MalariaNCT03554616
Efficacy of Three Novel Bi-treated Long Lasting Insecticidal Nets
A study testing Chlorfenapyr LLIN, pyriproxyfen LLIN and Piperonyl butoxide LLIN in people with Malaria and Anaemia, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
Trial summary
The massive scale-up of Long Lasting Insecticidal Nets (LLIN) has led to a major reduction in malaria burden (up to 50%) in many sub-Saharan African countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors. Read more about this study
- Who is it for?
- Ages 6 months to 14 yearsHealthy volunteers can take part
- What is being tested?
- Chlorfenapyr LLIN, pyriproxyfen LLIN and Piperonyl butoxide LLIN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,200 participants
- Where
- 1 siteTanzania
- Study dates
- 1 Feb 2019to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least one child between 6 months to 14 years old having permanent residence in selected household
- Having an adult caregiver willing to provide written consent for the household and clinical survey
Who cannot join
- Dwelling not found or vacant during the survey
- No adult caregiver capable to give informed consent
- Children severely ill
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Three Different Bi-treated Long Lasting Insecticidal Nets and Deployment Strategy for Control of Malaria Transmitted by Pyrethroid Resistant Vectors: A Randomised Controlled Trial
The massive scale-up of Long Lasting Insecticidal Nets (LLIN) has led to a major reduction in malaria burden (up to 50%) in many sub-Saharan African countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors. New types of LLIN combining a mixture of two insecticides or an insecticide and a synergist have been developed to control resistant mosquitoes.
The efficacy of three bi-treated LLIN are compared to a standard LLIN in a four-arm, single blinded, cluster-randomized trial in Misungwi district, Tanzania. The arms are; 1/ Royal Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and fertility of eggs, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, LLIN incorporating a mixture of two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ Olyset Plus an LLIN which incorporates a synergist, piperonyl butoxide (PBO), to enhance the potency of pyrethroid insecticides, and 4/ The control arm: Interceptor treated a standard LLIN treated with alpha-cypermethrin.
The primary outcome of the trial will be cross-sectional community prevalence of malaria infection (by RDT) in children aged 6 months to 14 years at 12 and 24 months post-intervention.
- Being tested
- Chlorfenapyr LLIN, pyriproxyfen LLIN, Piperonyl butoxide LLIN, Standard LLIN
- Keywords
- Malaria, Vector Control, Long lasting Insecticidal Net
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorfenapyr LLINOther
Dual active ingredient Long Lasting Insecticidal Net
pyriproxyfen LLINOther
Dual active ingredient Long Lasting Insecticidal Net
Piperonyl butoxide LLINOther
Combination insecticide and synergist Long Lasting Insecticidal Net
Standard LLINOther
Standard Long Lasting Insecticidal Net with one insecticide
| Study group | Role | What they receive |
|---|---|---|
| Pyriproxyfen LLIN | Experimental | Royal Guard® (Disease Control Technologies, LLC) is a Long Lasting Insecticidal Net made of polyethylene incorporating a mixture of 225 mg/m2 pyriproxyfen and 261mg/m2 alpha-cypermethrin. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis. Receives: Other: pyriproxyfen LLIN |
| Chlorfenapyr LLIN | Experimental | Interceptor® G2 (BASF corporation) is a LLIN made of polyester coated with a wash-resistant formulation of 200 mg/m2 chlorfenapyr and 100 mg/m2 alpha-cypermethrin. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis. Receives: Other: Chlorfenapyr LLIN |
| Piperonyl butoxide LLIN | Experimental | Olyset® Plus (Sumitomo Chemicals) is a LLIN combining Piperonyl butoxide (400mg/m2) and the repellent pyrethroid permethrin (800 mg/m2) incorporated into the polyethylene fibres. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis. Receives: Other: Piperonyl butoxide LLIN |
| Standard LLIN | Active comparator | Interceptor® (BASF Corporation) is a single pyrethroid-treated LLIN with alpha-cypermethrin (coated onto filaments) at a target dose of 200 mg/m2 of polyester fabric. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis. Receives: Other: Standard LLIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malaria infection prevalence in children 6 months to 14 years
Malaria prevalence will be assessed using Malaria Rapid Diagnostic test (CareStart Malaria histidine-rich protein 2 (HRP2)/plasmodium lactate dehydrogenase (pLDH) Combo, DiaSys, UK)
Measured: 24 months post intervention
Secondary outcomes (12)
Incidence of malaria cases in children 6 months to 10 years
Malaria incidence cases will be assessed using Malaria Rapid Diagnostic test (CareStart)
Measured: Two years post intervention follow up
Prevalence of anaemia in children under 5 years old
Hemoglobin (Hb) concentration will be tested to assess anaemia (<8 g/dL) using HemoCue Hb 201+.
