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

NCT06225297 | Suspended Phase 4

• 1 other identifier: RES-00634
• Study Type: interventional
• Target: 4,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (3)

• Difference in cumulative incidence of clinical malaria confirmed by rapid diagnostic test (RDT) between arms

  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 change in prevalence of microscopy-confirmed infection between arms

  Prevalence will be defined as the proportion of individuals with microscopy-confirmed infection assessed during the endline survey

  12 months

• Difference in pre-post change in prevalence of PCR-confirmed infection between arms

  Prevalence will be defined as the proportion of individuals with PCR-confirmed infection, assessed during cross-sectional surveys

  12 months

Secondary Outcomes (10)

• Difference in cumulative incidence of grade 3+ adverse events after drug administration between arms

  12 months

• Difference in the cumulative incidence of serious adverse events (SAE) after SMC administration between arms

  12 months

• Difference in human behavior on net use before and after ITN/meganet distribution

  12 months

• Difference in indoor and outdoor adjusted human biting rates between arms

  12 months

• Difference in Anopheles biting trends between arms

  12 months

Study Arms (2)

Intervention clusters

EXPERIMENTAL

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

Combination Product: Intervention package

Control clusters

NO INTERVENTION

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

Interventions

Intervention package 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.

Intervention clusters

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• PATH: lead
• L'université de Thiès: collaborator
• University of California, San Francisco: collaborator
• Tulane University: collaborator

Study Sites (1)

Daaras in Touba

Touba, Senegal

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean Louis Ndiaye

  L'université de Thiès

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study participants, community health workers, and study field staff will not be blinded to intervention assignment. However, the trial statistician and laboratory technicians carrying out subsequent analyses in reference laboratories will remain blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 25, 2024
• Study Start: January 19, 2024
• Primary Completion: December 23, 2024
• Study Completion: February 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)