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

NCT04157894 | Completed

• 1 other identifier: 1379279-2
• Study Type: observational
• Target: 5,606
• Locations: 1 country
• Sites: 1

Brief Summary

The use of insecticide-treated bed nets (ITN) has contributed to the substantial reduction in malaria cases and deaths. This progress is threatened by increasing resistance commonly used insecticides in mosquito populations. Newly developed, next-generation ITNs using two insecticides or an insecticide synergist and an insecticide are effective against 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 and collect data over three years on their entomological and epidemiological impact as well as anthropological factors that influence their uptake and use. Data collection will occur in three districts: one receiving dual-active ingredient ITNs, Interceptor® G2 (BASF), one receiving a standard pyrethroid long-lasting insecticidal net (LLIN), Interceptor® (BASF), and one receiving PermaNet®3.0 (Vestergaard) an LLIN containing an insecticide and an insecticide synergist. Data will be collected on malaria vector bionomics, disease epidemiology, and human behaviors 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; Anthropology; Durability; 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.

  July 2019 to December 2022, monthly

Secondary Outcomes (6)

• Vector species composition

  July 2019 to December 2022, monthly

• Species-specific population densities

  July 2019 to December 2022, monthly

• Biting behaviors

  July 2019 to December 2022, monthly

• Estimated entomological inoculation rates

  July 2019 to December 2022, monthly

• Insecticide resistance profile

  July 2019 to December 2022, monthly

Study Arms (3)

Standard LLIN

This group receives Interceptor ITNs during the mass distribution campaign.

Other: Standard long-lasting insecticidal net

Chlorfenapyr ITN

This group receives Interceptor G2 ITNs during the mass distribution campaign.

Other: Chlorfenapyr insecticide treated net

Piperonyl butoxide LLIN

This group receives PBO ITNs during the mass distribution campaign.

Other: Piperonyl butoxide long-lasting insecticidal net

Interventions

Standard long-lasting insecticidal net OTHER

Interceptor® (BASF) contains a pyrethroid insecticide

Also known as: Interceptor®

Standard LLIN

Chlorfenapyr insecticide treated net OTHER

Interceptor® G2 (BASF) is an ITN containing two active ingredients: Alpha-cypermethrin, a pyrethroid insecticide, and chlorfenapyr, a pyrrole insecticide.

Also known as: Interceptor G2®

Chlorfenapyr ITN

Piperonyl butoxide long-lasting insecticidal net OTHER

PermaNet®3.0 (Vestergaard) contains deltamethrin, a pyrethroid insecticide, and piperonyl butoxide, an insecticide synergist.

Also known as: PermaNet®3.0

Piperonyl butoxide LLIN

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cohorts will be selected from the population of five districts, Banfora, Gaoua, Orodara, Nouna, and Tougan, that will receive nets as part of the Burkina Faso mass distribution campaign of ITNs. The 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. The three southern districts (Orodara, Gaoua, Banfora) will receive enhanced data collection support, and the two northern districts (Nouna and Tougan) will be analyzed using routine health system data. Limit: 1000 characters.

You may qualify if:

• Passive data collection: All suspected malaria cases (fevers) that self-present to the national health system and are counted in the district health surveillance systems.
• Cross-sectional survey: Households in the district with a family member from the target age group.
• Residents of the household visited.
• Questionnaire: parent or guardian giving written informed consent (cross-sectional).
• Malaria screening: child aged 6 to 59 months from the above consenting household.
• Individuals of box sexes, not belonging to vulnerable categories (those with cognitive impairment or other person for whom full and open consent cannot be guaranteed) (Key informant interviews, focus group discussions, and participant observations).
• Individuals 20 years old and above (key informant interviews, focus group discussions, participant observations).
• Individuals of both sexes regardless of age (structured observations).

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 (20 years) and their children will not be included in study activities requiring consent.
• Individuals belonging to vulnerable categories (key informant interviews, focus group discussions, participant observations).
• Individuals unwilling and/or unable of giving consent (key informant interviews, focus group discussions, participant observations).
• Individuals below age of consent (20 years) (key informant interviews, focus group discussions, participant observations)
• Heads of households unwilling and/or unable of giving consent (structured observations)
• Individuals who do not wish to be included in observations will be excluded (structured observations)

Sponsors & Collaborators

• PATH: lead
• Centre national de recherche et de formation sur le paludisme: collaborator
• Liverpool School of Tropical Medicine: collaborator

Study Sites (1)

Centre National de Recherche et de Formation sur le Paludisme

Ouagadougou, 01 BP 2208, Burkina Faso

Location

Related Publications (5)

• 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

• Badolo A, Traore A, Jones CM, Sanou A, Flood L, Guelbeogo WM, Ranson H, Sagnon N. Three years of insecticide resistance monitoring in Anopheles gambiae in Burkina Faso: resistance on the rise? Malar J. 2012 Jul 16;11:232. doi: 10.1186/1475-2875-11-232.

  PMID: 22799568 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

• Bayili K, N'do S, Namountougou M, Sanou R, Ouattara A, Dabire RK, Ouedraogo AG, Malone D, Diabate A. Evaluation of efficacy of Interceptor(R) G2, a long-lasting insecticide net coated with a mixture of chlorfenapyr and alpha-cypermethrin, against pyrethroid resistant Anopheles gambiae s.l. in Burkina Faso. Malar J. 2017 May 8;16(1):190. doi: 10.1186/s12936-017-1846-4.

  PMID: 28482891 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

Related Links

• Ben-Shlomo Y, Brookes S, Hickman M. Lecture Notes: Epidemiology, Evidence-based Medicine and Public Health.
• Bernard, HR. Research Methods in Anthropology: Qualitative and Quantitative Approaches. 4th

MeSH Terms

Conditions

Malaria

Interventions

milbemycin oxime

Condition Hierarchy (Ancestors)

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

Study Officials

• Joseph Wagman, PhD

  PATH

  PRINCIPAL INVESTIGATOR

• Sagnon NFalé, MD

  Centre national de recherche et de formation sur le paludisme

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: November 8, 2019
• Study Start: July 7, 2019
• Primary Completion: July 6, 2022
• Study Completion: July 6, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)