EACCR 5th Year Report Final
Transcription
EACCR 5th Year Report Final
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 Fifth From [16th May 2013] To [31st March 2014] (Year 5) 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: [email protected] 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 3.5 million euros 16th May 2009 To 31st December 2014 *only applies to sites with legal entity status EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 1 of 25 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 Active (Y/N)* Role in Network Overall project coordinator HIV Male Prof. Pontiano Kaleebu Former Director MRC/UVRI Unit & co-applicant Deputy Overall project coordinator Facilitator of capacity-building activities & coapplicant Co-applicant & Head of institution HIV Male TB Male [email protected]/ [email protected] Immunology & Infectious Diseases Female [email protected] Malaria Male [email protected] Chairman EACCR Steering committee & Director, UVRI Malaria node coordinator HIV, Bioethics, oncology Male [email protected] Malaria Male [email protected] Member, EACCR Steering committee & training/mentorin g Member, EACCR Steering committee & Head of IHI Malaria, clinical trials, Training (elearning) Female [email protected]. uk Malaria Male [email protected]/ [email protected] Y 1. Uganda Virus Research Institute Uganda 2. MRC/UVRI Research Unit Uganda 3. Kilimanjaro Christian Medical Centre (KCMC) Tanzania 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 UK Dr. Trudie Lang Y Tanzania Area of expertise Name of collaborator Dr. Abdulla Salim EDCTP -East African Consortium for Clinical Research 5th Year report (2) Gender Current email Pontiano.Kaleebu@mrcug anda.org/pkaleebu@infoco m.co.ug heiner.grosskurth@gmail. com Page 2 of 25 DMS # 72347-V1 Site/Institution 10. National Institute for Medical Research – Mwanza 11. National Institute for Medical Research – Mwanza 12. Armauer Hansen Reserach Institute (AHRI) 13. Muhimbili University of Health and Allied Sciences (MUHAS) 14. Institute of Endemic Diseases (IEND) 15. Muhimbili University of Health and Allied Sciences (MUHAS) 16. National Institute for Medical Research Dar es Salaam 17. National Institute for Medical Research – Muhimbili 18. National Institute for Medical Research – Muhimbili 19. Muhimbili University of Health and Allied Sciences(MUHAS) Country Active (Y/N)* Name of collaborator 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 [email protected] HIV Male [email protected] Supervisor Training & coapplicant Mentoring & coapplicant Training Male [email protected]/en [email protected] HIV, Training Male [email protected]/mba [email protected] Facilitator of EACCR capacitybuilding activities Facilitator of EACCR capacitybuilding activities Malaria, Training Male mmukhtar@tropmedicine. org Training Female [email protected] Vice chair, Steering Committee & Director General – NIMR TB node coordinator Neglected infectious diseases Female [email protected]/ [email protected] TB Male [email protected] Facilitator of activities in the TB Node Scientist-TB Female [email protected]/be [email protected] m Trainer Training Male [email protected] Prof. Japhet Killewo EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 3 of 25 DMS # 72347-V1 Site/Institution 20. Muhimbili University of Health and Allied Sciences(MUHAS) Country Active (Y/N)* Name of collaborator Y Tanzania Prof. Eligius Lyamuya Y 21. Uganda Virus Research Institute Uganda 22. KEMRI/CDCKisumu Kenya 23. Walter Reed Project/KEMRI Kisumu 24. University of Nairobi/Kenya AIDS Vaccine Initiative (KAVI) 25. Maseno University Dr. Jonathan Kayondo Y Mr. Stephen Wandiga Y Kenya Dr. Berhards Ogutu Y Dr. Walter Godfrey Jaoko Kenya Kenya Y Prof.Ofulla Ayub V.O Y 26. Ugandan Ministry of Health Uganda Dr. Asuman Lukwago Y 27. St Rapheal Nsambya Hospital Uganda Dr. Martin Nsubuga N 28. NIMR-Tabora Tanzania 29. National Institute for Medical Research -Tanga Tanzania Dr. Zakayo Mrango Y Dr. Martha Lemnge EDCTP -East African Consortium for Clinical Research 5th Year report (2) Role in Network Area of expertise Member, steering committee & Trainer HIV, microbiology, immunology Male [email protected] Member, implementation committee HIV, malaria, molecular biology, bioinformatics TB Male [email protected] Male [email protected] Malaria Male [email protected] HIV, microbiology, training Male [email protected] Malaria, training Internal medicine, policy Male [email protected] Male [email protected] Internal medicine Male [email protected] o.uk/ martin.nsubuga.dr@gmail. com Parasitology, Human African Trypanosomia sis Malaria Male [email protected] Female [email protected] m Trainer/facilitator of capacitybuilding activities Steering committee member Co-applicant & trainer Co-applicant, trainer Steering committee member, coapplicant Director of sister site, co-applicant, source of potential participants Representative of sister site, coapplicant, source of potential participants Director of sister site, co-applicant Gender Current email Page 4 of 25 DMS # 72347-V1 Site/Institution Country Active (Y/N)* Name of collaborator Y 30. NIMR-Mbeya Tanzania 31. University of Munich Germany 32. Karolinska Institute Sweden Dr. Leonard Maboko N Dr. Michael Hoelscher Y Prof. Eric Sandstrom Y 33.Masaka Hospital 34.Centre for International Health, University of Bergen 35.KNCV Tuberculosis Foundation 36. Goteborg University 37. Infectious Disease Institute- Mulago 38. Radbourd University Medical center Nijmmegen (RUMCN) 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 Role in Network Area of expertise Gender Current email 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 [email protected] TB Male [email protected] HIV Male Eric.sandstrom@karolinsk a.se Paediatrics, epidemiology Female [email protected] or masakarrh.gmail.com TB Male [email protected] TB Male [email protected] Training Training Male [email protected] Facilitator of capacity-building HIV Male [email protected] CollaboratorNorthern partner, co-applicant Networking Male [email protected] *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 EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 5 of 25 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 2013, the East African Consortium for Clinical Research (EACCR) has continued its collaboration with the 35 17 leading regional stitutions and 7 northern partners to support initiatives towards conduct of multi-centre clinical trials (on drugs, devices and other solutions), capacity development and networking. The leading institutions work closely with other 18 sister sites. The Network addresses challenges of fragmented/uncoordinated efforts, diminishing indigenous scientists, insufficient funds and inadequate infrastructure in Eastern Africa in partnership with the 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 Europe and Northern America (Canada). Methods: With guidance of EDCTP, we held consultative stakeholder meetings, Networking, document review, email discussions and teleconferences between May 2013-March 2014. EACCR’s work packages are categorized into: governance, training, infrastructure, research and networking. Governance is structured regionally into 4 coordinating centers: Malaria (Kenya), TB (Tanzania), HIV (Uganda) and Training (Tanzania). We leveraged the main framework programme 6 (FP6) grant, the coordination support action (CSA) subgrant and the additional core support funds to consolidate key operations in the Network. Results and achievements: We maintained a consensus-governed and networked consortium whose contract with EDCTP has been extended to December 2014. This Network has also secured additional 95, 000 euros from EDCTP for essential operational and preparatory activities to respond to the upcoming EDCTP 2 grant calls. EACCR has contributed to: 2 additional published peer-review articles; training 10 regional scientists in 5 short courses; supporting 6 on-going masters degree students sponsored by EDCTP and 10 networking events. One of its EDCTP senior fellows was successfully awarded an African Research Leaders’ grant of up to 5 years support in mental health and capacity-building. Two more grant applications have been submitted by the TB node to sustain Network activities. In addition, other affiliated institutions have had more publications and co-funding mechanisms. Kindly note that this space is expandable 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 that was 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 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 EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 6 of 25 DMS # 72347-V1 To apply an interactive website for better communication, enhanced networking, advocacy, common databases and training To promote advocacy for: regionally-owned research and health agenda; research use in policy and programming and resource mobilization Results and outcomes EACCR contributed to 2 published peer-review articles in year 5 (annexes 1 and 2). It trained 10 regional scientists through 5 short courses conducted during this period. This Network also supported 6 continuing masters degree students sponsored by EDCTP. We maintained a consensus-governed and networked consortium whose contract was amended and extended to December 2014. EACCR has secured additional funds (95,000 euros) for core support functions in 2014. The consortium has engaged meaningfully in 10 networking events outlined below to increase its contributions to research plus capacity-building and visibility. In addition, other affiliated institutions have had more publications and co-funding mechanisms. Capacity building The Hon. Minister of State for Health in charge of primary health care, Dr. Sarah Opendi, was invited by EDCTP and EACCR to participate in a high-level meeting for policy makers in Dakar, Senegal on the 21st October 2013. Prior to this EDCTP meeting, EACCR secretariat updated her on the: contributions, activities of EDCTP in Uganda and the region; purpose of the scheduled meeting; possible areas of engagement by the Ugandan Ministry of Health and the challenges that the Network has experienced (annex 3: policy brief). EACCR continued to support 6 on-going Masters degree students sponsored by EDCTP and also trained 10 scientists and health workers through 5 short courses mentioned in section D below. Our pool of clinical monitors and research staff are now able to access an accredited open online research ethics course with the support of the Global Health Network website. More planned infrastructure upgrades were implemented at KCMC/KCRI as described in section D. The Network continued to work with the EDCTP Africa office and The Hague to coordinate and execute the EDCTP stepwise laboratory accreditation programme and the financial audit processes. Networking The HIV node coordinator and Network scientific liaison officer participated through learning observation in a Joint planning meeting of WANETAM and CANTAM in Dakar, Senegal in June 2013 with facilitation from EDCTP so that EACCR could hold a similar joint capacity-building event with TESA in July 2013 (Refer to photograph in annex 4) Mrs. Emily Nyanzi, the project manager, attended an evaluation meeting of MDGs organised by the Ugandan Economic Policy and Research Centre (EPRC) and UK Aid at Sheraton Hotel Kampala, Uganda in June 2013 The HIV node coordinator and Network scientific liaison officer was invited and attended some of the scientific presentations and the annual general meeting of the Welcome Trust-funded THRiVE consortium (www.thrive.or.ug) in Kampala, Uganda, 10-12 July 2013 EACCR participated in and contributed to a joint planning meeting of stakeholders from EACCR and TESA in Johannesburg, South Africa in mid July 2013 (see annex 5: SAPESA report) Prof. Kaleebu and Mr. Tom Lutalo attended and participated in the HIV stakeholders’ meeting in Lisbon, Portugal, 3rd - 4th september 2013 Dr. Sarah Opendi attended the EDCTP High-level meeting in Dakar, Senegal on 21st October 2013 upon the invitation of EDCTP and EACCR. The HIV node coordinator participated in a skills-sharing workshop on sexual and reproductive health organized by the Canada-Africa Prevention Trials Network at the Infectious Disease Institute, Mulago Hospital, Uganda in December 2013 (Refer to annex 6) EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 7 of 25 DMS # 72347-V1 1.4 Dr. Reginald Kavishe, the assistant training node coordinator, from KCMC represented EACCR at the WANETAM annual general meeting (AGM) in Dakar, Senegal, 16-18 December 2013 Dr. Miiro, the HIV node coordinator and Network liaison officer, attended an EU-funded information dissemination workshop on the released Horizon 2020 calls hosted by the Uganda National Council for Science and Technology (UNCST) in Kampala, Uganda on 22nd January 2014 followed by another workshop by UNCST at UVRI on the same subject in February 2014. Refer to annex 7. Dr. Miiro attended the 11th TaMoVac meeting in Dar es Salaam, Tanzania in February 2014 (Refer to report in annex 8) 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 research centres in the networks of excellence involved in clinical trials, EACCR facilitates collaboration in Eastern Africa by uniting 35 diverse regional institutions with their distinctive strengths into a network for synergy and complementarity. Its members are learning and developing ‘by doing’ how to plan jointly (instead of ‘silo’ planning), manage this initiative by consensus, share and pool limited resources equitably and jointly to 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 has created 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 UniversityUVRI 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) The network continued to hold regular teleconferences and Skype calls of its governance structure below for progress review, stakeholder consultations and consensus-building. We prepared and revised work plans and budgets for the main framework programme 6 grant, the Coordination Support Action sub-grant and for the core support funding. The respective contracts have been amended and signed with EDCTP. Ear-marked funds were harmoniously disbursed to the respective nodes and leading sites in accordance with the EDCTP financial guidelines. We have implemented the required interim financial audits. EACCR has facilitated the execution of the EDCTP stepwise laboratory accreditation programme in the 6 selected sites in partnership with the contracted LQT and the ASLM agencies. The EACCR secretariat and members have continued to share and discuss the emerging grants and training calls/opportunities to sustain the Network activities. EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 8 of 25 DMS # 72347-V1 Has there been any change to the management structure since submission of the last report to EDCTP? [Yes Dr. Kayla Laserson from KEMRI CDC in the organogram below, moved to new job. She was replaced by Mr. Steve Wandiga from the same organisation in Q3 2014 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. None at the moment! 