Clinical trial NCT02654912: Community-led Responses for Elimination: Controlled Trial of Reactive Case Detection Versus Reactive Drug Administration
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: malaria
elimination
surveillance and response
dihydroartemisinin+piperaquine
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Zambia
name: AKROS Global Health
First posted: 2016-01-13
Enrollment: 8682
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Malaria seropositivity in children under five
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of malaria confirmed by RDT or microscopy as measured through passive case detection at health posts and health centers
timeFrame: 24 months
measure: PCR parasite prevalence among individuals participating at 0, 30 and 90 days following a reactive research response for a period of 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Choma
country: Zambia
facility: Southern province medical office
state: Southern
Study officials:
affiliation: Akros
name: Daniel Bridges, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bridges DJ, Miller JM, Chalwe V, Moonga H, Hamainza B, Steketee R, Silumbe K, Nyangu J, Larsen DA. Community-led Responses for Elimination (CoRE): a study protocol for a community randomized controlled trial assessing the effectiveness of community-level, reactive focal drug administration for reducing Plasmodium falciparum infection prevalence and incidence in Southern Province, Zambia. Trials. 2017 Nov 2;18(1):511. doi: 10.1186/s13063-017-2249-0.