Malaria,FalciparumITENsNCT05125133
Evaluation of Insecticide-treated Eave Nets and Window Screens for Malaria Control in Tanzania.
A study testing ITENs + ITWS in people with Malaria,Falciparum, run by Ifakara Health Institute at 1 site in Tanzania.
Trial summary
This is a household randomized trial of a new tool for house modification, Insecticide-Treated Eave nets (ITENs) in combination with insecticide-treated window screens (ITWS), coated with a dual active ingredient (dual AI): Deltamethrin at 3g AI/kg, which corresponds to 144 mg/m² and PBO synergist at 10g/kg which… Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- ITENs + ITWS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteTanzania
- Study dates
- 9 Jul 2021to 30 Sep 2022
- 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 and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents of study households' members.
Who cannot join
- None residence.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site, 1 recruiting
- Recruiting
Vector Control Product Testing Unit Facility
Bagamoyo
Rose Philipo, MSc, +255 714583404, rphilipo@ihi.or.tz
Zawadi Mboma, PhD
About this study
Official title: A Household Randomized Control Trial of Insecticide-treated Eave Nets and Window Screens for Malaria Control in Chalinze District, Tanzania.
This is a household randomized trial of a new tool for house modification, Insecticide-Treated Eave nets (ITENs) in combination with insecticide-treated window screens (ITWS), coated with a dual active ingredient (dual AI): Deltamethrin at 3g AI/kg, which corresponds to 144 mg/m² and PBO synergist at 10g/kg which corresponds to 480 mg/m², as used in the so-called dual-AI LLIN or "resistance breaking" nets for resistance malaria vector control.
Four hundred and fifty (450) households with intact walls, opened eaves, and those without screens or nets on the windows in Chalinze district, Tanzania will be eligible and only recruited upon written informed consent. The households will be randomly allocated into two arms: one with ITENs and ITWS installed and the other without.
The primary outcome will be malaria parasite detection in household residents aged over 6 months old using a quantitative Polymerase Chain Reaction (qPCR) at approximately 12 months post-installation, coinciding with the long rainy season.
Read the detailed description
In Tanzania, long-lasting insecticidal nets (LLINs) contributed to the high reduction of malaria in the last decade. However, malaria reduction in Tanzania is threatened due to increasing insecticidal resistance of malaria vectors, low access to LLIN, LLINs not lasting up to three years, and net usage compliance. Therefore, it is evident that an additional cost-effective vector control tool is required that may confer protection against resistant malaria vectors, protect every member of the household, requires little or less compliance to use after distribution, and lasts longer.
The proposed additional vector control tool for trial is the Insecticide-Treated Eave nets (ITENs) in combination with Insecticide Treated Window screens (ITWS) for house modification. The tool is coated with a dual active ingredient (dual AI): Deltamethrin at 3g AI/kg, which corresponds to 144 mg/m², and PBO synergist at 10g/kg which corresponds to 480 mg/m², which are coated at the same concentration in insecticide-treated nets that are already in use in the population to control pyrethroid-resistant mosquitoes. These can protect everyone in the house by blocking mosquito entry and killing mosquitos that contact them to protect everyone in the community.
In this trial, 450 households will be randomly allocated into two arms. One arm with ITENs \& ITWS installed and the other without to serve as the control arm. The 450 households are recruited and assigned codes during baseline data collection. The assigned codes are randomized to either of the two arms by simple randomization in STATA and stratified by sub-village.
Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons, clinical officers will screen for malaria parasites in household residents of over 6 months old (it is estimated that 4.4 persons reside in each household, thus approx. 1,800 persons will be screened for malaria per survey) in both arms and confirmation of malaria parasite will be done using qPCR analysis as the primary assessment of the primary outcome. As a point of care, SD Bioline Malaria Ag Pf/Pan rapid diagnostic test (RDT) as per Tanzanian guidelines will also be conducted on all household residents. Any participant (s) with an axillary temperature of 37.5 degrees (fever) and that test positive using mRDT will be considered as a clinical malaria case. All malaria-positive participants will be treated using free Artemether Lumefantrine (ALu). This drug is approved by the national guideline for the treatment of uncomplicated malaria.
Other secondary objectives are:
- To evaluate malaria prevalence in households with ITENs \& ITWS and those without at approximately 6 months post-installation, coinciding with the short rainy season.
- To determine the prevalence of clinical malaria defined by an axillary temperature of 37.5 degrees and above (fever) and mRDT malaria positive cases at approximately 6 months and 12 months post-installation, coinciding with the rainy seasons.
