Three-arm Cluster Randomised Control Trial Evaluation of Guardian Spatial Emanator as a Complimentary Vector Control Tool in Papua New Guinea (WinMal)
WinMal Trial: Spatial Emanator Deployment Strategies for Malaria Control in Papua New Guinea
Malaria cases are increasing in Papua New Guinea, partly because insecticide-treated nets do not fully protect people, especially from mosquitoes that bite outdoors. Spatial emanators are new devices that release insecticide into the air to repel or kill mosquitoes. This study will test whether these devices reduce malaria infections in rural villages in Madang Province by comparing households using indoor or outdoor devices with those without them. The results will help guide national malaria control strategies.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
The WinMal trial is a large-scale cluster randomised control trial investigating whether spatial emanators reduce transmission of malaria infections. The study is being conducted with 150 rural villages in Bogia, Sumkar, Madang and Rai Coast districts of Madang Province, Papua New Guinea.
The trial will address the question: 'Do Guardian spatial emanators reduce malaria transmission when deployed in protected outdoor spaces or inside houses in PNG?'
The trial will evaluate the effectiveness, acceptability and feasibility of Guardian SE deployed indoors and outdoors for malaria prevention in PNG.
The WinMal trial will provide evidence to guide PNG National Department of Health decisions on how spatial emanators could be deployed alongside ITNs to address gaps in protection from outdoor biting.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Paul Daly, MPH MID
- Telefonszám: +61 3 9282 2111
- E-mail: paul.daly@burnet.edu.au
Tanulmányi helyek
-
-
Madang Province
-
Madang, Madang Province, Pápua Új-Guinea
- Sumkar, Bogia, Rai Coast and Madang Districts of Madang Province, Papua New Guinea
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Children aged 9-14 years at enrolment
- Sleeps in a household within allocated cluster >90% of the nights during any given month
Exclusion Criteria:
- Dissent (by child) to participate in the study
- No parental consent provided through the signing of informed consent form
- Unwillingness to take G6PD-guided radical cure treatment at enrolment with no previous ADRs to AL or PQ
- Plans for extended travel (>2 weeks) outside of household/cluster during the study
- G6PD activity ≤6.0 U/g Hb at screening
- Measured baseline of ≤8 mg/dL or who have signs of clinical decompensation
- Participating or planning to participate in another clinical trial investigating a drug, vaccine, medical device, or procedure during the study period
- Currently taking malaria prophylaxis
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Outdoor intervention arm
Guardian spatial emanators deployed in protected outdoor spaces, households will continue to use ITNs as per routine National Malaria Control Program |
Guardian spatial emanators deployed in protected outdoor spaces |
|
Kísérleti: Indoor intervention arm
Guardian spatial emanators deployed inside houses, households will continue to use ITNs as per routine National Malaria Control Program |
Guardian spatial emanators deployed inside houses |
|
Nincs beavatkozás: Control arm
No spatial emanators deployed, households will continue to use ITNs as per routine National Malaria Control Program |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Effectiveness of Guardian Spatial Emanator
Időkeret: 12 months
|
Time to first Plasmodium spp. infection detected by PCR at monthly follow-up visits or symptomatic ad-hoc visit between follow-ups over the 12-month intervention period in cohort participants from the core of the clusters. |
12 months
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Effectiveness of Guardian Spatial Emanator
Időkeret: 12 months
|
Time to first PCR-confirmed P. falciparum infection over the 12 months of follow-up. Time to first PCR-confirmed P. vivax infection over the 12 months of follow-up. |
12 months
|
|
Effectiveness of Guardian Spatial Emanator
Időkeret: 6 months
|
Time to first PCR-confirmed Plasmodium spp infection over the first 6 months of follow-up. Time to first PCR-confirmed P. falciparum infection over the first 6 months of follow-up. Time to first PCR-confirmed P. vivax infection over the first 6 months of follow-up. |
6 months
|
|
Effectiveness of Guardian Spatial Emanator
Időkeret: 12 months
|
Incidence of PCR-confirmed Plasmodium spp infections (first-time & recurrent together) in first 6m & full 12m. Incidence of PCR-confirmed Pf infections (first-time & recurrent together) in first 6m & full 12m. Incidence of PCR-confirmed Pv infections (first-time & recurrent together) in first 6m & full 12m Incidence of clinical episodes of malaria (first-time & recurrent together) in first 6m & full 12m Incidence of Pf clinical episodes of malaria (first-time & recurrent together) in first 6m & full 12m Incidence of Pv clinical episodes of malaria (first-time & recurrent together) in first 6m & full 12m Incidence of new Pf blood stage infections (molecular force of blood-stage infection - Pf molFOB) in first 6m & full 12m Incidence of new Pv blood stage infections (molecular force of blood-stage infection - Pv molFOB) in first 6m & full 12m Incidence of new blood stage infections (molecular force of blood-stage infection for Pf and Pv molFOB combined) in first 6m & full 12m |
12 months
|
|
Difference between indoor and outdoor arms
Időkeret: 12 months
|
Time to first Plasmodium spp. infection detected by PCR at monthly follow-up or symptomatic ad-hoc visit between follow-ups visits over the 12-month intervention period in cohort participants from the core of the clusters. |
12 months
|
|
Sensitivity of the estimates for epidemiological outcomes
Időkeret: 12 months
|
Spillover-adjusted estimates of intervention effectiveness for epidemiological endpoints, incorporating data from cluster buffer zone participants. |
12 months
|
|
Anopheles species composition
Időkeret: 12 months
|
Anopheles species composition in a subset of clusters, in the pre-deployment baseline period and at the end of the intervention. |
12 months
|
|
Presence of insecticide resistance mutations
Időkeret: 12 months
|
Prevalence of insecticide resistance markers in a subset of clusters in the pre-deployment baseline period and at the end of the intervention. |
12 months
|
|
Acceptability of spatial emanators
Időkeret: 12 months
|
Qualitative outcomes from Photovoice methodology, and associated focus group discussions with community members, followed by thematic analysis of drivers of behaviour change, barriers and enablers of spatial emanator acceptance and consistent use. |
12 months
|
|
Feasibility of spatial emanators
Időkeret: 12 months
|
Qualitative outcomes from key informant interviews with key study staff and health system stakeholders at district, provincial, and national level followed by descriptive summary of barriers and enablers to distribution, implementation & scale-up. |
12 months
|
|
Cost effectiveness of Guardian spatial emanators
Időkeret: 12 months
|
The costs of deploying spatial emanators (either indoor or outdoor) and the incremental cost-effectiveness ratios when compared with current practice. |
12 months
|
|
Self-reported adverse events
Időkeret: 12 months
|
Incidence of self-reported adverse events (AEs) and/or serious adverse events (SAEs) assessed as possibly or likely related to Guardian spatial emanators among cohort participants (through monthly follow-up) and wider community through passive surveillance. |
12 months
|
|
Coverage, attrition and re-location of spatial emanators
Időkeret: 12 months
|
Proportion of households with emanators in place at scheduled monitoring visits, the attrition rate per cluster per scheduled monitoring visit period, timing of redistribution events recorded per cluster. |
12 months
|
|
Transfluthrin quantity, installation environment and bioefficacy
Időkeret: 12 months
|
Mass percent transfluthrin retained in the spatial emanators related to installation environment and bioefficacy measure/s (e.g., knock down and mortality of colony mosquitoes exposed to spatial emanators). |
12 months
|
Együttműködők és nyomozók
Együttműködők
Nyomozók
- Kutatásvezető: Leanne Robinson, MPH PhD, Burnet Institute
- Kutatásvezető: Moses Laman, MBBS PHD, Papua New Guinea Institute of Medical Research
- Kutatásvezető: Stephan Karl, PhD, James Cook University, Queensland, Australia
- Kutatásvezető: Jacob Kisomb, MBBS, National Department of Health, Papua New Guinea
- Kutatásvezető: Maria Ome-Kaius, MBBS PhD, Papua New Guinea Institute of Medical Research
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- NATNAT WinMal cRCT
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .