P. Falciparum Infection Dynamics and Transmission to Inform Elimination (INDIE-1a)

London School of Hygiene and Tropical Medicine

Status: Completed

Conditions: Malaria

Treatments: Other: Enhanced Community Case Management (CCM); Other: Monthly Screening and Treatment (MSAT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03705624

INDIE-1a

Details and patient eligibility

About

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

Enrollment: 907 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Participants should be permanent residents of the compound
2. Participants should be willing to participate in repeated assessments of health and infection status and willing to donate a maximum of 37mL of blood (children <10 years of age) or 52mL of blood (older individuals) during an 18-month period

Exclusion criteria

1. Any (chronic) illness that would affect with study participation
2. Pre-existing severe chronic health conditions
3. Current participation in malaria vaccine trials or participation in such trials in the last 2 years
4. History of intolerance to artemether-lumefantrine

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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907 participants in 3 patient groups

Standard of Care

No Intervention group

Description:

Standard of care with passively monitored malaria incidence at health centers that receive appropriate diagnostic and clinical supplies and Seasonal Malaria Chemoprevention (SMC) for children less than 5 years of age

CCM

Experimental group

Description:

Standard of care supplemented with 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 artemether-lumefantrine (AL) according to national guidelines

Treatment:

Other: Enhanced Community Case Management (CCM)

CCM+MSAT

Experimental group

Description:

Standard of Care supplemented with CCM and 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.

Treatment:

Other: Enhanced Community Case Management (CCM)

Other: Monthly Screening and Treatment (MSAT)