- To investigate the effect of ITENs and ITWS on the density of malaria vectors and nuisance (Culex quinquefasciatus) mosquitoes in the community at approximately 6 months and 12 months post-installation, coinciding with the rainy seasons using Centres for Disease Control (CDC) light traps.
- To assess the number of fabric in meters and time of installing the intervention (feasibility of scaling-up ITENs and ITWS use) in local houses in the field during installation.
- To assess the adverse effects of ITENs and ITWS in the community.
- To determine the attrition and fabric integrity of ITENs and ITWS in the field post 6 months and 12 months of installation.
- To determine the mortality induced by (bioefficacy) ITENs and ITWS on laboratory-reared mosquitoes post 12 months of installation.
- To determine the insecticide retainment of ITENs and ITWS post 12 months of installation.
- To assess the acceptability of ITENs and ITWS to the local community post 6 months and 12 months of installation.
- Conditions
- Malaria,Falciparum
- Being tested
- ITENs + ITWS
- Keywords
- Insecticide-treated nets, Eaves, windows, Malaria, Tanzania.
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITENs + ITWSOther
A dual active ingredient (dual AI) Insecticide-Treated Eave nets (ITENs) in combination with Insecticide Treated Window screens (ITWS) for house modification.
| Study group | Role | What they receive |
|---|---|---|
| ITENs + ITWS | Experimental | Deltamethrin at 3g AI/kg, which corresponds to 144 mg/m², and PBO synergist at 10g/kg which corresponds to 480 mg/m² are coated in ITENs and ITWS nets that will be installed to cover opened eaves and windows. This was manufactured by Moon Netting FZCO, United Arab Emirates. Receives: Other: ITENs + ITWS |
| Negative arm | No intervention | The houses allocated NOT to receive ITENs and ITWS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Plasmodium falciparum parasite.
Prevalence of plasmodium falciparum parasite measured by qPCR among residents over 6 months old in houses with ITENs \& ITWS compared to houses without.
Measured: Approximately 12 months post-installation, coinciding with the long rainy season.
Secondary outcomes (11)
Prevalence of Plasmodium falciparum parasite.
Prevalence of plasmodium falciparum parasite in households' residents of over 6 months old with ITENs \& ITWS compared to those without using qPCR analysis.
Measured: Approximately 6 months post-installation, coinciding with the short rainy season.
Clinical malaria.
The prevalence of clinical malaria cases defined by an axillary temperature of 37.5 degrees (fever) and positive mRDT in houses with ITENs and ITWS compared to the houses without.
Measured: Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons.
The density of malaria vectors and nuisance mosquitoes density.
Indoor density of malaria vector and nuisance mosquitoes in houses with ITENs \& ITWS compared to houses without measured using Centres for Disease Control (CDC) light traps.
Measured: Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons.
ITENs & ITWS fabric cost
The number of metres of material applied to houses.
Measured: Baseline (During installation of ITENs & ITWS)
ITENS & ITWS time duration
Time in hours to install the intervention.
Measured: Baseline (During installation of ITENs & ITWS)
Adverse effects
The number of participants with perceived adverse effects from ITENs and ITWS.
Measured: Approximately one month post installation.
Attrition
Determination of the physical presence of ITENs and ITWS in the field.
Measured: Appriximately 6 months and 12 months post installation.
Fabric integrity
Determination of the number of holes in ITENs and ITWS in the field.
Measured: Appriximately 6 months and 12 months post installation.
The induced mosquito mortality of ITENs and ITWs on the population of laboratory-reared mosquitoes.
The bioefficacy (% induced mosquito mortality) of ITENs and ITWS after field use through WHO bioassays.
Measured: Approximately 12 months post installation.
Insecticide retainment
The retention of deltamethrin and PBO in grams per kg will be assessed through high performance liquid chromatography.
Measured: Appriximately 12 months post installation.
Use of ITENs and ITWS
Community opinions of ITENs and ITWS will be sought through questionnaires and Focus Group Discussions.
Measured: Approximately 6 months and 12 months post installation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start9 Jul 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malaria,FalciparumStudies 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
- Model description
- Households allocated into Two arms to receive ITENs+ITWS installed or none with a 1:1 ratio at sub-village level.
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ifakara Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Swiss Tropical & Public Health Institute
- Responsible party
- Sponsor
- Investigators
- John Bradley, PhD, Study director, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125133
- Sponsor's protocol ID
- ITENs
- Acronym
- ITENs
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be disseminated by a report to the sponsor, followed by peer-reviewed publications targeted towards consumers, scientists, and policy-makers. We will publish the results and data sets in open-access, indexed, peer-reviewed journals, making the findings and the data publicly available to all stakeholders. Data obtained from the study will be presented at international conferences and stakeholder meetings including the National Malaria Control Program, with priority given to the young scientists to practice their presentation and collaboration skills. At the end of the project, a meeting will be held to update the local community and the District Medical Officer (DMO), to present findings and answer any questions arising.
Publications
Gnanguenon V, Azondekon R, Oke-Agbo F, Beach R, Akogbeto M. Durability assessment results suggest a serviceable life of two, rather than three, years for the current long-lasting insecticidal (mosquito) net (LLIN) intervention in Benin. BMC Infect Dis. 2014 Feb 8;14:69. doi: 10.1186/1471-2334-14-69.
PubMed 24507444Matiya DJ, Philbert AB, Kidima W, Matowo JJ. Dynamics and monitoring of insecticide resistance in malaria vectors across mainland Tanzania from 1997 to 2017: a systematic review. Malar J. 2019 Mar 26;18(1):102. doi: 10.1186/s12936-019-2738-6.
PubMed 30914051Mboera LE, Mweya CN, Rumisha SF, Tungu PK, Stanley G, Makange MR, Misinzo G, De Nardo P, Vairo F, Oriyo NM. The Risk of Dengue Virus Transmission in Dar es Salaam, Tanzania during an Epidemic Period of 2014. PLoS Negl Trop Dis. 2016 Jan 26;10(1):e0004313. doi: 10.1371/journal.pntd.0004313. eCollection 2016 Jan.
PubMed 26812489Mboma ZM, Overgaard HJ, Moore S, Bradley J, Moore J, Massue DJ, Kramer K, Lines J, Lorenz LM. Mosquito net coverage in years between mass distributions: a case study of Tanzania, 2013. Malar J. 2018 Mar 1;17(1):100. doi: 10.1186/s12936-018-2247-z.
PubMed 29490649Gleave K, Lissenden N, Richardson M, Choi L, Ranson H. Piperonyl butoxide (PBO) combined with pyrethroids in insecticide-treated nets to prevent malaria in Africa. Cochrane Database Syst Rev. 2018 Nov 29;11(11):CD012776. doi: 10.1002/14651858.CD012776.pub2.
PubMed 30488945Odufuwa OG, Moore SJ, Mboma ZM, Mwanga R, Matwewe F, Hofer LM, Matanila I, Abbasi S, Rashid MA, Philipo R, Kihwele F, Moore J, Nguyen H, Bosselmann R, Skovmand O, Stevenson JC, Muganga JB, Bradley J. A household randomized-control trial of insecticide-treated screening for malaria control in unimproved houses in Tanzania. Malar J. 2025 Jun 8;24(1):182. doi: 10.1186/s12936-025-05434-2.
PubMed 40484966
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Household Randomized Control Trial of Insecticide-treated Eave Nets and Window Screens for Malaria Control in Chalinze District, Tanzania.
- ClinicalTrials.gov ID
- NCT05125133
- Acronym / sponsor ID
- ITENs / ITENs
- Conditions
- Malaria,Falciparum
- Keywords
- Insecticide-treated nets, Eaves, windows, Malaria, Tanzania.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Ifakara Health InstituteUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Swiss Tropical & Public Health Institute
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 18 Nov 2021 (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.
This is a household randomized trial of a new tool for house modification, Insecticide-Treated Eave nets (ITENs) in combination with insecticide-treated window screens (ITWS), coated with a dual active ingredient (dual AI): Deltamethrin at 3g AI/kg, which corresponds to 144 mg/m² and PBO synergist at 10g/kg which corresponds to 480 mg/m², as used in the so-called dual-AI LLIN or "resistance breaking" nets for resistance malaria vector control.
Four hundred and fifty (450) households with intact walls, opened eaves, and those without screens or nets on the windows in Chalinze district, Tanzania will be eligible and only recruited upon written informed consent. The households will be randomly allocated into two arms: one with ITENs and ITWS installed and the other without.
The primary outcome will be malaria parasite detection in household residents aged over 6 months old using a quantitative Polymerase Chain Reaction (qPCR) at approximately 12 months post-installation, coinciding with the long rainy season.
