Targeted Indoor Residual Spraying Against Malaria

NCT02556242 | Completed Phase 4 DMC

• 1 other identifier: EPIDZC8610
• Study Type: interventional
• Target: 393,387
• Locations: 1 country
• Sites: 2

Brief Summary

Since 2000, annual numbers of malaria cases in South Africa have sharply declined to about 5,000, with case numbers fairly stable since 2007. The principal malaria prevention strategy has consisted of generalised Indoor Residual Spraying (IRS) of all houses in malaria endemic districts. As recent case data indicate that the levels of transmission in many districts have been reduced to very low levels, the continuation of untargeted IRS in areas where there is little or no evidence of recent transmission may be unwarranted. Efforts to eliminate malaria will only be sustainable if mass prevention efforts can be scaled down in an evidence-based manner, whilst maintaining or enhancing high sensitivity of the surveillance system of the disease. This trial will provide scientific evidence for targeted malaria prevention responding to localised transmission in pre-elimination settings, compared to continuation of generalised IRS of all houses. Two methods of IRS delivery for community malaria prevention will be compared through an open-label cluster-randomised trial consisting of two study arms with 30 clusters per arm of approximately 8,000 inhabitants per cluster. Comparison is on the basis of non-inferiority by showing that malaria incidence in the targeted IRS arm is no higher than malaria incidence in the generalised IRS arm within a specified margin of difference, and on the basis of superiority showing that the proportion of houses targeted for spraying is higher in the intervention than the reference arm. Neighbourhood investigation in response to each locally acquired case in the intervention arm, and comparison neighbourhoods in the reference arm, will include testing for antibody sero-conversion to malarial antigens to assess whether cases arise in communities with long term exposure to malaria parasites. The trial will be carried out in the South African provinces of Limpopo and Mpumalanga, in localities which have average reported incidence of malaria of \<5 cases per 1000 per annum over the past five years.

Conditions

Malaria

Keywords

vector control; insecticide

Outcome Measures

Primary Outcomes (1)

• Malaria incidence, by routine passive case detection, of clinical malaria (fever ≥37.5°C, or history of fever (48 hours), in the presence of parasitaemia confirmed by RDT or microscopy).

  Communities will be followed for up to 20 months

Secondary Outcomes (6)

• Intervention costs per 1,000 households and cost-effectiveness of reactive, targeted indoor residual spraying (TIRS) compared to generalised IRS (GIRS)

  Up to 20 months

• Proportion of structures targeted for IRS unsprayed

  Up to 20 months whenever reactive spraying is triggered

• Household compliance (not painting, washing, re-plastering )

  By cross sectional household survey after 18 months

• Householder acceptability of IRS

  By cross sectional household survey after 18 months

• If unsprayed, proportions due to refusals, spray teams not making contact and spray teams not calling back

  By cross sectional household survey after 18 months

Study Arms (2)

Targeted indoor residual spraying

EXPERIMENTAL

The intervention arm of the trial will receive Indoor Residual Spraying delivery through targeted spraying in the neighbourhood of recent local cases only.

Other: Targeted indoor residual spraying

Generalised Indoor residual spraying

ACTIVE COMPARATOR

The reference (control) arm of the trial will receive Indoor Residual Spraying through generalised annual spraying of all structures, as is the current standard practice.

Other: Generalised Indoor residual spraying

Interventions

Targeted indoor residual spraying OTHER

IRS is carried out in neighbourhoods of cases

Targeted indoor residual spraying

Generalised Indoor residual spraying OTHER

IRS is carried out as normally practiced

Generalised Indoor residual spraying

Eligibility Criteria

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

You may qualify if:

• Entire communities of approximately 8000 persons
• Residents in malaria endemic districts of Limpopo and Mpumalanga Province
• Areas with local malaria incidence \<5 cases per 1000 per year on average over 5 years

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• University of Witwatersrand, South Africa: collaborator
• National Department of Health, South Africa: collaborator
• Medical Research Council: collaborator
• National Institute for Communicable Diseases, South Africa: collaborator

Study Sites (2)

Provincial Malaria Control Programme

Tzaneen, Limpopo, South Africa

Location

Provincial Malaria Control Programme

Mbombela, Mpumalnga, South Africa

Location

Related Publications (1)

• Bath D, Cook J, Govere J, Mathebula P, Morris N, Hlongwana K, Raman J, Seocharan I, Zitha A, Zitha M, Mabuza A, Mbokazi F, Machaba E, Mabunda E, Jamesboy E, Biggs J, Drakeley C, Moonasar D, Maharaj R, Coetzee M, Pitt C, Kleinschmidt I. Effectiveness and cost-effectiveness of reactive, targeted indoor residual spraying for malaria control in low-transmission settings: a cluster-randomised, non-inferiority trial in South Africa. Lancet. 2021 Feb 27;397(10276):816-827. doi: 10.1016/S0140-6736(21)00251-8.

  PMID: 33640068 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Maureen Coetzee, Phd

  University of Witwatersrand, South Africa

  PRINCIPAL INVESTIGATOR

• Immo Kleinschmidt, Phd

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 22, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

ZA (2)