Clinical trial NCT04147546: Additional Screening With Sensitives RDTs and Malaria
Official title: Operational Feasibility, Impact of Additional Screening Using Highly-sensitives RDTs Combined With High Coverage of IPTp on Placental Malaria and Low Birth Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plasmodium Falciparum Malaria
Malaria Diagnosis
Lead sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
Sponsor class: OTHER_GOV
Collaborators: name: European and Developing Countries Clinical Trials Partnership (EDCTP)
First posted: 2019-11-01
Enrollment: 340
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

Eligibility criteria: Inclusion Criteria:

* Gestational age of 16 to 24 weeks at their first booking
* At least (≥) 16 years old
* Residence in the study area and intention to stay in the area for the duration of the pregnancy and for delivery
* Willing to deliver at the health facility
* Willing to provide biological samples as and when required during the study period (blood and placental biopsy)
* Ability to provide written informed consent

Exclusion Criteria:

* A history of sensitivity to sulphonamides or to any of the study drugs;
* History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
* History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;
* Any significant illness at the time of screening that requires hospitalization, including severe malaria;
* Intent to move out of the study catchment area before delivery or deliver at relative's home out of the catchment area.
* Prior enrolment in the study or concurrent enrolment in another study.

Primary outcomes:
measure: Placental malaria prevalence
timeFrame: 36 months
measure: Low birthweight prevalence
timeFrame: 36 months
measure: Peripheral maternal malaria infection prevalence
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Institut de Recherche en Sciences de la Santé/ Clinical Research Unit of Nanoro
state: Kadiogo
Study officials:
References:
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