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. Sample repository Refubishment of Biorepository for more freezer space which has improved sample storage capacity and has contributed to the initial BL accreditation Laboratories BL expansion provided space for level II and III Labs and Biorepository. This has enabled organisation of the lab into specific units and biosafety levels. Clinical trial facilities Name of site KCRI Name of site KCRI Name of site *Level at baseline *Current level 3 4 *Level at baseline *Current level 2 3 *Level at baseline *Current level Extension of Clinical trial building at KCRI. Also purchase of equipments and furniture Refubishment of KCRI-Kibong’oto Research Unit Purchase of furniture for KCRI – Kibong’oto Research Unit KCRI 3 4 KIBONG’OTO 2 3 Data management Name of site *Level at baseline *Current level Purchase of furniture. This increased data entry spots, data management and processing capacity KCRI 2 3 Information technology and information sharing facilities Name of site *Level at baseline *Current level EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 9 of 25 DMS # 72347-V1 Short-term training [eg Short courses in GCP, HSRP, GCLP, IATA etc] Name of training Lead Auditor Course, Qualitative culture training and ISO 15189:2007 requirements Dates of training Duration of training Lead Auditor Course (22-26 July 2013) Qualitative culture training (7-20 July 2013) and ISO 15189:2007 requirements (2-5 October 2013) Lead Auditor Course (Nairobi, Kenya) Qualitative culture training (Kampala, Uganda) and ISO 15189:2007 requirements (Nairobi, Kenya) SGS (Lead Auditor Course), Qualitative culture training (Makerere University, Clinical Research Center) and ISO 15189:2007 requirements (Aga Khan University) Lead Auditor (5 days), Quantitative culture training (2 weeks) and ISO 15189:2007 (2 weeks) Number of participants 8 Venue Agency providing training Gabriel Omwalo Male Kenyan Position held within the network TB Quality Assurance Section Head Jeremiah Khayumbi Male Kenyan TB Lab Immunology Supervisor KEMRI CGHR Wlifred Bundi Male Kenyan Lab Technologist KEMRI CGHR KEMRI CGHR First name Surname Gender Nationality Institutional Affiliation (site name) KEMRI CGHR Shadrach Mutuku Male Kenyan Lab Technologist Ruth Sitati Female Kenyan Lab Technologist KEMRI CGHR Joseph Orure Male Kenyan Lab Technologist KEMRI CGHR Miliket Aytenew Female Ethiopian Lab Technologist AHRI-Ethiopian Wondale Mekonnen Male Ethiopian Lab Technologist AHRI-Ethiopian 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 0 Doctoral 0 EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 10 of 25 DMS # 72347-V1 Masters 6 *Others *Others may include candidates completing Honors, Bachelors degrees or National Diplomas Candidate Name Surname Gender Nationality Project Title Institution where registered Supervisor Date Registered Envisaged Date of completion Oct-10 Oct-14 Aug-10 May-14 Oct-10 April-15 Post-Doctoral NA Masters Student 1 Charles E. Makasi M Tanzanian No Research Topic since he is pursuing Masters in Clinical Trial University of London International Programmes/Lond on School of Hygiene and Tropical Medicine/Stewart N/A Student 2 Stella Zawedde Muyanja F Ugandan Evaluating the MDR TB Surveillance System in the West Nile Region. Makerere University Student 3 Patrick Kazooba M Ugandan Has not yet submitted the title University of London International Programmes/ London School of Hygiene and Tropical Medicine Prof. Joseph Kkonde Lule and Dr. Sheba Nakacubo-Ggita Department of Epidemiology, School of Public Health Ann Tholen EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 11 of 25 DMS # 72347-V1 Student 4 Lydia Student 5 Demissie Nabacwa F Uganda Befekadu Debebe F Ethiopia Student 6 James Ngocho M Tanzania Title to be submitted in April 2014 Evaluation of culture of mycobacterium tuberculosis on blood agar in resource limited setting in Ethiopia Assessment of the Clinical presentation and indentification of pathogenicbacteria among pupils with self-reported respiratory symptoms in Moshi municipality, Tanzania University of Liverpool, United Kingdom Kilimanjaro Christian Medical University College (KCMU Co) Kilimanjaro Christian Medical University College Name to be given April 2014 Prof. G. Kibiki, PhD Prof. G. Kibiki, MD, MMED, PhD Dec-11 Dec-14 Oct-12 Oct-14 Oct-12 Oct-14 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) Training Candidate Name Surname Plans once degree has been completed (i.e. MSc, PhD) Student 1 Charles E. Makasi MSc. Integrate into the current Network activities through NIMR once he completes in October 2014 Student 2 Stella Zawedde Muyanja MSc. Integrate into the current Network activities through IDI, Mulago Hospital and disseminate study findings through conferences and publications Student 3 Patrick Kazooba MSc. Will