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Mass Drug Administrations of DHA-PQP to Accelerate Towards Malaria Elimination in Magude District, Southern Mozambique (MDAM)

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ClinicalTrials.gov Identifier: NCT02914145
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
Barcelona Institute for Global Health
Information provided by (Responsible Party):
Centro de Investigacao em Saude de Manhica

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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Dihydroartemisinin-piperaquine Not Applicable

Detailed Description:

This study aims to deliver two yearly consecutive rounds of community wide MDA using DHA-PQP (full treatment, 3 days, only supervised as DOT on day 0) at months 1 and 2, combined with parasite prevalence surveys using RDTs and PCR.

The first RDT survey (conducted to the entire study population of 60,000 inhabitants before each individual's dose of MDA1) would provide a precise estimate of RDT measurable P. falciparum baseline prevalence. During this first round of MDA, full blood will also be collected in filter papers for all individuals for PCR evaluation to investigate PCR-based parasite prevalence in the community. During the second MDA round, blood will be collected in filter papers in a subsample of the study population for screening of PCR-based parasite prevalence in the community and among first-trimester pregnant women.

Effectiveness of the MDA rounds will be measured throughout a 12-month period.

During the first six months, impact will be measured based on RDT positivity and PCR positivity measured on month 1 (baseline; both methods) and subsequently (month 2, only PCR; month 6, both RDT and PCR); and on malaria incidence in the community measured through passive case detection (PCD) in the different health posts. The success of the two rounds of MDA, as measured by: a) Prevalence of malaria infection (by RDT and/or PCR) in a subgroup of the study population on month six; b) Incidence of malaria as detected through PCD (from months 1 to 6); c) Identification of hotspots of maintained transmission in the study area; or d) Coverage achieved of MDA1 and MDA2 rounds). Should the two rounds not achieve the predefined success milestones [1. Decrease in parasite prevalence by 90% by RDT and/or PCR; 2) Coverage of 80% or above for both rounds; 3) Absence of clear geographic hotspots and 4) Incidence of clinical malaria in the community<1% i.e <600 cases/year] a two more round of MDA (or a more targeted focal MDA) in the totality or a part of Magude district will be organized, starting on month 7.

DHA/PQP has been chosen as the drug of choice for MDA. The pharmacokinetic profile of piperaquine - the long half-life component drug in DHA-PQP - confers a minimum of a 1-month post-treatment prophylaxis effect. If administered monthly (for 3 days at a time) with a 4 weeks interval, the prophylactic effect could protect individuals from pre-treatment Plasmodium infected mosquitoes as well as from mosquitoes infected after mass treatment from residual circulating gametocytes. Mosquitoes live for a maximum of 28 days during which they return to feed from humans. During this period the population of pre-treatment infected mosquitoes will gradually die away, exhausting the mosquito reservoir of infection.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240502 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mass Drug Administration of Monthly DHA-PQP to Accelerate Towards Malaria Elimination in Magude District, Southern Mozambique
Study Start Date : November 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Participants
Any individual from the study area who participates and is medicated with DHAp in the mass drug administration campaign
Drug: Dihydroartemisinin-piperaquine
Mass drug administration
Other Name: Eurartesim




Primary Outcome Measures :
  1. Decrease in Parasite prevalence according to RDT [ Time Frame: 6 months ]
    the proportion of individuals (according to age group) with P. falciparum infection (detected by RDT) out of all tested individuals (in that age group)

  2. Decrease in Parasite prevalence according to PCR [ Time Frame: 6 months ]
    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)

  3. Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Population coverage of the MDA intervention [ Time Frame: 3 weeks ]
    the proportion of individuals (≥6 months old) that agreed to participate in the MDA intervention and took under DOT the first dose of the 3-day long treatment of DHA-PQP among all individuals ≥6 months old eligible to participate in the intervention in the target population.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914145


Sponsors and Collaborators
Centro de Investigacao em Saude de Manhica
Barcelona Institute for Global Health
Investigators
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Study Director: Pedro Aide, MD, MSc, PhD pedro.aide@manhica.net
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centro de Investigacao em Saude de Manhica
ClinicalTrials.gov Identifier: NCT02914145    
Other Study ID Numbers: 201/CNBS/15
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Piperaquine
Dihydroartemisinin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents