days of treatment
in newly diagnosed TB
patient on HRZE in
Kilimanjaro region.
Befekadu
Debebe
F
Ethiopian
To be communicated
Student
20
Petro
Paulo
M
Tanzanian
Student
21
Margaretha
L.
Student
22
Demissie
(KCMU Co)
Kilimanjaro
Christian Medical
University College
(KCMU Co)
University of
Liverpool, United
Kingdom
Kilimanjaro
Christian Medical
University College
(KCMU Co)
Kilimanjaro
Christian Medical
University College
(KCMU Co)
Kilimanjaro
Christian Medical
University College
(KCMU Co)
Student
23
James
Ngocho
M
Moses
Ngari
M
Tanzanian
To be communicated
Kilimanjaro
Christian Medical
University College
Effect of Rickets on child
survival in Kenya.
University of
London
Student
24
Kenyan
& Dr. Stella
Mpagama,
MD, MSc.
Dr. Hugh
Reyburn,
MMED(pead.
) PhD
Oct-10
Oct-11
Dec-11
Sep-13
Dr. R.
Kavishe,
PhD
Oct-11
Oct-13
Prof. F.
Mosha, PhD
Oct-11
Oct-13
September
2012
Sep-13
September
2012
Sep-13
Aug-11
Aug-13
Prof. G.
Kibiki, MD,
MMED, PhD;
Dr Bernard
Ngowi
(MD,PhD)
Dr James
Berkley &
Greg Fegan
(Kenya),
Simon Collin
(UK).
Page 18 of 44
DMS # 72347-V1
Student
25
Student
26
Ravelyne
Opar
F
Kenyan
None
Deborah
Mogaka
F
Kenyan
Regulatory affairs with
biomedical devices (MSc)
University of
Liverpool, U.K
North Eastern
University, Boston
(USA)
None
Oct-2011
Jun-2013
Prof Brad
Hossack
Apr-2011
Sept.2012
Please insert additional rows as required
Page 19 of 44
DMS # 72347-V1
Long-term trainees: Retention of Built Capacity
For those candidates who have completed or are approaching completion of their respective long-term training, please state their future plans (i.e plans to
integrate into current Network, further studies, application for Senior Fellowship, will be leaving the NoE, seeking employment etc)
Surname
Training
(i.e. MSc, PhD)
Mwinyiheri
MSc.
Employed permanently by the NIMR-Muhimbili
Chekata Inzaule
MSc.
To be communicated
Charles
Kabugo
MSc.
To be communicated
Student 8
Shimma
Ahmed
MSc.
Employed by IEND Sudan
Student 9
Aman
Elbadawi
MSc.
Employed by IEND Sudan
Student 10
Daveline
Nyakundi
MSc.
Student 11
Pauline
Candidate
Name
Student 1
Thomas
Student 4
Seith
Student 5
Student 12
Student 13
Student 14
Student 15
Philemon
Frank
Aoko
MPH
Tenu
Magogo
Rajabu
Rija
Tolbert
Sonda
Student 17
Jane
Rogathi
Student 18
Richard
Kinyaha
Student 19
Elizabeth
Kussaga
Plans once degree has been completed
Completed in June 2013. Now working with a contract research organization (PPD)
as a clinical research Associate
Hopes to proceed to PhD program if funding becomes available
MSc.
Back to employer (NIMR), Continued to PhD programme
MSc.
Integrated into current Network
MSc.
MSc.
Back to employer (KCRI), continued to PhD programme
MSc.
MSc.
MSc.
Employed by KCRI
Page 20 of 44
DMS # 72347-V1
Student 21
Petro
Paulo
Student 22
Margaretha L.
Sariko
Student 24
Moses
Student 25
Student 26
MSc.
Ngari
MSc.
MSc statistics
Hopes to proceed to PhD program if funding is available
Ravelyn
Opar
MPH.
To be communicated
Deborah
Mogaka
MSc in regulatory
affairs with
biomedical devices
No additional funds to support her position. She is in the process of leaving KEMRIKilifi to look for other job openings elsewhere
Please insert additional rows as required
Page 21 of 44
DMS # 72347-V1
Short-term training [eg Short courses in GCP, HSRP, GCLP, IATA etc]
Name of training
Reciprocal Scheme follow-up workshop on Clinical Trial Monitoring
Dates of training
30th - 31st May 2012
Venue
Lenana conference centre, Nairobi
Agency providing training
Duration of training
Number of participants
Global Health Network in partnership with World-Wide Antimalarial Resistance Network
2 days
22 pooled regional monitors
Name of Trainee
WANZE
Surname
Gender
KOHI
Nationality
Position held
Institutional Affiliation
(site name)
M
TANZANIAN
Clinical trial monitor
NIMR, Muhimbili
BEATRICE
MUTAYOBA
F
TANZANIAN
NIMR, Muhimbili
GODFATHER
KIMARO
M
TANZANIAN
NIMR, Muhimbili
JEREMIAH
KIDOLA
M
TANZANIAN
NIMR, Mwanza
GEORGE
PRAYGON
M
TANZANIAN
NIMR, Mwanza
ELIZABETH
AYUO
F
KENYAN
KEMRI-CDC
PENINNA
SOIPEI
F
KENYAN
KEMRI-KILIFI
JOHNSTONE
THITIRI
M
KENYAN
KEMRI-KILIFI
STACEY
GONDI
M
KENYAN
KEMRI-WRP
JACQUELINE
NYANGE
F
KENYAN
KAVI
JENIFFER
KIGERA
F
KENYAN
KAVI
PHILIP
NALUANDE
M
UGANDAN
UVRI, Uganda
ANNET
NANVUBYA
F
UGANDAN
UVRI, Uganda
NAMPIJJA
PROSSY
F
UGANDAN
UVRI, Uganda
MIRRIAM
AKELLO
F
UGANDAN
UVRI/MRC, Uganda
SARAH
NANZIGU
F
UGANDAN
Makerere University
Page 22 of 44
DMS # 72347-V1
NAKUYA
MARGARET
F
UGANDAN
Makerere University
ZEWDU HURISA
DADI
M
ETHIOPIAN
AHRI
DAVELINE
NYAKUNDI
F
KENYAN
PPD
MUZAMIL
MAHDI
F
SUDANESE
Qassr Univ, Khartoum
VICTORINE
OWIRA
F
KENYAN
KEMRI/WRP
HYRINE
MATHEKA
F
KENYAN
KEMRI-CDC
Please provide a few examples of how this training has enhanced capacity within this network
This follow-up training strengthened sharing of best practices and tools in monitoring clinical trials in Eastern Africa while enabling on-going mentoring of
junior/new monitors in cross-site/cross-study monitoring plus south-south and south-north networking among colleagues. There will be cost-saving instead of
always depending on hired clinical research organizations while improving quality of trials/studies conducted and gradually increasing on the number of clinical
monitors in the region over time. Refer to details of this workshop in annex 13.
Workshops [i.e Data Management; Grant writing, Laboratory techniques, Project Management]
Name of workshop
Date of training
Venue
Name of agency conducting workshop
Name of Trainee
Surname
GCP and GCLP
27th to 31st August 2012
NIMR CEEMI Conference hall
Kenya AIDS Vaccine Initiative (KAVI)/University of Nairobi in Collaboration with NIMR Muhimbili for EACCR,
TAMOVAC, NIH Project and REMSTART trial network.
5 days
33 (Refer to group photograph in annex 14)
Tanzanian
Principal Investigator, TAMOVAC
Trial
Study Investigator TAMOVAC Trial
(site name)
Muhimbili University of Health
and Allied Sciences (MUHAS)
MUHAS
M
Tanzanian
Study Investigator TAMOVAC Trial
MUHAS
F
Tanzanian
TAMOVAC Trial Staff
MUHAS
Tanzanian
TAMOVAC Trial Staff
MUHAS
Gender
Nationality
Mohamed
Bakari
M
Tanzanian
Mohamed
Janabi
M
Eric
Aris
Mary
Ngatolwa
Dorothea
Niima
F
Position held
Page 23 of 44
DMS # 72347-V1
Arafa
Khamis
F
Tanzanian
TAMOVAC Trial Staff
MUHAS
Dilly
Magdalena
Hassan
Lyimo
F
F
Tanzanian
Tanzanian
TAMOVAC Trial Staff
MUHAS
Sabrina
Mugusi
F
Tanzanian
TAMOVAC Trial Staff
TAMOVAC Trial Staff
MUHAS
MUHAS
Emmanuel
Kapesa
M
Tanzanian
TAMOVAC Trial Staff
MUHAS
Triphonia
Tesha
F
Tanzanian
TAMOVAC Trial Staff
MUHAS
MUHAS
Grace
Mbura
F
Tanzanian
TAMOVAC Trial Staff
Grace
Maghembe
F
Tanzanian
TAMOVAC Trial Staff
MUHAS
Abdallah
Ally
M
Tanzanian
TAMOVAC Trial Staff
MUHAS
Maijo
Biseko
M
Tanzanian
REMSTART Trial Staff
NIMR Muhimbili
Edwin
Chitaje
M
Tanzanian
NIMR Muhimbili
Mbaazi
Senkoro
M
Tanzanian
NIMR Muhimbili
Bernard
Poyo
M
Tanzanian
TB Staff NIH Iringa Study
Iringa Regional Hospital
Desderia
Nyakunga
F
Tanzanian
Onolina
Msisi
F
Tanzanian
Paulina
Lumao
F
Tanzanian
Flora
Changamke
F
Tanzanian
Joachim
Mgimba
M
Tanzanian
Fred
Mhalu
M
Tanzanian
Zena
Babu
F
Tanzanian
Fenella
Msangi
F
Tanzanian
Muhidin
Salehe
M
Tanzanian
Monica
Matovu
F
Tanzanian
Geneveva
Lualilo
F
Tanzanian
Jengela
Peter
M
Tanzanian
Paul
Mjelwa
M
Tanzanian
Peter
Muhanga
M
Tanzanian
Daudi
Mtuya
M
Tanzanian
Page 24 of 44
DMS # 72347-V1
This training improved the skills of the participants to conduct a GCP and GCLP compliant trials since most of the participants are from different trials going on in
Tanzania
Name of training
Skill-sharing workshop on best practices for conducting regional clinical trials in a resource-limited setting
Dates of training
14th February 2013
Venue
Sanctum Hotel, Entebbe, Uganda
Agency providing training
Global Health Network in partnership with UVRI
1 day
51 Participants
First name
Surname
Gender
Nationality
Position held
(site name)
Refer to annexes 15
and 16 with list of
participants and group
photograph
Shared lessons learned and recommended skills/approaches for promoting and supporting conduct of clinical trials in resource-limited settings. See annex 17 for
detailed report.
Page 25 of 44
DMS # 72347-V1
Network-linked Senior Fellowship Projects
Does this network have links or host recipients of EDCTP-funded Senior Fellowship Training Award scheme? If yes, please provide further details
Candidate
Name and
