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Community-led Responses for Elimination: Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration

Community-led Responses for Elimination (CoRE): A Cluster Randomized Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration in Malaria Elimination Areas in Southern Province Zambia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02654912
Acronym
CORE Zambia
Enrollment
8682
Registered
2016-01-13
Start date
2016-02-29
Completion date
2020-07-31
Last updated
2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

malaria, elimination, surveillance and response, dihydroartemisinin+piperaquine

Brief summary

This study is designed to compare the effectiveness of reactive focal drug administration (RFDA) using dihydroartemisinin+piperaquine (DHAP) versus reactive focal test and treat (RFTAT) using artemether+lumefantrine (AL) as a routine process for identifying and eliminating malaria transmission as measured through achieving zero seropositivity in children under five in Southern Province, Zambia. These two strategies are potential candidates for expanded malaria operational surveillance and elimination for low malaria transmission areas.

Detailed description

The study is a cluster randomized controlled trial designed to evaluate the impact of RFDA intervention against current standard of care for the impact on seropositivity in children under five years, passive surveillance for confirmed malaria case incidence, and elimination of transmission from hotspots. It will be conducted among a background population of \ 130,000 people in \ 30,000 households in 16 health center catchment areas across several districts in Southern Province. The government of Zambia is pursuing malaria elimination as a national goal on an accelerated timeline and this trial will help evaluate two treatment-based strategies for supporting malaria elimination. The secondary objectives of the study include: 1). Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing rapid diagnostic test (RDT) confirmed malaria incidence through passive case detection at health facilities; 2). Compare the effectiveness of RFDA using DHAP with RFTAT using AL in reducing the prevalence of malaria and preventing re-infection in individuals receiving reactive responses; 3). Compare the cost-effectiveness of RFDA using DHAP with RFTAT using AL in reducing the burden of malaria in the community; 4). Measure the proportion of P. falciparum infections likely attributable to importation and local transmission using parasite genotyping as well as defining genotype spatial distribution; 5). Assess the utility of using serology to measure short term changes in malaria transmission and evaluate malaria elimination programs; and 6). Assess the feasibility of using remotely sensed malaria risk maps to identify areas with higher potential for local malaria transmission.

Interventions

DRUGReactive Focal Drug Administration

This is the experimental arm and is described by a reactive response to passively detected index case of malaria. The reactive response consists of treating all individuals within a defined radius of each RDT-confirmed incident malaria case with dihydroartemisinin-piperaquine (DHAP).

Sponsors

Ministry of Health, Zambia
CollaboratorOTHER_GOV
AKROS Global Health
CollaboratorUNKNOWN
PATH
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
Yes

Inclusion criteria

* anyone not excluded and consenting

Exclusion criteria

* contraindications from manufacturer for medications including currently taking haloperidol, artane, Phenergan (Promethazine), chlorpromazine, erythromycin, Azithromycin, clarithromycin, Ketoconazole, fluconazole, mefloquine (as prophylaxis), lumefantrine (in Coartem), quinine, Septrin * anyone seriously ill * currently taking antimalarial medicines * allergy to artemisinin drugs * pregnant women in first trimester * children under 3 months of age * reported heart condition

Design outcomes

Primary

MeasureTime frameDescription
Malaria seropositivity in children under five24 monthsMalaria seropositivity in children under five after two-year intervention within health center catchment areas

Secondary

MeasureTime frameDescription
Incidence of malaria confirmed by RDT or microscopy as measured through passive case detection at health posts and health centers24 monthsQuality-improved incidence of malaria data confirmed by malaria rapid diagnostic test (RDT) or microscopy as measured through passive case detection at health posts and health centers in the study area.
PCR parasite prevalence among individuals participating at 0, 30 and 90 days following a reactive research response for a period of 24 months24 monthsPolymerase Chain Reaction (PCR)-based testing for malaria parasite prevalence of individuals participating in each community at 0, 30 and 90 days following a reactive research response for a period of 24 months

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026