Evaluating ATSBs for Malaria Reduction in Kenya

NCT05219565 | Completed DMC

• 1 other identifier: 21-027
• Study Type: interventional
• Target: 2,962
• Locations: 1 country
• Sites: 9

Brief Summary

The effectiveness of long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) in western Kenya are threatened by insecticide resistance and vector behaviour changes toward early evening and outdoor biting malaria vectors. New tools to control malaria are needed to reduce and even interrupt malaria transmission. Attractive Targeted Sugar Bait (ATSB) is a promising new intervention designed to attract and kill mosquitoes, including those that IRS and LLINs do not effectively target. The ATSB 'bait stations' are A4-sized panels containing thickened fruit syrup laced with a neonicotinoid insecticide, dinotefuran, to attract and kill the foraging vectors. Entomological field trials in western Mali showed that ATSBs successfully reduce mosquito densities and longevity and thus have the potential to reduce malaria transmission. In Kenya, the investigators will conduct an open-label cluster-randomized controlled trial in 80 village clusters (40 per arm) to evaluate the effect of ATSBs on the burden of malaria. During two years, households in half of these village clusters will receive two or three ATSB bait stations per household structure on exterior walls approximately 1.8 meters above the ground. ATSBs will be replaced every six months. The primary outcome will be the incidence of clinical malaria in children aged 1-\<15 years enrolled in a prospective cohort followed monthly for about six months each during a 2-year period. Secondary outcomes include malaria infection prevalence assessed by rapid diagnostic tests through household surveys and the case burden of clinical malaria assessed by passive facility-based and community-based surveillance. The study includes entomological monitoring and nested acceptability, feasibility, and health economics studies. The stand-alone trial in western Kenya is a part of a multi-country ATSB consortium conducting similar trials in Zambia and Mali.

Conditions

Malaria

Keywords

ATSB; Malaria; Kenya

Outcome Measures

Primary Outcomes (1)

• Clinical malaria

  The incidence rate of clinical malaria defined as current fever (axillary temperature of ≥37.5°C) or history of fever in last 48 hours and a positive rapid diagnostic test (RDT, pLDH or HRP2), in children aged 1-\<15 years enrolled in the cohort study

  Two years

Secondary Outcomes (25)

• Time to first malaria infection by PCR

  Two years

• Malaria infection incidence by RDT (pLDH)

  Two years

• Malaria infection prevalence by RDT (pLDH)

  Two years

• Incidence of malaria illness (passive surveillance)

  Two years

• Incidence of non-malaria illness (cohort)

  Two years

Study Arms (2)

Attractive Targeted Sugar Bait (ATSB)

EXPERIMENTAL

Clusters within the ATSB arm will have 2 ATSBs hung on all eligible structures in the cluster where consent from the corresponding compound has been given.

Device: Attractive Targeted Sugar Bait (ATSB)

Control

NO INTERVENTION

Clusters within the control arm will not receive ATSBs.

Interventions

Attractive Targeted Sugar Bait (ATSB) DEVICE

An ATSB is a A4-sized panel containing thickened fruit syrup laced with a neonicotinoid insecticide, dinotefuran. The syrup-insecticide mixture is covered with a protective membrane that allows mosquitoes to feed through the membrane while preventing non-target organisms from feeding. This device is designed to attract and kill mosquitoes.

Also known as: Attractive Toxic Sugar Bait

Attractive Targeted Sugar Bait (ATSB)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A grouping of contiguous rural villages in Alego-Usonga and Rarieda sub-counties of Siaya County
• A minimum of 200 households

You may not qualify if:

• Hard to reach in the rainy season
• Refusal to participate by village elders
• A resident of a household within the core area of a study cluster, defined as living in the household in the recent four months and planning to live in the same household for the next 6.5 months
• Aged ≥ 1 year and \< 15 years at the time of enrollment
• Written informed consent and/or assent
• A confirmed or suspected pregnancy. Pregnant women are excluded because they are eligible for intermittent preventive treatment of malaria in pregnancy (IPTp).
• Taking daily cotrimoxazole prophylaxis (because this has antimalarial effects)
• Known sickle cell disease (because they received antimalarial prophylaxis)
• Contraindication to artemether-lumefantrine, the medication used for parasite clearance
• Households located within one of the 40 clusters (core or buffer area) randomly allocated to the trial intervention arm with a least one permanent resident
• Refusal of consent by the head-of-household to deploy ATSB on the outer walls (intervention villages only)
• Vacated compounds
• Household located within the core area of the cluster
• Head of household or his/her representative is at least 18 years of age
• Written informed consent for the collection of entomological data by the head of household or representative