title
Surname
EDCTP project
code
Research
Study or
clinical trial
See info
already
given above
Gender
Nationality
Kinyanda
Male
Ugandan
To be
communicated
Dr. Jonathan
Kayondo
Male
Ugandan
T4.2009.40200.
See info
already
given above
ByakikaKibwika
Female
Ugandan
TA.09.40200.020
Dr. Pauline
See info
already
given above
Worodria
Male
Ugandan
To be
communicated
See info
already
given above
Dr. Eugene
Dr. William
How is the Senior
Fellowship project linked
with NOE?
Through research
attachment; patient
management; subject
recruitment at the MRC/UVRI
Unit; academic attachment at
Makerere University (EACCR
leading institutions)
Through laboratory research
attachment; subject
recruitment at the MRC/UVRI
Unit and UVRI; academic
attachment at Makerere
University (EACCR leading
institutions)
Through mentoring; patient
management; subject
recruitment; personal
academic attachment at
IDI/Makerere University
(EACCR leading institution)
Through research
attachment; patient
management; subject
recruitment; academic
attachment at Makerere
University (EACCR leading
institutions)
Contribution of Senior
Fellow to NoE
activities/objectives
Mental health and HIV
research publications; quality
mental health service offered
to patients; mentoring junior
colleagues; providing
expected research leadership
HIV basic research
publications; establishment of
molecular laboratory and bioinformatics; mentoring junior
expected research leadership;
contributions to EACCR
implementation committee
Malaria research publications;
quality health service offered
to patients; mentoring junior
TB research publications;
quality medical care services
offered to patients; mentoring
junior colleagues; providing
Page 26 of 44
DMS # 72347-V1
For the senior fellows above, please state plans to integrate them into the Network of Excellence with the aim of retaining built capacity ie. Lead research
teams, formation of new research teams/units, supervision of longterm trainees etc.
Name of Senior Fellow
Future plans within Network of Excellence (as part of staff retention strategy)
Dr. Eugene Kinyanda
Has already secured a new MRC African Research Leadership award of 5 years for leading a research program,
overseeing its execution to completion and mentoring junior colleagues within EACCR
Has already secured another research grant for strengthening capabilities in genome-wide association studies,
molecular biology and bio-informatics through H3 Africa. He is also mentoring junior colleagues at Makerere
University and UVRI.
Has been promoted to a position of associate professor at Makerere College of Health Sciences where she will
continue to build a research team, mentor junior colleagues, conduct more research and provide high quality
medical care to both patients and research volunteers
Has taken on more TB research at Makerere College of Health Sciences where he will continue to build a
research team, mentor junior colleagues, provide better health care to patients and is now eligible to pursuit a
post-doctoral research program
Dr. Jonathan Kayondo
Dr. Pauline Byakika-Kibwika
Dr.William Worodria
Research Staff, training and capacity development
Summary of numbers of staff employed on the grant
Staff category
Senior staff:
Senior Fellows/Professors/Senior Clinicians or equivalent
Mid-career staff: Intermediate level fellows
(> years postdoctoral experience)/clinicians/
lecturers or equivalent
Site 1-UVRI
Full-time
Part-time
Male
Female
Male
Female
2
1
Site 2-KCMC/KCRI
Full-time
Part-time
Male
Female
Male
Female
3
1
Doctoral and Masters students
Graduate researchers
Laboratory (Managers, technicians, assistants)
Nurses and Fieldworkers
Page 27 of 44
DMS # 72347-V1
Pharmacists
Data (Managers, IT officers and assistants)
2
1
2
Administrative staff
1
Quality Control (Managers, officers)
1
1
Finance staff
1
Others (ancillary i.e drivers, general assistants etc)
Total
Staff category
Senior staff:
Senior Fellows/Professors/Senior Clinicians or equivalent
Mid-career staff: Intermediate level fellows
(> years postdoctoral experience)/clinicians/
lecturers or equivalent
4
1
1
4
2
Site 3-KEMRI WT
Full-time
Part-time
Male
Female
Male
Female
1
5
1
Site 4-NIMR Dar es saalam
Full-time
Part-time
Male
Female
Male
Female
1
1
1
Doctoral and Masters students
Graduate researchers
Laboratory (Managers, technicians, assistants)
Nurses and Fieldworkers
Pharmacists
1
Data (Managers, IT officers and assistants)
1
1
Administrative staff
Page 28 of 44
DMS # 72347-V1
Quality Control (Managers, officers)
1
1
1
Finance staff
2
Others (ancillary i.e drivers, general assistants etc)
Total
4
1
1
2
3
3
Please add columns for additional sites
How has the grant contributed to the professional development of ALL staff employed on the project?
Highlight any individuals who have progressed in their careers or have been promoted.
Several short courses in grant writing, grant management and financial management have been conducted in partnership with EDCTP, other funders and
regional collaborators for both scientists and research administrators as part of their continuing professional development in order to improve personal
growth plus efficiency and effectiveness during implementation of existing and new grants. The acquired knowledge has been applied through learning by
doing. Opportunities have been opened for consultation of colleagues within and across institutions plus countries and sharing best practices. Similarly,
training in GCP and GCLP courses, clinical trial monitoring, scientific writing, epidemiology and data management was conducted for the project staff as per
reports provided. The same has been done for disease-specific and laboratory training.One of success stories is the promotion of Dr. Pauline ByakikaKibwika to the position of associate professor at Makerere University. Ms. Esther Kivaya, who is assistant coordinator of the malaria node, also progressed to
become a lead trial monitor at KEMRI-Kilifi after gaining massive experience in monitoring, training in GCP and monitoring.
Page 29 of 44
DMS # 72347-V1
SECTION E: RESEARCH OUTPUT
Please list the research outputs from this research grant during the current reporting period. You may include ‘in press or published material’
How many accepted (in press or published) peer-reviewed publications (research papers or books) have been produced during this reporting
period as a result of this grant?
Detail each publication in the following order: Author(s); Article Title; Journal Name; Year; Volume; Issue Number; Page Numbers, and confirm that EDCTP
funding has been acknowledged in all publications. Please include copies of research papers as supporting annexes.
Several publications have been generated from EACCR through other co-funding mechanisms closely linked to it although such information is yet to be collated
comprehensively in such a short time. Some selected publications are outlined below:
1. Byakika-Kibwika, P., Lamorde, M., Mayito, J., Nabukeera, L., Namakula, R., Mayanja-Kizza, H. et al. (2012a). Significant pharmacokinetic interactions
between artemether/lumefantrine and efavirenz or nevirapine in HIV-infected Ugandan adults.. J Antimicrob Chemother, 67(9), 2213-21.
2. Byakika-Kibwika, P., Lamorde, M., Mayito, J., Nabukeera, L., Mayanja-Kizza, H., Katabira, E. et al. (2012b). Pharmacokinetics and pharmacodynamics
of intravenous artesunate during severe malaria treatment in Ugandan adults.. Malar J., 11(132).
3. Lamorde, M., Byakika-Kibwika, P., Tamale, W., Kiweewa, F., Ryan, M., Amara, A. et al. (2012). Effect of Food on the Steady-State Pharmacokinetics of
Tenofovir and Emtricitabine plus Efavirenz in Ugandan Adults.. AIDS Res Treat., 2012(105980).
4. Lamorde, M., Byakika-Kibwika, P. & Merry, C. (2012). Pharmacokinetic interactions between antiretroviral drugs and herbal medicines. Br J Hosp Med
(Lond), 73(3), 132 - 136.
5. Davis Kibirige*, Richard Ssekitoleko, Edrisa Mutebi and William Worodria. Overt diabetes mellitus among newly diagnosed Ugandan tuberculosis
patients: a cross sectional study. BMC Infectious Diseases 2013, 13:122
6. Davis Kibirige, Edrisa Mutebi, Richard Ssekitoleko, William Worodria, and Harriet Mayanja-Kizza. Vitamin D deficiency among adult patients with
tuberculosis: a cross sectional study from a national referral hospital in Uganda. BMC Res Notes. 2013; 6: 293.
7. Catherine Abbo, Eugene Kinyanda, Ruth B Kizza, Jonathan Levin, Sheilla Ndyanabangi, Dan J Stein. Prevalence, comorbidity and predictors of anxiety
disorders in children and adolescents in rural north-eastern Uganda. Child and Adolescent Psychiatry and Mental Health 07/2013; 7(1):21.
8. Eugene Kinyanda et al. Prevalence and risk factors of depression in childhood and adolescence as seen in 4 districts of north-eastern Uganda
BMC Int Health Hum Rights 13:19. 2013.
9. E Kinyanda. Psychiatric disorders and psychosocial correlates of high HIV risk sexual behaviour in war-affected Eastern Uganda. AIDS Care 24:1323-32.
2012
10. Deogratius Ssemwanga, Anne Kapaata, Frederick Lyagoba, Brian Magambo, Maria Nanyonjo, Billy N. Mayanja, Chris M. Parry, and Pontiano Kaleebu.
AIDS Research and Human Retroviruses. December 2012, 28(12): 1784-1787. doi:10.1089/aid.2012.0090.
11. Seeley, Janet PhD*,†,‡; Nakiyingi-Miiro, Jessica PhD*,‡; Kamali, Anatoli MSc*,§; Mpendo, Juliet MPH¶; Asiki, Gershim MSc*; Abaasa, Andrew MSc*; De
Bont, Jan PhD‖; Nielsen, Leslie RN‖; Kaleebu, Pontiano PhD*,‡,§ High HIV Incidence and Socio-Behavioral Risk Patterns in Fishing Communities on the
Shores of Lake Victoria, Uganda. Sexually Transmitted Diseases:
June 2012 - Volume 39 - Issue 6 - p 433–439. doi: 10.1097/OLQ.0b013e318251555d
12. David Cooper; Fiona Ewings; Sarah Fidler; Martin Fisher; John Frater; Michelle Gabriel; Pontiano Kaleebu; Steve Kaye; Anthony Kelleher; Sabine
Kinloch; Myra McClure; Jose M Miro; Rodney Phillips; Kholoud Porter; Gita Ramjee; Helen Rees; Mauro Schechter; Giuseppe Tambussi; Jonathan
Weber; Abdel Babiker. Short-course antiretroviral therapy in primary HIV infection. The New England journal of medicine 2013;368(3):207-17.
13. George M Miiro; Francine Ntoumi; Alexander Pym; Maerangis Rahmani; Ousmane Sarr; Odile Ouwe Missi Oukem-Boyer; Keertan Dheda; Souleymane
MBoup; Pontiano Kaleebu. EDCTP regional networks of excellence: initial merits for planned clinical trials in Africa. BMC public health 2013;13():258.
Refer to annex 3.
Page 30 of 44
DMS # 72347-V1
Please provide details of any other publications resulting from this work
Please confirm that that EDCTP support has been acknowledged on each publication.
Yes, We confirm that EDCTP support was acknowledged in each publication.
Conference and academic workshop presentation
Give details of oral presentations and posters of this work, confirming that EDCTP has been acknowledged
September 28th 2012. Dr Mfinanga gave a brief talk about EDCTP in the annual Afrique one conference in Ndjamena Tchad. He discussed his experience in
networking with other consortia in Africa. See annex 12.Two EACCR members gave oral presentations at the 4th annual East African Health and Science
conference following successful peer-review of the submitted abstracts (annexes 7 & 8). This conference took place at Serena Hotel in Kigali, Rwanda. See
report in annex 9. Dr. George Miiro attended a scientific meeting in Les Diablerets, Switzerland at the invitation of the TB Vaccine Initiative (TBVI) and the
consortium on TB Vaccine Trials in Europe and Africa (TB-TEA) as indicated annex 5. EDCTP support was acknowledged in these presentations.
Give details of presentations to non-academic audiences
This includes feedback activities to research participants and related communities, meetings with policy makers or health care professionals, media coverage or
other related activity
Not applicable
Give details of any research resources or intellectual property resulting from this grant
This includes websites, software or database development, patents, product licenses or other related activity
EACCR interactive website (www.eaccr.org) with 12 electronic research modules are freely accessible online to interested scientists globally.
Page 31 of 44
DMS # 72347-V1
SECTION F: NETWORKING
New collaborations/partnerships
Please provide an update on any new collaborations/partnerships forged during this reporting period
Site
Lusaka Zambia
Maputo Mozambique
University of Oxford, UK
Collaborator/Partner
University Teaching Hospital (UTH) and
NIMR-Muhimbili node are running a trial
known as the Reduction of Early Mortality
among HIV patients Starting ART
(REMSTART), an EDCTP funded project
Centro de Investigação e Treino em Saúde da
Polana Caniço (CISPOC): Supporting a
project on HIV vaccine trials known as
TAMOVAC 2 (EDCTP-funded project). This is
in collaboration with other Tanzanian
institutions such as MUHAS and NIMR-Mbeya
Medical Research Program and University of
Munich Germany and Karolinska Institute
Sweden
Global Health Network: conducted a one day
workshop on best approaches and practices
for handling Clinical trials in Dar es Salaam
on the 12th July 2012 and in Entebbe on the
14th February 2013
Aims of the Partnership
To jointly strengthen capacity in conducting multi-centre HIV clinical
trials in Sub Saharan Africa
To improve south-south networking with TESA site and north-north
networking in doing clinical trials in Eastern and Southern Africa
To improve sharing of best practices/skills in doing high quality clinical
trials in Eastern Africa
Page 32 of 44
DMS # 72347-V1
Exchange/Mentorship Schemes
Please provide an update of any exchange and mentorship schemes developed at an inter or intra-network level
Participant name
Maliwaza Maganga
Mariamu Abdallah
Sites involved
Mwananyamala hospital (sister site) to the
leading NIMR Cytotoxic Reference Laboratory
(CTRL)
Mwananyamala hospital (sister site) to the
leading NIMR Cytotoxic Reference Laboratory
(CTRL)
Outcome of exchange
Completed mentorship attachment in TB laboratory techniques,
Completed mentorship attachment in TB laboratory techniques,
Network Communication Plan
Please provide an update of communication at the levels indicated below
Communication Level
Update
National
Node coordinators update national policy makers regularly (at least annually) about progress, lessons learnt, challenges
encountered, opportunities and prospects related to the EACCR activities
Through quarterly teleconferences or skype calls within the nodes, network and other NoEs such as CANTAM, TESA and
WANETAM. Complemented with e-mail discussions and EACCR website updates
Local authorities for example at Mwananyamala hospital, Kyela hospital (both in Tanzania), El Gazera (in Sudan), Kilifi
(Kenya) and UVRI (Uganda) have been updated regularly about the progress on infrastructural upgrades in their
institutions
Not applicable yet for this reporting period
NIMR-Muhimbili communicated with a northern partner Germany University of Munich and Glasgow University Scotland
about developing a Joint TB proposal. EACCR also participated in several international conferences/meetings already
mentioned above. In addition, EACCR has jointly organized with TESA to have a joint review and planning meeting of
stakeholders in Johannesburg in preparation for EDCTP 2.
Regional
Local authorities
Local community
International
Page 33 of 44
DMS # 72347-V1
SECTION G: IMPACT OF NETWORK
List other EDCTP-funded projects that are contributing or benefiting from Network of Excellence capacity
Project title
Project coordinator
EDCTP project code
TAMOVaC project
Dr Sayoki Mfinanga
To be communicated
REMSTART trial:
Reduction of Early
Mortality among HIV-infected
subjects starting antiretroviral
therapy: a randomised trial in
Tanzania
Dr Said Egwaga
(Assisted by Dr. Sayoki
Mfinanga)
IP.2009.33011.003
STAR-study at UVRI-IAVI
Dr. Noah Kiwanuka
To be communicated
Contribution
Shared Data unit
and back-up IT
server at NIMRMuhimbili
Web-based data
management at
NIMR-Muhimbili
plus networking
with TESA sites
Internal
reciprocal
monitoring
implemented in
site
Benefit
Project staff regularly
trained and equipped with
skills in data management
and GCP and GCLP
GCP/GCLP-adherence
strengthened by trained
staff through EACCRsponsored short course
Strategic quality
management and crosssite networking enhanced
SECTION H: INTER-NETWORK ACTIVITIES
Have there been any activities that involved participation/collaboration with any of the other Networks of Excellence? If yes please state the name and provide
brief details on the collaboration and state the outcomes, including all joint-publications







