Clinical trial NCT02914145: Mass Drug Administrations of DHA-PQP to Accelerate Towards Malaria Elimination in Magude District, Southern Mozambique
Official title: Mass Drug Administration of Monthly DHA-PQP to Accelerate Towards Malaria Elimination in Magude District, Southern Mozambique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Lead sponsor: Centro de Investigacao em Saude de Manhica
Sponsor class: OTHER
Collaborators: name: Barcelona Institute for Global Health
First posted: 2016-09-26
Enrollment: 240502
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Decrease in Parasite prevalence according to RDT
timeFrame: 6 months
measure: Decrease in Parasite prevalence according to PCR
timeFrame: 6 months
measure: Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages
timeFrame: 12 months
Secondary outcomes:
measure: Population coverage of the MDA intervention
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: pedro.aide@manhica.net
name: Pedro Aide, MD, MSc, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.