- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02517879
Community Point Distribution of Insecticide Treated Bed Nets
2015. augusztus 4. frissítette: IDinsight
Measuring Attendance of Community Point Distribution of Insecticide-treated Bed Nets and the Impact of Community Health Worker Hang-up in Rural Zambia: A Randomized Controlled Trial and Cost Analysis
All households in three zones in Zambia's Eastern Province were invited to attend a community point distribution of insecticide treated bed nets (ITNs).
Households were then randomized to different intervals for a community health worker (CHW) hang-up visit.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Részletes leírás
Households were asked to attend a community point distribution of ITNs in one of three zones in Zambia's Eastern Province.
Households that had been registered to receive ITNs were then randomized to one of five groups that received a CHW visit at different intervals.
Group 1 was visited 1-3 days after distribution, group 2 was visited 5-7 days after, group 3 was visited 10-12 days after, group 4 was visited 15-17 days after, and group 5 did not receive a hang-up visit.
Groups 1-4 were categorized as having received a hang-up visit and group 5 was categorized as not having received a hang-up visit.
All households in all five groups were visited at 7-11 weeks after the distribution and again at 5-6 months after the distribution to assess short- and medium-term ITN retention and usage.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
560
Fázis
- Nem alkalmazható
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
Inclusion Criteria:
- Household was pre-registered by the National Malaria Control Centre to receive ITNs ahead of the start of study activities.
- Household was located in one of the three study areas of Mukonka, Lukwipa, and Chipeketi in Rufunsa District, Zambia
Exclusion Criteria:
- Household was not pre-registered to receive ITNs
- Household was not located in one of the three study areas
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
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: Group 1 - 1-3 days
Community health worker hang-up visit 1-3 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
|
Kísérleti: Group 2 - 5-7 days
Community health worker hang-up visit 5-7 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
|
Kísérleti: Group 3 - 10-12 days
Community health worker hang-up visit 10-12 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
|
Kísérleti: Group 4 - 15-17 days
Community health worker hang-up visit 15-17 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
|
Placebo Comparator: Group 5 - No hang-up visit
Did not receive any hang-up visit after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Community point distribution attendance
Időkeret: At time 0
|
The percentage of pre-registered households that collected ITNs at the community point distributions on November 14, 19, and 21, 2013.
|
At time 0
|
|
Self-installation of ITNs
Időkeret: Each group is randomized to receive a community health worker visit after a different duration, an average of 7 days after the point distribution
|
The percentage of ITNs distributed to a household that the CHW found hanging at his/her visit.
|
Each group is randomized to receive a community health worker visit after a different duration, an average of 7 days after the point distribution
|
|
Household ITN retention
Időkeret: An average of 9 weeks after community point distribution
|
The percentage of ITNs distributed to a household that were found still in the household at the 7-11 week follow-up.
|
An average of 9 weeks after community point distribution
|
|
Household ITN retention
Időkeret: An average of 5.5 months after community point distribution
|
The percentage of ITNs distributed to a household that were found still in the household at the 5-6 month follow-up.
|
An average of 5.5 months after community point distribution
|
|
Household percentage of ITNs hung
Időkeret: An average of 9 weeks after community point distribution
|
The percentage of ITNs distributed to a household that were found hanging during the 7-11 week follow-up.
|
An average of 9 weeks after community point distribution
|
|
Household percentage of ITNs hung
Időkeret: An average of 5.5 months after community point distribution
|
The percentage of ITNs distributed to a household that were found hanging during the 5-6 month follow-up.
|
An average of 5.5 months after community point distribution
|
|
Household percentage of sleeping spaces covered
Időkeret: An average of 9 weeks after community point distribution
|
The percentage of sleeping spaces in the household that were covered by an ITN distributed during the community point distribution at the 7-11 week follow-up.
|
An average of 9 weeks after community point distribution
|
|
Household percentage of sleeping spaces covered
Időkeret: An average of 5.5 months after community point distribution
|
The percentage of sleeping spaces in the household that were covered by an ITN distributed during the community point distribution at the 5-6 month follow-up.
|
An average of 5.5 months after community point distribution
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2013. november 1.
Elsődleges befejezés (Tényleges)
2014. május 1.
A tanulmány befejezése (Tényleges)
2014. május 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2015. július 27.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2015. augusztus 4.
Első közzététel (Becslés)
2015. augusztus 7.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2015. augusztus 7.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2015. augusztus 4.
Utolsó ellenőrzés
2015. augusztus 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 003 (033)
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