NCT03705624

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 907 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Conditions

• Malaria

Interventions

Type	Name	Description
OTHER	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
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.

Timeline

• Start date: 2018-08-06
• Primary completion: 2020-02-14
• Completion: 2020-02-14
• First posted: 2018-10-15
• Last updated: 2020-02-28

Locations

1 site across 1 country: Burkina Faso