MalariaREDHOTNCT01575613
Reducing the Burden of Malaria by Targeting Hotspots of Malaria Transmission
A study testing Artemether-lumefantrine combination, Bacillus thuringiensis and Long lasting insecticide treated net (LLINs) in people with Malaria, run by Radboud University Medical Center at 1 site in Kenya.
Trial summary
In this study, the investigators propose to determine the value of rolling out four targeted malaria control efforts in reducing overall malaria transmission. These targeted control efforts include local upscaling of IRS and ITNs in hotspots of malaria transmission. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Artemether-lumefantrine combination, Bacillus thuringiensis and Long lasting insecticide treated net (LLINs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,506 participants
- Where
- 1 siteKenya
- Study dates
- Apr 2012to Nov 2012
- 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
None listed.
Who cannot join
- For LLINs, IRS and larviciding there are no exclusion criteria
- Pregnant women and children < 6 months of age are excluded from FSAT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing the Burden of Malaria by Targeting Hotspots of Transmission and Improving Malaria Control Measures in the Highlands of Western Kenya: Simultaneous Rollout of Four Malaria Control Interventions and Evaluation by Cross-sectional Surveys
In this study, the investigators propose to determine the value of rolling out four targeted malaria control efforts in reducing overall malaria transmission. These targeted control efforts include local upscaling of IRS and ITNs in hotspots of malaria transmission. In addition, larviciding will be employed to target malaria vectors, also those that are less susceptible to IRS and ITNs as a consequence of outdoor feeding and resting. Lastly, the human infectious reservoir will be reduced in hotspots of malaria transmission by treating parasite carriers and their household members with the current first-line antimalarial drug. The impact of these targeted interventions on overall transmission intensity will be assessed in the context of currently ongoing malaria control activities in a plausibility study. Hotspots of malaria transmission are defined in an area of 100km2 and randomized to receive hotspot targeted interventions and compared with their baseline and with control clusters where the routine (untargeted) malaria control activities continue. The interventions will be evaluated based on changes in parasite prevalence measured in community surveys inside and outside hotspots of malaria transmission. Parasite prevalence will be compared before and after the intervention in intervention clusters and between intervention and control clusters.
In addition to malaria surveys in the human population, an entomological evaluation will take place where the densities of mosquito larvae and adult mosquitoes are monitored longitudinally.
Read the detailed description
DEFINITIONS This study uses a plausibility design to determine the plausible impact of hotspot-targeted interventions on overall malaria transmission. Hotspots will be detected in the 100km2 study area. Hotspots are defined as areas with a level of transmission intensity that exceeds that in the surrounding area; indicated by a higher sero-conversion rate and/or age-adjusted density of malaria-specific antibodies.
Clusters for the intervention are defined as a hotspot and the area surrounding this hotspot in each direction up to 500 meters.
INTERVENTION Half of the clusters will be randomized to hotspot-targeted interventions, while the other half will serve as control. The plausible impact of hotspot targeted interventions will be evaluated by comparing malaria indices in intervention clusters with their baseline and with control clusters.
In each phase four hotspot-targeted interventions will be superimposed on ongoing control measures: hotspots will be targeted with a combination IRS, long-lasting insecticide treated nets (LLINs), larviciding and a focal screening and treatment (FSAT).
EVALUATION The primary outcome will be parasite prevalence in evaluation zones (i.e. the area surrounding malaria hotspots) of targeted and untargeted clusters. In addition, parasite prevalence will be determined inside hotspots of malaria transmission and in evaluation zones in relation to distance to the hotspot boundary. For this, community surveys are planned prior to the intervention and at two time-points after the intervention.
An entomological evaluation will take place concurrently in which mosquito breeding sites are monitored for productivity and mosquitoes will be sampled indoors and outdoors.
Malaria morbidity is assessed by passive case detection.
- Conditions
- Malaria
- Being tested
- Artemether-lumefantrine combination, Bacillus thuringiensis, Long lasting insecticide treated net (LLINs), Indoor Residual Spraying (IRS)
- Keywords
- malaria, heterogeneity, transmission, elimination
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrine combinationDrug
Focal screening and treatment in all households in malaria hotspots prior to the peak transmission season. Screening of a sentinel age group by rapid diagnostic tests; all parasitaemic individuals and household members of parasitaemic individuals will be treated.
Bacillus thuringiensisBiological
Treatment of all waterbodies within hotspots with Bti or Bs on weekly basis
Long lasting insecticide treated net (LLINs)Biological
Distribution of LLINs in all households in malaria hotspots; instruction about correct use.