Measured: 12, 18, 24, 30, 36 months post intervention
Indoor Anopheles density
Anopheles density per house per night will be assess every quarter in 8 houses per cluster using light trap. Anopheles density and sporozoite rate will be used to estimate the entomological inoculation rate (EIR)
Measured: Three years post intervention follow up
Sporozoite rate
A sub-samples of Anopheles collected indoor will be tested for Plasmodium falciparum circumsporozoite protein using an ELISA test. Sporozoite rate will be used to estimate the EIR with Anopheles density.
Measured: Three years post intervention follow up
Insecticide content in Long Lasting Insecticidal Net (LLIN)
30 LLINs will be collected at yearly interval and Insecticide content in g/kg assessed with High-performance liquid chromatography (HPLC)
Measured: at 0, 12, 24, 30, 36 months post intervention
Mortality in Anopheles after one hour exposure to every study LLIN
30 LLINs will be sampled every 6 months and tested in cone bio assay or tunnel test using resistant Anopheles and susceptible Kisumu Anopheles to assess for bio efficacy. 24, 48 and 72 hours mortality post exposure will be recorded.
Measured: at 0, 6, 12, 18, 24, 30, 36 months post intervention
LLIN usage
The proportion of study participant declaring sleeping under a LLIN the previous night will be assessed during household survey every 6 months using a questionnaire.
Measured: at 6, 12, 18, 24, 30, 36 months post intervention
Malaria infection prevalence in children 6 months to 14 years
Malaria prevalence will be assessed using Malaria Rapid Diagnostic test (CareStart Malaria histidine-rich protein 2 (HRP2)/plasmodium lactate dehydrogenase (pLDH) Combo, DiaSys, UK)
Measured: 12 months post intervention
Malaria infection prevalence in children 6 months to 14 years
Malaria prevalence will be assessed using Malaria Rapid Diagnostic test (CareStart Malaria histidine-rich protein 2 (HRP2)/plasmodium lactate dehydrogenase (pLDH) Combo, DiaSys, UK)
Measured: 18 months post intervention
Malaria infection prevalence in children 6 months to 14 years
Malaria prevalence will be assessed using Malaria Rapid Diagnostic test (CareStart Malaria histidine-rich protein 2 (HRP2)/plasmodium lactate dehydrogenase (pLDH) Combo, DiaSys, UK)
Measured: 30 months post intervention
Malaria infection prevalence in children 6 months to 14 years
Malaria prevalence will be assessed using Malaria Rapid Diagnostic test (CareStart Malaria histidine-rich protein 2 (HRP2)/plasmodium lactate dehydrogenase (pLDH) Combo, DiaSys, UK)
Measured: 36 months post intervention
Cost & DALYs of each type of bi-treated LLIN
Cost of each intervention will be gathered and used to calculate cost per malaria case averted and cost per DALY averted
Measured: Three years post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Feb 2019
- Primary completion28 Feb 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, National Institute for Medical Research, Tanzania, University of Ottawa
- Responsible party
- Sponsor
- Investigators
- Natacha Protopopoff, Phd, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554616
- Sponsor's protocol ID
- ITDCZN11
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2018
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in each publication will be shared and accessible in the LSHTM repository.
