Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Malaria
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 3 years and 125 years
Gender
Both males and females

Description

Cross-sectional surveys will be carried out in order to identify risk factors for residual malaria infection and disease at both the individual and household level, to supply parasite samples for detailed population-level molecular analyses and to supply epidemiological data for parameterization of ...

Cross-sectional surveys will be carried out in order to identify risk factors for residual malaria infection and disease at both the individual and household level, to supply parasite samples for detailed population-level molecular analyses and to supply epidemiological data for parameterization of new mathematical models of malaria transmission. SPECIFIC AIMS: Aim 1: Longitudinally determine malaria dynamics in a major residual malaria hotspot in Brazil. Aim 2: Identify and quantify population changes in P. vivax and P. falciparum to detect reintroductions, and to estimate parasite population complexity at baseline and potentially after interventions. Aim 3: Develop and apply mathematical models to describe changing dynamics of malaria incidence and parasitemia prevalence over time, and to assess potential effects of combinations of interventions on malaria control and elimination. The study will be developed in the urban area of Mâncio Lima, northwestern of Brazil. A census performed by our field team between Nov 2015 and Apr 2016 identified ~ 10,000 inhabitants in the urban area of Mâncio Lima. At the site preparation phase, a random sample of 20% of the households enumerated during our census will be visited by our field teams and all dwellers aged 3 months or up (or their parents/guardians) will be invited to participate in the cohort study. We expect to enroll ~ 2,000 subjects who will participate in 10 cross-sectional surveys (every six months) over five years (total of 20,000 observations), and contribute 120,000 person-months of follow-up. Because of the open-cohort design of this study, subjects who are lost for follow-up are replaced with newcomers, without affecting significantly the number of person-months of follow-up. At each visit, the subjects will be interviewed and 100ul of blood will be collected to Active (ACD) and Passive Case Detection (PCD) (symptom based surveying; microscopy-based diagnosis). Each visit will include an interview, physical examination and collection of 100 ?L of blood (finger prick) to malaria diagnosis by smear, RDT and qPCR. When the subjects are positive by smear or RDT (rapid diagnostic test for malaria), despite of presence of symptoms, ? 20 mL of venous blood will be draw of them to immunology and parasite genetics study and the immediate treatment per Ministry of Health of Brazil guidelines will be performed.

Tracking Information

NCT #
NCT03689036
Collaborators
University of Sao Paulo
Investigators
Study Director: Marcelo U Ferreira, PhD MD University of Sao Paulo Study Chair: simone l andrade, Phd MD Oswaldo Cruz Foundation