Indoor Residual Spraying (IRS)Biological
6-monthly IRS with deltamethrin in all households malaria hotspots.
| Study group | Role | What they receive |
|---|---|---|
| Hotspot Targeting | Experimental | Four hotspot-targeted interventions will be superimposed on ongoing control measures: hotspots will be targeted with a combination of IRS, long-lasting insecticide treated nets (LLINs), larviciding and a focal screening and treatment (FSAT)campaign. Receives: Drug: Artemether-lumefantrine combination; Biological: Bacillus thuringiensis; Biological: Long lasting insecticide treated net (LLINs); Biological: Indoor Residual Spraying (IRS) |
| Control | No intervention | Standard of care as determined by the Division of Malaria Control of the Kenyan Ministry of Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasite prevalence in the evaluation zone surrounding malaria hotspots
Parasite prevalence, determined by PCR, in the evaluation zone surrounding hotspots in intervention and control clusters
Measured: 3 cross-sectional surveys in up to 210 days, the timing being: at enrolment; 45-75 days post enrolment (coinciding with the peak malaria transmission season) and 150-210 days post enrolment (coinciding with the end of the malaria transmission season)
Secondary outcomes (6)
Parasite prevalence inside malaria hotspots
Parasite prevalence, determined by PCR, inside hotspot of malaria transmission in intervention and control clusters
Measured: 3 cross-sectional surveys in up to 210 days, the timing being: at enrolment; 45-75 days post enrolment (coinciding with the peak malaria transmission season) and 150-210 days post enrolment (coinciding with the end of the malaria transmission season)
Parasite prevalence in the evaluation zone as function of distance to the hotspot boundary
Parasite prevalence, determined by PCR, in relation to distance to the boundary of malaria hotspots in intervention and control clusters
Measured: 3 cross-sectional surveys in up to 210 days, the timing being: at enrolment; 45-75 days post enrolment (coinciding with the peak malaria transmission season) and 150-210 days post enrolment (coinciding with the end of the malaria transmission season)
Anopheles mosquito density
Indoor and outdoor anopheles mosquito density inside and outside hotspots of malaria transmission in intervention and control clusters
Measured: determined during fortnightly trapping, starting at enrolment and continuing until up to 210 days after enrolment
Passive case detection
Number of malaria cases reporting at health facilities, coming from intervention and control clusters
Measured: determined continuously for a period of up to 210 days after enrolment
Safety and acceptability of interventions
Side effects of FSAT, LLINs and IRS in targeted households
Measured: at a single cross-sectional survey 15-45 days after enrolment
Mosquito breeding site productivity
The presence and density of anopheles larvae in mosquito breeding sites in malaria hotspots in intervention and control clusters
Measured: determined on a weekly basis for a period of up to 210 days after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- None (open label)
- Enrolment
- 17,506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute, Centers for Disease Control and Prevention, International Centre of Insect Physiology and Ecology (ICIPE), Division of Malaria Control, Ministry of Health, Nairobi, Kenya
- Responsible party
- Sponsor
- Investigators
- Teun Bousema, PhD, Principal investigator, Radboud University Medical CenterJon Cox, PhD, Principal investigator, London School of Hygiene and Tropical MedicineJennifer Stevenson, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575613
- Sponsor's protocol ID
- REDHOT_OPP1024438
- Acronym
- REDHOT
- Status last verified
- Nov 2012
- First submitted
- 19 Mar 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bousema T, Griffin JT, Sauerwein RW, Smith DL, Churcher TS, Takken W, Ghani A, Drakeley C, Gosling R. Hitting hotspots: spatial targeting of malaria for control and elimination. PLoS Med. 2012 Jan;9(1):e1001165. doi: 10.1371/journal.pmed.1001165. Epub 2012 Jan 31.
PubMed 22303287Bousema T, Stresman G, Baidjoe AY, Bradley J, Knight P, Stone W, Osoti V, Makori E, Owaga C, Odongo W, China P, Shagari S, Doumbo OK, Sauerwein RW, Kariuki S, Drakeley C, Stevenson J, Cox J. The Impact of Hotspot-Targeted Interventions on Malaria Transmission in Rachuonyo South District in the Western Kenyan Highlands: A Cluster-Randomized Controlled Trial. PLoS Med. 2016 Apr 12;13(4):e1001993. doi: 10.1371/journal.pmed.1001993. eCollection 2016 Apr.
