Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine in Papua, Indonesia
Status:
Active, not recruiting
Trial end date:
2023-08-31
Target enrollment:
Participant gender:
Summary
Malaria in pregnancy is a major cause of maternal and neonatal death in Papua, Indonesia. A
recent trial in Papua showed that monthly intermittent preventive treatment (IPTp) with the
long-acting artemisinin-based combination dihydroartemisinin-piperaquine (DP) among pregnant
women in the second and third trimester was safe, tolerable and more efficacious than the
current policy of single screening at antenatal care (ANC) booking and treatment of rapid
diagnostic test (RDT)-positive cases. The Ministry of Health (MOH) Indonesia now plans to
pilot the strategy in the routine health system in Papua, Indonesia. This study will assess
the programme effectiveness of IPTp-DP delivery through antenatal care services and women's
adherence to the monthly 3-day DP treatment regimen in a 'real life' setting.
The study will be undertaken in ten community health centres in the lowlands and their
associated health posts in Timika city. In the first 18 months, MOH will be trained to
implement the intervention using quality improvement (QI) approaches to continuously
strengthen service delivery, uptake and adherence through plan-do-study-act cycles. The MOH
will also be supported to collect safety data for pharmacovigilance. A mixed-methods
evaluation will be conducted towards the end of the pilot using exit interviews to assess
delivery effectiveness, home visits to assess adherence, and qualitative research to explore
provider perceptions of the drivers of successful integration and scalability, and user
acceptability. The primary outcome is adherence, defined as the proportion of pregnant women
who receive the first dose of IPTp-DP by directly observed therapy (DOT) at ANC, have
received the correct number of DP tablets for subsequent doses, and when visited at home have
verified they completed the course. The net cost-effectiveness of implementing IPTp-DP and of
the current policy of single screening and treatment (SST) in the routine health system will
be assessed and compared. Net cost-effectiveness means that cost savings from averted malaria
will be deducted from the intervention costs. The incremental financial cost of implementing
IPTp-DP from the provider (MOH) perspective at scale in Papua, Indonesia, will also be
estimated.
Phase:
Phase 4
Details
Lead Sponsor:
Liverpool School of Tropical Medicine
Collaborators:
Gadjah Mada University Indonesia-MoH Yayasan Pengembangan Kesehatan dan Masyarakat Papua (Timika Research Facility)