The study workplan consists of a series of coordinated and time-bound milestones. These are contained in 6 distinct but interrelated work packages that constitute the overall workplan for the study.

Work Package 1: Management and Coordination

Lead: Centre for the Aids Programme of Research in SA (CAPRISA)

WP1 will comprise all activities related to the overall management of the consortium, study governance, clinical safety procedures, data safety & monitoring board (DSMB) and data management activities of the study. CAPRISA will take the lead on this work package, while the clinical safety responsibilities will be covered by Professor Stephen Gillespie of St Andrews. All partners will contribute to the development of the data management plan (DMP). This work package covers important aspects of study conduct and is activated at the start of the study, during development of the protocol, and will end at completion of the study.

Work Package 2: Study Implementation

Lead: WITS Health Consortium

WP2 will comprise all activities related to the regulatory compliance, study start-up and implementation. WITS will lead this work package with the support of CAPRISA, IHVN and EPHI.

Work Package 3: Implementation of Diagnostics

Lead : Foundation for Innovative New Diagnostics (FIND)

The overarching aim of this work package is to ensure adequate distribution and supply of the novel study diagnostics that will be tested and to ensure consistency in procedures and workflows between countries and sites. Retraining and supervision will also be central part of this package which will be conducted. This work package will be led by FIND with support from NIMR, St Andrews, KNCV and OSR.

Work Package 4: Data Analysis

Lead: Amsterdam Institute for Global Health and Development (AIGHD)

This work package will host all analysis aspects of the project. Data analyses include an interim analysis of the primary study objective, and final analyses for evaluation of the effectiveness, operational feasibility, acceptability, and cost-effectiveness of implementing the Xpert XDR for rapid triage and selection of short, all oral regimens for DR-TB. AIGHD will take the lead on this work package with support from CAPRISA and KNCV; cost-effectiveness analysis will be led by AIGHD and feasibility & acceptability by KNCV.

WP4 will develop a data analysis plan that will, for each analysis, specify the study question(s), the records and variables to be included, the analytical endpoints, the statistical approaches for dealing with random error, confounding and missing data, and the responsibilities within the consortium. The data analysis plan will be developed in close consultation with the development of the data management plan.

Work Package 5: Dissemination, Communication and Policy

Lead: Koninklljke Nederlandse Centrale Vereniging tot Bestrijding der Tuberculose (KNCV)

WP5 covers several critical aspects of effective communication and dissemination of information to all stakeholders for ethical and responsible study conduct. CAPRISA (WP1) will create a study specific plan with input of all consortium members that will be made available before the study initiates and will encompass the procedures for communication on study updates as well as plans for the dissemination of study results. KNCV will lead the preparation of plans for communication and dissemination of study results, while it will contribute to the realization of the other objectives as a partner, under the lead of WP1.

KNCV is used to working in partnership with policymakers at national and regional levels in the countries where it has an office (Ethiopia and Nigeria), and can advise partners responsible to take this up in South Africa (CAPRISA).

KNCV will facilitate the development of a study publication plan which will be prepared by senior members of the consortium. The plan will facilitate the accurate and timeous dissemination of results in line with the respective journal requirements. This process will be outlined in the communication plan. Study participants will be informed of study results before the general public.

The study report will be prepared simultaneously and will be submitted to regulators and co-funders at the end of the project. The study report will be developed by KNCV together with contributions from all partners.

Work Package 6: Capacity Development and Training

Lead: Institute of Human Virology Nigeria (IHVN)

The goal WP6 is to create a pathway for skills development, skills transfer and achievement of higher degrees through two mechanisms:

  1. First, develop a crop of next generation African scientists with capacity to conduct clinical trial research through degree awarding programs in relevant fields.
  2. Second, build capacity for the different WPs through provision of tailored training and transfer of skills to study staff and graduates of partners in areas outlined in the WPs.

During the funding period early-career scientists, post-doctoral fellows, PhD Masters (photos please) students will be mentored. In addition, trainees with the potential of developing into successful clinical trialists and investigators will be identified through a transparent rigorous process. Successful students could register for degree awarding courses available at their respective institutions or any of the participating institutions within the consortium. Courses must have relevance to the TRiAD project, and preference for on line courses will be encouraged to ensure the expertise of trained individuals at host institutions is not lost. Students will be recruited through the respective Universities at which research institutions are located or officially affiliated.

The project will also incorporate training and capacity development of staff and institutions of the TRiAD consortium in existing and novel TB diagnostic assays and the optimal use of new TB drugs. South to South training and transfer of skills will be encouraged to build capacity in under resourced institutions in administrative research areas such as finance, grants and compliance and quality management systems.