Project Title

A-TRACTION (Asian Tuberculosis Research and Clinical Trials Integrated Organisational Network) 

Project Year

2016   

Project Number

HWG 02 2016A 

Project Session

Session 1   

Project Type

Standard 

Project Status

Project in Implementation   
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Project No.

HWG 02 2016A 

Project Title

A-TRACTION (Asian Tuberculosis Research and Clinical Trials Integrated Organisational Network) 

Project Status

Project in Implementation 

Publication (if any)

 

Fund Account

APEC Support Fund 

Sub-fund

ASF: Human Security 

Project Year

2016 

Project Session

Session 1 

APEC Funding

150,000 

Co-funding Amount

228,000 

Total Project Value

378,000 

Sponsoring Forum

Health Working Group (HWG) 

Topics

Health 

Committee

SOM Steering Committee on Economic and Technical Cooperation (SCE) 

Other Fora Involved

 

Other Non-APEC Stakeholders Involved

 

Proposing Economy(ies)

Singapore 

Co-Sponsoring Economies

Malaysia; Philippines; Chinese Taipei; Viet Nam 

Expected Start Date

01/06/2016 

Expected Completion Date

31/12/2017 

Project Proponent Name 1

Nicholas Paton 

Job Title 1

Professor 

Organization 1

National University Health System 

Postal Address 1

Department of Medicine, Yong Loo Lin School of Medicine, NUHS Tower Block Level 10, 1E Kent Ridge Road, Singapore 119228 

Telephone 1

65 67726988 

Fax 1

Not Applicable 

Email 1

nick_paton2nuhs.edu.sg 

Project Proponent Name 2

Not Applicable 

Job Title 2

Not Applicable 

Organization 2

Not Applicable 

Postal Address 2

Not Applicable 

Telephone 2

Not Applicable 

Fax 2

Not Applicable 

Email 2

Not Applicable 

Declaration

Professor Nick Paton 

Project Summary

Tuberculosis (TB) is a high-priority infectious disease heavily burdening many developing APEC economies. We propose to create an Asian Tuberculosis Research And Clinical Trials Integrated Organisational Network (A-TRACTION), an initiative that brings together TB hospitals in high TB burden APEC economies. The aim is to establish a unified platform for conducting high-quality clinical trials to investigate novel TB treatments. A-TRACTION members will benefit from the development of human capital and infrastructure in the area of TB research, while all APEC economies will be able to access the Network for conduct of TB clinical trials. Besides providing a structured platform for TB research in Asia-Pacific, A-TRACTION’s activities will also attract funded TB research projects from outside APEC, thus fostering innovative economic growth. We seek APEC funding to support the Network initiation meeting in April 2016 in Singapore, and the launch of a TB Treatment Outcome Database in Q3-Q4 of 2016.

Relevance

Relevance - Region: Tuberculosis (TB) is one of WHO’s high-priority infectious diseases, with an estimated 9 million cases and 1.5 million deaths per year. TB is a critically important disease for Asia, which accounts for 59% of global cases. Alarmingly, incidence rates in APEC member economies such as Indonesia, the Philippines, and Vietnam exceed 200-300 per 100,000 population per year, classifying these regions as high TB burden areas. Other APEC economies such as China, Malaysia, Thailand, and Singapore are considered to be of intermediate TB burden (WHO Global TB Report 2015). Given such high disease burden, there is very high potential and benefit for conducting structured clinical TB research via an organized network that will bring together TB hospitals and research institutions in high TB burden APEC economies.

We propose to launch A-TRACTION (Asian Tuberculosis Research and Clinical Trials Integrated Organisational Network) – an initiative that will bring together selected TB hospitals and research institutes in high TB burden APEC economies that are able to conduct high quality TB research and clinical trials. Intended APEC-wide outcomes include building of human capital and infrastructure, developing novel ways to reduce the TB burden, and attracting funded TB research projects from outside the region, which will fuel economic growth.  It will also foster innovations in clinical research, development of new diagnostic methods, novel therapeutic regimens and advancement in scientific and clinical knowledge of TB, thus bringing the potential to improve people’s quality of life and advance the well-being of population in APEC and beyond. The Network will also benefit both developing and developed APEC member economies, by developing human capital and infrastructure in TB research on one hand, and providing a structured research platform to conduct integrated TB clinical trials on the other.

