Clinical trial NCT06122142: Spatial Repellents for Malaria Control
Official title: Advancing Spatial Repellents for Malaria Control: Effectiveness and Cost-Effectiveness of a Spatial Repellent Under Operational Use in Northern Uganda
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Malaria
Keywords: Malaria
Spatial Repellent
Transfluthrin
Vector-borne diseases
Mosquito vectors
Incidence
Lead sponsor: University of Notre Dame
Sponsor class: OTHER
Collaborators: name: S.C. Johnson & Son, Inc.
name: Catholic Relief Services
name: Infectious Diseases Research Collaboration, Uganda
First posted: 2023-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design will be a prospective cluster Randomized Control Trial (cRCT)
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Effectiveness of SR against malaria infection (both first-time and recurrent).
timeFrame: 12 months
Secondary outcomes:
measure: Cost-effectiveness of SR distribution.
timeFrame: 12 months
measure: Adverse Events and Serious Adverse Events.
timeFrame: 12 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Catholic Relief Services
city: Kampala
country: Uganda
facility: Infectious Disease Research Collaboration
Study officials:
affiliation: University of Notre Dame
name: John P Grieco, Ph.D.
role: STUDY_DIRECTOR
affiliation: Catholic Relief Services
name: Suzanne Van Hulle, M.H.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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-treated nets alone. Am J Trop Med Hyg. 2011 Dec;85(6):1080-6. doi: 10.4269/ajtmh.2011.10-0684.
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 Plasmodium vivax malaria in Western Yunnan Province, China. Malar J. 2014 May 31;13:208. doi: 10.1186/1475-2875-13-208.
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):404-9. doi: 10.2987/5743.1.
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:ULAFTO]2.0.CO;2.
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-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.
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.
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 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.
citation: The Republic of Uganda Ministry of Health. Annual Health Sector Performance Report Financial Year 2021/22. Ministry of Health, Uganda.
citation: 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.
citation: World Health Organization. Twelfth meeting of the WHO Vector Control Advisory Group. Geneva: World Health Organization; 2020.