P. Falciparum Infection Dynamics and Transmission to Inform Elimination (INDIE-1b)
Malaria
About this trial
This is an interventional diagnostic trial for Malaria focused on measuring falciparum, gametocyte, elimination, anopheles, transmission, diagnostic
Eligibility Criteria
Inclusion Criteria:
- Resident in the village.
- Willingness to participate in repeated assessments of health and infection status and to donate a maximum of 30 mL (milliliter) of blood (children <5 years of age), 37 mL (milliliter) of blood (children <10 years of age) or 52 mL (milliliter) of blood (older individuals) during an 18-month period.
Exclusion Criteria:
- Any chronic illness that would affect study participation.
- Pre-existing severe chronic health conditions
- History of intolerance to artemether-lumefantrine.
- Participants < 6months old and pregnant women in the first trimester (only for Arm with MDA-DP treatment).
- Hypersensitivity to DP (only for Arm with MDA-DP treatment).
- Taking drugs that influence cardiac function or prolong QTcorrected interval (only for Arm with MDA-DP treatment).
Sites / Locations
- Medical research Council Unit The Gambia at LSHTMRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
CCM:Standard of Care
CCM plus weekly fever screening and treatment
CCM plus MSAT
CCM plus dry season MDA
Community Case Management (CCM), with passively monitored malaria incidence by community health workers using standard RDTs and artemisinin-based combination therapy (ACT), artemether-lumefantrine (AL) according to national guidelines.
CCM plus active case detection (ACD) by fever screening and treatment if positive. Trained village health workers (VHW) recruited for this study will carry out weekly visits of all residents and screen for fever using research-grade thermometers. A standard RDT will be performed in all individuals with a body temperature ≥37.5°C or with reported fever in the last 24 hours. RDT positive individuals will be treated with AL according to national guidelines.
CCM plus monthly screening for malaria infection and treatment of positive individuals, regardless of symptoms. Screening will be performed by research staff and timed to ensure a gap of 25-35 days between screening rounds; Positive individuals will be treated with AL, according to national guidelines.
CCM plus plus 3 monthly rounds of MDA with a long-acting ACT (dihydroartemisinin-piperaquine, DP) starting in the dry season (April, May, June) (tablets of 320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet. Administration of a full course of DP will be done as per manufacturer's guidelines once daily for 3 days and according to body weight).