Attractive Targeted Sugar Bait Phase III Trial in Zambia

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT04800055
• Date of registration: 12/03/2021
• Prospective Registration: No
• Primary sponsor: PATH
• Public title: Attractive Targeted Sugar Bait Phase III Trial in Zambia
• Scientific title: Attractive Targeted Sugar Bait Phase III Trial in Zambia
• Date of first enrolment: December 1, 2020
• Target sample size: 3480
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04800055
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Zambia

Contacts

• Name: Kafula Silumbe, MPH

• Name: John M Miller, PhD

Key inclusion & exclusion criteria

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



Age minimum: 12 Months
Age maximum: 15 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Malaria,Falciparum

Vector-Borne Transmission of Infection

Intervention(s)

Other: Attractive Targeted Sugar Bait

Primary Outcome(s)

Clinical malaria case incidence [Time Frame: Seasonal (6 months)]

Secondary Outcome(s)

Incidence rate of passively reported clinical malaria [Time Frame: Seasonal (6 months)]

Prevalence, detected by PCR [Time Frame: 6 weeks]

Prevalence, detected by RDT [Time Frame: 6 weeks]

Time to first infection [Time Frame: Seasonal (6 months)]

Secondary ID(s)

1460046

1460046-5

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Macha Research Trust, Zambia

Ministry of Health, Zambia

Tulane University