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

Not Applicable

Completed

• Conditions: Malaria

• Registration Number: NCT03705624
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-19
• Status Verified: 2018-08
• Study Start: 2018-08-06
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-15
• Primary Completion: 2020-02-14
• Study Completion: 2020-02-14
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 907

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Parasite prevalence and density by molecular detection at the end of study cross-sectional survey.	Month 18 (end of second transmission season; January-February 2020)	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.

Secondary Outcome Measures

Name	Time	Method
Parasite prevalence and density by molecular detection at the end of year 1 cross-sectional survey.	Month 6 (end of first transmission season; January-February 2019)	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.
Parasite prevalence and density by molecular detection at the end of dry season cross-sectional survey.	Month 12 (prior to second transmission season; June 2019)	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.
Gametocyte prevalence and or density in P. falciparum infections at the end of study cross-sectional survey	Month 18 (end of second transmission season; January-February 2020)	Gametocyte prevalence in qPCR detected infections is assessed by molecular methods and compared between study arms.
Gametocyte prevalence and or density in P. falciparum infections at the end of year 1 cross-sectional survey	Month 6 (end of first transmission season; January-February 2019)	Gametocyte density of male and female gametocytes will be assessed by molecular methods and compared between study arms.
Gametocyte prevalence and or density in P. falciparum infections at the end of dry season cross-sectional survey	Month 12 (prior to second transmission season; June 2019)	Gametocyte density of male and female gametocytes will be assessed by molecular methods and compared between study arms.
Gametocyte prevalence and or density in P. falciparum during all study visits	Throughout study, an average of 18 months	Gametocyte density of male and female gametocytes will be assessed by molecular methods and compared between study arms.
The number of incident infections.	Throughout study, an average of 18 months	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.
Infectivity to mosquitoes of P. falciparum infections	Throughout study, an average of 18 months	For a selection of infections, infectiousness to mosquitoes is assessed by membrane feeding assays.

Trial Locations

Locations (1)

Centre National de Recherche et de Formation sur le Paludisme; 🇧🇫 Ouagadougou, Burkina Faso