Estimating the Malaria Prevention Impact of New Nets: Observational Analyses to Evaluate the Evidence Generated During Piloted New Net Distributions in Mozambique

NCT04716387 | Completed

• 1 other identifier: 1482331
• Study Type: observational
• Target: 8,726
• Locations: 1 country
• Sites: 1

Brief Summary

The use of insecticide-treated bed nets (ITNs) has contributed to the substantial reduction in malaria cases and deaths. This progress is threatened by increasing resistance to commonly used insecticides in important mosquito vector populations. Newly developed, next-generation ITNs that use two insecticides, or an insecticide synergist and an insecticide, are effective at killing resistant mosquitoes, but large-scale uptake of these nets has been slow due to higher costs and lack of enough evidence to support broad policy recommendations. This observational study will occur alongside a pilot distribution of next-generation ITNs in two regions of Mozambique. Over three years, data on the entomological and epidemiological impact of the different ITN types will be collected. Data collection will occur in six districts: two districts receiving the dual-active ingredient ITN Interceptor® G2 (BASF: alphacypermethrin + chlorfenapyr); one district that will receive the dual-active ingredient ITN Royal Guard® (Disease Control Technologies: alphacypermethrin + pyriproxyfen); one district receiving an ITN containing an insecticide plus an insecticide synergist , Olyset®Plus (Sumitomo Chemical: permethrin + piperonyl butoxide); and two districts receiving the standard pyrethroid-only ITNs DuraNet® (Shobikaa Impex Private Limited: alphacypermethrin). Data will be collected on malaria vector bionomics, disease epidemiology, and ITN use in order to help better demonstrate the public health value of next-generation ITNs and to support donors, policymakers, and National Malaria Control Programs in their ITN decision-making and planning processes.

Conditions

Malaria

Keywords

Long-lasting insecticidal net; LLIN; Insecticide treated net; ITN; Malaria; Epidemiology; Entomology; Anthropology; Durability monitoring; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Cumulative malaria incidence

  Malaria incidence measured through passive case detection at health facilities in each district. This measure accounts for symptomatic cases self-reporting to the formal health system for care.

  August 2020 to December 2022

Secondary Outcomes (10)

• Vectors species composition

  August 2020 to December 2022

• Species-specific population densities

  August 2020 to December 2022

• Biting behaviors

  August 2020 to December 2022

• Estimated entomological inoculation rates

  August 2020 to December 2022

• Insecticide resistance profile

  August 2020 to December 2022

Study Arms (4)

Chlorfenapyr ITN

These study districts will receive Interceptor G2 ITNs during the mass distribution campaign.

Other: Chlorfenapyr ITN

Piperonyl butoxide ITN

This study district will receive piperonyl butoxide ITN during the mass distribution campaign.

Other: Piperonyl butoxide ITN

Standard LLIN

These study districts will receive standard ITNs during the mass distribution campaign.

Other: Standard LLIN

Pyriproxyfen ITN

This study district will receive Royal Guard ITNs during the mass distribution campaign.

Other: Pyriproxyfen ITN

Interventions

Standard LLIN OTHER

Long-lasting insecticidal net containing alphacypermethrin, a pyrethroid insecticide, and manufactured by Shobikaa Impex Private Limited.

Also known as: DuraNet® LLIN

Standard LLIN

Piperonyl butoxide ITN OTHER

Insecticide treated net containing permethrin, a pyrethroid, and piperonyl butoxide, an insecticide synergist, manufactured by Sumitomo Chemical.

Also known as: Olyset®Plus ITN

Piperonyl butoxide ITN

Pyriproxyfen ITN OTHER

Insecticide treated net containing alpha-cypermethrin, a pyrethroid, and pyriproxyfen, an insect growth regulator, manufactured by Disease Control Technologies.

Also known as: Royal Guard® ITN

Pyriproxyfen ITN

Chlorfenapyr ITN OTHER

Insecticide-treated nets containing two active ingredients: alpha-cypermethrin, a pyrethroid insecticide, and chlorfenapyr, a pyrrole insecticide, manufactured by BASF.