PubMed 27071072Bousema T, Stevenson J, Baidjoe A, Stresman G, Griffin JT, Kleinschmidt I, Remarque EJ, Vulule J, Bayoh N, Laserson K, Desai M, Sauerwein R, Drakeley C, Cox J. The impact of hotspot-targeted interventions on malaria transmission: study protocol for a cluster-randomized controlled trial. Trials. 2013 Feb 2;14:36. doi: 10.1186/1745-6215-14-36.
PubMed 23374910
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Burden of Malaria by Targeting Hotspots of Transmission and Improving Malaria Control Measures in the Highlands of Western Kenya: Simultaneous Rollout of Four Malaria Control Interventions and Evaluation by Cross-sectional Surveys
- ClinicalTrials.gov ID
- NCT01575613
- Acronym / sponsor ID
- REDHOT / REDHOT_OPP1024438
- Conditions
- Malaria
- Keywords
- malaria, heterogeneity, transmission, elimination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,506 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute, Centers for Disease Control and Prevention, International Centre of Insect Physiology and Ecology (ICIPE), Division of Malaria Control, Ministry of Health, Nairobi, Kenya
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Apr 2012 (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.
In this study, the investigators propose to determine the value of rolling out four targeted malaria control efforts in reducing overall malaria transmission. These targeted control efforts include local upscaling of IRS and ITNs in hotspots of malaria transmission. In addition, larviciding will be employed to target malaria vectors, also those that are less susceptible to IRS and ITNs as a consequence of outdoor feeding and resting. Lastly, the human infectious reservoir will be reduced in hotspots of malaria transmission by treating parasite carriers and their household members with the current first-line antimalarial drug. The impact of these targeted interventions on overall transmission intensity will be assessed in the context of currently ongoing malaria control activities in a plausibility study. Hotspots of malaria transmission are defined in an area of 100km2 and randomized to receive hotspot targeted interventions and compared with their baseline and with control clusters where the routine (untargeted) malaria control activities continue. The interventions will be evaluated based on changes in parasite prevalence measured in community surveys inside and outside hotspots of malaria transmission. Parasite prevalence will be compared before and after the intervention in intervention clusters and between intervention and control clusters.
In addition to malaria surveys in the human population, an entomological evaluation will take place where the densities of mosquito larvae and adult mosquitoes are monitored longitudinally.
Detailed description
DEFINITIONS This study uses a plausibility design to determine the plausible impact of hotspot-targeted interventions on overall malaria transmission. Hotspots will be detected in the 100km2 study area. Hotspots are defined as areas with a level of transmission intensity that exceeds that in the surrounding area; indicated by a higher sero-conversion rate and/or age-adjusted density of malaria-specific antibodies.
Clusters for the intervention are defined as a hotspot and the area surrounding this hotspot in each direction up to 500 meters.
INTERVENTION Half of the clusters will be randomized to hotspot-targeted interventions, while the other half will serve as control. The plausible impact of hotspot targeted interventions will be evaluated by comparing malaria indices in intervention clusters with their baseline and with control clusters.
In each phase four hotspot-targeted interventions will be superimposed on ongoing control measures: hotspots will be targeted with a combination IRS, long-lasting insecticide treated nets (LLINs), larviciding and a focal screening and treatment (FSAT).
EVALUATION The primary outcome will be parasite prevalence in evaluation zones (i.e. the area surrounding malaria hotspots) of targeted and untargeted clusters. In addition, parasite prevalence will be determined inside hotspots of malaria transmission and in evaluation zones in relation to distance to the hotspot boundary. For this, community surveys are planned prior to the intervention and at two time-points after the intervention.
An entomological evaluation will take place concurrently in which mosquito breeding sites are monitored for productivity and mosquitoes will be sampled indoors and outdoors.
