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. 2017 Aug 4;18(1):367.
doi: 10.1186/s13063-017-2105-2.

Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial

John Hustedt  1   2 , Dyna Doum  3 , Vanney Keo  3 , Sokha Ly  4 , BunLeng Sam  4 , Vibol Chan  5 , Neal Alexander  6 , John Bradley  6 , Didot Budi Prasetyo  7 , Agus Rachmat  7 , Shafique Muhammad  3 , Sergio Lopes  3 , Rithea Leang  4 , Jeffrey Hii  3
Affiliations

Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial

John Hustedt et al. Trials. .

Abstract

Background: Evidence on the effectiveness of low-cost, sustainable, biological vector-control tools for the Aedes mosquitoes is limited. Therefore, the purpose of this trial is to estimate the impact of guppy fish (guppies), in combination with the use of the larvicide pyriproxyfen (Sumilarv® 2MR), and Communication for Behavioral Impact (COMBI) activities to reduce entomological indices in Cambodia.

Methods/design: In this cluster randomized controlled, superiority trial, 30 clusters comprising one or more villages each (with approximately 170 households) will be allocated, in a 1:1:1 ratio, to receive either (1) three interventions (guppies, Sumilarv® 2MR, and COMBI activities), (2) two interventions (guppies and COMBI activities), or (3) control (standard vector control). Households will be invited to participate, and entomology surveys among 40 randomly selected households per cluster will be carried out quarterly. The primary outcome will be the population density of adult female Aedes mosquitoes (i.e., number per house) trapped using adult resting collections. Secondary outcome measures will include the House Index, Container Index, Breteau Index, Pupae Per House, Pupae Per Person, mosquito infection rate, guppy fish coverage, Sumilarv® 2MR coverage, and percentage of respondents with knowledge about Aedes mosquitoes causing dengue. In the primary analysis, adult female Aedes density and mosquito infection rates will be aggregated over follow-up time points to give a single rate per cluster. This will be analyzed by negative binomial regression, yielding density ratios.

Discussion: This trial is expected to provide robust estimates of the intervention effect. A rigorous evaluation of these vector-control interventions is vital to developing an evidence-based dengue control strategy and to help direct government resources.

Trial registration: Current Controlled Trials, ID: ISRCTN85307778 . Registered on 25 October 2015.

Keywords: Cambodia; Community engagement; Dengue; Guppy; Pyriproxyfen; Vector control.

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Conflict of interest statement

Ethical approval and consent to participate

Ethical clearance for this trial has been received by the Cambodian National Ethics Committee for Health Research on 9 October 2014 (ethics reference number 0285). Additionally, ethics approval was received from the London School of Hygiene and Tropical Medicine Observational/Interventions Research Ethics Committee (ethics reference number 8812). The ethical review bodies will review the protocol annually with progress reports from the project teams. Any subsequent modifications to the protocol which may significantly impact or change the study including eligibility criteria, outcomes, or analysis will be communicated to partners and ethical bodies, and will be documented in further publications.

CHWs will explain the trial and receive informed consent from the head of the household before providing the interventions (see Additional file 2). The CHWs will receive prior training on how to seek informed consent. Those who are illiterate or otherwise cannot sign their name will be allowed to give their thumb print. All households will have the ability to remove themselves from the study at any point.

Entomology specimens will be stored at NAMRU-2. Data which contain identifying information, such as names, will be de-identified by assigning individual ID numbers. All village and respondent names will be deleted to ensure that no identifying information is included. Data from surveys will be entered and stored into a password-protected computer. All qualitative data will be collected in concordance with the guidelines of the Code of Ethics of the American Anthropological Association (AAA) [63].

Consent for publication

All authors have consented to publication of this article.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Example of a 200-m boundary around selected clusters
Fig. 2
Fig. 2
Flow chart of cluster selection. Selection of clusters in Kampong Cham, Cambodia
Fig. 3
Fig. 3
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) with schedule of enrollment, interventions, and assessments
Fig. 4
Fig. 4
Sumilarv® 2MR disk (5-cm radius)
See this image and copyright information in PMC

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