Two more students are doing their PhD program at the University of Bergen in Collaboration with the NIMR Muhimbili. This is an example showing
one of the outcomes of networking between the TB node of EACCR and the Afrique One consortium funded through Wellcome Trust. The students
are sharing the laboratory facility upgraded at NIMR MUhimbili through EACCR and are co-supervised by University of Bergen and NIMR Muhimbili
(EACCR’s collaborators). Wellcome Trust is funding their PhD program
TB node strengthened networking by interacting with TESA sites through the TAMOVAC trial, NIH TB diagnostic project and REMSTART trial in
aspects of training, web-based data management and sharing information
Cunducted a collaborative TB trial (TB-HAART) between TB node and TESA through NIMR Muhimbili Dar es Salaam, Tanzania and University
Teaching Hospital. Lusaka, Zambia, MRC South Africa
Conducting coordinated web-base data management between EACCR and TESA through NIMR Muhimbili Dar es Salaam, Tanzania and University
Teaching Hospital. Lusaka, Zambia
A new MSc course in epidemiology at KCMC/KCRI and 3 EACCR-sponsored MSc students were co-funded in partnership with the Wellcome Trustfunded THRiVE consortium
The Global Health Network, WWARN and EACCR joint supported the: generation of 12 e-learning research modules; comparison of 2 In-house
clinical trial monitoring schemes in Eastern Africa and South East Asia through a qualitative study and 2 workshops in Nairobi, later half of May 2012
on the potential strategies against the threat drug resistance to anti-malarial treatment and on clinical trial monitoring
EACCR and TESA have jointly organized a review and planning meeting in Johannesburg to engage their stakeholders to prepare adequately for
EDCTP 2.
Page 34 of 44
DMS # 72347-V1