Publications
Mosha JF, Kulkarni MA, Messenger LA, Rowland M, Matowo N, Pitt C, Lukole E, Taljaard M, Thickstun C, Manjurano A, Mosha FW, Kleinschmidt I, Protopopoff N. Protocol for a four parallel-arm, single-blind, cluster-randomised trial to assess the effectiveness of three types of dual active ingredient treated nets compared to pyrethroid-only long-lasting insecticidal nets to prevent malaria transmitted by pyrethroid insecticide-resistant vector mosquitoes in Tanzania. BMJ Open. 2021 Mar 8;11(3):e046664. doi: 10.1136/bmjopen-2020-046664.
PubMed 34006037Ranson 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.
PubMed 20843745Asidi A, N'Guessan R, Akogbeto M, Curtis C, Rowland M. Loss of household protection from use of insecticide-treated nets against pyrethroid-resistant mosquitoes, benin. Emerg Infect Dis. 2012 Jul;18(7):1101-6. doi: 10.3201/eid1807.120218.
PubMed 22709930Ochomo EO, Bayoh NM, Walker ED, Abongo BO, Ombok MO, Ouma C, Githeko AK, Vulule J, Yan G, Gimnig JE. The efficacy of long-lasting nets with declining physical integrity may be compromised in areas with high levels of pyrethroid resistance. Malar J. 2013 Oct 24;12:368. doi: 10.1186/1475-2875-12-368.
PubMed 24156715Mosha JF, Kulkarni MA, Lukole E, Matowo NS, Pitt C, Messenger LA, Mallya E, Jumanne M, Aziz T, Kaaya R, Shirima BA, Isaya G, Taljaard M, Martin J, Hashim R, Thickstun C, Manjurano A, Kleinschmidt I, Mosha FW, Rowland M, Protopopoff N. Effectiveness and cost-effectiveness against malaria of three types of dual-active-ingredient long-lasting insecticidal nets (LLINs) compared with pyrethroid-only LLINs in Tanzania: a four-arm, cluster-randomised trial. Lancet. 2022 Mar 26;399(10331):1227-1241. doi: 10.1016/S0140-6736(21)02499-5.
PubMed 35339225Lukole EA, Cook J, Mosha JF, Matowo NS, Kulkarni MA, Mallya E, Aziz T, Martin J, Rowland M, Kleinschmidt I, Manjurano A, Mosha FW, Protopopoff N. Community benefits of mass distribution of three types of dual-active-ingredient long-lasting insecticidal nets against malaria prevalence in Tanzania: evidence from a 3-year cluster-randomized controlled trial. BMC Public Health. 2025 Jan 28;25(1):346. doi: 10.1186/s12889-025-21586-x.
PubMed 39875853Lukole EA, Cook J, Mosha JF, Mallya E, Aziz T, Kulkarni MA, Matowo NS, Martin J, Rowland M, Kleinschmidt I, Manjurano A, Mosha FW, Protopopoff N. Will a lack of fabric durability be their downfall? Impact of textile durability on the efficacy of three types of dual-active-ingredient long-lasting insecticidal nets: a secondary analysis on malaria prevalence and incidence from a cluster-randomized trial in north-west Tanzania. Malar J. 2024 Jun 28;23(1):199. doi: 10.1186/s12936-024-05020-y.
PubMed 38943155Mosha JF, Matowo NS, Kulkarni MA, Messenger LA, Lukole E, Mallya E, Aziz T, Kaaya R, Shirima BA, Isaya G, Taljaard M, Hashim R, Martin J, Manjurano A, Kleinschmidt I, Mosha FW, Rowland M, Protopopoff N. Effectiveness of long-lasting insecticidal nets with pyriproxyfen-pyrethroid, chlorfenapyr-pyrethroid, or piperonyl butoxide-pyrethroid versus pyrethroid only against malaria in Tanzania: final-year results of a four-arm, single-blind, cluster-randomised trial. Lancet Infect Dis. 2024 Jan;24(1):87-97. doi: 10.1016/S1473-3099(23)00420-6. Epub 2023 Sep 27.
PubMed 37776879Messenger LA, Matowo NS, Cross CL, Jumanne M, Portwood NM, Martin J, Lukole E, Mallya E, Mosha JF, Kaaya R, Moshi O, Pelloquin B, Fullerton K, Manjurano A, Mosha FW, Walker T, Rowland M, Kulkarni MA, Protopopoff N. Effects of next-generation, dual-active-ingredient, long-lasting insecticidal net deployment on insecticide resistance in malaria vectors in Tanzania: an analysis of a 3-year, cluster-randomised controlled trial. Lancet Planet Health. 2023 Aug;7(8):e673-e683. doi: 10.1016/S2542-5196(23)00137-7.
PubMed 37558348Martin JL, Messenger LA, Mosha FW, Lukole E, Mosha JF, Kulkarni M, Churcher TS, Sherrard-Smith E, Manjurano A, Protopopoff N, Rowland M. Durability of three types of dual active ingredient long-lasting insecticidal net compared to a pyrethroid-only LLIN in Tanzania: methodology for a prospective cohort study nested in a cluster randomized controlled trial. Malar J. 2022 Mar 19;21(1):96. doi: 10.1186/s12936-022-04119-4.
PubMed 35305667
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Three Different Bi-treated Long Lasting Insecticidal Nets and Deployment Strategy for Control of Malaria Transmitted by Pyrethroid Resistant Vectors: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03554616
- Acronym / sponsor ID
- ITDCZN11
- Keywords
- Malaria, Vector Control, Long lasting Insecticidal Net
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,200 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, National Institute for Medical Research, Tanzania, University of Ottawa
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The massive scale-up of Long Lasting Insecticidal Nets (LLIN) has led to a major reduction in malaria burden (up to 50%) in many sub-Saharan African countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors. New types of LLIN combining a mixture of two insecticides or an insecticide and a synergist have been developed to control resistant mosquitoes.
The efficacy of three bi-treated LLIN are compared to a standard LLIN in a four-arm, single blinded, cluster-randomized trial in Misungwi district, Tanzania. The arms are; 1/ Royal Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and fertility of eggs, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, LLIN incorporating a mixture of two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ Olyset Plus an LLIN which incorporates a synergist, piperonyl butoxide (PBO), to enhance the potency of pyrethroid insecticides, and 4/ The control arm: Interceptor treated a standard LLIN treated with alpha-cypermethrin.
The primary outcome of the trial will be cross-sectional community prevalence of malaria infection (by RDT) in children aged 6 months to 14 years at 12 and 24 months post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pyriproxyfen LLIN | Experimental | Other: pyriproxyfen LLINRoyal Guard® (Disease Control Technologies, LLC) is a Long Lasting Insecticidal Net made of polyethylene incorporating a mixture of 225 mg/m2 pyriproxyfen and 261mg/m2 alpha-cypermethrin. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis. |
| Chlorfenapyr LLIN | Experimental | Other: Chlorfenapyr LLINInterceptor® G2 (BASF corporation) is a LLIN made of polyester coated with a wash-resistant formulation of 200 mg/m2 chlorfenapyr and 100 mg/m2 alpha-cypermethrin. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis. |
| Piperonyl butoxide LLIN | Experimental | Other: Piperonyl butoxide LLINOlyset® Plus (Sumitomo Chemicals) is a LLIN combining Piperonyl butoxide (400mg/m2) and the repellent pyrethroid permethrin (800 mg/m2) incorporated into the polyethylene fibres. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis. |
| Standard LLIN | Active comparator | Other: Standard LLINInterceptor® (BASF Corporation) is a single pyrethroid-treated LLIN with alpha-cypermethrin (coated onto filaments) at a target dose of 200 mg/m2 of polyester fabric. This LLIN will be distributed to all the households in 21 clusters on a 1 LLIN per two household residents basis. |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- At least one child between 6 months to 14 years old having permanent residence in selected household
- Having an adult caregiver willing to provide written consent for the household and clinical survey
Key exclusion criteria (3 listed)
- Dwelling not found or vacant during the survey
- No adult caregiver capable to give informed consent
- Children severely ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorfenapyr LLINDual active ingredient Long Lasting Insecticidal Net | Other | Chlorfenapyr LLIN |
| pyriproxyfen LLINDual active ingredient Long Lasting Insecticidal Net | Other | Pyriproxyfen LLIN |
| Piperonyl butoxide LLINCombination insecticide and synergist Long Lasting Insecticidal Net | Other | Piperonyl butoxide LLIN |
| Standard LLINStandard Long Lasting Insecticidal Net with one insecticide | Other | Standard LLIN |
Primary outcome
Malaria infection prevalence in children 6 months to 14 years
Time frame: 24 months post intervention
Malaria prevalence will be assessed using Malaria Rapid Diagnostic test (CareStart Malaria histidine-rich protein 2 (HRP2)/plasmodium lactate dehydrogenase (pLDH) Combo, DiaSys, UK)
12 secondary outcomes
Incidence of malaria cases in children 6 months to 10 years
Time frame: Two years post intervention follow up
Prevalence of anaemia in children under 5 years old
Time frame: 12, 18, 24, 30, 36 months post intervention
Indoor Anopheles density
Time frame: Three years post intervention follow up
Sporozoite rate
Time frame: Three years post intervention follow up
Insecticide content in Long Lasting Insecticidal Net (LLIN)
Time frame: at 0, 12, 24, 30, 36 months post intervention
Mortality in Anopheles after one hour exposure to every study LLIN
Time frame: at 0, 6, 12, 18, 24, 30, 36 months post intervention
LLIN usage
Time frame: at 6, 12, 18, 24, 30, 36 months post intervention
Malaria infection prevalence in children 6 months to 14 years
Time frame: 12 months post intervention
Malaria infection prevalence in children 6 months to 14 years
Time frame: 18 months post intervention
Malaria infection prevalence in children 6 months to 14 years
Time frame: 30 months post intervention
Malaria infection prevalence in children 6 months to 14 years
Time frame: 36 months post intervention
Cost & DALYs of each type of bi-treated LLIN
Time frame: Three years post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 34006037Mosha JF, Kulkarni MA, Messenger LA, Rowland M, Matowo N, Pitt C, Lukole E, Taljaard M, Thickstun C, Manjurano A, Mosha FW, Kleinschmidt I, Protopopoff N. Protocol for a four parallel-arm, single-blind, cluster-randomised trial to assess the effectiveness of three types of dual active ingredient treated nets compared to pyrethroid-only long-lasting insecticidal nets to prevent malaria transmitted by pyrethroid insecticide-resistant vector mosquitoes in Tanzania. BMJ Open. 2021 Mar 8;11(3):e046664. doi: 10.1136/bmjopen-2020-046664.
- Background: PubMed 20843745Ranson 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.
- Background: PubMed 22709930Asidi A, N'Guessan R, Akogbeto M, Curtis C, Rowland M. Loss of household protection from use of insecticide-treated nets against pyrethroid-resistant mosquitoes, benin. Emerg Infect Dis. 2012 Jul;18(7):1101-6. doi: 10.3201/eid1807.120218.
- Background: PubMed 24156715Ochomo EO, Bayoh NM, Walker ED, Abongo BO, Ombok MO, Ouma C, Githeko AK, Vulule J, Yan G, Gimnig JE. The efficacy of long-lasting nets with declining physical integrity may be compromised in areas with high levels of pyrethroid resistance. Malar J. 2013 Oct 24;12:368. doi: 10.1186/1475-2875-12-368.
