Acceptability, feasibility and economic studies in the context of the IMPROVE & IMPROVE-2 (Improving PRegnancy Outcomes with intermittent PReVEntive treatment) trials

Objectives

The objectives of this projects are:

1. To determine if IPTp with DP plus AZ, is superior to IPTp with DP alone for reducing adverse pregnancy outcomes.
2. To determine the safety of monthly IPTp with DP by conducting nested cardiac monitoring study to specifically address whether previously documented transient QTc prolongation associated with DP increases in magnitude with subsequent courses as well as monitoring adverse drug reactions and adverse/severe adverse events.
3. To conduct, on completion of the trial, a prospective meta-analysis combining the evidence from this and previous trials to provide (with ≥80% power) definitive evidence on whether IPTp with DP is superior to the existing strategy of IPTp with SP for controlling malaria and reducing adverse pregnancy outcomes in areas with intense year-round malaria transmission and high SP resistance.
4. To determine if the level of SP drug resistance, assessed by molecular markers, affects the potential impact of IPTp-DP or IPTp with DP+AZ relative to IPTp-SP.
5. To determine the efficacy of IPTp with DP+AZ on curable sexually-transmitted and reproductive –tract infections (STIs/RTIs) relative to IPTp with SP and DP alone.
6. To determine the effect of SP and AZ on the intestinal and vaginal microbiomes of mothers, and the intestinal microbiomes of neonates relative to DP alone.
7. To determine the effect of multiple doses of AZ on the prevalence of macrolide resistance in the pneumococcus.
8. To determine the cost-effectiveness of IPTp with DP and IPTp with DP+AZ compared to IPTp with SP.
9. To build trial research capacity in Kenya, Malawi and Tanzania