Status:
UNKNOWN
Attractive Targeted Sugar Bait Phase III Trial in Zambia
Lead Sponsor:
PATH
Collaborating Sponsors:
Tulane University
Ministry of Health, Zambia
Conditions:
Malaria
Malaria,Falciparum
Eligibility:
All Genders
12-15 years
Phase:
NA
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 clini...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
3480 Patients enrolled
Trial Details
Trial ID
NCT04800055
Start Date
December 1 2020
End Date
December 31 2023
Last Update
November 18 2023
Active Locations (1)
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1
Kaoma District
Kaoma, Western Province, Zambia