- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02517879
Community Point Distribution of Insecticide Treated Bed Nets
4 sierpnia 2015 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
560
Faza
- Nie dotyczy
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Eksperymentalny: 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.
|
|
Komparator placebo: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Community point distribution attendance
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 listopada 2013
Zakończenie podstawowe (Rzeczywisty)
1 maja 2014
Ukończenie studiów (Rzeczywisty)
1 maja 2014
Daty rejestracji na studia
Pierwszy przesłany
27 lipca 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
4 sierpnia 2015
Pierwszy wysłany (Oszacować)
7 sierpnia 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
7 sierpnia 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
4 sierpnia 2015
Ostatnia weryfikacja
1 sierpnia 2015
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 003 (033)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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