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

NCT02536222 | Completed Phase 4

• 1 other identifier: 762488-1
• Study Type: interventional
• Target: 20,379
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• Incidence of passively detected malaria cases

  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.

  one malaria transmission season (up to 5 months)

Secondary Outcomes (1)

• Prevalence of Plasmodium falciparum parasitaemia

  At the begining (one month after the first rain) and the end (one month after the last rain) of the transmission season

Study Arms (2)

Reactive case investigation : FT/FDA with DHA-PQ

EXPERIMENTAL

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

No Intervention: Standard of Care (Control)

NO INTERVENTION

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.

Interventions

Case investigation of malaria passively detected cases with FT/FDA OTHER

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.

Reactive case investigation : FT/FDA with DHA-PQ

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• PATH: lead
• National malaria Control Program of Senegal: collaborator
• Regional and district health authorities of Matam and Louga regions and Kanel Ranerou and Linguere districts of Senegal: collaborator

Study Sites (1)

six health posts in Kanel, Linguère and Ranérou districts

Oudallaye, Mbem-Mbem, Salalatou, Doundé, Nianghana, Gassane, Louga and Matam, Senegal

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 31, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

SE (1)