be communicated after completing study in December 2014 Student 4 Lydia Student 5 Demissie Student 6 James Student 7 Seith Nabacwa MSc. Will be communicated after completing study in December 2014 MSc. Will be communicated after completing study in October 2014 Ngocho MSc. Will be communicated after completing study in October 2014 Inzaule MSc. Take on new role as a Tutorial fellow teaching epidemiology and biostatistics at Jaramogi Oginga Odinga University Befekadu Debebe Please insert additional rows as required EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 12 of 25 DMS # 72347-V1 Short-term training [eg Short courses in GCP, HSRP, GCLP, IATA etc] Name of training HIV Laboratory Techniques and Good Laboratory Practices (Refer to annex 9) Dates of training 3rd - 14th June 2013 Venue – Infectious Disease Institute Training Hub- Mulago Hospital Agency providing training Infectious Disease Institute, Mulago- Kampala, Uganda Duration of training 2 weeks Number of participants One from the UVRI clinic Name of Trainee Sam Surname TWONGYEIRWE Gender Nationality Male Ugandan Position held UVRI Clinic (sister site) Laboratory Assistant Name of training HIV Laboratory Techniques and Good Laboratory Practices (Refer to annex 10) Dates of training 3rd - 14th June 2013 Venue Infectious Disease Institute Training Hub- Mulago Hospital Agency providing training Infectious Disease Institute, Mulago Hospital- Kampala, Uganda Duration of training 2 weeks Number of participants One from Masaka Hospital Name of Trainee Sarah Surname NAKIBUULE Gender Female EDCTP -East African Consortium for Clinical Research 5th Year report (2) Nationality Ugandan Institutional Affiliation (site name) Position held Laboratory Assistant Institutional Affiliation (site name) Masaka Regional Referral Hospital (sister site) Page 13 of 25 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. This information remains the same for EACCR and has already been shared in the 4th year report submitted to EDCTP. Summary of numbers of staff employed on the grant. “Same as in the 4th year report” Site 1 Site 1-UVRI Full-time Part-time Staff category Male Female Male Female Senior staff: 2 Senior Fellows/Professors/Senior Clinicians or equivalent Mid-career staff: Intermediate level fellows 1 (> years postdoctoral experience)/clinicians/ lecturers or equivalent Site 2 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 Pharmacists Data (Managers, IT officers and assistants) 2 1 2 Administrative staff 1 Quality Control (Managers, officers) 1 1 Finance staff 1 1 Others (ancillary i.e drivers, general assistants etc) EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 14 of 25 DMS # 72347-V1 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 4 Site 3-KEMRI WT Full-time Part-time Male Female Male Female 1 2 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 Quality Control (Managers, officers) 1 1 1 Finance staff 2 Others (ancillary i.e drivers, general assistants etc) Total Please add columns for additional sites 4 1 1 2 3 3 How has the grant contributed to the professional development of ALL staff employed on the project? Yes, through in-service training and different short courses and mentorship attachments organized. EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 15 of 25 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? 2 (but other publications from affiliated institutions have not been captured in this report) 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. Two peer-reviewed publications: 1. Chantler T, Cheah PY, Miiro G et al. International health research monitoring: exploring a scientific and a cooperative approach using participatory action research. BMJ Open 2014; 4: e004104 2. Inzaule S, Otieno J, Kalyango J et al. Incidence and predictors of first line antiretroviral regimen modification in Western Kenya. PLOS One 2014; 9(4): e93106 Please provide details of any other publications resulting from this work Please confirm that EDCTP support has been acknowledged on each publication Yes, I 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 1. Prof. Kaleebu gave an oral presentation on the progress updates, SWOT analysis and the future plans of EACCR at the joint review meeting of both TESA and EACCR in Johannesburg, South Africa, 3 rd week of July 2013. Refer to annex 11. 2. Prof. Pontiano Kaleebu, Paula Munderi and Tom Lutalo presented at the European & Developing Countries Clinical Trials Partnership (EDCTP) Stakeholders’ Meeting on HIV held at ISCTE - University Institute of Lisbon (ISCTE-IUL) in Lisbon, Portugal, on 3-4 September 2013. 