Project phases
Eligibility Criteria
Healthy individuals from the general population, reached through publicity campaigns, (in health centres) outpatient or inpatient accompanying adults (in health centres) and participating community members will be recruited according to the following criteria.
Inclusion criteria
- Age between 18-49 years
- Residency in the city where the study will be conducted (since at least two years)
- Consent form signed by the participant and the medical investigator at inclusion
Non-inclusion criteria
- Patients <18 years and ≥50years
- Severe clinical event under investigation, that is life-threatening, uncontrolled
- Refusal to participate in the study
- Patient who should travel a long distance to the study site
- History of coronary disease or stroke
- Active/chronic viral hepatitis
- HIV infection
- Tuberculosis known patients
- Fever or antimalarial drug intake within the last 2 months
- Other antiparasitic treatment within the 6 months preceding the recruitment
The study is performed through three phases
Phase I
the population and the chief from the districts of Libreville and Koulamoutou from two provinces in Gabon, will be informed about the aim, the importance and the benefit of the study. In addition, the study team will be trained on biological sample collection, testing and storage and the questionnaire related to this study will be tested. Phase I will be carried out over a period of six months. Data management standard operating procedures (SOPs) and methodology will be set up.
Start : October 2019
End : August 2020
The second Phase
will be the cross sectional survey, which corresponds to the screening for physical and biological risk factors over a 6 month-period. After eligibility criteria verification and informed consent, interview, clinical examination and blood collection for biochemical tests and further biomarkers measurements will be performed at day 0. On day 1, urine and stools samples will be collected for prasiyological tests and for aliquots of consenting participants for further sub-studies and will be stored in a -80°C freezer as well as dried blood spots.
Start : September 2020
End : In progress
The third Phase
will be the 18-month prospective cohort study comparing the frequency of the occurrence of CMDRF or events including hypertension among the parasite infected and uninfected participants of urban and rural areas. This phase will include three control visits: visit 1 (6 months after inclusion), visit 2 (12 months after inclusion) and visit 3 (18 months after inclusion). For all these visits, a delay of ± 1 month will be allowed. During each visit, record of medical history and treatment, a complete clinical examination with blood pressure, determination of blood glucose, HbA1c, and lipids parameters as well as sample for biomarker measurement and the Framingham score risk will be determined. The parasitological stool analysis will be performed during visit 2 and 3. At the last visit, the complete procedure as performed in phase 2, as well as the complete biomarkers measurement to determine the occurrence of CMD including hypertension or the modification of CMDRF will be realised.
Start : Not started
End : –
