A Phase 4 interventional study of Intervention package in Malaria, sponsored by PATH. Suspended at 1 site in Senegal. Open to participants aged 3 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by PATH · Phase 4, Interventional, and Prevention
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.
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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 4,600 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for daara:
Inclusion criteria for receiving DHA-PQ:
Additional inclusion criteria for receiving meganets:
Exclusion Criteria for receiving DHA-PQ:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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
Time frame: 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
Time frame: 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
Time frame: 12 months
Difference in cumulative incidence of grade 3+ adverse events after drug administration between arms
Defined as the number of grade 3+ AEs divided by the participant population who received at least one dose of drug.
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 12 months
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.
Time frame: 12 months
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
Time frame: 12 months
Acceptability of intervention package
Perceptions of intervention package and reasons for participation assessed through qualitative studies conducted throughout the study period
Time frame: 12 months
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).
Time frame: 12 months
Difference in distribution coverage of chemoprevention strategies between arms
Distribution coverage will be defined as the number of persons who received intervention divided by number of those targeted and eligible
Time frame: 12 months
Difference in crude coverage of chemoprevention strategies between arms
Crude 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)
Time frame: 12 months
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.
Time frame: 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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