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 The EACCR secretariat prepared a policy alert/brief for the Ugandan Minister of State for Health (Primary Health Care), Dr. Sarah Opendi, on the: contributions, activities of EDCTP in Uganda and the region; purpose of the scheduled meeting; possible areas of engagement by the Ugandan Ministry of Health and the challenges that the Network has experienced (annex 3). This facilitated her subsequent engagement in the high-level EDCTP meeting in Dakar, Senegal, 21st October 2013. EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 16 of 25 DMS # 72347-V1 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 Not applicable SECTION F: NETWORKING Exchange/Mentorship Schemes Please provide an update of any exchange and mentorship schemes developed at an inter or intra-network level Participant name Students for examinations Sites involved KCMC (Tanzania) and Radboud University (Netherlands) Outcome of exchange External examiners from the northern partner engaged and students’ examinations were supervised Network Communication Plan Please provide an update of communication at the levels indicated below Communication Level Update National Regional Local authorities Local community International Policy brief presented to the Ugandan Minister of State for Health (Primary Health Care) Network meetings outlined in sections G and H below NA NA Through 2 published articles and the EACCR website (www.eaccr.org) EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 17 of 25 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 TaMoVac II Project Project coordinator Prof. Eligius Lyamuya EDCTP project code To be communicated Contribution Invited to scientific sessions on HIV vaccine trial plans Benefit Shared Data unit and back-up IT server at NIMR-Muhimbili 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 The HIV node coordinator and Network scientific liaison officer participated through learning observation in a Joint planning meeting of WANETAM and CANTAM in Dakar, Senegal in June 2013 with facilitation from EDCTP so that EACCR could hold a similar joint capacity-building event with TESA in July 2013 (Refer to photograph in annex 4) Mrs. Emily Nyanzi, the project manager, attended an evaluation meeting of MDGs organised by the Ugandan Economic Policy and Research Centre (EPRC) and UK Aid at Sheraton Hotel Kampala, Uganda in June 2013 The HIV node coordinator and Network scientific liaison officer was invited and attended some of the scientific presentations and the annual general meeting of the Welcome Trust-funded THRiVE consortium (www.thrive.or.ug) in Kampala, Uganda, 10-12 July 2013 EACCR participated in and contributed to a joint planning meeting of stakeholders from EACCR and TESA in Johannesburg, South Africa in mid July 2013 (see annex 5: SAPESA report) Prof. Kaleebu and Mr. Tom Lutalo attended and participated in the HIV stakeholders’ meeting in Lisbon, Portugal, 3 rd - 4th september 2013 Dr. Sarah Opendi attended the EDCTP High-level meeting in Dakar, Senegal on 21st October 2013 upon the invitation of EDCTP and EACCR. The HIV node coordinator participated in a skills-sharing workshop on sexual and reproductive health organized by the Canada-Africa Prevention Trials Network at the Infectious Disease Institute, Mulago Hospital, Uganda in December 2013 (Refer to annex 6) Dr. Reginald Kavishe, the assistant training node coordinator, from KCMC represented EACCR at the WANETAM annual general meeting (AGM) in Dakar, Senegal, 16-18 December 2013 Dr. Miiro, the HIV node coordinator and Network liaison officer, attended an EU-funded information dissemination workshop on the released Horizon 2020 calls hosted by the Uganda National Council for Science and Technology (UNCST) in Kampala, Uganda on 22nd January 2014 followed by another workshop by UNCST at UVRI on the same subject in February 2014. Refer to annex 7. Dr. Miiro attended the 11th TaMoVac meeting in Dar es Salaam, Tanzania in February 2014 (Refer to report in annex 8) EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 18 of 25 DMS # 72347-V1 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 INTERNAL Ongoing training/mentoring activities for network affiliated personnel plus supervision Guidelines, policies, manuals and regular progress review meetings Reciprocal clinical trial monitoring scheme Accredited Institutional Ethics Committees Internal financial audits EXTERNAL External financial audits by EDCTP and European Union EDCTP financial guidelines ACADEMIC PROGRAMMES Affiliating to peer-reviewed and accredited training curricula of regional leading and northern partner academic institutions Engaging external examiners LABORATORY National Health Laboratory Service - South Africa for Laboratory External Quality Asurance UK – NEQAS, American college of pathologist accreditation Documented and shared Standard Operating Procedures EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 19 of 25 DMS # 72347-V1 SECTION J: FUNDING List any new funding that was secured during this reporting period Funding [cash/in-kind] Name of Co-funding Agency Amount* Activities funded Core/basic operational activities and preparatory activities to respond to EDCTP2 calls * Where co-funding is an ’’in-kind contribution’’, please estimate the amount in monetary value EDCTP Cash Co-funding letter attached (y/n) n 9500 euros Please list any joint research grants held by members of the network and joint proposals submitted by members of the network 1. Tehminah Mustafa of Haukeland University Hospital in Norway and the EACCR TB node submitted a proposal to the Norway GLOBVAC programme in September 2013, titled ‘Improved case detection, diagnosis and management of extrapulmonary tuberculosis in Central and East Africa using immunohistochemistry.’ Feedback on the outcome is awaited. 2. The TB node is part of a new consortium, Cystecercosis Network of Sub-Saharan Africa (CYSTNET) together with Makerere University School of Public Health, University of Zambia, University of Malawi, Sokoine University and other partners who have submitted a proposal for research and capacitybuilding in cystecercosis (a neglected tropical disease that sometimes causes brain infestation and convulsions in humans) in response to a call by the German Ministry of Higher Education and Research (BMBF). The outcome will be communicated. 3. An African Research Leaders’ Award was granted to Dr. Eugene Kinyanda and the Centre for Global Mental Health at the London School of Hygiene and Tropical Medicine to support the mental health among HIV infected Children and Adolescents in Kampala and Masaka, Uganda (CHAKA) project. The vision of CHAKA is to generate evidence to inform the development of mental health services for children & adolescents with HIV/AIDS through psychiatric diagnoses made. 4. UVRI, NIMR-Mwanza and KEMRI put together an application to respond to the MRC Health Systems Research "Exploring Strategies for Empowering communities and Improving Health Services for a population of Lake Victoria Fisherfolk." Has the Network been able to undertake any cost-saving initiatives during the current reporting period? No Cost-saving initiatives i.e In house lab testing as opposed to outsourcing N/A New activities supported Funds reallocated to training activity i.e GCLP Have there been any efforts to amass significant funding to ensure long-term sustainability of the Network? Yes. Please list below EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 20 of 25 DMS # 72347-V1 Organisation Norway GLOBVAC programme World Health Organization, Capacity-Strengthening Programme Germany Ministry of Higher Education and Research (BMBF) European Union Support Secured Grant application submitted by the TB node and the response is awaited $49, 104 sought was not successfully secured 1 grant application has been submitted by the TB node but another grant application by the HIV node was not submitted because the German partner was too committed elsewhere 2 grant applications by the HIV and TB nodes to Horizon 2020 calls of December 2013 were not submitted because the European partners to lead submission were already so engaged to participate further 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 Dr. Eugene Kinyanda, employed by the MRC/UVRI Uganda Research Unit on AIDS as a project leader of the mental health project and a former EDCTP senior fellow linked to EACCR, secured a prestigious highly competitive African research leader award by the joint United Kingdom MRC/DFID scheme in partnership with the Centre for Global Mental Health at the London School of Hygiene and Tropical Medicine. This award will provide support up to 5 years with the aim of strengthening research leadership in Sub-Saharan Africa by attracting and retaining exceptionally talented scientists to lead high quality research programmes. The award was granted to the Centre for Global Mental Health and Dr. Kinyanda to support the mental health among HIV infected Children and Adolescents in Kampala and Masaka, Uganda (CHAKA) project. The vision of CHAKA is to generate evidence to inform the development of mental health services for children & adolescents with HIV/AIDS through psychiatric diagnoses made. More detailed information is available on http://www.centreforglobalmentalhealth.org/newsevents/news/centre-awarded-mrcdfid-african-research-leader-fellowship. Mr. Seith Chekata Inzaule, a former Master of Science student of EACCR funded by EDCTP and a former employee of KEMRI-CDC, Kisumu, Kenya completed successfully his research work and thesis on ‘combined antiretroviral treatment switch and discontinuation among HIV infected patients’ which has been published in an open-access peer-reviewed journal of Plos-one in 2014. His abstract was also accepted for an oral presentation in the forthcoming 7th EDCTP forum in Berlin, Germany, 30th June-3rd July 2014. Seith has also steadily progressed to take a new employment as a tutorial fellow in the school of health sciences at Jaramogi University, Kenya to teach epidemiology and biostatistics. EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 21 of 25 DMS # 72347-V1 Social benefits Dr. Charles Kabugo, a former Master of Science student of EACCR, transferred from Masaka Regional Referral Hospital (a sister site) to Mulago