IMPROVE Trial

Chief Investigator:               Prof Feiko ter Kuile

Trial Manager:                      Dr Mwayi Madanitsa (Malawi)

Principal Investigators:        Prof John Lusingu (Tanzania), Dr Simon Kariuki (Kenya), Associate Prof Michael Alifrangis

                                              (Denmark), Assist Prof Pascal Magnussen (Denmark), Associate Prof Matthew Chico (UK), 

                                              Prof Frank Mosha (Tanzania)

Study Title

IPTp with dihydroartemisinin-piperaquine (DP) and azithromycin (AZ) for malaria, sexually transmitted and reproductive tract infections in pregnancy in high sulphadoxine-pyrimethamine resistance areas in Kenya, Malawi, and Tanzania

Aim:

To determine if monthly IPTp with DP, either alone or combined with a single course of AZ at enrolment, for the control of malaria and STIs/RTIs in pregnancy is safe and superior to monthly IPTp with SP for reducing adverse pregnancy outcomes.

Trial Design:

This is a multi-national, individually-randomized, 3-arm, partially-placebo controlled superiority trial comparing the efficacy, safety and tolerance of monthly IPTp-SP (control) versus monthly IPTp-DP, alone or combined with a single course of azithromycin at enrolment to reduce the adverse effects of malaria and curable STIs/RTIs in 4,680 women in 10 sites in high SP resistance areas in Kenya, Malawi, and Tanzania. The trial includes nested studies on cardiac monitoring for safety, assessment of antimalarial drug and macrolide resistance, nutritional outcomes, and the impact of SP and AZ on vaginal and intestinal microbiota.