IMPAACT4TB

Completed

IMPAACT4TB &
One To Three Study

  • Intervention Area
  • DKI Jakarta (5 municipalities), with expansion to Banten, West Java, Central Java, Yogyakarta, East Java (Phase I), and Persahabatan Hospital (Phase II)
  • Duration
  • August 2018 – August 2025
  • Funder
  • Unitaid through KNCV Tuberculosis Foundation
As part of the global Unitaid-funded IMPAACT4TB consortium led by The Aurum Institute, Yasa Karsa Insani (YKI) has advanced Indonesia’s progress in introducing and generating evidence for short-course tuberculosis preventive therapy (TPT). This multi-phase initiative represents a continuum of innovation, beginning with the introduction and national scale-up of the 3HP regimen (weekly rifapentine and isoniazid for three months) and followed by a phase IV clinical trial comparing 3HP with 1HP (daily rifapentine and isoniazid for one month). Together, these efforts position Indonesia as a regional leader in the implementation and evaluation of shorter, safer, and more effective TPT regimens.

During the first phase, IMPAACT4TB (2018–2022), Yasa Karsa Insani (YKI) collaborated with the Ministry of Health to localise global training and communication materials, build the capacity of more than 4,400 health workers, and develop national technical guidelines for latent TB infection (LTBI) management. The 3HP regimen was piloted in 41 primary health centres and one sentinel hospital before expanding to five provinces across Java. Yasa Karsa Insani (YKI) also provided technical assistance in drug procurement, supply chain management, monitoring, and integration of TPT data into the national TB information system (SITB).

Building on this foundation, the second phase, One To Three Study (2022–2025), is a phase IV, open-label, randomised clinical trial conducted at Persahabatan Hospital. The study, globally sponsored by the Aurum Institute with Yasa Karsa Insani (YKI) as the local sponsor, compares treatment completion, safety, and feasibility between 1HP and 3HP regimens. Technical partners include Equilab (CRO), George Clinical India (site monitoring), and Genomik Solidaritas Indonesia (NAT2 genotyping). Interim findings confirm that both regimens are safe, effective, and feasible for programmatic use in Indonesia.
  • Primary Objective
  • To support the Government of Indonesia in introducing, scaling, and evaluating short-course TPT regimens through operational implementation and clinical research, generating local evidence to inform national and global TB preventive therapy policy.

Key Achievements:

  • Introduced 3HP across six provinces, leading to inclusion in Indonesia’s National TB Strategic Plan (2020–2024).
  • Trained over 4,400 health workers and developed national technical guidelines for LTBI management.
  • Enrolled 300 participants in the comparative 1HP vs. 3HP trial, achieving completion rates of 92% and 98% respectively, with 64–68% mild or moderate adverse events, 3% severe, and 22 serious cases reported but no deaths. The interim findings confirm both regimens are safe, effective, and feasible for implementation in Indonesia.