Also known as: Interceptor® G2

Chlorfenapyr ITN

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study districts are located in Niassa and Zambezia provinces of northern Mozambique and Manica, Sofala, and Tete provinces in western Mozambique. The study districts, Mandima, Cuamba, Gurue, Changara, Guro, and Chemba will receive enhanced data collection. In addition, routine entomological and epidemiological data from all districts in these provinces will be used to compare trends. The study districts have similar malaria transmission dynamics. Routine data provided by in-country stakeholders show that these districts are comparable in underlying malaria prevalence, incidence, vector species composition, and insecticide resistance status, as well as general climate and geographic similarities.

You may qualify if:

• All suspected malaria cases (fevers) that self-present to the national health system and are counted in the district health surveillance systems (Passive data collection)
• Households in the district (Cross-sectional)
• Residents of the household visited (Cross-sectional
• Questionnaire: parent or guardian giving written informed consent (cross-sectional)
• Malaria screening: child aged 6 to 59 months from the above consenting household.

You may not qualify if:

• District non-residents
• Malaria screening: history of recent (within one month) malaria infection or treatment with anti-malarial medication (cross-sectional)
• Parents or guardians who have not yet reached age of consent (18 years) and their children will not be included in study activities requiring consent.
• Head of household unwilling and/or unable to give consent

Sponsors & Collaborators

• PATH: lead
• Tropical Health LLP: collaborator
• Ministry of Health, Mozambique: collaborator
• Instituto Nacional de Saúde, Mozambique: collaborator
• Tulane University: collaborator
• Liverpool School of Tropical Medicine: collaborator

Study Sites (1)

Programa Nacional de Controle da Malaria, Ministry of Health

Maputo, Mozambique

Location

Related Publications (13)

• Abilio AP, Marrune P, de Deus N, Mbofana F, Muianga P, Kampango A. Bio-efficacy of new long-lasting insecticide-treated bed nets against Anopheles funestus and Anopheles gambiae from central and northern Mozambique. Malar J. 2015 Sep 17;14:352. doi: 10.1186/s12936-015-0885-y.

  PMID: 26377825 BACKGROUND

• Alonso P, Noor AM. The global fight against malaria is at crossroads. Lancet. 2017 Dec 9;390(10112):2532-2534. doi: 10.1016/S0140-6736(17)33080-5. Epub 2017 Nov 29. No abstract available.

  PMID: 29195688 BACKGROUND

• Bass C, Nikou D, Donnelly MJ, Williamson MS, Ranson H, Ball A, Vontas J, Field LM. Detection of knockdown resistance (kdr) mutations in Anopheles gambiae: a comparison of two new high-throughput assays with existing methods. Malar J. 2007 Aug 13;6:111. doi: 10.1186/1475-2875-6-111.

  PMID: 17697325 BACKGROUND

• Bhatt S, Weiss DJ, Cameron E, Bisanzio D, Mappin B, Dalrymple U, Battle K, Moyes CL, Henry A, Eckhoff PA, Wenger EA, Briet O, Penny MA, Smith TA, Bennett A, Yukich J, Eisele TP, Griffin JT, Fergus CA, Lynch M, Lindgren F, Cohen JM, Murray CLJ, Smith DL, Hay SI, Cibulskis RE, Gething PW. The effect of malaria control on Plasmodium falciparum in Africa between 2000 and 2015. Nature. 2015 Oct 8;526(7572):207-211. doi: 10.1038/nature15535. Epub 2015 Sep 16.

  PMID: 26375008 BACKGROUND

• Fornadel CM, Norris LC, Franco V, Norris DE. Unexpected anthropophily in the potential secondary malaria vectors Anopheles coustani s.l. and Anopheles squamosus in Macha, Zambia. Vector Borne Zoonotic Dis. 2011 Aug;11(8):1173-9. doi: 10.1089/vbz.2010.0082. Epub 2010 Dec 13.

