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

NCT02654912 | Completed Phase 4 DMC

• 1 other identifier: PATH-WIRB-1155095
• Study Type: interventional
• Target: 8,682
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

malaria; elimination; surveillance and response; dihydroartemisinin+piperaquine

Outcome Measures

Primary Outcomes (1)

• Malaria seropositivity in children under five

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

  24 months

Secondary Outcomes (2)

• Incidence of malaria confirmed by RDT or microscopy as measured through passive case detection at health posts and health centers

  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

  24 months

Study Arms (2)

Reactive Focal Drug Administration

EXPERIMENTAL

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

Reactive Focal Test and Treat

NO INTERVENTION

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).

Interventions

Reactive Focal Drug Administration DRUG

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).

Reactive Focal Drug Administration

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• anyone not excluded and consenting

You may not qualify if:

• 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

Sponsors & Collaborators

• PATH: lead
• Ministry of Health, Zambia: collaborator
• AKROS Global Health: collaborator

Study Sites (1)

Southern province medical office

Choma, Southern Province, Zambia

Location

Related Publications (2)

• 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.

  PMID: 29096671 BACKGROUND

• Bridges DJ, Miller JM, Chalwe V, Moonga H, Hamainza B, Steketee RW, Mambwe B, Mulube C, Wu L, Tetteh KKA, Drakeley C, Chishimba S, Mwenda M, Silumbe K, Larsen DA. Reactive focal drug administration associated with decreased malaria transmission in an elimination setting: Serological evidence from the cluster-randomized CoRE study. PLOS Glob Public Health. 2022 Dec 5;2(12):e0001295. doi: 10.1371/journal.pgph.0001295. eCollection 2022.

  PMID: 36962857 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Daniel Bridges, PhD

  Akros

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: January 13, 2016
• Study Start: February 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 4, 2021

Record last verified: 2020-09

Locations

ZA (1)