Relevance - Rank: The project falls under APEC Rank 1, ‘Projects that demonstrate a direct link to promoting regional economic integration via free and open trade and investment’:

·  A-TRACTION seeks to build an integrated open economy in the Asia-Pacific featuring innovative development, interconnected growth, and shared interests, by facilitating integrated TB research and clinical trials, which would lead to novel ways of TB burden reduction.

·  A-TRACTION aims to develop infrastructure (research capabilities in TB hospitals) and attract investments from companies with funded TB research projects;

·  A-TRACTION seeks to develop human capital by equipping clinical research professionals with the necessary skills and experience.

Objectives

The A-TRACTION project seeks to achieve the following objectives:

·  To promote the efficient conduct of multicentre TB clinical studies and capacity building in the region through shared platforms and common governance structure;

·  To develop TB research skills and experience in APEC through clinical trials, Network meetings, training workshops, dissemination of collaboration opportunities; and

To establish a repository of TB research information in the form of a Treatment Outcome Database.

Alignment

Alignment – APEC: In alignment with APEC goals, the A-TRACTION Network project meets multiple priorities: 

·  Enhancing the Regional Economic Integration – the Network will promote innovation, collaboration, institutional and people connectivity in the area of TB research;

· Investing in Human Capital Development – the Network will develop human capital, by equipping participating clinical research professionals with the necessary skills and experience; 

·  Fostering Small and Medium Enterprises’ Participation in Regional and Global Markets – the Network will improve access of local and regional SMEs (e.g. clinical research organisations) to global clinical research projects. 

Alignment – Forum: In alignment with Health Working Group (HWG) goals, the Network seeks to enhance preparedness and management of infectious diseases through integrated research and clinical trials in TB, as well as strengthen health systems in the area of human capital development.

TILF/ASF Justification

Capacity building in developing APEC member economies:  Developing APEC economies are among the heaviest burdened with TB (due to various factors, such as developing health systems and TB control programmes).  Therefore, the proposed A-TRACTION network, by its very nature, will have to consist of members in developing economies.

The majority of A-TRACTION members will be TB hospitals and research institutions from developing APEC member economies, which have*:

·  High level of interest in taking part in such a regional collaborative initiative

·  Open organisational structure and benefits / communication accessible to all

·  Key collaborative individuals

·  Some experience in TB research

·  Adequate laboratory infrastructure and procedures

*Metrics for these criteria will be developed in the proposed network meetings in discussion with the prospective network members.

This group will benefit in terms of development of human capital, expertise and infrastructure building in TB clinical research and attraction of economic benefits via projects funded by developed economies in APEC and outside APEC.

We have already identified several hospitals in high and medium TB burden developing APEC economies that have the required level of expertise and interest to conduct high quality TB clinical trials:

·  the Philippines (Philippine Tuberculosis Society, Quezon Institute, Manila; Lung Centre of the Philippines, Manila);

·  Vietnam (Hanoi Lung Hospital; Thanh Hoa TB and Lung Hospital).

·  Indonesia (Faculty of Medicine University Indonesia, Jakarta; University of Padjadjaran, Bandung;

·  Hasanuddin University, Makassar;

·  Thailand (Siriraj Hospital – Mahidol University, Chulalongkorn Hospital, Bamrasnaradura Hospital);

Informal discussions conducted with a number of these prospective members have indicated high level of interest in taking part in such a regional collaborative Network. A systematic review of TB-specific research processes at each of the potential sites including governance, trials infrastructure, and laboratory processes will be done using a combination of site questionnaires and on-site visits. Ability to contribute to the scientific agenda will be the most important consideration in selecting network members – in particular, the ability to take part in the large trials, although other factors, such a desire to achieve geographic and patient diversity will also have an influence in the member consideration.

Following the selection of sites and formation of the network, harmonization and capacity building will be performed according to identified needs, such as strengthening of clinical research processes, laboratory procedures, sample storage processes, and training of clinical research manpower at sites using collaboration and partnerships wherever possible (supported by external co-funding).

Beneficiaries and Outputs

Outputs: This APEC funded project will convene two Network meetings (inaugural and follow up) attended by prospective (and later, official) Network members. The meetings will produce the Action Plan for the A-TRACTION network initiation and operations. This will act as the guidelines by which the network will operate and sustain beyond the APEC-funded project duration. 

There are further anticipated deliverables beyond the above-mentioned Network meetings, which include: 

·  Efficient conduct of multicentre TB clinical studies and capacity building in the region through shared platforms and common governance structure;

·  Development of TB research skills and experience in APEC through clinical trials, Network meetings, training workshops, dissemination of collaboration opportunities;

·  Establishment of a repository of TB research information in the form of a Treatment Outcome Database. 

Outcomes: In the medium term, the primary output from the A-TRACTION Network will be the research capability building and integration among Network members. In addition, we expect regional economic growth via the attraction of third-party funded clinical research projects.

The medium to long term goals of the Network will be the ultimate reduction of TB burden in affected populations by adopting the treatment methods that result from the Network’s research and clinical trial activities. For instance, the TRUNCATE-TB clinical trial, the flagship project that will be run by this Network, has the potential to increase patients’ adherence to treatment, improve quality of life, reduce public medical expenditures, and thereby advance the well-being of population in multiple APEC economies.

Beneficiaries: 

Beneficiary
1 Developing APEC member economies with high and medium TB burden:

Targeted A-TRACTION members will be TB hospitals and research institutions from high/medium TB burden APEC member economies (Vietnam, the Philippines, Indonesia, and Thailand among others), meeting member criteria specified in Section 4 (precise metrics for these criteria and qualifications will be developed in the proposed network meetings in discussion with the prospective network members in order to take into account broader opinions and considerations of the participating economies).

These economies will be the primary beneficiary of the project. The benefit will be in terms of:

·  Development of human capital, expertise and infrastructure in TB clinical research in the region by setting up a platform for multi-centre TB clinical trials and observational studies. The Network will allow members to coalesce around TRUNCATE-TB clinical trial, which will be the inaugural flagship trial for the network. TRUNCATE-TB is already funded (research grant funding from the UK), and the funds will be channeled to the members sites in the developing economies. The member sites will be provided with the necessary training to conduct TRUNCATE-TB, which will later enable them to take up other TB clinical research projects through the Network.

·   Reduction of TB burden – By adopting the treatment methods that result from the Network’s research and clinical trial activities. The Network projects will develop new diagnostic methods, novel therapeutic regimens and advancement in scientific and clinical knowledge of TB. It has the potential to increase patients’ adherence to treatment, improve quality of life, reduce public medical expenditures, and thereby advance the well-being of population in multiple APEC economies.

·   Economic Development – The Network will enable the growth of clinical research business in the region, attracting projects from multi-national pharmaceuticals and economies from outside the APEC region.

Beneficiary 2 – Developed APEC member economies supporting TB clinical research:

This group of member economies refers to those with substantial funding dedicated to TB clinical research (Australia, Canada, Japan, New Zealand, USA, Republic of Korea) in both private and public sector. The collaboration with A-TRACTION will be of interest to pharmaceutical and medical technology companies, as well as investigators in academic and research institutions (universities, institutes, research hospitals etc), which conduct clinical research in TB The required experience and qualifications of lead investigators of such studies will be determined by each A-TRACTION member economy’s clinical trial regulatory laws and will not be under the purview of the Network. These users and economies will benefit from A-TRACTION by:

·  Access to a structured TB research platform, which would reduce the time and expenses needed to conduct and complete TB clinical trials.

.  Information Sharing – The network will launch and run TB treatment outcome and genomic information databases, which brings with it significant potential for information sharing.

Dissemination

The results and outputs of the Network will be disseminated in multiple ways:

·  A-TRACTION Network Website. The website will contain public information about the network, as well as a separate section accessible only to members, which will have the Network’s terms of reference, Action Plan, project information – much of it developed in the proposed two Network meetings funded by APEC. Website maintenance will be funded by the Network (not APEC funding). Until 2019, the project overseer within his institution (National University of Singapore) will take the responsibility of maintaining and supporting the website and its associated costs. During the period, the website hosting and maintenance may be transferred to another designated institution in charge within the Network and supported from overhead funds generated by Network projects. This will be subject to decisions and approvals of the regular Network governance meetings. 