National Referral Hospital to increase his contributions to the provision of high quality health services to sick clients and to the provision of medical education to students at the quality improvent ward of the Infectious Disease Institute-Mulago (a leading site). Another current Master of Science student of EACCR on a distance learning programme of international health management with the Liverpool School of Hygiene and Tropical Medicine, UK, transferred from Uganda Virus Research Institute to concurrently take on new employment as an administrative assistant in the faculty of vocational and distance education at the Makerere University Business School, Nakawa, Uganda. Ms. Lydia Nabacwa is now assisting fellow students by handling their academic registration and orientation activities at this school; sorting their emerging academic issues or concerns; organizing faculty and academic meetings; writing monthly report updates; facilitating release of their examination timetables; invigilating their exams; entering students’ results on the school’s online system and supporting release of students’ testimonials. 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’’) EACCR has amended and extended its contract with EDCTP up to December 2014 and has secured core support funds for the prioritized essential operational activities in the nodes and the secretariat during this period. In this enabling context, the network will continue mobilizing its members to brain-storm, refine and develop concrete agreed-upon research ideas/questions and follow-on capacity-building plans to be included in the different proposals targeting the expected grant calls from EDCTP in the 3rd quarter of 2014 and other relevant emerging grants and training calls elsewhere for more funding. We shall also contribute to generating new strategies and potential work plans for inclusion in a new EACCR 2 strategic plan. This will be achieved through joint sharing of upcoming grant calls in email exchanges, the EACCR website and teleconferences; joint planning and grant writing; joint face-to-face meetings and networking with the identified new partners in Rwanda, product development partners and the other networks of excellence. We shall capitalize on the optimal sidemeetings of the capacity-building workshop planned during the 7th EDCTP forum in Berlin, Germany, 30th June to 3rd July 2014. EACCR will plan follow-on career pathways for its promising trained and existing scientists by creating or identifying further masters’ degree, doctoral and postdoctoral fellowships in the network research and capacity-building programs. We will continue to interact with the local, national and regional policy makers plus health-related programme managers through de-briefing meetings and research-policy workshops in order to ensure that the existing research evidence contributes to policy and practice. EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 22 of 25 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 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) NA Yes No Yes SECTION N: DECLARATION No No No No No No No (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 node and site coordinators and is submitted on behalf of the EACCR Network 02/05/2014 Signature of Project Coordinator EDCTP -East African Consortium for Clinical Research 5th Year report (2) Date [DD/MM/YYYY] Page 23 of 25 DMS # 72347-V1 LIST OF ANNEXES Annex Annex Annex Annex Annex Annex Annex Annex Annex Annex 1: Chantler T et al publication in BMJ Open 2014Annex 2: Nzaule S et al publication in PLOS One 2014 3: Minister’s policy brief/alert 4: Group photograph for the joint WANETAM-CANTAM meeting in Senegal, June 2013 5: Summary report of the joint TESA-EACCR meeting in South Africa, July 2013 6: Summary update of the sexual and reproductive health workshop by CAPT Network, December 2013 7: Summary on the information workshop of EU Horizon 2020 calls held in Uganda, January 2014 8: Summary update on the TaMoVac meeting in Dar es Salaam, Tanzania, February 2014 9: Training report by laboratory assistant from the UVRI clinic 10: Training report by the laboratory assistant from Masaka Hospital 11: Power-point presentation by Prof. Kaleebu at the joint TESA-EACCR meeting in South Africa, July 2013 EDCTP -East African Consortium for Clinical Research 5th Year report (2) Page 24 of 25 DMS # 72347-V1 ANNEX 2: 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 Demonstrated ability to follow-upcommunity involvement formalised IRB and National guidelines for clinical trials exist COMPONENTS Laboratories Clinical facilities Data management EDCTP -East African Consortium for Clinical Research 5th Year report (2) Excellent facilities both online access and hard copies Well established and audited accounting and administrative systems GCP qualified with experience Demonstrated ability to follow-upcommunity development programme IRB National guidelines for clinical trials exist Page 25 of 25