Attractive Targeted Sugar Bait Phase III Trial in Zambia

NCT04800055 | Unknown DMC

• 2 other identifiers: 14600461460046-5
• Study Type: interventional
• Target: 3,480
• Locations: 1 country
• Sites: 1

Brief Summary

The trial will evaluate the efficacy of ATSB deployment plus universal coverage of a WHO core vector control (VC) interventions over two transmission seasons on a minimum 30% reduction in cohort clinical disease incidence, confirmed case incidence, and parasite prevalence, as compared with VC alone. Measurement of entomological outcomes, assessment of acceptability and barriers to uptake and consistent use of ATSB, safety and adverse event monitoring and estimation of the cost and cost-effectiveness of ATSB will also occur.

Conditions

Malaria; Malaria,Falciparum; Vector-Borne Transmission of Infection

Keywords

Malaria; Attractive Targeted Sugar Bait; vector control; Africa; Zambia

Outcome Measures

Primary Outcomes (1)

• Clinical malaria case incidence

  Clinical malaria case incidence measured by cohort and defined as fever (history of fever in the past 48 hours or an axillary temperature ≥37.5o C. at follow-up visit) plus a positive RDT in children ≥12 months and \<15 years in age.

  Seasonal (6 months)

Secondary Outcomes (4)

• Time to first infection

  Seasonal (6 months)

• Prevalence, detected by PCR

  6 weeks

• Prevalence, detected by RDT

  6 weeks

• Incidence rate of passively reported clinical malaria

  Seasonal (6 months)

Study Arms (2)

ATSB + VC intervention

EXPERIMENTAL

Arm 1 will receive ATSBs for up to two years.

Other: Attractive Targeted Sugar Bait

VC only

NO INTERVENTION

Arm 2 will receive the standard of care of universal vector control coverage.

Interventions

Attractive Targeted Sugar Bait OTHER

ATSBs will be installed on all structures of consenting households in intervention areas for six months according to instructions from the manufacturer. Monitoring assistants will be responsible for providing individual level household orientation for the ATSB and seeking informed consent. Prior to ATSB deployment, community sensitization activities will be conducted to prepare communities for the intervention and research activities. Where appropriate, local media may be used to disseminate messages to sensitize the community to the intervention and the research.

Also known as: ATSB

ATSB + VC intervention

Eligibility Criteria

• Age: 12 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Household resident
• ≥12 months and \<15 years of age at the time of enrollment
• If age 12 months - 6 years of age, parent or guardian provides consent for child's participant
• If age 7-14 years, parent or guardian provides consent for child's participant and child provides assent for participation

You may not qualify if:

• Residence within the buffer zone
• Age \<12 months or ≥15 years of age at the time of cohort enrollment
• Household contained a participant in the first cohort (for participation in the second cohort)
• Pregnant at the time of cohort enrollment. Pregnant adolescents are excluded because they are eligible for protection from infection through pregnancy standard of care - intermittent preventative therapy during pregnancy (IPTp), and to avoid undue discomfort with repeated blood sampling.
• Pregnancy at any time during the cohort study. Pregnancy will be identified in adolescents at enrollment and follow-up visits through a single question regarding pregnancy status during each cohort visit. When an adolescent indicates that she is pregnant or is unsure of her pregnancy status, she will no longer be followed for ongoing blood testing for the reasons noted above and will be censored in the analysis.
• Does not provide consent/assent required according to age to participate in the study

Sponsors & Collaborators

• PATH: lead
• Tulane University: collaborator
• Ministry of Health, Zambia: collaborator
• Macha Research Trust, Zambia: collaborator

Study Sites (1)

Kaoma District

Kaoma, Western Province, Zambia

Location

Related Publications (5)

• Mancuso B, Orange E, Eisele TP, Ashton RA, Littrell M, Matches M, Miller JM, Chanda J, Assefa S, Wagman J, Silumbe K, Hamainza B, Saili K, Slutsker L, Yukich J. Cost and cost-effectiveness of attractive targeted sugar baits (ATSB) in the context of a phase III cluster randomized control trial in Western Province, Zambia. Malar J. 2025 Dec 19. doi: 10.1186/s12936-025-05716-9. Online ahead of print.

  PMID: 41420162 DERIVED

• Ashton RA, Saili K, Chishya C, Banda Yikona H, Arnzen A, Orange E, Chitoshi C, Chulu J, Tobolo T, Ndalama F, Kyomuhangi I, Ngulube W, Moonga H, Chirwa J, Slutsker L, Wagman J, Chanda J, Miller J, Silumbe K, Hamainza B, Eisele TP, Yukich J, Littrell M. Efficacy of attractive targeted sugar bait stations against malaria in Western Province Zambia: epidemiological findings from a two-arm cluster randomized phase III trial. Malar J. 2024 Nov 15;23(1):343. doi: 10.1186/s12936-024-05175-8.

  PMID: 39548456 DERIVED

• Wagman J, Chanda B, Chanda J, Saili K, Orange E, Mambo P, Muyabe R, Kaniki T, Mwenya M, Ng'andu M, Sakala J, Ngulube W, Miller J, Arnzen A, Silumbe K, Mwaanga G, Simubali L, Mungo A, Mburu MM, Simulundu E, Mambwe B, Kasaro R, Mulube C, Mwenda M, Hamainza B, Ashton RA, Eisele TP, Harris AF, Entwistle J, Yukich J, Slutsker L, Burkot TR, Littrell M. Entomological effects of attractive targeted sugar bait station deployment in Western Zambia: vector surveillance findings from a two-arm cluster randomized phase III trial. Malar J. 2024 Jul 18;23(1):214. doi: 10.1186/s12936-024-05045-3.

  PMID: 39026236 DERIVED

• Mwaanga G, Ford J, Yukich J, Chanda B, Ashton RA, Chanda J, Munsanje B, Muntanga E, Mulota M, Simuyandi C, Mulala B, Simubali L, Saili K, Simulundu E, Miller J, Hamainza B, Orange E, Wagman J, Mburu MM, Harris AF, Entwistle J, Littrell M. Residual bioefficacy of attractive targeted sugar bait stations targeting malaria vectors during seasonal deployment in Western Province of Zambia. Malar J. 2024 May 29;23(1):169. doi: 10.1186/s12936-024-04990-3.

  PMID: 38811947 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; Malaria, Falciparum

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Malaria Technical Advisor

Model Details: An open-label two-arm cluster randomized controlled trial (CRCT) design will be used comparing ATSB + universal coverage with a WHO core vector control intervention vs universal coverage with VC alone (standard of care). Universal VC (mainly LLIN) will be ensured in both arms prior to start of the study and will serve as the standard of care. Arm 1 will receive ATSBs for up to two years. Arm 2 will receive the standard of care of universal vector control coverage.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 16, 2021
• Study Start: December 1, 2020
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

ZA (1)