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

February 2, 2021 updated by: PATH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8682

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
    • Southern
      • Choma, Southern, Zambia
        • Southern province medical office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reactive 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).
Drug: Reactive 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).
No Intervention: Reactive Focal Test and Treat
This is the current standard of care in Southern Province and is described by a reactive response to passively detected index case of malaria. The reactive response consists of testing all individuals within a defined radius of each RDT-confirmed incident malaria case with an RDT and treating all positive individuals with artemether-lumefantrine (AL).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malaria seropositivity in children under five
Time Frame: 24 months
Malaria seropositivity in children under five after two-year intervention within health center catchment areas
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of malaria confirmed by RDT or microscopy as measured through passive case detection at health posts and health centers
Time Frame: 24 months
Quality-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.
24 months
PCR parasite prevalence among individuals participating at 0, 30 and 90 days following a reactive research response for a period of 24 months
Time Frame: 24 months
Polymerase 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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PATH

Collaborators

Ministry of Health, Zambia
AKROS Global Health

Investigators

  • Principal Investigator: Daniel Bridges, PhD, Akros

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

November 12, 2015

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PATH-WIRB-1155095

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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