- Results publication: PubMed 35339225Mosha JF, Kulkarni MA, Lukole E, Matowo NS, Pitt C, Messenger LA, Mallya E, Jumanne M, Aziz T, Kaaya R, Shirima BA, Isaya G, Taljaard M, Martin J, Hashim R, Thickstun C, Manjurano A, Kleinschmidt I, Mosha FW, Rowland M, Protopopoff N. Effectiveness and cost-effectiveness against malaria of three types of dual-active-ingredient long-lasting insecticidal nets (LLINs) compared with pyrethroid-only LLINs in Tanzania: a four-arm, cluster-randomised trial. Lancet. 2022 Mar 26;399(10331):1227-1241. doi: 10.1016/S0140-6736(21)02499-5.
- Derived from this study: PubMed 39875853Lukole EA, Cook J, Mosha JF, Matowo NS, Kulkarni MA, Mallya E, Aziz T, Martin J, Rowland M, Kleinschmidt I, Manjurano A, Mosha FW, Protopopoff N. Community benefits of mass distribution of three types of dual-active-ingredient long-lasting insecticidal nets against malaria prevalence in Tanzania: evidence from a 3-year cluster-randomized controlled trial. BMC Public Health. 2025 Jan 28;25(1):346. doi: 10.1186/s12889-025-21586-x.
- Derived from this study: PubMed 38943155Lukole EA, Cook J, Mosha JF, Mallya E, Aziz T, Kulkarni MA, Matowo NS, Martin J, Rowland M, Kleinschmidt I, Manjurano A, Mosha FW, Protopopoff N. Will a lack of fabric durability be their downfall? Impact of textile durability on the efficacy of three types of dual-active-ingredient long-lasting insecticidal nets: a secondary analysis on malaria prevalence and incidence from a cluster-randomized trial in north-west Tanzania. Malar J. 2024 Jun 28;23(1):199. doi: 10.1186/s12936-024-05020-y.
- Derived from this study: PubMed 37776879Mosha JF, Matowo NS, Kulkarni MA, Messenger LA, Lukole E, Mallya E, Aziz T, Kaaya R, Shirima BA, Isaya G, Taljaard M, Hashim R, Martin J, Manjurano A, Kleinschmidt I, Mosha FW, Rowland M, Protopopoff N. Effectiveness of long-lasting insecticidal nets with pyriproxyfen-pyrethroid, chlorfenapyr-pyrethroid, or piperonyl butoxide-pyrethroid versus pyrethroid only against malaria in Tanzania: final-year results of a four-arm, single-blind, cluster-randomised trial. Lancet Infect Dis. 2024 Jan;24(1):87-97. doi: 10.1016/S1473-3099(23)00420-6. Epub 2023 Sep 27.
- Derived from this study: PubMed 37558348Messenger LA, Matowo NS, Cross CL, Jumanne M, Portwood NM, Martin J, Lukole E, Mallya E, Mosha JF, Kaaya R, Moshi O, Pelloquin B, Fullerton K, Manjurano A, Mosha FW, Walker T, Rowland M, Kulkarni MA, Protopopoff N. Effects of next-generation, dual-active-ingredient, long-lasting insecticidal net deployment on insecticide resistance in malaria vectors in Tanzania: an analysis of a 3-year, cluster-randomised controlled trial. Lancet Planet Health. 2023 Aug;7(8):e673-e683. doi: 10.1016/S2542-5196(23)00137-7.
- Derived from this study: PubMed 35305667Martin JL, Messenger LA, Mosha FW, Lukole E, Mosha JF, Kulkarni M, Churcher TS, Sherrard-Smith E, Manjurano A, Protopopoff N, Rowland M. Durability of three types of dual active ingredient long-lasting insecticidal net compared to a pyrethroid-only LLIN in Tanzania: methodology for a prospective cohort study nested in a cluster randomized controlled trial. Malar J. 2022 Mar 19;21(1):96. doi: 10.1186/s12936-022-04119-4.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in each publication will be shared and accessible in the LSHTM repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natacha Protopopoff, Phd principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorfenapyr LLIN, pyriproxyfen LLIN and Piperonyl butoxide LLIN in people with Malaria and Anaemia, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malaria infection prevalence in children 6 months to 14 years (time frame: 24 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03554616, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.