Boosting the Impact of SMC Through Simultaneous Screening and Treatment of Roommates
Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
Malaria represents a major public health concern in sub-Sahara Africa. Seasonal malaria
chemoprevention (SMC) is one of the largest preventive measures. It consists to administer
Amodiaquine+Sulfadoxine-Pyrimethamine to children aged 3-59 months on a monthly basis during
the peak malaria transmission season. Despite its implementation, the burden of malaria is
still very high in children under five years old in Burkina Faso. This raises questions about
other hidden factors that can negatively affect the effectiveness of SMC intervention. Huge
effort aiming at preventing human-vector contact were deployed such as the large-scale
distribution of insecticide treated bed nets. Healthy humans are only infected via mosquitos
if there are parasites reservoir around. Yet, there is no strategy aiming at protecting
healthy humans from parasites reservoir. Under these circumstances, multiples humans sharing
the same habitat could continually entertain the transmission cycle despite adequate existing
measures. This would obviously jeopardize the expected impact of the SMC and the global
effort to control the disease. In such context, we postulate that screening and treating
malaria SMC-children's roommates could greatly improve the impact of SMC intervention and
reduce malaria transmission in endemic settings.
The goal of our study is to improve the impact of SMC intervention in terms of reducing
malaria morbidity and mortality in children under five years. Primary objectives include
assessing whether SMC + children's roommates screening and treatment with
Dihydro-artemisinin-piperaquine (DHAPPQ) is more effective than current routine
implementation of SMC alone as well as the assessment of the tolerance and safety of AQSP and
DHAPPQ. Secondary objectives include the assessment of the impact of the new strategy on the
circulating parasite population in terms of selection of resistant strains and the assessment
of determinants such as adherence and acceptability of the strategy.
Methodology: The study will be carried out in the Nanoro health district catchment area in
Burkina Faso. This will be a randomized superiority trial. The unit of randomization will be
the household and all eligible children from a household will be allocated to the same study
group to avoid confusion. Households with 3 - 59 months old children will be assigned to
either (i) control group (SMC alone) or (ii) intervention (SMC+ roommates screening with
standard HRP2-RDT and treatment if positive) or (iii) intervention (SMC+ roommates screening
with highly sensitive RDT and treatment if positive). The sample size will be 789 isolated
households per arm, i.e. around 1,578 children under CPS coverage and 2,630 roommates
expected. They will be followed-up for 24 months to fully cover two consecutive malaria
transmission seasons and then two SMC cycles. Children will be actively followed-up during
the malaria transmission seasons while in the dry seasons the followed-up will be passive.
Conclusion: The project will respond to a major public health concern by providing evidence
of the efficacy of a new strategy which should necessarily complement the existing ones to
achieve best impact in malaria control and elimination. The project is lifesaving and could
be scaled up easily at country and regional level in case of promising results. In addition,
if successful, the project will reinforce the capacity of the IRSS/CRUN by offering training
opportunities to young researchers.
Phase:
Phase 4
Details
Lead Sponsor:
Institut de Recherche en Sciences de la Sante, Burkina Faso