CANTAM and EACCR have continued to share experiences and lessons learnt during project implementation.
Jointly published a peer-review paper on the Regional Networks of Excellence by involving all colleagues from all the 4 NoEs
SECTION I: QUALITY ASSURANCE
List the internal and external measures that are currently in place to assess and maintain strict quality standards in all network activities
EACCR Secretariat
 Regular Node and implementation committe meeting have been conducted to assess progress of activities and also to handle pertinent issues that
may arise during implementation of activities. Minutes are made and circulted to all Nodes and members of the implemenatation committee for
information and comments.
 A governance structure, terms of reference and communication plan were developed and agreed upon by the three disease nodes (Malaria, TB, &
HIV) to guide operations.
 Navision software was installed and is used by a trained grants finance officer at UVRI to manage funds of this and other grants. Items only
approved by the accounting officers using a memo are entered in the templates by the grants officer. Items to be procured are sent to procurement
committee for approval of firms to supply any item or reagent or equipment by the committee and these are minuted and copies of minutes
attached on the requests. Terms of reference for consultants and contract agreements are agreed upon by both parties for procurement of services
or works.
 EACCR trained clinical trial monitors to strengthen quality of conducted trials through cross-site/cross-study monitoring visits. These monitors have
been invited by the study PIs and CO-PIs to monitor on-going studies.
 Regular reports (technical and financial) reports have been submitted as required by EDCTP. There has been shared input from all nodes into these
reports with consensus secured. Then, the overall project coordinator, node coordinators and grants finance officer sign the reports as required by
EDCTP.
NIMR-Muhimbili
 Currently, There is a system of finance control whereby internal auditing is done by internal auditors from the headquarter of NIMR and external
auditing by auditors from the Government Controller and Auditor General’s (CAG) office.
 Laboratory external quality assurance is handled by the supranational quality assurance scheme from the University of Antwerp, Belgium.
KCMC/KCRI
INTERNAL
 Internal financial audit system is in place
EXTERNAL
 External financial audit is planned
LABORATORY
Page 35 of 44
DMS # 72347-V1


National Health Laboratory Service ,-South Africa for Laboratory External Quality Assurance
UK – NEQAS, American college of pathologist accreditation also handle external quality assurance
SECTION J: FUNDING
List any new funding that was secured during this reporting period
Name of Co-funding Agency
Funding
[cash/in-kind]
Amount*
Cash
Canadian Global Health Research Initiative
$ 25, 000
Activities funded
School-based adolescent project with in-built
operational research on HIV/STI prevention
(Annex 21)
Co-funding letter
attached (y/n)
Yes
ICT upgrades for the Malaria Node sister
Yes (a request and
sites(Air conditioner,, upgrade of the Local
signed invoices
Area Network with cables, switches, patch
were sent by email
panels and sockets for Masaka regional
and courier to
referral hospital ,Video conferencing facility,
EDCTP)
5 Hp printers,5Hp computers and server for
KEMIR Kilifi);Training Node ( Switches, 8Ups,
5 computers and wireless access points , two
fibre modules and furniture for conference
The conditional support action Grant
Cash
€339,791
room ifor St. Rapheal Nsambya hospital –
(CSA)
Uganda);Training Node (SPSS and Antivirus
software,Cisco switches, Magic locks, 5
computers and Server for KCMC); HIV NodeInverter and e-library for UVRI and ; (HIV
related training for 2 trainees from Masaka, 2
from UVRI; and GCLP training for 1 trainnee
for Masaka, I UVRI and Research
Management training at KCMC for
participants from all nodes and sister sites.
* Where co-funding is an ’’in-kind contribution’’, please estimate the amount in monetary value
Please list any joint research grants held by members of the network and joint proposals submitted by members of the network
I summarize below some of the joint proposals submitted for funding elsewhere by members of EACCR:
Funding
Please declare any third party
funding received during the
Describe the funding achieved as
follows:
Other sources of funding for the project
Page 36 of 44
DMS # 72347-V1
course of the year which was not
envisaged at the start of the
project. Please note that EDCTP
would treat this as purely
supplementary funding and not
in any way to replace or reduce
EDCTP funding agreed at the
signing of the contract.
during the reporting period, if any:
a) Prepared a proposal to EDCTP for a
joint planning meeting of
stakeholders from EACCR and TESA in
July 2013
b) Submitted a research capacity
building proposal to WHO/TDR
c) Submitted research & capacity
building proposal to the Tropical
Health & Education Trust, UK in
partnership with University of Oxford
d) Submitted a proposal for a Youth
Community HIV/AIDS (YoCHA)
program to funders in Netherlands in
collaboration with a South African
partner
e) Submitted a proposal on a point-ofcare diagnostic for Malaria in
collaboration with a Canadian
industrial partner from Alberta to
Grand Challenges-Canada
On-going by 15th May 2013
Was funded
10th May 2013
Outcome awaited
Sept 2012
Not successful
July 2012
Not successful
Aug 2012
Not successful
For the failed adhoc grant
writing initiatives made through
teleconference calls and e-mail
discussions, we propose faceto-face grant writing teams &
seek additional grant writing
expertise from TESA and
northern partners to strengthen
possibility of more successful
outcomes
Has the Network been able to undertake any cost-saving initiatives during the current reporting period?
Cost-saving initiatives
New activities supported
Page 37 of 44
DMS # 72347-V1
For example the reciprocal monitoring scheme as opposed to
outsourcing expensive clinical research organizations
New EDCTP-funded STAR study (UVRI-IAVI), KEMRI-WRP study (Kenya), Wellcome funded
co-infection study project under MRC/UVRI research Unit and new trial sites in Rwanda have
been monitored.
Have there been any efforts to amass significant funding to ensure long-term sustainability of the Network? Please list below
Organisation
European Commission (EC)
Support Secured
A coordination support action (CSA) subgrant through EDCTP to EACCR for additional
bridging activities under the revised contract
Page 38 of 44
DMS # 72347-V1
SECTION K: SOCIAL IMPACT
In the spaces provided, briefly highlight success stories and social impact made by the Network (i.e recognition/staff or trainee awards/upliftment of local
communities etc). Photographs may be included.
Success stories

