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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

907 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2020-02-14

Brief Summary

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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

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Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized trial

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

CCM

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

Group Type EXPERIMENTAL

Enhanced Community Case Management (CCM)

Intervention Type OTHER

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

CCM+MSAT

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.

Group Type EXPERIMENTAL

Enhanced Community Case Management (CCM)

Intervention Type OTHER

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)

Intervention Type OTHER

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.

Interventions

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Enhanced Community Case Management (CCM)

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

Intervention Type OTHER

Monthly Screening and Treatment (MSAT)

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.

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes