MalariaPhase 3URCTNCT02938975
Field Efficacy Of Insecticide Treated Uniforms And Skin Repellents for Malaria Prevention
A Phase 3 study testing Ultra 30 Insect Repellent Lotion (30% Lipo DEET), Permethrin Factory-Treated Army Combat Uniforms and Army combat uniform in people with Malaria, run by Ifakara Health Institute at 1 site in Tanzania.
Trial summary
Purpose While there is strong evidence that permethrin treated clothing prevents insect bites there is insufficient evidence from trials to demonstrate a reduction in infections. The evidence that topical insect repellants prevent malaria is more robust, but studies in civilian suffer from poor compliance. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Ultra 30 Insect Repellent Lotion (30% Lipo DEET), Permethrin Factory-Treated Army Combat Uniforms and Army combat uniform
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 1 siteTanzania
- Study dates
- Nov 2017to Jun 2019
- Phase
- Phase 3
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Member of a platoon passes physical examination - no underlying health risks females that are not pregnant malaria negative at enrolment consents to participate
Who cannot join
- Not assigned to a platoon underlying health risks - does not pass physical examination pregnant female (pregnant females are not recruited into the army) malaria positive at enrolment does not consent to participate
Trial locations and contacts
1 site in 1 country.
Daniel F Msellemu, MSc contact
Tanzania1 site
Ifakara Health Institute
Bagamoyo, 74
Mercy Nyika, +255788-720602, mnyika@ihi.or.tz
Sarah J Moore, PhD
About this study
Official title: Field Efficacy Of Insecticide Treated Uniforms And Skin Repellents To Reduce Malaria Incidence In Military Personnel On Active Duty In Regions Of Hyperendemicity
Purpose
While there is strong evidence that permethrin treated clothing prevents insect bites there is insufficient evidence from trials to demonstrate a reduction in infections. The evidence that topical insect repellants prevent malaria is more robust, but studies in civilian suffer from poor compliance. It is not known if there is an added benefit from combining the two. The effectiveness of permethrin-treated uniforms with and without DEET lotion are compared in a 2x2 design in Mgambo Jeshi la Kujenga Taifa (JKT) military camp in Tanga region.
Read more
The four arms are: 1) combined intervention group receiving permethrin treated uniform (PTU) and 30% DEET (diethyl toluamide) liposome formula; 2) permethrin intervention group receiving PTU and placebo lotion; 3) DEET intervention group receiving untreated army combat uniform (ACU) and 30% DEET liposome formula; 4) placebo group receiving untreated ACU and placebo lotion. Both participants and investigators will be blinded to treatment allocation.
The outcome measure is the incidence of Plasmodium falciparum malaria infection measured by Polymerase Chain Reaction every month by active case detection.
Read the detailed description
The study is a prospective, cluster-randomised placebo controlled trial using a 4-arm non-inferiority design with 12 months of follow-up. Healthy recruits of the Tanzanian National Service Program JKT Mgambo Camp will be enrolled in the trial. The recruits come from all over Tanzania. The transmission in the camp is relatively high: the incidence of malaria infection in Mgambo camp among recruits in the last quarter of 2014 was 0.68 per person per year measured by RDT.
One thousand five hundred recruits will be enrolled in the trial. Randomisation will be based on combania (the company, comprising typically 30-50 recruits). Recruits in a combania perform all activities together as a group. The randomisation will be unequal since the investigators expect that the primary comparison requiring the greatest precision is that of adding DEET lotion to PTU. Investigators will randomise 500 recruits for each arm of the primary comparison (PTU plus DEET, PTU uniform only) and 250 recruits to each of DEET only and placebo.
Compliance will be maximised by requesting participants to use their uniforms and lotions only at night. Monitoring of uniform use will be conducted by random spot checks of participants in the evenings by study staff. In addition, bottles of lotion will be weighed on a monthly basis during active case detection as a direct measure of compliance with lotion use.
Artemether-lumefantrine (Co-Artem) will be given to any participant with a temperature of ≥37.5 degrees centigrade or a history of fever in the past 48h, and P. falciparum parasites detected by RDT in the absence of other detectable cause of fever.
The participants' activities for the previous two weeks will be recorded by questionnaire by study staff during active case detection. Time away from the camp or in the sick bay and prophylactic periods in the case of antimalarial treatment will be excluded from time at risk.
Soldiers are a vulnerable group because they have limited ability to protect their own interests. It is therefore, particularly important that they should be prevented from being involved in the research project because they feel it is their duty to do so or that they may be subject to penalty from senior members of the army. Therefore, in order to protect the soldiers from coercion the ethical review process for the research is conducted the same processes procedure as is required by a civilian Institutional Review Board (IRB). In addition, service members' commanders or supervisors may not be in the room during the consent process. It will be stressed to Tanzania People's Defence Force (TPDF) staff performing spot checks that they are merely to monitor compliance and should not coerce participants into wearing their uniforms when in the barracks
- Conditions
- Malaria
- Being tested
- Ultra 30 Insect Repellent Lotion (30% Lipo DEET), Permethrin Factory-Treated Army Combat Uniforms, Placebo lotion, Army combat uniform
- Keywords
- malaria, personal protection, permethrin treated clothing, insect repellents, army personnel, cluster randomised trial
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra 30 Insect Repellent Lotion (30% Lipo DEET)Other
One application of Lipo DEET protects for up to 12 hours and has a pleasant odour and non-greasy "feel" on the skin. DEET is a broad spectrum insect repellent and was selected this study because it has been extensively tested for safety and toxicity for human use and its efficacy against a broad variety of arthropod vectors. DEET was first registered in 1957 and has been conclusively proven to be safe for use on adults, children, pregnant and lactating mothers.
This Liposome-based repellent is the newest advancement in insect repellent technology. The Liposome envelops the active ingredient, DEET, and slowly time-releases it as needed, thereby extending the effectiveness of the repellent and reducing dermal absorption.
Permethrin Factory-Treated Army Combat UniformsOther
Permethrin is the U.S., Australian and United Kingdom (UK) military's standard repellent for application to fabric and is considered the most effective clothing treatment available to prevent insect bites through fabric. The Army objective is to provide 90% bite protection for at least 50 launderings; an objective easily met through factory treatment of uniforms, which demonstrates 99-100% bite protection up to 50 launderings (the expected lifetime of the uniform).
Placebo lotionOther
A liposome lotion with no DEET
Army combat uniformOther
Army combat uniform with no permethrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo group receiving untreated army combat uniform and placebo lotion. Assigned interventions: Placebo lotion - a liposome lotion with no DEET Army combat uniform - army combat uniform with no permethrin Receives: Other: Placebo lotion; Other: Army combat uniform |
| Combo | Active comparator | Combined intervention group of receiving Permethrin treated uniform 0.52% w/w and 30% DEET liposome formula.
Ultra 30 Insect Repellent Lotion (30% Lipo DEET) One application of Lipo DEET protects for up to 12 hours. DEET is a broad spectrum insect repellent that has been extensively tested for safety and toxicity for human use and its efficacy against a broad variety of arthropod vectors.
Permethrin Factory-Treated Army Combat Uniforms treated by the military apparel contractor Warmkraft Permethrin is considered the most effective clothing treatment available to prevent insect bites through fabric. The Army objective is to provide 90% bite protection for at least 50 launderings. Receives: Other: Ultra 30 Insect Repellent Lotion (30% Lipo DEET); Other: Permethrin Factory-Treated Army Combat Uniforms |
| Permethrin | Active comparator | permethrin intervention group receiving Permethrin treated uniform 0.52% w/w and placebo lotion.