·   Treatment Outcome Database. The database will be launched as part of this project and maintained by the Network after the completion of network funding. Treatment outcome data collection will be continually carried out by network members. The access rights and information sharing guidelines for the database will be determined by Network members and governance in the proposed Network meetings. Similarly as to the website above, the database initially will be maintained by the project overseer’s host institution and may later be transferred to another entity in charge subject to the Network’s governance decisions (more details in Section 14).

·  Peer-review Scientific Publications. This will be the ongoing network output dissemination method, with publications arising from the project that the Network undertakes. In the first 1-3 years, 3-5 research publications are anticipated. Depending on the scope of research projects and the impact of the obtained scientific data, peer reviewed journals for publications will be selected accordingly. For instance, the Network’s inaugural flagship clinical trial, TRUNCATE-TB, is anticipated to yield publications in high impact journals (such as Lancet, New England Journal of Medicine, JAMA), which are highly regarded by the medical and scientific community. 

The Network will be created with an intention to provide a structured platform to support the conduct of clinical trials and foster clinical research in TB. There are no intentions of selling outputs directly arising from this project funded by APEC.

Gender

The A-TRACTION network will consist of TB hospitals/sites in developing member economies. Key collaborative individuals – principal investigators will be the ones representing the member sites. The Network will seek to engage a gender-balanced profile of member representatives in order to promote equal gender engagement in the project. Indeed, the approached member sites to date in Indonesia and the Philippines have a healthy male-to-female principal investigator ratio, which the Network will seek to maintain. Further, the gender engagement item will be part of the Network inaugural meeting agenda and a terms of reference/Action Plan document will be produced after the discussion with participating Network member representatives.

From the broader perspective, TB is an infectious disease that affect men, women and children. The long term output of the Network activities – TB burden reduction – will benefit both genders and affected society groups. Depending on the scientific nature of each particular project that the Network may undertake, collection of gender-associated data may or not be feasible or required. However, in practice all clinical research projects in TB collect gender data, which would enable them to perform comparative analysis of age- and sex-disaggregated data. The Treatment outcome database (outlined above) will seek to provide comprehensive details of each case in order to create the most value for the scientific community and will thus include sections of gender-associated data. The WHO concept note on TB and Gender will be taken into consideration by the Network governance while developing data collection algorithms for the treatment outcome database.

Work Plan

This project seeks funding for the actualisation of the A-TRACTION Network, and the launch of a TB Treatment Outcome Database. These activities will run from the start of funding till December 2017.

Previously proposed (concept note) timelines were reviewed and adjusted in view of the APEC funding process timelines. 

·  Apr 2017: Inaugural Meeting of the A-TRACTION Network. An initiation meeting will be convened in Singapore to actualise the Network. This will gather identified and prospective TB clinical research representatives from 6 -15 hospitals/institutions from at least 4 APEC member economies. The Network governance will be discussed and elected in this meeting, the Action Plan will be created and endorsed and potential Network projects discussed. The planning of the meeting will commence immediately after the approval of this project by APEC (estimated July 2016). The first 2 months will be allocated to contacting the prospective participants and finalizing the meeting date. The travel plans will be arranged in finalized by the end of Dec 2016, with the remaining months before the event allocated to organisational matters at the meeting site. Due to the relatively small scale of the first meeting, no significant organisational difficulties are anticipated. The project overseer’s team is experienced in organising similar events and will employ they expertise in this project.

·   November 2017: Follow up Meeting of the A-TRACTION Network. The Network Inaugural members, as well as prospective new members, will convene in the second Network meeting to review Network implementation, share experience and lessons learned, update the Action Plan and review TB clinical research projects proposed for the Network. This will be the second and last meeting funded in this APEC scheme. Thereafter, the Network will enter its operational model and subsequent meetings (anticipated annually) will be funded from the funds generated by TB research projects that the Network undertakes**. From the administrative aspect, the follow up meeting is expected to be less complex from the organisational standpoint, with the key participants already established at the inaugural meeting and the organisational framework tapping into experience and lessons learned from the first meeting. The time elapsed between the two meetings (~7 months) will provide a generous time allowance for organisational matters from the project overseer’s side. 

·   Apr 2017 - Dec 2017: TB Treatment Outcome Database Launch. One of the focus points of the inaugural meeting (above) will be the creation of a TB Treatment Outcome Database, where participants will be free to discuss the types of data to be collected and the questions that might be addressed. This Database will set the foundation for the Network through information sharing and multilateral discussion. APEC funding is sought to support labour costs for database creation and data collection and initial entry. The database will be maintained by the Network funds after the expiry of APEC funding period. The planning of the database will commence immediately after the inaugural meeting (April 2017), as it is expected to provide a framework of the database. A contractor for the database design and programming will be sourced before the inaugural meeting. After the inaugural meeting, the database creation will start. Based on the project overseer’s experience with databases created for clinical research, 3 months should be sufficient to create, test and launch the database. The timelines of this project provide a generous 9-month allowance for the database creation and launch.

**To re-iterate, the Network’s flagship inaugural project will be TRUNCATE-TB – a large clinical trial to shorten treatment regimen for drug-sensitive TB that will recruit over 900 TB patients in Asia-Pacific. TRUNCATE-TB is now in its advanced planning stages. The inaugural meeting of the trial steering committee was convened in February 2015, while the trial protocol was finalised in July 2015, after receiving input from international experts. Patient recruitment the trial is slated to commence in early 2016. The trial will be funded by entities in UK.

Risks

The project proposed in this proposal is relatively straightforward in the nature of its implementation and no major risks will apply.

By project activities:

1) Organisation and conduct of two proposed network meetings

a)  Risk: Failure to adequately organise the meeting.

Risk mitigation: The project overseer’s team consists of joint administrative, management and scientific team is experienced organising, publicising and conducting both small and large scale events with particular niche experience in TB research (an example – Singapore TB research symposium (see www.tuberculosis.sg) is run by the same team). The team thus can tap on its plentiful experience, resources and local & international network to successfully plan and execute the event.

b)  Risk: Low interest in Network and its initiation meetings.

Risk mitigation: Extensive preliminary groundwork for the meeting and network initiation has already been done - the prospective Network sites and members have already been identified (see the list of economies and prospective members in each economy under Section 4) , high interest recorded and a meeting participant list pre-compiled.  It is anticipated that the inaugural Network meeting will be well attended by the identified prospective members, as well as potential new members.

c)  Risk: Members from developing economies will not have the resources or data to engage effectively with the project.

Risk mitigation: The member pre-selection process will be based on criteria provided in Section 4 – namely, prospective members will be expected to have certain infrastructure and prior experience in TB research to join the Network. However, members without these pre-requisites but coming from high TB burden economies and exhibiting high interest to participate will be accommodated by the provision of the necessary training (funded by Network project funds; outside the scope of this proposal), as well as supplying travel support for the Network meetings (part of this proposal).

2) Creation and Launch of Treatment Outcome Database.

a)  Risk: Lack of expertise to design a scientifically sound database.

Risk mitigation: The required scientific and clinical expertise for the data collection design of the database will be available from the Network members identified above. The project overseer also runs Singapore’s TB research programme, SPRINT-TB (www.sprinttb.org), which brings together a large group of TB experts. The project overseer and the programme have been running multiple clinical projects with associated databases and have extensive expertise in this area.

b)  Risk: Lack of expertise to programme and launch the database.

Risk mitigation: As outlined in the Budget section below, the project overseer plans to contract the Singapore Clinical Research Institute, which has expertise and a good track record in this area.

Monitoring and Evaluation

Evaluation:

·   Near-term measure of success: The launch of the Network’s flagship inaugural project TRUNCATE-TB trial, involving at least four APEC member economies.

·   Medium-term measure of success: The total number of TB research projects undertaken. Here, the economic impact will be measured by the flow of funds to participating APEC economies from project funding in later years.

·   Long term measure of success: Output generated by the Network’s projects, i.e. novel therapeutic regimens for TB and transformative input to TB health systems in the region.

Linkages

·   International Union against Tuberculosis and Lung Disease (IUTLD)

We will work closely with IUTLD, which has links with major national TB programmes worldwide and has given its enthusiastic support for the initiative.

·  Other research networks

We will also connect with other research networks that have been established in the region with a different focus (e.g. the TREATAsia Network and the South East Asia Infectious Disease Clinical Research Network) to identify potential cooperation opportunities.

