MalariaNCT04800055
Attractive Targeted Sugar Bait Phase III Trial in Zambia
A study testing Attractive Targeted Sugar Bait in people with Malaria and Malaria,Falciparum, run by PATH at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Malaria,Falciparum, Vector-Borne Transmission of Infection
- What is being tested?
- Attractive Targeted Sugar Bait
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,480 participants
- Where
- 1 siteZambia
- Study dates
- 1 Dec 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
An open-label two-arm cluster randomized controlled trial (CRCT) design will be used comparing ATSB + LLINS vs LLINS alone (standard of care). A cluster trial design is indicated given the intended community-level effect of ATSBs on malaria transmission. Universal LLIN coverage 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 two years. Arm 2 will receive the standard of care of universal LLIN coverage.
Sixty clusters will be used for the trial per site, with 30 clusters allocated to the ATSB intervention plus universal LLIN coverage arm, and 30 clusters allocated to the control with standard of care arm, universal LLIN coverage. Restricted randomization will be used to randomize the 60 clusters to intervention and control arms. The incidence cohort and cross-sectional household surveys will each be powered to detect a 30% reduction in the malaria outcome over two years.
Primary aim:
- Quantify the efficacy of ATSBs for reducing P. falciparum clinical case incidence, parasite prevalence, community infection incidence, and health facility confirmed malaria case incidence.
Secondary aims include:
- Quantify the efficacy of ATSBs for reducing target malaria vector density, altering the population age structure by reducing longevity, and reducing sporozoite and entomological inoculation rates (EIR).
- Assess the durability of the ATSB.
- Assess community acceptance of ATSB.
- Identify barriers to high and effective ATSB coverage.
- Understand the impact of ATSB deployment on LLIN use.
- Document cost and cost-effectiveness of ATSB deployment.
- Being tested
- Attractive Targeted Sugar Bait
- Keywords
- Malaria, Attractive Targeted Sugar Bait, vector control, Africa, Zambia
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attractive Targeted Sugar BaitOther
Also called ATSB
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.
| Study group | Role | What they receive |
|---|---|---|
| ATSB + VC intervention | Experimental | Arm 1 will receive ATSBs for up to two years. Receives: Other: Attractive Targeted Sugar Bait |
| VC only | No intervention | Arm 2 will receive the standard of care of universal vector control coverage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Seasonal (6 months)
Secondary outcomes (4)
Time to first infection
Time to first infection measured among the cohort and defined as the time to first PCR infection among participants aged ≥12 months and <15 years of age.
Measured: Seasonal (6 months)
Prevalence, detected by PCR
Prevalence of malaria infection measured by the cross-sectional household survey among participants aged ≥6 and older, detected by PCR.
Measured: 6 weeks
Prevalence, detected by RDT
Prevalence of malaria infection measured by the cross-sectional household survey among participants aged ≥6 and older, detected by RDT (patent infection).
Measured: 6 weeks
Incidence rate of passively reported clinical malaria
Incidence rate of clinical malaria among participants of all ages, defined as the number of malaria confirmed cases (by RDT or microscopy) per 1,000 population per year, using routine data from health facilities linked to study clusters (i.e. by name of village of residence) and cluster population sizes for the denominator.
Measured: Seasonal (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Dec 2020
- Primary completion31 Jul 2023
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3,480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Tulane University, Ministry of Health, Zambia, Macha Research Trust, Zambia
- Responsible party
- Principal investigator, John M. Miller, PhD, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800055
- Sponsor's protocol ID
- 1460046
- Other IDs
- 1460046-5
- Status last verified
- Nov 2023
- First submitted
- 12 Mar 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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;25(1):54. doi: 10.1186/s12936-025-05716-9.
PubMed 41420162Ashton 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.
PubMed 39548456Wagman 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.
PubMed 39026236Mwaanga 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.
PubMed 38811947Attractive 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.
PubMed 35945599
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attractive Targeted Sugar Bait Phase III Trial in Zambia
- ClinicalTrials.gov ID
- NCT04800055
- Acronym / sponsor ID
- 1460046
- Keywords
- Malaria, Attractive Targeted Sugar Bait, vector control, Africa, Zambia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,480 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Tulane University, Ministry of Health, Zambia, Macha Research Trust, Zambia
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An open-label two-arm cluster randomized controlled trial (CRCT) design will be used comparing ATSB + LLINS vs LLINS alone (standard of care). A cluster trial design is indicated given the intended community-level effect of ATSBs on malaria transmission. Universal LLIN coverage 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 two years. Arm 2 will receive the standard of care of universal LLIN coverage.
Sixty clusters will be used for the trial per site, with 30 clusters allocated to the ATSB intervention plus universal LLIN coverage arm, and 30 clusters allocated to the control with standard of care arm, universal LLIN coverage. Restricted randomization will be used to randomize the 60 clusters to intervention and control arms. The incidence cohort and cross-sectional household surveys will each be powered to detect a 30% reduction in the malaria outcome over two years.
Primary aim:
- Quantify the efficacy of ATSBs for reducing P. falciparum clinical case incidence, parasite prevalence, community infection incidence, and health facility confirmed malaria case incidence.
Secondary aims include:
- Quantify the efficacy of ATSBs for reducing target malaria vector density, altering the population age structure by reducing longevity, and reducing sporozoite and entomological inoculation rates (EIR).
- Assess the durability of the ATSB.
- Assess community acceptance of ATSB.
- Identify barriers to high and effective ATSB coverage.
- Understand the impact of ATSB deployment on LLIN use.
- Document cost and cost-effectiveness of ATSB deployment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ATSB + VC intervention | Experimental | Other: Attractive Targeted Sugar BaitArm 1 will receive ATSBs for up to two years. |
| VC only | No intervention | –Arm 2 will receive the standard of care of universal vector control coverage. |
Who may qualify
- Ages
- 12 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attractive Targeted Sugar BaitAlso: ATSBATSBs 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. | Other | ATSB + VC intervention |
Primary outcome
Clinical malaria case incidence
Time frame: Seasonal (6 months)
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.
4 secondary outcomes
Time to first infection
Time frame: Seasonal (6 months)
Prevalence, detected by PCR
Time frame: 6 weeks
Prevalence, detected by RDT
Time frame: 6 weeks
Incidence rate of passively reported clinical malaria
Time frame: Seasonal (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 41420162Mancuso 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;25(1):54. doi: 10.1186/s12936-025-05716-9.
- Derived from this study: PubMed 39548456Ashton 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.
- Derived from this study: PubMed 39026236Wagman 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.
- Derived from this study: PubMed 38811947Mwaanga 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.
- Derived from this study: PubMed 35945599Attractive 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attractive Targeted Sugar Bait in people with Malaria and Malaria,Falciparum, run by PATH at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical malaria case incidence (time frame: Seasonal (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04800055, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.