Attractive Targeted Sugar Bait Phase III Trial in Zambia

Not Applicable

Active, not recruiting

• Conditions: Malaria,Falciparum; Vector-Borne Transmission of Infection; Malaria
• Interventions: Other: Attractive Targeted Sugar Bait

• Registration Number: NCT04800055
• Lead Sponsor: PATH

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.

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 Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-16
• Primary Completion: 2023-07-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3480

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATSB + VC intervention	Attractive Targeted Sugar Bait	Arm 1 will receive ATSBs for up to two years.

Primary Outcome Measures

Name	Time	Method
Clinical malaria case incidence	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence, detected by RDT	6 weeks	Prevalence of malaria infection measured by the cross-sectional household survey among participants aged ≥6 and older, detected by RDT (patent infection).
Prevalence, detected by PCR	6 weeks	Prevalence of malaria infection measured by the cross-sectional household survey among participants aged ≥6 and older, detected by PCR.
Time to first infection	Seasonal (6 months)	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.
Incidence rate of passively reported clinical malaria	Seasonal (6 months)	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.

Trial Locations

Locations (1)

Kaoma District; 🇿🇲 Kaoma, Western Province, Zambia