  PMID: 21142969 BACKGROUND

• Kleinschmidt I, Bradley J, Knox TB, Mnzava AP, Kafy HT, Mbogo C, Ismail BA, Bigoga JD, Adechoubou A, Raghavendra K, Cook J, Malik EM, Nkuni ZJ, Macdonald M, Bayoh N, Ochomo E, Fondjo E, Awono-Ambene HP, Etang J, Akogbeto M, Bhatt RM, Chourasia MK, Swain DK, Kinyari T, Subramaniam K, Massougbodji A, Oke-Sopoh M, Ogouyemi-Hounto A, Kouambeng C, Abdin MS, West P, Elmardi K, Cornelie S, Corbel V, Valecha N, Mathenge E, Kamau L, Lines J, Donnelly MJ. Implications of insecticide resistance for malaria vector control with long-lasting insecticidal nets: a WHO-coordinated, prospective, international, observational cohort study. Lancet Infect Dis. 2018 Jun;18(6):640-649. doi: 10.1016/S1473-3099(18)30172-5. Epub 2018 Apr 9.

  PMID: 29650424 BACKGROUND

• Koekemoer LL, Kamau L, Hunt RH, Coetzee M. A cocktail polymerase chain reaction assay to identify members of the Anopheles funestus (Diptera: Culicidae) group. Am J Trop Med Hyg. 2002 Jun;66(6):804-11. doi: 10.4269/ajtmh.2002.66.804.

  PMID: 12224596 BACKGROUND

• Protopopoff N, Mosha JF, Lukole E, Charlwood JD, Wright A, Mwalimu CD, Manjurano A, Mosha FW, Kisinza W, Kleinschmidt I, Rowland M. Effectiveness of a long-lasting piperonyl butoxide-treated insecticidal net and indoor residual spray interventions, separately and together, against malaria transmitted by pyrethroid-resistant mosquitoes: a cluster, randomised controlled, two-by-two factorial design trial. Lancet. 2018 Apr 21;391(10130):1577-1588. doi: 10.1016/S0140-6736(18)30427-6. Epub 2018 Apr 11.

  PMID: 29655496 BACKGROUND

• Ranson H, N'guessan R, Lines J, Moiroux N, Nkuni Z, Corbel V. Pyrethroid resistance in African anopheline mosquitoes: what are the implications for malaria control? Trends Parasitol. 2011 Feb;27(2):91-8. doi: 10.1016/j.pt.2010.08.004. Epub 2010 Sep 16.

  PMID: 20843745 BACKGROUND

• Scott JA, Brogdon WG, Collins FH. Identification of single specimens of the Anopheles gambiae complex by the polymerase chain reaction. Am J Trop Med Hyg. 1993 Oct;49(4):520-9. doi: 10.4269/ajtmh.1993.49.520.

  PMID: 8214283 BACKGROUND

• Sherrard-Smith E, Griffin JT, Winskill P, Corbel V, Pennetier C, Djenontin A, Moore S, Richardson JH, Muller P, Edi C, Protopopoff N, Oxborough R, Agossa F, N'Guessan R, Rowland M, Churcher TS. Systematic review of indoor residual spray efficacy and effectiveness against Plasmodium falciparum in Africa. Nat Commun. 2018 Nov 26;9(1):4982. doi: 10.1038/s41467-018-07357-w.

  PMID: 30478327 BACKGROUND

• Tiono AB, Ouedraogo A, Ouattara D, Bougouma EC, Coulibaly S, Diarra A, Faragher B, Guelbeogo MW, Grisales N, Ouedraogo IN, Ouedraogo ZA, Pinder M, Sanon S, Smith T, Vanobberghen F, Sagnon N, Ranson H, Lindsay SW. Efficacy of Olyset Duo, a bednet containing pyriproxyfen and permethrin, versus a permethrin-only net against clinical malaria in an area with highly pyrethroid-resistant vectors in rural Burkina Faso: a cluster-randomised controlled trial. Lancet. 2018 Aug 18;392(10147):569-580. doi: 10.1016/S0140-6736(18)31711-2. Epub 2018 Aug 10.

  PMID: 30104047 BACKGROUND

• Weill M, Malcolm C, Chandre F, Mogensen K, Berthomieu A, Marquine M, Raymond M. The unique mutation in ace-1 giving high insecticide resistance is easily detectable in mosquito vectors. Insect Mol Biol. 2004 Feb;13(1):1-7. doi: 10.1111/j.1365-2583.2004.00452.x.

  PMID: 14728661 BACKGROUND

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph Wagman, PhD

  PATH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: August 18, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-01

Locations

MO (1)