Permethrin Factory-Treated Army Combat Uniforms treated by the military apparel contractor Warmkraft
Placebo lotion: liposome lotion with no DEET Receives: Other: Permethrin Factory-Treated Army Combat Uniforms; Other: Placebo lotion |
| DEET | Active comparator | DEET intervention group receiving untreated army combat uniform and 30% DEET liposome formula.
Ultra 30 Insect Repellent Lotion (30% Lipo DEET) Army combat uniform with no permethrin Receives: Other: Ultra 30 Insect Repellent Lotion (30% Lipo DEET); Other: Army combat uniform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Plasmodium falciparum malaria through monthly measurement of malaria positivity by direct polymerase chain reaction (PCR) to detect parasite DNA
Blood spots will be collected on Whatman 3 filter paper and processed for PCR detection of parasites
Measured: Monthly active case detection for 12 months
Secondary outcomes (3)
Incidence of clinical malaria through monthly measurement malaria positivity of SD Bioline Malaria Rapid Diagnostic Test to test for parasite antigen
Both active and passive malaria case detection will be taken by malaria RDT (SD Bioline Malaria Incidence of RDT positivity Participants will be tested for malaria every month using Rapid Diagnostic Test (RDT) SD Bioline Malaria Antigen Pf/Pan (SD RDT) with RDT results interpreted by the Deki Reader device.
Measured: Active and passive case detection for 12 months
Compliance with intervention as measured through spot checking and weighing of repellent bottles
Each month bottles of repellent or placebo lotion will be weighed to measure application of repellent. Compliance with uniforms will be observed by spot checks once a month.
Measured: Monthly assessment of intervention compliance with uniforms and lotions provided for 12 months
Protective efficacy of uniforms measured by reduction in Anopheles arabiensis bites among those wearing uniforms for a sub-sample of uniforms tested under laboratory conditions with free flying mosquitoes
A random sample of 100 uniforms will be tested in the laboratory at the end of the study to measure their efficacy in preventing mosquito bites.
Measured: After 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startNov 2017 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ifakara Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, Walter Reed Army Institute of Research (WRAIR), U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Sarah J Moore, PhD, Principal investigator, Ifakara Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938975
- Sponsor's protocol ID
- BIT014 PR001 V01
- Acronym
- URCT
- Status last verified
- Jun 2017
- First submitted
- 5 Aug 2016
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Msellemu D, Ross A, Temu L, Moshi I, Hofer L, Mwanziva C, Kohi YM, Moore SJ. Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent. Trials. 2021 Nov 21;22(1):825. doi: 10.1186/s13063-021-05801-9.
PubMed 34802455
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Efficacy Of Insecticide Treated Uniforms And Skin Repellents To Reduce Malaria Incidence In Military Personnel On Active Duty In Regions Of Hyperendemicity
- ClinicalTrials.gov ID
- NCT02938975
- Acronym / sponsor ID
- URCT / BIT014 PR001 V01
- Conditions
- Malaria
- Keywords
- malaria, personal protection, permethrin treated clothing, insect repellents, army personnel, cluster randomised trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Ifakara Health InstituteUniversity, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, Walter Reed Army Institute of Research (WRAIR), U.S. Army Medical Research and Development Command
- Study start
- Nov 2017 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- 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.
Purpose
While there is strong evidence that permethrin treated clothing prevents insect bites there is insufficient evidence from trials to demonstrate a reduction in infections. The evidence that topical insect repellants prevent malaria is more robust, but studies in civilian suffer from poor compliance. It is not known if there is an added benefit from combining the two. The effectiveness of permethrin-treated uniforms with and without DEET lotion are compared in a 2x2 design in Mgambo Jeshi la Kujenga Taifa (JKT) military camp in Tanga region.
The four arms are: 1) combined intervention group receiving permethrin treated uniform (PTU) and 30% DEET (diethyl toluamide) liposome formula; 2) permethrin intervention group receiving PTU and placebo lotion; 3) DEET intervention group receiving untreated army combat uniform (ACU) and 30% DEET liposome formula; 4) placebo group receiving untreated ACU and placebo lotion. Both participants and investigators will be blinded to treatment allocation.
The outcome measure is the incidence of Plasmodium falciparum malaria infection measured by Polymerase Chain Reaction every month by active case detection.
Detailed description
The study is a prospective, cluster-randomised placebo controlled trial using a 4-arm non-inferiority design with 12 months of follow-up. Healthy recruits of the Tanzanian National Service Program JKT Mgambo Camp will be enrolled in the trial. The recruits come from all over Tanzania. The transmission in the camp is relatively high: the incidence of malaria infection in Mgambo camp among recruits in the last quarter of 2014 was 0.68 per person per year measured by RDT.
One thousand five hundred recruits will be enrolled in the trial. Randomisation will be based on combania (the company, comprising typically 30-50 recruits). Recruits in a combania perform all activities together as a group. The randomisation will be unequal since the investigators expect that the primary comparison requiring the greatest precision is that of adding DEET lotion to PTU. Investigators will randomise 500 recruits for each arm of the primary comparison (PTU plus DEET, PTU uniform only) and 250 recruits to each of DEET only and placebo.
Compliance will be maximised by requesting participants to use their uniforms and lotions only at night. Monitoring of uniform use will be conducted by random spot checks of participants in the evenings by study staff. In addition, bottles of lotion will be weighed on a monthly basis during active case detection as a direct measure of compliance with lotion use.
Artemether-lumefantrine (Co-Artem) will be given to any participant with a temperature of ≥37.5 degrees centigrade or a history of fever in the past 48h, and P. falciparum parasites detected by RDT in the absence of other detectable cause of fever.
The participants' activities for the previous two weeks will be recorded by questionnaire by study staff during active case detection. Time away from the camp or in the sick bay and prophylactic periods in the case of antimalarial treatment will be excluded from time at risk.
Soldiers are a vulnerable group because they have limited ability to protect their own interests. It is therefore, particularly important that they should be prevented from being involved in the research project because they feel it is their duty to do so or that they may be subject to penalty from senior members of the army. Therefore, in order to protect the soldiers from coercion the ethical review process for the research is conducted the same processes procedure as is required by a civilian Institutional Review Board (IRB). In addition, service members' commanders or supervisors may not be in the room during the consent process. It will be stressed to Tanzania People's Defence Force (TPDF) staff performing spot checks that they are merely to monitor compliance and should not coerce participants into wearing their uniforms when in the barracks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo lotion, Other: Army combat uniformplacebo group receiving untreated army combat uniform and placebo lotion. Assigned interventions: Placebo lotion - a liposome lotion with no DEET Army combat uniform - army combat uniform with no permethrin |
| Combo | Active comparator | Other: Ultra 30 Insect Repellent Lotion (30% Lipo DEET), Other: Permethrin Factory-Treated Army Combat UniformsCombined intervention group of receiving Permethrin treated uniform 0.52% w/w and 30% DEET liposome formula. Ultra 30 Insect Repellent Lotion (30% Lipo DEET) One application of Lipo DEET protects for up to 12 hours. DEET is a broad spectrum insect repellent that has been extensively tested for safety and toxicity for human use and its efficacy against a broad variety of arthropod vectors. Permethrin Factory-Treated Army Combat Uniforms treated by the military apparel contractor Warmkraft Permethrin is considered the most effective clothing treatment available to prevent insect bites through fabric. The Army objective is to provide 90% bite protection for at least 50 launderings. |
| Permethrin | Active comparator | Other: Permethrin Factory-Treated Army Combat Uniforms, Other: Placebo lotionpermethrin intervention group receiving Permethrin treated uniform 0.52% w/w and placebo lotion. Permethrin Factory-Treated Army Combat Uniforms treated by the military apparel contractor Warmkraft Placebo lotion: liposome lotion with no DEET |