Malaria morbidity is assessed by passive case detection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hotspot Targeting | Experimental | Drug: Artemether-lumefantrine combination, Biological: Bacillus thuringiensis, Biological: Long lasting insecticide treated net (LLINs), Biological: Indoor Residual Spraying (IRS)Four hotspot-targeted interventions will be superimposed on ongoing control measures: hotspots will be targeted with a combination of IRS, long-lasting insecticide treated nets (LLINs), larviciding and a focal screening and treatment (FSAT)campaign. |
| Control | No intervention | –Standard of care as determined by the Division of Malaria Control of the Kenyan Ministry of Health |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- For LLINs, IRS and larviciding there are no exclusion criteria
- Pregnant women and children < 6 months of age are excluded from FSAT
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 |
|---|---|---|
| Artemether-lumefantrine combinationFocal screening and treatment in all households in malaria hotspots prior to the peak transmission season. Screening of a sentinel age group by rapid diagnostic tests; all parasitaemic individuals and household members of parasitaemic individuals will be treated. | Drug | Hotspot Targeting |
| Bacillus thuringiensisTreatment of all waterbodies within hotspots with Bti or Bs on weekly basis | Biological | Hotspot Targeting |
| Long lasting insecticide treated net (LLINs)Distribution of LLINs in all households in malaria hotspots; instruction about correct use. | Biological | Hotspot Targeting |
| Indoor Residual Spraying (IRS)6-monthly IRS with deltamethrin in all households malaria hotspots. | Biological | Hotspot Targeting |
Primary outcome
Parasite prevalence in the evaluation zone surrounding malaria hotspots
Time frame: 3 cross-sectional surveys in up to 210 days, the timing being: at enrolment; 45-75 days post enrolment (coinciding with the peak malaria transmission season) and 150-210 days post enrolment (coinciding with the end of the malaria transmission season)
Parasite prevalence, determined by PCR, in the evaluation zone surrounding hotspots in intervention and control clusters
6 secondary outcomes
Parasite prevalence inside malaria hotspots
Time frame: 3 cross-sectional surveys in up to 210 days, the timing being: at enrolment; 45-75 days post enrolment (coinciding with the peak malaria transmission season) and 150-210 days post enrolment (coinciding with the end of the malaria transmission season)
Parasite prevalence in the evaluation zone as function of distance to the hotspot boundary
Time frame: 3 cross-sectional surveys in up to 210 days, the timing being: at enrolment; 45-75 days post enrolment (coinciding with the peak malaria transmission season) and 150-210 days post enrolment (coinciding with the end of the malaria transmission season)
Anopheles mosquito density
Time frame: determined during fortnightly trapping, starting at enrolment and continuing until up to 210 days after enrolment
Passive case detection
Time frame: determined continuously for a period of up to 210 days after enrolment
Safety and acceptability of interventions
Time frame: at a single cross-sectional survey 15-45 days after enrolment
Mosquito breeding site productivity
Time frame: determined on a weekly basis for a period of up to 210 days after enrolment
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 27 Nov 2012.
- Background: PubMed 22303287Bousema T, Griffin JT, Sauerwein RW, Smith DL, Churcher TS, Takken W, Ghani A, Drakeley C, Gosling R. Hitting hotspots: spatial targeting of malaria for control and elimination. PLoS Med. 2012 Jan;9(1):e1001165. doi: 10.1371/journal.pmed.1001165. Epub 2012 Jan 31.
- Derived from this study: PubMed 27071072Bousema T, Stresman G, Baidjoe AY, Bradley J, Knight P, Stone W, Osoti V, Makori E, Owaga C, Odongo W, China P, Shagari S, Doumbo OK, Sauerwein RW, Kariuki S, Drakeley C, Stevenson J, Cox J. The Impact of Hotspot-Targeted Interventions on Malaria Transmission in Rachuonyo South District in the Western Kenyan Highlands: A Cluster-Randomized Controlled Trial. PLoS Med. 2016 Apr 12;13(4):e1001993. doi: 10.1371/journal.pmed.1001993. eCollection 2016 Apr.
- Derived from this study: PubMed 23374910Bousema T, Stevenson J, Baidjoe A, Stresman G, Griffin JT, Kleinschmidt I, Remarque EJ, Vulule J, Bayoh N, Laserson K, Desai M, Sauerwein R, Drakeley C, Cox J. The impact of hotspot-targeted interventions on malaria transmission: study protocol for a cluster-randomized controlled trial. Trials. 2013 Feb 2;14:36. doi: 10.1186/1745-6215-14-36.
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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.
Teun Bousema, PhD principal investigator
Radboud University Medical Center
Jon Cox, PhD principal investigator
London School of Hygiene and Tropical Medicine
Jennifer Stevenson, 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 Artemether-lumefantrine combination, Bacillus thuringiensis and Long lasting insecticide treated net (LLINs) in people with Malaria, run by Radboud University Medical Center at 1 site in Kenya.
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 0 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: finished, as of the sponsor's last update on 27 Nov 2012. 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 Kenya. 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?
Parasite prevalence in the evaluation zone surrounding malaria hotspots (time frame: 3 cross-sectional surveys in up to 210 days, the timing being: at enrolment; 45-75 days post enrolment (coinciding with the peak malaria transmission season) and 150-210 days post enrolment (coinciding with the end of the malaria transmission 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 NCT01575613, which also lists 3 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 27 Nov 2012.