Evaluation of a Package of Interventions to Reduce the Burden of Malaria in the Urban Daaras of Touba, Senegal

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06225297
• Other study ID #: RES-00634
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 19, 2024
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: PATH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4600
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months and older

Eligibility

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 50 to 100
• PECAdaara model has been integrated and fully operational
• Willingness of daara leader to participate in the study

Inclusion criteria for receiving SMC with 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:

• 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)

Related Conditions & MeSH terms

• Malaria

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
Senegal	Daaras in Touba	Touba

Sponsors (4)

Lead Sponsor	Collaborator
PATH	L'université de Thiès, Tulane University, University of California, San Francisco

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Difference in pre-post change in prevalence of microscopy-confirmed infection between arms	Prevalence will be defined as the proportion of individuals with microscopy-confirmed infection assessed during cross-sectional surveys	12 months
Primary	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	Difference in cumulative incidence of grade 3+ adverse events after SMC administration between arms	Defined as the number of grade 3+ AEs divided by the participant population who received at least one dose of SMC drug.	12 months
Secondary	Difference in the cumulative incidence of serious adverse events (SAE) after SMC administration between arms	Adverse events will be classified as serious or non-serious based on standardized AE grading scale	12 months
Secondary	Difference in human behavior on net use before and after ITN/meganet distribution	ITN use (e.g., sleeping under net in the previous night, sleeping indoors versus outdoors) will be assessed during cross-sectional surveys	12 months
Secondary	Difference in indoor and outdoor adjusted human biting rates between arms	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
Secondary	Difference in Anopheles biting trends between arms	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
Secondary	Acceptability of intervention package	Perceptions of intervention package and reasons for participation assessed through qualitative studies conducted throughout the study period	12 months
Secondary	Difference in proportion of refusals between arms	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
Secondary	Difference in crude coverage of chemoprevention strategies between arms	Crude coverage will be defined as the number of persons who received intervention divided by number of those targeted and eligible	12 months
Secondary	Difference in distribution coverage of chemoprevention strategies between arms	Distribution 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
Secondary	Cost per malaria case averted	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