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

Primary Purpose

Malaria

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dihydroartemisinin-piperaquine
Sponsored by
Centro de Investigacao em Saude de Manhica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Participants

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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)
    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)
    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.

    Secondary Outcome Measures

    Population coverage of the MDA intervention
    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.

    Full Information

    First Posted
    September 14, 2016
    Last Updated
    February 5, 2018
    Sponsor
    Centro de Investigacao em Saude de Manhica
    Collaborators
    Barcelona Institute for Global Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02914145
    Brief Title
    Mass Drug Administrations of DHA-PQP to Accelerate Towards Malaria Elimination in Magude District, Southern Mozambique
    Acronym
    MDAM
    Official Title
    Mass Drug Administration of Monthly DHA-PQP to Accelerate Towards Malaria Elimination in Magude District, Southern Mozambique
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centro de Investigacao em Saude de Manhica
    Collaborators
    Barcelona Institute for Global Health

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    240502 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants
    Arm Type
    Other
    Arm Description
    Any individual from the study area who participates and is medicated with DHAp in the mass drug administration campaign
    Intervention Type
    Drug
    Intervention Name(s)
    Dihydroartemisinin-piperaquine
    Other Intervention Name(s)
    Eurartesim
    Intervention Description
    Mass drug administration
    Primary Outcome Measure Information:
    Title
    Decrease in Parasite prevalence according to RDT
    Description
    the proportion of individuals (according to age group) with P. falciparum infection (detected by RDT) out of all tested individuals (in that age group)
    Time Frame
    6 months
    Title
    Decrease in Parasite prevalence according to PCR
    Description
    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)
    Time Frame
    6 months
    Title
    Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Population coverage of the MDA intervention
    Description
    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.
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pedro Aide, MD, MSc, PhD
    Organizational Affiliation
    pedro.aide@manhica.net
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    34585740
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    34105200
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    32797101
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    32371510
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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