Pauline Byakika-Kibwika, an EDCTP senior fellow, established a new collaboration with Joel Taming and his team of the clinical pharmacology laboratory
of Mahidol-Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand.

Another EDCTP senior fellow, Jonathan Kayondo, spearheaded a collaborative grant application with partners from Malawi for Genome-Wide Association
Studies to Sanger Institute at the Cambridge University. This comes along with additional research funds, collaborators and enhanced capability of UVRI
to engage in genomics research.

Eugene Kinyanda, another senior fellow, has just secured a new highly competitive MRC African Leadership Research award for the next 5 years. This
will empower him to lead a research program, oversee execution of program to completion, mentor more junior colleagues and to continue making
significant contributions within EACCR. His retention within the network is certain and long-term!

KEMRI-CDC facilitated both human and infrastructural upgrades at Siaya District Hospital which supported acquisition of epidemiological data and
reference ranges for infants and adolescents in preparation for a planned TB vaccine trial.

Through the TB Node and in partnership with TESA and US-based NIH, the REMSTART TB drug trial, WHO TB/HAART trial, TaMOVac HIV vaccine trial
and the TB diagnostic trial have been supported.
Social benefits

Research work that funded at UVRI-IAVI and involved the fishing communities procured a boat with funds from EDCTP. This has enabled more
exploratory studies to continue in what would be otherwise inaccessible areas on landing sites of Lake Victoria. This has in turn created cohorts of
followers for other studies. The fisher-folk benefit in terms of regular HIV Counseling and Testing and other related services provided when teams reach
out to them during research studies. The research communities receive treatment and are reffered to IDI-Mulago, Mildmay, Entebbe grade B hospital
and many other health facilities within their reach.

Pauline Byakika-Kibwika, an EDCTP senior fellow, secured a donation of toys through CHAPAS-3 paediatric trial team at the Joint Clinical Research
Centre (JCRC) for the children admitted to the paediatric wards in Mulago National Referral Hospital. This has improved the hospitalized children’s
ability to play as they recover from illness and a chance to smile while on the wards.

NIMR-Muhimbili and KEMRI-CDC established an inventory of chest-xray reading, recording and reporting (CRRR) panel which can train/mentor medical
radiographers and clinical officers in reviewing, interpreting and reporting x-rays.

Labaratory equipment bought for the UVRI clinic have improved the functionality and diagnostics at this health centre II and the renovations at UVRI
clinic and KCMC have improved the visibility of such facilities. The Local Area Network connections at Masaka Regional Referral hospital plus a terabyte
Page 39 of 44
DMS # 72347-V1
server, fibre connection and switches that were bought for Nsambya Hospital have improved their communication internally, nationally with UVRI and
Ministry of Health, regionally within EACCR and internationally with other global partners.

Three senior clinical trial monitors from the reciprocal scheme joined other reputable clinical research organizations such as Afenet, DNDI and PPD
where they continue to contribute to the strategic quality management of research for better health in the Eastern and Southern Africa region after
gaining experience through the EDCTP-funded projects, including EACCR.

An interactive Video conferencing machine was installed at NIMR Muhimbili which will enable direct meeting via the video with our northern partners
and within our EACCR member institutions.
SECTION L: FUTURE OF THE NETWORK
(To be completed by the Project Coordinator)
Briefly describe your plans for the next reporting period as well as your strategic vision to make this this Network a ’’Centre of Excellence’’ (in the context of
delivering ’’world class science’’ and ’’translating research into clinical innovation’’)
Plans for the next reporting period: We are now left with a few months to the end of the grant ending December 2013. We are aiming at completing
activities in the main EDCTP grant and CSA funding. The major areas are specific trainings both short term and long term (MSc) and mentorships,
infrastructure upgrade of the remaining sister institutions and reciprocal monitoring scheme activities. The staff hired through this NoE programme at various
institutions will continue to perform activities such as coordination/administration, finance and grant management in support of existing and planned research,
capacity-strengthening and networking activities. Institutions and scientists within the network will continue to look for additional funding to conduct research
and planned clinical trials in multi-disciplinary areas. We will continue to network, exchange information through emails, the website and teleconferences to
generate new strategic plus communication plans and design proposals for additional funding. Some EACCR members will participate in various EDCTP stake
holders’ meetings and attend the 7th EDCTP Forum in Dakar, Senegal where severe presentations of EDCTP-funded projects will be made.
Strategic vision: The vision is to consolidate, strengthen and expand EACCR’s contributions to capacity-building, networking and enhanced advocacy for more
clinical trials/other research aimed at finding new and/or improved interventions against Malaria, TB and HIV. We will also participate in the new areas
identified by EDCTP on Neglected Infectious Diseases and health systems optimization research in the context of phase IV trials and successful health products
generated for scaling up in programs. We will ensure scientists and institutions in our network actively respond to research funding calls including those from
EDCTP, Wellcome Trust, MRC-UK, EU and Gates Foundation among others by activating node grant writing groups.
Specifically, some of the future identified areas include: strengthening and expanding the initiated reciprocal monitoring scheme; contributing to better conduct
of multi-centre trials in a cost-effective manner; complete identifying hot spots for malaria and TB in order to identify target populations for interventions; plan
for intervention studies in HIV especially in high-risk groups e.g HIV vaccines and evaluating combination prevention interventions among others.
Multidisciplinary studies that include basic research and social sciences will be pursued. Malaria studies will include evaluation of new and innovative approaches
for malaria elimination including new drugs, drug resistance, vaccine research, control of malaria through mass treatment of asymptomatic carriers, vector
control and resistance to insecticide and pharmacovigilance. For TB, we shall look at exploring better TB diagnostics for improved case detection, drug trials to
optimize and shorten duration of TB treatment and testing TB candidate vaccines among others. We will also design research into health systems across the
Page 40 of 44
DMS # 72347-V1
different disease areas and across countries. In future, we are planning for follow-on career pathways for our scientists by identifying doctoral and postdoctoral positions and giving opportunities to young investigators to take on more leading roles in our network and research programs.
We will continue to interact with regional policy makers through de-briefing meetings and research-policy workshops in order to ensure our research evidence
contributes to policy and practice. This will also promote joint agenda setting of research, capacity-strengthening and networking for health while aligning and
harmonizing EACCR plans with those of national governments and control programs. At the same time, we want to continue advocating for enhanced
engagement in research governance structures and increased funding from African Governments, regional economic communities and the African Union.
Page 41 of 44
DMS # 72347-V1
SECTION M: CHECKLIST
Have you attached supporting documents relevant for this reporting period?
Yes/No/Not Applicable
CV’s of new collaborators
Copies of scientific publications/abstracts of conference poster presentations/meeting reports
No
Yes (see list of annexes
below)
Not applicable
Yes (see list of annexes
below)
No
No
No
No
Not applicable
Not applicable
Not applicable
Copies of newsletters with articles about the Network
Photographs for activities under Capacity Building
[site upgrades and purchase of capital equipment; project team photographs for short-term training]
Participant signature lists for attendance of short-term training courses
New cofunding letters
Success stories (newsletter articles/photographs)
Ethical approval letters/letters of amendment/ latest version of the protocol
Trial Insurance certificates (only applicable to clinical trials)
Index of Trial Master File (only applicable to clinical trials)
Report from last monitoring visit (only applicable to clinical trials)
SECTION N: DECLARATION
(To be completed by the Project Coordinator)
I, Professor Pontiano Kaleebu hereby declare that the information provided in this report to be correct and accurate. This report was prepared in consultation
with all site coordinators and is submitted on behalf of the EACCR Network.
Signature of Project Coordinator
Date [DD/MM/YYYY]
Page 42 of 44
DMS # 72347-V1
LIST OF ANNEXES
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
Annex
1: Social science survey report from KEMRI-CDC, Kisumu, Kenya
2: Social science survey report from NIMR-Mwanza, Tanzania
3: Peer-review article on the 4 EDCTP regional networks of excellence in the BMC Public Health journal
4: EACCR oral presentation at a WWARN-sponsored regional workshop in Nairobi, May 2012
5: EACCR oral presentation at a TBVI organized meeting in Switzerland, January 2013
6: EACCR oral presentation at the EAC conference in Kigali, Rwanda, March 2013
7: EACCR abstract submitted to the EAC conference in Kigali, Rwanda
8: EACCR abstract on the reciprocal monitoring scheme to the EAC conference in Kigali, Rwanda
9: Report on the 4th EAC conference in Kigali, Rwanda, March 2013
10: A sample of an EDCTP capacity needs assessment for Institutional Review Boards in the East Central & Southern Africa Health Community
11: Report on the TBVI organized meeting in Switzerland, January 2013
12: EACCR oral presentation at the Afrique One consortium, September 2012
13: EACCR oral presentation at a workshop sponsored by the Global Health Network in Nairobi, Kenya, May 2012
14: GCP-GCLP workshop photographs at NIMR-Muhimbili, Tanzania in 2012
15: List of trainees of a workshop in Entebbe sponsored by the Global Health Network in February 2013
16: Group photograph for some of the trainees of a workshop in Entebbe sponsored by the Global Health Network in February 2013
17: Report of a workshop in Entebbe sponsored by the Global Health Network in February 2013
18: Template-Updated EACCR Project Profile
19: With annexed participant list and photographs for the EACCR Project Profile
20: Criteria for classification of research institutions into various levels
21 Sub grant contract with University of Ottawa- Adolescent study
Page 43 of 44
DMS # 72347-V1
ANNEX 20:
Criteria for classification of research institutions into various levels
Level
Overall Institutional
Rating
1
Epidemiologically
relevant population and
interested investigators
2
Identified cohort and
follow-up capability
3
Sites with some clinical
trial capacity (Phase III)
4
Fully capable site for phase
I-III trials
Some access to
laboratory facilities
Ability to measure
clinical outcomes
Data collection field
staff
GCLP compliant
GCLP compliant
GCLP compliant
Access to facilities with
staff
Some computer infrastructure and basic
data-processing skills
Sample repository
Information Technology
(IT)
Absent
No internet access
Excellent facilities with
qualified staff
Biostatistics, sufficient
computer hardware and
software. Experienced data
processing staff
Available
Excellent IT facilities
established with adequate
qualified support staff
Library facilities
None
Finance and
Administration
Weak administrative
capability
Absent
Some computer
infrastructure with
limited internet access
(dial-up access)
Limited on-line
literature access
Basic administrative
capability
Investigators
Lack of GCP training
GCP exposure
Subjects
Target population
identified
Ethics
Institutional Review
Board (IRB) not yet
established
Demonstrated ability to
follow-up community
involvement
IRB and
national ethics
committee exist
Adequate facilities and
qualified staff
Sufficient computer
hardware and software.
Experienced data
processing staff
Part of laboratory
Sufficient computer
hardware and soft ware;
broad band access and
some IT support
Adequate facilities both
on-line and hard copies
Accounting and
administrative systems
available
GCP qualified with limited
experience
follow-upcommunity
involvement formalised
IRB and
National guidelines for
clinical trials exist
COMPONENTS
Laboratories
Clinical facilities
Data management
Excellent facilities both online access and hard copies
Well established and audited
accounting and
administrative systems
GCP qualified with
experience
follow-upcommunity
development programme
IRB
National guidelines for
clinical trials exist
Page 44 of 44

EDCTP EACCR 4th year report

Transcription

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