Clinical Trials Logo
  1. Home
  2. Malaria in Pregnancy
  3. NCT05294406

Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine in Papua, Indonesia — STOPMiP-2  

Malaria in Pregnancy Clinical Trial

Official title:
Evaluation of a Pilot Implementation of Intermittent Preventive Treatment With Dihydroartemisinin-piperaquine to Prevent Adverse Birth Outcomes in Papua, Indonesia

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05294406
Study type Interventional
Source Liverpool School of Tropical Medicine
Contact
Status Completed
Phase Phase 4
Start date February 7, 2022
Completion date December 31, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT03508349 - Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda N/A
Completed NCT01053325 - Establishing Effectiveness of Daily Co-trimoxazole Prophylaxis For Prevention of Malaria in Pregnancy Phase 3
Completed NCT00140517 - Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance N/A
Recruiting NCT05306067 - Plasmodium Falciparum Genomic Intelligence in Mozambique
Recruiting NCT05757167 - Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics Phase 4
Active, not recruiting NCT01555255 - Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria N/A
Completed NCT01136850 - Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea Phase 3
Terminated NCT04148690 - Assessing the Impact of Group Antenatal Care on IPTp Uptake in Tanzania N/A
Completed NCT04160026 - Acceptability and Feasibility in the Context of the IMPROVE Trial in Kenya Phase 4
Completed NCT04783051 - Comparison of ISTp- PYRAMAX-US-RDT to IPTp-SP to Prevent Malaria in Pregnant Women in DRC (ULTRAPYRAPREG) Phase 3
Not yet recruiting NCT05348746 - ERASE - Impact of COVID-19 on Malaria Control
Completed NCT03998839 - TIPTOP Sulfadoxine-pyrimethamine (SP) Drug Resistance Study
Completed NCT03208179 - Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa Phase 3
Completed NCT01120145 - Assessment of Sulphadoxine-pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Malawi N/A
Completed NCT00730366 - New Approaches to Improve Coverage and Compliance of Antimalarial Treatment for Pregnant Women in Rural Africa Phase 3
Completed NCT00852423 - Safe and Efficacious Artemisinin-based Combination Treatments for African Pregnant Women With Malaria Phase 3
Completed NCT00680732 - Prevention of Intrauterine Growth Retardation in Burkina Faso: the Malaria Component Phase 4
Recruiting NCT03754322 - LAMP Detection of Malaria in PREGnancy (LAMPREG) Trial N/A
Not yet recruiting NCT03944317 - Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Malaria Prevention in Pregnant Women (IPT-AZ/IPT-SP) N/A
Recruiting NCT04825782 - MiMBa Pregnancy Registry