Evaluation of IR3535 as a Spatial Repellent for Malaria Control.

NCT04419766 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-03-30

No results posted yet for this study

Summary

Mozambique contributes with 5% of global malaria cases, and despite control efforts the Sofala province continues to experience a high burden of malaria. The resistance to insecticides and changes in vector habits can compromise the use of common vector control tools. The use of spatial repellents is thus an interesting alternative, as it does not exert selective pressure on resistance genes or eliminate other insects with impact on biodiversity. IR3535 is a non-toxic repellent and if used at community level can extend protection to outdoor biting.

Hypothesis: Using the IR3535 repellent for indoor and outdoor spraying will reduce the prevalence of malaria and reduce vector density and infection.

An experimental Before-After-Control-Intervention will be carried out with two groups: a) Intervention (Tambai Q2 and Q6): with intra and extra-household spraying with IR3535 and b) Control (Tambai Q3 and Q4): without spraying. Tambai is acommunity of Bebedo, Nhamatanda, Sofala, Mozambique. The mosquito distribution, diversity, density and sporozoite rate will be monitored indoors and outdoors in both communities for 2 years. The prevalence of malaria will be determined in under five years old children at the beginning, the end of the 1st year and at the end of the study. Additionally, cross-sectional studies with a mixed approach assessing the community knowledge, attitudes and practices (KAP) will be carried out to detect gaps that persist at the community level. Heads of households and health professionals will be interviewed at the beginning of the study, the end of 1st year and at the end of the study. The data will be analyzed using SPSS and R software packages. For matching situations (before and after), the McNemar test will be used to ascertain statistical significance. Generalized Linear Models (GLM) will be used to jointly analyze several explanatory variables. Linear Mixed Models (LMM) and Generalized Estimation Equation (GEE) models will be used to compare longitudinal data. The prevalence of malaria and entomological indices relevant for transmission are expected to decrease with the intervention while community knowledge on malaria and its control are expected to increase.

Conditions

Interventions

OTHER

IR3535 (3-(N-acetyl-N-butyl) aminopropionic acid ethyl ester) house spraying

The spraying will be performed monthly during the first 3 months, bimonthly during the next 6 months and then quarterly thereafter. The spraying will be carried out inside and outside the houses during the morning.

Sponsors & Collaborators

  • Centro de Investigação Operacional da Beira, Mozambique

    collaborator UNKNOWN
  • Fundação Belmiro de Azevedo, Portugal

    collaborator UNKNOWN
  • Universidade Nova de Lisboa

    lead OTHER

Principal Investigators

  • Henrique Silveira, PhD · Universidade Nova de Lisboa, Portugal

  • Joaquim Lequechane, Lic · Centro de Investigação Operacional da Beira, INS, MISAU, Mozambique

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2025-07-31
Completion
2025-10-31

Countries

  • Mozambique

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04419766 on ClinicalTrials.gov