| DEET | Active comparator | Other: Ultra 30 Insect Repellent Lotion (30% Lipo DEET), Other: Army combat uniformDEET intervention group receiving untreated army combat uniform and 30% DEET liposome formula. Ultra 30 Insect Repellent Lotion (30% Lipo DEET) Army combat uniform with no permethrin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Member of a platoon passes physical examination - no underlying health risks females that are not pregnant malaria negative at enrolment consents to participate
Key exclusion criteria (1 listed)
- Not assigned to a platoon underlying health risks - does not pass physical examination pregnant female (pregnant females are not recruited into the army) malaria positive at enrolment does not consent to participate
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 |
|---|---|---|
| Ultra 30 Insect Repellent Lotion (30% Lipo DEET)One application of Lipo DEET protects for up to 12 hours and has a pleasant odour and non-greasy "feel" on the skin. DEET is a broad spectrum insect repellent and was selected this study because it has been extensively tested for safety and toxicity for human use and its efficacy against a broad variety of arthropod vectors. DEET was first registered in 1957 and has been conclusively proven to be safe for use on adults, children, pregnant and lactating mothers. This Liposome-based repellent is the newest advancement in insect repellent technology. The Liposome envelops the active ingredient, DEET, and slowly time-releases it as needed, thereby extending the effectiveness of the repellent and reducing dermal absorption. | Other | Combo, DEET |
| Permethrin Factory-Treated Army Combat UniformsPermethrin is the U.S., Australian and United Kingdom (UK) military's standard repellent for application to fabric and is considered the most effective clothing treatment available to prevent insect bites through fabric. The Army objective is to provide 90% bite protection for at least 50 launderings; an objective easily met through factory treatment of uniforms, which demonstrates 99-100% bite protection up to 50 launderings (the expected lifetime of the uniform). | Other | Combo, Permethrin |
| Placebo lotionA liposome lotion with no DEET | Other | Permethrin, Placebo |
| Army combat uniformArmy combat uniform with no permethrin | Other | DEET, Placebo |
Primary outcome
Incidence of Plasmodium falciparum malaria through monthly measurement of malaria positivity by direct polymerase chain reaction (PCR) to detect parasite DNA
Time frame: Monthly active case detection for 12 months
Blood spots will be collected on Whatman 3 filter paper and processed for PCR detection of parasites
3 secondary outcomes
Incidence of clinical malaria through monthly measurement malaria positivity of SD Bioline Malaria Rapid Diagnostic Test to test for parasite antigen
Time frame: Active and passive case detection for 12 months
Compliance with intervention as measured through spot checking and weighing of repellent bottles
Time frame: Monthly assessment of intervention compliance with uniforms and lotions provided for 12 months
Protective efficacy of uniforms measured by reduction in Anopheles arabiensis bites among those wearing uniforms for a sub-sample of uniforms tested under laboratory conditions with free flying mosquitoes
Time frame: After 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Derived from this study: PubMed 34802455Msellemu D, Ross A, Temu L, Moshi I, Hofer L, Mwanziva C, Kohi YM, Moore SJ. Effect of interventions to reduce malaria incidence among military personnel on active duty: study protocol for a cluster randomised controlled trial of the impact of etofenprox-treated uniforms, permethrin-treated uniforms and DEET insect repellent. Trials. 2021 Nov 21;22(1):825. doi: 10.1186/s13063-021-05801-9.
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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.
Daniel F Msellemu, MSc contact
Sarah J Moore, PhD principal investigator
Ifakara Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ultra 30 Insect Repellent Lotion (30% Lipo DEET), Permethrin Factory-Treated Army Combat Uniforms and Army combat uniform in people with Malaria, 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 1 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 6 Jun 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sarah J Moore, PhD (+255764802622, smoore@ihi.or.tz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Plasmodium falciparum malaria through monthly measurement of malaria positivity by direct polymerase chain reaction (PCR) to detect parasite DNA (time frame: Monthly active case detection for 12 months). 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 NCT02938975, which also lists 1 linked publication.
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 6 Jun 2017.