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

P

People Acting To Help (PATH)

Status and phase

Active, not recruiting
Phase 4

Conditions

Malaria

Treatments

Combination Product: Intervention package

Study type

Interventional

Funder types

Other

Identifiers

NCT06225297
RES-00634

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,600 patients

Sex

All

Ages

3+ months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

4,600 participants in 2 patient groups

Intervention clusters
Experimental group
Description:
will receive the following interventions: Distribution of meganets, defined as conventional insecticide-treated nets (ITNs) sewn together to adapt to taalibés sleeping conditions Three monthly cycles of targeted chemoprevention with dihydroartemisinin-piperaquine (DHA-PQ) for all daara residents, regardless of resident age Social behavior change (SBC) to promote intervention uptake
Treatment:
Combination Product: Intervention package
Control clusters
No Intervention group
Description:
will receive standard-of-care malaria interventions, which include: Distribution of conventional ITNs Three monthly cycles of SMC with sulfadoxine-pyrimethamine- amodiaquine (SP-AQ) given to children 3-120 months

Trial contacts and locations

1

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Central trial contact

Maia Cullen

Data sourced from clinicaltrials.gov

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