Spatial Repellents for Malaria Control

NCT ID: NCT06122142

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2025-05-31

Brief Summary

The primary objective of the study is to demonstrate and quantify the effectiveness of a spatial repellent (SR) product, in reducing malaria infection in humans under operational program conditions in a humanitarian assistance context. The design will be a cluster Randomized Control Trial (cRCT) representing an operational research study.

Detailed Description

Spatial repellents (SRs) have been widely used for the prevention of mosquito bites, and preliminary findings suggest efficacy against both malaria and Aedes-borne viruses but their effectiveness in reducing mosquito borne diseases under operational use has never been evaluated. SRs have the potential of being critical tools in the prevention of mosquito borne diseases in contexts where typical vectors control strategies, such as Insecticide-Treated Nets (ITNs) and indoor residual spray (IRS), are inaccessible or underutilized such as among displaced peoples or in emergency relief settings. To address this knowledge gap, the Bidibidi refugee settlement in the Yumbe District of North West Uganda was selected as the study site to estimate the impact of the SR on malaria related outcomes under operational use conditions given ongoing humanitarian relief efforts. Children will be enrolled in 3 separate cohorts to establish effectiveness of SRs in reducing malaria infection in distribution channels. One cohort will estimate the direct effect of the SR distributed through a reference channel (study personnel distribution). The two remaining cohorts will estimate the protection of the SR distributed through a voucher channel and village health team (VHT) channel. Cohorts will be followed twice a month (approximately every 15 days) during the first scheduled household visit in the month, a blood sample will be taken for malaria rapid diagnostic test (RDT) (Monthly Visit #1); and, during the second scheduled household visit, a blood sample will only be taken if the participant has a recent history of fever (Monthly Visit #2). The incidence of malaria in each cohort will be estimated and compared to the reference cohort to determine the benefit of using an SR in an area with high, year-round transmission of malaria.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Study personnel distribution channel

SR product will be delivered by paid study personnel.

Group Type: ACTIVE_COMPARATOR

Transfluthrin - delivery by paid study personnel

Intervention Type: DEVICE

Passive emanator with formulated transfluthrin, SR product will be delivered by paid study personnel

Voucher distribution channel

Voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household.

Group Type: EXPERIMENTAL

Transfluthrin - delivery by voucher system

Intervention Type: DEVICE

Passive emanator with formulated transfluthrin, voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household.

Village health team distribution channel

Village health teams will distribute SR products.

Group Type: EXPERIMENTAL

Transfluthrin - delivery by village health teams

Intervention Type: DEVICE

Passive emanator with formulated transfluthrin, village health teams will distribute SR products.

Interventions

Transfluthrin - delivery by paid study personnel

Passive emanator with formulated transfluthrin, SR product will be delivered by paid study personnel

Intervention Type: DEVICE

Transfluthrin - delivery by voucher system

Passive emanator with formulated transfluthrin, voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household.

Intervention Type: DEVICE

Transfluthrin - delivery by village health teams

Passive emanator with formulated transfluthrin, village health teams will distribute SR products.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children ≥ 6 months to ≤ 59 months
• Children ≥ 6 months to ≤ 59 months with Hb > 7g/dL and no other serious illness
• Sleeps in cluster (i.e. study area) ≥ 90% of nights during any given month
• Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the Trial
• Provision of informed consent form (ICF) signed by the parent(s) or guardian

Exclusion Criteria

• Children < 6 months and > 59 months
• Children ≥ 6 months to ≤ 59 months with Hb ≤ 7g/dL with signs of other serious illness or Hb ≤ 7 g/dL with signs of clinical decompensation
• Sleeps in cluster (i.e. study area) < 90% of nights during any given month
• Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
• No provision of ICF signed by the parent(s) or guardian

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

S.C. Johnson & Son, Inc.

