Clinical trial NCT05294406: Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine in Papua, Indonesia
Official title: Evaluation of a Pilot Implementation of Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine to Prevent Adverse Birth Outcomes in Papua, Indonesia
Conditions: Malaria in Pregnancy
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.
Interventions:
description: Pregnant women attending routine antenatal care visits in their second and third trimester are given monthly IPTp consisting of a treatment dose of dihydroartemisinin-piperaquine (3 tablets per day for 3 days, 9 tablets total)
name: Intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine
type: Drug
Study arms:
design_group_description: Pregnant women attending routine antenatal care visits in their second and third trimester are given a monthly, presumptive treatment dose of dihydroartemisinin-piperaquine of three tablets daily for three days (9 tablets). The first dose is given by directly observed therapy (DOT), and the remaining doses given to the women to take at home.
design_group_title: IPTp-DP
design_group_type: Experimental
Sponsor: Liverpool School of Tropical Medicine
Collaborators: Indonesia Ministry of Health
Universitas Gadjah Mada
Drug name mappings:
name: 双氢青蒿素/哌喹/伯氨喹/甲氧苄啶
lang: CN
name: Dihydroartemisinin/Piperaquine/Primaquine/Trimethoprim
lang: EN