Detailed description
In Tanzania, long-lasting insecticidal nets (LLINs) contributed to the high reduction of malaria in the last decade. However, malaria reduction in Tanzania is threatened due to increasing insecticidal resistance of malaria vectors, low access to LLIN, LLINs not lasting up to three years, and net usage compliance. Therefore, it is evident that an additional cost-effective vector control tool is required that may confer protection against resistant malaria vectors, protect every member of the household, requires little or less compliance to use after distribution, and lasts longer.
The proposed additional vector control tool for trial is the Insecticide-Treated Eave nets (ITENs) in combination with Insecticide Treated Window screens (ITWS) for house modification. The tool is coated with a dual active ingredient (dual AI): Deltamethrin at 3g AI/kg, which corresponds to 144 mg/m², and PBO synergist at 10g/kg which corresponds to 480 mg/m², which are coated at the same concentration in insecticide-treated nets that are already in use in the population to control pyrethroid-resistant mosquitoes. These can protect everyone in the house by blocking mosquito entry and killing mosquitos that contact them to protect everyone in the community.
In this trial, 450 households will be randomly allocated into two arms. One arm with ITENs \& ITWS installed and the other without to serve as the control arm. The 450 households are recruited and assigned codes during baseline data collection. The assigned codes are randomized to either of the two arms by simple randomization in STATA and stratified by sub-village.
Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons, clinical officers will screen for malaria parasites in household residents of over 6 months old (it is estimated that 4.4 persons reside in each household, thus approx. 1,800 persons will be screened for malaria per survey) in both arms and confirmation of malaria parasite will be done using qPCR analysis as the primary assessment of the primary outcome. As a point of care, SD Bioline Malaria Ag Pf/Pan rapid diagnostic test (RDT) as per Tanzanian guidelines will also be conducted on all household residents. Any participant (s) with an axillary temperature of 37.5 degrees (fever) and that test positive using mRDT will be considered as a clinical malaria case. All malaria-positive participants will be treated using free Artemether Lumefantrine (ALu). This drug is approved by the national guideline for the treatment of uncomplicated malaria.
Other secondary objectives are:
- To evaluate malaria prevalence in households with ITENs \& ITWS and those without at approximately 6 months post-installation, coinciding with the short rainy season.
- To determine the prevalence of clinical malaria defined by an axillary temperature of 37.5 degrees and above (fever) and mRDT malaria positive cases at approximately 6 months and 12 months post-installation, coinciding with the rainy seasons.
- To investigate the effect of ITENs and ITWS on the density of malaria vectors and nuisance (Culex quinquefasciatus) mosquitoes in the community at approximately 6 months and 12 months post-installation, coinciding with the rainy seasons using Centres for Disease Control (CDC) light traps.
- To assess the number of fabric in meters and time of installing the intervention (feasibility of scaling-up ITENs and ITWS use) in local houses in the field during installation.
- To assess the adverse effects of ITENs and ITWS in the community.
- To determine the attrition and fabric integrity of ITENs and ITWS in the field post 6 months and 12 months of installation.
- To determine the mortality induced by (bioefficacy) ITENs and ITWS on laboratory-reared mosquitoes post 12 months of installation.
- To determine the insecticide retainment of ITENs and ITWS post 12 months of installation.
- To assess the acceptability of ITENs and ITWS to the local community post 6 months and 12 months of installation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Households allocated into Two arms to receive ITENs+ITWS installed or none with a 1:1 ratio at sub-village level.
| Arm | Type | Receives |
|---|---|---|
| ITENs + ITWS | Experimental | Other: ITENs + ITWSDeltamethrin at 3g AI/kg, which corresponds to 144 mg/m², and PBO synergist at 10g/kg which corresponds to 480 mg/m² are coated in ITENs and ITWS nets that will be installed to cover opened eaves and windows. This was manufactured by Moon Netting FZCO, United Arab Emirates. |
| Negative arm | No intervention | –The houses allocated NOT to receive ITENs and ITWS. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Residents of study households' members.
Key exclusion criteria (2 listed)
- None residence.
- Pregnant women.
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 |
|---|---|---|
| ITENs + ITWSA dual active ingredient (dual AI) Insecticide-Treated Eave nets (ITENs) in combination with Insecticide Treated Window screens (ITWS) for house modification. | Other | ITENs + ITWS |
Primary outcome
Prevalence of Plasmodium falciparum parasite.
Time frame: Approximately 12 months post-installation, coinciding with the long rainy season.
Prevalence of plasmodium falciparum parasite measured by qPCR among residents over 6 months old in houses with ITENs \& ITWS compared to houses without.
11 secondary outcomes
Prevalence of Plasmodium falciparum parasite.
