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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230161
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Rwanda Biomedical Centre
University of Rwanda
Liverpool School of Tropical Medicine
Information provided by (Responsible Party):
PATH

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 in mosquito populations to commonly used insecticides. 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. Enhanced data collection will occur in three districts: one district that will receive Interceptor G2 ® ITN (BASF) and two comparator districts, one that will receive standard pyrethroid-only ITNs and one that will receive standard pyrethroid-only ITNs and indoor residual spraying (IRS). 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.


Condition or disease Intervention/treatment
Malaria Other: Standard long-lasting insecticidal net Other: Chlorfenapyr insecticide treated net Other: Indoor residual spraying

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Study Type : Observational
Estimated Enrollment : 3669 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estimating the Malaria Prevention Impact of New Nets: Observational Analyses to Evaluate the Evidence Generated During Piloted New Net Distributions in Rwanda
Estimated Study Start Date : January 13, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort Intervention/treatment
Standard LLIN
This group receives Yahe LN ITNs during the mass distribution campaign.
Other: Standard long-lasting insecticidal net
Yahe LN (Yamei Industry) contains a pyrethroid insecticide.
Other Name: Yahe LN

Chlorfenapyr ITN
This group receives Interceptor G2 ITNs during the mass distribution campaign.
Other: Chlorfenapyr insecticide treated net
Interceptor G2® (BASF) is an ITN containing two active ingredients: Alpha-cypermethrin, a pyrethroid insecticide, and chlorfenapyr, a pyrrole insecticide.
Other Name: Interceptor G2®

Standard LLIN and IRS
This group receives Yahe LN ITNs during the mass distribution campaign and IRS.
Other: Standard long-lasting insecticidal net
Yahe LN (Yamei Industry) contains a pyrethroid insecticide.
Other Name: Yahe LN

Other: Indoor residual spraying
Fludora Fusion (Bayer Vector Control) is a spray containing two active ingredients: clothianidin, a neonicotinoid insecticide, and deltamethrin, a pyrethroid insecticide.
Other Name: Fludora Fusion




Primary Outcome Measures :
  1. Cumulative malaria incidence [ Time Frame: November 2019 to December 2022, monthly ]
    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.


Secondary Outcome Measures :
  1. Vector species composition [ Time Frame: December 2019 to December 2022, monthly ]
    All Anopheles mosquitoes sampled during Centers for Disease Control and Prevention light traps (CDCLT) and human landing collections (HLC) will be identified morphologically to species group

  2. Species-specific population densities [ Time Frame: December 2019 to December 2022, monthly ]
    Based on Anopheles mosquitoes sampled during CDCLT

  3. Species-specific population densities [ Time Frame: December 2019 to December 2022, monthly ]
    Based on Anopheles mosquitoes sampled during HLC

  4. Biting behaviors [ Time Frame: December 2019 to December 2022, monthly ]
    Based on Anopheles mosquitoes sampled during CDCLT

  5. Biting behaviors [ Time Frame: December 2019 to December 2022, monthly ]
    Based on Anopheles mosquitoes sampled during HLC

  6. Estimated entomological inoculation rates [ Time Frame: December 2019 to December 2022, monthly ]
    Based on Anopheles mosquitoes sampled during CDCLT and HLC

  7. Insecticide resistance profile [ Time Frame: December 2019 to December 2022, monthly ]
    Measurement of kdr and ace-1 mutation frequencies, WHO tube bioassays at minimum and CDC bottle bioassays to characterize insecticide resistance intensity

  8. Parasite prevalence in children 6 months or older [ Time Frame: January 2020, January 2021, January 2022 ]
    Prevalence calculated from cross-sectional surveys conducted during the peak transmission season



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Households selected for enrollment in the cross-sectional survey will be randomly selected from each of the three study districts: Ruhango, Nyamagabe, and Karongi. All members of the selected households will be asked to participate in the malaria biomarker survey to test for malaria using an RDT.

The villages selected for anthropological surveillance will be the same as those used for entomological surveillance.

Passive case detection data will include all malaria tests recorded in all health facilities in the three study districts.

Criteria

Inclusion Criteria:

  • 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.

    • Residents of the household visited.
    • Questionnaire: any adult member of the household .
    • Malaria screening: all members aged 6 months or older 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 18 years old and above (Key informant interviews, focus group discussions, and participant observations).
  • Individuals of both sexes regardless of age (structured observations).

Exclusion Criteria:

  • 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.
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230161


Contacts
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Contact: Molly Robertson, MPH 2025404359 mrobertson@path.org
Contact: Joseph Wagman, PhD 2025404372 jwagman@path.org

Locations
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Rwanda
Rwanda Biomedical Centre
Kigali, Rwanda
Contact: Aimable Mbituyumuremyi, MD       aimable.mbituyumuremyi@rbc.gov.rw   
Sponsors and Collaborators
PATH
Rwanda Biomedical Centre
University of Rwanda
Liverpool School of Tropical Medicine
Investigators
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Principal Investigator: Molly Robertson, MPH PATH
Principal Investigator: Aimable Mbituyumuremyi, MD Rwanda Biomedical Centre

Additional Information:
World Health Organization (WHO). World Malaria Report 2018.  This link exits the ClinicalTrials.gov site World Health Organization (WHO). Training module on malaria control: Entomology and vector control.  This link exits the ClinicalTrials.gov site World Health Organization (WHO). Global Technical Strategy for Malaria: 2016 - 2030.  This link exits the ClinicalTrials.gov site World Health Organization (WHO). Achieving and maintaining universal coverage with long-lasting insecticidal nets for malaria control.  This link exits the ClinicalTrials.gov site Bernard, HR. Research Methods in Anthropology: Qualitative and Quantitative Approaches. 4th  This link exits the ClinicalTrials.gov site Ben-Shlomo Y, Brookes S, Hickman M. Lecture Notes: Epidemiology, Evidence-based Medicine and Public Health.  This link exits the ClinicalTrials.gov site Malaria and Other Parasitic Diseases Division (MOPDD) of the Rwanda Biomedical Center Ministry of Health. National Guidelines for the Treatment of Malaria in Rwanda.  This link exits the ClinicalTrials.gov site Malaria and Other Parasitic Diseases Division (MOPDD) of the Rwanda Biomedical Center Ministry of Health and ICF. Rwanda Malaria Indicator Survey (RMIS) 2017  This link exits the ClinicalTrials.gov site National Institute of Statistics of Rwanda (NISR), Ministry of Health (MOH) [Rwanda], and ICF International. Rwanda Demographic and Health Survey 2014 - 15  This link exits the ClinicalTrials.gov site The US President's Malaria Initiative (PMI) Africa Indoor Residual Spraying (AIRS) Project. The PMI AIRS Project Semi-Annual Report: October 1, 2016 - March 31, 2017.  This link exits the ClinicalTrials.gov site The US President's Malaria Initiative (PMI). Rwanda: Malaria Operational Plan FY 2019.  This link exits the ClinicalTrials.gov site United Nations (UN). Outreach Programme on the Rwanda Genoicde and the United Nations.  This link exits the ClinicalTrials.gov site Malkki, L., 1995. Purity and Exile: Violence, Memory, and National Cosmology.  This link exits the ClinicalTrials.gov site Lévi-Strauss, C., 1969. The elementary structures of kinship (No. 340).  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT04230161    
Other Study ID Numbers: 1409734-2
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PATH:
Long-lasting insecticidal net
LLIN
Insecticide treated net
ITN
Malaria
Epidemiology
Anthropology
Durability
Cost-effectiveness
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Milbemycin oxime
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents