Additional Screening With Sensitives RDTs and Malaria
Condition: Plasmodium Falciparum Malaria; Malaria Diagnosis
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 3

Summary: 
      National malaria control strategies in pregnant women relies primarily on effective case
      management along with the use of long lasting insecticide-treated nets (LLINs)throughout
      pregnancy and intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) in
      the second and third trimesters in malaria-endemic regions in sub-Saharan Africa (SSA). For
      the latter, 3 or more doses are recommended by the national malaria control program (NMCP)
      but available data suggests that only 19% of eligible women received this in 2016 despite
      observed high attendance to antenatal clinic (ANC). Adherence to IPTp may be affected by
      perceptions, acceptability and contextual factors that need to be understood and therefore
      improve the effectiveness of this health interventions. In addition, all malaria cases should
      be confirmed either by microscopy or using a rapid diagnostic test (RDTs) before any
      treatment. Despite the crucial role of RDTs in improving malaria case management SSA, many
      malaria cases are missed in pregnant women due to the power performance of recommended RDTs
      which are unable to detect very low parasitaemia. Identifying lower density infections in
      pregnant women by the use of highly-sensitive RDTs and clearing them with an effective ACT
      could improve the outcome of the pregnancy in addition to IPTp-SP.
    

Detailed description: 
      MiP remains a major public health issue in Burkina Faso, which would compromise the
      achievement of Sustainable Development Goals for maternal and child health (22). Malaria
      control program have been implemented by the Burkinabe Ministry of Health (MoH) since 2000;
      nevertheless, lower coverage and delays in implementation of these programs may have reduced
      their effectiveness.

      In Burkina Faso, recommended preventions strategies for malaria imply the administration of
      at least 3 doses of IPTp during ANCs and before delivery (23). IPTp have been proven to have
      a great impact on PM, LBW and peripheral malaria infection at delivery so increasing the
      number of IPTp doses given is a priority. Strategies to increase the number of IPTp doses and
      the coverage using reminders could improve this health intervention effectiveness. This can
      be considered as follow up of the Cosmic study (24) recommendations.

      However with increasing drug resistance, there is a progressively diminished efficacy of
      IPTp-SP in clearing existing infections and a shortening of the post-treatment prophylaxis
      period (25). Moreover, pregnant women can generally be infected with low parasites densities
      between ANCs compromising the outcome of the pregnancy (26). Therefore, additional screening
      with HS-RDTs between ANCs and treatment using ACTs with long Post-treatment prophylaxis
      effect in addition to IPTp-SP could have a great impact both for the mothers and their
      offspring's.

      This proposal aims to determine the operational feasibility and the impact of additional
      screening with HS-RDTs and treatment with DP on placental malaria (PM) and low birth weight
      (LBW) in a context of IPTp-SP, in rural central Burkina Faso. The findings obtained from this
      study will help to assist the MoH in the implementation of the appropriate interventions in
      this group at risk.

      Objectives

      General objective

      - To determine the operational feasibility and the impact of additional screening with
      HS-RDTs and treatment with DP on PM, LBW and peripheral malaria infection at delivery in in
      Burkina Faso

      Specific objectives are the following:

        -  To determine the gain of additional screening with HS-RDTs and treatment with DP against
           PM, LBW and peripheral malaria infection at delivery

        -  To assess the determinants of the poor coverage and improve the number of IPTp doses
           received using phone call or SMS as a reminder
    

Intervention name(s): Additional screening using ultra sensitive RDTs; Dihydroartemisinin-piperaquin; Reminders
Intervention type(s): Diagnostic Test; Drug; Other
Intervention description(s): At each ANC visit, study nurses will perform an HS-RDT for participants in the intervention arm; All pregnant women with a positive HS-RDT will be treated with a full course of dihydroartemisinin-piperaquine (DP) over 3 days. The first dose of DP will be administered under direct observation at the antenatal care clinic (ANC) and the subsequent doses of the intervention in days 2 and 3 will be taken unsupervised at home; Before each scheduled ANC visit, reminders using SMS or phone call will be used. This is order to increase ANC attendance
Other intervention name(s): Malaria Ag Pf ultra-sensitive RDT
Intervention MeSH terms: Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic