NCT02914145

Brief Summary

In line with the global and regional efforts towards malaria elimination, a five year program was established to assist the NMCP in adopting targeted evidence-based elimination plans through a 'learn by doing' strategy. The project aims to generate knowledge as data is generated to inform the programmatic aspects of the elimination plan, most importantly how to clear malaria parasites from the asymptomatic reservoir.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240,502

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

September 14, 2016

Last Update Submit

February 5, 2018

Conditions

Malaria

Outcome Measures

Primary Outcomes (3)

  • Decrease in Parasite prevalence according to RDT

    the proportion of individuals (according to age group) with P. falciparum infection (detected by RDT) out of all tested individuals (in that age group)

    6 months

  • Decrease in Parasite prevalence according to PCR

    as the proportion of individuals (according to age group) with P. falciparum infection (detected by PCR) out of all tested individuals (in that age group)

    6 months

  • Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages

    the number of OPD and IPD malaria parasitologically confirmed cases per person per year, as ascertained from the routine passive case detection system utilizing facility catchment population size estimates as denominator.

    12 months

Secondary Outcomes (1)

  • Population coverage of the MDA intervention

    3 weeks

Study Arms (1)

Participants

OTHER

Any individual from the study area who participates and is medicated with DHAp in the mass drug administration campaign

Drug: Dihydroartemisinin-piperaquine

Interventions

Dihydroartemisinin-piperaquineDRUG

Mass drug administration

Also known as: Eurartesim
Participants

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who consent to participate in the study
  • Residents in the study area
  • Older than 6 months of age (or weighing more than 5Kg)
  • Women in the second or third trimester who are not on IPTp

You may not qualify if:

  • Individuals who do not consent to participate in the study
  • Younger than 6 months of age (or weighing more than 5Kg)
  • Women in the first trimester of pregnancy
  • Severely ill individuals
  • Individuals on contra-indicated medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Shah MP, Hwang J, Choi L, Lindblade KA, Kachur SP, Desai M. Mass drug administration for malaria. Cochrane Database Syst Rev. 2021 Sep 29;9(9):CD008846. doi: 10.1002/14651858.CD008846.pub3.

    PMID: 34585740DERIVED

  • Thomas R, Cirera L, Brew J, Saute F, Sicuri E. The short-term impact of a malaria elimination initiative in Southern Mozambique: Application of the synthetic control method to routine surveillance data. Health Econ. 2021 Sep;30(9):2168-2184. doi: 10.1002/hec.4367. Epub 2021 Jun 8.

    PMID: 34105200DERIVED

  • Galatas B, Saute F, Marti-Soler H, Guinovart C, Nhamussua L, Simone W, Munguambe H, Hamido C, Montana J, Muguande O, Maartens F, Luis F, Paaijmans K, Mayor A, Bassat Q, Menendez C, Macete E, Rabinovich R, Alonso PL, Candrinho B, Aide P. A multiphase program for malaria elimination in southern Mozambique (the Magude project): A before-after study. PLoS Med. 2020 Aug 14;17(8):e1003227. doi: 10.1371/journal.pmed.1003227. eCollection 2020 Aug.

    PMID: 32797101DERIVED

  • Galatas B, Nhacolo A, Marti H, Munguambe H, Jamise E, Guinovart C, Cirera L, Amone F, Macete E, Bassat Q, Rabinovich R, Alonso P, Aide P, Saute F, Sacoor C. Demographic and health community-based surveys to inform a malaria elimination project in Magude district, southern Mozambique. BMJ Open. 2020 May 5;10(5):e033985. doi: 10.1136/bmjopen-2019-033985.

    PMID: 32371510DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Pedro Aide, MD, MSc, PhD

    pedro.aide@manhica.net

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 26, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02