Last Updated

09 Oct 2019

TIPTOP Sulfadoxine-pyrimethamine (SP) Drug Resistance Study

Objectives

The main objective of this study is to monitor SP resistance via molecular markers in the context of the TIPTOP project implementation of community distributed SP for women during pregnancy.

Principal Institution(s)

Principal Investigator
Rationale and Abstract

The TIPTOP (Transforming Intermittent Preventive Treatment for Optimal Pregnancy) project will explore an alternative innovative approach to antenatal care (ANC) facilities or clinic for the delivery of IPTp-SP. It will sustain and scale up a community-based delivery system to be implemented in addition to the traditional ANC clinic-based delivery system with the aim of expanding coverage of IPTp-SP. The innovative approach, called community IPTp (C-IPTp-SP), will be implemented in four sub-Saharan African countries: Nigeria, Democratic Republic of Congo (DRC), Madagascar and Mozambique. TIPTOP will use community health workers (CHWs) as a delivery channel to increase coverage of IPTp-SP to a minimum of 50% in project areas to prevent malaria in pregnancy (MiP). It is expected that this will lead to a substantial increase in the consumption of SP, not supervised by professional health workers. To address the concern that this may lead to an increase in the accumulation of mutations in dihydrofolate reductase (dhfr) and dihydropteroate synthetase (dhps) that could lead to an increase of the parasite resistance to SP, TIPTOP will monitor the prevalence of molecular markers of SP resistance in the population at three times during the project: at baseline, midline - following approximately 18 months of implementation - and endline - after 3 years of implementation. Providing evidence on the effects on SP resistance of C-IPTp is important for decision-making as to whether C-IPTp can be recommended as an additional channel for IPTp delivery or if the use of an alternative drug for IPTp should be considered.

Study Design

ClinicalTrials.gov Identifier: NCT03998839
Observational Model: Ecologic or Community
Time Perspective: Prospective