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Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts

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ClinicalTrials.gov Identifier: NCT02536222
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : September 15, 2016
Sponsor:
Collaborators:
National malaria Control Program of Senegal
Regional and district health authorities of Matam and Louga regions and Kanel Ranerou and Linguere districts of Senegal
Information provided by (Responsible Party):
PATH

Brief Summary:
The work will be conducted in six health posts in the regions of Matam (Kanel and Ranérou districts) and Louga (Linguère district), that were selected in 2014 on the basis of the malaria incidence rate, the heterogeneity of transmission between villages in the health post catchment areas, their proximity, and the availability of historical data from before 2014. Malaria elimination strategies were already implemented in the same health posts in 2014 and are still ongoing, thus this protocol aims to strengthen these activities. Seven health posts with similar characteristics but with a slightly lower incidence rate were chosen as controls. It will be implemented in all villages in the six intervention health posts and it will consist of investigating all passively detected cases (index cases) and conducting focal test and focal drug administration (FT/FDA) with dihydroartemisinin-piperaquine (DHAP) in all index case and neighboring households with a positive RDT. All household members in households with a positive RDT will be treated, regardless of their RDT results. Impact of the enhanced Step D on malaria incidence and prevalence will be evaluated using before-after comparison and compared to the change in the control health posts and the operational aspects will be assessed for subsequent scale up.

Condition or disease Intervention/treatment Phase
Malaria Other: Case investigation of malaria passively detected cases with FT/FDA Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20379 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts
Study Start Date : September 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Reactive case investigation : FT/FDA with DHA-PQ
All consenting household members eligible to receive DHA-PQ and living in a household where anyone in the household tests positive with a malaria rapid diagnostic test (RDT) will receive the age-appropriate treatment dose of DHA-PQ. If no one in the household tests RDT positive then no one in the household will receive DHA-PQ.
Other: Case investigation of malaria passively detected cases with FT/FDA
Systematic reactive malaria case investigation will be performed in all villages of the six intervention health posts. All malaria cases passively detected in a health post or in the community and confirmed with a positive rapid diagnostic test (RDT) will be considered an index case and will be investigated. A team (field worker and community health worker) will visit the household of the index case and the five closest households (in a 100 meter radius) and will test by RDT all the consenting individuals living in the households. Any households with at least one positive RDT (including the index case) will receive a systematic focal drug administration (FDA) treatment with DHAP through which all members will be treated.

No Intervention: No Intervention: Standard of Care (Control)
The standard of care arm will have the standard of care offered by the Ministry of Health which applies to all arms. This includes available mosquito net coverage and passive case detection of individuals seeking treatment from a health provider at a health post or community.



Primary Outcome Measures :
  1. Incidence of passively detected malaria cases [ Time Frame: one malaria transmission season (up to 5 months) ]
    Incidence of passively detected RDT-confirmed malaria cases among individuals older than 2 months (at the health posts or by community health workers), collected through the rapid reporting system already in place. Every week, health facility workers submit basic information on malaria burden, that is entered into DHIS2 (district health information system) at the district level. The quality of the rapid reporting system will be monitored through routine data quality audits (comparing health post registers with submitted data) and continuous monitoring of the data submitted to DHIS2. The estimated enrollment is 30 000 individuals. A comparison before and after the intervention and between interventions and control villages will be done using a difference-in-difference analysis.


Secondary Outcome Measures :
  1. Prevalence of Plasmodium falciparum parasitaemia [ Time Frame: At the begining (one month after the first rain) and the end (one month after the last rain) of the transmission season ]
    Prevalence of infection by RDT/polymerase chain reaction (PCR): will be measured during cross-sectional surveys at the beginning and at the end of the transmission season. 16,000 participants are expected to take part in both cross sectional surveys. The prevalence by PCR will only be available later when the laboratory results become available. A comparison before and after the intervention and between interventions and control villages will be done using a difference-in-difference analysis.



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Ages Eligible for Study:   2 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signs the informed consent form
  • Aged more than 2 months
  • Resident member of the selected household
  • Does not present any severity symptoms

Exclusion Criteria:

  • Refuses to sign the informed consent form
  • Aged less than 2 months
  • Is not a resident member of the selected household
  • Presents severity symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536222


Locations
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Senegal
six health posts in Kanel, Linguère and Ranérou districts
Oudallaye, Mbem-Mbem, Salalatou, Doundé, Nianghana, Gassane, Louga and Matam, Senegal
Sponsors and Collaborators
PATH
National malaria Control Program of Senegal
Regional and district health authorities of Matam and Louga regions and Kanel Ranerou and Linguere districts of Senegal
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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02536222    
Other Study ID Numbers: 762488-1
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases