MalariaPhase 4NCT06225297
Evaluation of Vector and Chemoprevention-based Interventions to Reduce Malaria Burden in Urban Daaras of Touba, Senegal
A Phase 4 study testing Intervention package in people with Malaria, run by PATH at 1 site in Senegal.
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)… Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Intervention package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,600 participants
- Where
- 1 siteSenegal
- Study dates
- 19 Jan 2024to Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Intervention package
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention packageCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (10)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 12 months
Acceptability of intervention package
Perceptions of intervention package and reasons for participation assessed through qualitative studies conducted throughout the study period
Measured: 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).
Measured: 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
Measured: 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)
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start19 Jan 2024
- Primary completion23 Dec 2024
- Study completionFeb 2025 (estimated)
Why it stopped: Executive order signed on January 20th 20254 to "reevaluate and realign US foreign aid", resulting in USAID funding freeze
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- L'université de Thiès, University of California, San Francisco, Tulane University
- Responsible party
- Sponsor
- Investigators
- Jean Louis Ndiaye, Principal investigator, L'université de Thiès
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225297
- Sponsor's protocol ID
- RES-00634
- Status last verified
- Feb 2025
- First submitted
- 8 Jan 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vector and Chemoprevention-based Interventions to Reduce Malaria Burden in Urban Daaras of Touba, Senegal
- ClinicalTrials.gov ID
- NCT06225297
- Acronym / sponsor ID
- RES-00634
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Executive order signed on January 20th 20254 to "reevaluate and realign US foreign aid", resulting in USAID funding freeze
- Enrolment
- 4,600 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- L'université de Thiès, University of California, San Francisco, Tulane University
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- Feb 2025 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention clusters | Experimental | Combination Product: Intervention packagewill 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 |
| 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 |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention packageIntervention 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. | Combination product | Intervention clusters |
Primary outcome
Difference in cumulative incidence of clinical malaria confirmed by rapid diagnostic test (RDT) between arms
Time frame: monthly basis over 12 months
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
Difference in change in prevalence of microscopy-confirmed infection between arms
Time frame: 12 months
Prevalence will be defined as the proportion of individuals with microscopy-confirmed infection assessed during the endline survey
Difference in pre-post change in prevalence of PCR-confirmed infection between arms
Time frame: 12 months
Prevalence will be defined as the proportion of individuals with PCR-confirmed infection, assessed during cross-sectional surveys
10 secondary outcomes
Difference in cumulative incidence of grade 3+ adverse events after drug administration between arms
Time frame: 12 months
Difference in the cumulative incidence of serious adverse events (SAE) after SMC administration between arms
Time frame: 12 months
Difference in human behavior on net use before and after ITN/meganet distribution
Time frame: 12 months
Difference in indoor and outdoor adjusted human biting rates between arms
Time frame: 12 months
Difference in Anopheles biting trends between arms
Time frame: 12 months
Acceptability of intervention package
Time frame: 12 months
Difference in proportion of refusals between arms
Time frame: 12 months
Difference in distribution coverage of chemoprevention strategies between arms
Time frame: 12 months
Difference in crude coverage of chemoprevention strategies between arms
Time frame: 12 months
Cost per malaria case averted
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Louis Ndiaye principal investigator
L'université de Thiès
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intervention package in people with Malaria, run by PATH at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in cumulative incidence of clinical malaria confirmed by rapid diagnostic test (RDT) between arms (time frame: monthly basis over 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.