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
About this trial
This is an interventional treatment trial for Malaria
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
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
NCT ID
NCT02914145
First Posted
September 14, 2016
Last Updated
February 5, 2018
Sponsor
Centro de Investigacao em Saude de Manhica
Collaborators
Barcelona Institute for Global Health
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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