P. Falciparum Infection Dynamics and Transmission to Inform Elimination

Summary

In the current study, three experimental approaches aiming at reducing malaria transmission will be tested. The study will cover two transmission season (2019 and 2020) and the interventions will vary by season. More specifically, in the 2019 transmission season (June-December) (Year 1), community case management of malaria (CCM) will be implemented in all eight villages as improved standard of care; in the 2020 transmission season (Year 2), the eight study villages will be divided into 4 study arms. CCM will continue in all villages; two villages will continue with CCM only (Arm 1, control); the three other pairs of villages will receive active fever screening and treatment (Arm 2); monthly mass screening and treatment (MSAT) (Arm 3); and mass drug administration (MDA) during the last 3 months of the dry season (April-June) (Arm 4). For MDA, the whole population (except for those not fulfilling the entry criteria) will be treated with a full course of dihydroartemisinin-piperaquine (DP) (320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet) per manufacturer's guidelines (once daily for 3 days and according to body weight). The MDA treatment will be repeated 3 times at monthly intervals.

Conditions

• Malaria

Interventions

OTHER

Community Case Management

Community Case Management (CCM), consisting of community health workers able to diagnose malaria by standard RDTs and treating positive individuals with artemether-lumefantrine (AL), according to national guidelines.

OTHER

Weekly fever screening and treatment

Consists of weekly visits by trained VHW who will screen for fever by taking the axillary temperature. If the body temperature is ≥37.5°C, a standard RDT will be performed and, if positive, the individual will be treated with AL, according to national guidelines.

OTHER

Monthly malaria screening

CCM plus monthly screening of the whole population with high sensitive RDT (HS-RDT); positive individuals will be treated with AL regardless of symptoms (MSAT).

OTHER

MDA

CCM plus 3 monthly rounds of MDA with dihydroartemisinin-piperaquine (DP) starting during the dry season, before the malaria transmission season starts.

Sponsors & Collaborators

• Medical Research Council Unit, The Gambia

  collaborator OTHER

• National Malaria Control Programme, The Gambia

  collaborator OTHER_GOV

• Radboud University Medical Center

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Institute for Disease Modeling

  collaborator UNKNOWN

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Chris Drakeley, PhD · London School Hygiene and Tropical medicine

• Umberto D'Alessandro, PhD, MD · MRC Unit The Gambia @ LSHTM

• Teun Bousema, PhD · Radboud University Medical Centre, Nijmegen, The Netherlands

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-08-15

Primary Completion

2022-05-31

Completion

2022-05-31

Countries

• The Gambia

Study Locations