Time frame: Approximately 6 months post-installation, coinciding with the short rainy season.
Clinical malaria.
Time frame: Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons.
The density of malaria vectors and nuisance mosquitoes density.
Time frame: Approximately 6 months and 12 months post-installation, coinciding with the rainy seasons.
ITENs & ITWS fabric cost
Time frame: Baseline (During installation of ITENs & ITWS)
ITENS & ITWS time duration
Time frame: Baseline (During installation of ITENs & ITWS)
Adverse effects
Time frame: Approximately one month post installation.
Attrition
Time frame: Appriximately 6 months and 12 months post installation.
Fabric integrity
Time frame: Appriximately 6 months and 12 months post installation.
The induced mosquito mortality of ITENs and ITWs on the population of laboratory-reared mosquitoes.
Time frame: Approximately 12 months post installation.
Insecticide retainment
Time frame: Appriximately 12 months post installation.
Use of ITENs and ITWS
Time frame: Approximately 6 months and 12 months post installation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Background: PubMed 24507444Gnanguenon V, Azondekon R, Oke-Agbo F, Beach R, Akogbeto M. Durability assessment results suggest a serviceable life of two, rather than three, years for the current long-lasting insecticidal (mosquito) net (LLIN) intervention in Benin. BMC Infect Dis. 2014 Feb 8;14:69. doi: 10.1186/1471-2334-14-69.
- Background: PubMed 30914051Matiya DJ, Philbert AB, Kidima W, Matowo JJ. Dynamics and monitoring of insecticide resistance in malaria vectors across mainland Tanzania from 1997 to 2017: a systematic review. Malar J. 2019 Mar 26;18(1):102. doi: 10.1186/s12936-019-2738-6.
- Background: PubMed 26812489Mboera LE, Mweya CN, Rumisha SF, Tungu PK, Stanley G, Makange MR, Misinzo G, De Nardo P, Vairo F, Oriyo NM. The Risk of Dengue Virus Transmission in Dar es Salaam, Tanzania during an Epidemic Period of 2014. PLoS Negl Trop Dis. 2016 Jan 26;10(1):e0004313. doi: 10.1371/journal.pntd.0004313. eCollection 2016 Jan.
- Background: PubMed 29490649Mboma ZM, Overgaard HJ, Moore S, Bradley J, Moore J, Massue DJ, Kramer K, Lines J, Lorenz LM. Mosquito net coverage in years between mass distributions: a case study of Tanzania, 2013. Malar J. 2018 Mar 1;17(1):100. doi: 10.1186/s12936-018-2247-z.
- Results publication: PubMed 30488945Gleave K, Lissenden N, Richardson M, Choi L, Ranson H. Piperonyl butoxide (PBO) combined with pyrethroids in insecticide-treated nets to prevent malaria in Africa. Cochrane Database Syst Rev. 2018 Nov 29;11(11):CD012776. doi: 10.1002/14651858.CD012776.pub2.
- Derived from this study: PubMed 40484966Odufuwa OG, Moore SJ, Mboma ZM, Mwanga R, Matwewe F, Hofer LM, Matanila I, Abbasi S, Rashid MA, Philipo R, Kihwele F, Moore J, Nguyen H, Bosselmann R, Skovmand O, Stevenson JC, Muganga JB, Bradley J. A household randomized-control trial of insecticide-treated screening for malaria control in unimproved houses in Tanzania. Malar J. 2025 Jun 8;24(1):182. doi: 10.1186/s12936-025-05434-2.
- Individual participant dataSharing planned: Yes. Data will be disseminated by a report to the sponsor, followed by peer-reviewed publications targeted towards consumers, scientists, and policy-makers. We will publish the results and data sets in open-access, indexed, peer-reviewed journals, making the findings and the data publicly available to all stakeholders. Data obtained from the study will be presented at international conferences and stakeholder meetings including the National Malaria Control Program, with priority given to the young scientists to practice their presentation and collaboration skills. At the end of the project, a meeting will be held to update the local community and the District Medical Officer (DMO), to present findings and answer any questions arising.
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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.
John Bradley, PhD study director
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 ITENs + ITWS in people with Malaria,Falciparum, run by Ifakara Health Institute 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zawadi Mboma, PhD (+255 787 428218, zmageni@ihi.or.tz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Plasmodium falciparum parasite. (time frame: Approximately 12 months post-installation, coinciding with the long rainy season.). 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 NCT05125133, which also lists 6 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 2 Dec 2021.