Reducing the Burden of Malaria by Targeting Hotspots of Malaria Transmission

NCT01575613 | Completed

• 1 other identifier: REDHOT_OPP1024438
• Study Type: interventional
• Target: 17,506
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Malaria

Keywords

malaria; heterogeneity; transmission; elimination

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  determined during fortnightly trapping, starting at enrolment and continuing until up to 210 days after enrolment

• Passive case detection

  determined continuously for a period of up to 210 days after enrolment

• Safety and acceptability of interventions

  at a single cross-sectional survey 15-45 days after enrolment

Study Arms (2)

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.

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

Interventions

Artemether-lumefantrine combination DRUG

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.

Hotspot Targeting

Bacillus thuringiensis BIOLOGICAL

Treatment of all waterbodies within hotspots with Bti or Bs on weekly basis

Hotspot Targeting

Long lasting insecticide treated net (LLINs) BIOLOGICAL

Distribution of LLINs in all households in malaria hotspots; instruction about correct use.

Hotspot Targeting

Indoor Residual Spraying (IRS) BIOLOGICAL

6-monthly IRS with deltamethrin in all households malaria hotspots.

Hotspot Targeting

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pregnant women and children \< 6 months of age are excluded from FSAT

Sponsors & Collaborators

• Radboud University Medical Center: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Kenya Medical Research Institute: collaborator
• Centers for Disease Control and Prevention: collaborator
• International Centre of Insect Physiology and Ecology (ICIPE): collaborator
• Division of Malaria Control, Ministry of Health, Nairobi, Kenya: collaborator

Study Sites (1)

Unknown Facility

Rachuonyo District, Kenya

Location

Related Publications (3)

• 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.

  PMID: 22303287 BACKGROUND

• Bousema 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.

  PMID: 27071072 DERIVED

• Bousema 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.

  PMID: 23374910 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Teun Bousema, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Jon Cox, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Jennifer Stevenson, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: April 11, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

KE (1)