- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02517879
Community Point Distribution of Insecticide Treated Bed Nets
tiistai 4. elokuuta 2015 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
560
Vaihe
- Ei sovellettavissa
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: 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.
|
Kokeellinen: 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.
|
Kokeellinen: 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.
|
Kokeellinen: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Community point distribution attendance
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Perjantai 1. marraskuuta 2013
Ensisijainen valmistuminen (Todellinen)
Torstai 1. toukokuuta 2014
Opintojen valmistuminen (Todellinen)
Torstai 1. toukokuuta 2014
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 27. heinäkuuta 2015
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 4. elokuuta 2015
Ensimmäinen Lähetetty (Arvio)
Perjantai 7. elokuuta 2015
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Perjantai 7. elokuuta 2015
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 4. elokuuta 2015
Viimeksi vahvistettu
Lauantai 1. elokuuta 2015
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 003 (NuSkin International)
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Yhdysvalloissa valmistettu ja sieltä viety tuote
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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