Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT04157894
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Collaborators:
National Center for Research and Training on Malaria
Liverpool School of Tropical Medicine
Information provided by (Responsible Party):
PATH

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.


Condition or disease Intervention/treatment
Malaria Other: Standard long-lasting insecticidal net Other: Chlorfenapyr insecticide treated net Other: Piperonyl butoxide long-lasting insecticidal net

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 6734 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 Burkina Faso
Actual Study Start Date : July 7, 2019
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 Interceptor ITNs during the mass distribution campaign.
Other: Standard long-lasting insecticidal net
Interceptor® (BASF) contains a pyrethroid insecticide
Other Name: Interceptor®

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®

Piperonyl butoxide LLIN
This group receives PBO ITNs during the mass distribution campaign.
Other: Piperonyl butoxide long-lasting insecticidal net
PermaNet®3.0 (Vestergaard) contains deltamethrin, a pyrethroid insecticide, and piperonyl butoxide, an insecticide synergist.
Other Name: PermaNet®3.0




Primary Outcome Measures :
  1. Cumulative malaria incidence [ Time Frame: July 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: July 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: July 2019 to December 2022, monthly ]
    Based on Anopheles mosquitoes sampled during CDCLT

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

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

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

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

  7. Insecticide resistance profile [ Time Frame: July 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 6-59 months [ Time Frame: July 2019, July 2020, July 2021, July 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.


Layout table for eligibility information
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
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.
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 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).

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 (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)

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): NCT04157894


Contacts
Layout table for location contacts
Contact: Molly Robertson, MPH 2025404359 mrobertson@path.org
Contact: Joseph Wagman, PhD 2025404372 jwagman@path.org

Locations
Layout table for location information
Burkina Faso
Centre National de Recherche et de Formation sur le Paludisme Recruiting
Ouagadougou, Burkina Faso, 01 BP 2208
Contact: Sagnon NFalé, MD       n.fale.cnlp@fasonet.bf   
Sponsors and Collaborators
PATH
National Center for Research and Training on Malaria
Liverpool School of Tropical Medicine
Investigators
Layout table for investigator information
Principal Investigator: Molly Robertson, MPH PATH
Principal Investigator: Sagnon NFalé, MD National Center for Research and Training on Malaria

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT04157894     History of Changes
Other Study ID Numbers: 1379279-2
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Malaria
Protozoan Infections
Parasitic Diseases
Milbemycin oxime
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents