Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06225297
Other study ID # RES-00634
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04601714 - Baseline Cohort Malaria Morbidity Study
Withdrawn NCT04020653 - A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria Phase 2
Terminated NCT04368910 - Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria Phase 3
Completed NCT03641339 - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans N/A
Completed NCT02544048 - Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
Completed NCT00527163 - Role of Nitric Oxide in Malaria
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Active, not recruiting NCT04704674 - Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
Completed NCT03276962 - Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age Phase 2
Completed NCT04966871 - Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults Phase 1
Completed NCT00289185 - Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants Phase 2
Recruiting NCT03937817 - Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Active, not recruiting NCT06153862 - Africa Ready Malaria Screening N/A
Completed NCT04545905 - Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
Recruiting NCT06278181 - Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
Withdrawn NCT02793388 - A Trial on Supervised Primaquine Use in Ethiopia Phase 4
Completed NCT02909712 - Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania Phase 2
Withdrawn NCT02793414 - Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
Completed NCT02793622 - Prevention of Malaria in HIV-uninfected Pregnant Women and Infants Phase 3
Completed NCT02536222 - Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts Phase 4