In the current randomized trial, the investigators will test the ability of two experimental approaches to malaria infection management to reduce malaria transmission potential. Compounds in Saponé, Burkina Faso, will be randomized to 1 of 3 study arms: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced community case management (CCM), comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus monthly screening and treatment (MSAT) using RDTs. The study will be conducted over approximately 18 months covering two high transmission seasons and the intervening dry season
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
907
Enhanced Community Case Management for malaria (CCM) involving weekly active screening for fever using a research-grade thermometer by a trained health worker. A measured temperature ≥37.5°C or reported fever in the last 24 hours will prompt screening with a conventional rapid diagnostic test (RDT). RDT positive individuals will be treated with AL according to national guidelines
Monthly Screening and Treatment (MSAT) regardless of symptoms with a conventional RDT. Screening will be performed by research staff with 25-35 days between screening rounds; RDT positive individuals will be treated with AL according to national guidelines.
Centre National de Recherche et de Formation sur le Paludisme
Ouagadougou, Burkina Faso
Parasite prevalence and density by molecular detection at the end of study cross-sectional survey.
The primary outcome measure is parasite prevalence in the cross-sectional survey conducted at the end of the transmission season of year 2. If CCM and MSAT result in the early detection of infections, parasite prevalence at the end of the study will be lower in these arms compared to the control arm.
Time frame: Month 18 (end of second transmission season; January-February 2020)
Parasite prevalence and density by molecular detection at the end of year 1 cross-sectional survey.
Parasite prevalence and density in the cross-sectional survey conducted at the end of the transmission season of year 1. If CCM and MSAT result in the early detection of infections, parasite prevalence will be lower in these arms compared to the control arm.
Time frame: Month 6 (end of first transmission season; January-February 2019)
Parasite prevalence and density by molecular detection at the end of dry season cross-sectional survey.
Parasite prevalence and density in the cross-sectional survey conducted at the end of the dry season. If CCM and MSAT result in the early detection of infections, parasite prevalence will be lower in these arms compared to the control arm.
Time frame: Month 12 (prior to second transmission season; June 2019)
Gametocyte prevalence and or density in P. falciparum infections at the end of study cross-sectional survey
Gametocyte prevalence in qPCR detected infections is assessed by molecular methods and compared between study arms.
Time frame: Month 18 (end of second transmission season; January-February 2020)
Gametocyte prevalence and or density in P. falciparum infections at the end of year 1 cross-sectional survey
Gametocyte density of male and female gametocytes will be assessed by molecular methods and compared between study arms.
Time frame: Month 6 (end of first transmission season; January-February 2019)
Gametocyte prevalence and or density in P. falciparum infections at the end of dry season cross-sectional survey
Gametocyte density of male and female gametocytes will be assessed by molecular methods and compared between study arms.
Time frame: Month 12 (prior to second transmission season; June 2019)
Gametocyte prevalence and or density in P. falciparum during all study visits
Gametocyte density of male and female gametocytes will be assessed by molecular methods and compared between study arms.
Time frame: Throughout study, an average of 18 months
The number of incident infections.
Regular visits by CCM and MSAT will result in the identification of malaria infections that are not detected during passive case detection. The numbers of infections that are detected in each arm are quantified and compared between arms.
Time frame: Throughout study, an average of 18 months
Infectivity to mosquitoes of P. falciparum infections
For a selection of infections, infectiousness to mosquitoes is assessed by membrane feeding assays.
Time frame: Throughout study, an average of 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.