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• Kenya Medical Research Institute: collaborator
• Centers for Disease Control and Prevention: collaborator
• PATH: collaborator
• Kenya Ministry of Health: collaborator

Study Sites (9)

Naya Health Centre

Siaya, Siaya County, 20200, Kenya

Location

Benga Dispensary

Siaya, Siaya County, Kenya

Location

Boro Dispensary

Siaya, Siaya County, Kenya

Location

Manyuanda Health Centre

Siaya, Siaya County, Kenya

Location

Nyadhi Dispensary

Siaya, Siaya County, Kenya

Location

Ong'ielo Model Health Centre

Siaya, Siaya County, Kenya

Location

Rabar Dispensary

Siaya, Siaya County, Kenya

Location

Rageng'ni Dispensary

Siaya, Siaya County, Kenya

Location

Rambugu Dispensary

Siaya, Siaya County, Kenya

Location

Related Publications (17)

• Huho B, Briet O, Seyoum A, Sikaala C, Bayoh N, Gimnig J, Okumu F, Diallo D, Abdulla S, Smith T, Killeen G. Consistently high estimates for the proportion of human exposure to malaria vector populations occurring indoors in rural Africa. Int J Epidemiol. 2013 Feb;42(1):235-47. doi: 10.1093/ije/dys214. Epub 2013 Feb 9.

  PMID: 23396849 BACKGROUND

• Amek N, Bayoh N, Hamel M, Lindblade KA, Gimnig JE, Odhiambo F, Laserson KF, Slutsker L, Smith T, Vounatsou P. Spatial and temporal dynamics of malaria transmission in rural Western Kenya. Parasit Vectors. 2012 Apr 28;5:86. doi: 10.1186/1756-3305-5-86.

  PMID: 22541138 BACKGROUND

• Moiroux N, Damien GB, Egrot M, Djenontin A, Chandre F, Corbel V, Killeen GF, Pennetier C. Human exposure to early morning Anopheles funestus biting behavior and personal protection provided by long-lasting insecticidal nets. PLoS One. 2014 Aug 12;9(8):e104967. doi: 10.1371/journal.pone.0104967. eCollection 2014.

  PMID: 25115830 BACKGROUND

• Sougoufara S, Diedhiou SM, Doucoure S, Diagne N, Sembene PM, Harry M, Trape JF, Sokhna C, Ndiath MO. Biting by Anopheles funestus in broad daylight after use of long-lasting insecticidal nets: a new challenge to malaria elimination. Malar J. 2014 Mar 28;13:125. doi: 10.1186/1475-2875-13-125.

  PMID: 24678587 BACKGROUND

• Killeen GF. Characterizing, controlling and eliminating residual malaria transmission. Malar J. 2014 Aug 23;13:330. doi: 10.1186/1475-2875-13-330.

  PMID: 25149656 BACKGROUND

• Killeen GF, Marshall JM, Kiware SS, South AB, Tusting LS, Chaki PP, Govella NJ. Measuring, manipulating and exploiting behaviours of adult mosquitoes to optimise malaria vector control impact. BMJ Glob Health. 2017 Apr 26;2(2):e000212. doi: 10.1136/bmjgh-2016-000212. eCollection 2017.

  PMID: 28589023 BACKGROUND

• Zhu L, Muller GC, Marshall JM, Arheart KL, Qualls WA, Hlaing WM, Schlein Y, Traore SF, Doumbia S, Beier JC. Is outdoor vector control needed for malaria elimination? An individual-based modelling study. Malar J. 2017 Jul 3;16(1):266. doi: 10.1186/s12936-017-1920-y.

  PMID: 28673298 BACKGROUND

• Traore MM, Junnila A, Traore SF, Doumbia S, Revay EE, Kravchenko VD, Schlein Y, Arheart KL, Gergely P, Xue RD, Hausmann A, Beck R, Prozorov A, Diarra RA, Kone AS, Majambere S, Bradley J, Vontas J, Beier JC, Muller GC. Large-scale field trial of attractive toxic sugar baits (ATSB) for the control of malaria vector mosquitoes in Mali, West Africa. Malar J. 2020 Feb 14;19(1):72. doi: 10.1186/s12936-020-3132-0.

  PMID: 32059671 BACKGROUND

• Beier JC, Muller GC, Gu W, Arheart KL, Schlein Y. Attractive toxic sugar bait (ATSB) methods decimate populations of Anopheles malaria vectors in arid environments regardless of the local availability of favoured sugar-source blossoms. Malar J. 2012 Feb 1;11:31. doi: 10.1186/1475-2875-11-31.

  PMID: 22297155 BACKGROUND

• Fiorenzano JM, Koehler PG, Xue RD. Attractive Toxic Sugar Bait (ATSB) For Control of Mosquitoes and Its Impact on Non-Target Organisms: A Review. Int J Environ Res Public Health. 2017 Apr 10;14(4):398. doi: 10.3390/ijerph14040398.

  PMID: 28394284 BACKGROUND

• Marshall JM, White MT, Ghani AC, Schlein Y, Muller GC, Beier JC. Quantifying the mosquito's sweet tooth: modelling the effectiveness of attractive toxic sugar baits (ATSB) for malaria vector control. Malar J. 2013 Aug 23;12:291. doi: 10.1186/1475-2875-12-291.

  PMID: 23968494 BACKGROUND

• Pocock SJ. When (not) to stop a clinical trial for benefit. JAMA. 2005 Nov 2;294(17):2228-30. doi: 10.1001/jama.294.17.2228. No abstract available.

  PMID: 16264167 BACKGROUND

• Protopopoff N, Mosha JF, Lukole E, Charlwood JD, Wright A, Mwalimu CD, Manjurano A, Mosha FW, Kisinza W, Kleinschmidt I, Rowland M. Effectiveness of a long-lasting piperonyl butoxide-treated insecticidal net and indoor residual spray interventions, separately and together, against malaria transmitted by pyrethroid-resistant mosquitoes: a cluster, randomised controlled, two-by-two factorial design trial. Lancet. 2018 Apr 21;391(10130):1577-1588. doi: 10.1016/S0140-6736(18)30427-6. Epub 2018 Apr 11.

  PMID: 29655496 BACKGROUND

• Gimnig JE, Walker ED, Otieno P, Kosgei J, Olang G, Ombok M, Williamson J, Marwanga D, Abong'o D, Desai M, Kariuki S, Hamel MJ, Lobo NF, Vulule J, Bayoh MN. Incidence of malaria among mosquito collectors conducting human landing catches in western Kenya. Am J Trop Med Hyg. 2013 Feb;88(2):301-8. doi: 10.4269/ajtmh.2012.12-0209. Epub 2012 Dec 18.

  PMID: 23249685 BACKGROUND

• Ogwang C, Samuels AM, McDermott DP, Kamau A, Lesosky M, Obiet K, Janssen JM, Odongo W, Gimnig JE, Gutman JR, Schultz JS, Towett O, Seda B, Chepkirui M, Muchoki M, Omondi S, Kosgei J, Polo B, Aduwo F, Otieno K, Donnelly MJ, Kariuki S, Ochomo E, Kuile FT, Staedke SG. Attractive targeted sugar baits for malaria control in western Kenya (ATSB-Kenya) - Effect of ATSBs on epidemiologic and entomologic indicators: A Phase III, open-label, cluster-randomised, controlled trial. PLOS Glob Public Health. 2025 Jun 26;5(6):e0004230. doi: 10.1371/journal.pgph.0004230. eCollection 2025.

  PMID: 40570028 DERIVED

• Kamau A, Obiet K, Ogwang C, McDermott DP, Lesosky M, Janssen J, Odongo W, Gutman JR, Schultz JS, Nicholas W, Seda B, Chepkirui M, Aduwo F, Towett O, Otieno K, Donnelly MJ, Ochomo E, Kariuki S, Samuels AM, O Ter Kuile F, Staedke SG. Attractive targeted sugar baits for malaria control in western Kenya (ATSB-Kenya): enrolment characteristics of cohort children and households. Malar J. 2024 Dec 30;23(1):403. doi: 10.1186/s12936-024-05234-0.

  PMID: 39736740 DERIVED

• Attractive Targeted Sugar Bait Phase III Trial Group. Attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia. Trials. 2022 Aug 9;23(1):640. doi: 10.1186/s13063-022-06555-8.

  PMID: 35945599 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Aaron Samuels, MD, MHS

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Eric Ochomo

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Using restricted randomization criteria, eighty clusters will be randomized 1:1 to either the intervention arm (ATSBs deployed throughout the cluster) or the control arm. The clusters will be followed in parallel for two years. In year one the first and second cohort were enrolled and followed up over 6 months each. In year 2, the third cohort was enrolled and followed up over 1 year.

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: February 2, 2022
• Study Start: March 7, 2022
• Primary Completion: March 21, 2024
• Study Completion: April 24, 2024
• Last Updated: June 10, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The full protocol and SAP will be published within the next 2 years. The individual de-identified data when data analysis is completed, within 6 months of trial completion.
• Access Criteria: A Data Access Committee will consider all requests for data for secondary analysis to ensure that the use of data is within the terms of consent and ethics approval.

Locations

KE (9)