42. Incorporate the development of pediatric specimen banks/repositories into studies to support faster clinical trials of new TB diagnostics and ensure open access to academic groups and manufacturers.
43. Support pediatric sample repositories, including non-sputum less invasive samples, for more expeditious technical evaluations of new diagnostics and regulatory approval processes.
44. Incorporate the development of pediatric chest X-ray image libraries into studies to develop and support improved machine learning algorithms for computer-assisted X-ray interpretation and ensure open access to other research groups and manufacturers.
58. Support MOHs to accelerate the introduction and roll out of optimized formulations in at least 6 countries: Kenya, Uganda, Tanzania, Senegal, Burkina Faso and Cameroon.
60. Collaboratively scale-up optimal pediatric antiretroviral multi-month dispensing and to contribute to the development tools, materials, and guidance to enhance home-based case management and support for ART.
61. Support select countries to rapidly complete the transition to currently available optimal pediatric ARVs (LPV/r and DTG 50 mg) and accelerate the scale-up of new pediatric ARV formulations as they become available in country.
62. Continue the collaboration with DNDi, EGPAF and EVA to develop resources for the introduction of the 4-in-1 including trainings, webinars and country specific technical assistance.
26. DNDi, ICAP, and EGPAF commit to collaborate on product uptake for solid oral dosage forms of
LPV/r (2-in-1’s and 4-in-1), including:
Development of healthcare workers’ training tools based on implementation research data generated by DNDi; and
Acceleration of product uptake in selected countries with engagement of all stakeholders including MOH, civil society, FBOs, and communities of people living with HIV, and to share the training toolkit and experience by disseminating information globally.
ICAP in collaboration with DNDi Finalized an information package for program managers on the 4-in-1 and completed a set of illustrated counseling cards with detailed guidance on administration of the 4-in-1
ICAP in collaboration with WHO, PEPFAR, EGPAF and CHAI developed an AIDS Free Policy Brief for programs on considerations for introducing new ARV drug formulations for children
ICAP provided virtual capacity building and orientation sessions for EGPAF teams and EVA representatives in Kenya, Tanzania, Uganda, Cote d’Ivoire, Senegal and Burkina Faso on pediatric ARV optimization
ICAP, in collaboration with CDC, finalized, published and disseminated illustrated counseling cards on LPV/r pellets and granule administration and teaching children to swallow tablets and;a participatory, five module training for health care workers which is designed to be adapted at the country level. ICAP, in collaboration with DNDi, is finalizing an information package for program managers about the 4-in-1 and; is developing counseling materials and an adaptable training package to guide programs that may choose to introduce ABC/3TC/LPV/r 60/30/40/10 mg granules.
ICAP in collaboration with CDC is developing training materials for pellet and granule administration. Developed materials for program managers on granules in collaboration with Mylan. EGPAF is reviewing materials and providing feedback. ICAP and CDC are finalizing training cards for LPVr solid formulations.
DNDi/ICAP/EVA/EGAPF collaboration to strengthen uptake of solid Lpv/r formulations expected to begin November 1 2019.
Action 5. Focus research efforts on optimal drugs and formulations as defined by PADO.
Action 19. Undertake studies that use weight-based dosing, enroll all paediatric weight-band groups concurrently irrespective of age, and maximize opportunities to accelerate enrollment of subjects.