Spatial Repellents for Malaria Control

Malaria Clinical Trial

— AEGIS Uganda  

Official title:

Advancing Spatial Repellents for Malaria Control: Effectiveness and Cost-Effectiveness of a Spatial Repellent Under Operational Use in Northern Uganda

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06122142
• Other study ID #: 23-05-7909
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: University of Notre Dame
• Contact: John P Grieco, Ph.D.
• Phone: 5746317572
• Email: jgrieco[@]nd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2160
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Malaria

Intervention

Device:
• Transfluthrin - delivery by paid study personnel
Passive emanator with formulated transfluthrin, SR product will be delivered by paid study personnel
• 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.
• Transfluthrin - delivery by village health teams
Passive emanator with formulated transfluthrin, village health teams will distribute SR products.

Locations

Country	Name	City	State
Uganda	Catholic Relief Services	Kampala
Uganda	Infectious Disease Research Collaboration	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
University of Notre Dame	Catholic Relief Services, Infectious Diseases Research Collaboration, Uganda, SC Johnson, A Family Company

Country where clinical trial is conducted

Uganda, 

References & Publications (11)

Achee NL, Bangs MJ, Farlow R, Killeen GF, Lindsay S, Logan JG, Moore SJ, Rowland M, Sweeney K, Torr SJ, Zwiebel LJ, Grieco JP. Spatial repellents: from discovery and development to evidence-based validation. Malar J. 2012 May 14;11:164. doi: 10.1186/1475-2875-11-164. — View Citation

Hamel MJ, Otieno P, Bayoh N, Kariuki S, Were V, Marwanga D, Laserson KF, Williamson J, Slutsker L, Gimnig J. The combination of indoor residual spraying and insecticide-treated nets provides added protection against malaria compared with insecticide-treat — View Citation

Hill N, Zhou HN, Wang P, Guo X, Carneiro I, Moore SJ. A household randomized, controlled trial of the efficacy of 0.03% transfluthrin coils alone and in combination with long-lasting insecticidal nets on the incidence of Plasmodium falciparum and Plasmodi — View Citation

Kawada H, Temu EA, Minjas JN, Matsumoto O, Iwasaki T, Takagi M. Field evaluation of spatial repellency of metofluthrin-impregnated plastic strips against Anopheles gambiae complex in Bagamoyo, coastal Tanzania. J Am Mosq Control Assoc. 2008 Sep;24(3):404- — View Citation

Lucas JR, Shono Y, Iwasaki T, Ishiwatari T, Spero N, Benzon G. U.S. laboratory and field trials of metofluthrin (SumiOne) emanators for reducing mosquito biting outdoors. J Am Mosq Control Assoc. 2007 Mar;23(1):47-54. doi: 10.2987/8756-971X(2007)23[47:ULA — View Citation

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- — View Citation

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. — View Citation

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 — View Citation

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

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.

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of SR against malaria infection (both first-time and recurrent).	Measured by rapid diagnostic tests in children aged between 6 months to 59 months.	12 months
Secondary	Cost-effectiveness of SR distribution.	Measure cost of SR implementation in relation to manufacturing, efficacy, and coverage to model projections of cost-effectiveness.	12 months
Secondary	Adverse Events and Serious Adverse Events.	Measured by solicited and unsolicited reports during the intervention period. Mean, minimum and maximum frequency and percentage of Adverse Events and Serious Adverse Eventss across clusters among enrolled subjects will be summarized by distribution channel arm.	12 months