Clinical trial NCT06225297: Evaluation of Vector and Chemoprevention-based Interventions to Reduce Malaria Burden in Urban Daaras of Touba, Senegal
Official title: Evaluation of Vector and Chemoprevention-based Interventions to Reduce Malaria Burden in Urban Daaras of Touba, Senegal
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: L'université de Thiès
name: University of California, San Francisco
name: Tulane University
First posted: 2024-01-25
Enrollment: 4600
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the effectiveness of the use of adapted insecticide-treated mosquito nets combined with extended DHA-PQ-based seasonal chemoprevention for all ages and behavior change communication in reducing the burden of malaria in relation to standards of protection and care among students (taalibés) in the daaras (Koranic schools) of Touba, Senegal.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Difference in cumulative incidence of clinical malaria confirmed by rapid diagnostic test (RDT) between arms
timeFrame: monthly basis over 12 months
measure: Difference in change in prevalence of microscopy-confirmed infection between arms
timeFrame: 12 months
measure: Difference in pre-post change in prevalence of PCR-confirmed infection between arms
timeFrame: 12 months
Secondary outcomes:
measure: Difference in cumulative incidence of grade 3+ adverse events after drug administration between arms
timeFrame: 12 months
measure: Difference in the cumulative incidence of serious adverse events (SAE) after SMC administration between arms
timeFrame: 12 months
measure: Difference in human behavior on net use before and after ITN/meganet distribution
timeFrame: 12 months
measure: Difference in indoor and outdoor adjusted human biting rates between arms
timeFrame: 12 months
measure: Difference in Anopheles biting trends between arms
timeFrame: 12 months
measure: Acceptability of intervention package
timeFrame: 12 months
measure: Difference in proportion of refusals between arms
timeFrame: 12 months
measure: Difference in distribution coverage of chemoprevention strategies between arms
timeFrame: 12 months
measure: Difference in crude coverage of chemoprevention strategies between arms
timeFrame: 12 months
measure: Cost per malaria case averted
timeFrame: 12 months
Other outcomes:
Locations:
city: Touba
country: Senegal
facility: Daaras in Touba
Study officials:
affiliation: L'université de Thiès
name: Jean Louis Ndiaye
role: PRINCIPAL_INVESTIGATOR
References: