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Trial no.:
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PACTR202008664678160 |
Date of Approval:
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19/08/2020 |
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Trial Status:
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Retrospective registration - This trial was registered after enrolment of the first participant |
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| TRIAL DESCRIPTION |
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Public title
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AFRO II Project |
| Official scientific title |
Evaluating the feasibility and impact on malaria transmission of community-based winter larviciding in Namibia, Botswana and Eswatini |
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Brief summary describing the background
and objectives of the trial
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Background
Malaria remains a major health threat in Africa and other countries of the sub-tropical and tropical world with 215 million malaria cases and 438,000 deaths due to the disease reported globally, with 91% of these being from Africa (WHO, 2016). However, this level of morbidity and mortality reflects a reduction of more than 60% since the year 2000 when renewed international and regional efforts culminated in dramatic scaling up of interventions especially in Africa (WHO, 2000). Vector control mainly through the use of long-lasting insecticide-treated nets (LLINs) and indoor residual spraying (IRS) is among the key strategies that have contributed to this significant reduction in disease burden(Bhatt et al., 2015), the others being access to prompt diagnosis and effective treatment. Globally there is optimism that malaria will be eliminated as envisaged in the goals and targets for 2016 -2030 as set by the World Health Organization (WHO), the roll back malaria partnership (RBM) as well as sustainable development goals on health (WHO, 2015). However, the international malaria community is also wary of potential threats to the success achieved with the current malaria control efforts, particularly due to increasing development of insecticide resistance among vector populations as well as residual transmission of the disease in settings where mosquitoes tend to bite people outdoors (WHO,2012; Killeen, 2014). The emergence of insecticide resistance among many malaria vector populations threatens to undermine the recent gains in malaria control associated with LLINs and IRS since both interventions are insecticide-based. According to recent WHO reports, insecticide resistance has now been identified in 64 countries, most of them in sub-Saharan Africa. In some areas the resistance problem is widespread and has been reported for all the four classes of insecticides approved by WHO for public health use. Beyond the challenge posed by insecticide resistance, controlling malaria-transmitting mosquitoes almost entirely using synthetic insecticides is also unsustainable in view of the latter’s potential negative impacts on both human health and the environment (Eskenazi et al, 2009). With regard to tackling residual transmission, it is becoming increasingly clear that in order to further reduce vector densities from the low levels currently achieved with LLINs or IRS to lower levels that may lead to faster and sustainable elimination of parasite transmission, the two primary interventions will need to be augmented with additional interventions, for example larval source management to reduce emergence of adult mosquitoes (Tusting et al 2015).
Main objective
To evaluate the feasibility and impact of community-based winter larviciding using biological agent Bacillus thuringiensis var. israelensis (Bti; VectoBac®) on malaria transmission in southern African countries aiming for malaria elimination
Specific objectives
• To assess whether winter larviciding combined with IRS prior to the rainy season reduces vector adult density inside and outside houses when compared with IRS alone
• To assess whether winter larviciding combined with IRS prior to the rainy season provides added protection against clinical malaria when compared with areas that receive IRS alone
• To determine whether the combined interventions reduces the proportion of aquatic habitats containing Anopheles larvae not only during the intervention but also when larviciding is not implemented (spill-over effect, synergistic effect with IRS)
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| Type of trial |
RCT |
| Acronym (If the trial has an acronym then please provide) |
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| Disease(s) or condition(s) being studied |
Infections and Infestations |
| Sub-Disease(s) or condition(s) being studied |
Malaria |
| Purpose of the trial |
winter larviciding with Bacillus thuringiensis israelensis |
| Anticipated trial start date |
01/10/2017 |
| Actual trial start date |
01/12/2018 |
| Anticipated date of last follow up |
30/04/2022 |
| Actual Last follow-up date |
30/04/2022 |
| Anticipated target sample size (number of participants) |
10000 |
| Actual target sample size (number of participants) |
10000 |
| Recruitment status |
Recruiting |
| Publication URL |
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