Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts
|ClinicalTrials.gov Identifier: NCT02536222|
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : September 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Other: Case investigation of malaria passively detected cases with FT/FDA||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20379 participants|
|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|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536222
|six health posts in Kanel, Linguère and Ranérou districts|
|Oudallaye, Mbem-Mbem, Salalatou, Doundé, Nianghana, Gassane, Louga and Matam, Senegal|