Evaluation of Vector and Chemoprevention-based Interventions to Reduce Malaria Burden in Urban Daaras of Touba, Senegal
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In Senegal, young children (mostly boys) may be sent to religious schools (daaras) to learn about the Koran and moral and cultural values. The students (talibés) often live and sleep in crowded conditions and as a result, insecticide-treated net (ITN) use is consistently low due to challenges faced in hanging ITNs as well as difficulty covering multiple children sleeping together. This study will consist of a two-arm cluster-randomized controlled trial to evaluate the effectiveness of an intervention package in urban daaras in Touba City, Diourbel region, Senegal.
The intervention package will include vector control through meganets (multiple insecticide-treated mosquito nets sewn together and adapted based on the needs and sleeping situation of the daara), seasonal malaria chemoprevention (SMC) extended to all ages using DHA-PQ, and behavior change communication.
Prior to evaluating an intervention, there will be 1) a mapping of the daaras in Touba City, Diourbel Region of Senegal to observe the various structures and types of daaras in order to select typical daaras for the entomological component, and to inform randomization, 2) human behavior observation (HBO) of students (talibes) and teachers (marabouts) in 2-3 daaras selected through the mapping to help tailor the intervention package, and 3) analysis of mosquito behavior observed through human landing catches.
Two cross-sectional surveys will be conducted, before and after the intervention, which will include an electronic questionnaire to be sent to the taalibés themselves or to their guardians, a temperature reading, an RDT for participants with a fever at the time of the survey, and a fingertip blood sample to assess parasite prevalence (microscopy and PCR). Qualitative surveys will be carried out using a mixed-method design, consisting of a literature review, in-depth individual interviews, focus groups, and on-site observations. Meganet monitoring surveys will be carried out after meganet distribution to assess the attrition and physical integrity of the nets.
Malaria incidence will be determined from records of community health workers assigned to the daaras who have been trained by the Ministry of Health to identify febrile students, test them for malaria using a rapid diagnostic test and treat confirmed cases with an antimalarial medicine. Additional data on students who seek care from health centers in their neighborhood will supplement the data obtained from community health workers.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Touba, Senegal
- Daaras in Touba
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria for daara:
- Located within the catchment area of Touba Health District
- Located within the catchment area of a health facility with an annual malaria incidence of ≥ 25 cases per 1000 population
- Daara is registered in the health system and the Serigne daara (i.e., daara leader) can provide caregiver consent for taalibé.
- Taalibé population between 29 to 120
- PECAdaara model has been integrated and fully operational
- Willingness of daara leader to participate in the study
Inclusion criteria for receiving DHA-PQ:
- Age ≥ 3 months
- Taalibé of study daara
- Willingness to comply with study procedures
- Provision of informed consent/assent
Additional inclusion criteria for receiving meganets:
- Sleeping in a superimposed area with ≥ 2 people
Exclusion Criteria for receiving DHA-PQ:
- Age < 3 months
- Refusal of informed consent
- Concomitant or recent use of antimalarials within the past two weeks
- Known allergy or hypersensitivity to DHA-PQ
- Confirmed diagnosis of clinical malaria
- Currently taking anti-worm or anti-infection drugs, including cotrimoxazole (BACTRIM), mebendazole, quinolones, sulfonamides (FANSIDAR, MALOXINE), dapsone, colchicine
- Currently taking medications that influence cardiac function or prolong the QTc interval
- Serious or chronic illness, including known HIV infection, heart disease, or severe malnutrition (weight-for-age or mid-upper arm circumference (MUAC) < 3 SD)
- Pregnancy (assessed by history or urine pregnancy test)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention clusters
will receive the following interventions:
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Intervention package will include vector control through meganets (multiple insecticide-treated mosquito nets sewn together), seasonal malaria chemoprevention (SMC) extended to all ages using DHA-PQ, and behavior change communication.
|
|
No Intervention: Control clusters
will receive standard-of-care malaria interventions, which include:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in cumulative incidence of clinical malaria confirmed by rapid diagnostic test (RDT) between arms
Time Frame: monthly basis over 12 months
|
Cumulative incidence will be defined as the number of RDT-confirmed malaria cases per 1000 population in each daara.
Cases will be identified from both PECAdaara and health facility registries
|
monthly basis over 12 months
|
|
Difference in pre-post change in prevalence of PCR-confirmed infection between arms
Time Frame: 12 months
|
Prevalence will be defined as the proportion of individuals with PCR-confirmed infection, assessed during cross-sectional surveys
|
12 months
|
|
Difference in change in prevalence of microscopy-confirmed infection between arms
Time Frame: 12 months
|
Prevalence will be defined as the proportion of individuals with microscopy-confirmed infection assessed during the endline survey
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in the cumulative incidence of serious adverse events (SAE) after SMC administration between arms
Time Frame: 12 months
|
Adverse events will be classified as serious or non-serious based on standardized AE grading scale
|
12 months
|
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Difference in human behavior on net use before and after ITN/meganet distribution
Time Frame: 12 months
|
ITN use (e.g., sleeping under net in the previous night, sleeping indoors versus outdoors) will be assessed during cross-sectional surveys
|
12 months
|
|
Difference in indoor and outdoor adjusted human biting rates between arms
Time Frame: 12 months
|
The human landing rate will be used as a proxy for the human biting rate (HBR).
The HBR data will be integrated with the human behavior observation (HBO) data on net use and sleep patterns data by calculating the hourly adjusted HBR.
|
12 months
|
|
Difference in Anopheles biting trends between arms
Time Frame: 12 months
|
Anopheles biting trends will be examined by measuring the Anopheles biting times (including peak biting time), biting locations (indoors and outdoors), and vector density (defined as mean number of bites received by one person in one night) during human landing catches
|
12 months
|
|
Acceptability of intervention package
Time Frame: 12 months
|
Perceptions of intervention package and reasons for participation assessed through qualitative studies conducted throughout the study period
|
12 months
|
|
Difference in proportion of refusals between arms
Time Frame: 12 months
|
Refusals will be defined as the number of those who refused a specific intervention divided by the number of participants who were targeted and eligible to receive the specific intervention (i.e., chemoprevention and meganets).
|
12 months
|
|
Cost per malaria case averted
Time Frame: 12 months
|
Total intervention costs will be calculated in both arms and compared with efficacy measures of malaria incidence to generate the incremental cost effectiveness ratio.
|
12 months
|
|
Difference in cumulative incidence of grade 3+ adverse events after drug administration between arms
Time Frame: 12 months
|
Defined as the number of grade 3+ AEs divided by the participant population who received at least one dose of drug.
|
12 months
|
|
Difference in distribution coverage of chemoprevention strategies between arms
Time Frame: 12 months
|
Distribution coverage will be defined as the number of persons who received intervention divided by number of those targeted and eligible
|
12 months
|
|
Difference in crude coverage of chemoprevention strategies between arms
Time Frame: 12 months
|
Crude coverage will be defined using WHO criteria as number of persons who received the intervention divided by number of those who were targeted (regardless of eligibility)
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean Louis Ndiaye, L'université de Thiès
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RES-00634
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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