Evaluation of Vector and Chemoprevention-based Interventions to Reduce Malaria Burden in Urban Daaras of Touba, Senegal

NCT ID: NCT06225297

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 4600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-19
• Study Completion Date: 2025-02-28

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention clusters

will receive the following interventions:

1. Distribution of meganets, defined as conventional insecticide-treated nets (ITNs) sewn together to adapt to taalibés sleeping conditions

2. Three monthly cycles of targeted chemoprevention with dihydroartemisinin-piperaquine (DHA-PQ) for all daara residents, regardless of resident age

3. Social behavior change (SBC) to promote intervention uptake

Group Type: EXPERIMENTAL

Intervention package

Intervention Type: COMBINATION_PRODUCT

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.

Control clusters

will receive standard-of-care malaria interventions, which include:

1. Distribution of conventional ITNs

2. Three monthly cycles of SMC with sulfadoxine-pyrimethamine- amodiaquine (SP-AQ) given to children 3-120 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention package

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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

• Age ≥ 3 months
• Taalibé of study daara
• Willingness to comply with study procedures
• Provision of informed consent/assent

• Sleeping in a superimposed area with ≥ 2 people

Exclusion Criteria

• 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)

• Minimum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

L'université de Thiès

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Tulane University

OTHER

Sponsor Role: collaborator

PATH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Louis Ndiaye

Role: PRINCIPAL_INVESTIGATOR

L'université de Thiès

Locations

Daaras in Touba

Touba, , Senegal

Countries

Senegal

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

RES-00634

Identifier Type: -

Identifier Source: org_study_id