·  Other APEC fora

There will be a strong basis for cross-fora cooperation with APEC Life Sciences Innovation Forum (LSIF), which has undertaken the project of APEC Multi-Regional Clinical Trial (MRCT) Regulatory Science Centre of Excellence seeking to achieve convergence of regulatory procedures in the region. We have not approached the Centre as yet, but foresee that the above project and A-TRACTION.

Sustainability

The activities in this proposal will lay the foundation for the A-TRACTION network via two initial Network meetings and the database launch. Thereafter, the Network will enter its operational mode and will be sustained via its operational and governance structure (below), which will attract, review and update new projects for the network. The structure will be implemented and officials will be elected in the proposed initiation meeting.

As shown in the diagram below, the network will be overseen by an Executive Committee, comprising the programme lead-PI, the leaders of core areas, member representatives, the Chairs of active research protocols, independent scientific representatives not directly linked to the network and a community representative (Figure 4). The Executive Committee will be responsible for leadership, communication and finance matters. It will actively seek to engage with community organisations and other key stakeholders (e.g. pharmaceutical companies, TB Alliance, FIND, WHO, Ministries of Health etc.) to develop scientific priorities and potential collaborations.

Under the Executive Committee, there will be an International Scientific Committee (ISC) that will comprise the lead investigators at each regional site, together with the Chairman of the Executive Committee and a representative of each of the core areas. It will make proposals and recommendations to the Executive Committee on the scientific priorities.

Three operational cores will be responsible for running of the network activities: a Laboratory Core, a Data and Statistical Core and a Study management core. A clinical core will co-ordinate clinical management advice for studies in the network. These core activities will be run from Singapore.




As referred above, immediately upon its inception the Network will have a flagship inaugural project around which it will coalesce:  TRUNCATE-TB. This will kick-start network research operations and the flow of new project proposals.

Treatment Outcome Database will be one of the key outcomes from the APEC-funded portion of this project. Its structure will be determined in the Network governance meetings, and its launch is planned towards December 2017. The database hosting and maintenance costs, which will be relatively minimal after its launch, will be supported by the project overseer via its host institution by self-funding outlined in the budget until mid-2019. During this transition period, the Network will mature and undertake new research projects. The overhead costs generated by these projects will support the Network’s operational activities, including the database maintenance.  The transition of the database hosting and maintenance to the Network will occur during this period (to be determined which member or economy will be a designated host).

Project Overseers

Project overseer Professor Nicholas Paton (National University of Singapore) is medical doctor and a clinical researcher who has extensive experience in conducting large scale clinical trials and inception of multinational research networks. He led the Chloroquine for Influenza Prevention Trial, one of the largest clinical trials ever conducted in Singapore during the 2009 influenza pandemic. He also lead  the EARNEST trial, the largest international trial of 2nd-line HIV therapy with 1200 patients across 5 economies in Africa and the PIVOT trial, a 600-patient trial in 45 research sites in the UK. He has also been involved in building a pan-European network of HIV clinical research sites (NEAT) and has been the PI for the UK CTU responsible for 8 European economies in the NIH-funded INSIGHT research network.

Professor Paton is now the Lead of the TRUNCATE-TB trial, currently the largest tuberculosis trial in the world, which will recruit 900 tuberculosis patients in multiple APEC economies and will form the flagship inaugural project for the proposed A-TRACTION network. Project Overseer is experienced in leading large projects and has an already assembled support team that will oversee the project management and conduct. The secondary contact point for this project will be Dr. Kristina Rutkute (National University of Singapore; Kristina_rutkute@nuhs.edu.sg).

Cost Efficiency

Not Applicable.

Drawdown Timetable

Not Applicable.

Direct Labour

Not Applicable.

Waivers

Not Applicable.

Are there any supporting document attached?

No 
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Project Year

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Total Project Value

Sponsoring Forum

Topics

Committee

Other Fora Involved

Other Non-APEC Stakeholders Involved

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Expected Start Date

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Declaration

Project Summary

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Alignment

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Beneficiaries and Outputs

Dissemination

Gender

Work Plan

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Monitoring and Evaluation

Linkages

Sustainability

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Cost Efficiency

Drawdown Timetable

Direct Labour

Waivers

Are there any supporting document attached?

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