Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product

• ClinicalTrials.gov Identifier: NCT02288637
• Recruitment Status: Completed
• First Posted: November 11, 2014
• Last Update Posted: April 27, 2018
• Sponsor: London School of Hygiene and Tropical Medicine
• Information provided by (Responsible Party): London School of Hygiene and Tropical Medicine

Study Description

Brief Summary:

The proposed study is a four-arm randomized control trial (RCT) in 48 villages in the Lakes region in Tanzania comparing the relative effectiveness of 4 vector control interventions for reducing malaria transmission and controlling vector populations in an area where An gambiae s.s is pyrethroid and carbamate resistant: 1/ a standard long lasting insecticidal net (LLIN), 2/ a LLIN which incorporates a piperonyl butoxide (PBO) synergist, 3/ a long lasting indoor residual spray (IRS) formulation used in conjunction with standard pyrethroid LLIN or 4/ the long lasting indoor residual spray (IRS) formulation used in conjunction with the LLIN which incorporates a PBO synergist.

The trial will provide epidemiological, entomological, economic and social evidence of impact, as the investigators shall be measuring the reductions in malaria prevalence and malaria transmission rates EIR, and changes in the frequency of resistance, mosquito species ratios and economic cost effectiveness. The proposed trial will demonstrate whether the novel LLIN and long lasting IRS formulation will be more effective for controlling An.gambiae s.s. and reducing malaria prevalence than current practice with the conventional LLIN. There is great interest in conducting this trial. Alternative vector control products are limited and most new insecticides are not suitable for use on LLINs or as IRS.

Condition or disease	Intervention/treatment	Phase
Malaria; Anaemia	Other: Olyset Plus LLIN; Other: Conventional Olyset LLIN; Other: IRS	Not Applicable

  Show Detailed Description

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3840 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product, Separately and Together, Against Malaria Transmitted by Pyrethroid Resistant Mosquitoes.
• Study Start Date: September 2014
• Actual Primary Completion Date: December 2017
• Actual Study Completion Date: April 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Conventional Olyset LLIN; High coverage (>80% access) of conventional Olyset LLIN The arm is the standard of care from the National Malaria Control Program	Other: Conventional Olyset LLIN; Olyset Plus is a LLIN containing the pyrethroid permethrin. The LLIN can withstand repeated washing and retains efficacy over years of use.; Other Names: Long Lasting Insecticidal Net; Olyset® Net; Sumitomo Chemical
Experimental: Olyset Plus LLIN; High coverage (>80% access) of Olyset Plus LLIN	Other: Olyset Plus LLIN; Olyset Plus is a LLIN containing the pyrethroid permethrin and the synergist piperonyl butoxide PBO as the active ingredients (AI).The LLIN can withstand repeated washing and retains efficacy over years of use; Other Names: Long Lasting Insecticidal Net; Olyset® Plus; Sumitomo chemical
Experimental: Conventional Olyset LLIN and IRS; High coverage (>80% access) of conventional Olyset LLIN and high coverage IRS (>80% of the household sprayed) with pirimiphos methyl CS	Other: Conventional Olyset LLIN; Olyset Plus is a LLIN containing the pyrethroid permethrin. The LLIN can withstand repeated washing and retains efficacy over years of use.; Other Names: Long Lasting Insecticidal Net; Olyset® Net; Sumitomo Chemical; Other: IRS; Actellic CS (Syngenta), is a microcapsule formulation of the organophosphate insecticide, pirimiphos-methyl. Microencapsulation greatly extends the compound's residual life when applied to interior walls and ceilings. Evaluation by LSHTM in experimental huts in Tanzania showed residual activity of more than a year. Parallel trials in Benin against pyrethroid-resistant mosquitoes killed more than 80% of An. gambiae for up to 10 months.; Other Names: Indoor Residual Spraying with Pirimiphos methyl CS; Actellic 300 CS; Syngenta
Experimental: Olyset Plus LLIN and IRS; High coverage (>80% access) of Olyset Plus LLIN and high coverage Indoor Residual Spraying (>80% of the household sprayed) with pirimiphos methyl CS	Other: Olyset Plus LLIN; Olyset Plus is a LLIN containing the pyrethroid permethrin and the synergist piperonyl butoxide PBO as the active ingredients (AI).The LLIN can withstand repeated washing and retains efficacy over years of use; Other Names: Long Lasting Insecticidal Net; Olyset® Plus; Sumitomo chemical; Other: Conventional Olyset LLIN; Olyset Plus is a LLIN containing the pyrethroid permethrin. The LLIN can withstand repeated washing and retains efficacy over years of use.; Other Names: Long Lasting Insecticidal Net; Olyset® Net; Sumitomo Chemical