INDUSTRY

Sponsor Role: collaborator

Catholic Relief Services

OTHER

Sponsor Role: collaborator

Infectious Diseases Research Collaboration, Uganda

OTHER

Sponsor Role: collaborator

University of Notre Dame

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John P Grieco, Ph.D.

Role: STUDY_DIRECTOR

University of Notre Dame

Suzanne Van Hulle, M.H.S.

Role: PRINCIPAL_INVESTIGATOR

Catholic Relief Services

Locations

Catholic Relief Services

Kampala, , Uganda

Infectious Disease Research Collaboration

Kampala, , Uganda

Countries

Uganda

References

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Reference Type: BACKGROUND

PMID: 22583679 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22144448 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 24885993 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 18939693 (View on PubMed)

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Reference Type: BACKGROUND

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Morrison AC, Reiner RC Jr, Elson WH, Astete H, Guevara C, Del Aguila C, Bazan I, Siles C, Barrera P, Kawiecki AB, Barker CM, Vasquez GM, Escobedo-Vargas K, Flores-Mendoza C, Huaman AA, Leguia M, Silva ME, Jenkins SA, Campbell WR, Abente EJ, Hontz RD, Paz-Soldan VA, Grieco JP, Lobo NF, Scott TW, Achee NL. Efficacy of a spatial repellent for control of Aedes-borne virus transmission: A cluster-randomized trial in Iquitos, Peru. Proc Natl Acad Sci U S A. 2022 Jun 28;119(26):e2118283119. doi: 10.1073/pnas.2118283119. Epub 2022 Jun 23.

Reference Type: BACKGROUND

PMID: 35737833 (View on PubMed)

Ogoma SB, Moore SJ, Maia MF. A systematic review of mosquito coils and passive emanators: defining recommendations for spatial repellency testing methodologies. Parasit Vectors. 2012 Dec 7;5:287. doi: 10.1186/1756-3305-5-287.

Reference Type: BACKGROUND

PMID: 23216844 (View on PubMed)

Syafruddin D, Asih PBS, Rozi IE, Permana DH, Nur Hidayati AP, Syahrani L, Zubaidah S, Sidik D, Bangs MJ, Bogh C, Liu F, Eugenio EC, Hendrickson J, Burton T, Baird JK, Collins F, Grieco JP, Lobo NF, Achee NL. Efficacy of a Spatial Repellent for Control of Malaria in Indonesia: A Cluster-Randomized Controlled Trial. Am J Trop Med Hyg. 2020 Jul;103(1):344-358. doi: 10.4269/ajtmh.19-0554. Epub 2020 May 14.

Reference Type: BACKGROUND

PMID: 32431275 (View on PubMed)

The Republic of Uganda Ministry of Health. Annual Health Sector Performance Report Financial Year 2021/22. Ministry of Health, Uganda.

Reference Type: BACKGROUND

Uganda National Malaria Control Division (NMCD), Uganda Bureau of Statistics (UBOS), and ICF. 2019. 2018-19 Uganda Malaria Indicator Survey Atlas of Key Indicators. Kampala, Uganda, and Rockville, Maryland, USA: NMCD, UBOS, and ICF.

Reference Type: BACKGROUND

World Health Organization. Twelfth meeting of the WHO Vector Control Advisory Group. Geneva: World Health Organization; 2020.

Reference Type: BACKGROUND

Nakyaze E, Van Hulle S, Hembling J, Arinaitwe E, Mbodji M, Alwano MG, Lamwaka FC, Tukwasibwe S, Gonahasa S, Liu F, Grieco JP, Achee NL. Advancing spatial repellents for malaria control: effectiveness and cost-effectiveness of a spatial repellent under operational use in Northern Uganda-study protocol for a cluster randomized controlled trial. Trials. 2024 Aug 22;25(1):555. doi: 10.1186/s13063-024-08378-1.

Reference Type: DERIVED

PMID: 39175062 (View on PubMed)

Other Identifiers

23-05-7909

Identifier Type: -

Identifier Source: org_study_id