Prevention Malawi – ISTp versus IPTp-SP
Scheduled intermittent screening and treatment in pregnancy (ISTp) versus intermittent preventive treatment with sulphadoxine-pyrimethamine (IPTp-SP) in women protected by insecticide treated nets (ITNs) for the control of malaria in pregnancy in Malawi: a randomized controlled trial.
Principal Investigator: Prof. Feiko Ter Kuile (UK)
Dr. Linda Kalilani (Malawi), Mwayiwawo Madanitsa (Malawi), Doreen Ali (Malawi), Brian Faragher (UK), Kara Hanson (UK), Silke Lutzelschwab (UK), Stephen Rogerson (Australia)
An on-going observational study in southern Malawi shows that intermittent preventive treatment with sulphadoxine-pyrimethamine (IPTp-SP) no longer provides protection against placental malaria, with approximately 1 in 3 primi,- and secundigravidae having evidence of current or recent infection regardless of whether they received IPTp-SP or not. Studies of alternative approaches to IPTp-SP are urgently needed. One promising alternative is intermittent screening and treatment in pregnancy (ISTp). The concept of ISTp is to provide scheduled screening for malaria using a rapid diagnostic test (RDT) and treating RDT-positive women with a long acting ACT, with the aim of clearing existing infections and providing additional post-treatment prophylaxis for three to six weeks. IST is not a standalone intervention and should be integrated with other point of care testing currently provided as part focused antenatal care (FANC) including screening for HIV, syphilis and anaemia.
To determine if scheduled intermittent screening with malaria RDTs and treatment of RDT-positive women with dihydroartemisinin-piperaquine (ISTp-DP) compared with IPTp-SP in the second and third trimesters of pregnancy among HIV-negative pregnant women protected by insecticide–treated bed nets (ITNs) in an area with decreasing malaria transmission and high levels of SP resistance in southern Malawi is associated with:
- >=27.5% reduction in adverse birth outcome (composite of miscarriage, stillbirth, low birth weight or preterm birth) in women in their first and second pregnancies (G1+2)
- >=50% reduction in active or recent infection assessed at delivery by placental histopathology or RDT in multigravidae (G3+).
This is an open label, two-arm randomized controlled superiority trial using stratified enrolment by two gravidity strata (G1+2 and G3+). In the IPTp-SP arm, women will receive 3 to 4 doses of IPTp with SP as part of FANC (according to current practice in Malawi women coming early get 4 doses, women coming from 24 weeks get 3 doses of SP). In the ISTp-DP arm, women will receive 3 or 4 screenings with an RDT at each scheduled FANC visit and treatment with DHA-PQ if they are RDT-positive.
The study is being undertaken in three semi-rural and rural antenatal clinics in southern Malawi in an area with moderate year-round malaria transmission (no IRS programs implemented yet), high levels of SP resistance, and high ITN coverage.
Additional sub-studies include a cost-effectiveness, acceptability and implementability study and an immunological study.