Outcome Measures

Primary Outcome Measures :

1. Difference in prevalence of malaria infection in children 0.5-14 years between intervention arms [ Time Frame: up to 15 months ]
   Malaria infection tested using Pf/Pan specific Malaria Rapid Diagnostic Test
2. Difference in Entomological Inoculation Rate [ Time Frame: up to 15 months ]
   Malaria transmission measured by the Entomological Inoculation Rate (EIR) for each mosquito vector species.

Secondary Outcome Measures :

1. Difference in Anaemia in children [ Time Frame: up to 15 months ]
2. Difference in Mosquito density for each vector species [ Time Frame: Up to 15 months ]
3. Difference in Sporozoite rate for each mosquito vector species [ Time Frame: up to 15 months ]
4. Prevalence of serological antibodies to malaria antigens [ Time Frame: at baseline ]
5. Change in prevalence of insecticide resistance markers including kdr and metabolic mechanisms [ Time Frame: at baseline and up to 15 months ]

Other Outcome Measures:

1. Number of resident owning and using a Long Lasting Insecticidal Net [ Time Frame: at 3, 9 and 15 months post intervention ]
   Self reported ownership and usage using questionnaire confirmed by visual verification. Usage rate (proportion of study population sleeping under an ITN the previous night among those with access and among all population) of the two types of LLIN in the two post intervention years
2. Number of houses and rooms sprayed [ Time Frame: at time of intervention ]
   Self reported praying coverage confirmed by presence of sticker on the door.
3. Proportion of household resident reporting being at risk for malaria [ Time Frame: up to 15 months ]
   Self reported perception
4. Change in attitude toward the interventions [ Time Frame: at baseline and up to 15 months ]
   Self reported attitude
5. Cost of the intervention [ Time Frame: up to 3 months ]
   Based on start up, on-going and capital cost

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

For the Household

• Having a children from 6 months to 14 years old in the household
• Provide written consent For the children
• Having between 6 months to 14 years
• Permanent residence in a selected household

Exclusion Criteria:

• Children severely ill

Contacts and Locations

Locations

Tanzania

District Muleba

Muleba, Kagera, Tanzania

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

Investigators

• Principal Investigator: Mark Rowland, Phd; London School of Hygiene and Tropical Medicine
• Principal Investigator: Franklin W Mosha, Phd; Kilimanjaro Christian Medical College
• Principal Investigator: William Kisinza, Phd; National Institute of Medical Research
• Principal Investigator: Immo Kleinshmidt, Phd; London School of Hygiene and Tropical Medicine
• Principal Investigator: Natacha Protopopoff, Phd; London School of Hygiene and Tropical Medicine

More Information

Publications:

West PA, Protopopoff N, Rowland MW, Kirby MJ, Oxborough RM, Mosha FW, Malima R, Kleinschmidt I. Evaluation of a national universal coverage campaign of long-lasting insecticidal nets in a rural district in north-west Tanzania. Malar J. 2012 Aug 10;11:273. doi: 10.1186/1475-2875-11-273.

West PA, Protopopoff N, Rowland M, Cumming E, Rand A, Drakeley C, Wright A, Kivaju Z, Kirby MJ, Mosha FW, Kisinza W, Kleinschmidt I. Malaria risk factors in North West Tanzania: the effect of spraying, nets and wealth. PLoS One. 2013 Jun 7;8(6):e65787. doi: 10.1371/journal.pone.0065787. Print 2013.

Protopopoff N, Matowo J, Malima R, Kavishe R, Kaaya R, Wright A, West PA, Kleinschmidt I, Kisinza W, Mosha FW, Rowland M. High level of resistance in the mosquito Anopheles gambiae to pyrethroid insecticides and reduced susceptibility to bendiocarb in north-western Tanzania. Malar J. 2013 May 2;12:149. doi: 10.1186/1475-2875-12-149.

Ngufor C, Tchicaya E, Koudou B, N'Fale S, Dabire R, Johnson P, Ranson H, Rowland M. Combining organophosphate treated wall linings and long-lasting insecticidal nets for improved control of pyrethroid resistant Anopheles gambiae. PLoS One. 2014 Jan 7;9(1):e83897. doi: 10.1371/journal.pone.0083897. eCollection 2014.

Kilian A, Koenker H, Baba E, Onyefunafoa EO, Selby RA, Lokko K, Lynch M. Universal coverage with insecticide-treated nets - applying the revised indicators for ownership and use to the Nigeria 2010 malaria indicator survey data. Malar J. 2013 Sep 10;12:314. doi: 10.1186/1475-2875-12-314.

Kabula B, Tungu P, Malima R, Rowland M, Minja J, Wililo R, Ramsan M, McElroy PD, Kafuko J, Kulkarni M, Protopopoff N, Magesa S, Mosha F, Kisinza W. Distribution and spread of pyrethroid and DDT resistance among the Anopheles gambiae complex in Tanzania. Med Vet Entomol. 2014 Sep;28(3):244-52. doi: 10.1111/mve.12036. Epub 2013 Nov 5.

Pennetier C, Bouraima A, Chandre F, Piameu M, Etang J, Rossignol M, Sidick I, Zogo B, Lacroix MN, Yadav R, Pigeon O, Corbel V. Efficacy of Olyset® Plus, a new long-lasting insecticidal net incorporating permethrin and piperonyl-butoxide against multi-resistant malaria vectors [corrected]. PLoS One. 2013 Oct 8;8(10):e75134. doi: 10.1371/journal.pone.0075134. eCollection 2013. Erratum in: PLoS One. 2013;8(10). doi:10.1371/annotation/bed4305a-d665-4150-a682-a20d9cf9b79f.

West PA, Protopopoff N, Wright A, Kivaju Z, Tigererwa R, Mosha FW, Kisinza W, Rowland M, Kleinschmidt I. Indoor residual spraying in combination with insecticide-treated nets compared to insecticide-treated nets alone for protection against malaria: a cluster randomised trial in Tanzania. PLoS Med. 2014 Apr 15;11(4):e1001630. doi: 10.1371/journal.pmed.1001630. eCollection 2014 Apr.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Protopopoff N, Mosha JF, Lukole E, Charlwood JD, Wright A, Mwalimu CD, Manjurano A, Mosha FW, Kisinza W, Kleinschmidt I, Rowland M. Effectiveness of a long-lasting piperonyl butoxide-treated insecticidal net and indoor residual spray interventions, separately and together, against malaria transmitted by pyrethroid-resistant mosquitoes: a cluster, randomised controlled, two-by-two factorial design trial. Lancet. 2018 Apr 21;391(10130):1577-1588. doi: 10.1016/S0140-6736(18)30427-6. Epub 2018 Apr 11.

• Responsible Party: London School of Hygiene and Tropical Medicine
• ClinicalTrials.gov Identifier: NCT02288637 History of Changes
• Other Study ID Numbers: ITDCZC58
• First Posted: November 11, 2014
• Last Update Posted: April 27, 2018
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Malaria; Protozoan Infections; Parasitic Diseases